−Removed: ITEM 9A CONTROLS AND PROCEDURES
−Removed: Management’s
−Removed: Annual Report on Internal Control over Financial Reporting
−Removed: The Company’s
−Removed: management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, have evaluated the
−Removed: effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the
−Removed: Securities Exchange Act of 1934, as amended (the “
−Removed: Exchange Act ”)) as of March 31, 2020, based on the criteria
−Removed: set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control (“COSO”).
−Removed: on that evaluation, the Company’s Chief Executive Officer and the Company’s Chief Financial Officer have concluded
−Removed: that the Company’s disclosure controls and procedures were effective as of March 31, 2020 to ensure that information required
−Removed: to be disclosed by our Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and
−Removed: reported within the time periods specified in Securities and Exchange Commission rules and forms and such information is accumulated
−Removed: and communicated to management as appropriate to allow timely decisions regarding required disclosures.
−Removed: The Company’s
−Removed: internal control over financial reporting was designed to provide reasonable assurance regarding the preparation of financial statements
−Removed: for external purposes in accordance with generally accepted accounting principles.
−Removed: Please note, however,
−Removed: as a result of inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
−Removed: projections of any evaluation of effectiveness of current internal controls over financial reporting to future periods, are subject
−Removed: to the risk that such current controls may become inadequate due to changes in conditions, or that a future deterioration in the
−Removed: degree of compliance with current policies and procedures may occur.
−Removed: The Company’s
−Removed: management assessed the effectiveness of the Company’s internal control over financial reporting as of March 31, 2020, with
−Removed: such assessment being pursuant to the criteria set forth by COSO in Internal Control-Integrated Framework (2013) .
−Removed: on our assessment, we determined that, based on those criteria, as of March 31, 2020, the Company’s internal control over
−Removed: financial reporting is effective.
−Removed: Changes in internal
+Added: CONTROLS AND PROCEDURES
+Added: Evaluation of Disclosure Controls and
+Added: term “disclosure controls and procedures,”
+Added: as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, refers to controls
+Added: and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits
+Added: under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and
+Added: Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required
+Added: to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s
+Added: management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding
+Added: required disclosure.
+Added: As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our
+Added: Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the
+Added: end of the period covered by this Annual Report on Form 10-K.
+Added: Based on that evaluation, our Chief Executive Officer and our Chief Financial
+Added: Officer concluded that our disclosure controls and procedures were effective as of March 31, 2021 at the reasonable assurance level.
+Added: Management’s Report on Internal
Control Over Financial Reporting
−Removed: During Fiscal 2020,
−Removed: the Company has taken significant actions to remediate the material weaknesses as described in our Annual Report on Form 10-K filed
−Removed: with the SEC on June 21, 2019 (the “2019 10-K”).
−Removed: Additional personnel were hired and independent, third party subject
−Removed: matter experts were engaged to assist with the documentation and evaluation of the existing control environment, identification
−Removed: of gaps and weaknesses in controls, as well as advise on the formulation and implementation of improved controls, testing and remediation
−Removed: of weaknesses identified.
−Removed: Changes in controls
−Removed: concerning remediation of material weaknesses relating to segregation of duties:
−Removed: In connection with
−Removed: the current year assessment, management, with the assistance of engaged subject matter experts, implemented the following in order
−Removed: to remediate material weaknesses relating to segregation of duties as described in the 2019 10-K:
−Removed: Key accounting/finance personnel were hired;
−Removed: New position in supply chain operations was created and staffed;
−Removed: Increased utilization of software resources resulting in more effective segregation of duties;
−Removed: Independent, third party, financial reporting experts were engaged to support the financial reporting process, providing enhancements to review and reconciliation activities during the financial statement preparation and review process.
−Removed: Changes in controls
−Removed: concerning remediation of material weaknesses relating to the testing of controls
−Removed: In connection with
−Removed: the current year assessment, management, with the assistance of engaged subject matter experts, implemented the following in order
−Removed: to remediate material weaknesses relating to the testing of controls, as described in the 2019 10-K:
−Removed: Internal personnel, including newly hired accounting/finance and supply chain professionals were trained in the relevant controls, the testing activities and assumed the increased responsibility of performing tests, as appropriate;
−Removed: Independent, third party, internal control experts were engaged to support the Company’s testing activities as well as perform selected tests, as necessary;
−Removed: Changes in controls
−Removed: concerning remediation of material weaknesses relating to the formalizing and implementation of revised controls, policies and
−Removed: procedure documentation
−Removed: Key accounting/finance and supply chain personnel were hired to assist in the formalizing and implementation of revised controls;
−Removed: Certain personnel, key to the implementation of the control environment received additional “Open SAP”
−Removed: training to enhance in-house SAP knowledge, capabilities, resulting in enhanced controls being identified, formulated and implemented;
−Removed: Independent, third party, internal control experts were engaged to support the Company’s formalizing and implementation of revised controls, policies and procedure documentation
−Removed: ITEM 9B OTHER
−Removed: ITEM 10 DIRECTORS,
−Removed: EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
−Removed: The following sets
−Removed: forth biographical information about each of our directors and executive officers as of the date of this report:
+Added: control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive Officer and Chief
+Added: Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding
+Added: the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
+Added: accepted accounting principles, and includes those policies and procedures that:
+Added: (1) pertain to the maintenance of records that in reasonable
+Added: detail accurately and fairly reflect the transactions and dispositions of our assets;
+Added: (2) provide reasonable assurance that transactions
+Added: are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles,
+Added: and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors;
+Added: provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s
+Added: assets that could have a material effect on the financial statements.
+Added: control over financial reporting may not prevent or detect all errors and all fraud.
+Added: A control system, no matter how well conceived and
+Added: operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are achieved.
+Added: Further, the design
+Added: of a control system must be balanced against resource constraints, and therefore the benefits of controls must be considered relative
+Added: to their costs.
+Added: Given the inherent limitations in all systems of controls, no evaluation of controls can provide absolute assurance all
+Added: control issues and instances of fraud, if any, within a company have been detected.
+Added: These inherent limitations include the realities
+Added: that judgments in decision making can be faulty and that breakdowns can occur because of a simple error or mistake.
+Added: Additionally, controls
+Added: can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls.
+Added: The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there
+Added: can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions;
+Added: over time, controls
+Added: may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate.
+Added: given the inherent limitations in a cost-effective system of internal control, financial statement misstatements due to error or fraud
+Added: may occur and may not be detected.
+Added: Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance
+Added: of achieving their objectives.
+Added: We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies
+Added: and procedures.
+Added: is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rules
+Added: 13a-15(f) and 15d-15(f) under the Exchange Act.
+Added: Under the supervision and with the participation of our management, including our Chief
+Added: Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial
+Added: Management has used the framework set forth in the report entitled “Internal Control—Integrated Framework (2013)”
+Added: published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal control
+Added: over financial reporting.
+Added: Based on its evaluation, management has concluded that our internal control over financial reporting was effective
+Added: as of March 31, 2021 at the reasonable assurance level.
+Added: Changes in internal control
+Added: over financial reporting
+Added: There were no changes in
+Added: our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of
+Added: the Exchange Act during the fiscal quarter ended March 31, 2021 that materially affected, or are reasonably likely to materially affect,
+Added: our internal control over financial reporting.
+Added: OTHER INFORMATION
+Added: DIRECTORS, EXECUTIVE OFFICERS AND
+Added: CORPORATE GOVERNANCE
+Added: The following sets forth
+Added: biographical information about each of our directors and executive officers as of the date of this report:
Director/Officer
−Removed: President, Chief Executive Officer and
+Added: President, Chief Executive Officer and Director
Barry Dash, Ph.
Jeffrey Whitnell
−Removed: Chief Financial Officer, Secretary and
+Added: Chief Financial Officer, Secretary and Treasurer
Douglas Plassche
2 unchanged sentences
and employment of each Director during the past five years is set forth below.
−Removed: In each instance in which dates are not provided
−Removed: in connection with a director’s business experience, such nominee has held the position indicated for at least the past
−Removed: Each director currently
−Removed: holds office until the expiration of his Tier (each for three years) or until such director’s death, resignation, or removal.
−Removed: Pursuant to our recently amended and restated bylaws, our Board of Directors is now classified into three separate tiers of directors,
−Removed: with each respective tier to serve a three-year term and until their successors are duly elected and qualified.
−Removed: has served as a Director, President, and Chief Executive officer since August 2013.
−Removed: He has been a member of the Audit Committee,
−Removed: member and chairman of the nominating Committee and member of the Compensation Committee since September 2016.
−Removed: Hakim has more
−Removed: than 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical
−Removed: Services, and Regulatory Compliance.
−Removed: He brings with him proven management experience, in-depth knowledge of manufacturing systems,
−Removed: development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations.
+Added: In each instance in which dates are not provided in connection
+Added: with a director’s business experience, such nominee has held the position indicated for at least the past five years.
+Added: Each director currently holds
+Added: office until the expiration of his Tier (each for three years) or until such director’s death, resignation, or removal.
+Added: to our recently amended and restated bylaws, our Board of Directors is now classified into three separate tiers of directors, with each
+Added: respective tier to serve a three-year term and until their successors are duly elected and qualified.
+Added: Nasrat Hakim has served
+Added: as a Director, President, and Chief Executive officer since August 2013.
+Added: He has been a member of the Audit Committee, member and chairman
+Added: of the nominating Committee and member of the Compensation Committee since September 2016.
+Added: Hakim has more than 30 years of pharmaceutical
+Added: and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services, and Regulatory Compliance.
+Added: He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and
+Added: extended release formulations and extensive regulatory experience of GMP and FDA regulations.
From 2004 to 2013, Mr.
−Removed: Hakim was employed by Actavis, Watson and Alpharma in various senior management positions.
−Removed: Most recently,
−Removed: Hakim served as International Vice President of Quality Assurance at Actavis, overseeing 25 sites with more than 3,000 employees
−Removed: under his leadership.
−Removed: Hakim also served as Corporate Vice President of Technical Services, Quality and Regulatory Compliance
−Removed: for Actavis U.S., Global Vice President, Quality, and Regulatory Compliance for Alpharma, as well as Executive Director of Quality
−Removed: Unit at TheraTech, overseeing manufacturing and research and development.
−Removed: Hakim founded Mikah Pharma, LLC, a virtual,
−Removed: fully functional pharmaceutical company.
−Removed: Hakim holds a Bachelor in Chemistry/Bio-Chemistry and Masters of Science in Chemistry
−Removed: from California State University at Sacramento, Sacramento, CA;
−Removed: a Masters in Law with Graduate Certification in U.S.
−Removed: and International
−Removed: Taxation from St.
+Added: Hakim was employed
+Added: by Actavis, Watson and Alpharma in various senior management positions.
+Added: Most recently, Mr.
+Added: Hakim served as International Vice President
+Added: of Quality Assurance at Actavis, overseeing 25 sites with more than 3,000 employees under his leadership.
+Added: Hakim also served as Corporate
+Added: Vice President of Technical Services, Quality and Regulatory Compliance for Actavis U.S., Global Vice President, Quality, and Regulatory
+Added: Compliance for Alpharma, as well as Executive Director of Quality Unit at TheraTech, overseeing manufacturing and research and development.
+Added: Hakim founded Mikah Pharma, LLC, a virtual, fully functional pharmaceutical company.
+Added: Hakim holds a Bachelor in Chemistry/Bio-Chemistry
+Added: and Masters of Science in Chemistry from California State University at Sacramento, Sacramento, CA;
+Added: a Masters in Law with Graduate Certification
+Added: and International Taxation from St.
Thomas University, School of Law, Miami, FL.;
−Removed: and a Graduate Certification in Regulatory Affairs (RAC) from
−Removed: California State University at San Diego, San Diego, CA.
−Removed: Hakim’s leadership experience (consisting of extensive experience
−Removed: in senior management positions, responsible for 25 global manufacturing/regulatory sites with more than 3,000 employees under
−Removed: his leadership), industry experience (comprising more than 30 years of pharmaceutical and medical industry experience served in
−Removed: various quality assurance, analytical research and development/technical services and compliance positions) and academic experience
−Removed: (including Bachelor degrees in Chemistry and Bio-Chemistry, Masters degrees in Chemistry and Law, with Graduate Certification
−Removed: and International Taxation, and a Graduate Certification in Regulatory Affairs) led to the conclusion that he is qualified
−Removed: to serve as a director.
+Added: and a Graduate Certification in Regulatory
+Added: Affairs (RAC) from California State University at San Diego, San Diego, CA.
+Added: Hakim’s leadership experience (consisting of extensive
+Added: experience in senior management positions, responsible for 25 global manufacturing/regulatory sites with more than 3,000 employees under
+Added: his leadership), industry experience (comprising more than 30 years of pharmaceutical and medical industry experience served in various
+Added: quality assurance, analytical research and development/technical services and compliance positions) and academic experience (including
+Added: Bachelor degrees in Chemistry and Bio-Chemistry, Masters degrees in Chemistry and Law, with Graduate Certification in U.S.
+Added: and International
+Added: Taxation, and a Graduate Certification in Regulatory Affairs) led to the conclusion that he is qualified to serve as a director.
Barry Dash, Ph.D.
−Removed: has served as a Director since April 2005, member of the Audit Committee since April 2005, member of the Nominating Committee
−Removed: since April 2005 and member and Chairman of the Compensation Committee since June 2007.
−Removed: Dash has been, since 1995, President
−Removed: and Managing Member of Dash Associates, L.L.C., an independent consultant to the pharmaceutical and health industries.
−Removed: to 1996 he was employed by Whitehall-Robins Healthcare, a division of American Home Products Corporation (now known as Wyeth),
−Removed: initially as Vice President of Scientific Affairs, then as Senior Vice President of Scientific Affairs and then as Senior Vice
−Removed: President of Advanced Technologies, during which time he personally supervised six separate departments:
−Removed: Medical and Clinical
−Removed: Affairs, Regulatory Affairs, Technical Affairs, Research and Development, Analytical R&D and Quality Management/Q.C.
−Removed: had been employed by the Whitehall Robins Healthcare from 1960 to 1976, during which time he served as Director of Product Development
−Removed: Research, Assistant Vice President of Product Development and Vice President of Scientific Affairs.
−Removed: Dash had been employed
+Added: Barry Dash has
+Added: served as a Director since April 2005, member of the Audit Committee since April 2005, member of the Nominating Committee since April
+Added: 2005 and member and Chairman of the Compensation Committee since June 2007.
+Added: Dash has been, since 1995, President and Managing Member
+Added: of Dash Associates, L.L.C., an independent consultant to the pharmaceutical and health industries.
+Added: From 1983 to 1996 he was employed
+Added: by Whitehall-Robins Healthcare, a division of American Home Products Corporation (now known as Wyeth), initially as Vice President of
+Added: Scientific Affairs, then as Senior Vice President of Scientific Affairs and then as Senior Vice President of Advanced Technologies, during
+Added: which time he personally supervised six separate departments:
+Added: Medical and Clinical Affairs, Regulatory Affairs, Technical Affairs, Research
+Added: and Development, Analytical R&D and Quality Management/Q.C.
+Added: Dash had been employed by the Whitehall Robins Healthcare from 1960
+Added: to 1976, during which time he served as Director of Product Development Research, Assistant Vice President of Product Development and
+Added: Vice President of Scientific Affairs.
+Added: Dash had been employed by J.B.
Williams Company (Nabisco Brands, Inc.) from 1978 to 1982.
−Removed: From 1976 to 1978 he was Vice President and Director of Laboratories
−Removed: of the Consumer Products Division of American Can Company.
−Removed: Dash holds a Ph.D.
+Added: 1976 to 1978 he was Vice President and Director of Laboratories of the Consumer Products Division of American Can Company.
from the University of Florida and M.S.
−Removed: degrees from Columbia University where he was Assistant Professor at the College of Pharmaceutical Sciences from 1956 to
−Removed: He is a member of the American Pharmaceutical Association, the American Association for the Advancement of Science and the
−Removed: Society of Cosmetic Chemist, American Association of Pharmaceutical Scientists, Drug Information Association, American Foundation
−Removed: for Pharmaceutical Education, and Diplomate American Board of Forensic Examiners.
−Removed: He is the author of scientific publications
−Removed: and patents in the pharmaceutical field.
−Removed: Dash’s extensive education in pharmaceutical sciences and his experience in
−Removed: the development of scientific products, including his experience in regulatory affairs, led to the conclusion that he is qualified
+Added: degrees from Columbia University where he was Assistant Professor at the College
+Added: of Pharmaceutical Sciences from 1956 to 1960.
+Added: He is a member of the American Pharmaceutical Association, the American Association for
+Added: the Advancement of Science and the Society of Cosmetic Chemist, American Association of Pharmaceutical Scientists, Drug Information Association,
+Added: American Foundation for Pharmaceutical Education, and Diplomate American Board of Forensic Examiners.
+Added: He is the author of scientific
+Added: publications and patents in the pharmaceutical field.
+Added: Dash’s extensive education in pharmaceutical sciences and his experience
+Added: in the development of scientific products, including his experience in regulatory affairs, led to the conclusion that he is qualified
to serve as a director.
Jeffrey Whitnell
−Removed: Jeffrey Whitnell
−Removed: has served as a Director since October 23, 2009, Chairman of the Audit Committee, member of the Compensation Committee since
−Removed: October 2009 and designated by the Board as an “
+Added: Jeffrey Whitnell has
+Added: served as a Director since October 23, 2009, Chairman of the Audit Committee, member of the Compensation Committee since October 2009
+Added: and designated by the Board as an “
audit committee financial expert ”
−Removed: as defined under applicable
−Removed: rules under the Exchange Act.
+Added: as defined under applicable rules under the Exchange
Since April 2015, Mr.
−Removed: Whitnell has provided financial advisory services, primarily to the healthcare
−Removed: industry, including LifeWatch Services, where he served as the Vice President, Finance & Controller.
−Removed: From June2010 to March
−Removed: Whitnell was the Chief Financial Officer for ReliefBand Medical Technologies, a medical device company.
−Removed: From June 2009
−Removed: to June 2010, Mr.
−Removed: Whitnell provided financial advisory services to various healthcare companies, including ReliefBand Medical
−Removed: Technologies.
+Added: Whitnell has provided financial advisory services, primarily to the healthcare industry, including LifeWatch
+Added: Services, where he served as the Vice President, Finance & Controller.
+Added: From June2010 to March 2015, Mr.
+Added: Whitnell was the Chief Financial
+Added: Officer for ReliefBand Medical Technologies, a medical device company.
From June 2009 to June 2010, Mr.
−Removed: Whitnell was Chief Financial Officer and Senior Vice President of Finance at Akorn,
+Added: Whitnell provided financial advisory
+Added: services to various healthcare companies, including ReliefBand Medical Technologies.
From June 2004 to June 2009, Mr.
−Removed: Whitnell was Vice President of Finance and Treasurer for Ovation Pharmaceuticals.
−Removed: Whitnell was Vice President of Finance and Treasurer for MediChem Research.
+Added: Whitnell was Chief
+Added: Financial Officer and Senior Vice President of Finance at Akorn, Inc.
+Added: From June 2002 to June 2004, Mr.
+Added: Whitnell was Vice President of
+Added: Finance and Treasurer for Ovation Pharmaceuticals.
+Added: From 1997 to 2001, Mr.
+Added: Whitnell was Vice President of Finance and Treasurer for MediChem
Prior to 1997, Mr.
−Removed: Whitnell held various
−Removed: finance positions at Akzo Nobel and Motorola.
−Removed: Whitnell began his career as an auditor with Arthur Andersen & Co.
−Removed: a certified public accountant and holds an M.B.A.
−Removed: in Finance from the University of Chicago Booth School of Business and a B.S.
+Added: Whitnell held various finance positions at Akzo Nobel and Motorola.
+Added: Whitnell began his career as an
+Added: auditor with Arthur Andersen & Co.
+Added: He is a certified public accountant and holds an M.B.A.
+Added: in Finance from the University of Chicago
+Added: Booth School of Business and a B.S.
in Accounting from the University of Illinois.
−Removed: Whitnell’s qualifications as an accounting and audit expert provide specific
−Removed: experience to serve as a director for the Company.
−Removed: has served as a Director since April 2016, and a member of the Audit Committee, the nominating Committee and the Compensation Committee
−Removed: since September 2016.
+Added: Whitnell’s qualifications as an accounting
+Added: and audit expert provide specific experience to serve as a director for the Company.
+Added: Davis Caskey has served
+Added: as a Director since April 2016, and a member of the Audit Committee, the nominating Committee and the Compensation Committee since September
He brings more than 40 years of pharmaceutical industry experience to this position.
−Removed: Caskey is currently
−Removed: President & CEO of Caskey LLC, which he formed in 2013 to serve as an umbrella to manage his pharmaceutical consulting and
−Removed: other business interests.
−Removed: From 1990 to 2013, Davis served as the operating officer of ECR Pharmaceuticals, of which he was a founding
−Removed: HiTech Pharmacal acquired the privately held ECR in 2009 and Mr.
+Added: Caskey is currently President & CEO
+Added: of Caskey LLC, which he formed in 2013 to serve as an umbrella to manage his pharmaceutical consulting and other business interests.
+Added: From 1990 to 2013, Davis served as the operating officer of ECR Pharmaceuticals, of which he was a founding member.
+Added: HiTech Pharmacal
+Added: acquired the privately held ECR in 2009 and Mr.
Caskey continued in his role until retiring in 2013.
−Removed: Caskey was credited with the establishment of the company's sales and marketing structure, its product distribution format,
−Removed: and the development and management of the firm’s internal organization.
−Removed: His responsibilities included the oversight of drug
−Removed: development and regulatory filings, product acquisitions, and acquisition of other companies.
−Removed: A primary focus was to conceive and
−Removed: develop, with the assistance of key strategic partners, unique dosage forms and extended release formulations of products which
−Removed: enhance patient compliance and safety.
+Added: Caskey was credited
+Added: with the establishment of the company’s sales and marketing structure, its product distribution format, and the development and management
+Added: of the firm’s internal organization.
+Added: His responsibilities included the oversight of drug development and regulatory filings, product
+Added: acquisitions, and acquisition of other companies.
+Added: A primary focus was to conceive and develop, with the assistance of key strategic partners,
+Added: unique dosage forms and extended release formulations of products which enhance patient compliance and safety.
Prior to ECR, Mr.
−Removed: Caskey was employed by A.H.
−Removed: Robins for 18 years in various field and home
−Removed: office management positions.
−Removed: His experience brings critical insight into the marketing and distribution of pharmaceutical products
−Removed: in a rapid and ever-changing competitive marketplace.
−Removed: Caskey attended the University of Texas (Austin) and Lamar University,
−Removed: and holds bachelor’s and master’s degrees.
−Removed: has served as Chief Financial Officer, Secretary, and Treasurer of the Company since July 1, 2009.
−Removed: Prior to joining the Company,
−Removed: from July 2005 to April 2009, Mr.
−Removed: Ward filled multiple finance and supply chain leadership roles with the Actavis Group and its
−Removed: subsidiary, Amide Pharmaceuticals.
−Removed: From September 2004 to June 2005, Mr.
−Removed: Ward was a consultant, mainly engaged in improving
−Removed: internal controls and supporting Sarbanes Oxley compliance of Centennial Communications Inc., a NASDAQ listed wireless communications
−Removed: From 1999 to September 2004, Mr.
−Removed: Ward was the Chief Financial Officer for Positive Healthcare/Ceejay Healthcare, a U.S.-Indian
−Removed: joint venture engaged in the manufacture and distribution of generic pharmaceuticals and nutraceuticals in India.
−Removed: his career as a certified public accountant in the audit department of KPMG and is a Certified Supply Chain Professional (“CSCP”).
−Removed: Ward holds a B.S.
−Removed: in Accounting from Long Island University, Brooklyn, NY, from where he graduated summa cum laude.
−Removed: experience and expertise in the area of finance and supply chain, provides the qualifications, attributes, and skills to serve
−Removed: as an officer for the Company.
+Added: was employed by A.H.
+Added: Robins for 18 years in various field and home office management positions.
+Added: His experience brings critical insight
+Added: into the marketing and distribution of pharmaceutical products in a rapid and ever-changing competitive marketplace.
+Added: Caskey attended
+Added: the University of Texas (Austin) and Lamar University, and holds bachelor’s and master’s degrees.
+Added: Marc Bregman has served
+Added: as Chief Financial Officer, Secretary and Treasurer of the Company since May 17, 2021.
+Added: Prior to joining the Company, from February 2015
+Added: to May 2021, Mr.
+Added: Bregman served as Controller of Langan Engineering.
+Added: From 2013 to 2015, Mr.
+Added: Bregman served as financial controller at
+Added: Chemtrade Logistics.
+Added: From 2009 to 2013, Mr.
+Added: Bregman held corporate finance positions at Chemetall.
+Added: From 1999 to 2009, Mr.
+Added: multiple corporate finance positions at National Starch and Chemical Company.
+Added: Bregman began his career as a certified public accountant
+Added: in the audit department of Ernst & Young, LLP.
+Added: Bregman is a Certified Public Accountant (“CPA”), and holds a Master
+Added: in Business degree from the New Jersey Institute of Technology, Newark, NJ and Bachelor of Science in Accounting from William Paterson
+Added: College, Wayne, NJ.
+Added: Bregman’s experience and expertise in the areas of finance, financial planning & analysis, Sarbanes
+Added: Oxley compliance, financial auditing and manufacturing accounting, provides the qualifications, attributes, and skills to serve as an
+Added: officer for the Company.
Douglas Plassche
2 unchanged sentences
Prior to joining the Company, from 2009 to 2013, Mr.
−Removed: served as the Managing Director of the New Jersey Solid Oral Dose Operations of Actavis, overseeing 450 employees and the production
−Removed: of more than 100 products.
+Added: Plassche served
+Added: as the Managing Director of the New Jersey Solid Oral Dose Operations of Actavis, overseeing 450 employees and the production of more
+Added: than 100 products.
From 2007 to 2009, Mr.
−Removed: Plassche was the Senior Director of Manufacturing for PAR Pharmaceuticals, overseeing
−Removed: 200 employees and the production of more than 70 products.
+Added: Plassche was the Senior Director of Manufacturing for PAR Pharmaceuticals, overseeing 200 employees
+Added: and the production of more than 70 products.
From 1990 –
−Removed: Plassche was employed by Schering-Plough,
−Removed: progressing steadily through multiple disciplines, locations, and technical operations sectors with increasing levels of responsibility.
−Removed: Plassche has a bachelor’s degree in Economics from Rochester University.
−Removed: There are no family
−Removed: relationships between any of our directors and executive officers.
+Added: Plassche was employed by Schering-Plough, progressing steadily
+Added: through multiple disciplines, locations, and technical operations sectors with increasing levels of responsibility.
+Added: a bachelor’s degree in Economics from Rochester University.
+Added: There are no family relationships
+Added: between any of our directors and executive officers.
Committees of the Board
−Removed: The Board of Directors
−Removed: has an Audit Committee, a Compensation Committee, and a Nominating Committee.
+Added: The Board of Directors has
+Added: an Audit Committee, a Compensation Committee, and a Nominating Committee.
Audit Committee
−Removed: During Fiscal 2020,
−Removed: the members of the Audit Committee were Jeffrey Whitnell (Chairman of the Audit Committee), Dr.
−Removed: Barry Dash, Davis Caskey and Nasrat
−Removed: We deem Messrs.
+Added: During Fiscal 2021, the members
+Added: of the Audit Committee were Jeffrey Whitnell (Chairman of the Audit Committee), Dr.
+Added: Barry Dash, Davis Caskey and Nasrat Hakim.
Whitnell, Dash, and Caskey to be independent and Mr.
−Removed: Whitnell to be qualified as an audit committee financial
−Removed: The Board of Directors has determined that Messrs.
−Removed: Whitnell, Dash and Caskey are independent directors as (i) defined
−Removed: in Rule 10A-3(b)(1)(ii) under the Exchange Act and (ii) under Sections 803A(2) and 803B(2)(a) of the NYSE American LLC Company
−Removed: Guide (although our securities are not listed on the NYSE American LLC or any other national exchange).
+Added: Whitnell to be qualified as an audit committee financial expert.
+Added: of Directors has determined that Messrs.
+Added: Whitnell, Dash and Caskey are independent directors as (i) defined in Rule 10A-3(b)(1)(ii) under
+Added: the Exchange Act and (ii) under Sections 803A(2) and 803B(2)(a) of the NYSE American LLC Company Guide (although our securities are not
+Added: listed on the NYSE American LLC or any other national exchange).
Nominating Committee
−Removed: During Fiscal 2020,
−Removed: the members of the Nominating Committee were Nasrat Hakim (Chairman of the Nominating Committee), Dr.
+Added: During Fiscal 2021, the members
+Added: of the Nominating Committee were Nasrat Hakim (Chairman of the Nominating Committee), Dr.
Barry Dash, and Davis Caskey.
−Removed: There were no material changes to the procedures by which security holders may recommend nominees to our Board of Directors since
−Removed: the filing of our last Annual Report on Form 10-K.
+Added: There were no
+Added: material changes to the procedures by which security holders may recommend nominees to our Board of Directors since the filing of our
+Added: last Annual Report on Form 10-K.
Compensation Committee
−Removed: During Fiscal 2020,
−Removed: the members of the Compensation Committee were Dr.
−Removed: Barry Dash (Chairman of the Compensation Committee), Jeffrey Whitnell, Davis
−Removed: Caskey and Nasrat Hakim.
+Added: During Fiscal 2021, the members
+Added: of the Compensation Committee were Dr.
+Added: Barry Dash (Chairman of the Compensation Committee), Jeffrey Whitnell, Davis Caskey and Nasrat
Code of Conduct and Ethics
−Removed: At the first meeting
−Removed: of the Board of Directors following the annual meeting of stockholders held on June 22, 2004, and as further updated effective
−Removed: July 2009, the Board of Directors adopted a Code of Business Conduct and Ethics that is applicable to the Company’s directors,
−Removed: officers, and employees.
−Removed: A copy of the Code of Business Conduct and Ethics is available on our website at www.elitepharma.com ,
−Removed: under Investor Relations.
+Added: At the first meeting of the
+Added: Board of Directors following the annual meeting of stockholders held on June 22, 2004, and as further updated effective July 2009, the
+Added: Board of Directors adopted a Code of Business Conduct and Ethics that is applicable to the Company’s directors, officers, and employees.
+Added: A copy of the Code of Business Conduct and Ethics is available on our website at www.elitepharma.com, under Investor Relations.
+Added: Delinquent Section 16(a) Reports
+Added: Section 16(a) of the Exchange
+Added: Act requires our directors and executive officers and persons who beneficially own more than ten percent of our common stock to report
+Added: their ownership of, and transactions in, our stock in filings with the SEC.
+Added: Copies of these reports are also required to be supplied
+Added: VPG believes, based solely on a review of the copies of such reports received, that our directors and executive officers and
+Added: persons who beneficially own more than ten percent of our common stock complied with all applicable Section 16(a) reporting requirements
+Added: during the year ended March 31, 2021, except that Mr.
+Added: Plassche filed one late Form 4 reporting the award of salary shares.
ITEM 11 EXECUTIVE COMPENSATION
−Removed: Compensation discussion and analysis
−Removed: Our approach to executive
−Removed: compensation, one of the most important and complex aspects of corporate governance, is influenced by our belief in rewarding
−Removed: people for consistently strong execution and performance.
−Removed: We believe that the ability to attract and retain qualified executive
−Removed: officers and other key employees is essential to our long-term success.
−Removed: Compensation Linked to Attainment of
−Removed: Performance Goals
−Removed: Our plan to obtain
−Removed: and retain highly skilled employees is to provide significant incentive compensation opportunities and market competitive salaries.
−Removed: The plan was intended to link individual employee objectives with overall company strategies and results, and to reward executive
−Removed: officers and significant employees for their individual contributions to those strategies and results.
−Removed: Furthermore, we believe
−Removed: that equity awards serve to align the interests of our executives with those of our stockholders.
−Removed: As such, equity is a key component
−Removed: of our compensation program.
Role of the Compensation Committee
−Removed: The Company formed
−Removed: the Compensation Committee in June 2007.
+Added: The Company formed the Compensation
+Added: Committee in June 2007.
Since the formation of the Compensation Committee all elements of the executives’
−Removed: compensation are determined by the Compensation Committee, which currently is comprised of three independent non-employee directors,
−Removed: and one director who is also the Company’s Chief Scientific Officer.
−Removed: However, the Compensation Committee’s decisions
−Removed: concerning the compensation of the Company’s Chief Executive Officer are subject to ratification by the independent directors
−Removed: of the Board of Directors.
−Removed: The members of the Compensation Committee are Dr.
−Removed: Barry Dash (Chairman
−Removed: of the Compensation Committee), Jeffrey Whitnell, Davis Caskey and Nasrat Hakim.
+Added: compensation are determined
+Added: by the Compensation Committee, which currently is comprised of three independent non-employee directors, and one director who is also
+Added: the Company’s Chief Scientific Officer.
+Added: However, the Compensation Committee’s decisions concerning the compensation of the
+Added: Company’s Chief Executive Officer are subject to ratification by the independent directors of the Board of Directors.
+Added: of the Compensation Committee are Dr.
+Added: Barry Dash (Chairman of the Compensation Committee), Jeffrey Whitnell, Davis Caskey and Nasrat Hakim.
The Committee operates pursuant to a charter.
−Removed: Under the Compensation
−Removed: Committee charter, the Compensation Committee has authority to retain compensation consultants, outside counsel, and other advisors
−Removed: that the committee deems appropriate, in its sole discretion, to assist it in discharging its duties, and to approve the terms
−Removed: of retention and fees to be paid to such consultants.
−Removed: The Compensation Committee did not engage any advisors.
+Added: Under the Compensation Committee charter, the Compensation Committee has authority to retain
+Added: compensation consultants, outside counsel, and other advisors that the committee deems appropriate, in its sole discretion, to assist
+Added: it in discharging its duties, and to approve the terms of retention and fees to be paid to such consultants.
+Added: During the fiscal year ended
+Added: March 31, 2021, the Compensation Committee did not engage any advisors.
Named Executive Officers
−Removed: The named executive
−Removed: officers for the fiscal year ended March 31, 2020 were:
−Removed: Nasrat Hakim, Chief Executive Officer, and President for the
−Removed: Ward, Chief Financial Officer, Secretary, and Treasurer
−Removed: for the full year;
+Added: The named executive officers
+Added: for the fiscal year ended March 31, 2021 were:
+Added: Nasrat Hakim, Chief Executive Officer, and President for the full year;
+Added: Ward, Chief Financial Officer, Secretary, and Treasurer for
+Added: the full year;
Douglas Plassche, Executive Vice President for the full year.
−Removed: These individuals
−Removed: are referred to collectively as the “
+Added: These individuals are referred
+Added: to collectively as the “
Named Executive Officers ”.
−Removed: We also had one key
−Removed: employee during the fiscal year ended March 31, 2020 - George Kenneth Smith.
Our executive compensation program
−Removed: The primary elements
−Removed: of our executive compensation program are base salary, incentive cash and stock bonus opportunities and equity incentives typically
−Removed: in the form of stock option grants or payment of a portion of annual salary as stock.
−Removed: Although we provide other types of compensation,
−Removed: these three elements are the principal means by which we provide the Named Executive Officers with compensation opportunities.
−Removed: The annual bonus opportunity
−Removed: and equity compensation components of the executive compensation program reflect our belief that a portion of an executive’s
−Removed: compensation should be performance-based.
−Removed: This compensation is performance-based because payment is tied to the achievement of
−Removed: corporate performance goals.
−Removed: To the extent that performance goals are not achieved, executives will receive a lesser amount of
−Removed: total compensation.
−Removed: Elements of our executive compensation
−Removed: We pay a base salary
−Removed: to certain of the Named Executive Officers, with such payments being made in either cash, Common Stock or a combination of cash
−Removed: and Common Stock.
−Removed: In general, base salaries for the Named Executive Officers are determined by evaluating the responsibilities
−Removed: of the executive’s position, the executive’s experience, and the competitive marketplace.
−Removed: Base salary adjustments
−Removed: are considered and take into account changes in the executive’s responsibilities, the executive’s performance, and
−Removed: changes in the competitive marketplace.
−Removed: We believe that the base salaries of the Named Executive Officers are appropriate within
−Removed: the context of the compensation elements provided to the executives and because they are at a level which remains competitive
−Removed: in the marketplace.
−Removed: The Board of Directors
−Removed: may authorize us to give discretionary bonuses, payable in cash or shares of Common Stock, to the Named Executive Officers and
−Removed: other key employees.
−Removed: Such bonuses are designed to motivate the Named Executive Officers and other employees to achieve specified
−Removed: corporate, business unit and/or individual, strategic, operational, and other performance objectives.
−Removed: Stock Options
−Removed: Stock options constitute
−Removed: performance-based compensation because they have value to the recipient only if the price of our Common Stock increases.
−Removed: options for each of the Named Executive Officers generally vest over time, obtainment of a corporate goal or a combination of
−Removed: The grant of stock
−Removed: options at Elite is designed to motivate our Named Executive Officers to achieve our short-term and long-term corporate goals.
−Removed: Retirement and Deferred Compensation
−Removed: We do not presently
−Removed: provide the Named Executive Officers with a defined benefit pension plan or any supplemental executive retirement plans, nor do
−Removed: we provide the Named Executive Officers with retiree health benefits.
−Removed: We have adopted a deferred compensation plan under Section
−Removed: 401(k) of the Code.
−Removed: The plan provides for employees to defer compensation on a pre-tax basis subject to certain limits, however,
−Removed: Elite does not provide a matching contribution to its participants.
−Removed: The retirement and
−Removed: deferred compensation benefits provided to the Named Executive Officers are not material factors considered in making other compensation
−Removed: determinations with respect to Named Executive Officers.
−Removed: Post-Termination/Change of Control
−Removed: Pursuant to his employment
−Removed: agreement, Nasrat Hakim, our Chief Executive Officer, is entitled to a payment in an amount equal to two year’s base annual
−Removed: salary in effect upon the date of termination, less applicable deductions, and withholdings, payable in Common Stock upon a Change
−Removed: of Control (as defined in the Hakim Employment Agreement).
−Removed: For more detailed information, please see “
−Removed: Agreements with
−Removed: Named Executive Officers ”
−Removed: We do not presently
−Removed: provide the Named Executive Officers with any plan or arrangement, other than those that may be contained in employment contracts,
−Removed: in connection with any termination, including, without limitation, through retirement, resignation, severance, or constructive
−Removed: termination (including a change in responsibilities) of such Named Executive Officer’s employment with the Company.
−Removed: As part of the Company’s
−Removed: efforts to ensure the retention and continuity of key employees, officers, and directors in the event of a change of control of
−Removed: the ownership of the Company, unless otherwise stated in applicable employment contracts, key executives would receive an amount
−Removed: equal to twelve months of such executive’s salary, and certain Directors and managers would receive an amount equal to six
−Removed: months of such Director’s or manager’s fees or salaries, as applicable.
−Removed: In addition, any outstanding and unvested
−Removed: options would immediately vest, in the event of a change of control.
−Removed: As described in more
−Removed: detail below, the perquisites provided to certain of the Named Executive Officers consist of car allowances and life insurance
−Removed: These perquisites represent a small fraction of the total compensation of each such Named Executive Officer.
−Removed: of the perquisites we provide are taxable to the Named Executive Officers and the incremental cost to us of providing these perquisites
−Removed: is reflected in the Summary Compensation Table.
−Removed: The Board of Directors believes that the perquisites provided are reasonable and
−Removed: For more information on perquisites provided to the Named Executive Officers, please see the “
−Removed: Compensation ”
−Removed: column of the Summary Compensation Table and “
+Added: Our approach to executive
+Added: compensation, one of the most important and complex aspects of corporate governance, is influenced by our belief in rewarding people for
+Added: consistently strong execution and performance.
+Added: We believe that the ability to attract and retain qualified executive officers and other
+Added: key employees is essential to our long-term success.
+Added: Our plan to obtain and retain highly skilled employees is to provide significant
+Added: incentive compensation opportunities and market competitive salaries.
+Added: We strive to link individual employee objectives with overall company
+Added: strategies and results, and to reward executive officers and significant employees for their individual contributions to those strategies
+Added: Furthermore, we believe that equity ownership serves to align the interests of our executives with those of our stockholders.
+Added: As such, equity is a key component of our compensation program.
+Added: The primary elements of our
+Added: executive compensation program are base salary, incentive cash and stock bonus opportunities and equity incentives typically in the form
+Added: of stock option grants or stock awards.
+Added: Although we provide other types of compensation, these three elements are the principal means
+Added: by which we provide the Named Executive Officers with compensation opportunities.
+Added: Elements of our executive compensation program
+Added: We pay a base salary to certain
+Added: of the Named Executive Officers, with such payments being made in either cash, Common Stock or a combination of cash and Common Stock.
+Added: In general, base salaries for the Named Executive Officers are determined by evaluating the responsibilities of the executive’s
+Added: position, the executive’s experience, and the competitive marketplace.
+Added: Base salary adjustments are considered and take into account
+Added: changes in the executive’s responsibilities, the executive’s performance, and changes in the competitive marketplace.
+Added: believe that the base salaries of the Named Executive Officers are appropriate within the context of the compensation elements provided
+Added: to the executives and because they are at a level which remains competitive in the marketplace.
+Added: In the section below entitled
+Added: Agreements with Named Executive Officers ”, we describe the breakdown between compensation paid in cash and in equity
+Added: for each Named Executive Officer during the fiscal year ended March 31, 2021.
+Added: Named Executive Officers may
+Added: earn discretionary bonuses, which are awarded by the Compensation Committee in its discretion after the end of a fiscal year based on
+Added: its assessment of factors including Company and individual performance.
+Added: Pursuant to his employment agreement, Mr.
+Added: Hakim was eligible to
+Added: earn a discretionary bonus for the fiscal year ended March 31, 2021 up to 100% of his base salary ($500,000 for fiscal 2021), which he
+Added: earned in full.
+Added: In addition, as described in the section below entitled “Agreements with Named Executive Officers,”
+Added: was guaranteed a $75,000 annual bonus for the fiscal year ended March 31, 2021.
+Added: Ward was awarded a $25,000 discretionary bonus for
+Added: his service during fiscal 2021.
+Added: As noted above, certain components of our Named Executive
+Added: Officers’
+Added: fiscal year 2021 base salary and bonuses were payable in shares of Common Stock.
+Added: In addition, Messrs.
+Added: Plassche are each entitled to an annual grant of restricted shares of Common Stock, as described in the section entitled
Agreements with Named Executive Officers ”
−Removed: Agreements with Named Executive
+Added: During the fiscal year ended 2021, this amount was $25,000
+Added: worth of fully vested restricted shares for Mr.
+Added: Ward and $30,000 worth of fully vested restricted shares for Mr.
+Added: From time to time, we also
+Added: grant stock options to our Named Executive Officers which generally vest over time, obtainment of a corporate goal or a combination of
+Added: We did not grant any stock options to our named executive officers in fiscal year 2021.
+Added: Retirement Benefits
+Added: We maintain a tax-qualified
+Added: retirement plan under Section 401(k) of the Code.
+Added: The plan allows employees to defer compensation on a pre-tax basis subject to certain
+Added: however, Elite does not provide a matching contribution to its participants.
+Added: Hakim receives a monthly
+Added: car allowance of up to $1,500 pursuant to the terms of his employment agreement.
+Added: Plassche receives a monthly car allowance of up to
+Added: Hakim is also entitled to a monthly housing allowance up to $5,000.
+Added: These perquisites represent a small fraction of the total
+Added: compensation of each such Named Executive Officer.
+Added: The value of the perquisites we provide are taxable to the Named Executive Officers
+Added: and the incremental cost to us of providing these perquisites is reflected in the Summary Compensation Table.
+Added: The Board of Directors believes
+Added: that the perquisites provided are reasonable and appropriate.
+Added: The Company generally covers life insurance premiums for its employee population,
+Added: including its Named Executive Officers.
+Added: For more information on perquisites provided to the Named Executive Officers, please see the “
+Added: Other Compensation ”
+Added: column of the Summary Compensation Table.
+Added: Agreements with Named Executive Officers
Pursuant to his August 2013
−Removed: 2013 employment agreement, and as amended on January 12, 2016 (the “
+Added: employment agreement, as amended on January 12, 2016 (the “
Hakim Employment Agreement ”), Mr.
−Removed: receives an annual salary of $500,000 per year.
−Removed: The Salary is paid in shares of the Company’s Common Stock pursuant to the
−Removed: Company’s current procedures for paying Company executives in Stock.
−Removed: He also is entitled to an annual bonus equal to up
−Removed: to 100% of his annual salary, payable in accordance with the Company’s payroll practices.
−Removed: The Board may also award discretionary
−Removed: bonuses in its sole discretion.
−Removed: Hakim is entitled to employee benefits (e.g., health, vacation, employee benefit plans and
−Removed: programs) consistent with other Company employees of his seniority and a car allowance.
−Removed: The Hakim Employment Agreement contains
−Removed: confidentially, non-competition and other standard restrictive covenants.
−Removed: Hakim’s
−Removed: employment is terminable by the Company for cause (as defined in the Hakim Employment Agreement).
−Removed: The Hakim Employment Agreement
−Removed: also may be terminated by the Company upon at least 30 days written notice due to disability (as defined in the Hakim Employment
−Removed: Agreement) or without cause.
−Removed: Hakim can terminate the Hakim Employment Agreement by resigning, provided he gives notice at
−Removed: least 60 days prior to the effective resignation date.
−Removed: Hakim is terminated for cause or he resigns, he only is entitled
−Removed: to accrued and unpaid annual salary, accrued vacation time and any reasonable and necessary business expenses, all through the
−Removed: date of termination and payable in stock (“Basic Termination Benefits”).
−Removed: Hakim is terminated because of disability
−Removed: or death, in addition to Basic Termination Benefits, He is entitled his pro rata annual bonus through the date of termination
−Removed: (payable in Stock).
+Added: Hakim receives an annual
+Added: salary of $500,000 per year.
+Added: The Salary is paid in shares of the Company’s Common Stock pursuant to the Company’s current
+Added: procedures for paying Company executives in Stock.
+Added: He also is entitled to an annual performance bonus equal to up to 100% of his annual
+Added: salary, payable in shares of Common Stock as well.
+Added: The Board may also award discretionary bonuses in its sole discretion.
+Added: entitled to employee benefits (e.g., health, vacation, employee benefit plans and programs) consistent with other Company employees of
+Added: his seniority and a car allowance of up to $1,500 per month.
+Added: The Hakim Employment Agreement contains restrictive covenants including a
+Added: confidentiality provision and a one year post-termination non-solicit provision.
+Added: Hakim’s employment
+Added: is terminable by the Company for cause (as defined below).
+Added: The Hakim Employment Agreement also may be terminated by the Company upon at
+Added: least 30 days written notice due to disability (as defined below) or without cause.
+Added: Hakim can terminate the Hakim Employment Agreement
+Added: by resigning, provided he gives notice at least 60 days prior to the effective resignation date.
+Added: Hakim is terminated
+Added: for cause or he resigns, he only is entitled to accrued and unpaid annual salary, accrued vacation time and any reasonable and necessary
+Added: business expenses, all through the date of termination and payable in stock (“Basic Termination Benefits”).
+Added: terminated because of disability or death, in addition to Basic Termination Benefits, he is entitled to a pro rata annual bonus through
+Added: the date of termination (payable in Stock), payable in a lump sum.
+Added: In addition, in the event of the termination of Mr.
+Added: Hakim’s employment
+Added: due to his disability, he will be entitled to a lump sum payment within 60 days of the termination date equal to one year of his base
+Added: salary (payable in Stock), subject to his execution of a release.
If the Company terminates Mr.
−Removed: Hakim without cause, in addition to Basic Termination Benefits, Mr.
−Removed: entitled to his pro rata annual bonus through the date of termination and an amount equal to two years’
−Removed: annual salary (all
−Removed: payable in Stock).
−Removed: Upon a Change of Control
−Removed: (as defined in the Hakim Employment Agreement), Mr.
−Removed: Hakim is entitled to a payment in an amount equal to two year’s base
−Removed: annual salary in effect upon the Date of Termination, less applicable deductions, and withholdings, payable in Stock computed
−Removed: in the same manner as set forth as the Salary.
−Removed: On November 12, 2009,
−Removed: the Company entered into an employment agreement with Mr.
+Added: Hakim without cause, in addition to Basic
+Added: Termination Benefits, Mr.
+Added: Hakim is entitled to his pro rata annual bonus through the date of termination and an amount equal to two years’
+Added: annual salary (all payable in Stock in a lump sum within 60 days of the termination date), and 12 months of continued health insurance
+Added: continuation under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”), at active employee rates,
+Added: subject to his execution of a release and his continued compliance with applicable restrictive covenants.
+Added: Upon a termination of employment
+Added: in connection with a Change of Control (as defined below), in addition to Basic Termination Benefits, Mr.
+Added: Hakim is entitled to a pro rata
+Added: annual bonus and payment in an amount equal to two year’s base annual salary in effect upon the Date of Termination, less applicable
+Added: deductions, and withholdings, payable in Stock in a lump sum within 60 days, and two years of health care continuation benefits.
+Added: all outstanding unvested equity held by Mr.
+Added: Hakim will then vest.
+Added: Under the Hakim Employment
+Added: “Cause”
+Added: Hakim’s failure or refusal to perform the services required under the agreement, (2) the material breach by Mr.
+Added: any of the terms of the agreement, or (3) Mr.
+Added: Hakim’s conviction of a crime that results in imprisonment or involves embezzlement,
+Added: dishonest or activities injurious to the Company or its reputation.
+Added: “Change of Control”
+Added: means generally (1) an acquisition or merger resulting in the holders of the Company’s voting stock immediately prior to the transaction
+Added: holding less than fifty (50%) percent of the combined voting power after the transaction;
+Added: (2) the sale of all or substantially all of
+Added: the assets or capital stock of the Company;
+Added: or (3) the securities of the Company representing greater than fifty (50%) percent of the
+Added: combined voting power of the Company’s then outstanding voting securities are acquired in a single transaction or series of related
+Added: transactions.
+Added: “Disability”
+Added: Hakim is prevented by illness, accident or other disability (mental or physical) from performing the essential functions of his
+Added: position for one or more periods cumulatively totaling 3 months during any consecutive 12 month period.
+Added: On November 12, 2009, the
+Added: Company entered into an employment agreement with Mr.
Ward (the “
−Removed: Ward Employment Agreement ”).
+Added: Ward Employment Agreement ”) which superseded
+Added: his prior agreement with the Company.
Pursuant to the terms of the Ward Employment Agreement, Mr.
−Removed: Ward continues as an at-will employee of the Company as its Chief
−Removed: Financial Officer.
−Removed: Ward receives a base salary of $150,000, with $125,000 of such amount being paid in accordance with the
−Removed: Company’s payroll practices and $25,000 of such amount being paid by the issuance of restricted shares of Common Stock,
−Removed: in lieu of cash.
−Removed: The Common Stock component of Mr.
−Removed: Ward’s compensation is to be computed on a quarterly basis, with the
−Removed: number of shares issued equal to the quotient of the quarterly amount due of $6,250 divided by the average daily closing price
−Removed: of the Company’s Common Stock for the quarter just ended.
−Removed: On February 2, 2013,
−Removed: the Board of Directors increased Mr.
−Removed: Ward’s base salary to $155,000 retroactive to January 1, 2013.
−Removed: This $5,000 increase
−Removed: to be paid by the issuance of restricted shares of Common Stock.
+Added: Ward continues as an at-will employee
+Added: of the Company as its Chief Financial Officer.
+Added: Under the Ward Employment Agreement, Mr.
+Added: Ward was entitled to an initial base salary of
+Added: $125,000 in accordance with the Company’s payroll practices and an additional $25,000 per annum paid by the issuance of restricted
+Added: shares of Common Stock.
The Common Stock component of Mr.
−Removed: Ward’s compensation is
−Removed: to be computed on a quarterly basis, with the number of shares issued equal to the quotient of the quarterly amount due of $7,500
−Removed: divided by the average daily closing price of the Company’s Common Stock for the quarter just ended.
−Removed: On March 1, 2015,
−Removed: Ward’s compensation was adjusted to include a total compensation of $187,200, consisting of $157,200 being paid in accordance
−Removed: with the Company’s payroll practices and $30,000 being paid by the issuance of restricted shares of Common Stock in lieu
−Removed: On March 1, 2016,
−Removed: Ward’s compensation was adjusted to include a total compensation of $192,816, consisting of $162,816 being paid in accordance
−Removed: with the Company’s payroll practices and $30,000 being paid by the issuance of restricted shares of Common Stock in lieu
−Removed: On April 1, 2020,
−Removed: Ward’s compensation was adjusted to include a total compensation of $200,529, consisting of $170,529 being paid in accordance
−Removed: with the Company’s payroll practices and $30,000 being paid by the issuance of restricted shares of Common Stock in lieu
−Removed: Ward’s rate
−Removed: of compensation has not changed since April 1, 2020.
−Removed: The Common Stock component
−Removed: Ward’s compensation is to be computed on a quarterly basis, with the number of shares issued being equal to the quotient
−Removed: of the quarterly amount due, divided by the average daily closing price of the Company’s Common Stock for the quarter just
+Added: Ward’s compensation is to be computed on a quarterly basis, with the number
+Added: of shares issued equal to the quotient of the quarterly amount due of $6,250 divided by the average daily closing price of the Company’s
+Added: Common Stock for the quarter just ended.
+Added: On April 1, 2020, Mr.
+Added: compensation was adjusted to include a total compensation of $200,529, consisting of $170,529 being paid in cash in accordance with the
+Added: Company’s payroll practices and $30,000 being paid by the issuance of restricted shares of Common Stock.
+Added: On March 1, 2021, Mr.
+Added: compensation was adjusted to include a total compensation of $208,543, consisting of $178,543 being paid in accordance with the Company’s
+Added: payroll practices and $30,000 being paid by the issuance of restricted shares of Common Stock.
+Added: Ward subsequently
+Added: resigned as CFO of the Company, effective May 14, 2021.
Douglas Plassche
−Removed: On July 20, 2013,
−Removed: the Company entered into an employment agreement with Mr.
+Added: On July 20, 2013, the Company
+Added: entered into an employment agreement with Mr.
Douglas Plassche (the “
Plassche Employment Agreeme nt”).
−Removed: Pursuant to the Plassche Employment Agreement, Mr.
−Removed: Plassche serves as an at-will employee, in the position of Vice President of
−Removed: Operations, commencing on August 12, 2013.
−Removed: The Plassche Employment Agreement includes a total base compensation of $236,000, consisting
−Removed: of $211,000 being paid in accordance with the Company’s payroll practices and $25,000 being paid by the issuance of restricted
−Removed: shares of Common Stock in lieu of cash.
−Removed: Plassche is also eligible for an annual bonus in cash and/or equity-based awards for
−Removed: up to an equivalent of 30% of base salary, with such annual bonus being granted based upon the achievement of agreed milestones
−Removed: and at the discretion of the Company and its Chief Executive Officer.
−Removed: In addition, pursuant to the Plassche Employment Agreement,
−Removed: he was granted options to purchase 3,000,000 shares of Common Stock, at a price of $ 0.07 per share, (the closing price of the
−Removed: Common Stock on the date of the Plassche Employment Agreement).
−Removed: The options were issued pursuant to the 2004 Employee Stock Option
−Removed: Plan and vest over a period of three years with the vesting period commencing one year from the date of issuance.
−Removed: Plassche’s
−Removed: employment is terminable by either party.
+Added: Pursuant to the
+Added: Plassche Employment Agreement, Mr.
+Added: Plassche serves as an at-will employee, in the position of Vice President of Operations, commencing
+Added: on August 12, 2013.
+Added: The Plassche Employment Agreement includes an initial base salary of $205,000 being paid in accordance with the Company’s
+Added: payroll practices and an additional $25,000 being paid by the issuance of restricted shares of Common Stock.
+Added: The Common Stock component
+Added: Plassche’s compensation is to be computed on an annual basis, with the number of shares issued being equal to the quotient
+Added: of the annual amount due, divided by the average daily closing price of the Company’s Common Stock for the calendar year just ended.
+Added: Plassche is also eligible
+Added: for an annual bonus in cash and/or equity-based awards for up to an equivalent of 30% of base salary, with such annual bonus being granted
+Added: based upon the achievement of agreed milestones and at the discretion of the Company and its Chief Executive Officer.
+Added: In addition, pursuant
+Added: to the Plassche Employment Agreement, he was initially granted options to purchase 3,000,000 shares of Common Stock, at a price of $ 0.07
+Added: per share, (the closing price of the Common Stock on the date of the Plassche Employment Agreement).
+Added: The options were issued pursuant
+Added: to the 2004 Employee Stock Option Plan and vested over a period of three years with the vesting period commencing one year from the date
+Added: Plassche’s employment
+Added: is terminable by either party.
If the Company terminates Mr.
Plassche without cause, Mr.
−Removed: Plassche is entitled to an
−Removed: amount equal to six months of base annual salary in effect upon the date of termination.
−Removed: On March 1, 2015,
−Removed: Plassche’s compensation was adjusted to include a total base compensation of $249,800, consisting of $224,800 being
−Removed: paid in accordance with the Company’s payroll practices and $25,000 being paid by the issuance of restricted shares of Common
−Removed: Stock in lieu of cash.
−Removed: On March 1, 2016,
−Removed: Plassche’s compensation was adjusted to include a total base compensation of $253,552, consisting of $228,552 being
−Removed: paid in accordance with the Company’s payroll practices and $25,000 being paid by the issuance of restricted shares of Common
−Removed: Stock in lieu of cash.
+Added: Plassche is entitled to an amount equal to six
+Added: months of base annual salary in effect upon the date of termination.
+Added: Throughout his tenure, Mr.
+Added: Plassche’s compensation was increased from time to time by the Board.
On June 21, 2019, Mr.
−Removed: Plassche entered into a retention agreement
−Removed: with the Company (the “Plassche Retention Agreement”), pursuant to which Mr.
−Removed: Plassche will be entitled to a lump sum
−Removed: retention payment of $253,552 at any time after June 30, 2021, provided Mr.
+Added: entered into a retention agreement with the Company (the “Plassche Retention Agreement”), as an in incentive for his continued
+Added: employment and cooperating during a transitional period for the Company.
+Added: Pursuant to the Plassche Retention Agreement, Mr.
+Added: entitled to a lump sum retention payment of $253,552 as of June 30, 2021, provided Mr.
Plassche remains continuously employed by the Company
1 unchanged sentence
In addition, Mr.
−Removed: Plassche is due a one-time $30,000 relocation payment and a guaranteed annual bonus of $75,000
−Removed: pursuant to the Plassche Retention Agreement.
−Removed: On April 1, 2020,
−Removed: Plassche’s compensation was adjusted to include a total base compensation of $272,530, consisting of $247,530 being
−Removed: paid in accordance with the Company’s payroll practices and $25,000 being paid by the issuance of restricted shares of Common
−Removed: Stock in lieu of cash.
−Removed: The Common Stock component
−Removed: Plassche’s compensation is to be computed on a quarterly basis, with the number of shares issued being equal to the
−Removed: quotient of the quarterly amount due, divided by the average daily closing price of the Company’s Common Stock for the quarter
−Removed: George Kenneth Smith
−Removed: On October 20, 2014,
−Removed: the Company entered into an employment agreement with Mr.
−Removed: George Kenneth Smith (the “
−Removed: Smith Employment Agreement ”).
−Removed: Pursuant to the Smith Employment Agreement, Mr.
−Removed: Smith serves as an at-will employee, in the position of Vice President, Legal,
−Removed: commencing on October 20, 2014.
−Removed: The Smith Employment Agreement includes a total base compensation of $400,000, consisting of $150,000
−Removed: being paid in accordance with the Company’s payroll practices and $250,000 being paid by the issuance of restricted shares
−Removed: of Common Stock in lieu of cash.
−Removed: Smith is also eligible for an annual bonus and discretionary bonus, with such being at the
−Removed: discretion of the Company and its Chief Executive Officer.
−Removed: In addition, pursuant to the Smith Employment Agreement, Mr.
−Removed: was granted options to purchase 1,500,000 shares of Common Stock, at a price of $ 0.29 per share, (the closing price of the Common
−Removed: Stock on the date of the Smith Employment Agreement).
−Removed: The options were issued pursuant to the 2009 Employee Stock Option Plan
−Removed: and vest over a period of three years with the vesting period commencing one year from the date of issuance.
−Removed: Smith’s
−Removed: employment is terminable by either party.
−Removed: If the Company terminates Mr.
−Removed: Smith without cause, or if Mr.
−Removed: Smith is terminated upon
−Removed: a change of control event, as defined in the Smith Employment Agreement, Mr.
−Removed: Smith is entitled to an amount equal to one year
−Removed: of base annual salary in effect upon the date of termination.
−Removed: On March 1, 2016,
−Removed: Smith’s compensation was adjusted to include a total base compensation of $412,000, consisting of $162,000 being paid
−Removed: in accordance with the Company’s payroll practices and $250,000 being paid by the issuance of restricted shares of Common
−Removed: Stock in lieu of cash.
−Removed: Smith’s
−Removed: rate of compensation has not changed since March 1, 2016.
−Removed: The Common Stock component
−Removed: Smith’s compensation is to be computed on a quarterly basis, with the number of shares issued being equal to the
−Removed: quotient of the quarterly amount due, divided by the average daily closing price of the Company’s Common Stock for the quarter
−Removed: Hedging Policy
−Removed: We do not permit the
−Removed: Named Executive Officers to “hedge”
−Removed: ownership by engaging in short sales or trading in any options contracts involving
−Removed: Options Exercised and Stock Vested
−Removed: No options have been
−Removed: exercised by our Named Executive Officers during the 2020 Fiscal Year.
−Removed: There was no vesting
−Removed: during Fiscal 2020 of options to purchase Common Stock that were issued to Named Executive Officers in prior periods.
−Removed: Pension Benefits
−Removed: We do not provide
−Removed: pension benefits to the Named Executive Officers.
−Removed: Nonqualified Deferred Compensation
−Removed: We do not have any
−Removed: defined contribution or other plan that provides for the deferral of compensation on a basis that is not tax qualified.
−Removed: Potential Payments Upon Termination
−Removed: or Change of Control
−Removed: We do not presently
−Removed: provide the Named Executive Officers with any plan or arrangement, other than those that may be contained in the employment contracts
−Removed: Nasrat Hakim, Mr.
−Removed: Douglass Plassche, and Mr.
−Removed: George Kenneth Smith, as disclosed above, in connection with any termination,
−Removed: including, without limitation, through retirement, resignation, severance, or constructive termination (including a change in
−Removed: responsibilities) of such Named Executive Officer’s employment with the Company.
+Added: Plassche was paid a one-time $30,000 relocation payment during fiscal year 2020.
+Added: Under the Plassche
+Added: Retention Agreement, the Company also guaranteed Mr.
+Added: Plassche a salary of $253,552 and an annual bonus of $75,000 during the two year
+Added: period following the agreement date.
+Added: On April 1, 2020, Mr.
+Added: Plassche’s
+Added: compensation was adjusted to include a total base compensation package of $272,530, consisting of $247,530 being paid in accordance with
+Added: the Company’s payroll practices and $25,000 being paid by the issuance of restricted shares of Common Stock.
+Added: On March 1, 2021, Mr.
+Added: Plassche’s
+Added: compensation was adjusted to include a total base compensation package of $278,606, consisting of $253,606 being paid in accordance with
+Added: the Company’s payroll practices and $25,000 being paid by the issuance of restricted shares of Common Stock.
+Added: Potential Payments Upon Termination or Change
+Added: Hakim and Plassche
+Added: are entitled to certain benefits upon a termination event (and in the case of Mr.
+Added: Hakim, in connection with a change of control), as described
+Added: in the section entitled “
+Added: Agreements with Named Executive Officers ”
+Added: We do not presently provide the Named Executive
+Added: Officers with any plan or arrangement, other than those that may be contained in the employment contracts disclosed above, in connection
+Added: with any termination, including, without limitation, through retirement, resignation, severance, or constructive termination (including
+Added: a change in responsibilities) of such Named Executive Officer’s employment with the Company.
As part of the Company’s
−Removed: efforts to ensure the retention and continuity of key employees, officers, and directors in the event of a change of control of
−Removed: the ownership of the Company, unless otherwise stated in applicable employment contracts, key executives would receive an amount
−Removed: equal to twelve months of such executive’s salary, and certain Directors and managers would receive an amount equal to six
−Removed: months of such Director’s or manager’s fees or salaries, as applicable.
−Removed: In addition, any outstanding and unvested
−Removed: options would immediately vest, in the event of a change of control.
−Removed: Compensation of named executive officers:
+Added: efforts to ensure the retention and continuity of key employees, officers, and directors in the event of a change of control of the ownership
+Added: of the Company, unless otherwise stated in applicable employment contracts, key executives would receive an amount not to exceed twelve
+Added: months of such executive’s salary, and certain Directors and managers would receive an amount equal to six months of such Director’s
+Added: or manager’s fees or salaries, as applicable.
+Added: In addition, any outstanding and unvested options would immediately vest, in the event
+Added: of a change of control.
+Added: Hedging Policy
+Added: We do not permit the Named
+Added: Executive Officers to “hedge”
+Added: ownership by engaging in short sales or trading in any options contracts involving securities.
+Added: Summary Compensation Table
Name and Principal Position
−Removed: Compensation (1)
Nasrat Hakim, President, Chief Executive Officer and Chairman of the Board of Directors
1 unchanged sentence
Douglas Plassche, Executive Vice President
−Removed: George Kenneth Smith, Vice President
−Removed: Represents amounts paid or accrued for the fiscal years ended
−Removed: March 31, 2020 and 2019, respectively.
−Removed: Represents total salaries paid or accrued to Mr.
−Removed: Hakim pursuant
−Removed: to the Hakim Employment Agreement, with such amounts to be paid via the issuance of Common Stock in lieu of cash.
−Removed: No shares of Common Stock have been issued to Mr.
−Removed: Hakim in payment
−Removed: of salaries due for Fiscal 2020.
+Added: (1) Represents
+Added: salary earned by Mr.
+Added: Hakim pursuant to the Hakim Employment Agreement for Fiscal 2021, with such amounts to be paid via the issuance
+Added: of Common Stock in lieu of cash.
+Added: No shares of Common Stock have been issued
+Added: Hakim in payment of salaries due for Fiscal 2021.
A total of 7,388,707 shares of Common Stock are due and owing to Mr.
−Removed: Hakim in payment of salaries
−Removed: earned by during Fiscal 2020.
+Added: in payment of salaries earned during Fiscal 2021.
A total of 6,305,856 shares of Common Stock are due and owing to Mr.
−Removed: Hakim in payment of salaries
−Removed: earned by Mr.
−Removed: Hakim during Fiscal 2019.
+Added: Hakim in payment
+Added: of salaries earned during Fiscal 2020.
In aggregate, a total of $2,125,000 is accrued, due and owing to Mr.
−Removed: Hakim for salaries
−Removed: earned during Fiscal 2020, Fiscal 2019 and the twenty-four months ended March 31, 2018, but not paid.
−Removed: This amount is to be paid
−Removed: via the issuance of 16,954,026 shares of Common Stock, with the date of such issuance of shares of Common Stock being undetermined.
−Removed: Represents bonuses paid or accrued to Mr.
−Removed: Hakim pursuant to the Hakim Employment Agreement.
−Removed: A total of $125,000 of bonus earned by
+Added: Hakim for salaries earned
+Added: during Fiscal 2021, Fiscal 2020, and the thirty-six months ended March 31, 2019, but not paid.
+Added: This amount is to be paid via the
+Added: issuance of 24,342,733 shares of Common Stock, with the date of such issuance of shares of Common Stock being undetermined.
+Added: The bonus earned by Mr.
+Added: Hakim for fiscal 2021.
+Added: Bonuses earned by Mr.
+Added: Hakim during Fiscal
+Added: 2021 were paid in accordance with the Company’s payroll practices during Fiscal 2021.
+Added: Hakim was also paid $437,500 during Fiscal 2021 for bonuses earned
+Added: and accrued during the twelve months ended March 31, 2018, and not paid previously.
+Added: Hakim was also paid $312,500 during Fiscal 2021
+Added: for bonuses earned and accrued during the twelve months ended March 31, 2019, and not previously paid.
+Added: Hakim accordingly was paid
+Added: a total of $1,250,000 during Fiscal 2021, with such amount representing bonuses earned during Fiscal 2021 and the twenty-four month period
+Added: ending March 31, 2019, and not previously paid.
+Added: A total of $125,000 of bonus earned by Mr.
Hakim during Fiscal 2020 was paid in accordance with the Company’s payroll practices.
−Removed: A total of $375,000 of bonus earned
+Added: A total of $375,000 of bonus earned by
Hakim during Fiscal 2020 was accrued and is owing to Mr.
−Removed: Hakim was also paid $125,000 during
−Removed: Fiscal 2020 for bonuses earned and accrued during the twelve months ended March 31, 2017, with such amount being paid in accordance
−Removed: with the Company’s payroll practices.
As of March 31, 2021, Mr.
−Removed: Hakim is owed
−Removed: an additional $1,000,000 in bonus earned during the twenty-four-month period ending March 31, 2019.
−Removed: Pursuant to the Hakim Employment
−Removed: Agreement, these bonuses are to be paid in accordance with the Company’s payroll practices.
−Removed: Represents amounts paid for auto and housing allowances.
+Added: Hakim is owed $562,500 in bonuses earned
+Added: during the twenty-four-month period ending March 31, 2020.
+Added: Pursuant to the Hakim Employment Agreement, these bonuses are to be paid in
+Added: accordance with the Company’s payroll practices.
+Added: Represents $18,000 amounts paid for auto allowance and $60,000 for housing allowances.
Represents salaries earned by Mr.
Ward pursuant to the Ward Employment Agreement.
−Removed: Fiscal 2020 salaries consist of $162,816
−Removed: being paid in accordance with the Company’s payroll practices and $30,000 being accrued, due and owing to be paid via the
−Removed: issuance of 378,362 shares of Common Stock.
−Removed: Fiscal 2019 salaries consist of $162,816
−Removed: being paid in accordance with the Company’s payroll practices and $30,000 being accrued, due and owing to be paid via the
−Removed: issuance of 328,414 shares of Common Stock.
−Removed: In aggregate, salaries totaling $67,500
−Removed: are accrued, due and owing to Mr.
−Removed: Ward for salaries earned and not paid during Fiscal 2020, Fiscal 2019 and the twelve month period
−Removed: ended March 31, 2018, with such accrued amount to be paid via the issuance of 775,171 shares of Common Stock, with the date of
−Removed: such issuance of shares of Common Stock being undetermined.
−Removed: Discretionary cash bonuses awarded by the Chief Executive Officer which was accrued and owing as of March 31, 2020 and paid during April 2020 in accordance with the Company’s payroll practices
+Added: Fiscal 2021 salaries consist of $171,197 being
+Added: paid in accordance with the Company’s payroll practices and $30,000 being accrued, due, owing and to be paid via the issuance of
+Added: 443,355 shares of Common Stock.
+Added: In aggregate, salaries totaling $97,500 are accrued,
+Added: due and owing to Mr.
+Added: Ward for salaries earned and not paid during Fiscal 2021, Fiscal 2020 and the twenty-four month period ended March
+Added: 31, 2019, with such accrued amount being paid via the issuance of 1,218,536 shares of Common Stock during May 2021.
+Added: Represents the bonus earned by Mr.
+Added: Ward for fiscal 2021.
Represents salaries earned by Mr.
Plassche pursuant to the Plassche Employment Agreement.
−Removed: Fiscal 2020 salaries consist of $228,552
−Removed: being paid in accordance with the Company’s payroll practices and $25,000 being accrued, due and owing and to be paid via
−Removed: the issuance of 315,302 shares of Common Stock.
−Removed: Fiscal 2019 salaries consist of $228,552 being paid in accordance with the Company’s
−Removed: payroll practices and $25,000 being accrued, due and owing and to be paid via the issuance of 276,678 shares of Common Stock.
−Removed: In aggregate, salaries totaling $56,250
−Removed: are accrued, due and owing to Mr.
−Removed: Plassche for salaries earned and not paid during Fiscal 2020, Fiscal 2019, and the twelve month
−Removed: period ended March 31, 2018, with such accrued amount to be paid via the issuance of 645,976 shares of Common Stock, with the date
−Removed: of such issuance of shares of Common Stock being undetermined.
−Removed: Cash bonuses paid pursuant to the Plassche Employment Agreement
−Removed: Bonus awarded during Fiscal 2020 was accrued as of March 31, 2020 and paid in April 2020 in accordance with the Company’s payroll practices.
−Removed: Bonus awarded during Fiscal 2019 was accrued as of March 31, 2019 and paid in April 2019 in accordance with the Company’s payroll practices.
+Added: Fiscal 2021 salaries consist of $242,536 being
+Added: paid in accordance with the Company’s payroll practices and $25,000 being accrued, due, owing and to be paid via the issuance of
+Added: 369,462 shares of Common Stock.
+Added: In aggregate, salaries totaling $25,000 are accrued,
+Added: due and owing to Mr.
+Added: Plassche for salaries earned and not paid during Fiscal 2021, with such accrued amount to be paid via the issuance
+Added: of 369,462 shares of Common Stock, with the date of such issuance of shares of Common Stock being undetermined.
+Added: Represents the bonus earned by Mr.
+Added: Plassche for fiscal 2021 pursuant to the Plassche Employment Agreement.
Represents amounts paid for auto allowances.
−Removed: Represents salaries earned by Mr.
−Removed: Smith pursuant to the Smith Employment Agreement.
−Removed: Fiscal 2020 salaries consist of $162,000
−Removed: being paid in accordance with the Company’s payroll practices and $250,000 being accrued, due and owing and to paid via the
−Removed: issuance of 3,153,020 shares of Common Stock.
−Removed: Fiscal 2019 salaries consist of $162,000 being paid in accordance with the Company’s
−Removed: payroll practices and $250,000 being accrued, due and owing and to be paid via the issuance of 2,736,780 shares of Common Stock.
−Removed: In aggregate, salaries totaling $562,500
−Removed: are accrued, due and owing to Mr.
−Removed: Smith for salaries earned and not paid during Fiscal 2020, Fiscal 2019, and the twelve month
−Removed: period ended March 31, 2018, with such accrued amount to be paid via the issuance of 6,459,757 shares of Common Stock, with the
−Removed: date of such issuance of shares of Common Stock being undetermined.
−Removed: Consists of auto allowances of $6,000 paid to Mr.
−Removed: Plassche during Fiscal 2020 and $30,000 relocation reimbursement due and owing to Mr.
−Removed: Plassche, pursuant to the Plassche Retention Agreement.
Outstanding Equity Awards at March 31, 2021
+Added: Option Awards
Unexercisable
4 unchanged sentences
Douglas Plassche
−Removed: George Kenneth Smith
−Removed: The following table sets forth information
−Removed: concerning director compensation for the year ended March 31, 2020:
−Removed: Non-qualified
+Added: Director Compensation
+Added: The following table sets forth
+Added: information concerning director compensation for the year ended March 31, 2021:
Jeffrey Whitnell
2 unchanged sentences
for details on the Company’s director fee compensation policy.
−Removed: Amounts represent Director fees earned during the fiscal year
−Removed: ended March 31, 2020 which are to be paid in cash.
−Removed: These fees were accrued and unpaid as of March 31, 2020, with a payment date
−Removed: being undetermined.
+Added: No directors held unexercised or unvested stock awards as of March 31, 2021.
+Added: Amounts represent Director fees earned during the
+Added: fiscal year ended March 31, 2021 which are to be paid in cash.
+Added: These fees were accrued and unpaid as of March 31, 2021, with a payment
+Added: date being undetermined.
In aggregate, Directors fees totaling $30,000 ($10,000 for each of the Company’s three non-employee
−Removed: Directors) is accrued, due and owing for Director fees earned during Fiscal 2020, Fiscal 2019 and the twelve month period ended
−Removed: March 31, 2018.
−Removed: This amount is to be paid in cash, with the date of such payment being undetermined.
−Removed: Director fees earned during the fiscal year ended March 31,
−Removed: 2020 which are to be paid via the issuance of an aggregate of 756,725 shares of Common Stock, with Dr.
+Added: Directors) is accrued, due and owing for Director fees earned during Fiscal 2021.
+Added: This amount is to be paid in cash, with the date
+Added: of such payment being undetermined.
+Added: Director equity compensation for the fiscal year ended March 31, 2021 consists of an entitlement to 295,570 shares of Common Stock for each of Dr.
+Added: Whitnell and Mr.
Caskey each receiving 295,570 shares of Common Stock.
−Removed: In aggregated, a total of 1,550,342 shares of Common Stock is
−Removed: accrued, due and owing as of March 31, 2018 (with each of Company’s three non-employee Directors being owed 516,781
−Removed: shares of this aggregate total) for Director fees earned during Fiscal 2020, Fiscal 2019 and the twelve month period ended
−Removed: March 31, 2018.
−Removed: Payment of this amount due via share issuance will be made at an undetermined date
+Added: Payment of this amount due via share issuance will be made at an as yet undetermined date.
Director Fee Compensation
−Removed: The Company’s
−Removed: policy regarding director fees is as follows:
−Removed: (i) Directors who are employees or consultants of the Company (and/or any of its
−Removed: subsidiaries) receive no additional remuneration for serving as directors or members of committees of the Board;
−Removed: (ii) all Directors
−Removed: are entitled to reimbursement for out-of-pocket expenses incurred by them in connection with their attendance at the Board or
−Removed: committee meetings;
−Removed: (iii) Directors who are not employees or consultants of the Company (and/or any of its subsidiaries) receive
−Removed: a $30,000 annual retainer fee, with $20,000 of this amount being paid via the issuance of restricted Common Stock of the Company
−Removed: in lieu of cash, as described below, and the remaining $10,000 being paid in cash;
−Removed: (iv) The Chairman of the Board receives a $30,000
−Removed: annual retainer fee paid via the issuance of restricted shares of Common Stock of the Company in lieu of cash, as described below;
−Removed: (v) Directors and the Chairman do not receive any additional compensation for attendance at or chairing of any meetings;
−Removed: Nasrat Hakim received no additional compensation, above the annual retainer fee due to the Chairman of the Board, for
−Removed: the period that he also served as Chief Executive Officer.
+Added: The Company’s policy
+Added: regarding director fees is as follows:
+Added: (i) Directors who are employees or consultants of the Company (and/or any of its subsidiaries)
+Added: receive no additional remuneration for serving as directors or members of committees of the Board;
+Added: (ii) all Directors are entitled to
+Added: reimbursement for out-of-pocket expenses incurred by them in connection with their attendance at the Board or committee meetings;
+Added: Directors who are not employees or consultants of the Company (and/or any of its subsidiaries) receive a $30,000 annual retainer fee,
+Added: with $20,000 of this amount being paid via the issuance of restricted Common Stock, and the remaining $10,000 being paid in cash;
+Added: Directors and the Chairman do not receive any additional compensation for attendance at or chairing of any meetings.
Director Equity Compensation
−Removed: Members of the Board
−Removed: of Directors and the Chairman are paid their annual retainer fees via the issuance of restricted shares of Common Stock of the
−Removed: Company, in lieu of cash.
−Removed: The number of shares to be issued to each Director and the Chairman is equal to the quotient of the
−Removed: quarterly amount due to each Director and the Chairman, respectively, divided by the average daily closing price of the Company’s
−Removed: stock for the quarter just ended.
−Removed: Members of the Board
−Removed: of Directors during the fiscal years ended March 31, 2020 and March 31, 2019 did not receive any options or equity compensation
−Removed: for serving as directors other than shares of Common Stock earned in lieu of cash in relation to Director fees due.
−Removed: The Company’s
−Removed: Articles of Incorporation provide for the indemnification of each of the Company’s directors to the fullest extent permitted
−Removed: under Nevada General Corporation Law.
−Removed: ITEM 12 SECURITY
−Removed: OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
−Removed: The following table
−Removed: sets forth certain information, as of June 23, 2020 (except as otherwise indicated), regarding beneficial ownership of our Common
−Removed: Stock and our Series J Preferred Stock by (i) each person who is known by us to own beneficially more than 5% of each such class,
−Removed: (ii) each of our directors, (iii) each of our executive officers and (iv) all our directors and executive officers as a group.
−Removed: As of June 23, 2020, we had 840,404,367 million shares of Common Stock outstanding (exclusive of 0.1 million treasury shares) and
−Removed: 24.0344 shares of Series J Preferred Stock outstanding.
−Removed: On any matter presented to the holders of our Common Stock for their action
−Removed: or consideration at any meeting of our Shareholders, each share of Common Stock entitles the holder to one vote and each share
−Removed: of Series J Preferred Stock entitles the holder to the number of votes equal to the number of shares of Common Stock into which
−Removed: such share of Series J Preferred Stock is convertible (6,574,631 shares of Common Stock per whole share of Series J Preferred Stock).
−Removed: As used in the table
−Removed: below and elsewhere in this report, the term beneficial ownership with respect to a security consists of sole or shared voting
−Removed: power, including the power to vote or direct the vote, and/or sole or shared investment power, including the power to dispose or
−Removed: direct the disposition, with respect to the security through any contract, arrangement, understanding, relationship, or otherwise,
−Removed: including a right to acquire such power(s) during the 60 days immediately following June 23, 2020.
−Removed: Except as otherwise indicated,
−Removed: the Shareholders listed in the table have sole voting and investment powers with respect to the shares indicated.
−Removed: Amount and Nature of
−Removed: Name and Address of Beneficial Owner of Common Stock
−Removed: Nasrat Hakim, President, Chief Executive
−Removed: Officer and Chairman of the Board of Directors*
−Removed: 107,760,381 (1)
+Added: As described above, members
+Added: of the Board of Directors and the Chairman are paid a portion of their annual retainer fees via the issuance of restricted shares of Common
+Added: Stock of the Company.
+Added: The number of shares to be issued to each Director and the Chairman is equal to the quotient of the quarterly amount
+Added: due to each Director and the Chairman, respectively, divided by the average daily closing price of the Company’s stock for the quarter
+Added: Members of the Board of Directors
+Added: during the fiscal year ended March 31, 2021 did not receive any options or equity compensation for serving as directors other than shares
+Added: of Common Stock earned in lieu of cash in relation to Director fees due.
+Added: The Company’s Articles
+Added: of Incorporation provide for the indemnification of each of the Company’s directors to the fullest extent permitted under Nevada
+Added: General Corporation Law.
+Added: SECURITY OWNERSHIP OF CERTAIN BENEFICIAL
+Added: OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
+Added: The following table sets forth
+Added: certain information, as of June 7, 2021 (except as otherwise indicated), regarding beneficial ownership of our Common Stock by (i) each
+Added: person who is known by us to own beneficially more than 5% of each such class, (ii) each of our directors, (iii) each of our executive
+Added: officers and (iv) all our directors and executive officers as a group.
+Added: As of June 7, 2021, we had 1,009,176,752 shares of Common Stock
+Added: outstanding (exclusive of 0.1 million treasury shares).
+Added: On any matter presented to the holders of our Common Stock for their action or
+Added: consideration at any meeting of our Shareholders, each share of Common Stock entitles the holder to one vote.
+Added: As used in the table below
+Added: and elsewhere in this report, the term beneficial ownership with respect to a security consists of sole or shared voting power, including
+Added: the power to vote or direct the vote, and/or sole or shared investment power, including the power to dispose or direct the disposition,
+Added: with respect to the security through any contract, arrangement, understanding, relationship, or otherwise, including a right to acquire
+Added: such power(s) during the 60 days immediately following June 7, 2021.
+Added: Except as otherwise indicated, the Shareholders listed in the table
+Added: have sole voting and investment powers with respect to the shares indicated.
+Added: Name and Address of Beneficial
+Added: Owner of Common Stock
+Added: Voting Securities
+Added: Nasrat Hakim, President, Chief Executive Officer
+Added: and Chairman of the Board of Directors*
273,166,287 (1)
4 unchanged sentences
Davis Caskey, Director*
−Removed: Ward, Chief Financial Officer *
1,042,243 (4)
−Removed: Douglas Plassche, Executive Vice President *
+Added: Ward, Former Chief Financial Officer
5,185,023 (5)
−Removed: Ashok Nigalaye, Former Director
+Added: Douglas Plassche, Executive Vice President *
4,503,394 (6)
1 unchanged sentence
283,120,113 (7)
−Removed: 24.03443452410 (2)
−Removed: * The address is c/o Elite Pharmaceuticals Inc.,
−Removed: 165 Ludlow Avenue, Northvale, NJ 07647.
−Removed: ** Less than 1%
−Removed: Includes 11,797,561 shares of Common Stock held and 16,954,159
−Removed: shares of Common Stock due and owing to Mr.
−Removed: Hakim as of March 31, 2020 (the latest practicable date) for compensation earned
−Removed: pursuant to Mr.
−Removed: Hakim’s employment agreement with the Company and 79,008,661 shares of Common Stock issuable upon exercise
−Removed: of the Series J Warrants.
−Removed: Series J Preferred Stock has an aggregate of 158,017,321 voting
−Removed: Includes 1,416,011 shares of Common Stock held and 516,781 shares
−Removed: of Common Stock due and owing to Dr.
−Removed: Dash as of March 31, 2020 (the latest practicable date) for Directors fees accrued as
−Removed: of such date.
+Added: address is c/o Elite Pharmaceuticals Inc., 165 Ludlow Avenue, Northvale, NJ 07647.
Includes 169,814,882 shares of Common Stock held and 24,342,744 shares
of Common Stock due and owing to Mr.
−Removed: Whitnell as of March 31, 2020 (the latest practicable date) for Directors fees accrued
+Added: Hakim as of March 31, 2021 (the latest practicable date) for compensation earned pursuant to Mr.
+Added: Hakim’s employment agreement with the Company and 79,008,661 shares of Common Stock issuable upon cash exercise of the Series J
+Added: Warrants with an exercise price of $0.1521 per share.
+Added: Includes 1,932,792 shares of Common Stock held and
+Added: 295,570 shares of Common Stock due and owing to Dr.
+Added: Dash as of March 31, 2021 (the latest practicable date) for Directors fees accrued
as of such date.
−Removed: Includes 229,892 shares of Common Stock held and 516,781 shares
−Removed: of Common Stock due and owing to Mr.
+Added: Includes 1,884,257 shares of Common Stock held and
+Added: 295,570 shares of Common Stock due and owing to Mr.
+Added: Whitnell as of March 31, 2021 (the latest practicable date) for Directors fees
+Added: accrued as of such date.
+Added: Includes 746,673 shares of Common Stock held and 295,570
+Added: shares of Common Stock due and owing to Mr.
Caskey as of March 31, 2021 (the latest practicable date) Date for Directors fees accrued
as of such date.
−Removed: Includes 3,771,919 shares of Common Stock held and 775,170 shares
−Removed: of Common Stock due and owing to Mr.
−Removed: Ward as of March 31, 2020 (the latest practicable date) for salaries earned pursuant
−Removed: Ward’s employment agreement with the Company, and vested options to purchase 150,000 shares of Common Stock.
−Removed: Includes 487,596 shares of Common Stock held 645,976 shares
−Removed: of Common Stock due and owing to Mr.
+Added: Ward resigned on May 14, 2021.
+Added: is c/o Enveric Biosciences Inc., 4851 Tamiami Trail N, Naples FL 34103.
+Added: Includes 3,771,919 shares of Common Stock
+Added: held and 1,263,104 shares of Common Stock due and owing to Mr.
+Added: Ward as of May 14, 2021.
+Added: for salaries earned pursuant to Mr.
+Added: employment agreement with the Company, with such shares being issued to Mr.
+Added: Ward during May 2021, and vested options to purchase
+Added: 150,000 shares of Common Stock.
+Added: Includes 1,133,932 shares of Common Stock held 369,462
+Added: shares of Common Stock due and owing to Mr.
Plassche as of March 31, 2021 (the latest practicable date) for salaries earned pursuant
−Removed: Plassche’s employment agreement with the Company, and vested options to purchase 3,000,000 shares of Common Stock.
−Removed: Nigalaye resigned on June 5, 2015.
−Removed: Address is c/o Granulation
−Removed: Technology Inc.
−Removed: 12 Industrial Road, Fairfield, NJ 07004.
−Removed: Includes 50,265,539 shares of Common Stock held with the Company’s
−Removed: transfer agent in account(s) that is (are) beneficially owned by Dr.
+Added: Plassche’s employment agreement with the Company, and shares of Common Stock issuable upon cash exercise of vested options
+Added: to purchase 3,000,000 shares of Common Stock.
Relates only to current directors and officers.
−Removed: 19,070,455 shares of Common Stock held, 19,925,648 shares of Common Stock due and owing as of June 23, 2020 for
−Removed: director’s fees and salaries accrued as of such date, vested options to purchase 3,150,000 shares of Common Stock, and
−Removed: warrants to purchase 79,008,661 shares of Common Stock.
−Removed: The denominator includes 158,017,321 votes attributable to the
−Removed: outstanding Series J Preferred Stock.
−Removed: Accordingly, the percentage of Common Stock beneficially owned by each Owner listed
−Removed: in the table other than Mr.
−Removed: Hakim is slightly greater than the percentage listed in this column.
−Removed: Series J Preferred
−Removed: Each share of Series
−Removed: J Preferred has a stated value of $1,000,000 (the “
−Removed: Stated Value ”).
−Removed: Commencing on the earlier of four years
−Removed: from the date of issuance of the Series J Preferred or the date that shareholder approval of an increase in the authorized shares
−Removed: of common stock is obtained (the “
−Removed: Shareholder Approval ”) and the requisite corporate action has been effected,
−Removed: each share of Series J Preferred is convertible into shares of Company Common Stock at a rate calculated by dividing the Stated
−Removed: Value by $0.1521 (the “
−Removed: Conversion Price”
−Removed: ) (prior to any adjustment, 6,574,622 shares of Common Stock per whole
−Removed: share of Series J Preferred).
−Removed: Shareholder Approval was obtained, so the Series J Preferred is now convertible.
−Removed: Subject to certain
−Removed: exceptions, the Conversion Price is subject to adjustment for any issuances or deemed issuances of common stock or common stock
−Removed: equivalents at an effective price below the then Conversion Price.
−Removed: The Conversion price also is adjustable upon the happening
−Removed: of certain customary events such as stock dividends and splits, pro rata distributions and fundamental transactions.
−Removed: Holders of Series
−Removed: J Preferred vote, along with the holders of Common Stock, on any matter presented to the shareholders.
−Removed: Each holder of Series J
−Removed: Preferred is entitled to cast the number of votes equal to the number of whole shares of Common Stock into which the shares of
−Removed: Series J Preferred held by such holder are convertible.
−Removed: The Series J Preferred
−Removed: ranks senior to the Common Stock with respect to the payment of dividends.
−Removed: So long as any shares of Series J Preferred remain
−Removed: outstanding, the Company cannot declare, pay, or set aside any dividends on shares of any other of its capital stock, unless the
−Removed: holders receive, a dividend on each outstanding share of Series J Preferred in an amount equal to the dividend the holders would
−Removed: have been entitled to receive upon conversion, in full, of the shares of Series J Preferred.
−Removed: Upon liquidation,
−Removed: dissolution or winding up of the Company, holders of Series J Preferred are entitled to receive for each share of Series J Preferred
−Removed: Stock, pari passu and pro rata with the holders of Common Stock, out of the Company’s assets, an amount equal to the amount
−Removed: distributable with regard to the number of whole shares of Common Stock into which the shares of Series J Preferred held by the
−Removed: holders are convertible as of the date of the Liquidation regardless of whether an Authorized Share Deficiency exists.
−Removed: Series J Warrants
−Removed: The Series J Warrants
−Removed: are exercisable for a period of 10 years from the date of issuance.
−Removed: The initial exercise price is $0.1521 per share and the Warrants
−Removed: can be exercised for cash or on a cashless basis.
−Removed: The exercise price is subject to adjustment for any issuances or deemed issuances
−Removed: of common stock or common stock equivalents at an effective price below the then exercise price.
−Removed: The Warrants provide for other
−Removed: standard adjustments upon the happening of certain customary events.
−Removed: ITEM 13 CERTAIN RELATIONSHIPS AND
−Removed: RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
+Added: 175,512,536 shares of Common Stock held, 25,598,916 shares of Common Stock due and owing as of March 31, 2021 (the latest practicable
+Added: date) for director’s fees and salaries accrued as of such date, 3,000,000 shares of Common Stock issuable upon cash exercise
+Added: of vested options and 79,008,661 shares of Common Stock issuable upon cash exercise of warrants at an exercise price of $0.1521 per
+Added: share of Common Stock.
+Added: CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
Certain Related Person Transactions
−Removed: In May 2020, SunGen,
−Removed: under an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement for Amphetamine IR and Amphetamine
−Removed: ER to Mikah Pharmaceuticals.
+Added: In May 2020, SunGen, under
+Added: an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement for Amphetamine IR and Amphetamine ER to
+Added: Mikah Pharmaceuticals.
The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s name.
−Removed: will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations for these
−Removed: products from SunGen.
+Added: Mikah will now be
+Added: Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations for these products from SunGen.
Mikah Pharmaceuticals was founded in 2009 by Nasrat Hakim.
Director Independence
−Removed: All related person
−Removed: transactions are reviewed and, as appropriate, may be approved or ratified by the Board of Directors.
−Removed: If a Director is involved
−Removed: in the transaction, he or she may not participate in any review, approval, or ratification of such transaction.
−Removed: Related person
−Removed: transactions are approved by the Board of Directors only if, based on all of the facts and circumstances, they are in, or not
−Removed: inconsistent with, our best interests and the best interests of our stockholders, as the Board of Directors determines in good
−Removed: The Board of Directors takes into account, among other factors it deems appropriate, whether the transaction is on terms
−Removed: generally available to an unaffiliated third-party under the same or similar circumstances and the extent of the related person’s
−Removed: interest in the transaction.
−Removed: The Board of Directors may also impose such conditions as it deems necessary and appropriate on us
−Removed: or the related person in connection with the transaction.
+Added: All related person transactions
+Added: are reviewed and, as appropriate, may be approved or ratified by the Board of Directors.
+Added: If a Director is involved in the transaction,
+Added: he or she may not participate in any review, approval, or ratification of such transaction.
+Added: Related person transactions are approved
+Added: by the Board of Directors only if, based on all of the facts and circumstances, they are in, or not inconsistent with, our best interests
+Added: and the best interests of our stockholders, as the Board of Directors determines in good faith.
+Added: The Board of Directors takes into account,
+Added: among other factors it deems appropriate, whether the transaction is on terms generally available to an unaffiliated third-party under
+Added: the same or similar circumstances and the extent of the related person’s interest in the transaction.
+Added: The Board of Directors may
+Added: also impose such conditions as it deems necessary and appropriate on us or the related person in connection with the transaction.
In the case of a transaction
1 unchanged sentence
of the transaction is appropriate.
−Removed: ITEM 14 PRINCIPAL ACCOUNTANT FEES
−Removed: The Company’s
−Removed: independent registered public accounting firm is Buchbinder Tunick & Company LLP (“
+Added: PRINCIPAL ACCOUNTANT FEES AND SERVICES
+Added: The Company’s independent
+Added: registered public accounting firm for the fiscal year ending March 31, 2022 is Buchbinder Tunick & Company LLP (“
Buchbinder ”).
−Removed: The following table
−Removed: presents fees, including reimbursements for expenses, for professional audit services rendered by Buchbinder, for the audits of
−Removed: our financial statements and interim reviews of our quarterly financial statements.
+Added: The following table presents
+Added: fees, including reimbursements for expenses, for professional audit services rendered by Buchbinder, for the audits of our financial
+Added: statements and interim reviews of our quarterly financial statements.
Audit-Related Fees
−Removed: Represents fees for
−Removed: professional services provided for the audit of our annual financial statements, services that are performed to comply with generally
−Removed: accepted auditing standards, and review of our financial statements included in our quarterly reports and services in connection
−Removed: with statutory and regulatory filings.
+Added: Represents fees for professional
+Added: services provided for the audit of our annual financial statements, services that are performed to comply with generally accepted auditing
+Added: standards, and review of our financial statements included in our quarterly reports and services in connection with statutory and regulatory
Audit-Related Fees
−Removed: Represents the fees
−Removed: for assurance and related services that were reasonably related to the performance of the audit or review of our financial statements.
−Removed: Represents preparation
−Removed: of Federal, State and Local income tax returns.
−Removed: The Audit Committee
−Removed: has determined that Buchbinder’s rendering of these audit-related services was compatible with maintaining auditor’s
−Removed: independence.
−Removed: The Board of Directors considered Buchbinder to be well qualified to serve as our independent public accountants.
−Removed: The Committee also pre-approved the charges for services performed in Fiscal 2020.
−Removed: The Audit Committee
−Removed: pre-approves all audit related and tax services and the terms thereof (which may include providing comfort letters in connection
−Removed: with securities underwriting) and non-audit services (other than non-audit services prohibited under Section 10A(g) of the Exchange
−Removed: Act or the applicable rules of the SEC or the Public Company Accounting Oversight Board) to be provided to us by the independent
−Removed: provided, however, the pre-approval requirement is waived with respect to the provisions of non-audit services for us
−Removed: if the “de minimus”
−Removed: provisions of Section 10A (i)(1)(B) of the Exchange Act are satisfied.
−Removed: This authority to pre-approve
−Removed: non-audit services may be delegated to one or more members of the Audit Committee, who shall present all decisions to pre-approve
−Removed: an activity to the full Audit Committee at its first meeting following such decision.
−Removed: ITEM 15 EXHIBITS, FINANCIAL STATEMENTS
−Removed: AND SCHEDULES
−Removed: The following are filed as part of this Annual Report
−Removed: The financial statements and schedules required to be filed
−Removed: by Item 8 of this Annual Report on Form 10-K and listed in the Index to Consolidated Financial Statements.
−Removed: The Exhibits required by Item 601 of Regulation S-K and listed
−Removed: below in the “
+Added: Represents the fees for assurance
+Added: and related services that were reasonably related to the performance of the audit or review of our financial statements.
+Added: Represents preparation of
+Added: Federal, State and Local income tax returns.
+Added: The Audit Committee has determined
+Added: that Buchbinder’s rendering of these audit-related services was compatible with maintaining auditor’s independence.
+Added: of Directors considered Buchbinder to be well qualified to serve as our independent public accountants.
+Added: The Committee also pre-approved
+Added: the charges for services performed in Fiscal 2021.
+Added: Pre-Approval Procedures
+Added: The Audit Committee pre-approves
+Added: all audit and tax services and the terms thereof (which may include providing comfort letters in connection with securities underwriting)
+Added: and non-audit services (other than non-audit services prohibited under Section 10A(g) of the Exchange Act or the applicable rules of
+Added: the SEC or the Public Company Accounting Oversight Board) to be provided to us by the independent auditor;
+Added: provided, however, the pre-approval
+Added: requirement is waived with respect to the provisions of non-audit services for us if the “de minimus”
+Added: provisions of Section
+Added: 10A (i)(1)(B) of the Exchange Act are satisfied.
+Added: This authority to pre-approve non-audit services may be delegated to one or more members
+Added: of the Audit Committee, who shall present all decisions to pre-approve an activity to the full Audit Committee at its first meeting following
+Added: such decision.
+Added: EXHIBITS, FINANCIAL STATEMENTS AND SCHEDULES
+Added: The following are filed as part of this Annual Report on
+Added: The financial statements and schedules required to be filed by Item
+Added: 8 of this Annual Report on Form 10-K and listed in the Index to Consolidated Financial Statements.
+Added: The Exhibits required by Item 601 of Regulation S-K and listed below
+Added: in the “
Index to Exhibits required by Item 601 of Regulation S- K.”
2 unchanged sentences
Index to Exhibits required by Item 601 of Regulation S-K.
−Removed: of Incorporation of Elite-Nevada, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed with the
−Removed: SEC on January 9, 2012.
−Removed: of Designations of the Series G Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on
−Removed: April 18, 2013, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated April 18, 2013 and filed
−Removed: with the SEC on April 22, 2013.
−Removed: of Designation of the Series H Junior Participating Preferred Stock, incorporated by reference to Exhibit 2 (contained in
−Removed: Exhibit 1) to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.
−Removed: Certificate of Designations of the Series I Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on February 6, 2014, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated February 6, 2014 and filed with the SEC on February 7, 2014.
−Removed: Certificate of Designations of the Series J Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on May 3, 2017, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated April 28, 2017 and filed with the SEC on April 28, 2017.
−Removed: Certificate of Amendment to Articles of Incorporation, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated June 24, 2020 and filed with the SEC on June 24, 2020.
−Removed: Amended and Restated By-Laws of the Company, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K dated April 23, 2020 and filed with the SEC on April 23, 2020.
−Removed: of specimen certificate for Series G Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.2
−Removed: to the Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC on April 22, 2013.
−Removed: Form of specimen certificate for Series I Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated February 6, 2014 and filed with the SEC on February 7, 2014.
−Removed: Rights Agreement, dated as of November 15, 2013, between the Company and American Stock Transfer & Trust Company, LLC., incorporated by reference to Exhibit 1 to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.
−Removed: Form of Series H Preferred Stock Certificate, incorporated by reference to Exhibit 1 to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.
−Removed: Warrant to purchase shares of Common Stock issued to Nasrat Hakim dated April 28, 2017 incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated April 28, 2017, and filed with the SEC on April 28, 2017.
−Removed: Description of Common Stock.*
+Added: of Incorporation of Elite-Nevada, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed with the SEC on
+Added: January 9, 2012.
+Added: of Designations of the Series G Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on April
+Added: 18, 2013, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC
+Added: on April 22, 2013.
+Added: of Designation of the Series H Junior Participating Preferred Stock, incorporated by reference to Exhibit 2 (contained in Exhibit
+Added: 1) to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.
+Added: of Designations of the Series I Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on February
+Added: 6, 2014, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated February 6, 2014 and filed with the SEC
+Added: on February 7, 2014.
+Added: of Designations of the Series J Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on May 3,
+Added: 2017, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated April 28, 2017 and filed with the SEC on
+Added: April 28, 2017.
+Added: of Amendment to Articles of Incorporation, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated June
+Added: 24, 2020 and filed with the SEC on June 24, 2020.
+Added: and Restated By-Laws of the Company, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K dated April 23, 2020
+Added: and filed with the SEC on April 23, 2020.
+Added: of specimen certificate for Series G Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.2 to the
+Added: Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC on April 22, 2013.
+Added: of specimen certificate for Series I Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.2 to the
+Added: Current Report on Form 8-K, dated February 6, 2014 and filed with the SEC on February 7, 2014.
+Added: Agreement, dated as of November 15, 2013, between the Company and American Stock Transfer & Trust Company, LLC., incorporated
+Added: by reference to Exhibit 1 to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.
+Added: of Series H Preferred Stock Certificate, incorporated by reference to Exhibit 1 to the Registration Statement on Form 8-A filed with
+Added: the SEC on November 15, 2013.
+Added: to purchase shares of Common Stock issued to Nasrat Hakim dated April 28, 2017 incorporated by reference to Exhibit 4.1 to the Current
+Added: Report on Form 8-K, dated April 28, 2017, and filed with the SEC on April 28, 2017.
+Added: of Common Stock, incorporated by reference to Exhibit 4.6 to the Report 10-K filed in June 2020.
Pharmaceuticals, Inc.
−Removed: 2014 Equity Incentive Plan, incorporated by reference to Appendix B to the Company’s Definitive
−Removed: Proxy Statement for its Annual Meeting of Shareholders, filed with the SEC on April 3, 2014.
−Removed: Form of Confidentiality Agreement (corporate), incorporated by reference to Exhibit 10.7 to the Form SB-2.
+Added: 2014 Equity Incentive Plan, incorporated by reference to Appendix B to the Company’s Definitive Proxy
+Added: Statement for its Annual Meeting of Shareholders, filed with the SEC on April 3, 2014.
+Added: of Confidentiality Agreement (corporate), incorporated by reference to Exhibit 10.7 to the Form SB-2.
of Confidentiality Agreement (employee), incorporated by reference to Exhibit 10.8 to the Form SB-2.
Agreement, dated as of August 15, 2005, between New Jersey Economic Development Authority (“NJEDA”) and the Company,
−Removed: incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC
−Removed: on September 6, 2005.
−Removed: A Note in the aggregate principal amount of $3,660,000.00 payable to the order of the NJEDA, incorporated by reference to
−Removed: Exhibit 10.2 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.
+Added: incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September
+Added: A Note in the aggregate principal amount of $3,660,000.00 payable to the order of the NJEDA, incorporated by reference to Exhibit
+Added: 10.2 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.
B Note in the aggregate principal amount of $495,000.00 payable to the order of the NJEDA, incorporated by reference to Exhibit 10.3
2 unchanged sentences
and filed with the SEC on September 6, 2005.
−Removed: between NJEDA and the Bank of New York as Trustee, dated as of August 15, 2005, incorporated by reference to Exhibit 10.5
−Removed: to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.
−Removed: Strategic Alliance Agreement, dated as of March 18, 2009, by and among the Company, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated March 18, 2009 and filed with the SEC on March 23, 2009.
−Removed: Amendment to Strategic Alliance Agreement, dated as of April 30, 2009, by and among the Company, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated April 30, 2009 and filed with the SEC on May 6, 2009.
−Removed: Second Amendment to Strategic Alliance Agreement, dated as of June 1, 2009, by and among the Company, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated June 1, 2009, and filed with the SEC on June 5, 2009.
−Removed: Third Amendment to Strategic Alliance Agreement, dated as of Aug 18, 2009, by and among the Company, Epic Pharma LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q, for the period ending June 30, 2009 and filed with the SEC on August 19, 2009.
−Removed: Employment Agreement, dated as of November 13, 2009, by and between the Company and Carter J.
−Removed: Ward, incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q, for the period ending September 30, 2009 and filed with the SEC on November 16, 2009.
−Removed: Elite Pharmaceuticals Inc.
−Removed: 2009 Equity Incentive Plan, as adopted November 24, 2009, incorporated by reference to Exhibit 10.1 to the Registration Statement Under the Securities Act of 1933 on Form S-8, dated December 18, 2009 and filed with the SEC on December 22, 2009.
−Removed: License Agreement, dated as of September 10, 2010, by and among Precision Dose Inc.
−Removed: and the Company, incorporated by reference to Exhibit 10.8 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010 (Confidential Treatment granted with respect to portions of the Agreement).
−Removed: Manufacturing and Supply Agreement, dated as of September 10, 2010, by and among Precision Dose Inc.
−Removed: and the Company, incorporated by reference to Exhibit 10.9 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010 (Confidential Treatment granted with respect to portions of the Agreement).
−Removed: August 1, 2013 Employment Agreement with Nasrat Hakim, incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.
−Removed: August 1, 2013 Mikah LLC Asset Purchase Agreement, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K/A, dated August 1, 2013 and filed with the SEC on August 30, 2018.
−Removed: (Confidential Treatment granted with respect to portions of the Agreement).
−Removed: August 1, 2013 Secured Convertible Note from the Company to Mikah Pharma LLC., incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.
−Removed: August 1, 2013 Security Agreement from the Company to Mikah Pharma LLC., incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.
−Removed: October 15, 2013 Hakim Credit Line Agreement, incorporated by reference to Exhibit 10.16 to the Quarterly Report on Form 10-Q for the period ended September 30, 2013.
−Removed: October 2, 2013 Manufacturing and Licensing Agreement with Epic Pharma LLC, incorporated by reference to Exhibit 10.17 to the Amended Quarterly Report on Form 10-Q/A for the period ended September 30, 2013 and filed with the SEC on April 25, 2014.
−Removed: Confidential Treatment granted with respect to portions of the Agreement.
−Removed: February 7, 2014 Amendment to Secured Convertible Note from the Company to Mikah, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated February 7, 2014 and filed with the SEC on February 7, 2014.
−Removed: Employment Agreement with Dr.
−Removed: Kenneth Smith, dated October 20, 2014, incorporated by reference to Exhibit 10.82 to the Quarterly Report on Form 10-Q for the period ended September 30, 2014 and filed with the SEC on November 14, 2014.
−Removed: January 28, 2015 First Amendment to the Loan Agreement between Nasrat Hakim and Elite Pharmaceuticals dated October 15, 2013, incorporated by reference to Exhibit 10.83 to the Quarterly Report on Form 10-Q for the period ended December 31, 2014 and filed with the SEC on February 17, 2015.
−Removed: January 28, 2015 Termination of Development and License Agreement for Mikah-001 between Elite Pharmaceuticals, Inc.
−Removed: and Mikah Pharma LLC and Transfer of Payment, incorporated by reference to Exhibit 10.84 to the Quarterly Report on Form 10-Q for the period ended December 31, 2014 and filed with the SEC on February 17, 2015.
−Removed: June 4, 2015 License Agreement with Epic Pharma LLC, incorporated by reference to Exhibit 10.85 to Amendment No.
−Removed: 1 to the Annual Report on Form 10-K for the fiscal year ended March 31, 2015 and filed with the SEC on July 11, 2016.
−Removed: (Confidential Treatment granted with respect to portions of the Agreement).
−Removed: Amendment No.
−Removed: 1 to Hakim Employment Agreement, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on January 29, 2016.
−Removed: August 24, 2016 Master Development and License Agreement between Elite and SunGen Pharma LLC.
−Removed: incorporated by reference to Exhibit 10.44 to the Quarterly Report on Form 10-Q for the period ended September 30, 2016 and filed with the SEC on November 9, 2016.
−Removed: (Confidential Treatment granted with respect to portions of the Agreement).
−Removed: Purchase Agreement between the Company and Lincoln Park Capital LLC dated May 1, 2017, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated May 2, 2017 and filed with the SEC on May 2, 2017.
−Removed: Registration Rights Agreement between the Company and Lincoln Park Capital LLC dated May 1, 2017, incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated May 2, 2017 and filed with the SEC on May 2, 2017.
−Removed: April 28, 2017 Exchange Agreement between the Company and Nasrat Hakim, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated April 28, 2017 and filed with the SEC on April 28.
−Removed: May 2017 Trimipramine Acquisition Agreement from Mikah Pharma, incorporated by reference to Exhibit 10.50 to the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
−Removed: May 2017 Secured Promissory Note from the Company to Mikah Pharma, incorporated by reference to Exhibit 10.51 to the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
−Removed: May 2017 Security Agreement between the Company to Mikah Pharma, incorporated by reference to Exhibit 10.52 to the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
−Removed: May 2017 Assignment of Supply and Distribution Agreement between Dr.
−Removed: Reddy’s Laboratories and Mikah Pharma, incorporated by reference to Exhibit 10.53 to the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
−Removed: May 2017 Assignment of Manufacturing and Supply Agreement between Epic and Mikah Pharma, incorporated by reference to Exhibit 10.54 to the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
−Removed: Supply and Distribution Agreement between Dr.
−Removed: Reddy’s Laboratories and Mikah Pharma, incorporated by reference to Exhibit 10.55 to the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
−Removed: (Confidential Treatment granted with respect to portions of the Agreement).
−Removed: Manufacturing and Supply Agreement between Epic and Mikah Pharma, incorporated by reference to Exhibit 10.56 to the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
+Added: between NJEDA and the Bank of New York as Trustee, dated as of August 15, 2005, incorporated by reference to Exhibit 10.5 to the
+Added: Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.
+Added: Agreement, dated as of November 13, 2009, by and between the Company and Carter J.
+Added: Ward, incorporated by reference to Exhibit 10.2
+Added: to the Quarterly Report on Form 10-Q, for the period ending September 30, 2009 and filed with the SEC on November 16, 2009.+
+Added: Agreement, dated as of September 10, 2010, by and among Precision Dose Inc.
+Added: and the Company, incorporated by reference to Exhibit
+Added: 10.8 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010 (Confidential
+Added: Treatment granted with respect to portions of the Agreement).
+Added: Manufacturing
+Added: and Supply Agreement, dated as of September 10, 2010, by and among Precision Dose Inc.
+Added: and the Company, incorporated by reference
+Added: to Exhibit 10.9 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November
15, 2010 (Confidential Treatment granted with respect to portions of the Agreement).
−Removed: Master Development and License Agreement For Products Between Elite Pharmaceuticals, Inc.
−Removed: And SunGen dated July 6, 2017, incorporated by reference to Exhibit 10.57 to the Quarterly Report on Form 10-Q for the period ended June 30, 2017 and filed with the SEC on August 9, 2017.
+Added: 1, 2013 Employment Agreement with Nasrat Hakim, incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K, dated
+Added: August 1, 2013 and filed with the SEC on August 5, 2013.+
+Added: 1, 2013 Mikah LLC Asset Purchase Agreement, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K/A, dated
+Added: August 1, 2013 and filed with the SEC on August 30, 2018.
(Confidential Treatment granted with respect to portions of the Agreement).
−Removed: First Amendment to Master Development And License Agreement For Products Between Elite Pharmaceuticals, Inc.
−Removed: and SunGen Pharma, LLC, incorporated by reference to Exhibit 10.59 to the Quarterly Report on Form 10-Q for the period ended June 30, 2017 and filed with the SEC on August 9, 2017.
+Added: 1, 2013 Secured Convertible Note from the Company to Mikah Pharma LLC., incorporated by reference to Exhibit 10.2 to the Current
+Added: Report on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.
+Added: 1, 2013 Security Agreement from the Company to Mikah Pharma LLC., incorporated by reference to Exhibit 10.3 to the Current Report
+Added: on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.
+Added: 15, 2013 Hakim Credit Line Agreement, incorporated by reference to Exhibit 10.16 to the Quarterly Report on Form 10-Q for the period
+Added: ended September 30, 2013.
+Added: 2, 2013 Manufacturing and Licensing Agreement with Epic Pharma LLC, incorporated by reference to Exhibit 10.17 to the Amended Quarterly
+Added: Report on Form 10-Q/A for the period ended September 30, 2013 and filed with the SEC on April 25, 2014.
+Added: Confidential Treatment granted
+Added: with respect to portions of the Agreement.
+Added: 7, 2014 Amendment to Secured Convertible Note from the Company to Mikah, incorporated by reference to Exhibit 10.1 to the Current
+Added: Report on Form 8-K, dated February 7, 2014 and filed with the SEC on February 7, 2014.
+Added: Agreement with Dr.
+Added: Kenneth Smith, dated October 20, 2014, incorporated by reference to Exhibit 10.82 to the Quarterly Report on
+Added: Form 10-Q for the period ended September 30, 2014 and filed with the SEC on November 14, 2014.+
+Added: 28, 2015 First Amendment to the Loan Agreement between Nasrat Hakim and Elite Pharmaceuticals dated October 15, 2013, incorporated
+Added: by reference to Exhibit 10.83 to the Quarterly Report on Form 10-Q for the period ended December 31, 2014 and filed with the SEC
+Added: on February 17, 2015.
+Added: 28, 2015 Termination of Development and License Agreement for Mikah-001 between Elite Pharmaceuticals, Inc.
+Added: and Mikah Pharma LLC
+Added: and Transfer of Payment, incorporated by reference to Exhibit 10.84 to the Quarterly Report on Form 10-Q for the period ended December
+Added: 31, 2014 and filed with the SEC on February 17, 2015.
+Added: 1 to Hakim Employment Agreement, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC
+Added: on January 29, 2016.
+Added: 24, 2016 Master Development and License Agreement between Elite and SunGen Pharma LLC.
+Added: incorporated by reference to Exhibit 10.44
+Added: to the Quarterly Report on Form 10-Q for the period ended September 30, 2016 and filed with the SEC on November 9, 2016.
+Added: (Confidential
+Added: Treatment granted with respect to portions of the Agreement).
+Added: Purchase Agreement between the Company and Lincoln Park Capital LLC dated July 8, 2020, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated July 9, 2020 and filed with the SEC on July 9, 2020.
+Added: Rights Agreement between the Company and Lincoln Park Capital LLC dated July 8, 2020, incorporated by reference to Exhibit 10.2 to
+Added: the Current Report on Form 8-K, dated July 9, 2020 and filed with the SEC on July 9, 2020.
+Added: 2017 Trimipramine Acquisition Agreement from Mikah Pharma, incorporated by reference to Exhibit 10.50 to the Annual Report on Form
+Added: 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
+Added: 2017 Secured Promissory Note from the Company to Mikah Pharma, incorporated by reference to Exhibit 10.51 to the Annual Report on
+Added: Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
+Added: 2017 Security Agreement between the Company to Mikah Pharma, incorporated by reference to Exhibit 10.52 to the Annual Report on Form
+Added: 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
+Added: 2017 Assignment of Supply and Distribution Agreement between Dr.
+Added: Reddy’s Laboratories and Mikah Pharma, incorporated by reference
+Added: to Exhibit 10.53 to the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
+Added: 2017 Assignment of Manufacturing and Supply Agreement between Epic and Mikah Pharma, incorporated by reference to Exhibit 10.54 to
+Added: the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
+Added: and Distribution Agreement between Dr.
+Added: Reddy’s Laboratories and Mikah Pharma, incorporated by reference to Exhibit 10.55 to
+Added: the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
+Added: (Confidential Treatment
+Added: granted with respect to portions of the Agreement).
+Added: Manufacturing
+Added: and Supply Agreement between Epic and Mikah Pharma, incorporated by reference to Exhibit 10.56 to the Annual Report on Form 10-K,
+Added: for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
+Added: (Confidential Treatment granted with respect to portions
+Added: of the Agreement).
+Added: Development and License Agreement For Products Between Elite Pharmaceuticals, Inc.
+Added: And SunGen dated July 6, 2017, incorporated by
+Added: reference to Exhibit 10.57 to the Quarterly Report on Form 10-Q for the period ended June 30, 2017 and filed with the SEC on August
(Confidential Treatment granted with respect to portions of the Agreement).
−Removed: Second Amendment to Master Development And License Agreement For Products Between Elite Pharmaceuticals, Inc.
−Removed: and SunGen Pharma, LLC, incorporated by reference to Exhibit 10.58 to the Quarterly Report on Form 10-Q for the period ended June 30, 2017 and filed with the SEC on August 9, 2017.
+Added: Amendment to Master Development And License Agreement For Products Between Elite Pharmaceuticals, Inc.
+Added: and SunGen Pharma, LLC, incorporated
+Added: by reference to Exhibit 10.59 to the Quarterly Report on Form 10-Q for the period ended June 30, 2017 and filed with the SEC on August
(Confidential Treatment granted with respect to portions of the Agreement).
−Removed: May 22, 2018 License, Manufacturing and Supply Agreement with Glenmark Pharmaceuticals Inc.
−Removed: USA, incorporated by reference to Exhibit 10.60 to the Annual Report on Form 10-K for the fiscal year ended March 31, 2018 and filed with the SEC on June 14, 2018.
+Added: Amendment to Master Development And License Agreement For Products Between Elite Pharmaceuticals, Inc.
+Added: and SunGen Pharma, LLC, incorporated
+Added: by reference to Exhibit 10.58 to the Quarterly Report on Form 10-Q for the period ended June 30, 2017 and filed with the SEC on August
(Confidential Treatment granted with respect to portions of the Agreement).
−Removed: August 1, 2018 Amendment to the Glenmark Pharmaceuticals Inc.
−Removed: USA License, Supply and Distribution Agreement, incorporated by reference to Exhibit 10.44 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February 10, 2020.
−Removed: (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
−Removed: License, Supply And Distribution Agreement effective March 6, 2019 by and between Elite Pharmaceuticals, Inc., and Elite Laboratories, Inc.
−Removed: and Lannett Company, Inc., USA, incorporated by reference to Exhibit 10.45 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February 10, 2020.
−Removed: (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
−Removed: License, Supply and Distribution Agreement effective April 9, 2019 by and between Elite Pharmaceuticals, Inc., and Elite Laboratories, Inc.
−Removed: and Lannett Company, Inc., USA, incorporated by reference to Exhibit 10.49 to the Annual Report on Form 10-K for the period ended March 31, 2019 and filed with the SEC on June 21, 2019 (portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
−Removed: License, Supply and Distribution Agreement effective March 6, 2019 by and between Elite Pharmaceuticals, Inc., and Elite Laboratories, Inc.
−Removed: and Lannett Company, Inc., USA, incorporated by reference to Exhibit 10.50 to the Annual Report on Form 10-K for the period ended March 31, 2019 and filed with the SEC on June 21, 2019 (portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
−Removed: Development Agreement effective December 3, 2018 by and between Mikah Pharma LLC and Elite Laboratories, Inc., incorporated by reference to Exhibit 10.51 to the Annual Report on Form 10-K for the period ended March 31, 2019 and filed with the SEC on June 21, 2019 (portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
−Removed: Asset Purchase Agreement dated November 13, 2019 by and between the Company and Nostrum Laboratories Inc.
−Removed: , incorporated by reference to Exhibit 10.49 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February 10, 2020.
−Removed: January 2, 2020 Amendment to the Glenmark Pharmaceuticals Inc.
−Removed: USA License, Supply and Distribution Agreement, incorporated by reference to Exhibit 10.50 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February 10, 2020.
+Added: Supply And Distribution Agreement effective March 6, 2019 by and between Elite Pharmaceuticals, Inc., and Elite Laboratories, Inc.
+Added: and Lannett Company, Inc., USA, incorporated by reference to Exhibit 10.45 to the Quarterly Report on Form 10-Q, for the period ended
+Added: December 31, 2019 and filed with the SEC on February 10, 2020.
+Added: (Portions of this Agreement have been redacted in compliance with
+Added: Regulation S-K Item 601(b)(10)).
+Added: Supply and Distribution Agreement effective April 9, 2019 by and between Elite Pharmaceuticals, Inc., and Elite Laboratories, Inc.
+Added: and Lannett Company, Inc., USA, incorporated by reference to Exhibit 10.49 to the Annual Report on Form 10-K for the period ended
+Added: March 31, 2019 and filed with the SEC on June 21, 2019 (portions of this Agreement have been redacted in compliance with Regulation
+Added: S-K Item 601(b)(10)).
+Added: Supply and Distribution Agreement effective March 6, 2019 by and between Elite Pharmaceuticals, Inc., and Elite Laboratories, Inc.
+Added: and Lannett Company, Inc., USA, incorporated by reference to Exhibit 10.50 to the Annual Report on Form 10-K for the period ended
+Added: March 31, 2019 and filed with the SEC on June 21, 2019 (portions of this Agreement have been redacted in compliance with Regulation
+Added: S-K Item 601(b)(10)).
+Added: Agreement effective December 3, 2018 by and between Mikah Pharma LLC and Elite Laboratories, Inc., incorporated by reference to Exhibit
+Added: 10.51 to the Annual Report on Form 10-K for the period ended March 31, 2019 and filed with the SEC on June 21, 2019 (portions of
+Added: this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
+Added: Purchase Agreement dated November 13, 2019 by and between the Company and Nostrum Laboratories Inc.
+Added: , incorporated by reference to
+Added: Exhibit 10.49 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February 10,
+Added: 2, 2020 Amendment to the Glenmark Pharmaceuticals Inc.
+Added: USA License, Supply and Distribution Agreement, incorporated by reference
+Added: to Exhibit 10.50 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February
(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
−Removed: Asset Purchase Agreement executed January 16, 2020 by and between the Company and Nostrum Laboratories Inc., incorporated by reference to Exhibit 10.49 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February 10, 2020.
−Removed: Employment Agreement
−Removed: with Douglas Plassche *
+Added: Purchase Agreement executed January 16, 2020 by and between the Company and Nostrum Laboratories Inc., incorporated by reference
+Added: to Exhibit 10.49 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February
+Added: Employment Agreement with Douglas Plassche *+
June 21, 2019 Retention Agreement with Douglas Plassche.* +
2 unchanged sentences
(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).*
−Removed: Subsidiaries of the Company, incorporated by reference to Exhibit 21 to the Annual Report on Form 10-K, for the period ended March 31, 2019 and filed with the SEC on June 21, 2019.
+Added: of the Company, incorporated by reference to Exhibit 21 to the Annual Report on Form 10-K, for the period ended March 31, 2019 and
+Added: filed with the SEC on June 21, 2019.
Consent of Buchbinder Tunick & Company LLP, Independent Registered Public Accounting Firm*
5 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
−Removed: Instance Document
−Removed: Taxonomy Schema Document
−Removed: Taxonomy Extension Calculation Linkbase Document
−Removed: Taxonomy Extension Definition Linkbase Document
−Removed: Taxonomy Extension Label Linkbase Document
−Removed: Taxonomy Extension Presentation Linkbase Document
−Removed: ITEM 16 FORM 10-K SUMMARY
−Removed: Pursuant to the requirements of Section 13 or 15(d) of the
−Removed: Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
−Removed: duly authorized.
+Added: XBRL Instance Document
+Added: XBRL Taxonomy Schema Document
+Added: XBRL Taxonomy Extension Calculation Linkbase Document
+Added: XBRL Taxonomy Extension Definition Linkbase Document
+Added: XBRL Taxonomy Extension Label Linkbase Document
+Added: XBRL Taxonomy Extension Presentation Linkbase Document
+Added: Cover Page Interactive Data File
+Added: Indicates management contract or compensatory plan or arrangement.
+Added: FORM 10-K SUMMARY
+Added: Pursuant to the requirements of Section 13 or
+Added: 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
+Added: thereunto duly authorized.
ELITE PHARMACEUTICALS, INC.
2 unchanged sentences
June 14, 2021
−Removed: /s/ Carter J.
+Added: /s/ Marc Bregman
Chief Financial Officer
1 unchanged sentence
Pursuant to the requirements of the Securities
−Removed: Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities and
−Removed: on the dates indicated.
−Removed: /s/ Nasrat Hakim
−Removed: Chief Executive Officer, President and Chairman of the Board of Directors
−Removed: June 29, 2020
−Removed: /s/ Carter J.
−Removed: Chief Financial Officer, Treasurer, Secretary
+Added: Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities and on the
+Added: dates indicated.
+Added: Chief Executive Officer,
+Added: President and Chairman of the
+Added: Board of Directors (Principal Executive Officer)
+Added: Chief Financial Officer, Treasurer, Secretary (Principal
June 14, 2021
−Removed: /s/ Barry Dash
+Added: Financial Officer and Principal Accounting Officer)
June 14, 2021
−Removed: /s/ Jeffrey Whitnell
+Added: Jeffrey Whitnell
June 14, 2021
−Removed: /s/ Davis Caskey
June 14, 2021
−Removed: ELITE PHARMACEUTICALS,
+Added: ELITE PHARMACEUTICALS, INC.
AND SUBSIDIARIES
−Removed: CONSOLIDATED FINANCIAL
−Removed: FOR THE YEARS
−Removed: ENDED MARCH 31, 2020 AND 2019
−Removed: REPORT OF INDEPENDENT
−Removed: REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: CONSOLIDATED BALANCE
+Added: CONSOLIDATED FINANCIAL STATEMENTS
+Added: FOR THE YEARS ENDED MARCH 31, 2021 AND 2020
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
+Added: CONSOLIDATED BALANCE SHEETS
CONSOLIDATED STATEMENTS OF OPERATIONS
−Removed: CONSOLIDATED STATEMENTS
−Removed: OF STOCKHOLDERS EQUITY (DEFICIT)
−Removed: CONSOLIDATED STATEMENTS
−Removed: OF CASH FLOWS
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’
+Added: CONSOLIDATED STATEMENTS OF CASH FLOWS
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
To the Board of Directors and
−Removed: Stockholders of Elite Pharmaceuticals, Inc.
−Removed: and Subsidiary
+Added: Stockholders of Elite Pharmaceuticals, Inc., and Subsidiary
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of
−Removed: Elite Pharmaceuticals, Inc.
−Removed: and Subsidiary (the Company) as of March 31, 2020 and 2019, and the related consolidated statements
−Removed: of operations, stockholders’
−Removed: Equity (deficit), and cash flows for each of the years in the two-year period ended March 31,
+Added: We have audited the accompanying
+Added: consolidated balance sheets of Elite Pharmaceuticals, Inc.
+Added: and Subsidiary (the Company) as of March 31, 2021 and 2020, and the related
+Added: consolidated statements of operations, stockholders’
+Added: equity, and cash flows for each of the years in the two-year period ended March
31, 2021, and the related notes (collectively referred to as the consolidated financial statements).
In our opinion, the consolidated
−Removed: financial statements present fairly, in all material respects, the financial position of the Company as of March 31, 2020 and 2019
−Removed: and the results of its operations and its cash flows for each of the years in the two-year period ended March 31, 2020 in conformity
−Removed: with accounting principles generally accepted in the United States of America.
+Added: financial statements present fairly, in all material respects, the financial position of the Company as of March 31, 2021 and 2020 and
+Added: the results of its operations and its cash flows for each of the years in the two-year period ended March 31, 2021 in conformity with
+Added: accounting principles generally accepted in the United States of America.
Basis for Opinion
−Removed: These consolidated financial statements are the responsibility of
−Removed: the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated financial statements
−Removed: based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
−Removed: (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and
−Removed: the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards of the
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
−Removed: are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged to perform,
−Removed: an audit of its internal control over financial reporting.
−Removed: As part of our audits, we are required to obtain an understanding of
−Removed: internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s
−Removed: internal control over financial reporting.
+Added: These consolidated financial statements
+Added: are the responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s consolidated
+Added: financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board
+Added: (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities
+Added: laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance
+Added: with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
+Added: the financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were
+Added: we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits, we are required to obtain an
+Added: understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the
+Added: Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
−Removed: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to
−Removed: error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence
−Removed: regarding the amounts and disclosures in the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting
−Removed: principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated
+Added: Our audits included performing procedures to assess
+Added: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
+Added: to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated
financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
−Removed: /s/ Buchbinder
−Removed: & Tunick Company LLP
−Removed: & Tunick Company LLP
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management,
+Added: as well as evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audits provide a reasonable
+Added: basis for our opinion.
+Added: Critical Audit Matter
+Added: The critical audit matter communicated
+Added: below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated
+Added: to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved
+Added: our especially challenging, subjective, or complex judgments.
+Added: The communication of the critical audit matter does not alter in any way
+Added: our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing
+Added: separate opinions on the critical audit matter or on the accounts or disclosures to which they relate.
+Added: Indefinite-Lived Intangible Assets Impairment
+Added: Assessments of ANDAs and Patents —
+Added: Refer to Notes 1, 4 and 15 to the financial statements
+Added: Critical Audit Matter Description
+Added: As of March 31,
+Added: 2021, the Company has capitalized costs of $6,168,351 for ANDAs and $465,684 for patents.
+Added: The Company evaluates its intangible assets
+Added: for impairment annually during the fourth quarter in accordance with ASC Topic 350, Intangibles Goodwill and Other, and between annual
+Added: evaluations if events occur or circumstances change that would more likely than not reduce the fair value of the assets carrying amount.
+Added: Management evaluates qualitative
+Added: factors to determine whether it is more likely than not that the fair value of the intangible assets is less than its carrying amount.
+Added: The qualitative factors management considers include, but are not limited to, the current project status, expected future cash flows,
+Added: decline in the Company’s stock price, legal and regulatory factors and industry and market considerations.
+Added: We identified the impairment evaluation
+Added: of the intangibles as a critical audit matter because of the significant judgements made by management to estimate the fair value of the
+Added: intangible assets.
+Added: Our audit procedures related to impairment
+Added: of indefinite lived intangible assets included review of management’s analysis and testing the significant assumptions used by management.
+Added: /s/ Buchbinder Tunick & Company LLP
+Added: Buchbinder Tunick & Company LLP
We have served as the Company’s auditor since 2010.
1 unchanged sentence
June 14, 2021,
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: CONSOLIDATED BALANCE
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: CONSOLIDATED BALANCE SHEETS
Current assets:
−Removed: Accounts receivable, net of allowance for doubtful accounts of $-0-, respectively
−Removed: Prepaid expenses and other current assets
+Added: Accounts receivable, net of allowance for doubtful accounts
+Added: of $-0-, respectively
+Added: Prepaid expenses and other current
Total current assets
−Removed: Property and equipment, net of accumulated depreciation of $10,957,334 and $9,651,718, respectively
−Removed: Intangible assets, net of accumulated amortization of $-0-, respectively
−Removed: Operating lease –
−Removed: right-of-use asset
+Added: Property and equipment, net of accumulated
+Added: depreciation of $12,153,626 and $10,957,334, respectively
+Added: Intangible assets, net of accumulated
+Added: amortization of $-0-, respectively
+Added: Operating lease - right-of-use asset
Other assets:
2 unchanged sentences
Total other assets
−Removed: LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’
−Removed: EQUITY (DEFICIT)
+Added: LIABILITIES AND SHAREHOLDERS’
Current liabilities:
5 unchanged sentences
Lease obligation - operating lease, current portion
−Removed: Customer deposits
−Removed: Senior secured promissory note - related party, current portion
+Added: Senior secured promissory note -
+Added: related party, current portion
Total current liabilities
1 unchanged sentence
Deferred revenue, net of current portion
−Removed: Bonds payable, net of current portion and bond issuance costs
−Removed: Senior secured promissory note - related party, net of current portion
+Added: Bonds payable, net of current portion and bond issuance
Loans payable, net of current portion
4 unchanged sentences
Total liabilities
−Removed: The accompanying notes are an integral
−Removed: part of these audited consolidated financial statements.
−Removed: ELITE PHARMACEUTICALS,
−Removed: AND SUBSIDIARIES
−Removed: CONSOLIDATED BALANCE
−Removed: Mezzanine equity
−Removed: Series J convertible
−Removed: preferred stock;
−Removed: par value $0.01;
−Removed: 50 shares authorized, 24.0344 issued and outstanding as of March 31, 2019
+Added: The accompanying notes are an integral part
+Added: of these audited consolidated financial statements.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: CONSOLIDATED BALANCE SHEETS
Shareholders’
−Removed: equity (deficit):
Series J convertible preferred stock;
−Removed: par value of $0.01 50 shares authorized;
−Removed: 24.0344 issued and outstanding as of March 31, 2020
+Added: value of $0.01;
+Added: 50 shares authorized;
+Added: 0 issued and outstanding as of March 31, 2021 and 24.0344 issued and outstanding as of March
Common Stock;
1 unchanged sentence
1,445,000,000 shares authorized;
−Removed: shares issued and 840,404,367 outstanding as of March 31, 2020;
−Removed: 995,000,000 shares authorized;
−Removed: 824,946,559 shares issued and
−Removed: 824,846,559 outstanding as of March 31, 2019
+Added: 1,009,276,752
+Added: shares issued and 1,009,176,752 shares outstanding as of March 31, 2021;
+Added: 840,504,367 shares issued and 840,404,367 shares outstanding
+Added: as of March 31, 2020
Additional paid-in capital
5 unchanged sentences
Total shareholders’
−Removed: Total liabilities, mezzanine equity
+Added: Total liabilities
and shareholders’
−Removed: equity (deficit)
−Removed: The accompanying notes are an integral
−Removed: part of these audited consolidated financial statements.
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS
−Removed: OF OPERATIONS
−Removed: Years Ended March 31,
+Added: The accompanying notes are an integral part
+Added: of these audited consolidated financial statements.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS
+Added: For the Years Ended
Manufacturing fees
1 unchanged sentence
Total revenue
−Removed: Cost of revenue
+Added: Cost of manufacturing
Operating expenses:
4 unchanged sentences
Total operating expenses
−Removed: Loss from operations
+Added: Income (loss) from operations
Other income (expense):
−Removed: Interest expense
−Removed: Change in fair value of derivative instruments - warrants
+Added: Change in fair value of derivative instruments
+Added: Interest expense and amortization of debt issuance costs
+Added: Gain on sale of fixed assets
+Added: Gain on transfer/discontinuance of intangible assets
Interest income
−Removed: Gain (loss) realized from
−Removed: transfer/discontinuance of intangible assets
−Removed: Other income (expense), net
−Removed: Loss from operations before income taxes
−Removed: Income tax provision
−Removed: Net benefit from sale of state net operating loss credits
−Removed: Net loss attributable to common shareholders
−Removed: $ (2,240,351 )
+Added: PPP loan forgiveness
+Added: Other income, net
+Added: Income (loss) from operations before income taxes
+Added: Income tax benefit (expense)
+Added: Net income (loss) attributable to common shareholders
$ (2,240,351 )
−Removed: Basic net loss per share attributable to common shareholders
−Removed: Diluted net loss per share attributable to common shareholders
+Added: Basic net income (loss) per share attributable to common shareholders
+Added: Diluted net income (loss) per share attributable to common shareholders
Basic weighted average Common Stock outstanding
Diluted weighted average Common Stock outstanding
−Removed: The accompanying notes are an integral
−Removed: part of these audited consolidated financial statements.
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS
−Removed: OF STOCKHOLDERS’
−Removed: EQUITY (DEFICIT)
−Removed: Series J Preferred Stock
−Removed: Additional Paid-In
+Added: The accompanying notes are an integral part
+Added: of these audited consolidated financial statements.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’
+Added: Preferred Stock
Treasury Stock
−Removed: Total Shareholders’
+Added: Shareholders’
Balance as of March 31, 2019
1 unchanged sentence
$ (151,806,059 )
−Removed: Common Stock sold pursuant to the Lincoln Park
−Removed: purchase agreement
−Removed: Common Stock issued as additional commitment shares
−Removed: pursuant to the LPC purchase agreement
+Added: $ (2,507,864 )
+Added: Common Stock sold pursuant to the Lincoln Park purchase
+Added: Common Stock issued as additional commitment shares pursuant
+Added: to the LPC purchase agreement
Costs associated with raising capital
−Removed: Non-cash compensation through
−Removed: the issuance of employee stock options
+Added: Non-cash compensation through the issuance of employee
+Added: stock options
+Added: Reclassification of mezzanine equity
+Added: to permanent equity
Balance at March 31, 2020
1 unchanged sentence
$ (154,046,410 )
+Added: Conversion of Preferred Stock to Common Stock
(13,903,960 )
−Removed: Common Stock sold pursuant to the Lincoln Park
−Removed: purchase agreement
−Removed: Common Stock issued as additional commitment shares
−Removed: pursuant to the LPC purchase agreement
+Added: Initial commitment shares issued pursuant to the 2020
+Added: Lincoln Park purchase agreement
+Added: Common Stock sold pursuant to the Lincoln Park purchase
+Added: Common Stock issued as additional commitment shares pursuant
+Added: to the LPC purchase agreement
Costs associated with raising capital
1 unchanged sentence
stock options
−Removed: Reclassification of mezzanine
−Removed: equity to permanent equity
+Added: Shares issued in payment of Director fees
+Added: Shares issued in payment of salaries
+Added: Shares issued in payment of consulting
Balance at March 31, 2021
1 unchanged sentence
$ 164,407,480
−Removed: The accompanying notes are an integral
−Removed: part of these audited consolidated financial statements.
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS
−Removed: OF CASH FLOWS
−Removed: Years Ended March 31,
−Removed: CASH FLOWS FROM OPERATING ACTIVITIES:
$ (148,957,989 )
+Added: The accompanying notes are an integral part
+Added: of these audited consolidated financial statements.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: For the Years Ended
+Added: CASH FLOWS FROM OPERATING ACTIVITIES:
+Added: Net income (loss)
$ (2,240,351 )
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization
−Removed: Amortization of operating leases –
−Removed: right-of-use assets
+Added: Amortization of operating leases - right-of-use assets
+Added: Gain on the disposal of property and equipment
Change in fair value of derivative financial instruments - warrants
+Added: PPP loan forgiveness
Non-cash compensation accrued
−Removed: Non-cash compensation through the issuance of employee stock options
+Added: Non-cash compensation from issuances of options
Non-cash rent expense and lease accretion
−Removed: Non-cash loss on sale and discontinuance of intangible assets
Change in operating assets and liabilities:
4 unchanged sentences
Lease obligations - operating leases
−Removed: Net cash used in operating activities
+Added: Net cash provided by (used in) operating activities
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
−Removed: Proceeds from sale of intangible assets
−Removed: Net cash (used in) provided by investing activities
+Added: Proceeds from disposal of property and equipment
+Added: Net cash used in investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Proceeds from the issuance of stock
+Added: Proceeds from the issuance of Common Stock
+Added: Proceeds from PPP loan
+Added: Payment of related party note payable
Payment of bond principal
Other loan payments
−Removed: Net cash provided by financing activities
+Added: Net cash (used in) provided by financing activities
Net change in cash and restricted cash
4 unchanged sentences
Financing of equipment purchases and insurance renewal
+Added: Stock issued in payment of Directors fees, salaries and consulting expenses
Commitment shares issued to Lincoln Park Capital
+Added: Conversion of preferred stock to Common Stock
Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets
−Removed: The accompanying notes are an integral
−Removed: part of these audited consolidated financial statements.
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: Elite Pharmaceuticals,
+Added: Elite Pharmaceuticals, Inc.
(the “Company”
−Removed: or “Elite”) was incorporated on October 1, 1997 under the laws of the State of Delaware,
−Removed: and its wholly-owned subsidiary Elite Laboratories, Inc.
−Removed: (“Elite Labs”) which was incorporated on August 23, 1990
−Removed: under the laws of the State of Delaware.
−Removed: On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State
−Removed: Elite Labs engages primarily in researching, developing, manufacturing and licensing generic, oral dose pharmaceuticals
−Removed: and proprietary orally administered, controlled-release drug delivery systems.
−Removed: The Company is equipped to manufacture immediate
−Removed: release and controlled-release products on a contract basis for third parties and itself, if and when the products are approved.
−Removed: These products include drugs that cover therapeutic areas that include, without limitation, pain, allergy, bariatric and infection.
−Removed: Research and development activities are done so with an objective of developing products that will secure marketing approvals
−Removed: from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products.
+Added: or “Elite”) was incorporated on October 1, 1997 under the laws of the State of Delaware, and its
+Added: wholly-owned subsidiary Elite Laboratories, Inc.
+Added: (“Elite Labs”) was incorporated on August 23, 1990 under the laws of the
+Added: State of Delaware.
+Added: On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of Nevada.
+Added: Elite Labs engages
+Added: primarily in researching, developing, licensing and manufacture of generic, oral dose pharmaceuticals.
+Added: The Company is equipped to manufacture
+Added: controlled-release products on a contract basis for third parties and itself, if and when the products are approved.
+Added: These products include
+Added: drugs that cover therapeutic areas for allergy, bariatric, attention deficit and infection.
+Added: Research and development activities are performed
+Added: with an objective of developing products that will secure marketing approvals from the United States Food and Drug Administration (“FDA”),
+Added: and thereafter, commercially exploiting such products.
Principles of Consolidation
The accompanying audited
−Removed: consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United
−Removed: States (“GAAP”) and in conformity with the instructions on Form 10-K and Rule 8-03 of Regulation S-X and the related
−Removed: rules and regulations of the Securities and Exchange Commission (“SEC”).
−Removed: The consolidated financial statements include
−Removed: the accounts of the Company and its wholly owned subsidiary, Elite Laboratories, Inc.
−Removed: All significant intercompany accounts and
−Removed: transactions have been eliminated in consolidation.
−Removed: The consolidated financial statements reflect all adjustments, consisting
−Removed: of normal recurring accruals, which are, in the opinion of management, necessary for a fair presentation of such statements.
+Added: consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States
+Added: (“GAAP”).
+Added: The audited consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary,
+Added: Elite Laboratories, Inc.
+Added: All significant intercompany accounts and transactions have been eliminated in consolidation.
+Added: The audited consolidated
+Added: financial statements reflect all adjustments, consisting of normal recurring items, which are, in the opinion of management, necessary
+Added: for a fair presentation of such statements.
Segment Information
−Removed: Financial Accounting
−Removed: Standards Board (“FASB”) Accounting Standards Codification (“ASC 280”), Segment Reporting , establishes
−Removed: standards for reporting information about operating segments.
−Removed: Operating segments are defined as components of an enterprise about
−Removed: which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making
−Removed: group, in deciding how to allocate resources and in assessing performance.
−Removed: The Company’s chief operating decision maker
−Removed: is the Chief Executive Officer, who reviews the financial performance and the results of operations of the segments prepared in
−Removed: accordance with GAAP when making decisions about allocating resources and assessing performance of the Company.
+Added: Financial Accounting Standards
+Added: Board (“FASB”) Accounting Standards Codification 280 (“ASC 280”), Segment Reporting , establishes standards
+Added: for reporting information about operating segments.
+Added: Operating segments are defined as components of an enterprise about which separate
+Added: financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group, in deciding
+Added: how to allocate resources and in assessing performance.
+Added: The Company’s chief
+Added: operating decision maker is the Chief Executive Officer, who reviews the financial performance and the results of operations of the segments
+Added: prepared in accordance with GAAP when making decisions about allocating resources and assessing performance of the Company.
The Company has determined
1 unchanged sentence
and products whose marketing approvals were secured via a New Drug Application (“NDA”).
−Removed: ANDA products are referred
−Removed: to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals.
−Removed: There are currently
−Removed: no intersegment revenues.
−Removed: Asset information by operating segment is not presented below since the chief operating decision maker
−Removed: does not review this information by segment.
−Removed: The reporting segments follow the same accounting policies used in the preparation
−Removed: of the Company’s audited consolidated financial statements.
+Added: ANDA products are referred to as
+Added: generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals.
+Added: There are currently no intersegment
+Added: Asset information by operating segment is not presented below since the chief operating decision maker does not review this
+Added: information by segment.
+Added: The reporting segments follow the same accounting policies used in the preparation of the Company’s audited
+Added: consolidated financial statements.
Please see Note 15 for further details.
Revenue Recognition
−Removed: The Company generates
−Removed: revenue from the development of pain management products, manufacturing of a line of generic pharmaceutical products with approved
−Removed: ANDA, commercialization of products either by license and the collection of royalties, or through the manufacture of formulations
−Removed: and the development of new products and the expansion of licensing agreements with other pharmaceutical companies, including co-development
−Removed: projects, joint ventures and other collaborations.
−Removed: The Company also generates revenue through its focus on the development of
−Removed: various types of drug products, including branded drug products which require NDAs.
−Removed: ELITE PHARMACEUTICALS,
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
+Added: The Company generates revenue
+Added: primarily from manufacturing and licensing fees.
+Added: Manufacturing fees include the development of pain management products, manufacturing
+Added: of a line of generic pharmaceutical products with approved ANDA, through the manufacture of formulations and the development of new products.
+Added: Licensing fees include the commercialization of products either by license and the collection of royalties, or the expansion of licensing
+Added: agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.
Under ASC 606, Revenue
−Removed: from Contacts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains control of
−Removed: promised goods or services, in an amount that reflects the consideration which is expected to be received in exchange for those
−Removed: goods or services.
−Removed: The Company recognize revenues following the five-step model prescribed under ASC 606:
−Removed: (i) identify contract(s)
−Removed: with a customer;
−Removed: (ii) identify the performance obligation(s) in the contract;
+Added: from Contacts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains control of promised
+Added: goods or services, in an amount that reflects the consideration which is expected to be received in exchange for those goods or services.
+Added: The Company recognizes revenues following the five-step model prescribed under ASC 606:
+Added: (i) identify contract(s) with a customer;
+Added: identify the performance obligation(s) in the contract;
(iii) determine the transaction price;
−Removed: (iv) allocate
−Removed: the transaction price to the performance obligation(s) in the contract;
−Removed: and (v) recognize revenues when (or as) the Company satisfies
−Removed: a performance obligation.
−Removed: The Company only applies the five-step model to contracts when it is probable that the entity will collect
−Removed: the consideration it is entitled to in exchange for the goods or services it transfers to the customer.
−Removed: At contract inception,
−Removed: once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within
−Removed: each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.
−Removed: The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation
−Removed: when (or as) the performance obligation is satisfied.
−Removed: Sales, value add, and other taxes collected on behalf of third parties are
−Removed: excluded from revenue.
+Added: (iv) allocate the transaction price to
+Added: the performance obligation(s) in the contract;
+Added: and (v) recognize revenues when (or as) the Company satisfies a performance obligation.
+Added: The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled
+Added: to in exchange for the goods or services it transfers to the customer.
+Added: At contract inception, once the contract is determined to be within
+Added: the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance
+Added: obligations and assesses whether each promised good or service is distinct.
+Added: The Company then recognizes as revenue the amount of the
+Added: transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
+Added: value add, and other taxes collected on behalf of third parties are excluded from revenue.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Nature of goods and services
−Removed: The following is a
−Removed: description of the Company’s goods and services from which the Company generates revenue, as well as the nature, timing
−Removed: of satisfaction of performance obligations, and significant payment terms for each, as applicable:
+Added: The following is a description
+Added: of the Company’s goods and services from which the Company generates revenue, as well as the nature, timing of satisfaction of
+Added: performance obligations, and significant payment terms for each, as applicable:
a) Manufacturing Fees
−Removed: The Company manufacturers
−Removed: immediate-release and controlled release generic pharmaceutical products for which required FDA approvals have been received and
−Removed: are owned by the Company.
−Removed: These products are either sold directly by the Company, under its own label, or are sold under licenses
−Removed: granted to a third party, under a third-party label.
−Removed: Please note that while the Company is equipped to manufacture immediate-release
−Removed: and controlled release generic pharmaceutical which are owned by third parties, on a contract basis, it did not engage in any
−Removed: such contract manufacturing activities during the periods within the scope of these financial statements.
−Removed: The Company recognizes
−Removed: revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of the contract.
−Removed: Revenue on product are presented gross because the Company is primarily responsible for fulfilling the promise to provide the
−Removed: product, is responsible to ensure that the product is produced in accordance with the related supply agreement and bears risk
−Removed: of loss while the inventory is in-transit to the commercial partner.
−Removed: Revenue is measured as the amount of consideration the Company
−Removed: expects to receive in exchange for transferring products to a customer.
+Added: The Company is equipped to
+Added: manufacture controlled-release products on a contract basis for third parties, if, and when, the products are approved.
+Added: These products
+Added: include products using controlled-release drug technology.
+Added: The Company also develops and markets (either on its own or by license to
+Added: other companies) generic and proprietary controlled-release pharmaceutical products.
+Added: The Company recognizes revenue
+Added: when the customer obtains control of the Company’s product based on the contractual shipping terms of the contract.
+Added: is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the product is produced in
+Added: accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial partner.
+Added: is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer.
b) License Fees
−Removed: The Company enters
−Removed: into licensing and development agreements, which may include multiple revenue generating activities, including milestone payments,
−Removed: licensing fees, product sales and services.
−Removed: The Company analyzes each element of its licensing and development agreements in accordance
−Removed: with ASC 606 to determine appropriate revenue recognition.
−Removed: The terms of the license agreement may include payment to the Company
−Removed: of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties
−Removed: on product sales.
+Added: The Company enters into licensing
+Added: and development agreements, which may include multiple revenue generating activities, including milestones payments, licensing fees,
+Added: product sales and services.
+Added: The Company analyzes each element of its licensing and development agreements in accordance with ASC 606
+Added: to determine appropriate revenue recognition.
+Added: The terms of the license agreement may include payment to the Company of licensing fees,
+Added: non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales.
If the contract contains
a single performance obligation, the entire transaction price is allocated to the single performance obligation.
−Removed: Contracts that
−Removed: contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone
−Removed: selling prices of the promised products or services underlying each performance obligation.
−Removed: The Company determines standalone
−Removed: selling prices based on the price at which the performance obligation is sold separately.
−Removed: If the standalone selling price is not
−Removed: observable through past transactions, the Company estimates the standalone selling price taking into account available information
−Removed: such as market conditions and internally approved pricing guidelines related to the performance obligations.
−Removed: The Company recognizes
−Removed: revenue from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual
−Removed: property to the customer.
−Removed: For those milestone payments which are contingent on the occurrence of particular future events (for
−Removed: example, payments due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion
−Removed: in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount
−Removed: As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone.
−Removed: Given the inherent uncertainty of the occurrence of future events, the Company will not recognize revenue from the milestone until
−Removed: there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event.
+Added: Contracts that contain
+Added: multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices
+Added: of the promised products or services underlying each performance obligation.
+Added: The Company determines standalone selling prices based on
+Added: the price at which the performance obligation is sold separately.
+Added: If the standalone selling price is not observable through past transactions,
+Added: the Company estimates the standalone selling price taking into account available information such as market conditions and internally
+Added: approved pricing guidelines related to the performance obligations.
+Added: The Company recognizes revenue
+Added: from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property
+Added: to the customer.
+Added: For those milestone payments which are contingent on the occurrence of particular future events (for example, payments
+Added: due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion in the calculation
+Added: of total consideration from the contract as a component of variable consideration using the most-likely amount method.
+Added: As such, the Company
+Added: assesses each milestone to determine the probability and substance behind achieving each milestone.
+Added: Given the inherent uncertainty of
+Added: the occurrence of future events, the Company will recognize revenue from the milestone when there is not a high probability of a reversal
+Added: of revenue, which typically occurs near or upon achievement of the event.
+Added: Significant management judgment
+Added: is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete
+Added: its performance obligations under the arrangement.
+Added: If the Company cannot reasonably estimate when its performance obligations either
+Added: are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates.
+Added: is then recognized over the remaining estimated period of performance using the cumulative catch-up method.
+Added: When determining the transaction
+Added: price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance,
+Added: resulting in a significant financing component.
+Added: Applying the practical expedient in ASC 606-10-32-18, the Company does not assess whether
+Added: a significant financing component exists if the period between when the Company performs its obligations under the contract and when
+Added: the customer pays is one year or less.
+Added: None of the Company’s contracts contained a significant financing component as of March 31,
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Significant management
−Removed: judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects
−Removed: to complete its performance obligations under the arrangement.
−Removed: If the Company cannot reasonably estimate when its performance
−Removed: obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably
−Removed: make such estimates.
−Removed: Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up
−Removed: When determining the
−Removed: transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly
−Removed: after performance, resulting in a significant financing component.
−Removed: Applying the practical expedient in ASC 606-10-32-18, the Company
−Removed: does not assess whether a significant financing component exists if the period between when the Company performs its obligations
−Removed: under the contract and when the customer pays is one year or less.
−Removed: None of the Company’s contracts contained a significant
−Removed: financing component as of March 31, 2020.
−Removed: In accordance with
−Removed: ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
+Added: In accordance with ASC 606-10-55-65,
+Added: royalties are recognized when the subsequent sale of the customer’s products occurs.
+Added: The Company entered into
+Added: a sales and distribution licensing agreement with Epic Pharma LLC, (“Epic”) dated June 4, 2015 (the “2015 Epic License
+Added: Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted
+Added: for accordingly.
+Added: The 2015 Epic License Agreement expired on June 4, 2020 without renewal.
+Added: The Company entered into
+Added: a Master Development and License Agreement with SunGen Pharma LLC dated August 24, 2016 (the “SunGen Agreement”), which has
+Added: been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly.
+Added: 2020, Elite and SunGen mutually agreed to discontinue any further joint product development activities.
Disaggregation of revenue
−Removed: In the following table,
−Removed: revenue is disaggregated by type of revenue generated by the Company and timing of revenue recognition.
−Removed: The table also includes
−Removed: a reconciliation of the disaggregated revenue with the reportable segments:
−Removed: For the Year Ended March 31,
+Added: In the following table, revenue
+Added: is disaggregated by type of revenue generated by the Company.
+Added: The table also includes a reconciliation of the disaggregated revenue with
+Added: the reportable segments:
+Added: For the Years Ended March 31,
Licensing fees
4 unchanged sentences
Total revenue
−Removed: Collaborative Arrangements
−Removed: Contracts are considered
−Removed: to be collaborative arrangements when they satisfy the following criteria defined in ASC 808, Collaborative Arrangements :
−Removed: ● The parties to the contract
−Removed: must actively participate in the joint operating activity;
−Removed: ● The joint operating activity
−Removed: must expose the parties to the possibility of significant risk and rewards, based on
−Removed: whether or not the activity is successful.
−Removed: The Company entered
−Removed: into a sales and distribution licensing agreement with Epic Pharma LLC, (“Epic”) dated June 4, 2015 (the “2015
−Removed: Epic License Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement,
−Removed: and is accounted for accordingly, in accordance with GAAP.
−Removed: The 2015 Epic License Agreement expired on June 4, 2020 without renewal.
−Removed: The Company entered
−Removed: into a Master Development and License Agreement with SunGen Pharma LLC dated August 24, 2016 (the “SunGen Agreement”),
−Removed: which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly,
−Removed: in accordance with GAAP.
−Removed: On April 3, 2020, Elite and SunGen mutually agreed to discontinue any further joint product development
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The Company considers
−Removed: all highly liquid investments with an original maturity of three months or less to be cash equivalents.
−Removed: Cash and cash equivalents
−Removed: consist of cash on deposit with banks and money market instruments.
−Removed: The Company places its cash and cash equivalents with high-quality,
+Added: The Company considers all
+Added: highly liquid investments with an original maturity of three months or less to be cash equivalents.
+Added: Cash and cash equivalents consist
+Added: of cash on deposit with banks and money market instruments.
+Added: The Company places its cash and cash equivalents with high-quality, U.S.
financial institutions and, to date has not experienced losses on any of its balances.
1 unchanged sentence
As of March 31, 2021
−Removed: and March 31, 2019, the Company had $404,802 and $398,125 of restricted cash, respectively, related to debt service reserve in
−Removed: regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5).
−Removed: Accounts Receivable
+Added: and March 31, 2020, the Company had restricted cash of $405,013 and $404,802, respectively, related to debt service reserve in regard
+Added: to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5).
Accounts Receivable
−Removed: are comprised of balances due from customers, net of estimated allowances for uncollectible accounts.
−Removed: In determining collectability,
−Removed: historical trends are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances.
−Removed: Inventory is recorded
−Removed: at the lower of cost or market on specific identification by lot number basis.
+Added: Accounts receivable are comprised
+Added: of balances due from customers, net of estimated allowances for uncollectible accounts.
+Added: In determining collectability, historical trends
+Added: are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances.
+Added: Inventory is recorded at
+Added: the lower of cost or market on specific identification by lot number basis.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Long-Lived Assets
The Company periodically
−Removed: evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events or changes
−Removed: in circumstances indicate that its carrying amounts may not be recoverable.
−Removed: Property and equipment
−Removed: are stated at cost.
−Removed: Depreciation is provided on the straight-line method based on the estimated useful lives of the respective
−Removed: assets which range from three to forty years.
+Added: evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events or changes in circumstances
+Added: indicate that its carrying amounts may not be recoverable.
+Added: Property and equipment are
+Added: stated at cost.
+Added: Depreciation is provided on the straight-line method based on the estimated useful lives of the respective assets which
+Added: range from three to forty years.
Major repairs or improvements are capitalized.
−Removed: Minor replacements and maintenance
−Removed: and repairs which do not improve or extend asset lives are expensed currently.
−Removed: Upon retirement or
−Removed: other disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting gain
−Removed: or loss, if any, is recognized in income.
+Added: Minor replacements and maintenance and repairs which
+Added: do not improve or extend asset lives are expensed currently.
+Added: Upon retirement or other
+Added: disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss, if
+Added: any, is recognized in income.
Intangible Assets
−Removed: The Company capitalizes
−Removed: certain costs to acquire intangible assets;
−Removed: if such assets are determined to have a finite useful life they are amortized on a
−Removed: straight-line basis over the estimated useful life.
−Removed: Costs to acquire indefinite lived intangible assets, such as costs related
−Removed: to ANDAs are capitalized accordingly.
−Removed: The Company tests
−Removed: its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that indicate
−Removed: impairment may have occurred.
+Added: The Company capitalizes certain
+Added: costs to acquire intangible assets;
+Added: if such assets are determined to have a finite useful life they are amortized on a straight-line
+Added: basis over the estimated useful life.
+Added: Costs to acquire indefinite lived intangible assets, such as costs related to ANDAs are capitalized
+Added: The Company tests its intangible
+Added: assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that indicate impairment may have
A significant amount of judgment is involved in determining if an indicator of impairment has occurred.
−Removed: Such indicators may include, among others and without limitation:
−Removed: a significant decline in the Company’s expected future
−Removed: a sustained, significant decline in the Company’s stock price and market capitalization;
−Removed: a significant adverse
−Removed: change in legal factors or in the business climate of the Company’s segments;
+Added: Such indicators may
+Added: include, among others and without limitation:
+Added: a significant decline in the Company’s expected future cash flows;
+Added: a sustained, significant
+Added: decline in the Company’s stock price and market capitalization;
+Added: a significant adverse change in legal factors or in the business
+Added: climate of the Company’s segments;
unanticipated competition;
−Removed: and slower growth
+Added: and slower growth rates.
As of March 31, 2021,
the Company did not identify any indicators of impairment.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Please also see Note
−Removed: 4 for further details on intangible assets.
+Added: Please also see Note 4 for
+Added: further details on intangible assets.
Research and Development
2 unchanged sentences
Contingencies
−Removed: Occasionally, the
−Removed: Company may be involved in claims and legal proceedings arising from the ordinary course of its business.
−Removed: The Company records
−Removed: a provision for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be
−Removed: reasonably estimated.
−Removed: If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the
−Removed: Company’s consolidated financial statements.
−Removed: Contingencies are inherently unpredictable, and the assessments of the value
−Removed: can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions.
+Added: Occasionally, the Company may be involved in claims and legal proceedings
+Added: arising from the ordinary course of its business.
+Added: The Company records a provision for a liability when it believes that it is both probable
+Added: that a liability has been incurred, and the amount can be reasonably estimated.
+Added: If these estimates and assumptions change or prove to
+Added: be incorrect, it could have a material impact on the Company’s consolidated financial statements.
+Added: Contingencies are inherently unpredictable,
+Added: and the assessments of the value can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions.
Income taxes are accounted
2 unchanged sentences
attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective
−Removed: Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary
−Removed: differences are expected to be recovered or settled.
−Removed: Where applicable, the Company records a valuation allowance to reduce any
−Removed: deferred tax assets that it determines will not be realizable in the future.
−Removed: The Company recognizes
−Removed: the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position
−Removed: is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position.
−Removed: These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate
−Removed: The Company operates
−Removed: in multiple tax jurisdictions within the United States of America.
−Removed: The Company remains subject to examination in all tax jurisdiction
−Removed: until the applicable statutes of limitation expire.
−Removed: As of March 31, 2020, a summary of the tax years that remain subject to examination
−Removed: in our major tax jurisdictions are:
+Added: Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary differences
+Added: are expected to be recovered or settled.
+Added: Where applicable, the Company records a valuation allowance to reduce any deferred tax assets
+Added: that it determines will not be realizable in the future.
+Added: The Company recognizes the
+Added: benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more
+Added: likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position.
+Added: These tax benefits
+Added: are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution.
+Added: The Company operates in multiple
+Added: tax jurisdictions within the United States of America.
+Added: The Company remains subject to examination in all tax jurisdiction until the applicable
+Added: statutes of limitation expire.
+Added: As of March 31, 2021, a summary of the tax years that remain subject to examination in our major
+Added: tax jurisdictions are:
United States –
Federal, 2016 and forward, and State, 2012 and forward.
−Removed: did not record unrecognized tax positions for the years ended March 31, 2020 and 2019.
+Added: The Company did not record unrecognized
+Added: tax positions for the years ended March 31, 2021 and 2020.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Warrants and Preferred Shares
The accounting treatment
−Removed: of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470, Debt , ASC 480,
−Removed: Distinguishing Liabilities from Equity , and ASC 815, Derivatives and Hedging , as applicable.
−Removed: Each feature of a freestanding
−Removed: financial instruments including, without limitation, any rights relating to subsequent dilutive issuances, dividend issuances,
−Removed: equity sales, rights offerings, forced conversions, optional redemptions, automatic monthly conversions, dividends and exercise
−Removed: are assessed with determinations made regarding the proper classification in the Company’s financial statements.
+Added: of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470, Debt , ASC 480, Distinguishing
+Added: Liabilities from Equity , and ASC 815, Derivatives and Hedging , as applicable.
+Added: Each feature of a freestanding financial instrument
+Added: including, without limitation, any rights relating to subsequent dilutive issuances, dividend issuances, equity sales, rights offerings,
+Added: forced conversions, optional redemptions, automatic monthly conversions, dividends and exercise is assessed with determinations made
+Added: regarding the proper classification in the Company’s financial statements.
Stock-Based Compensation
−Removed: The Company accounts
−Removed: for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation .
−Removed: Under the fair value recognition
−Removed: provisions, stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized
−Removed: as an expense on a straight-line basis over the requisite service period, based on the terms of the awards.
−Removed: The cost of the stock-based
−Removed: payments to nonemployees that are fully vested and non-forfeitable as at the grant date is measured and recognized at that date,
−Removed: unless there is a contractual term for services in which case such compensation would be amortized over the contractual term.
−Removed: In accordance with
−Removed: the Company’s Director compensation policy and certain employment contracts, director’s fees and a portion of employee’s
−Removed: salaries are to be paid via the issuance of shares of the Company’s common stock, in lieu of cash, with the valuation of
−Removed: such share being calculated on a quarterly basis and equal to the average closing price of the Company’s common stock.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: The Company accounts for
+Added: stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation .
+Added: Under the fair value recognition provisions,
+Added: stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as an expense on a
+Added: straight-line basis over the requisite service period, based on the terms of the awards.
+Added: The cost of the stock-based payments to nonemployees
+Added: that are fully vested and non-forfeitable as at the grant date is measured and recognized at that date, unless there is a contractual
+Added: term for services in which case such compensation would be amortized over the contractual term.
+Added: In accordance with the Company’s
+Added: Director compensation policy and certain employment contracts, director’s fees and a portion of employee’s salaries are to
+Added: be paid via the issuance of shares of the Company’s Common Stock (“Common Stock”), in lieu of cash, with the valuation
+Added: of such shares being calculated on a quarterly basis and equal to the simple average closing price of the Company’s Common Stock
+Added: for each trading day of the quarter just ended.
Earnings (Loss) Per Share Attributable
to Common Shareholders’
−Removed: The Company follows
−Removed: ASC 260, Earnings Per Share , which requires presentation of basic and diluted earnings (loss) per share (“EPS”)
−Removed: on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator
−Removed: and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation.
−Removed: In the accompanying
−Removed: financial statements, basic earnings (loss) per share is computed by dividing net income (loss) by the weighted average number
−Removed: of shares of common stock outstanding during the period.
−Removed: Diluted EPS excluded all potential dilutive shares if their effect was
−Removed: anti-dilutive.
−Removed: The following is the
−Removed: computation of loss per share applicable to common shareholders for the periods indicated:
−Removed: Years Ended March 31,
−Removed: Net loss attributable to common shareholders –
−Removed: $ (2,240,351 )
−Removed: $ (9,279,320 )
−Removed: Effect of dilutive instrument on net loss
−Removed: Net loss attributable to common shareholders - diluted
+Added: The Company follows ASC 260,
+Added: Earnings Per Share , which requires presentation of basic and diluted earnings (loss) per share (“EPS”) on the face
+Added: of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator and denominator
+Added: of the basic EPS computation to the numerator and denominator of the diluted EPS computation.
+Added: In the accompanying financial statements,
+Added: basic earnings (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of Common Stock outstanding
+Added: during the period.
+Added: The computation of diluted net income (loss) per share does not include the conversion of securities that would have
+Added: an antidilutive effect.
+Added: The following is the computation
+Added: of earnings (loss) per share applicable to common shareholders for the periods indicated:
+Added: For the Years Ended March 31,
+Added: Net income (loss) - basic
$ (2,240,351 )
+Added: Effect of dilutive instrument on net income
+Added: Net income (loss) - diluted
$ (1,128,803 )
Weighted average shares of Common Stock outstanding - basic
−Removed: Dilutive effect of stock options, warrants and convertible securities
−Removed: Weighted average shares of common stock outstanding –
−Removed: Net loss per share attributable to common shareholders
+Added: Dilutive effect of stock options and convertible securities
+Added: Weighted average shares of Common Stock outstanding - diluted
+Added: Net income (loss) per share
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Fair Value of Financial Instruments
−Removed: ASC 820, Fair Value
−Removed: Measurements and Disclosures (“ASC 820”) provides a framework for measuring fair value in accordance with generally
−Removed: accepted accounting principles.
−Removed: ASC 820 defines fair
−Removed: value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market
−Removed: participants at the measurement date.
−Removed: ASC 820 establishes a fair value hierarchy that distinguishes between (1) market participant
−Removed: assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own
−Removed: assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable
+Added: ASC 820, Fair Value Measurements
+Added: and Disclosures (“ASC 820”) provides a framework for measuring fair value in accordance with generally accepted accounting
+Added: ASC 820 defines fair value
+Added: as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants
+Added: at the measurement date.
+Added: ASC 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed
+Added: based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant
+Added: assumptions developed based on the best information available in the circumstances (unobservable inputs).
The fair value hierarchy
−Removed: consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets
−Removed: or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
−Removed: The three levels of the fair value hierarchy
−Removed: under ASC 820 are described as follows:
+Added: consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or
+Added: liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
+Added: The three levels of the fair value hierarchy under ASC
+Added: 820 are described as follows:
Level 1 –
−Removed: quoted prices in active markets for identical assets or liabilities that are accessible
−Removed: at the measurement date.
+Added: quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date.
Level 2 –
−Removed: than quoted prices included within Level 1 that are observable for the asset or liability,
−Removed: either directly or indirectly.
−Removed: Level 2 inputs include quoted prices for similar assets
−Removed: or liabilities in active markets;
−Removed: quoted prices for identical or similar assets or liabilities
−Removed: in markets that are not active;
−Removed: inputs other than quoted prices that are observable for
−Removed: the asset or liability;
−Removed: and inputs that are derived principally from or corroborated
−Removed: by observable market data by correlation or other means.
+Added: other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
+Added: 2 inputs include quoted prices for similar assets or liabilities in active markets;
+Added: quoted prices for identical or similar assets
+Added: or liabilities in markets that are not active;
+Added: inputs other than quoted prices that are observable for the asset or liability;
+Added: inputs that are derived principally from or corroborated by observable market data by correlation or other means.
Level 3 –
−Removed: are unobservable for the asset or liability.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: that are unobservable for the asset or liability.
Measured on a Recurring
−Removed: The following table
−Removed: presents information about our liabilities measured at fair value on a recurring basis, aggregated by the level in the fair value
−Removed: hierarchy within which those measurements fell:
−Removed: Fair Value Measurement Using
+Added: The following table presents
+Added: information about our liabilities measured at fair value on a recurring basis, aggregated by the level in the fair value hierarchy within
+Added: which those measurements fell:
+Added: Value Measurement Using
March 31, 2021
−Removed: Derivative financial instruments –
+Added: Derivative financial instruments
March 31, 2020
−Removed: Derivative financial instruments –
−Removed: See Note 11, for specific inputs used in
−Removed: determining fair value.
−Removed: The carrying amounts
−Removed: of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current
−Removed: assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments.
−Removed: Based upon current borrowing rates with similar maturities the carrying value of long-term debt approximates fair value.
−Removed: Non-Financial Assets
−Removed: that are Measured at Fair Value on a Non-Recurring Basis
−Removed: Non-financial assets
−Removed: such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized.
−Removed: Company did not record an impairment charge related to these assets in the periods presented.
−Removed: Treasury Stock
−Removed: The Company records
−Removed: treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’
−Removed: Recently Adopted Accounting Pronouncements
−Removed: The Financial Accounting
−Removed: Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (ASC 842) in
−Removed: February 2016 and subsequent ASUs in 2018 and 2019 (collectively referred to as “ASC 842”) on the treatment of leases,
−Removed: which guidance is effective for annual reporting periods beginning after December 15, 2019 and early adoption is permitted.
−Removed: ASC 842, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the commencement
−Removed: 1) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted
−Removed: basis, and 2) a right-of-use asset, which is an asset that represents the lessee’s right-of-use, or control the use of,
−Removed: a specified asset for the lease term.
−Removed: Entities are allowed to apply ASC 842 using a modified retrospective approach either (1)
−Removed: retrospectively to each reporting period presented in the financial statements with the cumulative effect adjustment recognized
−Removed: at the beginning of the earliest comparative period;
−Removed: or (2) retrospectively at the beginning of the period of adoption through
−Removed: a cumulative-effective adjustment.
−Removed: The modified retrospective approach includes a number of optional practical expedients that
−Removed: entities may elect to apply.
+Added: Derivative financial instruments - warrants
+Added: See Note 11, for specific
+Added: inputs used in determining fair value.
+Added: The carrying amounts of the
+Added: Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current assets, accounts
+Added: payable and accrued expenses, approximate their fair values because of the short maturity of these instruments.
+Added: Based upon current borrowing
+Added: rates with similar maturities the carrying value of long-term debt approximates fair value.
+Added: Non-Financial Assets that
+Added: are Measured at Fair Value on a Non-Recurring Basis
+Added: Non-financial assets such
+Added: as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized.
+Added: The Company did
+Added: not record an impairment charge related to these assets in the periods presented.
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: On April 1, 2019,
−Removed: the Company adopted ASC 842 using the modified retrospective basis with a cumulative-effect adjustment at the beginning of the
−Removed: period of adoption and therefore did not revise prior period information or disclosure.
−Removed: Further, the Company elected the package
−Removed: of practical expedients upon transition that allows the Company not to reassess the lease classification for expired and existing
−Removed: leases, whether initial direct costs qualify for capitalization for any expired or existing leases or whether any expired contracts
−Removed: are or contain leases.
−Removed: The adoption of ASU 2016-02 resulted in the recognition of operating leases and lease liabilities of approximately
−Removed: $0.6 million on the consolidated balance sheet as of April 1, 2019.
−Removed: The operating leases and lease liabilities relate to a real
−Removed: estate lease.
−Removed: The impact of the
−Removed: adoption of ASC 842 on the accompanying consolidated balance sheet as of April 1, 2019 was as follows:
−Removed: Operating lease - right of use
−Removed: Deferred rent liability
−Removed: Lease obligation - operating lease
−Removed: Lease obligation - operating lease, net of current portion
−Removed: See additional lease
−Removed: disclosures in Note 9.
−Removed: Recently Issued Accounting Pronouncements
+Added: Treasury Stock
+Added: The Company records treasury
+Added: stock at the cost to acquire it and includes treasury stock as a component of shareholders’
+Added: Recently Adopted Accounting Standards
August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (ASC 820):
−Removed: Disclosure Framework-Changes to the Disclosure
−Removed: Requirements for Fair Value Measurement (“ASU 2018-13”).
−Removed: ASU 2018-13 removes certain disclosures, modifies certain
−Removed: disclosures and adds additional disclosures.
−Removed: The ASU is effective for annual periods, including interim periods within those annual
−Removed: periods, beginning after December 15, 2019.
−Removed: Early adoption is permitted.
−Removed: The Company is evaluating the effect that this update
−Removed: will have on its consolidated financial statements and related disclosures.
−Removed: In November 2018,
−Removed: the FASB issued ASU 2018-18, Collaborative Arrangements (ASC 808), Clarifying the Interaction between ASC 808 and ASC 606
−Removed: (“ASU 2018-18”).
−Removed: The ASU clarifies when transactions between collaborative participants are in the scope of ASC 606.
−Removed: The ASU also provides some guidance on presentation of transactions not in the scope of ASC 606.
−Removed: ASU 2018-18 is effective for
−Removed: fiscal years, and interim periods within those years, beginning after December 15, 2019.
−Removed: Early adoption is permitted for fiscal
−Removed: years, and interim periods within those years.
−Removed: The Company is not materially impacted by the implementation of this pronouncement.
−Removed: In March 2020, the
−Removed: FASB issued ASU No.
−Removed: 2020-03, Codification Improvements to Financial Instruments .
−Removed: The ASU clarifies disclosure guidance
−Removed: for fair value options, adds clarifications to the subsequent measurement of fair value, clarifies disclosure for depository and
−Removed: lending institutions, clarifies the line-of-credit or revolving-debt arrangements guidance, and the interaction of Financial
−Removed: Instruments - Credit Losses (ASC 326) with Leases (ASC 842) and Transfers and Servicing-Sales of Financial Assets
−Removed: (ASC 860-20) .
+Added: Disclosure Framework-Changes to the Disclosure Requirements
+Added: for Fair Value Measurement .
+Added: ASU 2018-13 removes certain disclosures, modifies certain disclosures and adds additional disclosures.
+Added: The ASU is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2019.
+Added: adoption is permitted.
+Added: The Company adopted the guidance as of April 1, 2020.
+Added: The Company is not materially impacted by the implementation
+Added: of this pronouncement.
+Added: In November 2018, the FASB
+Added: issued ASU 2018-18, Collaborative Arrangements (Topic 808) , Clarifying the Interaction between Topic 808 and Topic 606.
+Added: clarifies when transactions between collaborative participants are in the scope of ASC 606.
+Added: The ASU also provides some guidance on presentation
+Added: of transactions not in the scope of ASC 606.
+Added: ASU 2018-18 is effective for fiscal years, and interim periods within those years, beginning
+Added: after December 15, 2019.
+Added: Early adoption is permitted for fiscal years, and interim periods within those years.
+Added: The Company adopted the
+Added: guidance as of April 1, 2020.
The Company is not materially impacted by the implementation of this pronouncement.
−Removed: In March 2020, the
−Removed: FASB issued ASU 2020-04, Reference Rate Reform (ASC 848):
−Removed: Facilitation of the Effects of Reference Rate Reform on Financial
−Removed: Reporting (“ASU 2020-04”).
−Removed: The guidance provides optional expedients and exceptions for applying U.S.
−Removed: contract modifications and hedging relationships, subject to meeting certain criteria, that reference LIBOR or another rate that
−Removed: is expected to be discontinued.
−Removed: The amendments in ASU 2020-04 are effective for all entities as of March 12, 2020 through December
+Added: In March 2020, the FASB issued
+Added: ASU 2020-03, Codification Improvements to Financial Instruments .
+Added: The ASU clarifies disclosure guidance for fair value options,
+Added: adds clarifications to the subsequent measurement of fair value, clarifies disclosure for depository and lending institutions, clarifies
+Added: the line-of-credit or revolving-debt arrangements guidance, and the interaction of Financial Instruments - Credit Losses (Topic 326) with
+Added: Leases (Topic 842) and Transfers and Servicing-Sales of Financial Assets (Subtopic 860-20).
+Added: In accordance with ASU 2020-03, the Company
+Added: adopted the guidance as of April 1, 2020.
The Company is not materially impacted by the implementation of this pronouncement.
+Added: Recently Issued Accounting Pronouncements
+Added: In June 2016, the FASB issued
+Added: ASU 2016-13, Financial Instruments - Credit Losses (Topic 326):
+Added: Measurement of Credit Losses on Financial Instruments.
+Added: This update requires
+Added: immediate recognition of management’s estimates of current expected credit losses (“CECL”).
+Added: Under the prior model,
+Added: losses were recognized only as they were incurred.
+Added: The new model is applicable to all financial instruments that are not accounted for
+Added: at fair value through net income.
+Added: The standard is effective for fiscal years beginning after December 15, 2022 for public entities qualifying
+Added: as smaller reporting companies.
+Added: Early adoption is permitted.
+Added: The Company is currently assessing the impact of this update on the consolidated
+Added: financial statements and does not expect a material impact on the consolidated financial statements.
Management has evaluated
−Removed: other recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant
−Removed: impact on our consolidated financial statements and related disclosures.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Inventory consisted
−Removed: of the following:
+Added: other recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant impact
+Added: on our consolidated financial statements and related disclosures.
+Added: Inventory consisted of the
Finished goods
1 unchanged sentence
Raw materials
−Removed: Inventory reserve
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
PROPERTY AND EQUIPMENT, NET
−Removed: Property and equipment
−Removed: consisted of the following:
+Added: Property and equipment consisted
+Added: of the following:
Land, building and improvements
−Removed: Laboratory, manufacturing, warehouse and transportation equipment
+Added: Laboratory, manufacturing, warehouse and transportation
Office equipment and software
1 unchanged sentence
Accumulated depreciation
−Removed: (10,957,334 )
−Removed: Depreciation expense
−Removed: was $1,305,616 and $1,242,739 for the years ended March 31, 2020 and 2019, respectively.
+Added: Depreciation expense was
+Added: $1,299,668 and $1,305,616 for the years ended March 31, 2021 and 2020, respectively.
INTANGIBLE ASSETS
−Removed: The following table
−Removed: summarizes the Company’s intangible assets:
−Removed: March 31, 2020
+Added: The following table summarizes
+Added: the Company’s intangible assets:
Patent application costs
ANDA acquisition costs
−Removed: March 31, 2019
Patent application costs
ANDA acquisition costs
−Removed: * Patent application costs were incurred in
−Removed: relation to the Company’s abuse deterrent opioid technology.
−Removed: Amortization of the
−Removed: patent costs will begin upon the issuance of marketing authorization by the FDA.
−Removed: will then be calculated on a straight-line basis through the expiry of the related patent(s).
−Removed: ELITE PHARMACEUTICALS,
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: The following ANDA’s, with an aggregate
−Removed: carrying amount of $291,491 were discontinued during Fiscal 2019:
−Removed: ● 40227 –
−Removed: Phentermine 30mg capsules
−Removed: ● 40448 –
−Removed: Phentermine 30mg capsules
−Removed: ● 40460 –
−Removed: Phentermine 15mg capsules
−Removed: The following ANDA’s,
−Removed: with an aggregate carrying amount of $787,475 were transferred to Epic Pharma for cash consideration totaling $450,000 during Fiscal
−Removed: ● 40600 –
−Removed: Hydroxyzine 10mg
−Removed: ● 40602 –
−Removed: Hydroxyzine 25mg
−Removed: ● 40604 –
−Removed: Hydroxyzine 50mg
−Removed: The primary catalyst
−Removed: for the discontinuance and transfer of the above referenced ANDA’s was the FDA’s Generic Drug User Fee Amendment (“GDUFA”)
−Removed: fee structure, which provides for additional annual fees in excess of $1.1 million (as per the most current fee schedule published
−Removed: in August 2018) for entities that own in excess of 19 ANDA’s as of the annual April 15 measurement date.
−Removed: The ANDA’s approved
−Removed: by the FDA subsequent to the prior year’s measurement date, when added to those previously approved and owned by the Company,
−Removed: would have resulted in the Company owning more than 19 ANDA’s.
−Removed: Management conducted an evaluation of all ANDA’s held
−Removed: and the feasibility of incurring the additional GDUFA fees and identified the above ANDA’s as being not significant to the
−Removed: Company’s plans.
−Removed: The ANDA’s that were discontinued were duplicates of ANDA’s currently in commercial production
−Removed: and the ANDA’s sold to Epic Pharma were related to products that were not qualified for manufacture at the Northvale Facility.
−Removed: The aggregate carrying
−Removed: amount of the four ANDAs discontinued or transferred during Fiscal 2020 was $0 and the aggregate cash consideration received in
−Removed: relation to the transfer of ANDAs was $1,502,500, resulting in a realized gain on transfer/discontinuance of intangible assets
−Removed: of $1,502,500.
−Removed: The aggregate carrying
−Removed: amount of the six ANDAs discontinued or transferred during Fiscal 2019 was $1,078,966 and the aggregate cash consideration received
−Removed: in relation to the transfer of ANDAs was $450,000, resulting in a realized loss on transfer/discontinuance of intangible assets
−Removed: During August 2005,
−Removed: the Company refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the “NJEDA
−Removed: and/or “Bonds”).
−Removed: During July 2014, the Company retired all outstanding Series B Notes, at par, along
−Removed: with all accrued interest due and owed.
−Removed: In relation to the
−Removed: Series A Notes, the Company is required to maintain a debt service reserve.
−Removed: The debt service reserve is classified as restricted
−Removed: cash on the accompanying audited consolidated balance sheets.
−Removed: The NJEDA Bonds require the Company to make an annual principal
−Removed: payment on September 1 st based on the amount specified in the loan documents and semi-annual interest payments on March
−Removed: 1 st and September 1 st , equal to interest due on the outstanding principal.
−Removed: The annual interest rate on the
−Removed: Series A Note is 6.5%.
−Removed: The NJEDA Bonds are collateralized by a first lien on the Company’s facility and equipment acquired
−Removed: with the proceeds of the original and refinanced bonds.
+Added: Patent application costs
+Added: were incurred in relation to the Company’s abuse deterrent opioid technology.
+Added: Amortization of the patent costs will begin upon
+Added: the issuance of marketing authorization by the FDA.
+Added: Amortization will then be calculated on a straight-line basis through the expiry
+Added: of the related patent(s).
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The following tables
−Removed: summarize the Company’s bonds payable liability:
+Added: During August 2005, the Company
+Added: refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the “NJEDA Bonds”
+Added: and/or “Bonds”).
+Added: During July 2014, the Company retired all outstanding Series B Notes, at par, along with all accrued interest
+Added: due and owed.
+Added: In relation to the Series
+Added: A Notes, the Company is required to maintain a debt service reserve.
+Added: The debt service reserve is classified as restricted cash on the
+Added: accompanying consolidated balance sheets.
+Added: The NJEDA Bonds require the Company to make an annual principal payment on September 1st based
+Added: on the amount specified in the loan documents and semi-annual interest payments on March 1st and September 1st, equal to interest due
+Added: on the outstanding principal.
+Added: The annual interest rate on the Series A Note is 6.5%.
+Added: The NJEDA Bonds are collateralized by a first lien
+Added: on the Company’s facility and equipment acquired with the proceeds of the original and refinanced bonds.
+Added: The following tables summarize
+Added: the Company’s bonds payable liability:
Gross bonds payable
−Removed: NJEDA Bonds - Series A Notes
−Removed: Current portion of bonds payable (prior to deduction
−Removed: of bond offering costs)
−Removed: Long-term portion of bonds payable (prior to deduction
−Removed: of bond offering costs)
+Added: NJEDA Bonds -
+Added: Series A Notes
+Added: Current portion of
+Added: bonds payable (prior to deduction of bond offering costs)
+Added: Long-term portion of bonds
+Added: payable (prior to deduction of bond offering costs)
Bond offering costs
1 unchanged sentence
Bond offering costs, net
−Removed: Current portion of bonds payable - net of bond offering costs
−Removed: Current portions of bonds payable
−Removed: Bonds offering costs to be amortized in the next
Current portion of bonds payable - net of bond offering
−Removed: Long term portion of bonds payable - net of bond offering costs
−Removed: Long term portion of bonds payable
−Removed: Bond offering costs to be amortized subsequent
−Removed: to the next 12 months
−Removed: Long term portion of bonds payable, net of bond offering
−Removed: Amortization expense
−Removed: was $14,174 and $14,172 for the years ended March 31, 2020 and 2019, respectively.
−Removed: Maturities of bonds for the next five years
−Removed: are as follows:
+Added: Current portions of bonds
+Added: Bonds offering costs
+Added: to be amortized in the next 12 months
+Added: Current portion of bonds
+Added: payable, net of bond offering costs
+Added: Long term portion of bonds payable - net of bond
+Added: offering costs
+Added: Long term portion of bonds
+Added: Bond offering costs
+Added: to be amortized subsequent to the next 12 months
+Added: Long term portion of bonds
+Added: payable, net of bond offering costs
+Added: Amortization expense was
+Added: $14,179 and $14,174 for the year ended March 31, 2021 and 2020, respectively.
+Added: As of March 31, 2021 and 2020, interest payable was $7,963
+Added: and $8,531, respectively.
+Added: Maturities of bonds for the next five years are
Years ending March 31,
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
LOANS PAYABLE
−Removed: Loans payable consisted
−Removed: of the following:
−Removed: Equipment and insurance financing loans
−Removed: payable, between 3.5% and 12.73% interest and maturing between March 2020 and July 2024
+Added: Loans payable consisted of
+Added: the following:
+Added: Equipment and insurance financing
+Added: loans payable, between 3.5% and 12.73% interest and maturing between January 2021 and October 2026
Current portion of loans payable
Long-term portion of loans payable
−Removed: The interest expense
−Removed: associated with the loans payable was $79,870 and $114,980 for the years ended March 31, 2020 and 2019, respectively.
+Added: The interest expense associated
+Added: with the loans payable was $77,218 and $79,870 for the years ended March 31, 2021 and 2020, respectively.
+Added: Loan principal payments for
+Added: the next five years are as follows:
+Added: Years ending March 31,
+Added: 2020 Paycheck Protection
+Added: Program Term Note
+Added: In April 2020, the Company
+Added: entered into a Paycheck Protection Program Term Note (the “PPP Note”) with TD Bank, NA in the amount of $1,013,480.
+Added: Note was issued to the Company pursuant to the Coronavirus, Aid, Relief, and Economic Security Act’s (the “CARES Act”)
+Added: 116-136) Paycheck Protection Program (the “Program”).
+Added: Under the Program, all or a portion of the PPP Note may be forgiven
+Added: in accordance with the Program requirements.
+Added: On January 12, 2021, the
+Added: Company received notification that the United States Small Business Administration (“SBA”), had approved, in full, the Company’s
+Added: application for forgiveness of amounts received pursuant to the CARES Act and the Program.
+Added: RELATED PARTY SECURED PROMISSORY NOTE
+Added: WITH MIKAH PHARMA, LLC
+Added: For consideration of the
+Added: assets acquired on May 15, 2017, the Company issued a Secured Promissory Note (the “Mikah Note”) to Mikah Pharma, LLC (“Mikah”)
+Added: for the principal sum of $1,200,000.
+Added: Mikah was founded in 2009 by Nasrat Hakim (“Hakim”), a related party and, the Company’s
+Added: President, Chief Executive Officer and Chairman of the Board.
+Added: The Mikah Note matured on December 31, 2020 and was retired at par in March
+Added: The principal amount of $1,200,000 was repaid by the Company at maturity.
+Added: Interest expense associated with the Note was $90,000 and $120,000
+Added: for the years ended March 31, 2021 and 2020, respectively.
+Added: A total of $435,000 in accrued interest expense, representing interest expense
+Added: accrued during the life of the Mikah Note was due and owing as of the maturity date of the Note.
+Added: Of the $435,000 accrued interest due
+Added: at maturity, $238,451 of accrued interest was satisfied by offset against amounts due from Mikah pursuant to the development agreement
+Added: between the Company and Mikah, dated December 3, 2018 (see Note 16).
+Added: The balance of $196,549 of accrued interest expense owing in relation
+Added: to the Mikah Note is recorded as a non-interest bearing, general liability of the Company.
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Loan principal payments for the next five
−Removed: years are as follows:
−Removed: Years ending March 31,
−Removed: RELATED PARTY SECURED PROMISSORY
−Removed: NOTE WITH MIKAH PHARMA LLC
−Removed: For consideration
−Removed: of the assets acquired on May 15, 2017, the Company issued a Secured Promissory Note (the “Note”) to Mikah for the
−Removed: principal sum of $1,200,000.
−Removed: The Note matures on December 31, 2020 in which the Company shall pay the outstanding principal balance
−Removed: Interest shall be computed on the unpaid principal amount at the per annum rate of ten percent (10%);
−Removed: provided, upon
−Removed: the occurrence of an Event of Default as defined within the Note, the principal balance shall bear interest from the date of such
−Removed: occurrence until the date of actual payment at the per annum rate of fifteen percent (15%).
−Removed: All interest payable hereunder shall
−Removed: be computed on the basis of actual days elapsed and a year of 360 days.
−Removed: Instalment payments of interest on the outstanding principal
−Removed: shall be paid as follows:
−Removed: quarterly commencing August 1, 2017 and on November 1, February 1, May 1 and August 1 of each year thereafter.
−Removed: No principal or interest payments have been made on the Note since its issuance.
−Removed: All unpaid principal and accrued but unpaid interest
−Removed: shall be due and payable in full on the Maturity Date.
−Removed: The interest expense associated with the Note was $120,000 for the years
−Removed: ended March 31, 2020 and 2019.
−Removed: Accrued interest due and owing on this note was $345,000 and $225,000 as of March 31, 2020 and
−Removed: March 31, 2019, respectively.
DEFERRED REVENUE
−Removed: Deferred revenues
−Removed: in the aggregate amount of $238,891 as of March 31, 2020, were comprised of a current component of $180,000 and a long-term component
−Removed: Deferred revenues in the aggregate amount of $1,252,223 as of March 31, 2019, were comprised of a current component
−Removed: of $1,013,333 and a long-term component of $238,890.
−Removed: These line items represent the unamortized amounts of a $200,000 advance
−Removed: payment received for a TAGI licensing agreement with a fifteen-year term beginning in September 2010 and ending in August 2025
−Removed: and the $5,000,000 advance payment Epic Collaborative Agreement with a five-year term beginning in June 2015 and ending in May
−Removed: These advance payments were recorded as deferred revenue when received and are earned, on a straight-line basis over the
−Removed: life of the licenses.
−Removed: The current component is equal to the amount of revenue to be earned during the 12-month period immediately
−Removed: subsequent to the balance date and the long-term component is equal to the amount of revenue to be earned thereafter.
+Added: Deferred revenues in the
+Added: aggregate amount of $58,891 as of March 31, 2021, were comprised of a current component of $13,333 and a long-term component of
+Added: Deferred revenues in the aggregate amount of $238,891 as of March 31, 2020, were comprised of a current component of $180,000
+Added: and a long-term component of $58,891.
+Added: These line items represent the unamortized amounts of a $200,000 advance payment received for a
+Added: TAGI Pharma (“TAGI”) licensing agreement with a fifteen-year term beginning in September 2010 and ending in August 2025 and
+Added: the $5,000,000 advance payment Epic Collaborative Agreement with a five-year term beginning in June 2015 and ending in May 2020.
+Added: advance payments were recorded as deferred revenue when received and are earned, on a straight-line basis over the life of the licenses.
+Added: The current component is equal to the amount of revenue to be earned during the 12-month period immediately subsequent to the balance
+Added: sheet date and the long-term component is equal to the amount of revenue to be earned thereafter.
COMMITMENTS AND CONTINGENCIES
−Removed: Occasionally, the
−Removed: Company may be involved in claims and legal proceedings arising from the ordinary course of its business.
−Removed: The Company records
−Removed: a provision for a liability when it believes that is both probable that a liability has been incurred, and the amount can be reasonably
−Removed: If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s
−Removed: consolidated financial statements.
−Removed: Contingencies are inherently unpredictable, and the assessments of the value can involve a
−Removed: series of complex judgments about future events and can rely heavily on estimates and assumptions.
−Removed: Operating Leases –
−Removed: The Company entered
−Removed: into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “135
+Added: Occasionally, the Company may be involved in claims and legal proceedings
+Added: arising from the ordinary course of its business.
+Added: The Company records a provision for a liability when it believes that is both probable
+Added: that a liability has been incurred, and the amount can be reasonably estimated.
+Added: If these estimates and assumptions change or prove to
+Added: be incorrect, it could have a material impact on the Company’s consolidated financial statements.
+Added: Contingencies are inherently unpredictable,
+Added: and the assessments of the value can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions.
+Added: Operating Leases
+Added: The Company entered into
+Added: an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “135 Ludlow
lease”).
1 unchanged sentence
lease is for approximately 15,000 square feet of floor space and began on July 1, 2010.
−Removed: During July 2014, the Company modified the 135 Ludlow Ave.
−Removed: lease in which the Company was permitted to occupy the entire
−Removed: 35,000 square feet of floor space in the building (“135 Ludlow Ave.
+Added: July 2014, the Company modified the 135 Ludlow Ave.
+Added: lease in which the Company was permitted to occupy the entire 35,000 square feet
+Added: of floor space in the building (“135 Ludlow Ave.
Modified Lease”).
The 135 Ludlow Ave.
−Removed: modified lease includes an initial term, which expired on December 31, 2016 with two tenant renewal options of five years each,
−Removed: at the sole discretion of the Company.
−Removed: On June 22, 2016, the Company exercised the first of these renewal options, with such option
−Removed: including a term that begins on January 1, 2017 and expires on December 31, 2021.
+Added: Lease includes an initial term, which expired on December 31, 2016 with two tenant renewal options of five years each, at the sole discretion
+Added: of the Company.
+Added: On June 22, 2016, the Company exercised the first of these renewal options, with such option including a term that begins
+Added: on January 1, 2017 and expires on December 31, 2021.
The 135 Ludlow Ave.
−Removed: property required significant leasehold improvements and qualifications, as a prerequisite, for its intended future use.
+Added: lease property required significant leasehold improvements and qualifications, as a prerequisite, for its intended future use.
Manufacturing,
packaging, warehousing and regulatory activities are currently conducted at this location.
−Removed: Additional renovations and construction
−Removed: to further expand the Company’s manufacturing resources are in process.
+Added: Additional renovations and construction to
+Added: further expand the Company’s manufacturing resources are in progress.
+Added: The Company plans to exercise
+Added: the second option pursuant to the 135 Ludlow Ave.
+Added: Modified Lease in June 2021.
+Added: This option includes a term that begins on January 1, 2022
+Added: and expires on December 31, 2026.
+Added: Minimum lease payments required during the five year term of this option total $1,212,480.
+Added: In October 2020, the Company
+Added: entered into an operating lease for office space in Pompano Beach, Florida (the “Pompano Office Lease”).
+Added: The Pompano Office
+Added: Lease is for approximately 1,275 square feet of office space, with Elite taking occupancy on November 1, 2020.
+Added: The Pompano Office includes
+Added: a 3 month abatement from November 2020 through February 2021 and has a term of three years, ending on October 31, 2023.
+Added: The Company assesses whether
+Added: an arrangement is a lease or contains a lease at inception.
+Added: For arrangements considered leases or that contain a lease that is accounted
+Added: for separately, the Company determines the classification and initial measurement of the right-of-use asset and lease liability at the
+Added: lease commencement date, which is the date that the underlying asset becomes available for use.
+Added: The Company has elected to account for
+Added: non-lease components associated with its leases and lease components as a single lease component.
+Added: The Company recognizes a
+Added: right-of-use asset, which represents the Company’s right to use the underlying asset for the lease term, and a lease liability,
+Added: which represents the present value of the Company’s obligation to make payments arising over the lease term.
+Added: The present value
+Added: of the lease payments is calculated using either the implicit interest rate in the lease or an incremental borrowing rate.
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The Company assesses
−Removed: whether an arrangement is a lease or contains a lease at inception.
−Removed: For arrangements considered leases or that contain a lease
−Removed: that is accounted for separately, the Company determines the classification and initial measurement of the right-of-use asset
−Removed: and lease liability at the lease commencement date, which is the date that the underlying asset becomes available for use.
−Removed: Company has elected to account for non-lease components associated with our leases and lease components as a single lease component.
−Removed: The Company recognizes
−Removed: a right-of-use asset, which represents the Company’s right-of-use the underlying asset for the lease term, and a lease liability,
−Removed: which represents the present value of the Company’s obligation to make payments arising over the lease term.
−Removed: value of the lease payments is calculated using either the implicit interest rate in the lease or an incremental borrowing rate.
−Removed: Lease assets and liabilities
−Removed: are classified as follows on the consolidated balance sheet:
+Added: Lease assets and liabilities are classified as follows on the consolidated
+Added: balance sheet:
Classification
+Added: of March 31, 2021
Operating lease –
−Removed: right-of-use asset
Total leased assets
1 unchanged sentence
operating lease
−Removed: Lease obligation –
+Added: obligation –
operating lease, net of current portion
Total lease liabilities
−Removed: expense is recorded on the straight-line basis.
−Removed: Rent expense under the 135 Ludlow Ave.
−Removed: modified lease for the years ended March
−Removed: 31, 2020 and 2019, was $220,650 and $219,638, respectively.
−Removed: Rent expense is recorded in general and administrative expense in
−Removed: the audited consolidated statements of operations.
−Removed: table below show the future minimum rental payments, exclusive of taxes, insurance and other costs, under the 135 Ludlow Ave.
+Added: Rent expense is recorded on the straight-line basis.
+Added: Rent expense under
+Added: the 135 Ludlow Ave.
+Added: Modified lease for the years ended March 31, 2021 and 2020, is $219,638 and $220,650, respectively.
+Added: Rent expense under
+Added: the Pompano Office Lease for the years ended March 31, 2021 and 2020, is $9,544 and $0, respectively.
+Added: Rent expense is recorded in general
+Added: and administrative expense in the audited consolidated statements of operations.
+Added: The table below show the
+Added: future minimum rental payments, exclusive of taxes, insurance and other costs, in aggregate, under the 135 Ludlow Ave.
modified lease
−Removed: Years ending March 31,
−Removed: Total future minimum lease payments
+Added: and the Pompano Office Lease:
+Added: Subsequent to March 31, 2026
+Added: Total future minimum lease
Present value of lease payments
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The weighted-average
−Removed: remaining lease term and the weighted-average discount rate of our lease was as follows:
+Added: The weighted-average remaining
+Added: lease term and the weighted-average discount rate of our lease was as follows:
Lease Term and Discount Rate
+Added: March 31, 2021
Remaining lease term (years)
2 unchanged sentences
Operating leases
−Removed: The Company has an
−Removed: obligation for the restoration of its leased facility and the removal or dismantlement of certain property and equipment as a
−Removed: result of its business operation in accordance with ASC 410, Asset Retirement and Environmental Obligations –
−Removed: Asset Retirement
−Removed: Obligations .
−Removed: The Company records the fair value of the asset retirement obligation in the period in which it is incurred.
−Removed: The Company increases, annually, the liability related to this obligation.
−Removed: The liability is accreted to its present value each
−Removed: period and the capitalized cost is depreciated over the useful life of the related asset.
−Removed: Upon settlement of the liability, the
−Removed: Company records either a gain or loss.
−Removed: As of March 31, 2020, and March 31, 2019, the Company had a liability of $35,442 and $46,402,
−Removed: respectively, and recorded as a component of other long-term liabilities.
−Removed: PREFERRED STOCK
−Removed: Series J convertible preferred stock
−Removed: On April 28, 2017,
−Removed: the Company created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the Certificate
−Removed: of Designations (“Series J COD”).
−Removed: A total of 50 shares of Series J Preferred were authorized, 24.0344 shares are issued
−Removed: and outstanding, with a stated value of $1,000,000 per share and a par value of $0.01 as of March 31, 2020.
−Removed: The shares were issued
−Removed: pursuant to an Exchange Agreement with Nasrat Hakim, (“Hakim”) a related party and the Company’s President,
−Removed: CEO and Chairman of the Board of Directors.
−Removed: Pursuant to the Exchange Agreement the Company exchanged 158,017,321 shares of Common
−Removed: Stock for 24.0344 shares of Series J Preferred and warrants to purchase 79,008,661 shares of common stock at $0.1521 per share.
−Removed: The aggregate stated value of the Series J Preferred issued was equal to the aggregate value of the shares of common stock exchanged,
−Removed: with such value of each share of Common Stock exchanged being equal to the closing price of the Common Stock on April 27, 2017.
−Removed: In connection with the Exchange Agreement, the Company also issued warrants to purchase 79,008,661 shares of common stock at $0.1521
−Removed: per share, and such warrants were classified as liabilities on the accompanying audited consolidated balance sheet as of March
−Removed: 31, 2020 (See Note 11).
−Removed: Each Series J Preferred
−Removed: is convertible at the option of the holder into shares of common stock, that is the earlier of (i) the date that shareholder approval
−Removed: is obtained, and the requisite corporate action has been effected regarding a Fundamental Transaction (as defined in the Series
−Removed: or (ii) not less than three years subsequent to the Original Issue Date (the date of the first issuance of any shares
−Removed: of the Series J Preferred Stock) (the “Conversion Date”).
−Removed: The number of common shares is calculated by dividing the
−Removed: Stated Value of such share of Series J Preferred by the Conversion Price.
−Removed: The conversion price for the Series J Preferred shall
−Removed: equal $0.1521, subject to adjustment as discussed below.
−Removed: Based on the current
−Removed: conversion price, the Series J Preferred is convertible into 158,017,321 shares of common stock.
−Removed: The conversion price is subject
−Removed: to the following adjustments:
−Removed: (i) stock dividends and splits, (ii) sale or grant of shares below the conversion price, unless
−Removed: such adjustment is specifically excluded (iii) pro rata distributions;
−Removed: or (iv) fundamental changes (merger, consolidation, or
−Removed: sale of all or substantially all assets).
−Removed: The holders of the
−Removed: Series J Preferred shall have voting rights on any matter presented to the shareholders of the Company for their action or consideration
−Removed: at any meeting of shareholders of the Company (or by written consent of shareholders in lieu of meeting).
−Removed: Each holder shall be
−Removed: entitled to cast the number of votes equal to the number of whole shares of common stock into which the shares of Series J Preferred
−Removed: held by the holder are convertible as of the record date for determining the shareholders entitled to vote on such matter regardless
−Removed: of whether an Authorized Share Deficiency Exists.
+Added: The Company has an obligation
+Added: for the restoration of its leased facility and the removal or dismantlement of certain property and equipment as a result of its business
+Added: operation in accordance with ASC 410, Asset Retirement and Environmental Obligations –
+Added: Asset Retirement Obligations .
+Added: Company records the fair value of the asset retirement obligation in the period in which it is incurred.
+Added: The Company increases, annually,
+Added: the liability related to this obligation.
+Added: The liability is accreted to its present value each period and the capitalized cost is depreciated
+Added: over the useful life of the related asset.
+Added: Upon settlement of the liability, the Company records either a gain or loss.
+Added: As of March 31,
+Added: 2021, and March 31, 2020, the Company had a liability of $37,628 and $35,442, respectively, recorded as a component of other long-term
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The Company has determined
−Removed: that the Series J Preferred host instrument was more akin to equity than debt and that the above identified conversion feature,
−Removed: subject to adjustments, was clearly and closely related to the host instrument, and accordingly bifurcation and classification
−Removed: of the conversion feature as a derivative liability was not required.
−Removed: The Company has accounted for the Series J Preferred as
−Removed: contingently redeemable preferred stock for which redemption is not probable.
−Removed: Accordingly, the Series J Preferred is presented
−Removed: in mezzanine equity based on their initial measurement amount (fair value), as required by ASC 480-10-S99, Distinguishing Liabilities
−Removed: from Equity –
−Removed: SEC Materials.
−Removed: No subsequent adjustment of the initial measurement amounts for these contingently redeemable
−Removed: Series J Preferred is necessary unless the redemption of the Series J Preferred becomes probable.
−Removed: Accordingly, the amount presented
−Removed: as temporary equity for the contingently redeemable Series J Preferred outstanding is its issuance-date fair value.
−Removed: J Preferred was initially measured at its fair value, $13,903,960 at April 28, 2017.
−Removed: The fair value of
−Removed: the Series J Preferred issued by the Company pursuant to the exchange agreement was calculated using a Monte Carlo Simulation
−Removed: because of the probability assumptions associated with the shareholder approval provisions;
−Removed: the following are the Monte Carlo
−Removed: Fair value of the Company’s common stock
−Removed: Initial exercise price
−Removed: Number of Series J Preferred issued
−Removed: Fully diluted shares outstanding as of measurement date
−Removed: Risk-free rate
−Removed: Shareholder approval threshold
−Removed: Probability of approval is ending stock price is greater than threshold - midpoint
−Removed: Probability of approval is ending stock price is greater than threshold - midpoint
+Added: PREFERRED STOCK
+Added: Series J convertible preferred stock
+Added: On April 28, 2017, the Company
+Added: created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the Certificate of Designations
+Added: (“Series J COD”).
+Added: A total of 50 shares of Series J Preferred were authorized, zero shares are outstanding, with a stated
+Added: value of $1,000,000 per share and a par value of $0.01 as of March 31, 2021.
+Added: On April 27, 2017, a total of 24.0344 shares of Series J Preferred
+Added: were issued pursuant to an exchange agreement (the “Exchange Agreement”) with Nasrat Hakim (“Mr.
+Added: Hakim”), a related
+Added: party and the Company’s President, Chief Executive Officer and Chairman of the Board of Directors.
+Added: The Exchange Agreement provided
+Added: for Hakim to exchange 158,017,321 shares of Common Stock for 24.0344 shares of Series J Preferred and warrants to purchase 79,008,661
+Added: shares of Common Stock at $0.1521 per share.
+Added: The aggregate stated value of the Series J Preferred issued was equal to the aggregate value
+Added: of the shares of Common Stock exchanged, with such value of each share of Common Stock exchanged being equal to the closing price of the
+Added: Common Stock on April 27, 2017.
+Added: In connection with the Exchange Agreement, the Company also issued warrants to purchase 79,008,661 shares
+Added: of Common Stock at $0.1521 per share, and such warrants are classified as liabilities on the accompanying consolidated balance sheet as
+Added: of March 31, 2021 (See Note 11).
+Added: An amendment to the Company’s
+Added: Articles of Incorporation to increase the number of shares of Common Stock the Company is authorized to issue from 995,000,000 shares
+Added: to 1,445,000,000 shares was approved at the Company’s Annual Meeting of Shareholders held on December 4, 2019.
+Added: Prior to the approval
+Added: of the increase in the number of authorized shares, there were insufficient authorized shares if the Series J Preferred Stock were converted.
+Added: As a result, the shares were classified in mezzanine equity.
+Added: After the approval of the increase in the number of authorized shares, there
+Added: are now sufficient authorized shares in the event of a full conversion of Series J Preferred Stock.
+Added: With the approval of the increase
+Added: in the number of authorized shares, there is no longer the presumption that a cash settlement will be required.
+Added: Therefore, the Series
+Added: J Preferred was reclassified from mezzanine equity to permanent equity at its carrying amount of $13,903,960 on the consolidated balance
+Added: sheet as of March 31, 2020.
+Added: On June 23, 2020, the Company
+Added: held a Special Meeting of Shareholders, with such including a proposal for shareholders to again vote on the above referenced amendment
+Added: to the Company’s Articles of Incorporation.
+Added: This proposal was also passed by shareholder vote.
+Added: On August 24, 2020, Hakim
+Added: converted the 24.0344 shares of Series J Preferred into 158,017,321 shares of Common Stock at a conversion price of $0.1521 per share.
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Authorized, issued
−Removed: and outstanding shares, along with carrying value are as follows:
−Removed: Shares authorized
−Removed: Shares outstanding
−Removed: Conversion price
−Removed: Common Stock to be issued upon conversion
−Removed: Carrying value of Series J convertible preferred stock
−Removed: Increase in Authorized Shares
−Removed: to the Company’s Articles of Incorporation to increase the number of shares of common stock the Company is authorized to
−Removed: issue from 995,000,000 shares to 1,445,000,000 shares was approved at the Company’s Annual Meeting of Shareholders held
−Removed: on December 4, 2019.
−Removed: Prior to the approval of the increase in the number of authorized shares, there were insufficient authorized
−Removed: shares if the Series J Preferred Stock were converted.
−Removed: As a result, the shares were classified in mezzanine equity.
−Removed: approval of the increase in the number of authorized shares, there are now sufficient authorized shares in the event of a full
−Removed: conversion of Series J Preferred Stock.
−Removed: With the approval of the increase in the number of authorized shares, there is no longer
−Removed: the presumption that a cash settlement will be required.
−Removed: Therefore, the Series J Preferred has been reclassified from mezzanine
−Removed: equity to permanent equity at its current carrying amount of $13,903,960 on the accompanying consolidated balance sheet.
DERIVATIVE FINANCIAL INSTRUMENTS
−Removed: The Company evaluates
−Removed: and accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments and Hedging
−Removed: The Company issued
−Removed: warrants, with a term of seven years, to Nasrat Hakim, pursuant to the Exchange Agreement detailed below.
−Removed: A summary of warrant
−Removed: activity is as follows:
−Removed: March 31 2020
−Removed: March 31, 2019
+Added: The Company evaluates and
+Added: accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments and Hedging Activities .
+Added: The Company issued warrants,
+Added: with a term of ten years, to affiliates in connection with an exchange agreement dated April 28, 2017, as further described in this note
+Added: A summary of warrant activity
+Added: is as follows:
+Added: Average Exercise Price
+Added: Average Exercise Price
Balance at beginning of period
−Removed: Warrants granted pursuant to the issuance of Series J convertible
−Removed: preferred shares
+Added: granted pursuant to the issuance of Series J convertible preferred shares
Warrants exercised, forfeited and/or expired, net
Balance at end of period
−Removed: On April 28, 2017,
−Removed: the Company entered into an exchange agreement (the “Exchange Agreement”
−Removed: ) with Nasrat Hakim, the Chairman of
−Removed: the Board, President, and Chief Executive Officer of the Company, pursuant to which the Company issued to Mr.
−Removed: Hakim 23.0344 shares
−Removed: of its newly designated Series J Convertible Preferred Stock ( “Series J Preferred ”) and Warrants to purchase
−Removed: an aggregate of 79,008,661 shares of its Common Stock (the “Series J Warrants”
−Removed: and, along with the Series J Preferred
−Removed: issued to Mr.
−Removed: Hakim, the “
−Removed: Securities”
−Removed: ) in exchange for 158,017,321 shares of Common Stock owned by Mr.
+Added: On April 28, 2017, the Company entered into an Exchange Agreement with
+Added: Hakim, the Chairman of the Board, President, and Chief Executive Officer of the Company, pursuant to which the Company issued to Hakim
+Added: 24.0344 shares of its Series J Preferred and warrants to purchase an aggregate of 79,008,661 shares of its Common Stock (the “Series
+Added: J Warrants”
+Added: and, along with the Series J Preferred issued to Mr.
+Added: Hakim, the “Securities”) in exchange for 158,017,321
+Added: shares of Common Stock owned by Mr.
The fair value of the Series J Warrants was determined to be $6,474,674 upon issuance at April
−Removed: The Series J Warrants
−Removed: are exercisable for a period of 10 years from the date of issuance, commencing on the earlier of (i) the date that Shareholder
−Removed: Approval is obtained, and the requisite corporate action has been effected;
−Removed: or (ii) April 28, 2020.
−Removed: The initial exercise price
−Removed: is $0.1521 per share and the Series J Warrants can be exercised for cash or on a cashless basis.
−Removed: The exercise price is subject
−Removed: to adjustment for any issuances or deemed issuances of common stock or common stock equivalents at an effective price below the
−Removed: then exercise price.
−Removed: Such exercise price adjustment feature prohibits the Company from being able to conclude the warrants are
−Removed: indexed to its own stock and thus such warrants are classified as liabilities and measured initially and subsequently at fair
−Removed: The Series J Warrants also provide for other standard adjustments upon the happening of certain customary events.
−Removed: J Warrants are not exercisable during any period when an Authorized Share Deficiency exists and will expire on the expiry date,
−Removed: without regards to the existence of an Authorized Shares Deficiency (see Note 10).
−Removed: As of March 31, 2020, the Company does not
−Removed: have a sufficient number of unreserved authorized shares to effect the entire conversion of the Series J Preferred, therefore
−Removed: the Series J Warrants are not currently exercisable.
−Removed: Please also see Note 10.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The fair value of
−Removed: the warrants issued by the Company pursuant to the issuance of Series J convertible preferred shares (79,008,661 warrant shares)
−Removed: was calculated using a Monte Carlo Simulation because of the probability assumptions associated with the Shareholder Approval
−Removed: The following are the key assumptions used in the Monte Carlo Simulation:
−Removed: Fair value of the Company's Common Stock
−Removed: Initial exercise price
−Removed: Number of common warrants
−Removed: Fully diluted shares outstanding as of measurement date
−Removed: Warrant term (in years)
−Removed: Risk-free rate
−Removed: Shareholder approval threshold
−Removed: Probability of approval if ending stock price is greater than threshold - midpoint
−Removed: Probability of approval if ending stock price is greater than threshold - midpoint
−Removed: Fair value of derivative financial instruments - warrants
−Removed: The fair value of
−Removed: the warrants issued by the Company pursuant to the issuance of Series J convertible preferred shares (79,008,661 warrant shares)
−Removed: was calculated using a Black-Scholes model instead of a Monte Simulation because the probability with the shareholder approval
−Removed: provisions was no longer a factor.
−Removed: The following assumptions were used in the Black-Scholes model to calculate the fair value
−Removed: of warrants issued by the Company pursuant to the issuance of Series J convertible preferred shares (79,008,661 warrant shares):
−Removed: Fair value of the Company’s common stock
+Added: The Series J Warrants are
+Added: exercisable for a period of 10 years from the date of issuance, commencing April 28, 2020.
+Added: The initial exercise price is $0.1521 per
+Added: share and the Series J Warrants can be exercised for cash or on a cashless basis.
+Added: The exercise price is subject to adjustment for any
+Added: issuances or deemed issuances of Common Stock or Common Stock equivalents, other than shares issued pursuant to the 2020LPC Purchase
+Added: Agreement (as defined below), at an effective price below the then exercise price.
+Added: Such exercise price adjustment feature prohibits the
+Added: Company from being able to conclude the warrants are indexed to its own stock and thus such warrants are classified as liabilities and
+Added: measured initially and subsequently at fair value.
+Added: The Series J Warrants also provide for other standard adjustments upon the happening
+Added: of certain customary events.
+Added: The fair value of the Series
+Added: J Warrants was calculated using a Black-Scholes model.
+Added: The following assumptions were used in the Black-Scholes model to calculate the
+Added: fair value of the Series J Warrants:
+Added: Fair value of the Company’s Common
Initial exercise price
2 unchanged sentences
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The changes in warrants
−Removed: (Level 3 financial instruments) measured at fair value on a recurring basis for the year ended March 31, 2020 were as follows:
−Removed: Balance as of March 31, 2018
+Added: The changes in warrants (Level
+Added: 3 financial instruments) measured at fair value on a recurring basis for the years ended March 31, 2021 were as follows:
+Added: Balance at March 31, 2019
Change in fair value of derivative financial instruments
−Removed: Balance as of March 31, 2019
+Added: Balance at March 31, 2020
Change in fair value of derivative financial instruments
−Removed: Balance as of March 31, 2020
+Added: Balance at March 31, 2021
SHAREHOLDERS’
1 unchanged sentence
Purchase Agreement
−Removed: On May 1, 2017, the
−Removed: Company entered into a purchase agreement (the “
−Removed: 2017 LPC Purchase Agreement ”), together with a registration
−Removed: rights agreement (the “
−Removed: 2017 LPC Registration Rights Agreement ”), with Lincoln Park.
−Removed: Under the terms and
−Removed: subject to the conditions of the 2017 LPC Purchase Agreement, the Company has the right to sell to and Lincoln Park is obligated
−Removed: to purchase up to $40 million in shares of common stock, subject to certain limitations, from time to time, over the 36-month
−Removed: period commencing on June 5, 2017.
−Removed: The Company may direct Lincoln Park, at its sole discretion and subject to certain conditions,
−Removed: to purchase up to 500,000 shares of common stock on any business day, provided that at least one business day has passed since
−Removed: the most recent purchase, increasing to up to 1,000,000 shares, depending upon the closing sale price of the common stock (such
−Removed: purchases, “
−Removed: Regular Purchases ”).
−Removed: However, in no event shall a Regular Purchase be more than $1,000,000.
−Removed: purchase price of shares of common stock related to the future funding will be based on the prevailing market prices of such shares
−Removed: at the time of sales.
−Removed: In addition, the Company may direct Lincoln Park to purchase additional amounts as accelerated purchases
−Removed: under certain circumstances.
−Removed: In the case of both Regular Purchases and accelerated purchases, the purchase price per share will
−Removed: be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar
−Removed: transaction occurring during the business days used to compute the purchase price.
−Removed: Sales of shares of common stock to Lincoln
−Removed: Park under the 2017 LPC Purchase Agreement are limited to no more than the number of shares that would result in the beneficial
−Removed: ownership by Lincoln Park and its affiliates, at any single point in time, of more than 4.99% of the then outstanding shares of
−Removed: common stock.
−Removed: In connection with
−Removed: the 2017 LPC Purchase Agreement, the Company issued to Lincoln Park 5,540,551 shares of common stock and is required to issue
−Removed: up to 5,540,551 additional shares of Common Stock pro rata as the Company requires Lincoln Park to purchase shares under the 2017
−Removed: LPC Purchase Agreement over the term of the agreement.
−Removed: Lincoln Park has represented to the Company, among other things, that it
−Removed: is an “accredited investor”
−Removed: (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933,
−Removed: as amended (the “Securities Act”)).
−Removed: The Company sold the securities in reliance upon an exemption from registration
−Removed: contained in Section 4(a)(2) under the Securities Act.
−Removed: The securities sold may not be offered or sold in the United States absent
−Removed: registration or an applicable exemption from registration requirements.
−Removed: The 2017 LPC Purchase
−Removed: Agreement and the 2017 LPC Registration Rights Agreement contain customary representations, warranties, agreements and conditions
−Removed: to completing future sale transactions, indemnification rights and obligations of the parties.
−Removed: The Company has the right to terminate
−Removed: the 2017 LPC Purchase Agreement at any time, at no cost or penalty.
−Removed: Actual sales of shares of common stock to Lincoln Park under
−Removed: the 2017 LPC Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among
−Removed: others, market conditions, the trading price of the Common Stock and determinations by us as to the appropriate sources of funding
−Removed: for us and our operations.
−Removed: There are no trading volume requirements or, other than the limitation on beneficial ownership discussed
−Removed: above, restrictions under the 2017 LPC Purchase Agreement.
−Removed: Lincoln Park has no right to require any sales by the Company but is
−Removed: obligated to make purchases from the Company as directed in accordance with the 2017 LPC Purchase Agreement.
−Removed: Lincoln Park has
−Removed: covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company’s
−Removed: The net proceeds received
−Removed: by the Company under the 2017 LPC Purchase Agreement will depend on the frequency and prices at which the Company sells shares
−Removed: of common stock to Lincoln Park.
−Removed: A registration statement on Form S-3 was filed with the SEC on May 10, 2017 and was declared
−Removed: effective on June 5, 2017.
−Removed: The Company, from
−Removed: time to time and at the Company’s sole discretion but no more frequently than every other business day, could direct Lincoln
−Removed: Park to purchase (a “Regular Purchase”) up to 500,000 shares of common stock on any such business day, increasing
−Removed: up to 1,000,000 shares, depending upon the closing sale price of the common stock, provided that in no event shall Lincoln Park
−Removed: purchase more than $760,000 worth of common stock on any single business day.
−Removed: The purchase price of shares of common stock related
−Removed: to the future Regular Purchase funding will be based on the prevailing market prices of such shares at the time of sales (or over
−Removed: a period of up to ten business days leading up to such time), but in no event, will shares be sold to Lincoln Park on a day the
−Removed: Common Stock closing price is less than the floor price of $0.10 per share, subject to adjustment.
−Removed: ELITE PHARMACEUTICALS,
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED
−Removed: FINANCIAL STATEMENTS
−Removed: In addition to Regular
−Removed: Purchases, on any business day on which the Company has properly submitted a Regular Purchase notice and the closing sale price
−Removed: is not below $0.15, the Company may purchase (an “Accelerated Purchase”) an additional “accelerated amount”
−Removed: under certain circumstances.
−Removed: The amount of any Accelerated Purchase cannot exceed the lesser of three times the number of purchase
−Removed: shares purchased pursuant to the corresponding Regular Purchase;
−Removed: and 30% of the aggregate shares of the Company’s common
−Removed: stock traded during normal trading hours on the purchase date.
−Removed: The purchase price per share for each such Accelerated Purchase
−Removed: will be equal to the lower of (i) 97% of the volume weighted average price during the purchase date;
−Removed: or (ii) the closing sale
−Removed: price of the Company’s common stock on the purchase date.
−Removed: In the case of both
−Removed: Regular Purchases and Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization,
−Removed: non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute
−Removed: the purchase price.
−Removed: Other than as set
−Removed: forth above, there are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control
−Removed: the timing and amount of any sales of the Company’s common stock to Lincoln Park.
−Removed: The Company’s
−Removed: sales of shares of common stock to Lincoln Park under the Purchase Agreement are limited to no more than the number of shares
−Removed: that would result in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 9.99%
−Removed: of the then outstanding shares of common stock.
−Removed: The Purchase Agreement
−Removed: and the Registration Rights Agreement contain customary representations, warranties, agreements, and conditions to completing
−Removed: future sale transactions, indemnification rights and obligations of the parties.
−Removed: The Company has the right to terminate the Purchase
−Removed: Agreement at any time, at no cost or penalty.
−Removed: Actual sales of shares of common stock to Lincoln Park under the Purchase Agreement
−Removed: will depend on a variety of factors to be determined by the Company from time to time, including, without limitation, market conditions,
−Removed: the trading price of the Common Stock and determinations by the Company as to appropriate sources of funding for the Company and
−Removed: its operations.
−Removed: There are no trading volume requirements or restrictions under the Purchase Agreement.
−Removed: Lincoln Park has no right
−Removed: to require any sales by the Company but is obligated to make purchases from the Company as it directs in accordance with the Purchase
−Removed: Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or
−Removed: hedging of Company shares.
−Removed: During the year ended
−Removed: March 31, 2020, a total of 15,358,627 shares were sold to Lincoln Park pursuant to the 2017 LPC Agreement for net proceeds totaling
−Removed: In addition, 199,181 shares were issued to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Agreement.
−Removed: During the year ended March 31, 2019, a total of 22,033,967 shares were sold to Lincoln Park pursuant to the 2017 LPC Agreement
+Added: On May 1, 2017, the Company
+Added: entered into a purchase agreement (the “2017 LPC Purchase Agreement”), together with a registration rights agreement (the
+Added: “2017 LPC Registration Rights Agreement”), with Lincoln Park.
+Added: Under the terms and subject to the conditions of the 2017 LPC Purchase
+Added: Agreement, the Company had the right to sell to and Lincoln Park was obligated to purchase up to $40 million in shares of Common Stock,
+Added: subject to certain limitations, from time to time, over the 36-month period that commenced on June 5, 2017.
+Added: The 2017 LPC Purchase Agreement
+Added: expired on July 1, 2020.
+Added: During the year ended March
+Added: 31, 2021, there were no shares sold to Lincoln Park pursuant to the 2017 LPC Purchase Agreement.
+Added: In addition, there were no shares issued
+Added: to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Purchase Agreement.
+Added: During the year ended March 31, 2020, a
+Added: total of 15,358,627 shares were sold to Lincoln Park pursuant to the 2017 LPC Purchase Agreement for net proceeds totaling $15,359.
+Added: addition, 199,181 shares were issued to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Purchase Agreement.
+Added: Lincoln Park Capital Transaction - July
+Added: 8, 2020 Purchase Agreement
+Added: On July 8, 2020, Elite Pharmaceuticals,
+Added: Inc., a Nevada corporation (the “Company”), entered into a purchase agreement (the “Purchase Agreement”), and
+Added: a registration rights agreement (the “Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln
+Added: Park”), pursuant to which Lincoln Park has committed to purchase up to $25.0 million of the Company’s common stock, $0.001
+Added: par value per share (the “Common Stock”), from time to time over the term of the Purchase Agreement, at the Company’s
+Added: During the year ended March
+Added: 31, 2021 the Company issued an aggregate of 5,975,857 shares of Common Stock in the amount of $469,105 to Lincoln Park as initial commitment
+Added: The Company sold 640,543 shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the year ended March 31,
2021 for net proceeds totaling $42,223.
−Removed: In addition, 285,831 shares were issued to Lincoln Park as additional commitment shares,
−Removed: pursuant to the 2017 LPC Agreement.
+Added: In addition, 10,094 shares were issued to Lincoln Park as additional commitment shares, pursuant
+Added: to the 2020 LPC Agreement.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Summary of Common Stock Activity
−Removed: During the years ended
−Removed: March 31, 2020 and 2019, the Company issued 15,557,808 and 22,319,798 shares of Common Stock, respectively, with such issuances
−Removed: of Common Stock being summarized as follows:
−Removed: Years Ended March 31,
−Removed: Common Stock issued as of March 31, 2019 and 2018, respectively
−Removed: Common Stock sold pursuant to the Lincoln Park Capital Purchase Agreements, with net proceeds of such shares totaling $1,437,978 and $2,063,541 for the years ended March 31, 2020 and 2019, respectively.
−Removed: Common Stock issued as initial and additional commitment shares pursuant to the Lincoln Park Capital Purchase Agreements
−Removed: Common Stock issued during the fiscal year
−Removed: Common Stock issued as of March 31, 2020 and 2019, respectively
+Added: During the years ended March
+Added: 31, 2021 and 2020, the Company issued 168,772,385 and 15,557,808 shares of Common Stock, respectively, with such issuances of Common
+Added: Stock being summarized as follows:
+Added: Stock issued as of March 31, 2021 and 2020, respectively
+Added: stock converted from Preferred Stock
+Added: Stock sold pursuant to the Lincoln Park Capital Purchase Agreements, with net proceeds of such shares totaling $42,223 and $1,437,978
+Added: for the years ended March 31, 2021 and 2020, respectively.
+Added: Stock issued as initial and additional commitment shares pursuant to the Lincoln Park Capital Purchase Agreements
+Added: Stock issued in payment of Directors fees, salaries and consulting fees
+Added: Stock issued during the fiscal year
+Added: Stock issued as of March 31, 2021 and 2020, respectively
+Added: 1,009,276,752
STOCK-BASED COMPENSATION
Part of the compensation
−Removed: paid by the Company to its Directors and employees consists of the issuance of common stock or via the granting of options to
−Removed: purchase common stock.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: paid by the Company to its Directors and employees consists of the issuance of Common Stock or via the granting of options to purchase
+Added: Common Stock.
Stock-based Director Compensation
−Removed: The Company’s
−Removed: Director compensation policy was instituted in October 2009 and further revised in January 2016, includes provisions that a portion
−Removed: of director’s fees are to be paid via the issuance of shares of the Company’s common stock, in lieu of cash, with the
−Removed: valuation of such shares being calculated on quarterly basis and equal to the average closing price of the Company’s common
−Removed: During the year ended
−Removed: March 31, 2020, the Company did not issue any shares of common stock to its Directors in payment of director’s fees.
−Removed: During the year ended
−Removed: March 31, 2020, the Company accrued director’s fees totaling $60,000, which will be paid via cash payments totaling $30,000
−Removed: and the issuance of 756,725 shares of Common Stock.
+Added: The Company’s Director
+Added: compensation policy, instituted in October 2009 and further revised in January 2016, includes provisions that a portion of director’s
+Added: fees are to be paid via the issuance of shares of the Company’s Common Stock, in lieu of cash, with the valuation of such shares
+Added: being calculated on quarterly basis and equal to the average closing price of the Company’s Common Stock.
+Added: During the year ended March
+Added: 31, 2021, the Company issued 1,550,343 shares of Common Stock to its Directors in payment of director’s fees totaling an aggregate of
+Added: $135,000 and with such aggregate director’s fees being earned and accrued over the twenty-seven month period beginning on January 1,
+Added: 2018 and ending on March 31, 2020.
+Added: In addition, the Company made cash payments totaling an aggregate of $67,500 in payment of director’s
+Added: fees earned over the same twenty-seven month period.
+Added: During the year ended March 31, 2021, the Company
+Added: accrued director’s fees totaling $60,000, which will be paid via cash payments totaling $30,000 and the issuance of 886,710 shares
+Added: of Common Stock.
As of March 31, 2021,
−Removed: the Company owed its Directors a total of $67,500 in cash payments and 1,550,342 shares of Common Stock in payment of director
−Removed: fees totaling $202,500 due and owing.
−Removed: The Company anticipates that these shares of Common Stock will be issued prior to the end
−Removed: of the current fiscal year.
+Added: the Company owed its Directors a total of $30,000 in cash payments and 886,710 shares of Common Stock in payment of director fees totaling
+Added: $60,000 due and owing.
+Added: The Company anticipates that these shares of Common Stock will be issued prior to the end of the subsequent fiscal
Stock-based Employee/Consultant Compensation
−Removed: Employment contracts
−Removed: with the Company’s President and Chief Executive Officer, Chief Financial Officer and certain other employees and engagement
−Removed: contracts with certain consultants include provisions for a portion of each employee’s salaries or consultant’s fees
−Removed: to be paid via the issuance of shares of the Company’s Common Stock, in lieu of cash, with the valuation of such shares being
−Removed: calculated on a quarterly basis and equal to the average closing price of the Company’s Common Stock.
−Removed: During the year ended
−Removed: March 31, 2020, the Company did not issue any shares pursuant to employment contracts with the Company’s President and Chief
−Removed: Executive Officer, Chief Financial Officer or certain other employees.
−Removed: During the year ended March 31, 2020, the Company did not
−Removed: issue any shares pursuant to the engagement contracts with certain consultants.
−Removed: During the year ended
−Removed: March 31, 2020, the Company accrued salaries totaling $305,000 owed to the Company’s President and Chief Executive Officer,
−Removed: Chief Financial Officer and certain other employees which will be paid via the issuance of 3,846,685 shares of Common Stock.
+Added: Employment contracts with
+Added: the Company’s President and Chief Executive Officer, Chief Financial Officer and certain other employees and engagement contracts
+Added: with certain consultants include provisions for a portion of each employee’s salaries or consultant’s fees to be paid via
+Added: the issuance of shares of the Company’s Common Stock, in lieu of cash, with the valuation of such shares being calculated on a
+Added: quarterly basis and equal to the average closing price of the Company’s Common Stock.
+Added: During the year ended March
+Added: 31, 2021, the Company issued 646,336 shares of Common Stock in payment of salaries totaling $56,250 pursuant to the employment contract
+Added: of the Company’s Executive Vice President of Operations and with such salaries being earned and accrued over the thirty-month period
+Added: beginning on January 1, 2018 and ending on June 30, 2020.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: During the year ended March
+Added: 31, 2021, the Company accrued salaries totaling $748,750 owed to the Company’s President and Chief Executive Officer, Chief Financial
+Added: Officer and certain other employees which will be paid via the issuance of 11,250,185 shares of Common Stock.
As of March 31, 2021,
the Company owed its President and Chief Executive Officer, Chief Financial Officer and certain other employees’
−Removed: totaling $2,311,250 which will be paid via the issuance of 24.8 million shares of Common Stock.
−Removed: Under its 2014 Stock
−Removed: Option Plan and prior option plans, the Company may grant stock options to officers, selected employees, as well as members of
−Removed: the Board of Directors and advisory board members.
−Removed: All options have generally been granted at a price equal to or greater than
−Removed: the fair market value of the Company’s Common Stock at the date of the grant.
−Removed: Generally, options are granted with a vesting
−Removed: period of up to three years and expire ten years from the date of grant.
+Added: salaries totaling
+Added: $3,060,000 which will be paid via the issuance of 36,085,114 shares of Common Stock.
+Added: During the year ended March
+Added: 31, 2021, the Company issued 1,931,891 shares of Common Stock in payment of consulting fees totaling $161,033, pursuant to engagement
+Added: contracts with a certain consultant, and with such consulting expenses being earned and accrued over the twenty seven month period beginning
+Added: on January 1, 2018 and ending March 31, 2020.
+Added: Under its 2014 Stock Option
+Added: Plan and prior options plans, the Company may grant stock options to officers, selected employees, as well as members of the Board of
+Added: Directors and advisory board members.
+Added: All options have generally been granted at a price equal to or greater than the fair market value
+Added: of the Company’s Common Stock at the date of the grant.
+Added: Generally, options are granted with a vesting period of up to three years
+Added: and expire ten years from the date of grant.
+Added: A summary of the activity of Company’s 2014 Stock Option Plan for the years ended March
+Added: 31, 2021and 2020 is as follows:
Outstanding at March 31, 2019
4 unchanged sentences
Exercisable at March 31, 2021
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying
−Removed: awards and the quoted price of the Company common stock as of March 31, 2020 and March 31, 2019 of $0.07 and $0.10, respectively.
−Removed: CONCENTRATIONS AND CREDIT
+Added: The aggregate intrinsic value
+Added: for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the
+Added: Company’s Common Stock as of March 31, 2021 and March 31, 2020 of $0.06 and $0.07, respectively.
+Added: CONCENTRATIONS AND CREDIT RISK
+Added: Two customers accounted for
+Added: approximately 92% of the Company’s revenues for the year ended March 31, 2021.
+Added: These two customers accounted for approximately
+Added: 77% and 15% of revenues each, respectively.
Three customers accounted
1 unchanged sentence
These three customers accounted for approximately
−Removed: 55%, 24%, and 13% of revenues each.
−Removed: Four customers accounted
−Removed: for substantially all the Company’s revenues for the year ended March 31, 2019.
−Removed: These four customers accounted for approximately
55%, 24%, and 13% of revenues each, respectively.
Accounts Receivable
−Removed: Four customers accounted
−Removed: for substantially all the Company’s accounts receivable as of March 31, 2020.
−Removed: These four customers accounted for approximately
−Removed: 73%, 13%, 8% and 5% of accounts receivable each.
+Added: Three customers accounted
+Added: for approximately 99% of the Company’s accounts receivable as of March 31, 2021.
+Added: These three customers accounted for approximately
+Added: 73%, 15% and 11% of accounts receivable each, respectively.
Four customers accounted
1 unchanged sentence
These four customers accounted for approximately
−Removed: 38%, 34%, 19%, and 4% of accounts receivable each.
−Removed: Three suppliers accounted
+Added: 73%, 13%, 8%, and 5% of accounts receivable each, respectively.
+Added: ELITE PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Four suppliers accounted
for approximately 78% of the Company’s purchases of raw materials for the year ended March 31, 2021.
−Removed: These three suppliers
−Removed: that accounted for approximately 41%, 23%, and 7% of purchases each.
+Added: These four suppliers accounted
+Added: for approximately 54%, 13%, 6% and 5% of purchases each, respectively.
Three suppliers accounted
−Removed: for more than 60% of the Company’s purchases of raw materials for year ended March 31, 2019.
+Added: for more than 71% of the Company’s purchases of raw materials for the year ended March 31, 2020.
These three suppliers accounted
1 unchanged sentence
SEGMENT RESULTS
−Removed: ASC 280-10-50 requires
+Added: FASB ASC 280-10-50 requires
use of the “management approach”
2 unchanged sentences
management organized segments within the company for making operating decisions and assessing performance.
−Removed: Reportable segments
−Removed: are based on products and services, geography, legal structure, management structure, or any other manner in which management
−Removed: disaggregates a company.
+Added: Reportable segments are based
+Added: on products and services, geography, legal structure, management structure, or any other manner in which management disaggregates a company.
The Company has determined
that its reportable segments are ANDAs for generic products and NDAs for branded products.
−Removed: The Company identified its reporting
−Removed: segments based on the marketing authorization relating to each and the financial information used by its chief operating decision
−Removed: maker to make decisions regarding the allocation of resources to and the financial performance of the reporting segments.
−Removed: Asset information
−Removed: by operating segment is not presented below since the chief operating decision maker does not review this information by segment.
−Removed: The reporting segments follow the same accounting policies used in the preparation of the Company’s audited consolidated
−Removed: financial statements.
+Added: The Company identified its reporting segments
+Added: based on the marketing authorization relating to each and the financial information used by its chief operating decision maker to make
+Added: decisions regarding the allocation of resources to and the financial performance of the reporting segments.
+Added: Asset information by operating
+Added: segment is not presented below since the chief operating decision maker does not review this information by segment.
+Added: The reporting segments
+Added: follow the same accounting policies used in the preparation of the Company’s consolidated financial statements.
+Added: Disaggregated revenue
+Added: by reportable segments is disclosed in Note 1.
The following represents
selected information for the Company’s reportable segments:
−Removed: Years Ended March 31,
−Removed: Revenue by Segment
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Years Ended March 31,
−Removed: Operating Income (Loss) by Segment
−Removed: $ (4,361,649 )
−Removed: $ (4,238,688 )
+Added: For the Years Ended March 31,
+Added: Operating Income by Segment
The table below reconciles
−Removed: the Company’s operating loss by segment to loss from operations before provision for income taxes as reported in the Company’s
−Removed: audited consolidated statements of operations.
−Removed: Years Ended March 31,
−Removed: Operating income (loss) by segment
−Removed: $ (4,238,688 )
+Added: the Company’s operating income by segment to income (loss) from operations before provision for income taxes as reported in the
+Added: Company’s consolidated statements of operations.
+Added: For the Years Ended March 31,
+Added: Operating income by segment
Corporate unallocated costs
Interest income
−Removed: Interest expense and amortization of debt issuance
+Added: Interest expense and amortization of debt issuance costs
Depreciation and amortization expense
Significant non-cash items
−Removed: Change in fair value of derivative
−Removed: Loss from operations before income
−Removed: $ (2,238,351 )
+Added: PPP loan forgiveness
+Added: Change in fair value of derivative instruments
+Added: Income (loss) from operations before income taxes
$ (2,238,351 )
−Removed: COLLABORATIVE AGREEMENT WITH
−Removed: EPIC PHARMA LLC
−Removed: On June 4, 2015, the
−Removed: Company executed an exclusive License Agreement (the “
−Removed: 2015 SequestOx™
−Removed: License Agreement ”) with Epic Pharma
−Removed: LLC (“Epic”), to market and sell in the U.S., SequestOx™, an immediate release oxycodone with sequestered naltrexone
−Removed: capsule, owned by us.
−Removed: Epic will have the exclusive right to market ELI-200 and its various dosage forms as listed in Schedule A
−Removed: of the Agreement.
−Removed: Epic is responsible for all regulatory and pharmacovigilance matters related to the products.
−Removed: Pursuant to the
−Removed: 2015 SequestOx™
−Removed: License Agreement, Epic will pay us non-refundable milestone payments totaling $15 million, with such amount
−Removed: representing the cost of an exclusive license to SequestOx™, the cost of developing the product, the filing of an NDA with
−Removed: the FDA and the receipt of the approval letter for the NDA from the FDA.
−Removed: The 2015 SequestOx™
−Removed: License Agreement expired
−Removed: on June 4, 2020.
−Removed: During the term of this agreement, the Company received $7.5 million in non-refundable payments, with such amount
−Removed: consisting of $5 million due and owing on the execution date of the 2015 SequestOx™
−Removed: License Agreement and $2.5 million
−Removed: being earned upon the Company’s filing of an NDA with the FDA for the relevant product in January 2016.
−Removed: The remaining $7.5
−Removed: million in non-refundable payments required FDA approval of the relevant product, a milestone that was not achieved prior to the
−Removed: expiration of the agreement.
−Removed: COLLABORATIVE
−Removed: AGREEMENT WITH SUNGEN PHARMA LLC
−Removed: On August 24, 2016,
−Removed: as amended we entered into an agreement with SunGen Pharma LLC (“SunGen”) (the “SunGen Agreement”) to undertake
−Removed: and engage in the research, development, sales and marketing of eight generic pharmaceutical products.
−Removed: Two of the products are
−Removed: classified as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers and the remaining
−Removed: four products consist of antidepressants, antibiotics and antispasmodics.
−Removed: The Company has received approval from the FDA for Amphetamine
−Removed: IR Tablets, Amphetamine ER Capsules and has filed an ANDA for an antibiotic product.
−Removed: Under the terms of
−Removed: the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will
−Removed: share substantially in the profits from sales.
−Removed: Upon approval, the know-how and intellectual property rights to the products will
−Removed: be owned jointly by Elite and SunGen.
−Removed: Three of the eight products will be jointly owned, three products will be owned by SunGen,
−Removed: with Elite having exclusive marketing rights and the remaining two products will be owned by Elite, with SunGen having exclusive
−Removed: marketing rights.
−Removed: Elite will manufacture and package all eight products on a cost-plus basis.
−Removed: On December 10, 2018,
−Removed: the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall ®
−Removed: , an immediate-release
−Removed: mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate,
−Removed: Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets.
−Removed: The product is a central
−Removed: nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
−Removed: The product is jointly owned by Elite and SunGen.
−Removed: Elite manufactures and packages this product, at the Northvale Facility,
−Removed: on a cost-plus basis, and it is currently sold pursuant to the Lannett Alliance, with the first commercial shipment of this product
−Removed: occurring in April 2019.
−Removed: Please see the section below titled “Strategic Marketing Alliance with Lannett Company Inc.”
−Removed: for further details on the Lannett Alliance
−Removed: On January 3, 2019,
−Removed: the Company filed an ANDA with the FDA for a generic version of an antibiotic product.
−Removed: According to QVIA (formerly QuintilesIMS
−Removed: Health) data, the branded product for this antibiotic and its equivalents had total annual U.S.
−Removed: sales of approximately $94 million
−Removed: for the twelve months ending September 30, 2018.
−Removed: The product is jointly owned by Elite and SunGen.
−Removed: Upon approval by the
−Removed: FDA of this ANDA, Elite will manufacture and package the product on a cost-plus basis.
−Removed: The ANDA is currently under review by the
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: On December 12, 2019,
−Removed: the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR ®
−Removed: , an extended-release
−Removed: mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate,
−Removed: Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg capsules.
−Removed: The product is a central nervous system stimulant
−Removed: and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
−Removed: The product is jointly owned by Elite
−Removed: Elite manufactures and packages this product, at the Northvale Facility, on a cost-plus basis and it is currently sold
−Removed: pursuant to the Lannett Alliance, with the first commercial shipment of this product occurring in March 2020.
−Removed: Please see the section
−Removed: below titled “Strategic Marketing Alliance with Lannett Company Inc.”
−Removed: for further details on the Lannett Alliance.
−Removed: On April 3, 2020, the
−Removed: Company and SunGen mutually agreed to discontinue any further joint product development activities.
−Removed: In May 2020, SunGen,
−Removed: under an asset purchase agreement, assigned its rights and obligations under the Master Development and License Agreement for Amphetamine
−Removed: IR and Amphetamine ER to Mikah Pharmaceuticals.
−Removed: The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s
−Removed: Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations
−Removed: for these products from SunGen.
−Removed: There can be no assurances
−Removed: that any of these products will receive marketing authorization and achieve commercialization within this time period, or at all.
−Removed: In addition, even if marketing authorization is received, and even for those products for which marketing authorization has already
−Removed: been received, there can be no assurances that there will be future revenues of profits, or that any such future revenues or profits
−Removed: would be in amounts that provide adequate return on the significant investments made to secure these marketing authorizations or
−Removed: provide sufficient financial contributions to support costs of operations and overheads.
−Removed: RELATED PARTY TRANSACTION AGREEMENTS WITH EPIC PHARMA
−Removed: The Company has entered
−Removed: into two agreements with Epic which constitute agreements with a related party due to the management of Epic including a member
−Removed: on our Board of Directors at the time such agreements were executed.
−Removed: On June 4, 2015, the
−Removed: Company entered into the 2015 Epic License Agreement (please see Note 16 above).
−Removed: The 2015 Epic License Agreement includes milestone
−Removed: payments totaling $10 million upon the filing with and approval of an NDA with the FDA.
−Removed: The Company has determined these milestones
−Removed: to be substantive, with such assessment being made at the inception of the 2015 Epic License Agreement, and based on the following:
−Removed: ● The Company’s performance
−Removed: is required to achieve each milestone;
−Removed: ● The milestones will relate
−Removed: to past performance, when achieved;
−Removed: ● The milestones are reasonable
−Removed: relative to all of the deliverables and payment terms within the 2015 Epic License Agreement
−Removed: The 2015 SequestOx™
−Removed: License Agreement expired on June 4, 2020.
−Removed: During the term of this agreement, the Company received $7.5 million in non-refundable
−Removed: payments, with such amount consisting of $5 million due and owing on the execution date of the 2015 SequestOx™
−Removed: Agreement and $2.5 million being earned upon the Company’s filing of an NDA with the FDA for the relevant product in
−Removed: January 2016.
−Removed: The remaining $7.5 million in non-refundable payments required FDA approval of the relevant product, a milestone
−Removed: that was not achieved prior to the expiration of the agreement.
−Removed: This transaction is
−Removed: not to be considered as an arms-length transaction.
−Removed: Please also note that,
−Removed: effective April 7, 2016, all Directors on the Company’s Board of Directors that were also owners/managers of Epic had resigned
−Removed: as Directors of the Company and all current members of the Company’s Board of Directors have no relationship to Epic.
−Removed: Epic no longer qualifies as a party that is related to the Company.
−Removed: MANUFACTURING, LICENSE AND
−Removed: DEVELOPMENT AGREEMENTS
−Removed: The Company has entered into the following
−Removed: active agreements:
−Removed: ● License agreement with Precision Dose, dated September
−Removed: 10, 2010, as amended (the “Precision Dose License Agreement”);
−Removed: ● Development and License Agreement with SunGen (the “SunGen
−Removed: Agreement”);
−Removed: ● Strategic Marketing Alliance with Glenmark Pharmaceuticals,
−Removed: USA dated May 22, 2018 (the “Glenmark Alliance”).
−Removed: ● Strategic Marketing Alliance with Lannett Company.
−Removed: dated March 6, 2019 (the “Lannett-SunGen Product Alliance”)
−Removed: ● Strategic Marketing Alliance with Lannett Company.
−Removed: dated April 9, 2019 (the “Lannett-Elite Product Alliance”)
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The Precision Dose
−Removed: Agreement currently provides for the marketing and distribution, by Precision Dose and its wholly owned subsidiary, TAGI Pharma,
−Removed: of Phentermine 37.5mg tablets (launched in April 2011), Phentermine 15mg capsules (launched in April 2013), Phentermine 30mg capsules
−Removed: (launched in April 2013), Naltrexone 50mg tablets (launched in September 2013) and certain additional products that require approval
−Removed: from the FDA which has not been received.
−Removed: Precision Dose will have the exclusive right to market these products in the United
−Removed: States and Puerto Rico and a non-exclusive right to market the products in Canada.
−Removed: Pursuant to the Precision Dose License Agreement,
−Removed: Elite received $200k at signing, and is receiving milestone payments and a license fee which is based on profits achieved from
−Removed: the commercial sale of the products included in the agreement.
−Removed: Revenue from the $200k
−Removed: payment made upon signing of the Precision Dose Agreement is being recognized over the life of the Precision Dose Agreement.
−Removed: The milestones, totaling
−Removed: $500k (with $405k already received), consist of amounts due upon the first shipment of each identified product, as follows:
−Removed: 37.5mg tablets ($145k), Phentermine 15 & 30mg capsules ($45k), Hydromorphone 8mg ($125k), Naltrexone 50mg ($95k) and the balance
−Removed: of $95k due in relation to the first shipment of generic products which still require marketing authorizations from the FDA, and
−Removed: to which there can be no assurances of such marketing authorizations being granted and accordingly there can be no assurances that
−Removed: the Company will earn and receive these milestone amounts.
−Removed: These milestones have been determined to be substantive, with such determination
−Removed: being made by the Company after assessments based on the following:
−Removed: ● The Company’s performance
−Removed: is required to achieve each milestone;
−Removed: ● The milestones will relate
−Removed: to past performance, when achieved;
−Removed: ● The milestones are reasonable
−Removed: relative to all of the deliverables and payment terms within the Precision Dose License
−Removed: The license fees provided
−Removed: for in the Precision Dose Agreement are calculated as a percentage of net sales dollars realized from commercial sales of the
−Removed: related products.
−Removed: Net sales dollars consist of gross invoiced sales less those costs and deductions directly attributable to each
−Removed: invoiced sale, including, without limitation, cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price
−Removed: adjustments, returns, short date adjustments, charge backs, promotions, and marketing costs.
−Removed: The rate applied to the net sales
−Removed: dollars to determine license fees due to the Company is equal to an amount negotiated and agreed to by the parties to the Precision
−Removed: Dose License Agreement, with the following significant factors, inputs, assumptions, and methods, without limitation, being considered
−Removed: by either or both parties:
−Removed: ● Assessment of the opportunity
−Removed: for each generic product in the market, including consideration of the following, without
−Removed: market size, number of competitors, the current and estimated future regulatory,
−Removed: legislative, and social environment for each generic product, and the maturity of the
−Removed: ● Assessment of various avenues
−Removed: for monetizing the generic products, including the various combinations of sites of manufacture
−Removed: and marketing options;
−Removed: ● Capabilities of each party
−Removed: with regards to various factors, including, one or more of the following:
−Removed: manufacturing
−Removed: resources, marketing resources, financial resources, distribution capabilities, ownership
−Removed: structure, personnel, assessment of operational efficiencies and stability, company culture
−Removed: ● Stage of development of each
−Removed: generic product, all of which did not have FDA approval at the time of the discussions/negotiations
−Removed: and an assessment of the risks, probability, and time frame for achieving marketing authorizations
−Removed: from the FDA for the products;
−Removed: ● Assessment of consideration
−Removed: offered by Precision and other entities with whom discussions were conducted;
−Removed: ● Comparison of the above factors
−Removed: among the various entities with whom the Company was engaged in discussions relating
−Removed: to the commercialization of the generic products.
−Removed: The SunGen Agreement
−Removed: provides for the research, development, sales and marketing of eight generic pharmaceutical products.
−Removed: Two of the products are
−Removed: classified as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers and the remaining
−Removed: four products consist of antidepressants, antibiotics and antispasmodics.
−Removed: To date, the Company has received approval of ANDA’s
−Removed: filed for Amphetamine IR Tablets and Amphetamine ER Capsules, both of which have been commercially launched and are sold pursuant
−Removed: to the Lannett Alliance.
−Removed: The Company has also filed, pursuant to the SunGen Agreement, an ANDA, which is under review by the FDA,
−Removed: for an antibiotic product.
−Removed: On April 3, 2020, the Company and SunGen mutually agreed to discontinue any further joint product development
−Removed: Under the terms of
−Removed: the SunGen Agreement, Elite and SunGen share in the responsibilities and costs in the development of these products and will share
−Removed: substantially in the profits from sales.
−Removed: Upon approval, the know-how and intellectual property rights to the products will be owned
−Removed: jointly by Elite and SunGen.
−Removed: Three of the eight products will be jointly owned, three products will be owned by SunGen, with
−Removed: Elite having exclusive marketing rights and the remaining two products will be owned by Elite, with SunGen having exclusive marketing
−Removed: Elite will manufacture and package all eight products on a cost-plus basis.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: In May 2020, SunGen,
−Removed: under an asset purchase agreement, assigned its rights and obligations under the Master Development and License Agreement for Amphetamine
−Removed: IR and Amphetamine ER to Mikah Pharmaceuticals.
−Removed: The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s
−Removed: Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations
−Removed: for these products from SunGen.
−Removed: The Glenmark Alliance,
−Removed: provides for the manufacture by Elite and exclusive marketing by Glenmark of Isradipine capsules, Trimipramine capsules and Methadone
−Removed: Tablets, and semi-exclusive marketing rights for Phendimetrazine tablets.
−Removed: All marketing rights relating to Methadone Tablets were
−Removed: terminated by mutual agreement in January 2020 and all marketing rights relating to Phendimetrazine Tablets were terminated by
−Removed: mutual agreement in February 2020.
−Removed: In addition to the purchase prices for the products, Elite will receive license fees well in
−Removed: excess of 50% of gross profits.
−Removed: Gross profit is defined as net sales less the price paid to Elite for the products, distribution
−Removed: fees (less than 10%) and shipping costs.
−Removed: The Agreement has an initial term of three years and automatically renews for one-year
−Removed: periods absent prior written notice of non-renewal.
−Removed: In addition to customary termination provisions, the Agreement permits Glenmark
−Removed: to terminate with regard to a product on at least three months’
−Removed: prior written notice if it determines to stop marketing and
−Removed: selling such product, and it permits Elite to terminate with regard to a product if at any time after the first twelvemonths from
−Removed: the first commercial sale, the average license fee paid by Glenmark for such product is less than $100,000 for a six-month sales
−Removed: Pursuant to Lannett-SunGen
−Removed: Product Alliance with Lannett Company Inc.
−Removed: (“Lannett”), Lannett will be the exclusive U.S.
−Removed: marketer and distributor
−Removed: for Amphetamine IR Tablets and Amphetamine ER Capsules.
−Removed: Elite will manufacture and Lannett will purchase the products from Elite
−Removed: and then sell and distribute them.
−Removed: In addition to the purchase prices for the products, Elite will receive license fees in excess
−Removed: of 50% of net profits, which will be shared equally with SunGen, pursuant to the SunGen Agreement.
−Removed: The Lannett-SunGen Product
−Removed: Alliance has an initial term of three years and automatically renews for one-year periods absent prior written notice of non-renewal.
−Removed: In addition to customary termination provisions, the Agreement permits Lannett to terminate with regard to a product on at least
−Removed: six months’
−Removed: prior written notice, and it permits Elite or Lannett to terminate with regard to a product if at any time after
−Removed: the first twelve months from the first commercial sale, the average license fee paid by Lannett for such product is less than
−Removed: $300,000 for a six month sales period.
−Removed: In addition to manufacturing fees and license fees, Lannett also paid a milestone, of $750,000
−Removed: upon the March 2020 commercial launch of Amphetamine ER Capsules.
−Removed: This milestone payment was shared equally by Elite and SunGen,
−Removed: pursuant to the SunGen Agreement.
−Removed: The first commercial
−Removed: shipment of Amphetamine IR Tablets, a generic version of Adderall ®
−Removed: , with strengths of 5mg, 7.5mg, 10mg, 12.5mg,
−Removed: 15mg, 20mg and 30mg, pursuant to the Lannett-SunGen Product Alliance occurred in April 2019.
−Removed: The first commercial shipment of
−Removed: Amphetamine ER Capsules, a generic version of Adderall XR ®
−Removed: , with strengths of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg,
−Removed: pursuant to the Lannett-SunGen Product Alliance occurred in March 2020.
−Removed: Pursuant to the Lannett-Elite
−Removed: Product Alliance, Lannett is the exclusive U.S.
−Removed: marketer and distributor for Dantrolene Capsules.
−Removed: Elite manufactures and Lannett
−Removed: purchases, markets and distributes this product.
−Removed: In addition to the purchase prices for the products, Elite receives license fees
−Removed: in excess of 50% of net profits.
−Removed: Net profits are defined as net sales less the price paid to Elite for the products, distribution
−Removed: fees (less than 10%) and shipping costs.
−Removed: The Lannett-Elite Product Alliance has an initial term of three years and automatically
−Removed: renews for one-year periods absent prior written notice of non-renewal.
−Removed: In addition to customary termination provisions, the Agreement
−Removed: permits Lannett to terminate with regard to a product on at least six months’
−Removed: prior written notice and it permits Elite
−Removed: or Lannett to terminate with regard to a product if at any time after the first twelve months from the first commercial sale,
−Removed: the average license fee paid by Lannett for such product is less than $300,000 for a six month sales period.
−Removed: The first commercial
−Removed: shipment of Dantrolene Capsules occurred in June 2019.
RELATED PARTY AGREEMENTS WITH MIKAH PHARMA, LLC
−Removed: On December 3, 2018,
−Removed: the Company executed a development agreement with Mikah, pursuant to which Mikah and the Company will collaborate to develop and
−Removed: commercialize generic products including formulation development, analytical method development, bioequivalence studies and manufacture
−Removed: of development batches of generic products.
−Removed: The Company received a total of $480,000 from Mikah as an advance payment for the
−Removed: purchase of pharmaceutical materials relating to future product development conducted pursuant to this agreement.
−Removed: was recorded as a deposit and contained within the customer deposits financial statement line item on the consolidated balance
−Removed: As of the date of this report, the Company has purchased raw materials with an aggregate cost of $542,214 pursuant to this
−Removed: As of March 31, 2020, the balance due from Mikah was $62,214 and was included in the financial statement line of prepaid
−Removed: expenses and other current assets on the accompanying consolidated balance sheet.
+Added: On December 3, 2018, the
+Added: Company executed a development agreement with Mikah pursuant to which Mikah and the Company will collaborate to develop and commercialize
+Added: generic products including formulation development, analytical method development, bioequivalence studies and manufacture of development
+Added: batches of generic products.
+Added: As of the date of this report, the Company has incurred costs which are $238,451 in excess of advanced payments
+Added: received to date from Mikah.
+Added: This balance due from Mikah was offset, in full, against accrued interest due and owing to Mikah pursuant
+Added: to the Mikah Note (see Note 7).
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The components of
−Removed: the credit for income taxes are as follows:
−Removed: Year Ended March 31,
+Added: In May 2020, SunGen Pharma LLC (“SunGen”), under an asset
+Added: purchase agreement, assigned its rights and obligations under the SunGen Agreement for Amphetamine IR and Amphetamine ER to Mikah Pharmaceuticals.
+Added: The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s name.
+Added: Mikah will now be Elite’s partner with
+Added: respect to Amphetamine IR and ER and will assume all the rights and obligations for these products from SunGen.
+Added: Mikah Pharmaceuticals
+Added: was founded in 2009 by Nasrat Hakim.
+Added: The components of the income
+Added: taxes benefit (expense) are as follows:
+Added: Ended March 31,
Benefit from sale of state net operating loss credits
Net benefit from sale of state net operating loss credits
−Removed: The major components
−Removed: of deferred tax assets and liabilities at March 31, 2020 and 2019 are as follows (amounts in thousands of dollars):
+Added: The major components of deferred
+Added: tax assets and liabilities as of March 31, 2021 and 2020 are as follows (amounts in thousands of dollars):
Year Ended March 31,
4 unchanged sentences
At March 31, 2021 and
−Removed: 2019 a 100% valuation allowance is provided, as it is uncertain if the deferred tax assets will provide any future benefits because
−Removed: of the uncertainty about the Company’s ability to generate the future taxable income necessary to use the net operating loss
−Removed: carry forwards.
−Removed: The company believes
−Removed: that temporary timing differences between accrual and payment of income taxes are not material to the financial position of the
+Added: 2020 a 100% valuation allowance is provided, as it is uncertain if the deferred tax assets will provide any future benefits because of
+Added: the uncertainty about the Company’s ability to generate the future taxable income necessary to use the net operating loss carry
+Added: Absent the above mentioned allowance, at March 31, 2021, the Company’s federal and state income taxes due were $0.4 million
+Added: and $0.2 million, respectively.
+Added: Absent the above mentioned allowance, at March 31, 2020, the Company’s federal and state income
+Added: taxes due were $0.2 million and $0.1 million, respectively.
+Added: The company believes that
+Added: temporary timing differences between accrual and payment of income taxes are not material to the financial position of the Company.
As of March 31, 2021,
−Removed: Elite has a federal net operating loss carry forward of $21.4 million, which do not expire and net operating loss carry forward
−Removed: in state tax jurisdictions of $2.2 million some of which will begin to expire in 2020.
−Removed: OTHER INCOME –
−Removed: PROCEEDS FROM SALE OF ANDAs
−Removed: Sale of ANDAs
−Removed: for Oxycodone Hydrochloride and Acetaminophen, USP CII (generic version of Percocet®)
−Removed: In November 2019, approved
−Removed: ANDAs for a generic version of Percocet ®
−Removed: (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg
−Removed: tablets with 325mg of acetaminophen were sold to Nostrum Laboratories Inc.
−Removed: (“Nostrum”) for cash consideration totaling
−Removed: The three related approved ANDA’s were developed by Elite, with the costs of such development being charged to
−Removed: expense in the periods incurred, in accordance with generally accepted accounting principles.
−Removed: Sale of ANDAs
−Removed: for Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco)
−Removed: In November 2019, approved
−Removed: ANDAs for a generic version of Norco ®
−Removed: (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg,
−Removed: 7.5mg/325mg and 10mg/325mg tablets were sold to Nostrum for cash consideration totaling $300,000.
−Removed: The four related approved ANDA’s
−Removed: were developed by Elite, with the costs of such development being charged to expense in the periods incurred, in accordance with
−Removed: generally accepted accounting principles.
+Added: Elite has a federal net operating loss carry forward of $99.5 million, which do not expire and net operating loss carry forward in state
+Added: tax jurisdictions of $9.3 million some of which will began to expire in 2021.
ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARIES
+Added: AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Sale of ANDAs
−Removed: for Methadone hydrochloride tablets (generic version of Dolophine)
−Removed: In February 2020, approved
−Removed: ANDAs for a generic version of Dolophine®
−Removed: (methadone hydrochloride tablets, 5 mg and 10 mg) were sold to Nostrum for cash consideration
−Removed: totaling $300,000.
−Removed: The two related approved ANDA’s were developed by Elite, with the costs of such development being charged
−Removed: to expense in the periods incurred, in accordance with generally accepted accounting principles.
−Removed: for Hydromorphone HCl tablet (generic version of Dilaudid)
−Removed: In February 2020,
−Removed: the approved ANDA for a generic version of Dilaudid®
−Removed: (hydromorphone hydrochloride tablets, 8mg) were sold to Nostrum for cash
−Removed: consideration totaling $300,000.
−Removed: The carrying value of the asset relating to this ANDA was zero.
−Removed: Sale of ANDAs
−Removed: for Phendimetrazine tartrate tablet (generic version of Bontril)
−Removed: In February 2020, approved
−Removed: ANDAs for a generic version of Bontril PDM®
−Removed: (phendimetrazine tartrate tablet, 35 mg) were sold to Nostrum for cash consideration
−Removed: totaling $300,000.
−Removed: The related approved ANDA’s were developed by Elite, with the costs of such development being charged
−Removed: to expense in the periods incurred, in accordance with generally accepted accounting principles.
+Added: Sale of New Jersey Net Operating Loss
+Added: In April 2020, Elite Laboratories
+Added: Inc., a wholly owned subsidiary of Elite Pharmaceuticals Inc., received final approval from the New Jersey Economic Development Authority
+Added: for the sale of net tax benefits of $607,635 relating to New Jersey net operating losses and net tax benefits of $338,772, relating to
+Added: R&D tax credits.
+Added: The Company sold the net tax benefits approved for sale for total proceeds of $946,407.
COVID-19 UPDATE
−Removed: In December 2019, the
−Removed: Novel Corona Virus, COVID-19 was reported to have emerged in Wuhan, China.
+Added: In December 2019, the Novel
+Added: Corona Virus, COVID-19 was reported to have emerged in Wuhan, China.
In March 2020, the World Health Organization (“WHO”)
declared the COVID-19 outbreak a global pandemic.
−Removed: Governments at the national, state and local level in the United States, and
−Removed: globally, have implemented aggressive actions to reduce the spread of the virus, with such actions including, without limitation,
−Removed: lockdown and shelter in place orders, limitations on non-essential gatherings of people, suspension of all non-essential travel,
−Removed: and ordering certain businesses and governmental agencies to cease non-essential operations at physical locations.
−Removed: The Company’s
−Removed: business is deemed essential and it has continued to operate in all aspects of its pharmaceutical manufacturing, distribution,
−Removed: product development, regulatory compliance and other activities.
−Removed: The Company’s management has developed and implemented a
−Removed: range of measures to address the risks, uncertainties, and operational challenges associated with operating in a COVID-19 environment.
−Removed: The Company is closely monitoring the rapidly evolving and changing situation and are implementing plans intended to limit the
−Removed: impact of COVID-19 on our business so that the Company can continue to manufacture those medicines used by end user patients.
−Removed: the Company has taken to date are, without limitation, further described below.
−Removed: The Company has taken
−Removed: and will continue to take, proactive measures to provide for the well-being of our workforce while continuing to safely produce
−Removed: pharmaceutical products.
−Removed: The Company has implemented alternative working practices, which include, without limitation, modified
−Removed: schedules, shift rotation and work at home abilities for appropriate employees to best ensure adequate social distancing.
−Removed: the Company increased our already thorough cleaning protocols throughout our facilities and have prohibited visits from non-essential
−Removed: Certain of these measures have resulted in increased costs.
−Removed: Manufacturing
−Removed: and Supply Chain
+Added: Governments at the national, state and local level in the United States, and globally,
+Added: have implemented aggressive actions to reduce the spread of the virus, with such actions including, without limitation, lockdown and
+Added: shelter in place orders, limitations on non-essential gatherings of people, suspension of all non-essential travel, and ordering certain
+Added: businesses and governmental agencies to cease non-essential operations at physical locations.
+Added: Under current and applicable laws and regulations,
+Added: the Company’s business is deemed essential and it has continued to operate in all aspects of its pharmaceutical manufacturing,
+Added: distribution, product development, regulatory compliance and other activities.
+Added: The Company’s management has developed and implemented
+Added: a range of measures to address the risks, uncertainties, and operational challenges associated with operating in a COVID-19 environment.
+Added: The Company is closely monitoring the rapidly evolving and changing situation and are implementing plans intended to limit the impact
+Added: of COVID-19 on our business so that the Company can continue to manufacture those medicines used by end user patients.
+Added: Actions the Company
+Added: has taken to date are, without limitation, further described below.
+Added: The Company has taken and
+Added: will continue to take, proactive measures to provide for the well-being of its workforce while continuing to safely produce pharmaceutical
+Added: The Company has implemented alternative working practices, which include, without limitation, modified schedules, shift rotation
+Added: and work at home abilities for appropriate employees to best ensure adequate social distancing.
+Added: In addition, the Company increased its
+Added: already thorough cleaning protocols throughout its facilities and has prohibited visits from non-essential visitors.
+Added: Certain of these
+Added: measures have resulted in increased costs.
+Added: Manufacturing and Supply Chain
During the year ended March
−Removed: 31, 2020, and as of the date of this Annual Report on Form 10-K, the Company has not experience material, detrimental issues related
−Removed: to COVID-19 in our manufacturing, supply chain, quality assurance and regulatory compliance activities, and have been able to operate
−Removed: without interruption.
−Removed: The Company has taken, and plan to continue to take, commercially practical measures to keep our facility
−Removed: Our supply chains remain intact and operational, and the Company is in regular communications with our suppliers and third-party
−Removed: Please note, however, that a prolonging of the current situation relating to COVID-19 may result in an increased risk
−Removed: of interruption in our supply chain in the future, with no assurances given as the materiality of such future interruption on our
−Removed: business, financial condition, results of operations and cash flows.
+Added: 31, 2021, the Company has not experienced material, detrimental issues related to COVID-19 in its manufacturing, supply chain, quality
+Added: assurance and regulatory compliance activities, and has been able to operate without interruption.
+Added: The Company has taken, and plans to
+Added: continue to take, commercially practical measures to keep its facilities open.
+Added: The Company’s supply chains remain intact and operational,
+Added: and the Company is in regular communications with its suppliers and third-party partners.
+Added: A prolonging of the current situation relating
+Added: to COVID-19 may result in an increased risk of interruption in the Company supply chain in the future, with no assurances given as the
+Added: materiality of such future interruption on the Company’s business, financial condition, results of operations and cash flows.
SUBSEQUENT EVENTS
−Removed: The Company has evaluated
−Removed: subsequent events from the consolidated balance sheet date through June 29, 2020 (the latest practicable date).
−Removed: The following
−Removed: are material subsequent events:
−Removed: Loan received pursuant to the Payroll Protection Program
−Removed: In April 2020, the
−Removed: Company was approved for, and received a loan with proceeds of $1.01 million under the Paycheck Protection Program (“PPP”).
−Removed: The PPP, established as part of the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), provides for loans
−Removed: to qualifying businesses, with the amount of the loan being determined by application of a formula defined in the CARES Act that
−Removed: is based, in large part, on payroll expenses incurred by the Company.
−Removed: Amounts received pursuant to the PPP are intended to fund
−Removed: qualifying expenses, as defined in the CARES Act, which include, without limitation, employee payroll, health care benefits, rent
−Removed: and utilities, mortgage payments and interest on other debt obligations incurred prior to February 15, 2020.
−Removed: Under the terms of
−Removed: the PPP, certain amounts received as a loan may be forgiven if they are used for qualifying expenses.
−Removed: The United States Treasury
−Removed: Department published an interim final rule in the Federal Registry on June 1, 2020, with such interim final rule allowing for further
−Removed: comments up to July 1, 2020, to define the terms and conditions under which amounts will qualify for forgiveness.
−Removed: the Paycheck Program Flexibility Act of 2020 was signed into law by the President of the United States on June 5, 2020, which amends
−Removed: the CARES Act and eases the rules on the use of loan proceeds and forgiveness criteria.
−Removed: Any loan amounts that are not forgiven
−Removed: are required to be repaid over a two-year period, with a deferral period of six months and at an annual interest rate of 1%.
−Removed: note that the terms and conditions governing forgiveness and repayment could be amended or revised in the future.
−Removed: The loan received has
−Removed: been recorded as a liability by the Company as of the date received.
−Removed: The Company intends to apply for forgiveness of amounts received
−Removed: under the PPP, in accordance with requirements of the CARES Act, as amended.
−Removed: Any loan amounts forgiven will be removed from liabilities
−Removed: Please note that there can be no assurances of forgiveness of any or all of the loan amount received pursuant to the
−Removed: PPP and there can also be no assurances as to the terms and conditions of repayment of any loan amounts not forgiven.
−Removed: Sale of New Jersey Net Operating
−Removed: In April 2020, Elite
−Removed: Laboratories Inc., a wholly owned subsidiary of Elite Pharmaceuticals Inc., received final approval from the New Jersey Economic
−Removed: Development Authority for the sale of net tax benefits of $607,635 relating to New Jersey net operating losses and net tax benefits
−Removed: of $338,772, relating to R&D tax credits.
−Removed: The Company sold the net tax benefits approved for sale at a transfer price equal
−Removed: to ninety-two cents for every benefit dollar for total proceeds of $870,695.
−Removed: Shareholder Meeting of June 23, 2020
−Removed: The Company held a
−Removed: Special Meeting of Shareholders on June 23, 2020.
−Removed: The requisite quorum for the meeting of 50.0% was present.
−Removed: At the meeting, Shareholders
−Removed: voted as follows:
−Removed: To again vote on the amendment of our Articles
−Removed: of Incorporation to increase the number of shares of common stock the Company is authorized to issue from 995,000,000 shares to
−Removed: 1,445,000,000 shares and to file a new amendment to our Articles of Incorporation reflecting such approval.
−Removed: Granting discretionary authority to adjourn
−Removed: the virtual Special Meeting, if necessary, to solicit additional proxies in the event that there are not sufficient votes at the
−Removed: time of the virtual Special Meeting to approve Proposal No.
−Removed: Following approval of Proposal No.
−Removed: the Company filed an amendment to its Articles of Incorporation with the Secretary of State of the State of Nevada re-adopting
−Removed: the prior amendment increasing the number of shares of common stock that it is authorized to issue from 995,000,000 shares to 1,445,000,000
−Removed: The par value of the common stock remains $0.001 per share.
+Added: Sale of New Jersey Net Operating Loss and
+Added: Research and Development Tax Credit
+Added: In April 2021, Elite Laboratories
+Added: Inc., a wholly owned subsidiary of Elite Pharmaceuticals Inc.
+Added: received final approval from the New Jersey Economic Development Authority
+Added: for the sale of net tax benefits of $798,889 relating to New Jersey net operating losses and net tax benefits of $58,490, relating to
+Added: research and development tax credits.
+Added: The Company sold the net tax benefits approved for sale at a transfer price equal to ninety three
+Added: and one half cents for every benefit dollar and incurred transaction fees of $12,861, resulting in net proceeds to the Company of $788,789.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.