4 unchanged sentences
We have organized the description of these risks into groupings in an effort to enhance readability, but many of the risks interrelate or could be grouped or ordered in other ways, so no special significance should be attributed to the groupings or order below.
−Removed: On March 9, 2021, we completed t h e merger with ImmunityBio, Inc .
−Removed: , a private company r e ferred to below as “Imm u nityBio.” After t he completion of this merger, we (formerly known as NantK w est, Inc.) changed our name to ImmunityBio, Inc., and references below to “the c ompan y ,” “the combined company,” “we,” “us,” and “our” refer to ImmunityBio, Inc.
+Added: On March 9, 2021, we completed the merger with ImmunityBio, Inc., a private company referred to below as “ImmunityBio.” After the completion of this merger, we (formerly known as NantKwest, Inc.) changed our name to ImmunityBio, Inc., and references below to “the company,” “the combined company,” “we,” “us,” and “our” refer to ImmunityBio, Inc.
and its subsidiaries.
Risk Factor Summary
−Removed: R i sks Relat e d to Our Limited Operating History, F inan c ial Condition and Capital R e qui r em e n ts
−Removed: W e will need additional f i nancing to fund our operations and complete the dev e lopment and comme r cialization of our various pr o duct candidates, and if we are unable to obtain such financing when needed, or on acceptable terms, we may be unable to complete the dev e lopment and commercialization o f our product candidates.
−Removed: Raising addit i onal capital may cause dilution to our stockholders, restrict our operat i ons or require us to relinquish rights to our technologies or product candidates.
−Removed: Our debt could adversely affect our cash flows and limit our f l exib i li t y to ra i s e a ddit i onal c a pit a l.
−Removed: Our b u sinesses may not be integrated succ e ssfully, or such integration may be more d i fficult, time consuming or costly than ex p ected.
−Removed: Operating costs, customer loss and business disruption, including difficult i es i n m a int a in i ng re l a t ionsh i ps with e m ploye e s , c u s tom e r s , suppliers or vendors, may be greater than expected for the combined company .
−Removed: Revenues may be lower than expec t ed for the combined company.
+Added: Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
+Added: • We will need additional financing to fund our operations and complete the development and commercialization of our various product candidates, and if we are unable to obtain such financing when needed, or on acceptable terms, we may be unable to complete the development and commercialization of our product candidates.
+Added: Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
+Added: • Our debt could adversely affect our cash flows and limit our flexibility to raise additional capital.
+Added: • Our businesses may not be integrated successfully, or such integration may be more difficult, time consuming or costly than expected.
+Added: Operating costs, customer loss and business disruption, including difficulties in maintaining relationships with employees, customers, suppliers or vendors, may be greater than expected for the combined company.
+Added: Revenues may be lower than expected for the combined company.
• We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale.
−Removed: W e have a history of operat i ng losses, and we expect to continue to incur losses and may never be profitable, which together with our limited operating history, makes it difficult to assess our future viability.
+Added: We have a history of operating losses, and we expect to continue to incur losses and may never be profitable, which together with our limited operating history, makes it difficult to assess our future viability.
• We invest our cash on hand in various financial instruments, which are subject to risks that could adversely affect our business, results of operations, liquidity and financial condition.
−Removed: R i s k s Related to Our Business and I n d u stry R e gulation
+Added: Risks Related to Our Business and Industry
• We will be substantially dependent on the success of our product candidates and cannot guarantee that these product candidates will successfully complete development, receive regulatory approval or be successfully commercialized.
−Removed: W e may develop product candidates in combination with other therapies, which exposes us to additional risks.
+Added: • We may develop product candidates in combination with other therapies, which exposes us to additional risks.
• Due to the significant resources required for the development of our product candidates, and depending on our ability to access capital, we must prioritize among many different opportunities.
We may expend our limited resources on programs that do not yield successful product candidates as opposed to indications that may be more profitable or for which there is a greater likelihood of success.
−Removed: Our clinical trial costs may be higher than for more conventional therapeutic t e chnologies or drug products.
−Removed: Our clinical trials may f a il to demonst r ate adequately the sa f e ty a nd efficacy of our product cand i dates, which would prevent o r delay regulatory approval and co m mer c i a li z at i on.
−Removed: Interim, initial, “top-line” and preliminary data from our clinical tri a ls that we announce or publi s h from time to time may c hange as more patient data become a v a i lab l e and a re sub j e c t t o audit and veri f ication procedures that c ould re s ult in m a t e rial c hang e s in the final data.
−Removed: W e have limited experience conducting clinical trials and have r e lied and will rely on third p a rties and relat e d parties to c o nduct many of our preclinical studies and clin i cal trials and to manufacture products.
−Removed: Any failure by a third party, relat e d party, or by us to conduct the clinical trials according to Good Clinical Practi c e (“GCP”) regulations, and in a timely manner may delay or prevent our ability to seek or o btain re g ulato r y a p p r o val for or commercialization of our product candidates.
−Removed: Our clinical trials may not be initiated or completed when we expec t , or at all, they may take longer and cost more to complete than we project and we may be required to conduct additional clinical t r i a ls or modify current or future cli n ical trials based on feedback we receive from the United States (“U.S.”) Food and Drug Administration (“ F DA ”) .
+Added: • Our clinical trial costs may be higher than for more conventional therapeutic technologies or drug products.
+Added: • Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization.
+Added: • Interim, initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
+Added: • We have limited experience conducting clinical trials and have relied and will rely on third parties and related parties to conduct many of our preclinical studies and clinical trials and to manufacture products.
+Added: Any failure by a third party, related party, or by us to conduct the clinical trials according to Good Clinical Practice (“GCP”) regulations, and in a timely manner may delay or prevent our ability to seek or obtain regulatory approval for or commercialization of our product candidates.
+Added: • Our clinical trials may not be initiated or completed when we expect, or at all, they may take longer and cost more to complete than we project, and we may be required to conduct additional clinical trials or modify current or future clinical trials based on feedback we receive from the United States (“U.S.”) Food and Drug Administration (“FDA”).
• We will be unable to commercialize our product candidates if our trials are not successful.
• Even if one of our product candidates is approved and commercialized, we may not become profitable.
−Removed: W e use Immuno-Oncology Clinic, Inc .
−Removed: (the “Clinic”) , a related party, in some of our clinical trials which may expose us to significant regul a tory risks.
−Removed: If our data f o r this site is not sufficiently robust or if there are any data integrity i s sues, we may be requ i red to repeat such studies or required t o c ontra c t w i th o t her cl i ni c al tr i a l s i t e s, and our clinical developme n t plans will be significantly delayed, and we will inc u r additional c o s t s.
−Removed: If we encounter delays or difficulties enr o lling and/or maintaining patients in our clinical trials, our clinical devel o pment activities and receipt of ne c essary marketing approvals could be delayed or otherwise adversely affected.
−Removed: Our prod u ct candidates may cause undesirable side effects or h a ve other properties that could halt their clinical development, prev e nt t heir regulatory approval, limit the i r c omm e rc i a l pot e nti a l or result i n significant negative consequences.
−Removed: T he manufacture of our product c a ndidates is complex, and we may encounter difficulties in p r o duction, particularly with resp e c t t o process development, quali t y control, or scaling-up of our m a nufacturing capabili t ies.
−Removed: If we or our related parties, or any of our third-party manufacturers encounter such d i fficulties, our ability to provide adequate supply of our product candidates for clinical trials or our p roducts for patients, if approved, could be delayed or stoppe d , or we may be unable to maintain a commerc i ally viable cost structure.
+Added: • We use Immuno-Oncology Clinic, Inc.
+Added: (the “Clinic”), a related party, in some of our clinical trials which may expose us to significant regulatory risks.
+Added: If our data for this site is not sufficiently robust or if there are any data integrity issues, we may be required to repeat such studies or required to contract with other clinical trial sites, and our clinical development plans will be significantly delayed, and we will incur additional costs.
+Added: • If we encounter delays or difficulties enrolling and/or maintaining patients in our clinical trials, our clinical development activities and receipt of necessary marketing approvals could be delayed or otherwise adversely affected.
+Added: • Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
+Added: • The manufacture of our product candidates is complex, and we may encounter difficulties in production, particularly with respect to process development, quality control, or scaling-up of our manufacturing capabilities.
+Added: If we or our related parties, or any of our third-party manufacturers encounter such difficulties, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
• Cell-based therapies and biologics rely on the availability of reagents, specialized equipment and other specialty materials, which may not be available to us on acceptable terms or at all.
For some of these reagents, equipment and materials, we rely or may rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our products, if approved.
−Removed: Our efforts to develop, manufacture a n d market COVID‑19 therapeutics will require additional personnel who w i ll require training, which may cause some of our employees to reallocate t h e i r t i me from other duties which could in turn cause delays in clinical supply of our other product candidates or trials.
−Removed: Our ability to use net operating losses and research and development credits to offset future t axable income may be subject to c e rtain l im i tat i ons.
−Removed: Changes in tax law could adv e r s e ly affe c t o u r b u sin e ss and financial co n dition.
+Added: • Our ability to use net operating losses and research and development credits to offset future taxable income may be subject to certain limitations.
+Added: • Changes in tax law could adversely affect our business and financial condition.
Negative or unexpected tax consequences could adversely affect our results of operations.
−Removed: Our transfer pricing poli c ies may be subject to challenge by the Internal Revenue Service (“IRS”) or other taxing a u thorities.
−Removed: We could be subje c t to additional income tax liabilities and to examinations of our tax returns by t h e IRS and other domestic a n d foreign tax authorities.
−Removed: An adverse out c ome of any such audit or examination by the IRS or other tax authority cou l d have a material adver s e eff e ct on o u r op e rating results and finan c ial condit i on.
+Added: • Our transfer pricing policies may be subject to challenge by the Internal Revenue Service (“IRS”) or other taxing authorities.
+Added: • We could be subject to additional income tax liabilities and to examinations of our tax returns by the IRS and other domestic and foreign tax authorities.
+Added: An adverse outcome of any such audit or examination by the IRS or other tax authority could have a material adverse effect on our operating results and financial condition.
• Our projections regarding the market opportunities for our product candidates may not be accurate, and the actual market for our products, if approved, may be smaller than we estimate.
5 unchanged sentences
• As a condition of approval, the FDA may require that we implement various post-marketing requirements and conduct post-marketing studies, any of which would require a substantial investment of time, effort, and money, and which may limit our commercial prospects.
−Removed: W e have never commercial i zed a product candidate before, and we may lack the necessary exper t ise, personnel and resources to successfully commercia l ize any products on our o w n or together with suitable collaborators.
+Added: • We have never commercialized a product candidate before, and we may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators.
We may be unable to establish effective marketing and sales capabilities or enter into agreements with third parties or related parties to market and sell our product candidates, if they are approved, and as a result, we may be unable generate product revenues.
2 unchanged sentences
• If our product candidates do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
−Removed: We will need to obtain FDA approval of a n y proposed branded product names, and any f a ilure or delay associated with such approval may adversely affect o u r b u s i n e s s .
−Removed: Our i n te r n al c omputer s y s t ems, or those used by our contract research organizations (“ CROs”), contract manufacturing organizations (“C M Os”), c li n i c al s i t e s or other contractors or consultants, m a y fail or suffer s e c u rity b r ea c h e s.
+Added: • Our product candidates may face competition sooner than anticipated.
+Added: • We will need to obtain FDA approval of any proposed branded product names, and any failure or delay associated with such approval may adversely affect our business.
+Added: • Our internal computer systems, or those used by our contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), clinical sites or other contractors or consultants, may fail or suffer security breaches.
• Our business could be adversely affected by the effects of health epidemics, pandemics or contagious diseases, including the recent COVID-19 pandemic, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
3 unchanged sentences
• We will be heavily dependent on our senior management, particularly Dr.
−Removed: Soon-Shiong, our Executive Chairman, and a loss of a member of our senior management team in the future, even if only temporary, could harm our business.
+Added: Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer, and a loss of a member of our senior management team in the future, even if only temporary, could harm our business.
• We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
• If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
−Removed: We may b e come i n v olv e d i n securit i es l it i gation or stockholder derivative l it i gation i n conn e c t ion wi t h our recent merger, and this could divert the attention of our ma n agement and harm our bus i n e s s , and i n s u rance c ov e rage may not be s u ffi c ie n t to cov e r all r e l ated costs and damages.
−Removed: A variety of risks associated with mar k eting our product candidates int e rnationally could materially adversely affect our bus i ness.
+Added: • We may become involved in securities litigation or stockholder derivative litigation in connection with our recent merger, and this could divert the attention of our management and harm our business, and insurance coverage may not be sufficient to cover all related costs and damages.
+Added: • A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
Risks Related to Government Regulation
1 unchanged sentence
or foreign regulatory approval and, as a result, be unable to commercialize our product candidates.
−Removed: We are, and if we receive regulatory app r oval of our product candidates, will continue to be subject to ongoing extensive regulation, regulatory obligations and continued regulatory review, which may result in significant additional expense.
+Added: We are, and if we receive regulatory approval of our product candidates, will continue to be subject to ongoing extensive regulation, regulatory obligations and continued regulatory review, which may result in significant additional expense.
• Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
1 unchanged sentence
and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we may receive and subject us to other penalties that could materially harm our business.
−Removed: Results for any patient who r e ceives compassionate use access to our product candidates should not be viewed as representative of how the product candidate will perform in a well-controlled clinical trial, and cannot be used to establish safety or efficacy for regulatory approval.
−Removed: Our GMP - in-a-Box will be regulated by the FDA as a medical device, and regulatory compliance for m e dical devices is expensive, complex and uncertain, and a failure to com p ly could lead to enf o r c e m ent a c tions aga i nst us and other negative consequences for our business.
+Added: • Results for any patient who receives compassionate use access to our product candidates should not be viewed as representative of how the product candidate will perform in a well-controlled clinical trial, and cannot be used to establish safety or efficacy for regulatory approval.
+Added: • Our GMP-in-a-Box will be regulated by the FDA as a medical device, and regulatory compliance for medical devices is expensive, complex and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
• We will be subject to governmental export and import controls that could impair our ability to compete in international markets due to licensing requirements and subject us to liability if we are not in compliance with applicable laws.
• We are subject to U.S.
−Removed: and for e ign anti-corruption and anti-money l aundering l aws with r e sp e c t to our o p erations and non-compl i an c e with such laws can subj e c t us to c riminal an d / or civil liabi l ity and harm our business.
+Added: and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
• Our failure to comply with state, national and/or international data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
1 unchanged sentence
• Disruptions at the FDA, the Securities and Exchange Commission (“SEC”) and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
−Removed: If we fail to comp l y with f e deral and s t ate healthcare and promotional laws, including fraud and ab u se and information privacy and security laws, we could face substantial penalties and o u r busines s , fi n an c ial c onditio n , r e sults of operations, and prospects could be adversely affe c ted.
+Added: • If we fail to comply with federal and state healthcare and promotional laws, including fraud and abuse and information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, and prospects could be adversely affected.
• Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates profitably.
• We may face difficulties from changes to current regulations and future legislation.
−Removed: Go v e r n m e n ts o u tside t h e Un i ted S t ates tend t o i mpose s t r i ct pri c e co n trols, whi c h may ad v e r s e ly aff e ct our r e v e n u e s , if an y .
−Removed: Our employees, independent contractors, consultants, commercial partners, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper ac t i v it i es, in c luding non c omp l ian c e with r e gu la tory standards a n d requirements.
−Removed: R i s k s R e lat e d to I n te l le c tual P r o p er t y
−Removed: If we are unable to obtain, maintain, p r o t ect and enforce p a tent protection and other propri e tary rights for our product cand i dates and technologies, we may not be able to compete effectively or operate profitably and our ab i l i ty t o pr e vent our competitors from comme r cializing sim i lar or identical technology and product candidates would be a d v e rsely affected.
+Added: • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
+Added: • Our employees, independent contractors, consultants, commercial partners, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
+Added: Risks Related to Intellectual Property
+Added: • If we are unable to obtain, maintain, protect and enforce patent protection and other proprietary rights for our product candidates and technologies, we may not be able to compete effectively or operate profitably and our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected.
• If any of our owned or in-licensed patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.
−Removed: W e or our licensors, collaborators, or any future strategic partners may become subject to third party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights, and we may need to resort to litigation to protect or enforce our patents or o t her intellectual property or the patents or other intellectual property of our licenso r s, all of which c o uld be expensive, time-consuming a nd unsuccessful, may delay or prevent the development and commercialization of our product candidates, or may put our patents and other proprietary rights at risk.
−Removed: T he use of our technology a n d p r oduct candidates could potentially conflict with the rights of others, and third-party claims of i nt e ll e ctu a l property infringement, misa p p r o p r iation or other violation against us, our licensors or our collaborators may prevent or delay the development and commercialization of our product candidat e s and technologies.
−Removed: Obtaining and maintaining our patent pro t ection depends on compliance with various p r ocedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be r e duced or eliminated for non-compl i an c e with t h ese r e quirements.
−Removed: Changes in United States patent law could diminish the value of patents in general, t h e r e by i m pairing our ability to protect our product candidates.
−Removed: Our rights to develop and comme r cialize our product cand i dates and technologies are s u b j ec t , in part, to the t e r m s and condit i o ns of l i c e n s es granted to us by others.
−Removed: If we fail to comp l y with our obl i gations i n t h e agr e em e n t s u n der wh i c h we l i c e n s e i n tellectual property r i ghts from third par t ies or otherwise experience disruptions to our business r e lat i o n s h ips with o u r lic e n s ors, we may be required to pay damages and we co u l d lo s e l ic e n s e righ t s t h at are important to our b u s i n e s s .
−Removed: We have l i mi t e d for e ign int e l l ec t ual proper t y rights and may not be able to protect o u r intellectual property rights t h roug h out the world.
−Removed: We may be subject to claims that our employees, consultants or i n depende n t co n trac t ors h ave wro n gfully used or disclosed trade s e cr e ts or oth e r confident i al i n forma t ion of third parti e s or claims asserti n g ownership of what we regard as our own intellectual property.
−Removed: We may not be able to li c ense or acquire new or necessary i n tellectual property rights or t e chnology from t h i r d pa r ti e s.
−Removed: If we do not ob t ain pa t ent t e rm ext e nsion and data exclusivity for any product ca n didat e s we may d e v e lop, our business may be m at e r i ally harmed.
−Removed: We may be subject to claims challenging the inv e n t orship of our patents a n d oth e r int e ll e c t ual propert y .
−Removed: If we are unable to protect t h e confidentiality of o u r t r ade s e c r ets, o u r business and co m pe t it i ve pos i t i on wou l d be h ar m ed.
−Removed: If our trademarks and trade names are not ad e quately protected, t h en we may not be able to build name recognition in our marke t s of interest and o u r busi n e ss may be adversely affected.
−Removed: Intellectual pr o perty rights do not necessarily address all potential threats.
+Added: • We or our licensors, collaborators, or any future strategic partners may become subject to third party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights, and we may need to resort to litigation to protect or enforce our patents or other intellectual property or the patents or other intellectual property of our licensors, all of which could be expensive, time-consuming and unsuccessful, may delay or prevent the development and commercialization of our product candidates, or may put our patents and other proprietary rights at risk.
+Added: • The use of our technology and product candidates could potentially conflict with the rights of others, and third-party claims of intellectual property infringement, misappropriation or other violation against us, our licensors or our collaborators may prevent or delay the development and commercialization of our product candidates and technologies.
+Added: • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
+Added: • Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
+Added: • Our rights to develop and commercialize our product candidates and technologies are subject, in part, to the terms and conditions of licenses granted to us by others.
+Added: • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we may be required to pay damages and we could lose license rights that are important to our business.
+Added: • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
+Added: • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed trade secrets or other confidential information of third parties or claims asserting ownership of what we regard as our own intellectual property.
+Added: • We may not be able to license or acquire new or necessary intellectual property rights or technology from third parties.
+Added: • If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
+Added: • We may be subject to claims challenging rights in our patents and other intellectual property.
+Added: • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
+Added: • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
+Added: • Intellectual property rights do not necessarily address all potential threats.
Risks Related to Our Common Stock
−Removed: Patrick Soon-Shiong, o ur E xecutive C hairman a nd our principal stockholder, has significant interests in other companies which may conflict wi t h our int e rests.
−Removed: Soon-Shiong, th r o u gh his voting c ontrol of the company, has the ability to con t rol actions that re q uire stockholder approval.
−Removed: T he market price of our common stock has b e en and may continue to be volatile, and inves t ors may have difficulty selling their shar e s.
+Added: Patrick Soon-Shiong, our Executive Chairman, Global Chief Scientific and Medical Officer and our principal stockholder, has significant interests in other companies which may conflict with our interests.
+Added: Soon-Shiong, through his voting control of the company, has the ability to control actions that require stockholder approval.
+Added: • The market price of our common stock has been and may continue to be volatile, and investors may have difficulty selling their shares.
• Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plan, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
−Removed: W e have incurred and will continue to incur costs as a result of operating as a public company and our management has been and w i ll be required to devote substantial time to compliance initiatives and corporate governance p r actices, including maintaining an eff ec tive sys t em of internal control over financial r e porting.
+Added: • We have incurred and will continue to incur costs as a result of operating as a public company and our management has been and will be required to devote substantial time to compliance initiatives and corporate governance practices, including maintaining an effective system of internal control over financial reporting.
• If a restatement of our financial statements were to occur, our stockholders’ confidence in the company’s financial reporting in the future may be affected, which could in turn have a material adverse effect on our business and stock price.
8 unchanged sentences
Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
−Removed: We will need ad d iti o nal financing to fund our operations and compl e te the de v e lop m ent and com m e r cialization of our various pro d u c t candidat e s , and if we are unable to obtain such financi n g when needed, or on acceptable terms, we may be u n able t o co m ple t e t h e dev e lopment and commercia l ization of our produ c t ca n didat e s.
+Added: We will need additional financing to fund our operations and complete the development and commercialization of our various product candidates, and if we are unable to obtain such financing when needed, or on acceptable terms, we may be unable to complete the development and commercialization of our product candidates.
The development of biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete.
−Removed: Our operations have consumed sub s tantial amounts of cash since inception.
−Removed: A sign i fic a nt p o r tion of our funding had been in the form of promissory notes r e presenting $300.3 million in i ndebtedness, including interest thereon, as of June 30, 2021 held by entities affiliated with Dr.
+Added: Our operations have consumed substantial amounts of cash since inception.
+Added: A significant portion of our funding had been in the form of promissory notes representing $303.2 million in indebtedness, including interest thereon, as of September 30, 2021 held by entities affiliated with Dr.
Soon-Shiong with a maturity date of September 30, 2025.
−Removed: As of June 30, 2021, we held cash, cash equiv a lents and ma r k etable securities totaling $104.8 million .
−Removed: We will need to obtain a dditional financing to fund our fut u re o p erations, including completing the development and commercial i zation of our product candidates.
−Removed: C hanging cir c umstances may cause us to increase our spending s i gnif i can t ly faster th a n we curr e ntly an t ic ip ate and we may n eed to raise additional funds sooner than we presently anticipate.
−Removed: Moreover, research and development and our operating costs and fixed expenses such as rent and other contractual co m mitm e nt s , in c l uding those for our research collaborat i ons, are subs t a nt i a l and are e xpec t ed to i ncr e a se in the futur e .
−Removed: Our future funding requ i rements will depend on many factors, including, but not limited to:
−Removed: progr e s s, t i ming, number, scope a nd c os t s of researching and developing our product candidates and our on g oing, plan n e d a nd po t ent i al c lin i c a l t ria l s ;
−Removed: t ime and cost of regulatory approvals;
+Added: As of September 30, 2021, we held cash, cash equivalents and marketable securities totaling $81.2 million.
+Added: We will need to obtain additional financing to fund our future operations, including completing the development and commercialization of our product candidates.
+Added: Changing circumstances may cause us to increase our spending significantly faster than we currently anticipate and we may need to raise additional funds sooner than we presently anticipate.
+Added: Moreover, research and development and our operating costs and fixed expenses such as rent and other contractual commitments, including those for our research collaborations, are substantial and are expected to increase in the future.
+Added: Our future funding requirements will depend on many factors, including, but not limited to:
+Added: • progress, timing, number, scope and costs of researching and developing our product candidates and our ongoing, planned and potential clinical trials;
+Added: • time and cost of regulatory approvals;
• our ability to successfully commercialize any product candidates, if approved and the costs of such commercialization activities;
−Removed: revenue from p r oduct candidates that we may commercialize, if any, i n cluding the selling prices for su c h potential products and the availabi l ity of adequate third-party cover a ge and reimbursement for patients;
−Removed: c ost of building, staffing and validating our own manufacturing facilities in t he Un i ted Sta t es, including having a product candidate successfully manufactured consistent with FDA and European Medicines Agency regulations;
−Removed: t erms, t iming and costs of our current and any pote n tial future collaborations, business or product acquisitions , contingent value rights (“CVRs”), m i lestones, r o yalti e s, l i c e n s i n g or other arrangements that we have established or may establish;
−Removed: t ime and cost necessary to respond to technological, regulatory, po l itical and market developments;
−Removed: c osts of filing, prosecuting, maintaining, defending and enforcing any patent claims a n d other intellectual property rights.
−Removed: Unless and until we can generate a suffic i ent amount of reve n ues, we m a y finance f uture cash needs through pu b lic or private equity offerings, license agreements, debt financings, col l abor a t i ons, str a teg i c al l ian c e s and marketing or dis t ribution arrangements.
+Added: • revenue from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients;
+Added: • cost of building, staffing and validating our own manufacturing facilities in the United States, including having a product candidate successfully manufactured consistent with FDA and European Medicines Agency regulations;
+Added: • terms, timing and costs of our current and any potential future collaborations, business or product acquisitions, contingent value rights (“CVRs”), milestones, royalties, licensing or other arrangements that we have established or may establish;
+Added: • time and cost necessary to respond to technological, regulatory, political and market developments;
+Added: • costs of filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights.
+Added: Unless and until we can generate a sufficient amount of revenues, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements.
However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms, or at all, including but not limited to the offering, issuance and sale by us of up to a maximum aggregate amount of $500.0 million of our common stock that may be issued and sold under an “at-the-market” sales agreement with Jefferies LLC (the “ATM”).
−Removed: To the extent that we raise additional c a pital through the sale of equity or conver t ible debt securitie s including through the ATM or other offerings , your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
−Removed: The incurrence of additional indebtedness would result in increased fixed payment obligations and could involve certain r e strictive covenants, such as limitations on o u r abil i ty to incur additional debt, li m it a tions on our a bil i ty to a c qu i re or l i c e nse i n t e l le c tu a l p r operty rights and other operating r e strictions that could adversely impact our ability to conduct our business.
−Removed: If we raise additional funds through strategic partnerships a nd alliances and licensing arrangements with third parti e s, w e m a y have to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms unfavorable to us.
+Added: To the extent that we raise additional capital through the sale of equity or convertible debt securities including through the ATM or other offerings, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
+Added: The incurrence of additional indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
+Added: If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms unfavorable to us.
We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts.
1 unchanged sentence
As a result, we may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.
−Removed: Our debt could adversely affect o u r cash flows and limit our flexib i li t y t o raise addit i onal c apita l .
−Removed: We have a significant amount of debt and m a y need to incur additional debt to support our growth.
−Removed: As of June 30, 2021 , our in debtedness was $300.3 million, consisting of related - party promissory notes and interest thereon, all held by ent i ties affiliated w ith Dr.
−Removed: Soon-Shiong, w i th a m a t urity date of September 30, 2025.
+Added: Our debt could adversely affect our cash flows and limit our flexibility to raise additional capital.
+Added: We have a significant amount of debt and may need to incur additional debt to support our growth.
+Added: As of September 30, 2021, our indebtedness was $303.2 million, consisting of related-party promissory notes and interest thereon, all held by entities affiliated with Dr.
+Added: Soon-Shiong, with a maturity date of September 30, 2025.
Our substantial amount of debt could have important consequences and could:
−Removed: require us to dedicate a substantial portion of our cash and c a sh equivalents to make interest and p r incipal payments on our d ebt, reducing the availability of our cash and cash equivalents and c a sh flow from operations to fund future capital expenditures, working c a pit a l, execution of our strategy and other general corporate requirements;
−Removed: i ncrease o ur cost of borrowing and even limit our ability to access additional debt to fund future growth;
−Removed: i ncrease o ur vulnerability to general adverse economic a nd industry conditions and adverse c h anges in governm e ntal regulation s ;
−Removed: l imit our flexibility in planning for, or reacting to, changes in our business and industry, which may place us at a disadvantage compared with our competitors;
−Removed: l imit our ability to borrow additional fund s , even when necessary to m a intain adequate liquidity, w h ich would also limit our a bi l ity to further expand our business.
−Removed: The occurrence of any of the foregoing facto r s could have a material adverse effect on our business, results of o perations and financial condition.
−Removed: We may also need to refinance a portion of our outstanding debt as it mat u res.
−Removed: We may not be able to refina n c e existing debt or the terms of any refinanci n g may not be as f a vorable as the terms of our existing debt.
−Removed: F u rthermore, if prevailing int e rest rates or other fact o rs at the time of refinancing result in higher interest rates upon refinancing, then the interest expense relating to that refinanced ind e btedness would inc re a s e .
−Removed: The s e risks could materially adversely a ffect our financial condition, cash flows and results of ope r a tions.
−Removed: O u r b u s i n e s s es may not be i n t e gra t ed s u c c essfu l ly, or su c h integrat i on m a y be more difficult, time consuming or cos t ly than exp e c t ed.
−Removed: Operat i n g costs, customer loss and busin e ss disruption, including d i ffi c u l ti e s in m aintaining re l ationsh i ps with employe e s , c u stom e rs, s uppliers or vendors, may be greater than e xp e cted for the combined company .
−Removed: R ev e n u es may be low e r t h an exp e ct e d for the combined company.
−Removed: The co m bina t ion of two busin e s s e s is c ompl e x, costly and time-consuming and may divert significant managem e nt attention and re s ources to c o mbining o u r prior businesses.
−Removed: This process may dis r upt our businesses.
−Removed: The failure to meet the challenges involved in combining the two businesses and to rea l i z e t he ant i c i p a t e d b e nefi t s of t he merg e r c ould cause an i n terruption of, or a loss of mom e n t um i n, the a c tiv i ti e s of the combined company and could adversely affect the results of operations of the combined comp a ny.
−Removed: Our ability to realize the anticipated benefits of the merger will depend, to a large extent, on our ability to integrate our businesses in a manner that facilitates growth opportunities and achieves the projected synergies identified by each company without adversely affecting current revenues and investments in future growth.
−Removed: The overall combination of our b usines s es may a l s o r e sult in m a t e rial un a nti c ipa t ed problems, expenses, li a bilities, competitive responses, and loss of customer and other business relationships.
−Removed: The difficulties of combining the o p erations of the companies include, among others:
−Removed: t he diversion of management attention to integration matters;
−Removed: d i fficu l ti e s in in t e gra t ing operations and systems, including intellectual property and communications syste m s, a dmin i s t ra t ive and information technology infrastruc t ure and financial reporting and internal control systems;
−Removed: c hallenges in conforming standards, controls, procedu r es and accounting and o t her policies, business cultures and compensation struc t ures between the two companies;
−Removed: difficulties in integrating employees and attracting and r e taining key personnel, including talent;
−Removed: difficulties in achiev i ng anticipated cost savings, synergies, accretion targets, business opportunit i es, financing plans and growth prospects from the combination;
−Removed: difficulties in managing the exp a nded operations of a significantly l a rger and more complex company;
−Removed: c onting e nt li a bil i ti e s th a t are l a rger than exp e ct e d;
−Removed: potential unknown liabili t ies, adverse cons e quences and unforeseen increased exp e nses ass o ciated with the merger.
−Removed: Many of these factors are outside of our c ontrol, and any one of them could result in lower revenues, higher costs and diversi o n of management time and energy, which could materially i m pact the b usiness, financial cond i tion and results of operations of the combined company.
−Removed: In a ddit i on, even if the o p erations of our businesses are integrated su c c e s sful l y, the full ben e fits of the m e r g er may not be real i zed, i nc l ud i ng, a m ong others, the synergies or growth opportunities that are expected.
−Removed: These b e nefits may not be achieved within the anticipated time frame or at all.
−Removed: Furthe r , additional unanticipated costs may be incurred in the integration of our businesses.
−Removed: All of these factors cou l d negatively impact the company’s operations and/or the price of the company’s common stock .
−Removed: As a result, it cannot be assured that the combination of our businesses will result in the re a l i za t ion of the full ben e fits e xpe c ted from the m e rger w i thin the a nti c ipa t ed ti m e fram e s or a t al l .
−Removed: A c cord i ngly, hold e rs of t he combined comp a ny’s common stock may experie n ce a loss a s a res u lt of a de c line in the m a rket pri c e of s uch common sto c k.
−Removed: In addition, a dec l ine in the m a rket pri c e of the combined company’s com m on stock could adversely affect the c o mpany’s ability to issue a d d i t i on a l s e cur i ti e s and to obta i n additio n al financing in the future.
+Added: • require us to dedicate a substantial portion of our cash and cash equivalents to make interest and principal payments on our debt, reducing the availability of our cash and cash equivalents and cash flow from operations to fund future capital expenditures, working capital, execution of our strategy and other general corporate requirements;
+Added: • increase our cost of borrowing and even limit our ability to access additional debt to fund future growth;
+Added: • increase our vulnerability to general adverse economic and industry conditions and adverse changes in governmental regulations;
+Added: • limit our flexibility in planning for, or reacting to, changes in our business and industry, which may place us at a disadvantage compared with our competitors;
+Added: • limit our ability to borrow additional funds, even when necessary to maintain adequate liquidity, which would also limit our ability to further expand our business.
+Added: The occurrence of any of the foregoing factors could have a material adverse effect on our business, results of operations and financial condition.
+Added: We may also need to refinance a portion of our outstanding debt as it matures.
+Added: We may not be able to refinance existing debt or the terms of any refinancing may not be as favorable as the terms of our existing debt.
+Added: Furthermore, if prevailing interest rates or other factors at the time of refinancing result in higher interest rates upon refinancing, then the interest expense relating to that refinanced indebtedness would increase.
+Added: These risks could materially adversely affect our financial condition, cash flows and results of operations.
+Added: Our businesses may not be integrated successfully, or such integration may be more difficult, time consuming or costly than expected.
+Added: Operating costs, customer loss and business disruption, including difficulties in maintaining relationships with employees, customers, suppliers or vendors, may be greater than expected for the combined company.
+Added: Revenues may be lower than expected for the combined company.
+Added: The combination of two businesses is complex, costly and time-consuming and may divert significant management attention and resources to combining our prior businesses.
+Added: This process may disrupt our businesses.
+Added: The failure to meet the challenges involved in combining the two businesses and to realize the anticipated benefits of the merger could cause an interruption of, or a loss of momentum in, the activities of the combined company and could adversely affect the results of operations of the combined company.
+Added: Our ability to realize the anticipated benefits of the merger will depend, to a large extent, on our ability to integrate our businesses in a manner that facilitates growth opportunities and achieves the projected synergies
+Added: identified by each company without adversely affecting current revenues and investments in future growth.
+Added: The overall combination of our businesses may also result in material unanticipated problems, expenses, liabilities, competitive responses, and loss of customer and other business relationships.
+Added: The difficulties of combining the operations of the companies include, among others:
+Added: • the diversion of management attention to integration matters;
+Added: • difficulties in integrating operations and systems, including intellectual property and communications systems, administrative and information technology infrastructure and financial reporting and internal control systems;
+Added: • challenges in conforming standards, controls, procedures and accounting and other policies, business cultures and compensation structures between the two companies;
+Added: • difficulties in integrating employees and attracting and retaining key personnel, including talent;
+Added: • difficulties in achieving anticipated cost savings, synergies, accretion targets, business opportunities, financing plans and growth prospects from the combination;
+Added: • difficulties in managing the expanded operations of a significantly larger and more complex company;
+Added: • contingent liabilities that are larger than expected;
+Added: • potential unknown liabilities, adverse consequences and unforeseen increased expenses associated with the merger.
+Added: Many of these factors are outside of our control, and any one of them could result in lower revenues, higher costs and diversion of management time and energy, which could materially impact the business, financial condition and results of operations of the combined company.
+Added: In addition, even if the operations of our businesses are integrated successfully, the full benefits of the merger may not be realized, including, among others, the synergies or growth opportunities that are expected.
+Added: These benefits may not be achieved within the anticipated time frame or at all.
+Added: Further, additional unanticipated costs may be incurred in the integration of our businesses.
+Added: All of these factors could negatively impact the company’s operations and/or the price of the company’s common stock.
+Added: As a result, it cannot be assured that the combination of our businesses will result in the realization of the full benefits expected from the merger within the anticipated time frames or at all.
+Added: Accordingly, holders of the combined company’s common stock may experience a loss as a result of a decline in the market price of such common stock.
+Added: In addition, a decline in the market price of the combined company’s common stock could adversely affect the company’s ability to issue additional securities and to obtain additional financing in the future.
We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale.
4 unchanged sentences
Because of the numerous risks and uncertainties associated with our product development efforts, we are unable to predict when we may become profitable, if at all.
−Removed: Since the commencement of our operations, we have incurred significant losses in each year and, as of June 30, 2021 we had an accumulated deficit of $1.8 billion.
+Added: Since the commencement of our operations, we have incurred significant losses in each year and, as of September 30, 2021 we had an accumulated deficit of $1.9 billion.
We expect to continue to incur significant expenses as we seek to expand our business, including in connection with conducting research and development across multiple therapeutic areas, participating in clinical trial activities, continuing to acquire or in-license technologies, maintaining, protecting and expanding our intellectual property, seeking regulatory approvals, increasing our manufacturing capabilities and, upon successful receipt of FDA approval, commercializing our products.
Moreover, we do not expect to have significant product sales or revenue for the foreseeable future.
−Removed: If our resea r ch and development efforts are successful, we may also face the risks a ssociated with the shift from development to commercialization of new products based on innovative technologies .
+Added: If our research and development efforts are successful, we may also face the risks associated with the shift from development to commercialization of new products based on innovative technologies.
Our ability to achieve profitability is dependent upon obtaining regulatory approvals for our product candidates and successfully commercializing our product candidates alone or with third parties.
2 unchanged sentences
As a result, it may be more difficult for you to assess our future viability than it could be if we had a longer operating history.
−Removed: We inv e st our cash on hand in various finan c ial ins t rum e n t s which are sub j ect t o ris k s that could adversely affect our busines s , r e sul t s of op e rations, l iquidi t y and finan c ial condi t ion.
−Removed: We invest our cash in a variety of financi a l instruments, principally c o mmercial paper, corporate debt securities and foreign g overnment bonds.
−Removed: All of these inv e s t men t s are subj e c t to cr e dit, li quidity, market and interest r a te ris k .
−Removed: Such risks, in c luding the failure or severe financial distress of the financial institutions that hold our cash, cash equiv a lents and investments, may result in a loss of liquid i ty, impairment to our investments, realization of substantial future losses, or a complete l o ss of the investments in the long-term, which may have a material adverse effect on our business, results of o p erations, liquidity and financi a l condition.
−Removed: In order to manage t h e risk to our investments, we maintain an investment policy that, among other things, limits the amount that we may invest in any one issue or any single issuer and re q uires us to only i n v e st in high credit quali t y secur i ti e s to preserve liqu i d i ty.
−Removed: R i s k s R e lated to O u r Business a n d I n d u st r y
+Added: We invest our cash on hand in various financial instruments which are subject to risks that could adversely affect our business, results of operations, liquidity and financial condition.
+Added: We invest our cash in a variety of financial instruments, principally commercial paper, corporate debt securities and foreign government bonds.
+Added: All of these investments are subject to credit, liquidity, market and interest rate risk.
+Added: Such risks, including the failure or severe financial distress of the financial institutions that hold our cash, cash equivalents and investments, may result in a loss of liquidity, impairment to our investments, realization of substantial future losses, or a complete loss of the investments in the long-term, which may have a material adverse effect on our business, results of operations, liquidity and financial condition.
+Added: In order to manage the risk to our investments, we maintain an investment policy that, among other things, limits the amount that we may invest in any one issue or any single issuer and requires us to only invest in high credit quality securities to preserve liquidity.
+Added: Risks Related to Our Business and Industry
We will be substantially dependent on the success of our product candidates and cannot guarantee that these product candidates will successfully complete development, receive regulatory approval or be successfully commercialized.
Other than our proprietary GMP-in-a-Box bioreactors for which we have received nominal revenue to date, we currently have no products approved for commercial sale or for which regulatory approval to market has been sought.
−Removed: We have invested a significant portion of our efforts and financial resources in the development of our main product candidates, Anktiva, aldoxorubicin and human adenovirus serotype 5 (“hAd5”) vaccine candidates, some or all of which are used in combination with our natural killer cells.
+Added: We have invested a significant portion of our efforts and financial resources in the development of our main product candidates, an antibody cytokine fusion protein (an IL-15 superagonist (N-803) known as Anktiva™) , aldoxorubicin and second-generation adenovirus (“hAd5”) vaccine candidates, some or all of which are used in combination with our natural killer cells.
Our product candidates will require additional clinical and non-clinical development, regulatory approval, commercial manufacturing arrangements, establishment of a commercial organization, significant marketing efforts, and further investment before we can generate any revenues from product sales.
5 unchanged sentences
We currently generate no meaningful revenues from the sale of any product candidates, and we may never be able to develop or commercialize a product.
−Removed: We may develop product can d idates in combination with other therapies, w h ich exposes us to additional risks.
+Added: We may develop product candidates in combination with other therapies, which exposes us to additional risks.
We may develop product candidates in combination with one or more other therapies.
4 unchanged sentences
It is possible that the results of these trials could show that any positive results are attributable to the already approved product.
−Removed: Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or comparable foreign regulatory authorities could revoke approval of the therapy used in combination with our product or that safety, efficacy, manufacturing or supply issues could arise with any of those existing therapies.
+Added: Even if any product candidate we develop were to receive marketing approval or be commercialized for use in
+Added: combination with other existing therapies, we would continue to be subject to the risks that the FDA or comparable foreign regulatory authorities could revoke approval of the therapy used in combination with our product or that safety, efficacy, manufacturing or supply issues could arise with any of those existing therapies.
Following product approval, the FDA may require that products used in conjunction with each other be cross labeled for combined use.
1 unchanged sentence
The occurrence of any of these risks could result in our own products, if approved, being removed from the market or being less successful commercially.
−Removed: We also may evaluate product candid a tes in combination with one or more the r a p ies that have not yet been approved for marketing by the FDA or comparable foreign regulatory authorities.
−Removed: We will not be able to market and sell any product candid a te in c o mb i nat i on with an u n approved therapy if that unapproved therapy does not ultimately obtain marketing approval.
−Removed: In addition, unapproved therapies f ace the same risks described with respect to our product candidates currently in development and clinical trials, including the potential for serious adverse effects, delays in c l ini c al t ria l s and la c k o f FDA approval.
−Removed: If the FDA or comparable foreign regulatory authorities do not approve or revoke t h eir approval of these other therapies, or if safety, efficacy, quality, manufacturing or supply issues arise with, the therapies we choo s e to evaluate in combination with any of our product candidates, we may be unable to obtain approval of or m a rket such comb i nat i on t herapy.
+Added: We also may evaluate product candidates in combination with one or more therapies that have not yet been approved for marketing by the FDA or comparable foreign regulatory authorities.
+Added: We will not be able to market and sell any product candidate in combination with an unapproved therapy if that unapproved therapy does not ultimately obtain marketing approval.
+Added: In addition, unapproved therapies face the same risks described with respect to our product candidates currently in development and clinical trials, including the potential for serious adverse effects, delays in clinical trials and lack of FDA approval.
+Added: If the FDA or comparable foreign regulatory authorities do not approve or revoke their approval of these other therapies, or if safety, efficacy, quality, manufacturing or supply issues arise with, the therapies we choose to evaluate in combination with any of our product candidates, we may be unable to obtain approval of or market such combination therapy.
Due to the significant resources required for the development of our product candidates, and depending on our ability to access capital, we must prioritize among many different opportunities.
−Removed: W e may expend our limited resources on programs that do not yield successful product candidates as opposed to indications that may be more profitable or for which there is a greater likelihood of success.
+Added: We may expend our limited resources on programs that do not yield successful product candidates as opposed to indications that may be more profitable or for which there is a greater likelihood of success.
We do not have sufficient resources to pursue development of all or even a substantial portion of the potential opportunities that we believe will be afforded to us by our product candidates.
3 unchanged sentences
If we select and commit resources to opportunities that we are unable to successfully develop, or we forego more promising opportunities, our business, financial condition and results of operations will be adversely affected.
−Removed: Our c l inical t r i al c osts may be higher t h an for mo r e co n v e n tional therapeutic techno l ogies or drug products.
+Added: Our clinical trial costs may be higher than for more conventional therapeutic technologies or drug products.
Because our product candidates include, and we expect our future product candidates to include, candidates based on advanced therapy technologies, we expect that they will require extensive research and development and have substantial manufacturing costs.
2 unchanged sentences
Accordingly, our clinical trial costs are likely to be significantly higher per patient than those of more conventional therapeutic technologies or drug products.
−Removed: Our c l inical t r i als may fa i l to d e mons t r a t e adequately the safety and e fficacy of our product cand i dates, which would prevent o r d e lay regulatory a p proval and com m ercia l ization.
+Added: Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization.
The clinical trials of our product candidates as well as the manufacturing and marketing of our product candidates will be subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and market our product candidates.
Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe and effective.
−Removed: Because most of our product candidates will be subject to regulation as biological drug products, we will need to demonstrate that they are safe, pure, and potent for use in their target indications.
+Added: Because most of our product candidates will be subject to
+Added: regulation as biological drug products, we will need to demonstrate that they are safe, pure, and potent for use in their target indications.
Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use.
21 unchanged sentences
As a result, our ability to generate clinical safety and effectiveness data sufficient to support submission of a marketing application or commercialization of our product candidates is uncertain and is subject to significant risk.
−Removed: Int e r i m, ini t ial, “top- l in e ” and preliminary data from our c lini c al trials that we ann oun ce or p u blish from ti m e to t ime m ay c h ange as more patient d a ta become available and are sub j ect to audit and verification p r ocedures that could result in mat e r i al ch anges in the final d ata.
+Added: Interim, initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
From time to time, we may publicly disclose preliminary, interim or top-line data from our preclinical studies and clinical trials, which are based on preliminary analyses of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
8 unchanged sentences
If the interim, top-line or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.
−Removed: We h ave l i mi t e d experi e n c e co n du c t i ng cl i nical trials and have relied and will rely on third parties and related parties to co n duct many of our pr e c l i n i cal stud i e s and c l i n i c al trials and to manufacture products .
−Removed: Any failure by a third part y , r e l a t e d part y , or by us to c onduct t h e c lini c al t r i als a ccording to GCP regulations, and in a timely manner , may delay or prevent our ab i lity to seek o r obtain regulatory approval for or commercialization of our product candidates.
+Added: We have limited experience conducting clinical trials and have relied and will rely on third parties and related parties to conduct many of our preclinical studies and clinical trials and to manufacture products.
+Added: Any failure by a third party, related party, or by us to conduct the clinical trials according to GCP regulations, and in a timely manner, may delay or prevent our ability to seek or obtain regulatory approval for or commercialization of our product candidates.
Large-scale clinical trials require significant financial and management resources.
21 unchanged sentences
In addition, these third parties are not our employees, and except for remedies available to us under our agreements with them, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical and preclinical programs.
−Removed: If these third parties conducting our clinical trials (i) do not successfully carry out their contractual duties, (ii) do not meet expected deadlines , (iii) experience work stoppages, (iv) do not conduct our clinical trials in accordance with regulatory requirements or our stated protocols, (v) need to be replaced , (vi) experience financial hardships or (vi) terminate their agreements with us or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical trial protocols, GCP or other regulatory requirements or for other reasons, our trials may need to be repeated, extended, delayed or terminated, we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates, we will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates or we or they may be subject to regulatory enforcement actions.
+Added: If these third parties conducting our clinical trials (i) do not successfully carry out their contractual duties, (ii) do not meet expected deadlines, (iii) experience work stoppages, (iv) do not conduct our clinical trials in accordance with regulatory requirements or our stated protocols, (v) need to be replaced, (vi) experience financial hardships or (vii) terminate their agreements with us or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical trial protocols, GCP or other regulatory requirements or for other reasons, our trials may need to be repeated, extended, delayed or terminated, we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates, we will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates or we or they may be subject to regulatory enforcement actions.
Additionally, we may need to conduct additional clinical trials or enter into new arrangements with alternative CROs, clinical investigators or other third parties.
17 unchanged sentences
Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services.
−Removed: Our c l inical t r i als may not be init i ated or c ompl e t e d w h en we e xpect, or at all, they may take longer and cost more to complete than we project and we may be required to conduct addit i onal c lini c al t r i als or modify current or future clinical trials based on feedback we receive from the FDA.
+Added: Our clinical trials may not be initiated or completed when we expect, or at all, they may take longer and cost more to complete than we project, and we may be required to conduct additional clinical trials or modify current or future clinical trials based on feedback we receive from the FDA.
We cannot guarantee that any current or future clinical trials will be conducted as planned or completed on schedule, if at all, or that any of our product candidates will receive regulatory approval.
1 unchanged sentence
We may also experience delays in completing planned clinical trials for a variety of reasons, including delays related to:
−Removed: regulators or Institutional Review Boards (“IRBs”) may (i) not authorize us or our inv e s t iga t ors to com m ence a c lin i c a l t ri a l, co n duct a c lin i c a l t ri a l a t a prosp e ct i ve tri a l s i te, or a m end t ri a l pro t oco l s, or (ii) r e quire that we modify or amend our c l ini c al trial protocols;
−Removed: delays in reaching, or a failure to reach, a consensus with regulatory authorities on t rial design or e l igib i li t y c r it e ria for p a t i ent enro l lm e nt;
−Removed: t he FDA or comparable foreign regulatory authorities may (i) disagree with our intended indications, or o ur interpre t ation of data from preclinical studies and clinical trials, (ii) find that a product candidate’s benefits do not outweigh its safety risks, (iii) not a cc e pt data from t r ia l s w i th cl i nic a l tri a l s i tes in for e ign cou n tr i e s, (iv) fail to approve or subsequently find fault with the manufacturing processes or our manufacturing facilities for clinical and future commercial supplies or (v) take longer than we anticipate when making a decision on our product candidates;
−Removed: t he FDA may not allow us to use the cli n ical trial data from a research institution to support an investigational new drug (“IN D ”) application if we cannot demonstrate the comparability of our product candidates with the product candidate used by the relevant research instit u tion in its c lin i c a l t ri a ls;
−Removed: d e lays in or fa i lure to re a c h an agre e m e nt on a c c e ptab l e ter m s w i th prosp e ct i ve CROs and c l i nic a l tri a l s i tes, the t e rms of which can be subject to extensive negotiation and may vary significantly among different CROs and c linical trial sites;
−Removed: i mposition of a temporary or permanent clinical hold, such as the clinical hold on the Phase II/III clinical trial for our hAd5 COVID-19 vaccine candidate pending modifications to the protocol and FDA’s review of additional information, including of immunogenicity and safety data from the Phase I portion of the study;
−Removed: delays in adding new investigators or c l ini c al tr i a l s i t e s, or w i thdr a w a l of c l ini c al tr i a l sit e s from a tr i a l, including scheduling conflicts with participating clinicians and clinical institutions;
+Added: • regulators or Institutional Review Boards (“IRBs”) may (i) not authorize us or our investigators to commence a clinical trial, conduct a clinical trial at a prospective trial site, or amend trial protocols, or (ii) require that we modify or amend our clinical trial protocols;
+Added: • delays in reaching, or a failure to reach, a consensus with regulatory authorities on trial design or eligibility criteria for patient enrollment;
+Added: • the FDA or comparable foreign regulatory authorities may (i) disagree with our intended indications, or our interpretation of data from preclinical studies and clinical trials, (ii) find that a product candidate’s benefits do not outweigh its safety risks, (iii) not accept data from trials with clinical trial sites in foreign countries, (iv) fail to approve or subsequently find fault with the manufacturing processes or our manufacturing facilities for clinical and future commercial supplies or (v) take longer than we anticipate when making a decision on our product candidates;
+Added: • the FDA may not allow us to use the clinical trial data from a research institution to support an investigational new drug (“IND”) application if we cannot demonstrate the comparability of our product candidates with the product candidate used by the relevant research institution in its clinical trials;
+Added: • delays in or failure to reach an agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;
+Added: • imposition of a temporary or permanent clinical hold, such as the clinical hold on the Phase II/III clinical trial in the U.S.
+Added: for our hAd5 COVID-19 vaccine candidate pending modifications to the protocol and the FDA’s review of additional information, including immunogenicity and safety data from the Phase I portion of the study;
+Added: • delays in adding new investigators or clinical trial sites, or withdrawal of clinical trial sites from a trial, including scheduling conflicts with participating clinicians and clinical institutions;
• difficulties in identifying and enrolling patients who meet trial eligibility criteria and who remain in the study until its conclusion;
−Removed: f a ilure by our CROs, cl i ni c al tr i a l s i t e s or patients, or other third parties, or us t o a dhere to c l ini c al tr i a l requ i re m e nts, including regulatory, contractual or pro t ocol requirements;
−Removed: failure to perform in accordance with the GCP requiremen t s, or applicable regulatory guidelines in other countries;
−Removed: occurrence of adverse events associated with the product can d idate that a r e viewed to outweigh its potential benefits;
−Removed: c hanges in regulatory requireme n t s and guid a nce that r e quire amending or submitting n e w clinical protocols to regulatory auth o ri t ies and IRBs, and which may cause delays in our development programs, or chan g e s to regulatory review times;
−Removed: t here may be regulatory qu e stions or disagreements regarding interpretations of data and resul t s, or new information may emerge regarding our p r o duct candidates;
−Removed: c hanges in the standard of care on which a clinical development plan was based, which may require new or additional trials;
+Added: • failure by our CROs, clinical trial sites or patients, or other third parties, or us to adhere to clinical trial requirements, including regulatory, contractual or protocol requirements;
+Added: • failure to perform in accordance with the GCP requirements, or applicable regulatory guidelines in other countries;
+Added: • occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;
+Added: • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols to regulatory authorities and IRBs, and which may cause delays in our development programs, or changes to regulatory review times;
+Added: • there may be regulatory questions or disagreements regarding interpretations of data and results, or new information may emerge regarding our product candidates;
+Added: • changes in the standard of care on which a clinical development plan was based, which may require new or additional trials;
• the availability of financial resources to commence and complete the planned trials;
• ambiguous or negative interim results, which may result in our deciding, or regulators requiring us, to conduct additional clinical trials, or preclinical studies, or abandon product development programs;
−Removed: obtaining sufficient supply of therapies that may be used in combination with our molecular agents or as comparative agents in clinical trials or i nterruption of, or delays in receiving, supplies of our product candidates or other drugs or components of our therapies due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;
−Removed: e arly results from our clinical trials of our product candidates may be negatively affected by changes in e fficacy measures such as overall response rate and duration of re s ponse as more patients are enrolled in our clinical trials or as new cohorts of our clinical t ria l s are t e sted, and overall response rate and duration of response may be negat i vely a f fected by the inclusion of unconfirmed res p onses in pre l iminary results that we report if such r e sponses are not later confirmed;
−Removed: we may not be able to demonst r ate that a product candidate provides an a d vantage over current standards of care or current or future competitive therapies in developme n t;
−Removed: t here may be changes to the therapeutics or their regulatory s t atus which we are administering in combination with our product candidates;
+Added: • obtaining sufficient supply of therapies that may be used in combination with our molecular agents or as comparative agents in clinical trials or interruption of, or delays in receiving, supplies of our product candidates or other drugs or components of our therapies due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;
+Added: • early results from our clinical trials of our product candidates may be negatively affected by changes in efficacy measures such as overall response rate and duration of response as more patients are enrolled in our clinical trials or as new cohorts of our clinical trials are tested, and overall response rate and duration of response may be negatively affected by the inclusion of unconfirmed responses in preliminary results that we report if such responses are not later confirmed;
+Added: • we may not be able to demonstrate that a product candidate provides an advantage over current standards of care or current or future competitive therapies in development;
+Added: • there may be changes to the therapeutics or their regulatory status which we are administering in combination with our product candidates;
• transfer of our manufacturing processes to our CMOs or other larger-scale facilities operated by a CMO or by us and delays or failure by our CMOs or us to commence, make any necessary changes to or complete such manufacturing process;
−Removed: our use of different manufactur i ng processes within our clinical tri a l s , and any eff e cts that may result from the use of diff e rent processes on the c l ini c al d a ta th a t we have r e ported and will report in the future;
−Removed: delays in manufacturing, testing, releasing, validatin g , or importing/exporting sufficient sta b le quantities of our product c a ndidates for use in clini ca l tri a ls or the in a bili t y to do any of the foregoing, including as a result of any qua l ity issu e s associ a t e d wi t h the contract manufacturer;
−Removed: delays and additional costs associated with business disruption s , new regulatory requirements, social distancing and other re s tri c tions imposed b y governmental or regulatory agenc i es and clinical trial sites due to the C OVID ‑ 19 pandemic, which may include enroll m ent d e lays or f a ilur e s to follow tri a l protoco l s.
−Removed: Collaborations with other entities may be subject to additional delays bec a use of the management of the trials, contract negotiations, the need to obtain agreement from multiple par t ies and the necessity of obtaining additional approvals for ther a peut i cs used in the co m bina t ion tri a ls.
−Removed: Th e se c o m bin a tion ther a pi e s w i ll requ i re additional testing and clinical trials will require additional FDA regulatory approval and will increase our future costs.
−Removed: Any inab i li t y t o suc c essfu l ly c omp l e te pr e c l i ni c a l and cl i ni c al development could result in addit i onal costs to us, slow down our product development and approval process or impair o u r ability to commence product sales and generate revenues.
−Removed: In addition, if we m a ke manufacturing changes to our product candidates, we m a y be required to, or we may elect to, conduct additional trials to bridge our modified product candidates to earlier versions.
−Removed: These changes may require FDA approval or no t ification and may not have their desired effect.
−Removed: The FDA may also not acc e pt data from prior versions of the product to support an application, delaying our clinical t r ials or programs or nec e ssi t a t ing a ddit i onal c l ini c al tr i a l s or pr e c l i ni c a l s t udi e s .
−Removed: We may find that this change has unintended con s equences that necessitates additional development and manufacturing work, additional clinical and precl i nical studies, or that results in refusal to file or non-app r oval of a BLA and/or NDA.
−Removed: Clinical trial delays could shorten any p e riods during which our product candidates have patent protecti o n and may allow our c o mpetitors to bring products to market before we do, which c ould impair our ability to successfully commercialize our product candidates and may h a rm our business and results of operati o ns.
+Added: • our use of different manufacturing processes within our clinical trials, and any effects that may result from the use of different processes on the clinical data that we have reported and will report in the future;
+Added: • delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing, including as a result of any quality issues associated with the contract manufacturer;
+Added: • delays and additional costs associated with business disruptions, new regulatory requirements, social distancing and other restrictions imposed by governmental or regulatory agencies and clinical trial sites due to the COVID ‑ 19 pandemic, which may include enrollment delays or failures to follow trial protocols.
+Added: Collaborations with other entities may be subject to additional delays because of the management of the trials, contract negotiations, the need to obtain agreement from multiple parties and the necessity of obtaining additional approvals for therapeutics used in the combination trials.
+Added: These combination therapies will require additional testing and clinical trials will require additional FDA regulatory approval and will increase our future costs.
+Added: Any inability to successfully complete preclinical and clinical development could result in additional costs to us, slow down our product development and approval process or impair our ability to commence product sales and generate revenues.
+Added: In addition, if we make manufacturing changes to our product candidates, we may be required to, or we may elect to, conduct additional trials to bridge our modified product candidates to earlier versions.
+Added: These changes may require FDA approval or notification and may not have their desired effect.
+Added: The FDA may also not accept data from prior versions of the product to support an application, delaying our clinical trials or programs or necessitating additional clinical trials or preclinical studies.
+Added: We may find that this change has unintended consequences that necessitates additional development and manufacturing work, additional clinical and preclinical studies, or that results in refusal to file or non-approval of a BLA and/or NDA.
+Added: Clinical trial delays could shorten any periods during which our product candidates have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.
If we fail to commence or complete, or experience delays in, any of our planned clinical trials, our stock price and our ability to conduct our business as currently planned could be harmed.
−Removed: We wi l l be u n able to co m merc ia lize our product candidat e s if our trials a r e not s u c ce ssf u l .
+Added: We will be unable to commercialize our product candidates if our trials are not successful.
Our research and development programs are each at an early stage and our current product candidates are in the early stages of development.
3 unchanged sentences
We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of our product candidates, including but not limited to the following:
−Removed: s a fety a nd e ffic a cy re s ults in various human clinical trials reported in scientific and medic a l literature may not be indicat i ve of res u lts we obtain in our clinical trials;
−Removed: a fter re v i ewing test res u lts, we or our collaborators may a b andon projects that we might previously have believed to be promising;
−Removed: we, our collaborators or regulators may sus p e nd or t e r m ina t e cl i nic a l tri a ls i f t he p a rticipating subjects or patients are be i ng exposed to unacceptable health risks;
−Removed: t he standard of care may change as the result of new tech n ology or therapies in our target clinical i ndicatio n s, precluding r e gulatory approval or limited commercial use if approved;
−Removed: t he effects our potential products have may not be the desired effects or may include undesirab l e side effects or other chara c teristi c s that precl u de regulatory approval or limit their commercial use if approved;
−Removed: m anufacturers may not meet the necessary standa r ds for the production of the p r oduct candidates or may not be able to supply t he product candidates in a sufficient quantity;
+Added: • safety and efficacy results in various human clinical trials reported in scientific and medical literature may not be indicative of results we obtain in our clinical trials;
+Added: • after reviewing test results, we or our collaborators may abandon projects that we might previously have believed to be promising;
+Added: • we, our collaborators or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks;
+Added: • the standard of care may change as the result of new technology or therapies in our target clinical indications, precluding regulatory approval or limited commercial use if approved;
+Added: • the effects our potential products have may not be the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved;
+Added: • manufacturers may not meet the necessary standards for the production of the product candidates or may not be able to supply the product candidates in a sufficient quantity;
• regulatory authorities may find that our clinical trial design or conduct does not meet the applicable approval requirements.
27 unchanged sentences
Additionally, we may not be able to obtain the labeling claims necessary or desirable for the promotion of our product candidates.
−Removed: Additionally, in connection with the merger with ImmunityBio, we assum e d the obligation to issue CVRs to the former stockholde r s of Al t or BioScience Corporation (succeeded by Altor B i oScience LLC) (“Altor”) in connection with the acquisit i on of Altor.
−Removed: These CVRs b e come payable u p on the attainment of certa i n regulatory and sales milestones related to Anktiva.
−Removed: The former Altor stockholders have t h e ability to choose to receive these payments either in cas h , in an equivalent value of our common stock or in a combination of both cash and stock at t h e time such payments are due, except that Dr.
−Removed: S o on-Shiong and his related party, as prior stockholders of Altor, have irrevocably elected to receive all pay m ents in re s pe c t of th e ir CVRs in the form of our common stock.
+Added: Additionally, in connection with the merger with ImmunityBio, we assumed the obligation to issue CVRs to the former stockholders of Altor BioScience Corporation (succeeded by Altor BioScience LLC) (“Altor”) in connection with the acquisition of Altor.
+Added: These CVRs become payable upon the attainment of certain regulatory and sales milestones related to Anktiva™.
+Added: The former Altor stockholders have the ability to choose to receive these payments either in cash, in an equivalent value of our common stock or in a combination of both cash and stock at the time such payments are due, except that Dr.
+Added: Soon-Shiong and his related party, as prior stockholders of Altor, have irrevocably elected to receive all payments in respect of their CVRs in the form of our common stock.
Such CVR payments to Dr.
Soon-Shiong and his related party aggregate to approximately $279.5 million.
−Removed: We may, however, still be requi r e d to pay the other prior Altor stockholders up to $164.2 million for the CVRs r e lating to the regulatory milestone and up to $164.2 million for the CVRs relating to the sales milestone should they cho o se to have the s e CVRs paid in c ash instead of common stock.
−Removed: If this were to occur, we may need to seek additional sources of capital, and we may not be able to a c hieve profitability or p o sitive cash flow.
−Removed: We plan to collaborate with governmen t al, academic and corporate pa r tners, including affili a tes, to improve and develop Anktiva, hAd5 and other therapies for new indications for use in combinat i on with other therapies and to imp r o v e and develop other prod u ct candidates, which may e xpose us to additional risks, or we may not realize the benefits of such collaborations.
+Added: We may, however, still be required to pay the other prior Altor stockholders up to $164.2 million for the CVRs relating to the regulatory milestone and up to $164.2 million for the CVRs relating to the sales milestone should they choose to have these CVRs paid in cash instead of common stock.
+Added: If this were to occur, we may need to seek additional sources of capital, and we may not be able to achieve profitability or positive cash flow.
+Added: We plan to collaborate with governmental, academic and corporate partners, including affiliates, to improve and develop Anktiva™, hAd5 and other therapies for new indications for use in combination with other therapies and to improve and develop other product candidates, which may expose us to additional risks, or we may not realize the benefits of such collaborations.
We use the Clinic, a related party, in some of our clinical trials which may expose us to significant regulatory risks.
3 unchanged sentences
Prior to June 30, 2019, one of the company’s officers was an investigator or sub-investigator for certain of the company’s trials conducted at the Clinic.
−Removed: NantWorks, which is wholly owned by our Executive Chairman, Dr.
+Added: NantWorks, which is wholly owned by our Executive Chairman and Global Chief Scientific and Medical Officer, Dr.
Soon‑Shiong, provides certain administrative services (and has loaned money) to the Clinic.
29 unchanged sentences
Undesirable side effects or unacceptable toxicities caused by our product candidates could cause us, IRBs, Drug Safety Monitoring Boards, the FDA or comparable foreign regulatory authorities to interrupt, delay or halt clinical trials or order our clinical trials to be placed on clinical hold, and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities for any or all targeted indications.
−Removed: The FDA or comparable foreign regulatory authorities may also require additional data, clinical studies, or preclinical studies should unacceptable toxicities arise.
+Added: For example, we currently have a clinical hold on the Phase II/III clinical trial in the U.S.
+Added: for our hAd5 COVID-19 vaccine candidate pending modifications to the protocol and the FDA’s review of additional information, including immunogenicity and safety data from the Phase I portion of the study.
+Added: In addition, the FDA or comparable foreign regulatory authorities may also require additional data, clinical studies, or preclinical studies should unacceptable toxicities arise.
We may need to abandon development or limit development of that product candidate to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk/benefit perspective.
47 unchanged sentences
To the extent we use CMOs, we are ultimately responsible for the manufacture of our products, if approved, and product candidates.
−Removed: A failure to comply with these requirements may result in regulatory enforcement actions against our manufacturers or us, including fines and civil and criminal penalties, which could result in imprisonment, suspension or restrictions of production, injunctions, delay or denial of product approval or supplements to approved products, clinical holds or termination of clinical trials, warning or untitled letters, regulatory authority communications warning the public about safety issues with the biologic, refusal to permit the import or export of the products, product seizure, detention, or recall, operating restrictions, suits under the federal civil False Claims Act (“ FCA ”), co rporate integrity agreements, consent decrees, or withdrawal of product approval.
+Added: A failure to comply with these requirements may result in regulatory enforcement actions against our manufacturers or us, including fines and civil and criminal penalties, which could result in imprisonment, suspension or restrictions of production, injunctions, delay or denial of product approval or supplements to approved products, clinical holds or termination of clinical trials, warning or untitled letters, regulatory authority communications warning the public about safety issues with the biologic, refusal to permit the import or export of the products, product seizure, detention, or recall, operating restrictions, suits under the federal civil False Claims Act (“FCA”), corporate integrity agreements, consent decrees, or withdrawal of product approval.
Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidate, impair commercialization efforts, increase our cost of goods, and have a material adverse effect on our business, financial condition, results of operations and growth prospects.
11 unchanged sentences
If such a change occurs for a product candidate that is already in clinical testing, the change may require us to perform both ex vivo comparability studies and to collect additional data from patients prior to undertaking more advanced clinical trials.
−Removed: Our efforts to develop, manufacture a n d market COVID‑19 therapeutics will require additional personnel who w i ll require training, which may cause some of our employees to reallocate t h e i r t i me from other duties which could in turn cause delays in clinical supply of our other product candidates or trials.
−Removed: We have been planning for the development of COVID ‑ 19-related p r oduct candidates.
−Removed: We have repurposed some of our personnel overseeing q u ality, clinical operations and manufacturing of our oncology product cand i dates to support our COVID ‑ 19 e fforts and we plan to hire a ddit i onal s t aff to support the COVID ‑ 19 efforts, which will increase our expenses.
−Removed: If our personnel fail to remain focused on our o n cology or oth e r infectious disease drug candidates or, if the services of employees that may have shifted to the COV I D ‑ 19 efforts are not adequately covered by o t her em p l oyees, or if new personnel that we plan to hire to support the COVID ‑ 19 effor t s require extensive training, our current oncology ope r a tions may be adversely impacted.
−Removed: Our ability to use net operating losses and research and development credits to offset future t axable income may be subject to c e rtain l im i tat i ons
−Removed: In general, under Sections 382 and 383 of the Internal Revenue Code (“Code”), a corporation that undergoes an “ow n ership change” is subject to limitatio n s on its a bi l ity to utilize its pre-change net operating losses or tax credits (“ NOLs”) or cr e dits, to offset future t a xab l e inco m e or t a xes.
−Removed: For th e s e pu r poses, an ownership change generally occurs where the aggregate stock ownership of one or mo r e s t ockholders or groups of stockho l ders who owns at least 5% of a corporation’s stock increases its ownership by mo r e than 50 percentage points over its l o west ownership percentage with i n a spe c ifi e d t e sting period.
−Removed: We have not conducted a complete study to assess whether a change of control has occurred or whether there h a ve been multiple chan g e s of control since inception d u e to the significant complexity and cost associated with such a study.
−Removed: If we have e xperienced a change of control, as defined by Section 382, at any time since inception (inc l udi n g as a result of the merger), utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an a nnual limitation under Section 382.
−Removed: Any limitation may r e sult in expiration of a portion o f the net operating loss carryforwards or research and development tax credit carryforwards before utilization.
−Removed: I n addition, our NOLs or credits may also be impaired under state law.
−Removed: Acc o rdingly, we m a y not be able to utilize a material portion of our NOLs or credits.
−Removed: Since we will need to raise s ubstantial ad d i ti o nal funding to finance our operations, we may e xperience further ownership chan g e s in the futur e , some of which may be outside of our contr o l.
−Removed: L i mi t s on our abi l ity to use our pre-change NOLs or credits to offset U.S.
−Removed: federal taxable income could potentially result in increased future tax liability to us if we earn net taxable income in t h e future.
−Removed: In addition, under the legislation commonly referred to as the Tax Cuts and Jobs Act of 2017 (“TCJA”), as modified by the Co r o n a virus Aid, Relief, and E c onomic Security Act (“ CARES Act”), t h e amount of NOLs generated in taxable periods beginning after December 31, 2017, that we are permitted to deduct in any taxable year beginning after December 31, 2020 is limited to 80% of our taxable income in such year, where t a xable income is determined wi t hout regard to the NOL deduction it s e lf.
−Removed: The TCJA a llo w s p o st-2017 unused NOLs to be car r ied forward indefi n itely.
−Removed: Similar rul e s may apply under state tax laws.
−Removed: Changes in tax law could adv e r s e ly affe c t o u r b u sin e ss and financial co n dition.
+Added: Our ability to use net operating losses and research and development credits to offset future taxable income may be subject to certain limitations.
+Added: In general, under Sections 382 and 383 of the Internal Revenue Code (“Code”), a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses or tax credits (“NOLs”) or credits, to offset future taxable income or taxes.
+Added: For these purposes, an ownership change generally occurs where the aggregate stock ownership of one or more stockholders or groups of stockholders who owns at least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period.
+Added: We have not conducted a complete study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study.
+Added: If we have experienced a change of control, as defined by Section 382, at any time since inception (including as a result of the merger), utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382.
+Added: Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization.
+Added: In addition, our NOLs or credits may also be impaired under state law.
+Added: Accordingly, we may not be able to utilize a material portion of our NOLs or credits.
+Added: Since we will need to raise substantial additional funding to finance our operations, we may experience further ownership changes in the future, some of which may be outside of our control.
+Added: Limits on our ability to use our pre-change NOLs or credits to offset U.S.
+Added: federal taxable income could potentially result in increased future tax liability to us if we earn net taxable income in the future.
+Added: In addition, under the legislation commonly referred to as the Tax Cuts and Jobs Act of 2017 (“TCJA”), as modified by the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the amount of NOLs generated in taxable periods beginning after December 31, 2017, that we are permitted to deduct in any taxable year beginning after December 31, 2020 is limited to 80% of our taxable income in such year, where taxable income is determined without regard to the NOL deduction itself.
+Added: The TCJA allows post-2017 unused NOLs to be carried forward indefinitely.
+Added: Similar rules may apply under state tax laws.
+Added: Changes in tax law could adversely affect our business and financial condition.
Negative or unexpected tax consequences could adversely affect our results of operations.
10 unchanged sentences
In addition, adverse changes in the financial outlook of our operations or further changes in tax laws or regulations could lead to changes in our valuation allowances against deferred tax assets on our consolidated balance sheets, which could materially affect our results of operations.
−Removed: Our transfer pricing poli c ies may be subject to challenge by the IRS or other taxing a u thorities.
−Removed: Our intercompany relationships are subject to complex trans f er pricing regulations administered by taxing authorities in vario u s juri s di c tions.
−Removed: The relevant taxing authorities may disa g r ee with our deter m ina t ions a s to the va l ue of a s se t s sold or acquired or income and expe n ses a ttr i butab l e to sp e c if i c jurisdictions.
−Removed: If such a disagreement were to occur, and our position were not sustain e d, we could b e required to pay additional taxes, interest and penalties, which could result in one-time tax charges, high e r effective tax rates, reduced cash flows, and lower overall profitability of our operations.
−Removed: We bel i eve th a t our fin a nc i a l s t a t em e nts r e fle c t ad e quate r e s e rves to cover such a contingency, but there can be no assurances in that regard.
−Removed: We could be subje c t to additional income tax liabilities and to examinations of our tax returns by t h e IRS and other domestic a n d foreign tax authorities.
−Removed: An adverse out c ome of any such audit or examination by the IRS or other tax authority cou l d have a material adver s e eff e ct on o u r op e rating results and finan c ial condit i on.
+Added: Our transfer pricing policies may be subject to challenge by the IRS or other taxing authorities.
+Added: Our intercompany relationships are subject to complex transfer pricing regulations administered by taxing authorities in various jurisdictions.
+Added: The relevant taxing authorities may disagree with our determinations as to the value of assets sold or acquired or income and expenses attributable to specific jurisdictions.
+Added: If such a disagreement were to occur, and our position were not sustained, we could be required to pay additional taxes, interest and penalties, which could result in one-time tax charges, higher effective tax rates, reduced cash flows, and lower overall profitability of our operations.
+Added: We believe that our financial statements reflect adequate reserves to cover such a contingency, but there can be no assurances in that regard.
+Added: We could be subject to additional income tax liabilities and to examinations of our tax returns by the IRS and other domestic and foreign tax authorities.
+Added: An adverse outcome of any such audit or examination by the IRS or other tax authority could have a material adverse effect on our operating results and financial condition.
We are a U.S.-based company subject to tax in the U.S.
1 unchanged sentence
Significant judgment is required in determining our global provision for income taxes, deferred tax assets or liabilities, and in evaluating our tax positions on a worldwide basis.
−Removed: We may become subject to regular review and audit by the IRS a nd other tax authorities in various domestic and foreign jurisdi c tions.
−Removed: As a resul t , we may in the future r e ce i ve ass e ssm e nts i n m u l t i ple jurisdi c t i ons on various tax-related assert i ons.
−Removed: Taxing authorities may in t h e future challenge our tax p o sitions and methodologies on var i ous matters, including our posit i ons r e garding the collection of sales and use taxes, the d e termination and payment of value added taxes and the jurisdictions in which we are subject to t a xes, which could e xpose us to additional taxes.
−Removed: We regularly assess the likelihood of adverse outcomes result i ng from future tax e x aminations to determine the a d equacy of our provision for income taxes.
+Added: We may become subject to regular review and audit by the IRS and other tax authorities in various domestic and foreign jurisdictions.
+Added: As a result, we may in the future receive assessments in multiple jurisdictions on various tax-related assertions.
+Added: Taxing authorities may in the future challenge our tax positions and methodologies on various matters, including our positions regarding the collection of sales and use taxes, the determination and payment of value added taxes and the jurisdictions in which we are subject to taxes, which could expose us to additional taxes.
+Added: We regularly assess the likelihood of adverse outcomes resulting from future tax examinations to determine the adequacy of our provision for income taxes.
These assessments can require considerable estimates and judgments.
−Removed: The calculation of our tax liabilities involv e s dealing with uncertainties in the applic a tion of complex tax laws and regulations in a variety of jurisdictions.
−Removed: While we believe our tax positions are consistent with the tax laws in the jurisdictions in which we conduct our business, there can be no assurance that our tax positions and m e thodologies or calculati o n of our tax liabilities are accurate or that the outcomes f r o m ongoing and future tax examinations will not have an adverse eff e ct on our operati n g results and financial condition.
−Removed: Our projections regarding the market opportu n ities for our product candidates may not be accurate, and the actual market for o u r products, if a p proved, may be small e r t h a n w e e s t ima t e .
−Removed: We do not have verifia b le data regarding the potential size of the commercial ma r kets for our current product c andidates or any future prod u ct candidates.
−Removed: Since our c u rrent product candidates and any future product candidates will represent novel approaches to t reating various conditions, it may be difficult, in any eve n t, to accurately estimate the potential revenues from these product candidates.
−Removed: Ac c ordingly, we may spend sig n ificant capital trying to obtain approval for product candidates that have an uncertain commercial market.
−Removed: Our projections of addressable patient populations that may benefit from treatme n t with our product cand i dates are based on our beliefs and estimates.
−Removed: These estimates have been derived from a v a riety of sources, including scientific lite r ature, surve y s of clinics, patient foun d ations, or mar k et r e s e ar c h by third parties, and may prove to be incorrec t .
−Removed: Further, new studies or a pprovals of new therapeutics m a y change t he e sti m at e d in cidence or prevalence of these diseases.
+Added: The calculation of our tax liabilities involves dealing with uncertainties in the application of complex tax laws and regulations in a variety of jurisdictions.
+Added: While we believe our tax positions are consistent with the tax laws in the jurisdictions in which we conduct our business, there can be no assurance that our tax positions and methodologies or calculation of our tax liabilities are accurate or that the outcomes from ongoing and future tax examinations will not have an adverse effect on our operating results and financial condition.
+Added: Our projections regarding the market opportunities for our product candidates may not be accurate, and the actual market for our products, if approved, may be smaller than we estimate.
+Added: We do not have verifiable data regarding the potential size of the commercial markets for our current product candidates or any future product candidates.
+Added: Since our current product candidates and any future product candidates will represent novel approaches to treating various conditions, it may be difficult, in any event, to accurately estimate the potential revenues from these product candidates.
+Added: Accordingly, we may spend significant capital trying to obtain approval for product candidates that have an uncertain commercial market.
+Added: Our projections of addressable patient populations that may benefit from treatment with our product candidates are based on our beliefs and estimates.
+Added: These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research by third parties, and may prove to be incorrect.
+Added: Further, new studies or approvals of new therapeutics may change the estimated incidence or prevalence of these diseases.
The number of patients may turn out to be lower than expected.
−Removed: Add i tionally, the potentia l ly addressable patie n t population for our prod u ct candidates may be limited or may not be amenable to treatment with our p r o d uct candidates and may also be limited by t h e cost of our tre a tm e nts a nd t he r e i m burs e ment of those tre a t m ent costs by thi r d-party payors.
−Removed: Even if we obtain significant market share for our product candidat e s, because the p o t e nt i a l t a rg e t p o pulations may be s m all, we may never achie v e profitability without obtaining regulatory approval f o r additional indications.
−Removed: Because our current product candidates r e present, and o u r other potential product candidates w i ll represent novel approaches to the treat m ent of dis e ase, t h ere are many un certa i n t ies r e gard i ng t h e dev e lop m e n t, market acceptance, third-party reimbursement coverage and t h e co m merc i al p o tential of our product candidates.
+Added: Additionally, the potentially addressable patient population for our product candidates may be limited or may not be amenable to treatment with our product candidates and may also be limited by the cost of our treatments and the reimbursement of those treatment costs by third-party payors.
+Added: Even if we obtain significant market share for our product candidates, because the potential target populations may be small, we may never achieve profitability without obtaining regulatory approval for additional indications.
+Added: Because our current product candidates represent, and our other potential product candidates will represent novel approaches to the treatment of disease, there are many uncertainties regarding the development, market acceptance, third-party reimbursement coverage and the commercial potential of our product candidates.
Human immunotherapy products are a new category of therapeutics.
−Removed: B e cause this is a relatively new and expanding area of novel therapeutic int e rv e nt i on s , th e re a re m a ny un ce rt a inti e s r e l a ted to de v e lopment, marke t ing, reimbursement and the co m me r ci a l poten t ial for o ur product candidates.
−Removed: There can be no assurance as to the length of the trial period, the number of patients t h e FDA will requ i re to be e nrol l ed i n t he tri a ls i n order to est a blish the safety, efficacy, purity and potency of immunotherapy p r o ducts, or that the data g e nerated in these trials will be accepta b le to the FDA to support marketing approval.
−Removed: The FDA may t a ke longer than usual to come to a decision on any BLA and/ o r NDA that we submit and may ultimately det e rmine that there is not en o ugh data, information, or exper i ence with our product candidates to support an approval decision.
−Removed: The FDA may also require that we conduct additional post-marketing studies or implement risk management programs, such as REMS, until more experience with our p roduct candidates is obtained.
−Removed: Finall y , after i n creased usage, we may find that our product candidates do not have the i n tended effect, do not w o rk with other combinati o n therapies or have unanticipated side eff e c t s, pot e nt i al l y j e opard i z ing in i ti a l or continuing regulatory approval and commercial prospects.
−Removed: There is no assurance that the approaches offered by our product candidates will gain broad acceptance among docto r s or patients or that governmental agencies or third-party medical insurers will be willing to provide reimbursement coverage for our p r oposed product candidates.
−Removed: The ma r ket for any prod u cts that we successfully develop will also depend on the cost of the product.
−Removed: We d o not yet have sufficient information to r e l i ably est i ma t e wh a t it will cost to commercially manu f acture our current produ c t candidates, and the actual cost to manufacture these products could materially and adversely affect the commercial viability of the s e products.
+Added: Because this is a relatively new and expanding area of novel therapeutic interventions, there are many uncertainties related to development, marketing, reimbursement and the commercial potential for our product candidates.
+Added: There can be no assurance as to the length of the trial period, the number of patients the FDA will require to be enrolled in the trials in order to establish the safety, efficacy, purity and potency of immunotherapy products, or that the data generated in these trials will be acceptable to the FDA to support marketing approval.
+Added: The FDA may take longer than usual to come to a decision on any BLA and/or NDA that we submit and may ultimately determine that there is not enough data, information, or experience with our product candidates to support an approval decision.
+Added: The FDA may also require that we conduct additional post-marketing studies or implement risk management programs, such as REMS, until more experience with our product candidates is obtained.
+Added: Finally, after increased usage, we may find that our product candidates do not have the intended effect, do not work with other combination therapies or have unanticipated side effects, potentially jeopardizing initial or continuing regulatory approval and commercial prospects.
+Added: There is no assurance that the approaches offered by our product candidates will gain broad acceptance among doctors or patients or that governmental agencies or third-party medical insurers will be willing to provide reimbursement coverage for our proposed product candidates.
+Added: The market for any products that we successfully develop will also depend on the cost of the product.
+Added: We do not yet have sufficient information to reliably estimate what it will cost to commercially manufacture our current product candidates, and the actual cost to manufacture these products could materially and adversely affect the commercial viability of these products.
Our goal is to reduce the cost of manufacturing and providing our therapies.
−Removed: However, u n less we can reduce those costs to an acceptable amount, we may never be able to develop a commercial l y viable product.
−Removed: If we do not succes s fully develop and commercialize products based upon our approach or find suit a ble and economical sources for materials used in the production of our potential products, we will not become profitable, which would materially and adver s ely affect the value of our com m on stock.
−Removed: Our Anktiva therapies and our o t her therapies may be provided to pat i ents in combination with other agents provided by third parties or our affiliates.
−Removed: The cost of such co m bina t ion t her a py may inc r ease the ov e rall c ost of therapy and may result in issues regarding t h e allocation of reimbursements between our thera p y and the other agents, all of which may affect our ability to o b tain reimbursement coverage for the combi n ation therapy from governmental or private t hird-party medical insu r e rs.
−Removed: If product liability law s uits are brought against u s , we may incur substanti a l liabilities and may be r e quired to limit commer c ialization of our product candidates.
−Removed: We face an inherent risk of product liability as a result of the clinical development, testing and manufacturing of o ur product candidates and will face an e v en gre a ter risk i f we commercialize any products.
−Removed: For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise u n suitable during clinical tes t i n g, manufacturing, marketing or sale.
−Removed: Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dange r s inherent in the product, negligence, strict lia b ility or a brea c h of warranties.
−Removed: Claims could also be asse r ted under state consumer pro t ection acts.
−Removed: Large judgements have b een awarded in c l ass action lawsuits based o n ther a peu t ics that h a d u n anticipated side effec t s.
−Removed: If we cannot successfu l ly defend ourselves against product lia b ility claims, we may incur substant i al l i ab i li t ies or be required to limit commercia l ization of our product candidates.
−Removed: Even successful defense w ould require significant financial and management resources.
−Removed: Regardless of the merits or eventual ou t com e , li a bil i ty cl a ims may result in a regulatory investigation of the safety and effectiveness of our products, our third-party manufacturer’s manufacturing processes and facilities or our marketing programs and potentially a recall of our products or more serious enforcement action, including limitations on the approved indications for which our product candidates may be used or suspension or withdrawal of approvals, decreased demand for our products, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources, substantial monetary awards to trial participants or patients and a decline in our stock price.
−Removed: Our inability to obtain sufficient product l i ability insurance at an acceptable cost to protect again s t potential product liab i lity claims could prevent or inhibit the commercialization of products we may develop, alone or with corporate c o llaborators.
−Removed: Our insurance policies may also have various exclusions, and we may be subject to product liability claims for which we have no cove r a ge.
−Removed: While we have obta i ned clinical t rial insurance for our cl i ni c al tr i a ls, we may have to pay am o unts awarded by a court or negotiated in a set t l e ment th a t exceed our coverage li m it a tions or th a t are not covered by our insurance, and we may not have, or be able to ob t ain, sufficient c a pital to pay such amounts.
−Removed: Even if our agreem e nts w i th a ny future corporate collaborators entitle us to indem n ifi c a t ion a ga i nst losses, such i ndemn i fi c a t ion may not be a v ail a ble or adequate should any claim arise.
−Removed: We wi l l face signifi c ant c ompe t it i on from other biotech n ology and pharmaceutical companies and from non-prof i t ins t itut i ons.
+Added: However, unless we can reduce those costs to an acceptable amount, we may never be able to develop a commercially viable product.
+Added: If we do not successfully develop and commercialize products based upon our approach or find suitable and economical sources for materials used in the production of our potential products, we will not become profitable, which would materially and adversely affect the value of our common stock.
+Added: Our Anktiva™ therapies and our other therapies may be provided to patients in combination with other agents provided by third parties or our affiliates.
+Added: The cost of such combination therapy may increase the overall cost of therapy and may result in issues regarding the allocation of reimbursements between our therapy and the other agents, all of which may affect our ability to obtain reimbursement coverage for the combination therapy from governmental or private third-party medical insurers.
+Added: If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
+Added: We face an inherent risk of product liability as a result of the clinical development, testing and manufacturing of our product candidates and will face an even greater risk if we commercialize any products.
+Added: For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale.
+Added: Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties.
+Added: Claims could also be asserted under state consumer protection acts.
+Added: Large judgements have been awarded in class action lawsuits based on therapeutics that had unanticipated side effects.
+Added: If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates.
+Added: Even successful defense would require significant financial and management resources.
+Added: Regardless of the merits or eventual outcome, liability claims may result in a regulatory investigation of the safety and effectiveness of our products, our third-party manufacturer’s manufacturing processes and facilities or our marketing programs and potentially a recall of our products or more serious enforcement action, including limitations on the approved indications for which our product candidates may be used or suspension or withdrawal of approvals, decreased demand for our products, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources, substantial monetary awards to trial participants or patients and a decline in our stock price.
+Added: Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we may develop, alone or with corporate collaborators.
+Added: Our insurance policies may also have various exclusions, and we may be subject to product liability claims for which we have no coverage.
+Added: While we have obtained clinical trial insurance for our clinical trials, we may have to pay amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
+Added: Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.
+Added: We will face significant competition from other biotechnology and pharmaceutical companies and from non-profit institutions.
Competition in the field of cancer and viral infectious disease therapy is intense and is accentuated by the rapid pace of technological development.
12 unchanged sentences
Our competitors may:
−Removed: develop safe r , more convenient or more effective immunothe r a pies and other therapeutic products;
+Added: • develop safer, more convenient or more effective immunotherapies and other therapeutic products;
• develop therapies that are less expensive or have better reimbursement from private or public payors;
−Removed: reach the market more rapid l y, reducing the potential sales of our product candidates;
−Removed: e stablish superior proprietary positions.
+Added: • reach the market more rapidly, reducing the potential sales of our product candidates;
+Added: • establish superior proprietary positions.
Even if we obtain regulatory approval for our product candidates, the availability and price of our competitors’ products could limit the demand and the price we are able to charge for our therapies.
The level of generic competition and the availability of reimbursement from government and other third-party payors will also significantly affect the pricing and competitiveness of our products.
−Removed: A large number of compa n ies, government agenc i es and academic centers around t h e world are developing COVID ‑ 1 9 vaccines, and many of t hese ent i ti e s are i n more advanced stages of development than we are, including some that have started P hase II and/or III clinical trials or have already obtained emergency regulato r y approval in the United States and internationally .
−Removed: Even if our COVID ‑ 19 vaccine candidate is ultimately approved for m arketing, the value of our op p o r tunity will be adversely impacted by other COVID ‑ 19 vaccines that have obtained emergency regulatory approval, obtain full regulatory approval, or demonstrate better efficacy or sa f e ty than our COVID ‑ 19 vaccine candidate.
+Added: A large number of companies, government agencies and academic centers around the world are developing COVID ‑ 19 vaccines, and many of these entities are in more advanced stages of development than we are, including some that have started Phase II and/or III clinical trials or have already obtained emergency regulatory approval in the United States and internationally.
+Added: Even if our COVID ‑ 19 vaccine candidate is ultimately approved for marketing, the value of our opportunity will be adversely impacted by other COVID ‑ 19 vaccines that have obtained emergency regulatory approval, obtain full regulatory approval, or demonstrate better efficacy or safety than our COVID ‑ 19 vaccine candidate.
We may not be able to implement our business plan if the acceptance of our product candidates is inhibited by price competition or the reluctance of physicians to switch from other methods of treatment to our product, or if physicians switch to other new therapies, drugs or biologic products or choose to reserve our product candidates for use in limited circumstances.
We may be adversely impacted if any of these competitors gain market share as a result of new technologies, commercialization strategies or otherwise.
−Removed: Pu b l ic opinion and s c rutiny of immunotherapy app r oaches may impact public per c eption of us and our product candi d ates, which may ad v e rsely aff e ct our abil i ty to condu c t our business and implement our business plans.
−Removed: We use r e latively novel technologies in v olving the Anktiva, a ldoxorubicin, hAd5 and yeast technologies and cell-based therapies and o ur natural killer cell platform utilizes a relatively novel technology involv i ng the genetic modification of human cells and util i zation of those modified cells in other individuals.
−Removed: Public pe r ception may be influ e nced by claims, such as claims that our technologies are unsafe, unethical or immo r al and, consequently, our approach may not gain the acceptance of the public or the medical community.
−Removed: Negative public react i on to cell-based immunotherapy in general could result in greater government regulation a nd stricter labeling requirem e nts of immunotherapy products, including our product candidates, and could cause a decrease in t h e demand for any products we may develop.
−Removed: Adverse public attitudes may adversely impact our ability to enro l l patients in c lin i c a l trials.
−Removed: Moreover, our success will depend upon physicians specializing in the treatment of those dis e ases that our p r o duct can d ida t es t a rget pr e s c ribing, and their patients being willing to receive treatments that involve the use of our product candidates in lieu of, or in addit i on to, ex i s t ing tre a tm e nts t hey are already familiar with and f or which greater clinical data may be available.
−Removed: More restrictive gove r n ment reg u lations or negative public o p inion could have an adverse effect on our business or financial condition and may del a y or impair the de v e lopme n t and commercialization of our product candidates or demand for any products we may develop.
−Removed: Adverse events in our clinical trial s , even if not ultimately attributable to our p r oduct candidates, and the resulting publicity could result in increas e d governmental regulation, unfavorable pub l ic perception, potential regulatory del a ys in the testing or approval of our potential product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.
+Added: Public opinion and scrutiny of immunotherapy approaches may impact public perception of us and our product candidates, which may adversely affect our ability to conduct our business and implement our business plans.
+Added: We use relatively novel technologies involving the Anktiva™, aldoxorubicin, hAd5 and yeast technologies and cell-based therapies and our natural killer cell platform utilizes a relatively novel technology involving the genetic modification of human cells and utilization of those modified cells in other individuals.
+Added: Public perception may be influenced by claims, such as claims that our technologies are unsafe, unethical or immoral and, consequently, our approach may not gain the acceptance of the public or the medical community.
+Added: Negative public reaction to cell-based immunotherapy in general could result in greater government regulation and stricter labeling requirements of immunotherapy products, including our product candidates, and could cause a decrease in the demand for any products we may develop.
+Added: Adverse public attitudes may adversely impact our ability to enroll patients in clinical trials.
+Added: Moreover, our success will depend upon physicians specializing in the treatment of those diseases that our product candidates target prescribing, and their patients being willing to receive treatments that involve the use of our product candidates in lieu of, or in addition to, existing treatments they are already familiar with and for which greater clinical data may be available.
+Added: More restrictive government regulations or negative public opinion could have an adverse effect on our business or financial condition and may delay or impair the development and commercialization of our product candidates or demand for any products we may develop.
+Added: Adverse events in our clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our potential product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.
We may seek orphan drug status or Fast Track or Breakthrough Therapy designations or other designation for one or more of our product candidates, but even if any such designation or status is granted, it may not lead to faster development or a faster regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval and we may be unable to maintain any benefits associated with such designations or status, including market exclusivity.
9 unchanged sentences
may be lost if we seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if we are unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
−Removed: As a condition of approval, the FDA m a y re q u ire that we implement var i ous post-marketing requirements and conduct post-marketi n g studies, any of which would require a substantial investment of time, effort, and money, and which may l im i t our c omm e rcial prospects.
+Added: As a condition of approval, the FDA may require that we implement various post-marketing requirements and conduct post-marketing studies, any of which would require a substantial investment of time, effort, and money, and which may limit our commercial prospects.
As a condition of biologic licensing, the FDA is authorized to require that sponsors of approved BLAs implement various post-market requirements, including REMS and Phase IV trials.
8 unchanged sentences
For product candidates for which we retain commercialization rights and marketing approval, if approved, in order to commercialize our product candidates, we must build our marketing, sales and distribution capabilities, including a comprehensive healthcare compliance program, or arrange with third parties to perform these services, which will take time and require significant financial expenditures and could delay any product launch and we may not be successful in doing so.
−Removed: There are significant risks involved with building and managing a commercial infrastructure.
+Added: There are significant risks involved with building and managing a
+Added: commercial infrastructure.
We, or our collaborators, will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train, manage and retain medical affairs, marketing, sales and commercial support personnel.
27 unchanged sentences
If a third party fails to timely report or adjust prices as required or errs in calculating government pricing information from transactional data in our financial records, it could impact our discount and rebate liability, and potentially subject us to regulatory sanctions or FCA lawsuits.
−Removed: If our product candidates do not achieve b r oad market acceptance, the rev e nues that we generate from their sales will be limit e d.
+Added: If our product candidates do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
We have not commercialized a product candidate for any indication.
23 unchanged sentences
If any product candidate we commercialize fails to achieve market acceptance, it could have a material and adverse effect on our business, financial condition, results of operations and prospects.
−Removed: Our product candidates may face c o mpetition sooner than anticipated.
−Removed: The enactment of the Biologics Price Competition and Innovation A c t of 2009 (“BPCIA”) created an abbre v iated p a thway for the a p proval of biosimilar and inte r c hangeable biological products.
−Removed: The abbreviated regulatory pathway establi s hes legal authority for the FDA to review and approve biosimilar biologics, including the possible d e signation of a biosimilar as “in t erchangeable” based on its sim i lar i ty to a n e xisting brand product.
−Removed: Under the BPCIA, the FDA cannot make an approval of an a pplication for a biosimilar product effective until 12 years after t h e original branded product was approved under a BLA.
−Removed: Certain changes, ho w ever, and supplements to an app r oved BLA, and subsequent applications fil e d by the same spons o r, manufacturer, li c ensor, pred e cessor i n in t e r e st or other related entity do not qualify for the 12-year exclusivity period.
+Added: Our product candidates may face competition sooner than anticipated.
+Added: The enactment of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) created an abbreviated pathway for the approval of biosimilar and interchangeable biological products.
+Added: The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an existing brand product.
+Added: Under the BPCIA, the FDA cannot make an approval of an application for a biosimilar product effective until 12 years after the original branded product was approved under a BLA.
+Added: Certain changes, however, and supplements to an approved BLA, and subsequent applications filed by the same sponsor, manufacturer, licensor, predecessor in interest or other related entity do not qualify for the 12-year exclusivity period.
Our product candidates may qualify for the BPCIA’s 12-year period of exclusivity.
−Removed: Howev e r, the r e is a risk that the FDA will n o t consider our p r od u ct candidates to be reference products for competing products, p o ten t ially creating the opport u nity f o r bi o similar competition sooner th a n a nti c ipa t ed.
−Removed: Additionally, this pe r iod of regulatory exclusivity does not b l ock companies pursu i ng regulatory approval via their own tradit i onal BLA, rather than via the abbreviated pathway.
−Removed: Changes may also b e made to this exclusivity period as a result of future legis l ation as there have b e en ongoing efforts to reduce the period of exclusivity.
−Removed: Even if we receive a period of BPCIA exclusivity for our first licensed product, if subse q ue n t products do not include a modification to the structure of the produ c t that impacts safety, purity, or potency, we may not receive a dditional periods of exclusivity for those prod u cts.
−Removed: Moreover, the extent to which a biosimilar, once approv e d, will be substituted for a ny one of our refere n c e product candidates in a way that is similar to traditional generic substitution for non-biological products is not y e t clear, and will dep e nd on a number of marke t place and regulatory factors that are still developing.
−Removed: Medicare Part B encourages use of biosimilars by paying the provider the sa m e perc e nt a ge of the r e f e rence product average sale price as a mark-up, regardless of whi c h product is reimbursed.
−Removed: It is also possible that payors w ill give rei m bursement pr e feren c e to biosim i lars even o v er reference biologics abs e nt a de t e rm i na t ion of interchangeability.
+Added: However, there is a risk that the FDA will not consider our product candidates to be reference products for competing products, potentially creating the opportunity for biosimilar competition sooner than anticipated.
+Added: Additionally, this period of regulatory exclusivity does not block companies pursuing regulatory approval via their own traditional BLA, rather than via the abbreviated pathway.
+Added: Changes may also be made to this exclusivity period as a result of future legislation as there have been ongoing efforts to reduce the period of exclusivity.
+Added: Even if we receive a period of BPCIA exclusivity for our first licensed product, if subsequent products do not include a modification to the structure of the product that impacts safety, purity, or potency, we may not receive additional periods of exclusivity for those products.
+Added: Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference product candidates in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.
+Added: Medicare Part B encourages use of biosimilars by paying the provider the same percentage of the reference product average sale price as a mark-up, regardless of which product is reimbursed.
+Added: It is also possible that payors will give reimbursement preference to biosimilars even over reference biologics absent a determination of interchangeability.
For our small molecular product candidates, if qualified, the regulatory exclusivity period is less than for our biologic product candidates.
−Removed: The Federal Food, Drug, and Cosmetic Act (“FDCA”) provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a drug where the FDA has not previously approved any other new drug containing the same active molecule or ion respons i ble for the action of the drug substance.
−Removed: During the e x clusivity period, the FDA may not a c cept for rev i ew a n abbr e vi a ted new drug application or a 505(b)(2) NDA submitted by another company for a generic version of such drug where the applica n t does not own or have a legal right of refe re n c e to a ll th e da ta required for approval.
−Removed: However, an application may be submitted after four years if it c ontains a certification of patent inva l idity or non-infringement.
−Removed: The FDCA also provides three years of mar k eting exclu s ivity for an NDA, 505(b ) (2) N D A or supplement to an exi s ting NDA if new c l in i c al investigations, other than bioav a ilability studies, that were c onducted or sponsored by the appli c ant a r e deemed b y the FDA to be e ss e nti a l to t he approval of the applicatio n , f or example, n e w indications, dosages or strengths of an existing drug.
−Removed: As su c h, we m a y f a ce c omp e tition from gene r ic versions of our small molecule product c a ndidates, which will negative l y impact our long-term busi n ess prospects and marketing opportunities.
−Removed: We will need to obtain FDA approval of a n y proposed branded product names, and any f a ilure or delay associated with such approval may adversely affect o u r b u s i n e s s .
−Removed: Any name we intend to use for our product c a ndidates in the United States will require approval from the FDA regardless of whether we have secured a formal t r ademark registration from the U.S.
+Added: The Federal Food, Drug, and Cosmetic Act (“FDCA”) provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a drug where the FDA has not previously approved any other new drug containing the same active molecule or ion responsible for the action of the drug substance.
+Added: During the exclusivity period, the FDA may not accept for review an abbreviated new drug application or a 505(b)(2) NDA submitted by another company for a generic version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval.
+Added: However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement.
+Added: The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, new indications, dosages or strengths of an existing drug.
+Added: As such, we may face competition from generic versions of our small molecule product candidates, which will negatively impact our long-term business prospects and marketing opportunities.
+Added: We will need to obtain FDA approval of any proposed branded product names, and any failure or delay associated with such approval may adversely affect our business.
+Added: Any name we intend to use for our product candidates in the United States will require approval from the FDA regardless of whether we have secured a formal trademark registration from the U.S.
Patent and Trademark Office (“USPTO”).
−Removed: The FDA typically conducts a review of prop o sed product names, including an e v aluation of the pote n tial for confusion with other product names.
−Removed: The FDA may also object to a product n a me if it beli e v e s the name i n appropriately implies medical claims or contributes to an overstatement of e fficacy.
+Added: The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names.
+Added: The FDA may also object to a product name if it believes the name inappropriately implies medical claims or contributes to an overstatement of efficacy.
If the FDA objects to any of our proposed product names, we may be required to adopt alternative names for our product candidates.
−Removed: If we adopt alternative names, we would lose the benefit of any existing tradema r k applications for such product cand i date and may be required to expend significant a dditional resources in an effort t o iden t ify a sui t ab l e prod u ct name that would qualify under applicable trademark laws, not infringe or other w ise violate the existing ri g hts of third parties, and be ac c ep t a ble to the FDA.
−Removed: We may be unable to build a successful brand identity for a new product name in a timely manner or at all, which w o uld li m it our a bil i ty to commercialize our product candidates.
−Removed: Our i n te r n al c omputer s y s t ems, or those used by our CROs, C M Os, c li n i c al s i t e s or other contractors or consultants, m a y fail or suffer s e c u rity b r ea c h e s.
−Removed: We will be dependent upon inform a tion technology systems, infrastruc t ure and data.
−Removed: In the ordinary course of our business, we will directly or indirectly col l ec t , s t ore and transm i t s e ns i tive d a ta, including intellectual property, confidential i nforma t ion, pre c l i nic a l and c l i nic a l tri a l dat a , proprie t a ry bus i ness information, personal data and personally identifiable health information of our cl i nic a l tri a l sub j ec t s and employees, in our data centers and on our networks, or on those of third parties.
−Removed: T h e secure processing, ma i nten a nce a nd tr a ns m iss i on of this inform a tion is c rit i c a l to our operations.
−Removed: The multitude a n d complexity of our computer systems and those of our CROs, CMOs, clinical sites or other con t ractors or consultan t s make them inherently vulnerable to service interruption or destruction, mal i cious intrusion and r a ndom attack.
−Removed: Data privacy or security b reaches by third parties, employees, contractors or others may pose a risk that sensiti v e data, including our intellectual property, trade secrets or personal information of our employees, patients, or other business partn e rs may be exposed to unaut h o r ized persons or to the public.
−Removed: Despite the implement a tion of security measures, our internal computer systems and those of our CROs, C M Os, c l ini c al sit e s and oth e r c ontractors and consultants are vulnerable to failure or damage from computer viruses and other mal w are, employee error, unauthorized a n d authori z ed a c c e ss or oth e r cybe r s ecurity attacks, natural disasters, terrorism, war, fire and telecommunication and electrical failures.
−Removed: Cyberattacks are increasing in their f r equency, sophistica t ion and intensity.
−Removed: The techniques used by cyber crimina l s change frequently, may not be recognized until launched and can originate from a wide variety of sources, including o u tside groups such as external service p r oviders, organized crime aff i liates, terrorist organizations or ho s tile foreign gove r nments or a gen c ie s .
−Removed: Cy b e rattacks could include the deployment of h a rmful m a lwar e , deni a l-of-serv i ce, soc i al engineering and other means to affect s ervice reliability and thre a ten da t a confid e nti a l i ty, in t e gri t y a nd av a i l a bi l ity.
−Removed: W hile we and our shared services partner, NantWorks, have invested, and continue to invest, in the protection of our data and information technolo g y infrastruc t ure, there can be no assurance that our efforts, or the e f forts of our partners, vendors, CROs, CMOs, clinical sites and other c o ntractors and co n sultants will prevent service inte r ruptions, or identify brea c hes in our or their systems, that could adversely a ffect our business and operations and/or result in the loss of cr i ti c al or s e nsi t ive infor m a t io n , which could result in financial, legal, business or reputational harm to us.
−Removed: In addit i on, our liability insurance may not be suf f icient in type or a m ount to cover us against claims rel a t e d to s e cur i ty b r ea c hes, cyb e r a ttacks and other related breaches.
−Removed: If a n y such event were to occur and cause interruptions in our operations, it could r e sult in a dis r u ption of our product develop m ent progra m s.
−Removed: F or e xa m p l e, the loss of clinical trial data from completed or ongoing clinical trials for a product candidate could r e sult in delays in our regulatory approval efforts and significantly increase our costs to r e cover or r e produce the data, or may limit our ability to effec t ively execute a product recall, if required.
−Removed: To the extent that a n y disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of personal, confid e nti a l or propri e t a ry i nforma t ion, we could in c ur l i abi l ity and the further development and commercialization of any p r od u ct candidates could b e dela y e d.
−Removed: Any such event could also result in legal claims or proceedings, liability under laws that p r otect t h e privacy of personal information and si g nificant regulatory penalties, and damage to our reputation and a loss of confidence in us and our ability to conduct clinical trials.
−Removed: O u r b u s i n e s s c o u l d be adversely affected by t h e eff e c t s of h e a l th ep i de m i c s, pandemics or contagious diseases, including the r e cent COVID ‑ 19 pandemic , in regio n s w h e r e w e o r t h i r d parties on which we r e ly ha v e signif i c ant man u fa c tu r i n g faci l it i es, co n c e n t ra t ions of c lini c al t r i al s i t e s or other business operations .
+Added: If we adopt alternative names, we would lose the benefit of any existing
+Added: trademark applications for such product candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe or otherwise violate the existing rights of third parties, and be acceptable to the FDA.
+Added: We may be unable to build a successful brand identity for a new product name in a timely manner or at all, which would limit our ability to commercialize our product candidates.
+Added: Our internal computer systems, or those used by our CROs, CMOs, clinical sites or other contractors or consultants, may fail or suffer security breaches.
+Added: We will be dependent upon information technology systems, infrastructure and data.
+Added: In the ordinary course of our business, we will directly or indirectly collect, store and transmit sensitive data, including intellectual property, confidential information, preclinical and clinical trial data, proprietary business information, personal data and personally identifiable health information of our clinical trial subjects and employees, in our data centers and on our networks, or on those of third parties.
+Added: The secure processing, maintenance and transmission of this information is critical to our operations.
+Added: The multitude and complexity of our computer systems and those of our CROs, CMOs, clinical sites or other contractors or consultants make them inherently vulnerable to service interruption or destruction, malicious intrusion and random attack.
+Added: Data privacy or security breaches by third parties, employees, contractors or others may pose a risk that sensitive data, including our intellectual property, trade secrets or personal information of our employees, patients, or other business partners may be exposed to unauthorized persons or to the public.
+Added: Despite the implementation of security measures, our internal computer systems and those of our CROs, CMOs, clinical sites and other contractors and consultants are vulnerable to failure or damage from computer viruses and other malware, employee error, unauthorized and authorized access or other cybersecurity attacks, natural disasters, terrorism, war, fire and telecommunication and electrical failures.
+Added: Cyberattacks are increasing in their frequency, sophistication and intensity.
+Added: The techniques used by cyber criminals change frequently, may not be recognized until launched and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations or hostile foreign governments or agencies.
+Added: Cyberattacks could include the deployment of harmful malware, denial-of-service, social engineering and other means to affect service reliability and threaten data confidentiality, integrity and availability.
+Added: While we and our shared services partner, NantWorks, have invested, and continue to invest, in the protection of our data and information technology infrastructure, there can be no assurance that our efforts, or the efforts of our partners, vendors, CROs, CMOs, clinical sites and other contractors and consultants will prevent service interruptions, or identify breaches in our or their systems, that could adversely affect our business and operations and/or result in the loss of critical or sensitive information, which could result in financial, legal, business or reputational harm to us.
+Added: In addition, our liability insurance may not be sufficient in type or amount to cover us against claims related to security breaches, cyberattacks and other related breaches.
+Added: If any such event were to occur and cause interruptions in our operations, it could result in a disruption of our product development programs.
+Added: For example, the loss of clinical trial data from completed or ongoing clinical trials for a product candidate could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data, or may limit our ability to effectively execute a product recall, if required.
+Added: To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development and commercialization of any product candidates could be delayed.
+Added: Any such event could also result in legal claims or proceedings, liability under laws that protect the privacy of personal information and significant regulatory penalties, and damage to our reputation and a loss of confidence in us and our ability to conduct clinical trials.
+Added: Our business could be adversely affected by the effects of health epidemics, pandemics or contagious diseases, including the recent COVID‑19 pandemic, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
Outbreaks of epidemic, pandemic or contagious diseases, such as the COVID ‑ 19 pandemic, may significantly disrupt our operations and adversely affect our business, financial condition and results of operations.
2 unchanged sentences
and international markets and has resulted in increased risks to our operations.
−Removed: The COVI D ‑ 19 pandemic and any actions we have taken in response, could materially affect our operations, including at our headquarters and at our manufacturing facilities, which have been and may in the future be subject to state executive orders and shelter-in-place orders, and at our clinical trial sites, as well as the business or operations of our CROs, CMOs, clinical sites or other third parties with whom we conduct business.
+Added: The COVID ‑ 19 pandemic and any actions we have taken in response, could
+Added: materially affect our operations, including at our headquarters and at our manufacturing facilities, which have been and may in the future be subject to state executive orders and shelter-in-place orders, and at our clinical trial sites, as well as the business or operations of our CROs, CMOs, clinical sites or other third parties with whom we conduct business.
Any such epidemic or pandemic may heighten the risk that a significant portion of our workforce could suffer illness or otherwise not be permitted or be unable to work, and may require that certain of our employees work remotely, which heightens certain risks, including those related to cybersecurity and internal controls.
−Removed: We are monitoring a number of risks related to this pandemic, includi n g the following:
+Added: We are monitoring a number of risks related to this pandemic, including the following:
+Added: • Financial :
We anticipate that the pandemic could have an adverse financial impact in the short-term and potentially beyond.
−Removed: We expect to continue spending on research and development during the ye a r-ended December 31, 2021 and beyond, and we could also have unexpected expenses related to the pandemic.
+Added: We expect to continue spending on research and development during the year ending December 31, 2021 and beyond, and we could also have unexpected expenses related to the pandemic.
The short-term continued expenses, as well as the overall uncertainty and disruption caused by the pandemic, will likely cause a delay in our ability to commercialize a product and adversely impact our financial results.
9 unchanged sentences
This pandemic may adversely affect certain of our clinical trials, including our ability to initiate and complete our clinical trials within the anticipated timelines.
−Removed: Due to site and participant availability during the pandemic, new subject enrollment is expected to slow, a t l e ast in the short-term, for most of our clinical trials.
+Added: Due to site and participant availability during the pandemic, new subject enrollment is expected to slow, at least in the short-term, for most of our clinical trials.
For ongoing trials, we have seen an increasing number of clinical trial sites imposing restrictions on patient visits to limit risks of possible COVID ‑ 19 exposure, and we may experience issues with participant compliance with clinical trial protocols as a result of quarantines, travel restrictions and interruptions to healthcare services.
1 unchanged sentence
As a result, our anticipated filing and marketing timelines may be adversely impacted.
−Removed: Overall Economic and Capital Markets Environmen t :
+Added: • Overall Economic and Capital Markets Environment :
The impact of the COVID ‑ 19 pandemic could result in a prolonged recession or depression in the United States or globally that could harm the banking system, limit demand for all products and services and cause other seen and unforeseen events and circumstances, all of which could negatively impact us.
5 unchanged sentences
These government actions can impact us, our members and our suppliers.
−Removed: There is also the possibility that we may experience delays with obtaining approvals for our IND applications, BLA s , and/or NDA s .
+Added: There is also the possibility that we may experience delays with obtaining approvals for our IND applications, BLAs, and/or NDAs.
We have formed, and may in the future form or seek, strategic alliances or enter into collaborations with third parties or additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
−Removed: If we fail to enter into such strategic alliances, collaborations or licensing arrangement, or such strategic alliances, collaborations or licensing arrangements are not successful, we may not be able to capitalize on the market potential of our product candidates.
+Added: If we fail to enter into such strategic alliances, collaborations or licensing arrangements, or such strategic alliances, collaborations or licensing arrangements are not successful, we may not be able to capitalize on the market potential of our product candidates.
We have formed, and may in the future form or seek, strategic alliances, create joint ventures or collaborations or enter into additional licensing arrangements with third and related parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may develop.
38 unchanged sentences
We will be heavily dependent on our senior management, particularly Dr.
−Removed: Soon-Shiong, our E xecutive C hairman, and a loss of a member of our senior manageme n t t e a m in t h e fu t u r e , e ven if only temporary, c ould harm o u r busines s .
+Added: Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer, and a loss of a member of our senior management team in the future, even if only temporary, could harm our business.
Our operations will be dependent upon the services of our executives and our employees who are engaged in research and development.
2 unchanged sentences
Our existing operations and our future development depend to a significant extent upon the performance and active participation of certain key individuals, particularly Dr.
−Removed: Soon-Shiong, our Executive Chairman.
+Added: Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer.
Soon-Shiong focuses heavily on our matters and is highly active in our management, he does devote a significant amount of his time to a number of different endeavors and companies, including NantHealth, Inc., NantMedia Holdings, LLC (which operates the Los Angeles Times and the San Diego Union-Tribune) and NantWorks, which is a collection of multiple companies in the healthcare and technology space.
8 unchanged sentences
We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees.
−Removed: We will need to grow the size and capabili t ies of our organization, and we may experie n ce difficulties in managing this growth.
+Added: We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of their attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.
3 unchanged sentences
Future growth will impose significant added responsibilities on members of management, including:
−Removed: i dentifying, recruiting, integrating, mai n t a in i ng, and m otiv a ting additional employees;
−Removed: m anaging our internal develop m ent efforts effectively, including the clinical and FDA rev i ew process for our product candidat e s , wh i l e complying with our contractual obligations to contractors and other third parties;
−Removed: i mproving our operational, financial and management controls, re p o r ting systems, and procedures.
−Removed: We currently rely, and for the foreseeable future we exp e ct to re l y, in substan t i a l part on certain independent organizations, advisors and c onsultants to provide certain services.
−Removed: There can be no a s surance that the services of these indep e ndent organizations, a dvisors and consult a nts will continue to b e ava i lab l e to us on a t i me l y b a s i s when n e e d ed, or that we can find q ualified replacemen t s on economically reasonable terms, or at all.
−Removed: In addition, if we are unable to ef f ectively manage our o u tsourced activities or if the quality, compliance or accuracy of the services provided by c o nsultants is compromised for any reason, our cl i nic a l tri a ls may be extended, delayed, or terminated, and we may not be able to obtain regulato r y approval of o ur product candidates or otherwise advance our b u siness.
−Removed: If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to su cc e s sfully implem e nt the t a sks necessary to further develop and commercialize our p r oduct candidates and, accordi n gl y , may not achieve our res e arch, d e ve l opmen t , and c om m erc i a l iz a tion goals on a timely b a s i s, or at a ll.
−Removed: If we engage in future acquis i tions or strate g i c partne r ships, this may increase our capital requirements, dilute our stockhol de r s , c a u s e u s t o i n c u r debt or assume contingent liabilities, and subject us to oth e r risk s .
−Removed: We may evaluate various acqui s itions and strategic par t nerships, including licensing or acqu i ring complementary products, inte l lectual property rights, technologies, or business e s.
−Removed: Any potential acquisition or strategic partnership may ent a il numerous risks, including:
−Removed: a ssimilati o n of operation s , intellectual property a n d products of an acquired compa n y or p r oduct, including d i fficulties associ a ted with integrating new personnel;
−Removed: t he diversion of our managem e nt’s attention from our existing product programs a nd initiatives in pursuing such a strategic m e rger or acquisition;
−Removed: retention of key employees, the loss of k e y personnel, and uncert a inties in our ability to mai n tain key business relationship s ;
−Removed: r i s ks a nd un c er t a in t ies asso c ia t ed w i th t h e other pa r ty to such a transaction, inc l uding the prospects of that party and their existing products or product candidates and regulatory approvals;
−Removed: our inability to generate revenues from acquired technology and/or products sufficient to meet our objectives in undertaking t he acquisition or even to offset the associated acquisition and maintenance costs.
−Removed: Depending on the size and nat u r e of future strategic acquisitions, we may acquire assets or busine s ses that require us to raise a ddit i onal c a pit a l or to o p erate or manage businesses in which we have limited experience.
−Removed: Mak i ng larger acquisitions that require us to raise additional capital to fund the acquisition will expo s e us to the risks associated with capital raising activities.
−Removed: Acquiring and t h ere a fter operating larger new busin e s s e s w i ll a l so increase our management, operat i ng and reporting costs and burdens (including increased cash requirements).
−Removed: In addition, if we undertake acquisitions, we may issue di l utive equity s e curiti e s, a ssume or incur additional debt o b ligations or contingent liabilities, incur large one- t ime expenses and acquire int a ngible assets that co u l d res u lt in significant future a m ort i za t ion expense.
−Removed: Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow o r ob t ain a c c e ss t o technology or products that m a y be important to the development of our business.
−Removed: We may b e come i n v olv e d i n securit i es l it i gation or stockholder derivative l it i gation i n conn e c t ion wi t h our recent merger, and this could divert the attention of our ma n agement and harm our bus i n e s s , and i n s u rance c ov e rage may not be s u ffi c ie n t to cov e r all r e l ated costs and damages.
−Removed: Securities litigation o r stockho l der derivative litigation frequently follows the annou n cement of certain significant business t rans a c tions, such as the s a l e of a business division or announcement of a bu s iness combination transaction.
−Removed: We are involved in this type of litigation in c o n nection with our recent merger, and we may become involved in this type of litigation in the future.
−Removed: Litigation often is expensive and dive rt s management’s attention and reso u r ces, which could adversely affect our business and the combined company.
−Removed: A v ariety of r i s ks associat e d with ma r keti n g our product candidates internationally could materially adversely affect our busi n e ss.
−Removed: We plan to seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we will be subj e c t to additional risks related to operating in foreign countries if we ob t ain the necessary approvals, including:
−Removed: differing regulato r y requirem e nts in foreign countries;
−Removed: unexpected changes in tariffs, trade b a rriers, price and exchange controls and o t her regulatory requirements;
−Removed: e conomic weakness, including inflation, or political instability in particular fore i gn economies and markets;
−Removed: c ompliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
−Removed: foreign taxes, including wi t hholding of payroll taxes;
−Removed: foreign currency fluctuations, which could re s ult in in c re a s e d op e r a t i ng expenses and reduced revenues, and oth e r obligations incident to doing business in an o t her count r y;
−Removed: difficulties sta f fing and managing foreign operations;
+Added: • identifying, recruiting, integrating, maintaining, and motivating additional employees;
+Added: • managing our internal development efforts effectively, including the clinical and FDA review process for our product candidates, while complying with our contractual obligations to contractors and other third parties;
+Added: • improving our operational, financial and management controls, reporting systems, and procedures.
+Added: We currently rely, and for the foreseeable future we expect to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services.
+Added: There can be no assurance that the services of these independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements on economically reasonable terms, or at all.
+Added: In addition, if we are unable to effectively manage our outsourced activities or if the quality, compliance or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed, or terminated, and we may not be able to obtain regulatory approval of our product candidates or otherwise advance our business.
+Added: If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development, and commercialization goals on a timely basis, or at all.
+Added: If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
+Added: We may evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights, technologies, or businesses.
+Added: Any potential acquisition or strategic partnership may entail numerous risks, including:
+Added: • assimilation of operations, intellectual property and products of an acquired company or product, including difficulties associated with integrating new personnel;
+Added: • the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;
+Added: • retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;
+Added: • risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals;
+Added: • our inability to generate revenues from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
+Added: Depending on the size and nature of future strategic acquisitions, we may acquire assets or businesses that require us to raise additional capital or to operate or manage businesses in which we have limited experience.
+Added: Making larger acquisitions that require us to raise additional capital to fund the acquisition will expose us to the risks associated with capital raising activities.
+Added: Acquiring and thereafter operating larger new businesses will also increase our management, operating and reporting costs and burdens (including increased cash requirements).
+Added: In addition, if we undertake acquisitions, we may issue dilutive equity securities, assume or incur additional debt obligations or contingent liabilities, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense.
+Added: Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.
+Added: We may become involved in securities litigation or stockholder derivative litigation in connection with our recent merger, and this could divert the attention of our management and harm our business, and insurance coverage may not be sufficient to cover all related costs and damages.
+Added: Securities litigation or stockholder derivative litigation frequently follows the announcement of certain significant business transactions, such as the sale of a business division or announcement of a business combination transaction.
+Added: We are involved in this type of litigation in connection with our recent merger, and we may become involved in this type of litigation in the future.
+Added: Litigation often is expensive and diverts management’s attention and resources, which could adversely affect our business and the combined company.
+Added: A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
+Added: We plan to seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:
+Added: • differing regulatory requirements in foreign countries;
+Added: • unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
+Added: • economic weakness, including inflation, or political instability in particular foreign economies and markets;
+Added: • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
+Added: • foreign taxes, including withholding of payroll taxes;
+Added: • foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;
+Added: • difficulties staffing and managing foreign operations;
• workforce uncertainty in countries where labor unrest is more common than in the United States;
−Removed: differing payor reimbursement regimes, governm e ntal payors or patient self-pay systems, and price controls;
−Removed: potential liability under the Foreign C o rrupt Practices Act of 1977 (“ FCP A”) or comparable foreign regulations;
−Removed: c hallenges enforcing our contrac t ual and intellectual property rights, especially in those for e ign countries that do not resp e ct and protect i nte l le c tu a l p r op e rty rights to t he s a me ex t e nt as the Un i t e d S ta t es;
−Removed: production s h o r tages resulting from any events affecting raw mat e rial supply or manufact u ring capabilities abroad;
−Removed: t he impact of public health epidemics on the global economy, such as the coronavirus pandemic currently hav i ng an impact throughout the world;
−Removed: business interruptions resulting from geo-po l itical actions, including war and terrorism.
−Removed: These and oth e r risks a s soc i at e d wi t h i nter n ational operations may material l y adv e rsely aff e ct our a bi l ity to a t t a in or m a in t a i n profitable operations.
−Removed: R i s k s R e lat e d to Government Regulation
+Added: • differing payor reimbursement regimes, governmental payors or patient self-pay systems, and price controls;
+Added: • potential liability under the Foreign Corrupt Practices Act of1977 (“FCPA”) or comparable foreign regulations;
+Added: • challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
+Added: • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
+Added: • the impact of public health epidemics on the global economy, such as the coronavirus pandemic currently having an impact throughout the world;
+Added: • business interruptions resulting from geo-political actions, including war and terrorism.
+Added: These and other risks associated with international operations may materially adversely affect our ability to attain or maintain profitable operations.
+Added: Risks Related to Government Regulation
We may be unable to obtain U.S.
22 unchanged sentences
and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we may receive and subject us to other penalties that could materially harm our business.
−Removed: Any regulatory approvals that we receive for our product candidates will requi r e surveillance to monitor the safety and efficacy of the product ca n didate.
−Removed: The FDA may also require a REMS to app r ove our product candidates, which could entail requirements for a medication guide, phy s i c ian communication plans or addit i onal elements to ensure safe use, such as restricted distribution methods, patient regist r ies and other risk minimization tools.
−Removed: The FDA may also requi r e post-approv a l P hase IV trials.
−Removed: Moreover, the F DA and comp a rable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval.
−Removed: In addition, we, o ur contractors, and o u r collab o r ators are and will remain responsible for FDA compliance, including requirem e nts related to product design, t e s t ing, clinical trials and preclinical studies approval, manufacturing processes and quality, lab e ling, packaging, d i stribution, adverse event and deviation reporting, storage, advertising, marketing, promotion, sale, imp o r t, export, sub m issions of safety and other post-ma r keting information and reports such as deviation reports, registration, product listing, annual user fees, and reco r dkeeping for our product candidat e s.
−Removed: We and any of o u r collaborators, including our con t ract manufacturers, could be s ubject to periodic unannounced ins p ections by the FDA to monitor and ensure compliance with regulatory requ i rements.
−Removed: Application holders must further notify the FDA, and depending on the nature of the c h ange, obtain FDA pre-approval for product and manufacturing changes.
−Removed: The cost of compl i ance with post-approval regulat i ons may have a negative effe c t on our operating results and financial condition.
+Added: Any regulatory approvals that we receive for our product candidates will require surveillance to monitor the safety and efficacy of the product candidate.
+Added: The FDA may also require a REMS to approve our product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
+Added: The FDA may also require post-approval Phase IV trials.
+Added: Moreover, the FDA and comparable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval.
+Added: In addition, we, our contractors, and our collaborators are and will remain responsible for FDA compliance, including requirements related to product design, testing, clinical trials and preclinical studies approval, manufacturing processes and quality, labeling, packaging, distribution, adverse event and deviation reporting, storage, advertising, marketing, promotion, sale, import, export, submissions of safety and other post-marketing information and reports such as deviation reports, registration, product listing, annual user fees, and recordkeeping for our product candidates.
+Added: We and any of our collaborators, including our contract manufacturers, could be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with regulatory requirements.
+Added: Application holders must further notify the FDA, and depending on the nature of the change, obtain FDA pre-approval for product and manufacturing changes.
+Added: The cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition.
If the FDA or comparable foreign regulatory authorities become aware of new safety information or previously unknown problems after approval of any of our product candidates, including:
9 unchanged sentences
The results of our compassionate use program may not be used to establish safety or efficacy or regulatory approval.
−Removed: Our GMP-in-a-Box will be regulated by the FDA as a medical device, and regulatory com p liance for medical devices is expensive, complex and uncertain, and a failure to com p ly could lead to enforcement actions against us and o t her negative consequen c es for our busine s s.
−Removed: The FDA a nd si m il a r a genc i es r e gula t e med i c a l devices.
+Added: Our GMP-in-a-Box will be regulated by the FDA as a medical device, and regulatory compliance for medical devices is expensive, complex and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
+Added: The FDA and similar agencies regulate medical devices.
All of our potential medical device products and material modifications will be subject to extensive regulation and clearance or approval from the FDA and non-U.S.
regulatory agencies prior to commercial sale and distribution as well as after clearance or approval.
−Removed: Complying with t h ese regulations is costly, time-consuming, complex and u ncertain.
−Removed: For instance, be f ore a new medical device, or a new intended use for an existing dev i ce , c a n be m a rketed in the Unit e d State s , a c o mpany must f irst submit and receive either 510(k) clearance or pre-marketing approval from the F D A, unless an exe m ption applies.
+Added: Complying with these regulations is costly, time-consuming, complex and uncertain.
+Added: For instance, before a new medical device, or a new intended use for an existing device, can be marketed in the United States, a company must first submit and receive either 510(k) clearance or pre-marketing approval from the FDA, unless an exemption applies.
FDA regulations and regulations of similar agencies are wide-ranging and include, among other things, oversight of:
−Removed: product design, development, manufacture (including su p plie r s) and testing;
−Removed: l aboratory and preclinical s t udi e s and cl i nic a l tri a ls;
+Added: • product design, development, manufacture (including suppliers) and testing;
+Added: • laboratory and preclinical studies and clinical trials;
• product safety and effectiveness;
1 unchanged sentence
• product storage and shipping;
−Removed: record kee p ing;
+Added: • record keeping;
• pre-market clearance or approval;
−Removed: m arketing, adverti s ing and promotion;
+Added: • marketing, advertising and promotion;
• product sales and distribution;
1 unchanged sentence
• product recalls;
−Removed: post-market surveillance and r e porting of deaths o r serious injuries and certain malfunctions.
−Removed: Medical devices regulated by the FDA are subj e c t to gen e ral con t rols whi c h in c lud e:
−Removed: r e gistr a tion w i th the FDA;
−Removed: list i ng c omm e rc i ally distributed prod u cts with the FDA;
+Added: • post-market surveillance and reporting of deaths or serious injuries and certain malfunctions.
+Added: Medical devices regulated by the FDA are subject to general controls which include:
+Added: registration with the FDA;
+Added: listing commercially distributed products with the FDA;
complying with cGMP under Quality Systems Regulations;
−Removed: filing reports with t h e FDA of and keeping recor d s r e l a tive t o certain types of adverse events associated with devices under the medical device repo r ting regulation;
−Removed: assuring that device la b eling complies with device labeling requirements;
−Removed: reporting c e rtain device field removals and corrections to the FDA;
+Added: filing reports with the FDA of and keeping records relative to certain types of adverse events associated with devices under the medical device reporting regulation;
+Added: assuring that device labeling complies with device labeling requirements;
+Added: reporting certain device field removals and corrections to the FDA;
and obtaining pre-market notification 510(k) clearance for devices prior to marketing.
−Removed: Some devices known as 510(k)-exempt d e vices can be m a rketed without prior marketing-clearance or a p proval from the FDA.
−Removed: In addition to the general controls, some Class II medical devices a re also sub j ect t o spe c ial controls, including adherence to a particular guidance d o cument and compliance with the performa n ce standard.
−Removed: Instead of obtaining 510(k) cle a rance, most Class I II devices are subje c t to pre-m a rket approval (“ PMA”).
+Added: Some devices known as 510(k)-exempt devices can be marketed without prior marketing-clearance or approval from the FDA.
+Added: In addition to the general controls, some Class II medical devices are also subject to special controls, including adherence to a particular guidance document and compliance with the performance standard.
+Added: Instead of obtaining 510(k) clearance, most Class III devices are subject to pre-market approval (“PMA”).
The FDA can also refuse to clear or approve pre-market applications for any medical device we develop.
2 unchanged sentences
Any enforcement action by the FDA and other comparable non-U.S.
−Removed: regulatory agencies c ould have a material adver s e effect on our business, f i nancial condit i on and results of operations.
−Removed: Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may i n clude any of the following a c tions:
−Removed: un t it l ed le t ters, warn i ng l e tt e rs, fines, in j unctions, consent dec r ees and civil penalties;
−Removed: un a nti c ip a ted exp e nditur e s to address or defend such actions;
−Removed: c ustomer notificatio n s for repair, replacement or refunds;
+Added: regulatory agencies could have a material adverse effect on our business, financial condition and results of operations.
+Added: Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following actions:
+Added: • untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
+Added: • unanticipated expenditures to address or defend such actions;
+Added: • customer notifications for repair, replacement or refunds;
• recall, detention or seizure of our products;
−Removed: operating restrictions or partial suspension or total sh u t down of p r o duction;
+Added: • operating restrictions or partial suspension or total shutdown of production;
• refusing or delaying our requests for 510(k) clearance or PMA approval of new products or modified products;
−Removed: operating r e s t ri c tions;
−Removed: withdrawing 510(k) clearances or PMA approvals that h a ve already been granted;
+Added: • operating restrictions;
+Added: • withdrawing 510(k) clearances or PMA approvals that have already been granted;
• refusal to grant export approval for our products;
−Removed: c riminal prosecution.
−Removed: If a n y of these events were to occur, it would have a material and adverse effect on our business, financial condition and res u lts of operatio n s.
+Added: • criminal prosecution.
+Added: If any of these events were to occur, it would have a material and adverse effect on our business, financial condition and results of operations.
The FDA also regulates the advertising and promotion of medical devices to ensure that the claims are consistent with their regulatory clearances or approvals, that there are adequate and reasonable data to substantiate the claims and that the promotional labeling and advertising is neither false nor misleading in any respect.
3 unchanged sentences
If any of our medical device products cause or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
−Removed: We will be subject to governmental export and import controls that could impair our ability to compete in international markets du e to l i c e n s i n g requirements and subject u s to liability if we are n ot in c omplian c e with applicable laws.
+Added: We will be subject to governmental export and import controls that could impair our ability to compete in international markets due to licensing requirements and subject us to liability if we are not in compliance with applicable laws.
Our product candidates will be subject to export control and import laws and regulations, including the U.S.
Export Administration Regulations, U.S.
−Removed: Cust o m s regulations and v a rious economic and trade s a nctions regulations administered by the U.S.
−Removed: Treasury Department’s Office of Foreign Assets Co n t rols.
+Added: Customs regulations and various economic and trade sanctions regulations administered by the U.S.
+Added: Treasury Department’s Office of Foreign Assets Controls.
Exports of our product candidates and solutions outside of the United States must be made in compliance with these laws and regulations.
−Removed: If we f a il to comp l y with th e s e l a ws and regu l ations, we and certain of our employees could b e subject to substantial civil or criminal penalties, including the possible loss of export or import privi l eges;
−Removed: fines, which may be i m posed on us and responsible employees or managers;
−Removed: and, i n e x tre m e c a s e s , t he incarceration of responsible employees or managers.
−Removed: In addition, changes in our product candidat e s or solutions or changes in applicable export or import laws and regulations may cr e a t e d e l a ys in the introduction, provision, or sale of our product candidates and solutions in international markets, prevent customers from using o u r product candidates and solutions or, in some cases, preve n t the export or import of our product candidates and solutions to certain countries, governments or persons altogether.
−Removed: Any limitations on our ability to export, provide, or sell our produ c t candidates and solutions could adversely affect our business, financial condition and results of operations.
+Added: If we fail to comply with these laws and regulations, we and certain of our employees could be subject to substantial civil or criminal penalties, including the possible loss of export or import privileges;
+Added: fines, which may be imposed on us and responsible employees or managers;
+Added: and, in extreme cases, the incarceration of responsible employees or managers.
+Added: In addition, changes in our product candidates or solutions or changes in applicable export or import laws and regulations may create delays in the introduction, provision, or sale of our product candidates and solutions in international markets, prevent customers from using our product candidates and solutions or, in some cases, prevent the export or import of our product candidates and solutions to certain countries, governments or persons altogether.
+Added: Any limitations on our ability to export, provide, or sell our product candidates and solutions could adversely affect our business, financial condition and results of operations.
We are subject to U.S.
−Removed: and for e ign anti-corruption and anti-money l aundering l aws with r e sp e c t to our o p erations and non-compl i an c e with such laws can subj e c t us to c riminal an d / or civil liabi l ity and harm our business.
−Removed: We are subject to the FCPA, the U .
−Removed: domestic bribery sta t ute contained in 18 U.S.C.
+Added: and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
+Added: We are subject to the FCPA, the U.S.
+Added: domestic bribery statute contained in 18 U.S.C.
§201, the U.S.
−Removed: T r avel Act, the USA PATRIOT Act and possibly other state and nation a l anti-bribery and anti-money laund e ring laws in countries in which we conduct a c tivities.
−Removed: Anti-corruption laws are interpreted broadly and prohibit companies and their e m ployees, agents, third-party in t e rm e di a ries, jo i nt ventu r e partners and collaborato r s from authorizing, promising, offering or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector.
−Removed: We use CROs abroad for clinical t r ials.
−Removed: I n addition, we m a y engage third-party intermediaries to sell our product candidates and solu t ions abroad once we enter a commercialization phase for our product cand i dates and/or to obtain nec e ssary permits, licenses, and other regulatory approvals.
−Removed: We or our third-party intermediaries may have direct or in d i rect interactions with o fficials and employees of government agencies or state-owned or a ffi l i a ted en t it i es.
−Removed: We c a n be h e ld li a ble for the corrupt or other i l leg a l ac t ivi t ies of these third-party intermediarie s , o ur employees, representatives, contractors, partners and agents, even if we do not explicitly authori z e or have actual knowledge of such activities.
+Added: Travel Act, the USA PATRIOT Act and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities.
+Added: Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, third-party intermediaries, joint venture partners and collaborators from authorizing, promising, offering or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector.
+Added: We use CROs abroad for clinical trials.
+Added: In addition, we may engage third-party intermediaries to sell our product candidates and solutions abroad once we enter a commercialization phase for our product candidates and/or to obtain necessary permits, licenses, and other regulatory approvals.
+Added: We or our third-party intermediaries may have direct or indirect interactions with officials and employees of government agencies or state-owned or affiliated entities.
+Added: We can be held liable for the corrupt or other illegal activities of these third-party intermediaries, our employees, representatives, contractors, partners and agents, even if we do not explicitly authorize or have actual knowledge of such activities.
We have adopted an anti-corruption policy, which mandates compliance with the FCPA and other anti-corruption laws applicable to our business throughout the world.
−Removed: However, the r e can be no assurance that our employees and third-par t y in t e rm e di a ries w i ll co m ply wi t h t his po l icy or such anti-corruption laws.
−Removed: Non-compl i ance wi t h a nti-corruption and anti-money laundering laws could subject us to whistleblower compl a ints, investigations, sanctions, settlements, prosecution, other investigations, or other en f orcement actions.
−Removed: If such actions are launched, or governm e ntal or o t her sanctions a r e imposed, or if we do not prevail in any p o ssible civil or criminal liti g ation, our business, results of operations and financial condition could be mat e rially harmed.
−Removed: In addition, res p onding to any ac t ion w i ll lik e ly result in a ma t e r i al l y sign i ficant diversion of manag e me n t ’s attention and resources and significant defense and compliance costs and other professional fees.
−Removed: In certa i n cases, enforcement a u tho r ities may even cause us to appoint an inde p e ndent compliance monitor, whi c h c a n result in added costs and administrative burdens.
+Added: However, there can be no assurance that our employees and third-party intermediaries will comply with this policy or such anti-corruption laws.
+Added: Non-compliance with anti-corruption and anti-money laundering laws could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other investigations, or other enforcement actions.
+Added: If such actions are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, results of operations and financial condition could be materially harmed.
+Added: In addition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense and compliance costs and other professional fees.
+Added: In certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor, which can result in added costs and administrative burdens.
Our failure to comply with state, national and/or international data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
29 unchanged sentences
If we, or any third-party contract manufacturers or suppliers that we engage, fail to comply with environmental, health, and safety laws and regulations, including regulations governing the handling, storage or disposal of hazardous materials, we could become subject to fines or penalties or incur costs that could harm our business.
−Removed: We and any of our third-party manufacturers or suppliers will be subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, manufacture, storage, treatment and disposal of hazardous materials and wastes.
+Added: We and any of our third-party contract manufacturers or suppliers will be subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, manufacture, storage, treatment and disposal of hazardous materials and wastes.
Our operations and research and development activities involve the controlled use of medical and hazardous materials, including chemicals, biological materials and infectious agents.
20 unchanged sentences
Further, future government shutdowns, delays, or prioritization policies could potentially impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
−Removed: If we fail to comp l y with f e deral and s t ate healthcare and promotional laws, including fraud and ab u se and information privacy and security laws, we could face substantial penalties and o u r busines s , fi n an c ial c onditio n , r e sults of operations, and prospects could be adversely affe c ted.
−Removed: As a biopharmaceutical company, we are sub j ect to many federal and sta t e healthcare laws, including the federal Anti - Kickback S t a tut e (“ AKS”), t he FCA, the civil monetary pen a lt i es st a tut e , the Medicaid Drug Rebate s t atute and other price reporting requirements, the federal Physician Payment Sunshine Act, the Veter a ns Health Care Act of 1992, HIP A A (as amended b y the Health Inf o rmation Technology for Economics and C l ini c al He a lth Act), the FCPA, the Patient Pro t ection and Affordable Care Act of 2010 (as amended by the Health Care and Education Reconcilia t ion Act) ( the “ACA”) and similar state laws.
−Removed: Even though we do not make referrals of healthcare services or bill directly to M e dicare, Medicaid, or other third-party payors, certain fe d e ral and sta t e healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and w i ll be applicable to our b u siness.
−Removed: If we do not comply with all app l icable fraud and abuse laws, we may be sub j ect to healthcare fraud and abuse enforc e ment by both the federal government and the states in which we conduct our business.
−Removed: Laws and re g ulations re q uire c a lculation and reporting of compl e x pricing information for presc r iption drugs, and compliance will require us to invest in sig n ificant resources to develop a price reporting infrastructure or depend on third parties to compute and report our drug p ricing.
−Removed: Pricing reported to the Centers for Medicare and Med i caid Services (“ CMS”) must be certified.
−Removed: Non - compliant activiti e s expose us to FCA risk if t he y re s u l t in o v ercharging agencies, underpaying rebates to age n cies, or causing agencies to overpay providers.
−Removed: If we or our operations are found to be in violation of any fed e ral o r state healthcare law, or any other gove r n mental regulations that apply to us, we may be subject to penalties, including civ i l, c r im i nal, a nd a dministrative pen a lties, d a mag e s, fin e s, d i sgorgement, debarment from government contracts, refusal of orders under existing contracts, exclusion from participation in U.S.
−Removed: federal or state hea l th care programs, corpor a te i ntegr i ty agre e m e nts a nd the curtailment or restructuring of our op e rations, any of which could materially adv e rsely affect our ability to operate our business and our financial results.
−Removed: If any of the physicians or other healthcare p r o v iders or entities with whom we expect to do bu s iness, including our collaborators, is found not to be in compliance with applicable laws, they may be subject to criminal, civil, or administrative sanctions, including but not limited to, exclusions from participation in government healt h care programs, which could also materially affect our business.
+Added: If we fail to comply with federal and state healthcare and promotional laws, including fraud and abuse and information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, and prospects could be adversely affected.
+Added: As a biopharmaceutical company, we are subject to many federal and state healthcare laws, including the federal Anti-Kickback Statute (“AKS”), the FCA, the civil monetary penalties statute, the Medicaid Drug Rebate statute and other price reporting requirements, the federal Physician Payment Sunshine Act, the Veterans Health Care Act of 1992, HIPAA (as amended by the Health Information Technology for Economics and Clinical Health Act), the FCPA, the Patient Protection and Affordable Care Act of 2010 (as amended by the Health Care and Education Reconciliation Act) (the “ACA”) and similar state laws.
+Added: Even though we do not make referrals of healthcare services or bill directly to Medicare, Medicaid, or other third-party payors, certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business.
+Added: If we do not comply with all applicable fraud and abuse laws, we may be subject to healthcare fraud and abuse enforcement by both the federal government and the states in which we conduct our business.
+Added: Laws and regulations require calculation and reporting of complex pricing information for prescription drugs, and compliance will require us to invest in significant resources to develop a price reporting infrastructure or depend on third parties to compute and report our drug pricing.
+Added: Pricing reported to the Centers for Medicare and Medicaid Services (“CMS”) must be certified.
+Added: Non-compliant activities expose us to FCA risk if they result in overcharging agencies, underpaying rebates to agencies, or causing agencies to overpay providers.
+Added: If we or our operations are found to be in violation of any federal or state healthcare law, or any other governmental regulations that apply to us, we may be subject to penalties, including civil, criminal, and administrative penalties, damages, fines, disgorgement, debarment from government contracts, refusal of orders under existing contracts, exclusion from participation in U.S.
+Added: federal or state health care programs, corporate integrity agreements and the curtailment or restructuring of our operations, any of which could materially adversely affect our ability to operate our business and our financial results.
+Added: If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our collaborators, is found not to be in compliance with applicable laws, they may be subject to criminal, civil, or administrative sanctions, including but not limited to, exclusions from participation in government healthcare programs, which could also materially affect our business.
In particular, if we are found to have impermissibly promoted any of our product candidates, we may become subject to significant liability and government fines.
We, and any of our collaborators, must comply with requirements concerning advertising and promotion for any of our product candidates for which we or they obtain marketing approval.
−Removed: Pro m otional communications with respe c t t o t her a peut i cs are subject to a variety of legal and regulatory restrictions and continuing review by the FDA, Department of Justice, Department of Health and Human Services’ Office of Inspector General, state attorneys general, members of Congress, and the public.
−Removed: When the FDA or comparable foreign regulatory authorities issue regulatory approval for a product candidate, the regulato r y approval is limited to t hose specific uses and i n dications for which a product is approved.
−Removed: If we are not able to obtain FDA approval for desired uses or indications for our produ c t candidates, we may not m arket or promote our prod u ct candidates for those indic a tions and uses, refe r red to as off-label uses, and our busin e ss may be adversely affected.
−Removed: While physicians may c h oose to prescribe produ c ts for uses that are not described in the product’s labeling and for uses that d iffer from those tested in clinical trials and approved by the regula t ory authorities, we are prohibited from m a rketing and promoting the products for indications and uses that are n o t specifically approved by the FDA.
−Removed: These off-label uses are common across medical specialties and may c onstitute an appropriate tr ea t m e nt for s o me pat i ents in v a ri e d c i rcu m s t anc e s.
−Removed: Regulatory authorities in the United States generally do not restrict or regulate the behavi o r of physicians in their choice of treatment within the practice of medicine.
−Removed: Regulatory au t horities do, however, restrict communications by biopharmace u t i c a l co mp a n i e s concerning off-label use.
+Added: Promotional communications with respect to therapeutics are subject to a variety of legal and regulatory restrictions and continuing review by the FDA, Department of Justice, Department of Health and Human Services’ Office of Inspector General, state attorneys general, members of Congress, and the public.
+Added: When the FDA or comparable foreign regulatory authorities issue regulatory approval for a product candidate, the regulatory approval is limited to those specific uses and indications for which a product is approved.
+Added: If we are not able to obtain FDA approval for desired uses or indications for our product candidates, we may not market or promote our product candidates for those indications and uses, referred to as off-label uses, and our business may be adversely affected.
+Added: While physicians may choose to prescribe products for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, we are prohibited from marketing and promoting the products for indications and uses that are not specifically approved by the FDA.
+Added: These off-label uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances.
+Added: Regulatory authorities in the United States generally do not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine.
+Added: Regulatory authorities do, however, restrict communications by biopharmaceutical companies concerning off-label use.
We further must be able to sufficiently substantiate any claims that we make for our product candidates including claims comparing our product candidates to other companies’ products and must abide by the FDA’s strict requirements regarding the content of promotion and advertising.
−Removed: The FDA and ot h e r agencies actively enforce the laws and regulations r e garding product promotion, p a rticularly those prohibiting the promotion of off-label uses, and a company t h at is found to ha v e imprope r ly promoted a produ c t may be subject to s i gnificant sanctions.
−Removed: The fe d e ral government has lev i ed large c ivil a nd cr i min a l fines aga i nst c ompan i e s for a l leged improper promotion and has en j oined s e ver a l comp a nies from engaging in off-label promotio n .
+Added: The FDA and other agencies actively enforce the laws and regulations regarding product promotion, particularly those prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted a product may be subject to significant sanctions.
+Added: The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion.
The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.
−Removed: Thus, we and any of our collaborators will not be able to promote any products we develop for indicat i ons or uses for which they are not approved.
−Removed: In the United States, engaging in the imp e rmissible promotion of our products, follow i ng approval, for off-label uses can also subje c t us to false c l ai m s and other litigation under f e deral and state statutes, inc l uding fraud and abuse and consumer protection laws, which can lead to civil and criminal penalties and fines, agreements with governmental authori t ies that materially restrict the manner in whi c h we promote or distr i bute therapeutic products and do business through, for example, corporate integrity agreements, sus p ension or exclusion f rom participation in fede r a l and s t ate h e a l thc a re programs, and debarment from gove r n ment c o ntracts and refusal of future orders under existing contracts.
−Removed: These false claims st a tut e s in c lude the F CA, which allows any individual to bring a l a wsuit against a biopharmaceut i cal company on behalf of t h e fe d e ral government alleging submission of false or fraudulent claims or causing others to pre s ent such false or fraudulent claims, for p a yment by a federal program such as Medic a re or Medicaid.
−Removed: If the g o vernment decides to intervene a nd pr e va i ls in the l a wsu i t, t h e individual will share in the proceeds from any fines or settl e me n t funds.
−Removed: If the g o vernment declines to inte r v ene, the individ u al may pursue the case alone.
−Removed: The s e FCA lawsuits a ga i nst m a nufacture r s of drugs a nd biologics have increased significantly in volume and breadt h , l e ading to s e ver a l substan t i a l c ivil a nd criminal settlements, up to $3.0 billi o n, pertaining to c e rta i n s a l e s practices and promoting off - label u ses.
−Removed: In addition, FCA lawsuits may e x pose manufacturers to fol l ow-on claims by private payo r s based on fraudulent marketing practices.
−Removed: This growth in litigation has increased the risk that a biopharmaceutical company will have to defend a f a lse claim action, pay s e tt l em e nt fines or r e s t itu t ion, as w e ll as c rim i nal and c i vil pen a lt i es, agr e e t o c omply with burdensome reporting and compliance obligations, and be exc l uded from M e d i c a re, M e d i ca i d, or ot h e r federal and state hea l thcare programs.
−Removed: If we or our future c oll a bora t ors do not law f ully promote our approved products, if any, we may become s ubject to such litigation and, if we do not successfully defend against such actions, those actions may have a material adve r s e effect on our bu s iness, financial condition, resul t s of o perations and prospects.
−Removed: Although an effective compliance program can mitigate the risk of investigation and pro s ecution for violations of these laws, t he risks cannot be entirely eliminated.
−Removed: Moreo v er, achieving and sustaining c ompl i an c e w i th a ppli c ab l e feder a l a nd state fraud laws may prove costly.
−Removed: Any action against u s for violation of these laws, even if we succ e ssfully defend against it, could cause us to incur significant legal expenses and div e rt our ma n a gement’s attention from the oper a tion of our business.
−Removed: Coverage and reimbursement may be limited or unavai l able in certain market segments for o u r product candidates, which could ma k e it difficult for us to sell our product candidates pro f itably.
+Added: Thus, we and any of our collaborators will not be able to promote any products we develop for indications or uses for which they are not approved.
+Added: In the United States, engaging in the impermissible promotion of our products, following approval, for off-label uses can also subject us to false claims and other litigation under federal and state statutes, including fraud and abuse and consumer protection laws, which can lead to civil and criminal penalties and fines, agreements with governmental authorities that materially restrict the manner in which we promote or distribute therapeutic products and do business through, for example, corporate integrity agreements, suspension or exclusion from participation in federal and state healthcare programs, and debarment from government contracts and refusal of future orders under existing contracts.
+Added: These false claims statutes include the FCA, which allows any individual to bring a lawsuit against a biopharmaceutical company on behalf of the federal government alleging submission of false or fraudulent claims or causing others to present such false or fraudulent claims, for payment by a federal program such as Medicare or Medicaid.
+Added: If the government decides to intervene and prevails in the lawsuit, the individual will share in the proceeds from any fines or settlement funds.
+Added: If the government declines to intervene, the individual may pursue the case alone.
+Added: These FCA lawsuits against manufacturers of drugs and biologics have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements, up to $3.0 billion, pertaining to certain sales practices and promoting off-label uses.
+Added: In addition, FCA lawsuits may expose manufacturers to follow-on claims by private payors based on fraudulent marketing practices.
+Added: This growth in litigation has increased the risk that a biopharmaceutical company will have to defend a false claim action, pay settlement fines or restitution, as well as criminal and civil penalties, agree to comply with burdensome reporting and compliance obligations, and be excluded from Medicare, Medicaid, or other federal and state healthcare programs.
+Added: If we or our future collaborators do not lawfully promote our approved products, if any, we may become subject to such litigation and, if we do not successfully defend against such actions, those actions may have a material adverse effect on our business, financial condition, results of operations and prospects.
+Added: Although an effective compliance program can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated.
+Added: Moreover, achieving and sustaining compliance with applicable federal and state fraud laws may prove costly.
+Added: Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.
+Added: Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates profitably.
In both domestic and foreign markets, sales of our product candidates, if approved, depend on the availability of coverage and adequate reimbursement from third-party payors.
67 unchanged sentences
The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenues, attain profitability or commercialize our product candidates.
−Removed: Legislative and regulatory proposals may also be made to expand post-approval requirements and restrict s a les and promotional a ctivities for drugs.
−Removed: We cannot be sure whether add i tional legislati v e changes will be enacted, or whether t h e FDA regulations, guid a nce, or interpretations will be changed, or what the impact of such c h anges on the m a rketing approvals of our produ c t candidates, if any, may b e .
−Removed: In addition, increased s c rutiny by Congress of the FDA’s approval process may si g nificantly delay or prevent marketing approval, as w e ll as subject us to more stringent prod u ct labeling and post-marketing testing and other requirements.
−Removed: In addition, there ha v e been increasing legislative efforts and enforcement interest in the United States with respect to drug pricing practices, including Congressional inquiries and proposed federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
+Added: Legislative and regulatory proposals may also be made to expand post-approval requirements and restrict sales and promotional activities for drugs.
+Added: We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance, or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be.
+Added: In addition, increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.
+Added: In addition, there have been increasing legislative efforts and enforcement interest in the United States with respect to drug pricing practices, including Congressional inquiries and proposed federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
At the federal level, in 2020, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives, some of which resulted in lawsuits against the U.S Department of Health and Human Services challenging various aspects of the rules.
1 unchanged sentence
The impact of these lawsuits as well as legislative, executive, and administrative actions of the Biden administration on us and the pharmaceutical industry as a whole remains unclear.
−Removed: At the sta t e level, legislatures have increasingly passed legislation and implemented regulations designed to control p h armaceutical and biological product pricing, including price or patient reimbursem e nt constraints, dis c ounts, restrictions on certain product access and marketing cost discl o sure and transparency measures, an d , in some cases, designed to encou r age importation from other countries and bulk purc h asing .
−Removed: We are unable to predict the future course of federal or state healthcare l e g i s l at i on in the Uni t ed States directed at broaden i ng the availability of healthcare and containing or lowering the cost of h e a l thc a re.
−Removed: T he ACA and any further changes in t h e law or regulatory framewo r k that reduce our revenues or increase our costs could also have a material and a d verse effect on our business, financial con d ition and results o f operations.
−Removed: Go v e r n m e n ts o u tside t h e Un i ted S t ates tend t o i mpose s t r i ct pri c e co n trols, whi c h may ad v e r s e ly aff e ct our r e v e n u e s , if an y .
−Removed: In international markets, reimbu r sement and health care pa y m ent systems vary significantly by country, and many countries have i ns t itu t e d price ceilings o n specific products and therapies.
−Removed: I n some countries, p a rticularly the countries of t h e EU, the pricing of prescript i on pharmaceuticals is subject to governmental contr o l.
−Removed: In these countries, pricing negotiations with governmental authorities can take considerable time aft e r the r e c e ipt of m a rk e ting approval for a product.
−Removed: To obtain coverage and reimbursement or pricing approval in s o me countries, we may be required to conduct a c l ini c al tr i a l th a t compares the cost-effectiveness of our product candidate to other avail a ble therapies.
−Removed: There can be no assurance that our prod u ct candidates will be considered cost-effective by third-party payors, that an adequate level of reimbursement will be ava i lable, or that the third- p arty payors’ reimbursement p o licies will not adversely affect our ability to sell our product c a ndidates pro f itably.
−Removed: If r e imbu r sement of our product cand i dates is unavailable or limited in scope or amount, or if pricing is set at unsatis f actory l e vels, our business c ould be harmed, possibly materially.
−Removed: Our employees, independent contractors, consultants, commercial partners, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper ac t i v it i es, in c luding non c omp l ian c e with r e gu la tory standards a n d requirements.
−Removed: We are exposed to the risk of employee fraud or other illegal activity by our employee s , independent contractors, consultants, commercial partners, principal investigators, CROs, suppliers and vendors.
−Removed: Misconduct by these parties could inc l ude intentional, reckless and/or negli g ent conduct that fails to:
−Removed: comply with t h e laws of the F DA and other similar foreign regulatory bodies, provide true, complete and accurate information to the FDA and other similar foreign r egulatory bodies, comply with manufacturing standards we have established, comply with h e alt h care fraud and abuse laws in the Un i t e d S ta t es a nd si m il a r foreign f r audulent misconduct laws, or report f i nancial i n f ormation or data accu r ately or to disclose unauthorized activities to us.
−Removed: I f we obtain FDA approval of any of our prod u ct candidates and begin comm e rcializing those product candidates in the United States, our potential exposure under such l aws will in c re a se sig n ificantly, and o u r costs associated with compliance with such laws are also likely to increase.
−Removed: In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business a r rangements in the healthcare industry, are subje c t t o extensive laws designed to prevent fraud, kickb a cks, self-dealing and other abusive pra c ti c es.
−Removed: Th e s e l a ws and regulations may restrict or prohibit a wide range of pricing, discounting, mar k eting and promotion, structuring and commission(s), certain customer incentive programs and other bu s iness arrangements generally.
−Removed: Activities subject to these laws also involve the improper use of information obta i ned in the course of patient rec r uit m ent for c l i nic a l tri a ls.
−Removed: It is not always possible to identify a nd deter misconduct or other imp r oper activities by our employ e es or third parties that we engage for our business o p erations and the precautions we take to detect and prevent inappropriate conduct may not be e ffective in cont r o lli n g unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations.
−Removed: If any such actions are instituted against us, a nd we are not successful in defending oursel v es or asserting our rights, those actions could have a si g nificant impact on our business, including the imposit i on of civil, criminal and administrative penalties, d a mages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other fed e ral healthcare programs, contr a ctual damages, reputational ha r m, diminished profits and future earnings, compliance agreeme n ts, withdrawal of product approvals, and c u rtailme n t of our oper a tions, among other th i ngs, any of which could adversely affect our ability to oper a te our business and our results of operations.
−Removed: In addition, the approval and commer c ialization of any of our prod u ct candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mention e d above, among other foreign laws.
+Added: At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
+Added: We are unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and containing or lowering the cost of healthcare.
+Added: The ACA and any further changes in the law or regulatory framework that reduce our revenues or increase our costs could also have a material and adverse effect on our business, financial condition and results of operations.
+Added: Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
+Added: In international markets, reimbursement and health care payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.
+Added: In some countries, particularly the countries of the EU, the pricing of prescription pharmaceuticals is subject to governmental control.
+Added: In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product.
+Added: To obtain coverage and reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies.
+Added: There can be no assurance that our product candidates will be considered cost-effective by third-party payors, that an adequate level of reimbursement will be available, or that the third-party payors’ reimbursement policies will not adversely affect our ability to sell our product candidates profitably.
+Added: If reimbursement of our product candidates is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.
+Added: Our employees, independent contractors, consultants, commercial partners, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
+Added: We are exposed to the risk of employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners, principal investigators, CROs, suppliers and vendors.
+Added: Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to:
+Added: comply with the laws of the FDA and other similar foreign regulatory bodies, provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies, comply with manufacturing standards we have established, comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws, or report financial information or data accurately or to disclose unauthorized activities to us.
+Added: If we obtain FDA approval of any of our product candidates and begin commercializing those product candidates in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase.
+Added: In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices.
+Added: These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally.
+Added: Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.
+Added: It is not always possible to identify and deter misconduct or other improper activities by our employees or third parties that we engage for our business operations and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations.
+Added: If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, compliance agreements, withdrawal of product approvals, and curtailment of our operations, among other things, any of which could adversely affect our ability to operate our business and our results of operations.
+Added: In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.
Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs.
−Removed: R i s k s R e lat e d to I n te l le c tual P r o p er t y
−Removed: If we are unable to obtain, mai n tain, protect and enfor c e patent protection and other proprietary rights for our product candi d ates and technologies, we may n ot be able to c omp e t e e ffectively or oper a te profitably and our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected.
+Added: Risks Related to Intellectual Property
+Added: If we are unable to obtain, maintain, protect and enforce patent protection and other proprietary rights for our product candidates and technologies, we may not be able to compete effectively or operate profitably and our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected.
Our success is dependent in large part on our obtaining, maintaining, protecting and enforcing patents and other proprietary rights in the United States and other countries with respect to our product candidates and technology and on our ability to avoid infringing the intellectual property and other proprietary rights of others.
16 unchanged sentences
Moreover, it is possible that competitors may infringe our patents or successfully avoid the patented technology through design innovation.
−Removed: To stop these activities, we may need to file a lawsuit.
+Added: To counter infringement or other unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming, even if we were successful in stopping the violation of our patent rights.
We or our licensors may be subject to a third-party preissuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant and inter partes review, or interference proceedings or other similar proceedings challenging our owned or licensed patent rights.
4 unchanged sentences
An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, our owned or in-licensed patent rights, allow third parties to commercialize our Anktiva™, hAd5 or other product candidates or other technologies and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.
−Removed: If we or our collaborators are unsuccessful in any such proceeding or other priority or inventorship dispute, w e may be required to cease using the technology or to obtain and maintain license rights from prevailing third parties , including parties involved in any such interference proceedings or other priority or inventorship disputes.
+Added: If we or our collaborators are unsuccessful in any such proceeding or other priority or inventorship dispute, we may be required to cease using the technology or to obtain and maintain license rights from prevailing third parties, including parties involved in any such interference proceedings or other priority or inventorship disputes.
A prevailing party in that case may not offer us a license on commercially acceptable terms or at all.
11 unchanged sentences
Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and growth prospects.
−Removed: If any of our owned or in-lice n sed patent applications do not issue as patents in any jurisdi c tion, we may not be able to compete e f fec t i v el y .
+Added: If any of our owned or in-licensed patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.
Changes in either the patent laws or their interpretation in the United States and other countries may diminish our ability to protect our inventions, obtain, maintain, and enforce our intellectual property rights and, more generally, could affect the value of our intellectual property or narrow the scope of our owned and licensed patents.
6 unchanged sentences
Therefore, we cannot be certain that we or our licensors were the first to make the inventions claimed in any of our owned or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions.
−Removed: We or our licensors, collaborators, or any future strategic partners may be come subject to third party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights, and we may need to resort to litigation to protect or enforce our patents or other intellectual property or the patents or other intellectual property of our licensors, all of which could be expensive, time-consuming and unsuccessful , may delay or prevent the development and commercialization of our product candidates, or may put our patents and other proprietary rights at risk .
−Removed: Competitors and other third parties may infringe, misappropriate or otherwise violate our patents or other intellectual property or the patents or other intellectual property of our licensors.
−Removed: In addition, our patents or the patents of our licensors also may become involved in inventorship, priority or validity disputes.
−Removed: To counter infringement or other unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming, even if we were successful in stopping the violation of our patent rights.
+Added: We or our licensors, collaborators, or any future strategic partners may become subject to third party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights, and we may need to resort to litigation to protect or enforce our patents or other intellectual property or the patents or other intellectual property of our licensors, all of which could be expensive, time-consuming and unsuccessful, may delay or prevent the development and commercialization of our product candidates, or may put our patents and other proprietary rights at risk.
If we or one of our licensors initiate legal proceedings against a third party to enforce a patent covering one of our product candidates or other technologies, the defendant could counterclaim that the patent is invalid and/or unenforceable or that we infringe their patents.
5 unchanged sentences
With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our licensor, our or our licensor’s patent counsel and the patent examiner were unaware during prosecution.
+Added: Moreover, even if our patents were to survive such a litigation challenge to their validity, the patents might still be held to be valid but unenforceable if a court were to decide that the patents are being enforced in a manner inconsistent with the antitrust laws, or that the patents were obtained through deceit during patent office examination or other such failure of sufficient candor to the patent office.
If a third party were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates.
14 unchanged sentences
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.
−Removed: T h e u se of o u r t e c h no l ogy a n d product candidates could pote n t ia l ly confli c t with the rights of others, and third-party claims of intellectual property in f r ingement, misappropriat i on or other violation against us, our licensors or our collaborators may prevent or delay the deve l opment and com m ercia l ization of our product candidates a n d technologies.
−Removed: Our com m er c ial suc c ess dep e nds in part on ou r , our lice n sors’ and our collaborators’ ability to avoid infringing, misappropriating and otherwise violating the patents and other intellectu a l property rights of third parties.
−Removed: There is a substantial amount of complex litiga t ion involving patents and other intellectual property rights in the biopharmaceutic a l industry.
−Removed: Our potential competitors or other parties may have, develop or acquire patent or other intellectual property rights that they could assert again s t us.
−Removed: If they do so, then we may be required to alter our product candidates, pay lic e nsing fees or cease our development and comme r cialization activiti e s with respect to the applicable product candidates or technologies.
−Removed: If our product candidates conflict with patent or other intellectual property rights of others, such parti e s could bring legal act i ons against us or our collaborators, licensees, suppliers or customers, claim i ng damages and seeking to enjoin manufacturing, use and marketing of the affected products.
−Removed: Although we have conducted fr e edom - to-operate (“ FTO”) analyses of the patent landscape with respect to our lead product candi d ates and continue to u n dertake FTO analyses of our manufacturing processes, our Anktiva product candidate, and contemplated future processes and pr o ducts, because patent applications do not p ublish for 18 months, and because the claims o f patent applicat i ons can change ov e r ti m e, no F T O analysis can be considered exhaustive.
−Removed: We may not be aware of patents that have already been issued and that a competitor or other third party m i ght a s sert are infringed by our c u r rent or future product c a ndidates or technologies.
+Added: The use of our technology and product candidates could potentially conflict with the rights of others, and third-party claims of intellectual property infringement, misappropriation or other violation against us, our licensors or our collaborators may prevent or delay the development and commercialization of our product candidates and technologies.
+Added: Our commercial success depends in part on our, our licensors’ and our collaborators’ ability to avoid infringing, misappropriating and otherwise violating the patents and other intellectual property rights of third parties.
+Added: There is a substantial amount of complex litigation involving patents and other intellectual property rights in the biopharmaceutical industry.
+Added: Our potential competitors or other parties may have, develop or acquire patent or other intellectual property rights that they could assert against us.
+Added: If they do so, then we may be required to alter our product candidates, pay licensing fees or cease our development and commercialization activities with respect to the applicable product candidates or technologies.
+Added: If our product candidates conflict with patent or other intellectual property rights of others, such parties could bring legal actions against us or our collaborators, licensees, suppliers or customers, claiming damages and seeking to enjoin manufacturing, use and marketing of the affected products.
+Added: Although we have conducted freedom-to-operate (“FTO”) analyses of the patent landscape with respect to our lead product candidates and continue to undertake FTO analyses of our manufacturing processes, our Anktiva™ product candidate, and contemplated future processes and products, because patent applications do not publish for 18 months, and because the claims of patent applications can change over time, no FTO analysis can be considered exhaustive.
+Added: We may not be aware of patents that have already been issued and that a competitor or other third party might assert are infringed by our current or future product candidates or technologies.
It is also possible that we could be found to have infringed patents owned by third parties of which we are aware, but which we do not believe are relevant to our product candidates or technologies.
−Removed: In addition, because patent applications can take many years to i s su e , th e re m a y be curr e ntly pending patent a ppli c a t ions th a t may l a ter result i n issued p atents that our product candidates or technologies may i n f r inge.
−Removed: Furthermore, patent and other intellectu a l property rights in biotechnology remains an evolving area with many risks and uncertainties.
+Added: In addition, because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our product candidates or technologies may infringe.
+Added: Furthermore, patent and other intellectual property rights in biotechnology remains an evolving area with many risks and uncertainties.
As such, we may not be able to ensure that we can market our product candidates without conflict with the rights of others.
−Removed: If intellectual property-related leg a l ac t ions a s s e r t ed aga i nst us a re su c c e s sful, i n a ddit i on to any pot e nti a l l i a bil i ty for d amages (including treble damages and attorneys’ fees for willful i n fringement), we could be enjoined from, or required to obtain a license to continue, manufacturing, promoting the use of or marketing the affected p r o d ucts.
−Removed: We may n ot prevail in any legal a c tion and a required license under the applicable patent or other int e ll e ctu a l proper t y m a y not be available on acceptable terms or at a ll.
−Removed: E ven if we were a ble to obta i n a l i c e ns e , it cou l d be non-exclusive, thereby giving our competitors and other t h ird parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments.
−Removed: We also cou l d be required to redesign our infringing p r o ducts, which may be impossible or require substantial time and monetary expenditure.
−Removed: Defense of i n f ringement claims, regardless of their merit, wou l d involve substantial litigation expense and would be a substan t ial diversion of management and other employee re s ources from our business, and may i m pact our reputation.
−Removed: Some of our competitors may be able to su s t a in the c osts of litigation or administrative proceedings more effectively than we can because of greater fin a ncial resources.
−Removed: In addition, t here could be public announcements of the results of hearings, m o tions, or other interim proceedings or dev e lopments, and if securities analysts or investors per c e i v e th e s e results to be negative, it could have a substantial adve r s e effect on the price of our common s t ock.
−Removed: The occurrence of any of t he foregoing could have a material adve r s e effect on our bu s iness, financial condition, resul t s of o perations and prospects.
−Removed: Obtaining and maintaining our patent prote c tion depends on compliance with various procedural, do c ument submission, fee paymen t , and other requirements imposed by govern m ent patent agencies, and our patent protection could be red u ced or eliminated for non-compliance with th e se r e qu i r e m e n t s.
−Removed: Periodic maintenance fees, renewal fees, annuity fees, and various other government fees on pat e nts and patent applications are due to be p a id to t he USPTO and foreign patent agencies in several stages over the lifetime of a patent.
−Removed: The USPTO and various fore i gn governmental pat e nt agen c i e s require compliance with sever a l procedural, documentary, fee payment and other similar provisions during the pat e nt application p r ocess.
−Removed: In certain circumstances, we rely on our licensors to pay these fees and take the ne c e ss a ry ac t ions t o co m ply w i th t hese requi r e m e nts.
−Removed: Wh i le an inadvertent lapse can in many cases be cured by payment of a late f e e or by o t her me a ns in a c cord a n c e with the app l ic a ble rul e s, there a re s i tua t ions in which n o ncompliance can result in ab a ndonment or lapse of the patent or patent applica t ion, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
−Removed: Noncompliance e v ents that cou l d result in abandonment or lapse of a patent or patent applica t ion inclu d e, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.
−Removed: In such an event, our competitors might be able to e n ter the market with similar or identical products or technology, which would have a mat e rial a dverse imp a ct on our business, financial condition, results of operations and prospects.
−Removed: Changes in United States patent law could diminish the value of patents in general, t h e r e by i m pairing our ability to protect our product candidates.
−Removed: As is the case with other i m munotherapy and biopharmaceutical companies, our success is dependent on intellec t ual property, particularly patents.
−Removed: Obtaining and enforcing patents in the b i opharmaceutical industry invol v e both technological and legal complexity, and is ther e fore costly, time-consuming and inherently uncertain.
−Removed: In a ddit i on, the Unit e d S t a tes h a s r e cen t ly ena c ted and is currently implementing wide-ranging patent reform legislation.
−Removed: Assuming that other requir e m e nts for pat e nt a bil i ty a re m e t, prior to M a rch 2013, i n t he Un i ted S t at e s, the first t o invent the claimed invention was entitled to t h e p a t e nt, while outside t he Un i ted S t a t es, the first to file a p a tent a ppli c at i on was e nt i tl e d to t he patent.
−Removed: After March 2013, u n der the Leahy-Smith America Inv e nts Act ( the “ America Invents Act”) enacted in September 2011, the United States transitioned to a first-to-file system in which, assuming that other requir e men t s for p a t e ntab i li t y a re m e t , the first inventor to file a patent application w i ll be en t it l ed t o t he p a t e nt on an invention regardless of whether a third party was the first to invent the claimed inve n t ion.
−Removed: A third party that files a pat e nt application in the USPTO after March 2013, but before us could the r efore be awarded a patent covering an invention of ours even if we had made the inve n tion before it was made by such third party.
−Removed: This will require us to be co g nizant of the time from invention to filing of a patent application.
−Removed: Since patent appli ca t ions in the United States a n d most other countries a r e con f idential for a period of time after filing or until issuance, we cannot be cert a in that we or our licensors were the first to either file any patent ap p l ication r e lated to our product candidates or other technologies or invent any of t he inventions c l aimed in our or o u r licensor’s patents or patent applications.
−Removed: The Ame r ica I nvents Act also includes a n u mber of significant changes that affect the way patent applications will be pro s e c ut e d a nd a l so m a y a ffect patent litig a t i on.
−Removed: These in c lude a l lowing thi r d-party submission of p r ior art to the USPTO during patent p r osecution and additional proced u r es to attack the validity of a p a tent by USPTO-administered post - g r ant proceedings, i ncluding post-grant review, int e r pa r t e s review, a n d derivation proceedings.
−Removed: There f ore, the America Invents Act and its imp l ementation could increase the uncertainties and costs surrounding the prosecution of our owned or in-licensed patent appli c ations and the enforcement or defense of our owned o r in-licensed issued patents, all of which c ould have a material adverse effect on our business, financial condition, res u lts of operations, and prosp e c ts.
−Removed: Additionally, recent U .
−Removed: Supreme Court rulings have narr o wed the scope of patent pro t ec t ion ava i lab l e in cer t a in c i rcu m s t anc e s and weak e ned the rights of patent owners in cer t ain situations.
−Removed: I n addition to i n creasing uncertainty with regard to our ability to obtain pate n ts in the futur e , this comb i nat i on of even t s has cre a t e d unc e rt a inty with respe c t t o the value of patents, once ob t ained.
−Removed: Depending on decisio n s by Congress, the federal courts, and the USPTO, t h e laws and regulations governing patents could change in unpredictable ways that would weaken our abi l ity to obtain new patents or to enforce our exist i ng patents and patents that we m i ght obtain in the fut u re.
−Removed: While we do not believe that any of the patents ow n e d or licensed by us will be found invalid based on the foregoing, we cannot predict how future decisions by Congress, the federal c o urts or the USPTO may impact the value of our patents.
−Removed: Our rights to develop and comme r cialize our product cand i dates and technologies are s u b j ec t , in part, to the t e r m s and condit i o ns of l i c e n s es granted to us by others.
−Removed: We will rely on licenses to cer t ain patent rights and proprietary technology from third parties t h at are important or necessary to the developme n t of aldoxorubicin and products enabled by our yeast, inclu d ing T armogen, technologies.
−Removed: License agreements may not prov i de exclusive r ights to use certain licensed i n tellectual property and technology in all releva n t fiel d s of use and in all territories in which we may wish to dev e lop or commercialize our technology and produ c t candidates in the f uture.
−Removed: As a result, we may not be able to prevent competitors or other third parties from developi n g and commercializing competitive products that a l so utilizes technology that we have in-l i cens e d.
−Removed: In addition, subject to the terms of any s u ch license agreements, we do n ot have the right to control the preparation, filing, prosecution and maintenance, and we may not have the right to control the enforcement, and defense of patents and patent appli c ations covering the technology that we l i cense from third parties.
−Removed: We cannot be cer t ain that our in-licensed or out - licensed patents and patent applications that are controlled by our licensors or licensees will be prepa r ed, filed, prosecuted, maintained, enforced, a n d defended in a manner con s istent with the best interests of our b usiness.
−Removed: If our licensors or li c e ns e es f a il to pros e c ut e , m a int a in, e nforce, and defend such patents, or lose rig h ts to those patents or patent application s , the rights we have licensed may be reduced or eliminated, our right to develop and commercialize A nktiva and any of our product candidates that are subject of such licensed rights could be adversely affec t ed, and we may not be able to prevent competitors from making, using and s e lling competing products.
−Removed: I n addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inact i o ns of our licensees, our licensors and the i r counsel that took place prior to the date upon which we assumed control over patent prosecution.
−Removed: Furthermore, our owned and in-li c ensed patents may be su b j ect to a reservation of rights by one or more third parties.
+Added: If intellectual property-related legal actions asserted against us are successful, in addition to any potential liability for damages (including treble damages and attorneys’ fees for willful infringement), we could be enjoined from, or required to obtain a license to continue, manufacturing, promoting the use of or marketing the affected products.
+Added: We may not prevail in any legal action and a required license under the applicable patent or other intellectual property may not be available on acceptable terms or at all.
+Added: Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments.
+Added: We also could be required to redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.
+Added: Defense of infringement claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from our business, and may impact our reputation.
+Added: Some of our competitors may be able to sustain the costs of litigation or administrative proceedings more effectively than we can because of greater financial resources.
+Added: In addition, there could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
+Added: The occurrence of any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.
+Added: Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
+Added: Periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and patent applications are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of a patent.
+Added: The USPTO and various foreign governmental patent agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process.
+Added: In certain circumstances, we rely on our licensors to pay these fees and take the necessary actions to comply with these requirements.
+Added: While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
+Added: Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.
+Added: In such an event, our competitors might be able to enter the market with similar or identical products or technology, which would have a material adverse impact on our business, financial condition, results of operations and prospects.
+Added: Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
+Added: As is the case with other immunotherapy and biopharmaceutical companies, our success is dependent on intellectual property, particularly patents.
+Added: Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain.
+Added: In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation.
+Added: Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent.
+Added: After March 2013, under the Leahy-Smith America Invents Act (the “America Invents Act”) enacted in September 2011, the United States transitioned to a first-to-file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.
+Added: A third party that files a patent application in the USPTO after March 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party.
+Added: This will require us to be cognizant of the time from invention to filing of a patent application.
+Added: Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either file any patent application related to our product candidates or other technologies or invent any of the inventions claimed in our or our licensor’s patents or patent applications.
+Added: The America Invents Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect patent litigation.
+Added: These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter parte s review, and derivation proceedings.
+Added: Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned or in-licensed patent applications and the enforcement or defense of our owned or in-licensed issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
+Added: Additionally, recent U.S.
+Added: Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations.
+Added: In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.
+Added: Depending on decisions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.
+Added: While we do not believe that any of the patents owned or licensed by us will be found invalid based on the foregoing, we cannot predict how future decisions by Congress, the federal courts or the USPTO may impact the value of our patents.
+Added: Our rights to develop and commercialize our product candidates and technologies are subject, in part, to the terms and conditions of licenses granted to us by others.
+Added: We will rely on licenses to certain patent rights and proprietary technology from third parties that are important or necessary to the development of aldoxorubicin as well as products enabled by our adenoviral and yeast, including Tarmogen, vaccine technologies.
+Added: License agreements may not provide exclusive rights to use certain licensed intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and product candidates in the future.
+Added: As a result, we may not be able to prevent competitors or other third parties from developing and commercializing competitive products that also utilizes technology that we have in-licensed.
+Added: In addition, subject to the terms of any such license agreements, we do not have the right to control the preparation, filing, prosecution and maintenance, and we may not have the right to control the enforcement, and defense of patents and patent applications covering the technology that we license from third parties.
+Added: We cannot be certain that our in-licensed or out-licensed patents and patent applications that are controlled by our licensors or licensees will be prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with the best interests of our business.
+Added: If our licensors or licensees fail to prosecute, maintain, enforce, and defend such patents, or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, our right to develop and commercialize Anktiva™ and any of our product candidates that are subject of such licensed rights could be adversely affected, and we may not be able to prevent competitors from making, using and selling competing products.
+Added: In addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution.
+Added: Furthermore, our owned and in-licensed patents may be subject to a reservation of rights by one or more third parties.
For example, certain of our in-licensed intellectual property was funded in part by the U.S.
−Removed: As a res u lt, t h e U.S.
−Removed: government m a y have certain rig h t s to s u c h in t e l l e c tu al property.
−Removed: When new technologies are deve l oped with U.S.
−Removed: government f unding, the U.S.
−Removed: gover n ment generally obtains certain righ t s in any resulting patents, including a non-exclusive license au t horizing the U.S.
−Removed: gover n ment to use the invention or to have others use the invention on its behalf.
−Removed: government’s righ t s may also permit it to disclose the funded inventions and technology to third parties and to exercise m arch-in rights to use or allow third parties to use the technology we have licensed that was developed using U.S.
+Added: As a result, the U.S.
+Added: government may have certain rights to such intellectual property.
+Added: When new technologies are developed with U.S.
+Added: government funding, the U.S.
+Added: government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the U.S.
+Added: government to use the invention or to have others use the invention on its behalf.
+Added: government’s rights may also permit it to disclose the funded inventions and technology to third parties and to exercise march-in rights to use or allow third parties to use the technology we have licensed that was developed using U.S.
government funding.
−Removed: government may ex e rcise i t s march-in rights if it determines that action is necessary because we fail to achieve practical a pplication of the government-funded technology, or because ac t ion is ne c e ssary to a ll e vi a te he a lth or saf e ty ne e ds, t o m e et requirements of fed e ral regulations, or to give preference to U.S.
−Removed: In addition, our rights in such inventions may be subject to certain requirements to manufact u re products embodying s u ch inventions in the Unit e d Stat e s in c e rt a in circumstances if this requir e ment is not waived.
+Added: government may exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, or because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S.
+Added: In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States in certain circumstances if this requirement is not waived.
Any exercise by the U.S.
−Removed: government of such rights or by any third party of its reserved rights could have a material adverse effect on our competitive positi o n, business, financial cond i tion, results of operations and growth prosp e c t s .
−Removed: If we fail to comp l y with our obl i gations i n t h e agr e em e n t s u n der wh i c h we l i c e n s e i n tellectual property r i ghts from third par t ies or otherwise experience disruptions to our business r e lat i o n s h ips with o u r lic e n s ors, we may be required to pay damages and we co u l d lo s e l ic e n s e righ t s t h at are important to our b u s i n e s s .
−Removed: We have en t e r e d in t o l ic e nse a gre e men t s with third par t ies and may need to obtain additional lice n ses from others to advance our research or allow commercialization of our product c a ndidates.
−Removed: It is possible that we may be unable to obtain additional licen s es at a reasonable cost or on reasonable terms, if at all.
−Removed: In that event, we may be r e quired to expend sign i ficant time and resources to redesign our technology, product candidates, or the methods for manufacturing them or to deve l op or license replace m ent technology, all of which may not be feasible on a technical or commercial basis.
−Removed: If we are unable to do so, we may be unable to develop or com m ercialize the aff e cted product candidates or continue to utilize our existing technology, which could harm our business, financial condition, results of operations and growth prospects significan t ly.
−Removed: We cannot provide any assurances that third-party p a tents do not exist which might be enforced aga i nst our current technology, manufacturing methods, p r o duct candid a tes, or future methods or products resulting in either an injunct i on prohibiting our man u f acture or fut u r e sales, or, with respect to our future sale s , an obligation on our part to pay royalties and/or other forms of compensation to third parti e s, which could be significant.
−Removed: In addition, each of our license agreements, and we expect our future agreements, will im p ose various development, diligence, c ommercialization, and other obligatio n s on us.
−Removed: Certain of our license agreements also r e quire us to meet development ti m el i nes, or t o e xerc i se c omm er cially reasonable efforts to develop and commercialize licensed product s , in order to maintain the licenses.
−Removed: In spite o f our efforts, our licensors mig h t conclude that we have ma t e ri a l l y bre a ch e d our oblig a tions und e r such l i c e nse ag r ee m e n ts a nd might ther e fore t e rmin a te the lic e nse a gr e ements, th e reby removing or limiting our ability to develop and com m ercialize products and t e chnology covered by these license agr e ements.
−Removed: If these in-licenses are t e rmin a t e d, or if the u n derlying patents fail to provide the int e nded exclusivity, competitors or other third parties would have t h e freedom to seek regulatory approval of, and to market, products identical to ours and we may be required to cease our development and commerciali z ation of certain of our product candidates or of Anktiva.
−Removed: Any of the foregoing could have a material adver s e effect on our comp e titive position, business, financial conditions, results of o p erations and growth prospects.
−Removed: Moreover, disputes may arise regar d ing intellectual property subject to a licensing agr e ement, including:
−Removed: t he scope of rights granted un d er the license a g r e em e nt and o t her int e rpre t a t i on-re l a t e d i s sues;
−Removed: t he extent to which our technology and p r ocesses infringe on intellectual property of the licensor that is not subject to the l i censing agr e em e nt;
−Removed: t he sublicensing of patent a nd other rights under our collaborative development relationships;
−Removed: our diligence obligations under the license agreement and what activ i ties satisfy those diligence obligations;
−Removed: t he inventorship a n d ownership of inventions and know-how resulting from the joint c r eati o n or use of intellect u a l property by our licensors and us a nd our pa r tners;
−Removed: t he priority of invent i on of patented technology.
−Removed: In addition, the agreements und e r which we curre n t ly license i n tellectual property or technology from third parties are complex, and certain provisions in such agr e e m ents m a y be susc e ptib l e to m ult i ple in t e rpr e ta t i ons.
−Removed: The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant i n tellectual property or technology, or increase what we b elieve to be our financial or other obligations under t h e relevant agreement, either of which could have a material adverse eff e ct on our business, financial condition, results of o p erations and growth prospects.
−Removed: Moreover, if disputes over intellectual property that we have l i censed prevent or impair our a b i li t y to m a int a in our current l ic e ns i ng arrangements on com m erc i a l ly a c c e pt a ble t e rms, we m a y be unable to successfully develop and commerci a li z e the aff e c t ed p r odu c t c a ndida t e s, wh i ch could have a material adve r s e effect on our busi n ess, financial conditions, results of operations and growth prospects.
−Removed: We have l i mi t e d for e ign int e l l ec t ual proper t y rights and may not be able to protect o u r intellectual property rights t h roug h out the world.
−Removed: We have limited int e llectual property rights outside the United States.
−Removed: Filing, prosecuting and def e nding patents on product c a ndidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the Unit e d S t a tes can be l e ss extensive than those in the Uni t ed States.
−Removed: In addition, the laws of some foreign countries do not protect int e llectual property rights to the s a me e xt e nt a s feder a l and s t ate l a ws in the Unit e d St a te s .
−Removed: Consequently, we may not be able to p r event third parties from p r acticing our inv e ntions in all countries o u tside the United States, or from selling or importing products made using our inventions in and into t h e United States or other jurisdictions.
−Removed: Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise in f ringing products to territories w h ere we have patent protection, but enforcement is not as strong as that i n the Unit e d Stat e s.
−Removed: The s e prod u cts may compete with our product candid a tes and our patents or other intellectual property rights may not be effective or suff i ci e nt to pr e vent th e m from c omp e ting.
−Removed: Many companies ha v e encountered significant problems in protecting and defending intellectual property rights in foreign juris d ictions.
−Removed: The legal systems of certain countries, particularly certain developing c ount r ies, do not favor the enforcement of patents, trade secrets and other intellectual property protection, parti c ularly those relating to biopharma c eutical p r o d ucts, whi c h could make it diffic u lt for us to stop the infringement of our patents or marketing of competing products in vio l ation of our proprietary rights generally.
−Removed: Proceedings to enforce our patent rights i n foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent appli c ations at risk of not issuing and could provoke third parties to assert claims ag a inst us.
−Removed: We may not prevail in a ny l a wsu i ts t h a t we i nit i at e , and the damages or other r e medies awa r ded, if any, may not be c o m m er c ia l ly me a ningful.
−Removed: A c cordingly, our e f forts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
+Added: government of such rights or by any third party of its reserved rights could have a material adverse effect on our competitive position, business, financial condition, results of operations and growth prospects.
+Added: If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we may be required to pay damages and we could lose license rights that are important to our business.
+Added: We have entered into license agreements with third parties and may need to obtain additional licenses from others to advance our research or allow commercialization of our product candidates.
+Added: We may be unable to obtain certain additional licenses at a reasonable cost or on reasonable terms, if at all.
+Added: In that event, we may be required to expend significant time and resources to redesign our technology, product candidates, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.
+Added: If we are unable to do so, we may be unable to develop or commercialize the affected product candidates or continue to utilize our existing technology, which could harm our business, financial condition, results of operations and growth prospects significantly.
+Added: We cannot provide any assurances that third-party patents do not exist which might be enforced against our current technology, manufacturing methods, product candidates, or future methods or products resulting in either an injunction prohibiting our manufacture or future sales, or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties, which could be significant.
+Added: In addition, each of our license agreements, and we expect our future agreements, will impose various development, diligence, commercialization, and other obligations on us.
+Added: Certain of our license agreements also require us to meet development timelines, or to exercise commercially reasonable efforts to develop and commercialize licensed products, in order to maintain the licenses.
+Added: In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technology covered by these license agreements.
+Added: If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors or other third parties would have the freedom to seek regulatory approval of, and to market, products identical to ours and we may be required to cease our development and commercialization of certain of our product candidates or of Anktiva™.
+Added: Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and growth prospects.
+Added: Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including:
+Added: • the scope of rights granted under the license agreement and other interpretation-related issues;
+Added: • the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
+Added: • the sublicensing of patent and other rights under our collaborative development relationships;
+Added: • our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
+Added: • the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;
+Added: • the priority of invention of patented technology.
+Added: In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.
+Added: The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
+Added: Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations and growth prospects.
+Added: We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
+Added: We have limited intellectual property rights outside the United States.
+Added: Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States.
+Added: In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.
+Added: Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.
+Added: Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States.
+Added: These products may compete with our product candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
+Added: Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
+Added: The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally.
+Added: Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.
+Added: We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.
+Added: Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.
−Removed: I n addition, many countries limit the enforceabili t y of patents against government agencies or gov e rnment contractors.
−Removed: In these countries, the patent owner may have li m it e d r e med i es, wh i c h could materially diminish the value of such patent.
−Removed: If we or any of our licensors is forced to grant a l i c e nse to th i rd pa r ti e s w i th respect to any patents relevant to our business, our competi t ive position may be impaired, and our business, financial conditi o n, results of operations and prospects may be a dversely affected.
−Removed: We may be subject to claims that our employees, consultants or i n depende n t co n trac t ors h ave wro n gfully used or disclosed trade s e cr e ts or oth e r confident i al i n forma t ion of third parti e s or claims asserti n g ownership of what we regard as our own intellectual property.
−Removed: We have r e c e ived conf i dent i al and proprietary information from third parties and their employees and con t ractors.
−Removed: In addition, we plan to employ and contract with individuals who were previously e m ployed at other biotechnology or pharmaceutical companies.
−Removed: We may be subject to c la i ms t hat we or o u r employees, consultants or ind e pendent contractors have inadver t ently or otherwise used or disclosed the trade secrets or o t her confidential information of these third parties o r our emp l oyees’ former e m ployers.
−Removed: Litigation may be necessary to defend against or pursue these c l ai m s .
−Removed: E ven if we are succ e ssful in resolv i ng th e s e c l a ims, l i tig a tion cou l d result in sub s t a nti a l c ost and be a distraction to our management and employees.
−Removed: In addition, while it is our poli c y to require our empl o yees, c onsultants and independ e nt contractors who m a y be involved in the conception or development of intellectual prop e rty to execute agreements assigning such intell e ctual property to us, we may be unsuccessful i n executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own.
−Removed: The assignment o f intellectual property rights may not be self-executing, or t h e a s s i gn m e nt agr e e m ents may be bre a ched, a nd we may be forced to bring claims against t h ird parties, or defend claims that they may bring against us, to determine the ownership of wh a t we r e gard as our int e ll e ctual property.
−Removed: Any of the f o r e going could have a material adve r s e effect on our bu s iness, financial condition, resul t s of o perations, and prospects.
−Removed: We may not be able to li c ense or acquire new or necessary i n tellectual property rights or t e chnology from t h i r d pa r ti e s.
−Removed: An element of our intellectual property s t rategy is to license intel l ectual property rights and t echnologies from third parties and/or our a f filiates.
−Removed: Other parties, including our competitors or our affiliates, may have p a tents and have filed and are l i kely filing pat e nt applications potentially relevant to our b u siness.
−Removed: In order to avoid infringing these patents, we may find it necessary or prud e nt to obtain licenses to such patents f r om such parties.
−Removed: In addition, w i th r e sp e c t to any pa t e nts we c o-own w i th other parties, including our affiliates, we may require l i c e nses to such co-owners’ in terest to such patents.
−Removed: The licensing or acquisition of intellectual property rights is a competitive area, and other mo r e established companies may pursue strategies to license or acquire third-party intellect u al property rights that we may consider attract i ve or necessary.
−Removed: These established companies may have a competitive advantage over us due t o t heir siz e , c a pit a l r es ources and greater clinical development and commercial i z a tion c a p a bi l it i es.
+Added: In addition, many countries limit the enforceability of patents against government agencies or government contractors.
+Added: In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent.
+Added: If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.
+Added: We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed trade secrets or other confidential information of third parties or claims asserting ownership of what we regard as our own intellectual property.
+Added: We have received confidential and proprietary information from third parties and their employees and contractors.
+Added: In addition, we plan to employ and contract with individuals who were previously employed at other biotechnology or pharmaceutical companies.
+Added: We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed the trade secrets or other confidential information of these third parties or our employees’ former employers.
+Added: Litigation may be necessary to defend against or pursue these claims.
+Added: Even if we are successful in resolving these claims, litigation could result in substantial cost and be a distraction to our management and employees.
+Added: In addition, while it is our policy to require our employees, consultants and independent contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own.
+Added: The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property.
+Added: Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, and prospects.
+Added: We may not be able to license or acquire new or necessary intellectual property rights or technology from third parties.
+Added: An element of our intellectual property strategy is to license intellectual property rights and technologies from third parties and/or our affiliates.
+Added: Other parties, including our competitors or our affiliates, may have patents relevant to our business, may have already filed patent applications relevant to our business, and are likely filing patent applications potentially relevant to our business.
+Added: In order to avoid infringing these patents, we may find it necessary or prudent to obtain licenses to such patents from such parties.
+Added: In addition, with respect to any patents we co-own with other parties, including our affiliates, we may require licenses to such co-owners’ interest to such patents.
+Added: The licensing or acquisition of intellectual property rights is a competitive area, and other more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary.
+Added: These established companies may have a competitive advantage over us due to their size, capital resources, and greater clinical development and commercialization capabilities.
In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.
−Removed: We also may be unable to license or acquire third party intelle c tual property rights on terms that would allow us to make an approp r iate return on our inv e stment or at all.
−Removed: No assurance can be given that we will be succ e s s ful in licensing any additional rights or technologies from t h ird parties and/or our af f iliates.
−Removed: Our inability to l i cense the rights and techno l ogies that we have identified, or th a t we m a y i n t he future id e ntify, c ould have a material a dverse impact on our ability to c o mplete the development of our product candidates or to develop additional product c a ndidates.
−Removed: Even if we were able to obtain a lice n se, it could be non-exclu s ive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments.
−Removed: Failure to obtain any necessary rights or licenses may detriment a lly af f ect our planned development of o u r current or future additional product candidates and could increase the cost, and extend the timelines associated with our development, of such other products, and we may have to abandon development of the relevant program or product candidate.
−Removed: Any of the foregoing could have a material adverse e ffect on our business, financial co n dition, results of o p erations and prospects.
−Removed: If we do not ob t ain pa t ent t e rm ext e nsion and data exclusivity for any product ca n didat e s we may d e v e lop, our business may be m at e r i ally harmed.
−Removed: Depending upon the timing, duration and specifi c s of any FDA marketing approval of any product candidates we may develop, one o r more of our owned or in-licensed U.S.
−Removed: patents may be eligible for limited patent term extension under the D r u g Price Competition and Patent Term Restoration Act of 1984 ( the “ Hatch-Wa x m an Act”).
−Removed: The Hatch-Waxman Act permits a patent term extension of up to five years as compensation for patent te r m lost d u r ing the FDA reg u latory review p r o c ess.
−Removed: A patent term extension cannot extend the remaining term of a patent beyond a total o f 14 years from the date of product approval, only one patent may be extended and only tho s e claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.
−Removed: Similar e x tensions as compensation for patent term lost during r e gulatory re v i ew processes are also a va i lab l e in certain foreign countries and territories, such as in Europe under a Supplementary Patent Certificate.
−Removed: Howev e r, we may not be g ranted an extension in the United States and/or foreign countries and territories because of, for example, failing to exercise due diligence during t h e testing phase or regulatory review process, failing to apply within applicable d e adlines, failing to apply prior to e xpiration of relevant patents, or otherwise fa i ling to s a tisfy applicable requirements.
−Removed: Mor e over, the a ppli c ab l e ti m e period or the scope of patent protect i on afforded could be less than we request.
−Removed: If we are unable to obtain patent term extension or the term of any such extension is shorter t h an what we request, our competitors may obtain approval of competing prod u cts following our patent e x piration, and our busine s s, financial condition, results of operations and growth prospects co u ld be m a t e ri a lly harm e d.
−Removed: We may be subject to claims challenging the inv e n t orship of our patents a n d oth e r int e ll e c t ual propert y .
−Removed: We or our licensors may be subject to claims that fo r mer employees, collaborators or o t her third par t ies h a ve an int e rest in our owned or in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inv e ntor.
−Removed: For example, we or our licensors may ha v e inventorship disputes a r ise from conflicting obligations of emplo y ees, consult a nts or others who are involved in developing our product candidates.
−Removed: Litigation may be necessary to defend against these and other c l aims challenging inventorship or our or our licensors’ ownership of our owned or in-licensed patents, trade secrets or oth e r intellectual property.
−Removed: If we or our licensors fail in defending any such claims, in addition to p a ying monetary dam a ges, we m a y lose v a lu a ble in t e l l ec t ual prope r ty rights, such as exclusive ownership of, or right to use, valuable in t e l l e c tual property.
−Removed: Even if we are successful in defending against such claims, litigation could r e sult in sub s t a nti a l c osts and be a distraction to management and other employees.
−Removed: Any of the foregoing could have a material adverse e ffect on our b usin e ss, financial condition, results of operati o ns and growth prospects.
+Added: We also may be unable to license or acquire
+Added: third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all.
+Added: No assurance can be given that we will be successful in licensing any additional rights or technologies from third parties and/or our affiliates.
+Added: Our inability to license the rights and technologies that we have identified, or that we may in the future identify, could have a material adverse impact on our ability to complete the development of our product candidates or to develop additional product candidates.
+Added: Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments.
+Added: Failure to obtain any necessary rights or licenses may detrimentally affect our planned development of our current or future additional product candidates and could increase the cost, and extend the timelines associated with our development, of such other products, and we may have to abandon development of the relevant program or product candidate.
+Added: Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.
+Added: If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
+Added: Depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our owned or in-licensed U.S.
+Added: patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).
+Added: The Hatch-Waxman Act permits a patent term extension of up to five years as compensation for patent term lost during the FDA regulatory review process.
+Added: A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval.
+Added: Only one patent may be extended per new drug, and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.
+Added: Similar extensions as compensation for patent term lost during regulatory review processes are also available in certain foreign countries and territories, such as in Europe under a Supplementary Patent Certificate.
+Added: However, we may not be granted an extension in the United States and/or foreign countries and territories because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements.
+Added: Moreover, the applicable time period or the scope of patent protection afforded could be less than we request.
+Added: If we are unable to obtain patent term extension or the term of any such extension is shorter than what we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations and growth prospects could be materially harmed.
+Added: We may be subject to claims challenging rights in our patents and other intellectual property.
+Added: We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our owned or in-licensed patents, trade secrets, or other intellectual property, including as an inventor or co-inventor.
+Added: For example, we or our licensors may have disputes arise from conflicting obligations of employees, consultants or others who are involved in developing our product candidates.
+Added: Litigation may be necessary to defend against these and other claims challenging inventorship, or our or our licensors’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property.
+Added: If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of or right to use valuable intellectual property.
+Added: Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
+Added: Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
On September 10, 2020, a legal complaint was filed in a California court where Institute for Cancer Research (d/b/a Fox Chase Cancer Center) argued that it has a co-ownership interest in U.S.
2 unchanged sentences
15/529,848, as well as in certain related patent applications or issued patents that include claimed subject matter allegedly invented by one of the claimant’s employees.
−Removed: On September 30, 2020, we filed motion with the court asking that the complaint be dismissed.
We disagree that this claim for co-ownership has merit and intend to vigorously defend our position.
−Removed: All of the existing named inventors have assigned their rights in this patent to us.
+Added: All of the named inventors have assigned their rights in this patent to us.
We will continue to have an undivided interest in the entire patent even if claimant succeeds in this suit.
1 unchanged sentence
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
−Removed: If we are unable to protect t h e confidentiality of o u r t r ade s e c r ets, o u r business and co m pe t it i ve pos i t i on wou l d be h ar m ed.
−Removed: In addition to seeking patents for Anktiva, hAd5 and yeast te c hn o logies and other p r oduct candidates and technologies, we a lso r e ly on tr a de s e cr e ts and confidentiality agreements to p r otect o u r unpatented know-how, technology, and other proprietary information and to mainta i n our c omp e ti t ive p o sition.
+Added: If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
+Added: In addition to seeking patents for Anktiva™, hAd5 and yeast technologies and other product candidates and technologies, we also rely on trade secrets and confidentiality agreements to protect our unpatented know-how, technology, and other proprietary information and to maintain our competitive position.
Trade secrets and know-how can be difficult to protect.
−Removed: We expect our trade secrets and know-how to over time be dis s e m ina t ed w i thin the industry through independent deve l opment, the publication of journ a l articles des c ribing the methodology, and the movement of p ersonnel from academic to industry s c ientific positions.
−Removed: We seek to protect these trade secrets a nd other proprietary technology, in part, by entering into nondisclosure and confidentia l i t y agr e e m ents w i th parties who have access to them, such as our employees, corporate collaborators, outs i de s c ien t ific c oll a borators, CROs, CMOs, consultants, advisors, and other th i rd par t i e s.
−Removed: W e also ent e r i nto c onfid e nti a li t y and invention or pat e nt a s sign m ent agr e e m ents with our employees and consultants as well as t r ain our employees not to bring or use proprietary information or t e chnology from former employers to us or in their w o r k, and remind former empl o yees when they leave t h eir employment of their confidentiality obli g ations.
−Removed: We cannot guarantee that we have e nt e red into su c h agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes.
−Removed: Despite our efforts, any of these par t ies may bre a ch the agr e em e nts a nd disclose our proprietary i n formation, including our trade secrets, and we may not be able to obtain adequate rem e dies for such bre a ches.
−Removed: Enfor c ing a cl a im th a t a p a rty il l e g ally disclosed or misappropriated a t rade secr e t is d i fficu l t, expensive, and time-consuming, and the outcome is unpredictable.
−Removed: In addition, some c ourts inside and outside the Uni t ed States are less willing or u n willing to protect trade secrets.
−Removed: If any of our trade secrets w e re to be lawfully obtained o r independently developed by a c o mpetitor or other third party, we would have no rig h t to prevent them from using that technology or information to compete with us.
−Removed: If any of our t r ade secr e ts were t o be disclosed to or independently developed by a competitor or other third party, our com p etitive p osition would be materially and adversely harmed.
−Removed: If our trademarks and trade names are not ad e quately protected, t h en we may not be able to build name recognition in our marke t s of interest and o u r busi n e ss may be adversely affected.
−Removed: Our registered or unregistered trademarks or t r ade names may be challenged, infringed, circumvented or dec l ared generic or det e rmined to be infringing on other marks.
−Removed: We may not be able to pro t e c t our righ t s to these tr a dem a rks a nd tr a de names, which we need to build name reco g nition among p o tential partners or customers in our markets of interest.
−Removed: At times, competitors or other t h ird parties may adopt trade names or tr a de m arks sim i l a r to o u r s , t h ereby im p e ding our ability to build brand identity and possibly leading to mar k et confusion.
−Removed: In addition, there could be potential trade name or tradema r k infringement claims brought by owners of other registered t r ademarks or trademarks that incorporate variations of our registered or u n r e gistered trademarks or trade names.
−Removed: Over the long term, if we are unable to e s tablish n a me recognition based on our tradem a rks and trade names, th e n w e m a y not be able to c om p ete eff e ctively and our business may be adversely aff e cted.
−Removed: Our efforts to enforce or protect o u r proprietary rights related to trademarks, trade sec r ets, domain names, copyrights or other intellectual property m a y be ineffective and could resu l t in substan t i a l c os t s and diversion of resources and could adversely affect our business, financial condition, r e sults of operations and growth prospect s .
−Removed: Intellectual pr o perty rights do not necessarily address all potential threats.
−Removed: The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to m a i nta i n our comp e ti t ive advantage.
−Removed: others may be able to make p r o ducts t h at are similar to our product candidates or utilize similar technology but that are not covered by the claims of the patents that we license or may own;
−Removed: we, or our current or future licensors or collaborators, might not have been the first to make the inven t ions covered by the i ssued patent or pending patent appl i cation that we license or own now or in the future;
−Removed: we, or our current or future licensors or collaborators, might not have been the first to file p a tent a pplications covering c e rtain of our or their inventions;
−Removed: others may independently deve l op similar or alternati v e technologies or duplicate any of our technologies without infringing our ow n e d or l i c en s e d in t e l l e c tual property rights;
−Removed: i t is possible that our current or future pending owned or licensed patent applications will not le a d t o issued pat e nts;
−Removed: i ssued patents that we hold r ights to may be held invalid or unenforceable, including as a result of legal challenges by our c ompetitors or other third parties;
−Removed: our competitors or other third pa r ties m i ght conduct research and development activities in countries where we do not have pa t ent rights and then use the information learned from s u ch activities to develop competitive products for sale in our major commercial mark e t s;
−Removed: we may not develop additional proprietary technologies that are patenta b le;
−Removed: t he patents of others m a y harm our business;
−Removed: we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a p a tent covering such intellectual property.
−Removed: Should any of these events occur, they could have a material adverse ef f ect on our business, financial condition, results of operations a n d growth prospects.
+Added: We expect our trade secrets and know-how will over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology, and the movement of personnel from academic to industry scientific positions.
+Added: We seek to protect these trade secrets and other proprietary technology, in part, by entering into nondisclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, CROs, CMOs, consultants, advisors, and other third parties.
+Added: We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants as well as train our employees not to bring or use proprietary information or technology from former employers to us or in their work, and remind former employees when they leave their employment of their confidentiality obligations.
+Added: We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes.
+Added: Despite our efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
+Added: Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and the outcome is unpredictable.
+Added: In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets.
+Added: If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them from using that technology or information to compete with us.
+Added: If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third party, our competitive position would be materially and adversely harmed.
+Added: If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
+Added: Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
+Added: We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest.
+Added: At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion.
+Added: In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names.
+Added: Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
+Added: Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and growth prospects.
+Added: Intellectual property rights do not necessarily address all potential threats.
+Added: The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage.
+Added: • others may be able to make products that are similar to our product candidates or utilize similar technology but that are not covered by the claims of the patents that we license or may own;
+Added: • we, or our current or future licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or own now or in the future;
+Added: • we, or our current or future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their inventions;
+Added: • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;
+Added: • it is possible that our current or future pending owned or licensed patent applications will not lead to issued patents;
+Added: • issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors or other third parties;
+Added: • our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
+Added: • we may not develop additional proprietary technologies that are patentable;
+Added: • the patents of others may harm our business;
+Added: • we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
+Added: Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Risks Related to Our Common Stock
−Removed: Soon-Shiong, o u r E xecutive C hairman and our principal stockholder, h a s signifi c ant interests in oth e r c ompanies w h i c h may c onfli c t w i th our i n t e r e sts.
−Removed: Our Executive C hairma n , Dr.
+Added: Soon-Shiong, our Executive Chairman, Global Chief Scientific and Medical Officer and our principal stockholder, has significant interests in other companies which may conflict with our interests.
+Added: Our Executive Chairman, Global Chief Scientific and Medical Officer and our principal stockholder, Dr.
Soon-Shiong, is the founder of NantWorks.
9 unchanged sentences
We are also pursuing supply arrangements for various investigational agents controlled by affiliates to be used in their clinical trials.
−Removed: Soon-Shiong w e re to cease his affiliation with us or NantWorks, these entities may be unwilling to continue these relationships with us on commercially reasonable terms, or at all, and as a result may impede our ability to control the supply chain for our combination therapies.
+Added: Soon-Shiong were to cease his affiliation with us or NantWorks, these entities may be unwilling to continue these relationships with us on commercially reasonable terms, or at all, and as a result may impede our ability to control the supply chain for our combination therapies.
These collaboration agreements do not typically specify how sales will be apportioned between the parties upon successful commercialization of the product.
As a result, we cannot guarantee that we will receive a percentage of the revenues that is at least proportional to the costs that we will incur in commercializing the product candidate.
−Removed: We have entered into sh a red s e rvic e s agr e e m ents with NantWorks, pursuant to which NantWorks and its affiliates provide corporate, general and administrative and other support services to us .
+Added: We have entered into shared services agreements with NantWorks, pursuant to which NantWorks and its affiliates provide corporate, general and administrative and other support services to us.
Soon-Shiong was to cease his affiliation with us or with NantWorks, we may be unable to establish or maintain this relationship with NantWorks on a commercially reasonable basis, if at all.
As a result, we could experience a lack of business continuity due to loss of historical and institutional knowledge and a lack of familiarity of new employees and/or new service providers with business processes, operating requirements, policies and procedures, and we may incur additional costs as new employees and/or service providers gain necessary experience.
−Removed: In addition, the loss of the services of NantWorks might significantly delay or prevent the development of our product ca n didates or achievement of other business objectives by diverting management’s attention to transition matters and identification of suitable replacements, if any, and could have a material adverse effect on our business and results of operations.
−Removed: Soon-Shiong, through his voti n g co n t r ol of t h e compan y , has the ability to control actions that req u ire stockholder a p proval.
−Removed: Soon-Shiong, through his direct and indi r ect ownership of the company’s common stock, has voting control of the company.
−Removed: As of June 30, 2021 , Dr.
−Removed: So o n - S hiong and certain of his af f iliates beneficially own approximately 80.3% of the company’s common stock outstanding.
−Removed: A dditionally, an affilia t e of Dr.
−Removed: Soon-Shiong holds a warrant to pur c ha s e an additional 1,638,000 shares of the comp a ny’s common stock that will become exercisable if certain perfor m ance conditions are satisfie d .
−Removed: Soon-Shiong and his related party also h old approximately $279.5 million in the aggregate of C V Rs iss u ed to the fo r mer s t ockholders of Altor in connection with NantCell ’s acquisition of Altor.
−Removed: I f the u n derlying conditions for payment are met, the CVRs become paya b l e in cash or shares of the company’s common stock or any combination as the holder elects.
+Added: In addition, the loss of the services of NantWorks might significantly delay or prevent the development of our product candidates or achievement of other business objectives by diverting management’s attention to transition matters and identification of suitable replacements, if any, and could have a material adverse effect on our business and results of operations.
+Added: Soon-Shiong, through his voting control of the company, has the ability to control actions that require stockholder approval.
+Added: Soon-Shiong, through his direct and indirect ownership of the company’s common stock, has voting control of the company.
+Added: As of September 30, 2021, Dr.
+Added: Soon-Shiong and his affiliates beneficially own approximately 79.4% of the company’s common stock outstanding.
+Added: Additionally, an affiliate of Dr.
+Added: Soon-Shiong holds a warrant to purchase an additional 1,638,000 shares of the company’s common stock that will become exercisable if certain performance conditions are satisfied.
+Added: Soon-Shiong and his related party also hold approximately $279.5 million in the aggregate of CVRs issued to the former stockholders of Altor in connection with NantCell’s acquisition of Altor.
+Added: If the underlying conditions for payment are met, the CVRs become payable in cash or shares of the company’s common stock or any combination as the holder elects.
Soon-Shiong and his related party have irrevocably agreed to receive shares of the company’s common stock in satisfaction of their CVRs.
−Removed: Soon-Shiong is in a position to con t rol the outcome of corporate actions that require, or may be accomplished by, sto c kholder approval, including amending the bylaws of the company, the elect i on or removal of directors and transactions involving a change of control.
−Removed: Soon-Shiong’s controlling ownership could limit the a b ility of the remaining stockholders of the company to influence corporate m a t t ers, and the interests of Dr.
−Removed: Soon-Shiong may not coincide with the company’s interests or the int e rests of its remaining stockholders.
−Removed: In a ddit i on, ent i ti e s affiliated with Dr.
−Removed: Soon-Shiong hold p r o m issory notes representing $300.3 million in indebtedness, including interest thereon, of the company as of June 30, 2021 .
+Added: Soon-Shiong is in a position to control the outcome of corporate actions that require, or may be accomplished by, stockholder approval, including amending the bylaws of the company, the election or removal of directors and transactions involving a change of control.
+Added: Soon-Shiong’s controlling ownership could limit the ability of the remaining stockholders of the company to influence corporate matters, and the interests of Dr.
+Added: Soon-Shiong may not coincide with the company’s interests or the interests of its remaining stockholders.
+Added: In addition, entities affiliated with Dr.
+Added: Soon-Shiong hold promissory notes representing $303.2 million in indebtedness, including interest thereon, of the company as of September 30, 2021.
In addition, pursuant to the Nominating Agreement between us and Cambridge Equities, LP (“Cambridge”), an entity that Dr.
39 unchanged sentences
If our stockholders sell, or the market perceives that our stockholders intend to sell substantial amounts of our common stock in the public market, the market price of our common stock could decline significantly.
−Removed: In addition, our Executive Chairman, Dr.
−Removed: Soon-Shiong, and his affiliates cur r ently beneficially own approximately 80.3% of our outstanding shares of common stock as of June 30, 2021.
+Added: In addition, our Executive Chairman and Global Chief Scientific and Medical Officer, Dr.
+Added: Soon-Shiong, and his affiliates currently beneficially own approximately 79.4% of our outstanding shares of common stock as of September 30, 2021.
Sales of stock by Dr.
4 unchanged sentences
In addition, we expect that additional capital may be needed in the future to continue our planned operations, including conducting clinical trials, commercialization efforts, expanded research and development activities and costs associated with operating as a public company.
−Removed: To raise capital, we may sell common stock, including as part of t he ATM , convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.
+Added: To raise capital, we may sell common stock, including as part of the ATM, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.
If we sell common stock, including through the ATM, convertible securities or other equity securities, investors may be materially diluted and new investors could gain rights, preferences and privileges senior to the holders of our common stock.
We have incurred and will continue to incur costs as a result of operating as a public company and our management has been and will be required to devote substantial time to compliance initiatives and corporate governance practices, including maintaining an effective system of internal control over financial reporting.
−Removed: As a public company listed in the U.S., and increasingly after we no longer qual i fy as a “smaller reporting company,” we have incurred and will continue to incur significant additional legal, accounting and other expenses as a result of operating as a public company.
+Added: As a public company listed in the U.S., and increasingly after we no longer qualify as a “smaller reporting company” as of December 31, 2021, we have incurred and will continue to incur significant additional legal, accounting and other expenses as a result of operating as a public company.
In addition, changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002 (“Sarbanes Oxley”) and regulations implemented by the SEC and Nasdaq, may increase legal and financial compliance costs and make some activities more time consuming.
4 unchanged sentences
The controls and other procedures are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC is disclosed accurately and is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms.
−Removed: In addition, we are required to disclose any material weakn e sses identified by our management in our internal control over financial reporting, and, since we no longer qualify as a “ s maller reporting company” as of fiscal year end 2021, we are required to provide a statement that our independent registered public accounting firm has issued an opinion on our internal control over financial reporting in our Annual Report on Form 10-K.
+Added: In addition, we are required to disclose any material weaknesses identified by our management in our internal control over financial reporting, and, since we no longer qualify as a “non-accelerated filer” as of December 31, 2021, we will be required to provide a statement that our independent registered public accounting firm has issued an opinion on our internal control over financial reporting in our Annual Report on Form 10-K.
We have initiated the process of engaging and coordinating with our independent registered public accounting firm to perform an audit of, and give an opinion on, our internal control over financial reporting for the annual period ending December 31, 2021.
8 unchanged sentences
Furthermore, if we are unable to certify that our internal control over financial reporting is effective and in compliance with Section 404, we may be subject to sanctions or investigations by regulatory authorities, such as the SEC or stock exchanges, and investors could lose confidence in the accuracy and completeness of our financial reports, which could hurt our business, the price of our common stock and our ability to access the capital markets.
−Removed: Operating as a public company make s it more expensive for us to obtain director s’ and officer s’ liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.
+Added: Operating as a public company makes it more expensive for us to obtain directors’ and officers’ liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.
These factors could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, on committees of our board of directors, or as members of senior management.
8 unchanged sentences
Because we are relying on the exemptions from corporate governance requirements as a result of being a “controlled company” within the meaning of the Nasdaq listing standards, you do not have the same protections afforded to stockholders of companies that are subject to such requirements.
−Removed: Our Executive Chairman, Dr.
+Added: Our Executive Chairman and Global Chief Scientific and Medical Officer, Dr.
Patrick Soon-Shiong, and entities affiliated with him, control a majority of our common stock.
4 unchanged sentences
We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies could make our common stock less attractive to investors.
−Removed: Although we no longer qualify as an emerging g r owth company, we qualify as a “smaller r e porting company” during fiscal year 2021, which allows us to take advantage of many of the same e x emptions from disclosu r e requirements, including reduced dis c losure obligations regard i ng executive compensation in our periodic reports and proxy statements.
+Added: Although we no longer qualify as an emerging growth company, we qualify as a “smaller reporting company” during fiscal year 2021, which allows us to take advantage of many of the same exemptions from disclosure requirements, including reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
These exemptions include:
2 unchanged sentences
• reduced disclosure obligations regarding executive compensation.
−Removed: Investors may find our common stock less a t t ra c tive a s a result of our re l i a nce on th ese exemptio n s.
−Removed: If some investors f ind our common stock less at t ra c tive a s a result, t here m a y be a l e ss a c tive tr a ding mark e t for our common stock and the m a rket price of o u r common stock may be reduced or more v o l a til e .
+Added: Investors may find our common stock less attractive as a result of our reliance on these exemptions.
+Added: If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and the market price of our common stock may be reduced or more volatile.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.
9 unchanged sentences
An “interested stockholder” is a person who, together with affiliates and associates, owns (or, in certain cases, within three years prior, did own) 15% or more of the corporation’s voting stock.
−Removed: Our decision not to be subject to Section 203 will allow, for example, our Executive C hairman (who, with members of his immediate family and entities affiliated with him, currently beneficially own, in the aggregate, approximately 80.3% of our common stock as of June 30, 2021) to transfer shares in excess of 15% of our voting stock to a third-party free of the restrictions imposed by Section 203.
+Added: Our decision not to be subject to Section 203 will allow, for example, our Executive Chairman and Global Chief Scientific and Medical Officer (who, with members of his immediate family and entities affiliated with him, currently beneficially own, in the aggregate, approximately 79.4% of our common stock as of September 30, 2021) to transfer shares in excess of 15% of our voting stock to a third-party free of the restrictions imposed by Section 203.
This may make us more vulnerable to takeovers that are completed without the approval of our board of directors and/or without giving us the ability to prohibit or delay such takeovers as effectively.
26 unchanged sentences
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.