What changed in this filing

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Item 1. Business

2021-12-10 compared with 2020-12-11 · 240 added, 132 removed, 369 unchanged (50% of the section changed)

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with a broad collection of spherical, toric and multifocal contact lenses.

Acquisitions also expanded CooperVision's access to myopia management and specialty eye care markets with new products, such as orthokeratology (ortho-k) and scleral lenses.

CooperVision offers contact lenses in a variety of materials including silicone hydrogel Aquaform ® technology and phosphorylcholine technology (PC) Technology™.

Further, acquisitions expanded CooperVision's access to myopia management and specialty eye care markets with new products, such as orthokeratology (ortho-k) and scleral lenses.

In November 2019, CooperVision received United States Food and Drug Administration (FDA) approval for its MiSight ® 1 day lens, which is the first and only FDA-approved product indicated to slow the progression of myopia in children with treatment initiated between the ages of 8-12 and became available in the United States during fiscal 2020.

Further, CooperVision offers contact lenses in a variety of materials including silicone hydrogel Aquaform ® technology and phosphorylcholine technology (PC) Technology™.

In August 2021, CooperVision received Chinese National Medical Products Administration (NMPA) approval for its MiSight ® 1 day lens for use in China.

CooperVision’s major manufacturing and distribution facilities are located in Belgium, Costa Rica, Hungary, Puerto Rico, the United Kingdom and the United States, with other smaller locations also existing in multiple locations around the world.

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• Toric and multifocal lenses including lenses that, in addition to correcting near- and farsightedness, address more complex visual defects such as astigmatism and presbyopia by adding optical properties of cylinder and axis, which correct for irregularities in the shape of the cornea.

In order to achieve comfortable and healthy contact lens wear, products are sold with recommended replacement schedules, often defined as modalities, with the primary modalities being single-use lenses and frequently replaced lenses, which are designed for two-week and monthly replacement.

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CooperVision offers spherical, toric, multifocal and toric multifocal lens products in most modalities.

We believe that in order to compete successfully in the numerous categories of the contact lens market, companies must offer differentiated products that are priced competitively and manufactured efficiently.

CooperVision uses three different manufacturing processes to produce its lenses:

lathing, cast molding and FIPS™, a cost-effective combination of lathing and molding.

We believe this manufacturing flexibility allows CooperVision to compete in its markets by:

CooperVision uses different manufacturing processes, primarily cast molding, to produce its lenses.

We believe this allows CooperVision to compete in its markets by:

• Producing high, medium and low volumes of lenses made with a variety of materials for a broader range of market niches:

single-use, two-week, monthly and quarterly disposable sphere, toric and multifocal lenses and custom toric lenses for patients with a high degree of astigmatism.

single-use, two-week, monthly and quarterly disposable sphere, toric and multifocal lenses, custom toric lenses for patients with a high degree of astigmatism, and myopia management contact lenses.

• Offering a wide range of lens parameters, leading to a higher rate of successful fitting for practitioners and better visual acuity for patients.

The market for spherical lenses is growing with the addition of new value-added products, such as spherical lenses to alleviate dry eye symptoms, reduce eye fatigue from use of digital devices and add aspherical optical properties and/or higher oxygen permeable lenses such as silicone hydrogels.

Sales of contact lenses utilizing silicone hydrogel materials continue to grow.

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Under the Biofinity brand, CooperVision markets monthly silicone hydrogel spherical (including Biofinity Energys ® ), toric, multifocal and toric multifocal lens products.

CooperVision markets single-use silicone hydrogel lenses with a complete line of spherical, toric, extended toric and multifocal lenses under our clariti ® 1 day brand and single-use silicone hydrogel spherical and toric lenses under our MyDay ® brand.

We also compete in the traditional hydrogel single-use product segment with several lenses including our Proclear ® 1 day lenses.

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CooperVision believes that myopia management opens up an attractive new market for contact lenses.

With MiSight, CooperVision offers the only FDA approved product to control the progression of myopia in children.

With MiSight, CooperVision offers the only FDA approved and first Chinese NMPA approved product to control the progression of myopia in children.

CooperVision is investing to create this new market by educating eye care practitioners, patients and their families which increases awareness.

CooperVision is focused on greater worldwide market penetration of recently introduced products, and we continue to expand our presence in existing and emerging markets, including through acquisitions.

In fiscal 2020, CooperVision completed the acquisition of a privately-held U.S contact lens manufacturer focusing on ortho-k lenses.

This acquisition expands CooperVision’s specialty eye care portfolio and its leadership in addressing the increasing severity and prevalence of myopia.

In fiscal 2019, CooperVision

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acquired a privately-held scleral lens company, which expands CooperVision's specialty and scleral lens portfolio.

In fiscal 2021, CooperVision acquired a privately held medical device company and a privately-held UK contact lenses manufacturer.

In fiscal 2020, CooperVision acquired a privately-held U.S.

contact lens manufacturer focusing on ortho-k lenses.

These acquisitions expanded CooperVision’s specialty eye care portfolio and its leadership in addressing the increasing severity and prevalence of myopia.

Contact Lens Product Sales

Single-use spheres – Our single-use lens portfolio includes clariti 1 day, MyDay, MiSight, Proclear 1 day and Biomedics 1 day

Toric – Toric lenses include Biofinity toric, MyDay toric, clariti 1 day toric, Biomedics toric, Proclear toric and Avaira Vitality toric

Multifocal – Multifocal lenses include Biofinity multifocal, Biofinity toric multifocal, clariti 1 day multifocal, MyDay multifocal and Proclear 1 day multifocal

Non single-use sphere, other – Our FRP (frequent replacement product) lens portfolio and other include Biofinity, Biofinity Energys, Avaira Vitality, Biomedics, Proclear, clariti, ortho-k, scleral and custom lens, solutions and other

CooperVision Competition

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CooperVision believes that laser vision correction is not a significant threat to its sales of contact lenses based on the growth of the contact lens market over the past decade.

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CooperVision competes in the silicone hydrogel segment of the market with its following products:

clariti 1 day brand of single-use sphere, toric and multifocal lenses;

MyDay single-use spherical and toric lenses;

Biofinity monthly spherical, toric, multifocal and toric multifocal lenses and Avaira Vitality TM two-week spherical and toric lenses.

MyDay ® single-use spherical, toric and multifocal lenses;

Biofinity monthly spherical, toric, multifocal and toric multifocal lenses and Avaira Vitality ® two-week spherical and toric lenses.

CooperVision believes the clariti 1 day and MyDay brands of single-use contact lenses provide the broadest product portfolio in the single-use silicone hydrogel market.

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Its private label option is frequently offered as part of a larger customized solution for its customers.

It also competes in the specialty contact lens space with its FDA approved MiSight 1 day contact lens for myopia management, when first prescribed to children ages 8-12, as well as OrthoK and scleral lenses.

It also competes in the specialty contact lens space with its FDA approved MiSight 1 day contact lens for myopia management as well as ortho-k and scleral lenses.

In addition to a broad offering of silicone hydrogel and specialty contact lenses, CooperVision competes with different manufacturing processes which allow it to produce a broad range of spheres, toric and multifocal lens parameters, which we believe provides wide choices for patient and practitioner and a high level of visual acuity.

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CooperVision believes that there are opportunities for contact lenses to gain market share, particularly in markets where the penetration of contact lenses in the vision correction market is low.

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COOPERSURGICAL

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The result is a broad portfolio of products and services that are intended to aid in the delivery of improved clinical outcomes that health care professionals use routinely in the diagnosis and treatment of a wide spectrum of women's health and reproductive issues.

One of CooperSurgical’s focus areas is key accounts which include large group practices, integrated delivery networks and certain buying groups within the office/surgical business and fertility clinic networks within the fertility business.

We believe our portfolio of offerings and focus on service, quality and clinical education will support the accelerated growth of our business in the key account groups.

Since its inception in 1990, CooperSurgical has established its market presence and distribution system by developing products and acquiring products and companies that complement its business model.

In fiscal 2021, CooperSurgical acquired three privately-held medical device companies and one privately-held in vitro fertilization (IVF) cryo-storage software solutions company.

In fiscal 2020, CooperSurgical acquired a privately-held distributor of IVF medical devices and systems.

In fiscal 2019, CooperSurgical acquired a privately-held U.S.

medical device company that develops mechanical surgical solutions for skin closure.

We intend to continue investing in CooperSurgical's business with the goal of expanding our integrated solutions model within the areas of family health, fertility and diagnostics.

On November 6, 2021, subsequent to the fiscal year ended October 31, 2021, CooperSurgical entered into an Agreement and Plan of Merger (the “Merger Agreement”) to acquire Generate Life Sciences, a privately held leading provider of donor egg and sperm for fertility treatments, fertility cryopreservation services and newborn stem cell (cord blood and cord tissue) storage.

The aggregate consideration is $1.605 billion in cash, subject to adjustment as set forth in the Merger Agreement.

The transaction is anticipated to close in the first quarter of fiscal 2022 and is subject to customary closing conditions, including regulatory approval.

Subsequent Events of the Consolidated Financial Statements for more details.

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Market for Women's and Family Reproductive Health Care

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During the reproductive years, fertility awareness and family planning are key areas of focus.

CooperSurgical expects growth in fertility treatments as infertility rates increase and awareness of and access to services expand.

The attention in maternity care to improving the safety and efficacy of obstetrical care continues.

The attention in maternity care to improving access to safe, effective, and equitable obstetrical care continues.

As we expect an increase in the population of women over the age of 65, office visits focused around abnormal bleeding, incontinence and menopause will likely increase.

Another trend in the market for women's health care includes the continued migration of OB/GYN health care professionals away from private practice ownership and toward aligning with group practices or employment with hospitals and health care systems.

This trend includes the increasing influence of supply chain controls, such as value analysis committees, on product evaluation and procurement.

This overall trend of consolidation of healthcare systems includes the increasing influence of supply chain controls, such as value analysis committees, on product evaluation and procurement across these care-delivery systems.

CooperSurgical believes that the market factors that are driving this trend will continue in the near term.

We believe our broad product portfolio can be a benefit in this changing environment as health systems look to standardize and consolidate vendors.

Recent trends in the United States market include the development of more cost-effective health care delivery models, including moving treatment out of hospitals and surgery centers and into the office setting without compromising care.

We expect this trend to continue.

While general medical practitioners play an important role in women's primary care, the OB/GYN specialist is the primary market for our medical devices.

Some significant features of this market are:

Recent trends of patient-centered, value-based care in the United States market include the development of more cost-effective health care delivery models, including moving treatment out of hospitals and surgery centers and into the office setting without compromising care.

We expect to see continued changes in reimbursement and clinical best practices as payment models and policies continue to evolve.

Some significant features of the OB/GYN market are:

• Routine office visits:

annual well-women checkups, preventative cancer screening and contraception.

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• Evaluation and management (E/M) office visits:

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• Hysterectomy and cesarean section remain common hospital surgical interventions in women worldwide.

Infertility rates are increasing globally.

Patient awareness and access are also on the rise.

Initial evaluation and treatments for infertility, such as ovulatory medications and intrauterine insemination (IUI), begin with the OB/GYN then transition to fertility clinics.

In-Vitro Fertilization (IVF) is performed by reproductive endocrinologists, specialized OB/GYNs.

• Initial evaluation and treatments for infertility, such as uterine assessment, ovulatory medications and intrauterine insemination (IUI), begin with the OB/GYN then transition to fertility clinics.

CooperSurgical expects growth in fertility treatments as:

• Infertility rates are increasing globally, and there is a significant unmet need for fertility services.

• Patient awareness of and access to services are increasing at a rapid pace.

• The number of fertility clinics is rising worldwide.

• The fertility market is fueled by dynamics such as increasing maternal age, single parents by choice, and LGBTQ+ identifying individuals starting families.

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Women's and Family Reproductive Health Care Product Sales

Office/Surgical – Our significant office and surgical products include PARAGARD, Uterine Manipulators, Retractors, Closure products, Point-of-Care products, LEEP products, Endosee, Illuminate and Fetal Pillow

Fertility – Our significant fertility products and services include fertility consumables, fertility equipment, Embryo Options and preimplantation genetic testing

CooperSurgical Competition

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Competition in the medical device industry is dynamic and involves the search for technological and therapeutic innovations.

CooperSurgical's strategy includes developing and acquiring new products.

CooperSurgical continues to expand its presence in the significantly larger hospital and outpatient surgical procedure segment of the market that is at present dominated by bigger competitors such as Johnson & Johnson, Boston Scientific, Hologic and Medtronic.

CooperSurgical's strategy includes developing and acquiring new solutions.

These competitors have well-established positions within the operating room environment.

CooperSurgical leverages its relationship with gynecologic

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surgeons and focus on devices specific to gynecologic surgery to facilitate our expansion within the surgical segment of the market.

CooperSurgical leverages its relationship with gynecologic surgeons and focus on devices specific to gynecologic surgery to facilitate our expansion within the surgical segment of the market.

CooperSurgical also competes in the fertility category of the women's and family health care market.

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In fertility clinics, our products include media, micro-tools and lab equipment.

and to improve IVF outcomes we offer screening testing services intended to increase implantation rates and decrease miscarriages.

CooperSurgical leverages its relationship with fertility clinics to expand its presence in the fertility market against competitors in the media and microtools categories that include Vitrolife, Cook and FujiFilm-Irvine Scientific and competitors in fertility and familial reproductive genetic testing that include Natera, Invitae and Igenomix.

CooperSurgical competes in the Intrauterine Device (IUD) market.

Additionally, services offered to clinics and families undergoing assisted reproductive technologies include embryo screening testing, genetic counseling and management of storage options.

CooperSurgical competes with a large number of competitors in the fertility market including Vitrolife, FujiFilm-Irvine Scientific, Cook, Hamilton Thorne, Natera and Invitae.

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CooperSurgical competes in the Intrauterine Device (IUD) contraceptive market.

PARAGARD is the only FDA approved non-hormonal IUD option in the United States and has a 10-year use indication.

In the United States, where all IUDs within the Long-Acting Reversible Contraceptive (LARC) space are regulated as drug products, we compete with manufacturers of hormonal IUDs including Bayer and AbbVie Allergan.

Outside of the United States, non-hormonal IUDs are typically regulated as devices and are sold by a number of manufacturers.

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The Company employs approximately 300 people in research and development.

CooperVision's product development and clinical research is supported by internal and external specialists in lens design, formulation science, polymer chemistry, clinical trials, microbiology and biochemistry.

CooperVision's product development and clinical research is supported by internal and external specialists in lens design, formulation science, polymer chemistry, engineering, clinical trials, microbiology and biochemistry.

CooperVision's research and development activities primarily include programs to develop new contact lens designs and manufacturing technology, along with improving formulations and existing products.

CooperSurgical conducts research and development in-house and has consulting agreements with external specialists.

CooperSurgical conducts research and development in-house and has consulting agreements with external specialists in software, hardware and electrical engineering, genetic science and embryology.

CooperSurgical's research and development activities include the design and improvement of surgical procedure devices, the advancement and expansion of CooperSurgical's portfolio of assisted reproductive technology (ART) products, genetic screening and testing, as well as products within the general OB/GYN offerings.

GOVERNMENT REGULATION

Medical Device and Pharmaceutical Regulation

Medical Device Regulation in the United States

Most of our products are medical devices subject to extensive regulation by the FDA in the United States and other regulatory bodies abroad.

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Because we cannot be assured that any new products we develop, or any product enhancements, will be exempt from the premarket clearance or approval requirements or will be subject to the shorter 510(k) clearance process rather than the PMA process, significant delays in the introduction of any new products or product enhancements may occur.

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Device Classification

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The majority of CooperSurgical's products are Class II devices.

Class I devices are devices with the lowest risk and are those for which safety and effectiveness can be assured by adherence to the FDA's general regulatory controls for medical devices, which include compliance with the applicable portions of the FDA's Quality System Regulation (QSR), facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials (General Controls).

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registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials (General Controls).

Some Class I devices also require premarket clearance by the FDA through the 510(k) premarket notification process described below.

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If the FDA determines that the device is not substantially equivalent to a legally marketed predicate, the device is automatically designated as a Class III device.

The device sponsor must fulfill

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more rigorous PMA requirements, or can request a risk-based classification determination for the device in accordance with the de novo process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

The device sponsor must fulfill more rigorous PMA requirements, or can request a risk-based classification determination for the device in accordance with the de novo process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novo classification.

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If the FDA disagrees with a manufacturer's determination that a new clearance or approval is not required for a particular modification, the FDA may require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or until premarket approval is obtained or a de novo classification request is granted.

In these circumstances, a manufacturer also may be subject to significant regulatory fines or penalties.

In these circumstances, a manufacturer also may be subject to significant regulatory fines or

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We have made and plan to continue to make additional product enhancements and modifications to our devices that we believe do not require new 510(k) clearances.

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These proposals have not yet been finalized or adopted, and the FDA may work with Congress to implement such proposals through legislation.

More recently, in September 2019, the FDA published updated guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.

In September 2019, the FDA published updated guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.

The FDA intends to develop and maintain a list of device types appropriate for the “safety and performance based” pathway and will continue to develop product-specific guidance documents that identify the performance criteria for each such device type, as well as the testing methods recommended in the guidance documents, where feasible.

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The FDA, by statute and regulation, has 180 days to review an accepted PMA application, although the review generally occurs over a significantly longer period of time, and can take up to several years.

During this review period, the FDA may request additional information, including clinical data, non-clinical data or

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clarification of information already provided, and the FDA may issue a major deficiency letter to the applicant, requesting the applicant's response to deficiencies communicated by the FDA.

During this review period, the FDA may request additional information, including clinical data, non-clinical data or clarification of information already provided, and the FDA may issue a major deficiency letter to the applicant, requesting the applicant's response to deficiencies communicated by the FDA.

The FDA considers a PMA or PMA supplement to have been voluntarily withdrawn if an applicant fails to respond to an FDA request for information (e.g., major deficiency letter) within 180 days after the FDA issues such request.

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The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s).

The FDA may approve a PMA application with post-approval conditions intended to ensure the safety and effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution and collection of long-term follow-up data from patients in the clinical study that supported approval.

The FDA may approve a PMA application with post-

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approval conditions intended to ensure the safety and effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution and collection of long-term follow-up data from patients in the clinical study that supported approval.

The FDA may also condition approval of a PMA application on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use.

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Regardless of the degree of risk presented by the medical device, clinical studies must be approved by, and conducted under the oversight of, an Institutional Review Board (IRB) for each clinical site.

The IRB is responsible for the initial and continuing review of the study, and may pose additional requirements for the conduct of

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The IRB is responsible for the initial and continuing review of the study, and may pose additional requirements for the conduct of the study.

There can be no assurance that submission of an IDE will result in the ability to commence clinical trials.

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the QSR, which requires manufacturers to follow design, testing, production, control, complaint handling, documentation and other quality assurance procedures during the manufacturing process;

labeling regulations, which prohibit the promotion of products for uncleared or unapproved or “off-label” uses and impose other restrictions on labeling, advertising and promotion;

labeling regulations, which prohibit the

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promotion of products for uncleared or unapproved or “off-label” uses and impose other restrictions on labeling, advertising and promotion;

new FDA unique device identifier regulations, which require changes to labeling and packaging;

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On October 3, 2014, the FDA issued two draft guidance documents entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),” or the Framework Guidance, and “FDA Notification and Medical Device Reporting for LDTs,” or the Reporting Guidance.

The Framework Guidance stated that FDA intended to modify its policy of

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enforcement discretion with respect to LDTs in a risk-based manner consistent with the classification of medical devices generally in Classes I through III.

The Framework Guidance stated that FDA intended to modify its policy of enforcement discretion with respect to LDTs in a risk-based manner consistent with the classification of medical devices generally in Classes I through III.

The Reporting Guidance would have further enabled the FDA to collect information regarding the LDTs currently being offered for clinical use through a notification process, as well as to enforce its regulations for reporting safety issues and collecting information on any known or suspected adverse events related to the use of an LDT.

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Legislative and administrative proposals proposing to amend the FDA’s oversight of LDTs have been introduced in recent years and we expect that new legislative and administrative proposals will continue to be introduced from time to time.

For example, key congressional committees with jurisdiction over FDA matters have indicated an interest in continuing negotiations on potential legislation regarding LDTs.

For example, key congressional committees with jurisdiction over FDA matters have indicated an interest in continuing negotiations on potential legislation regarding

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In March 2020, the VALID Act was introduced in the House and an identical version of the bill was introduced in the U.S.

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As proposed, the bill would establish a risk-based approach to imposing requirements related to premarket review, quality systems, and labeling requirements on all IVCTs, including LDTs, but would create exemptions for certain LDTs marketed before the effective date of the bill (though other regulatory requirements may apply, such as registration and adverse event reporting).

In June 2021, a revised version of the VALID Act was reintroduced in both the House and the Senate.

It is unclear whether the VALID Act or any other legislative proposals (including any proposals to reduce FDA oversight of LDTs) would be passed by Congress or signed into law by the President.

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If Congress does not take action in connection with the VALID Act or other LDT legislation, it is possible that the FDA could change its regulatory policy governing LDTs in a way that could require that our currently marketed genetic tests, and any future products that we anticipate marketing as LDTs, comply with certain additional FDA requirements.

However, the IVDR will regulate the testing of human embryos which will be classified as Class C.

In addition, even though we commercialize our tests as LDTs, our tests may in the future become subject to more onerous regulation by the FDA.

As we operate a genetic testing laboratory, we are required to hold certain federal, state and local licenses, certifications and permits to conduct our business.

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Penalties for non-compliance with CLIA requirements include suspension, limitation or revocation of the laboratory’s CLIA certificate, as well as a directed plan of correction, state on-site monitoring, civil money penalties, civil injunctive suit or criminal penalties.

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In addition to federal certification requirements of laboratories under CLIA, licensure is required and maintained for our laboratory under state law.

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If a laboratory is out of compliance with such statutory or regulatory standards, the state may suspend, limit, revoke or annul the laboratory’s license, censure the holder of the license or assess civil money penalties.

Pharmaceutical Regulation

Pharmaceutical Regulation in the United States

FDA has determined that the primary mode of action for PARAGARD is the drug component and is therefore regulated by FDA’s Center for Drug Evaluation and Research as a drug product.

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Failure to comply with the applicable U.S.

requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending New Drug Applications (NDA), withdrawal of an approval, imposition of a clinical hold, untitled letters, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

requirements at any time during the product

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development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending New Drug Applications (NDA), withdrawal of an approval, imposition of a clinical hold, untitled letters, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

Any drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including manufacturing, periodic reporting, product sampling and distribution, advertising, promotion, drug shortage reporting, compliance with any post-approval requirements imposed as a conditional of approval such as Phase 4 clinical trials, a Risk Evaluation and Mitigation Strategy (REMS), and surveillance, recordkeeping and reporting requirements, including adverse experiences.

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Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in withdrawal of marketing approval, mandatory revisions to the approved labeling to add new safety information or other limitations, imposition of post-market studies or clinical

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trials to assess new safety risks, or imposition of distribution or other restrictions under a REMS program, among other consequences.

The FDA closely regulates the marketing and promotion of drugs.

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Failure to comply with any of the FDA’s requirements, which are subject to new legislation and change, could result in significant adverse enforcement actions.

These include a variety of administrative or judicial sanctions, such as refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, cyber letters, modification of promotional materials or labeling, product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution, debarment, injunctions, fines, consent decrees, corporate integrity agreements, refusals of government contracts and new orders under existing contracts, exclusion from participation in federal and state healthcare programs, restitution, disgorgement or civil or criminal penalties, including fines and imprisonment.

These include a variety of administrative or

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judicial sanctions, such as refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, cyber letters, modification of promotional materials or labeling, product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution, debarment, injunctions, fines, consent decrees, corporate integrity agreements, refusals of government contracts and new orders under existing contracts, exclusion from participation in federal and state healthcare programs, restitution, disgorgement or civil or criminal penalties, including fines and imprisonment.

It is also possible that failure to comply with the FDA’s requirements relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws.

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Foreign Regulation

Health authorities in foreign countries regulate Cooper's clinical trials and medical device sales.

Health authorities in foreign countries regulate Cooper's clinical studies and medical device sales.

The regulations vary widely from country to country.

Even if the FDA has cleared or approved a product in the United States, the regulatory agencies in other countries must approve new products before they may be marketed there.

The time required to obtain approval in another country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ.

There is a trend towards harmonization of quality system standards among the European Union, United States, Canada and various other industrialized countries.

Even if the FDA has cleared or approved a product in the United States, the regulatory agencies or notified bodies in other countries must approve or certify new products before they may be marketed there.

The time required to obtain approval or certification in another country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ.

There is a trend towards harmonization of quality system standards among the European Union (EU), United States, Canada and various other industrialized countries.

Japan has one of the most rigorous regulatory systems in the world and requires in-country clinical trials.

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A CE Mark is an international symbol of adherence to certain standards and compliance with applicable European medical device requirements.

These quality programs and approvals are required by the European Medical Device Directive and must be maintained for all products intended to be sold in the European market.

The ISO 13485 Quality Measurement System registration is now also required for registration of products in Asia Pacific and

These quality programs and approvals are required by the European Medical Device Regulation and must be maintained for all products intended to be sold in the European market.

The ISO 13485 Quality Measurement System registration is now also required for registration of products in Asia Pacific and Latin American countries.

In order to maintain these quality benchmarks, the Company is subjected to rigorous biannual reassessment audits of its quality systems and procedures.

Regulation of Medical Devices and In Vitro Diagnostic Medical Devices in the European Union

The EU has adopted specific directives and regulations regulating the design, manufacture, clinical investigations, conformity assessment, labeling and adverse event reporting for medical devices (including in vitro diagnostic medical devices (IVDs)).

I n the EU, until May 25, 2021, medical devices were regulated by the Council Directive 93/42/EEC, or the EU Medical Devices Directive, which has been repealed and replaced by Regulation (EU) No 2017/745 (the EU MDR).

Unlike directives, regulations are directly applicable in all EU member states without the need for member states to implement into national law.

IVDs are currently regulated by the EU In Vitro Diagnostic Medical Devices Directive (Directive 98/79/EC) (the IVDD).

However, on April 5, 2017, Regulation (EU) 2017/746 of the European Parliament and of the Council on IVDs and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (the EU IVDR) was adopted to establish a modernized and more robust EU legislative framework, with the aim of ensuring better protection of public health and patient safety.

The EU IVDR will become applicable five years after publication (on

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Latin American countries.

In order to maintain these quality benchmarks, the Company is subjected to rigorous biannual reassessment audits of its quality systems and procedures.

In May 2017, the MDR (Regulation 2017/745) was adopted.

The MDR was originally scheduled to become applicable three years after publication (in May 2020), however due to the COVID 19 pandemic, the enforcement date was delayed by 12 months;

the new enforcement date is May 26, 2021.

Once applicable, the new regulations will bring significant new requirements for many medical devices, including enhanced requirements for clinical evidence and documentation, increased focus on device identification and traceability, and additional post market surveillance and vigilance.

Compliance with the MDR will require re-certification of many of our products to the enhanced standards.

Further, products sold as IVDs in Europe will be regulated under the In Vitro Diagnostics Directive (98/79/EC).

A new regulation, the IVDR (EU) 2017/746, the IVDR, has been released and will become fully enforceable in 2022.

These regulations include requirements for both presentation and review of performance data and quality-system requirements.

Both CooperVision and CooperSurgical have been actively deploying regulatory and compliance initiatives designed to allow the continued ability to sell and market their respective products in the EU under the MDR and the IVDR.

May 26, 2022).

However, on October 14, 2021, the European Commission proposed a “progressive” roll-out of the EU IVDR to prevent disruption in the supply of IVDs.

Consequently, if the European Parliament and Council adopt the proposed regulation, the EU IVDR will fully apply on May 26, 2022, but there will be a tiered system extending the grace period for many devices (depending on their risk classification) before they have to be fully compliant with the regulation.

Both the EU MDR and IVDR seek to:

• strengthen the rules on placing devices on the market and reinforce surveillance once they are available;

• establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

• establish explicit provisions on importers’ and distributors’ obligations and responsibilities;

• impose an obligation to identify a responsible person who is ultimately responsible for all aspects of compliance with the requirements of the new regulation;

• improve the traceability of medical devices throughout the supply chain to the end-user or patient through the introduction of a unique identification number, to increase the ability of manufacturers and regulatory authorities to trace specific devices through the supply chain and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk;

• set up a central database (Eudamed) to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;

• strengthen rules for the assessment of certain high-risk devices that may have to undergo an additional check by experts before they are placed on the market.

In the EU, there is currently no premarket government review of medical devices (including IVDs).

However, all medical devices (including IVDs) placed on the EU market must respectively meet general safety and performance requirements for medical devices and essential requirements for IVDs, including that a medical device must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose.

Medical devices must be safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.

Compliance with the essential or general safety and performance requirements is a prerequisite for European Conformity Marking, or CE Mark, without which medical devices cannot be marketed or sold in the EU.

To demonstrate compliance with the essential or general safety and performance requirements medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification.

Except for low-risk medical devices (Class I) or general IVDs, where the manufacturer can self-assess the conformity of its products with the essential or general safety and performance requirements (except for any parts which relate to sterility, metrology or reuse aspects of a medical device), a conformity assessment procedure requires the intervention of a notified body.

Notified bodies are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market.

A notified body would typically audit and examine a product’s technical dossiers and the manufacturers’ quality system (notified body must presume that quality systems which implement the relevant harmonized standards—ISO 13485:2016 for Quality Management Systems—conform to these requirements).

If satisfied that the relevant product conforms to the essential or general safety and performance requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.

The manufacturer may then apply the CE Mark to the device, which allows the device to be placed on the market throughout the EU.

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Throughout the term of the certificate of conformity, the manufacturer will be subject to periodic surveillance audits to verify continued compliance with the applicable requirements.

In particular, there will be a new audit by the notified body before it will renew the relevant certificate(s).

All manufacturers placing medical devices on the market in the EU must comply with the EU medical device vigilance system.

Under this system, serious incidents and Field Safety Corrective Actions (FSCAs) must be reported to the relevant authorities of the EU member states.

Manufacturers are required to take FSCAs to prevent or reduce a risk of a serious incident associated with the use of a medical device that is made available on the market.

An FSCA may include the recall, modification, exchange, destruction or retrofitting of the device.

The advertising and promotion of medical devices is subject to some general principles set forth by EU directives.

Only devices that are CE-marked may be marketed and advertised in the EU in accordance with their intended purpose.

Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, while not specific to the advertising of medical devices, also apply to the advertising thereof and contain general rules, for example requiring that advertisements are evidenced, balanced and not misleading.

Specific requirements are defined at the national level.

EU member states laws related to the advertising and promotion of medical devices, which vary between jurisdictions, may limit or restrict the advertising and promotion of products to the general public and may impose limitations on promotional activities with healthcare professionals.

In the EU, regulatory authorities have the power to carry out announced and, if necessary, unannounced inspections of companies, as well as suppliers and/or sub-contractors and, where necessary, the facilities of professional users.

Failure to comply with regulatory requirements (as applicable) could require time and resources to respond to the regulatory authorities’ observations and to implement corrective and preventive actions, as appropriate.

Regulatory authorities have broad compliance and enforcement powers, and if such issues cannot be resolved to their satisfaction can take a variety of actions, including untitled or warning letters, fines, consent decrees, injunctions, or civil or criminal penalties.

Regulation of Laboratory Developed Tests in the European Union

In the EU, laboratory developed tests (LDTs) are exempt from the regulations that govern medical devices and IVDs under certain conditions.

According to Article 1(5) of the IVDD, “[this Directive] shall not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity.” Article 1(5) further provides that this exemption does not affect the right of an EU member state from imposing “appropriate protection requirements.” In order to fall within this exemption under the IVDD, medical devices, including laboratory developed tests, must be designed and used within such health institution (which may include hospitals, laboratories and public health institutions that support the healthcare system and/or address patient needs but do not treat or care for patients directly) on a non-industrial scale, without being released into the market.

However, the legal framework for applying the exemption under the IVDD to laboratory developed tests is not entirely clear, as the IVDD does not specify what non-industrial scale would be.

When the EU IVDR comes into effect, it may provide greater clarity on the regulation of LDTs.

Under the EU IVDR, the general safety and performance requirements set out in Annex I of the EU IVDR are also applicable to devices manufactured and used only within health institutions.

Manufacturers of such devices are required to demonstrate conformity with the general safety and performance requirements set out in Annex I of the EU IVDR through performance evaluations in accordance with Article 56 of the EU IVDR and the manufacturer’s quality management system framework.

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The EU IVDR provides that the relevant general safety and performance requirements set out in Annex I of the EU IVDR do not generally apply to devices manufactured and used only within health institutions established in the EU, provided that the conditions set out in Article 5 of the EU IVDR are met.

Under the EU IVDR, health institutions may manufacture, modify and use medical devices within such institutions, thereby addressing the specific needs of target patient groups on a non-industrial scale.

Under such circumstances, where the LDTs are manufactured and used strictly within health institutions (which may include hospitals, laboratories, public health institutions that support the healthcare system and/or address patient needs but do not treat or care for patients directly), LDTs would continue to be exempt from regulation.

However, compared to the previous regulatory regime, the exemptions for LDTs will, overall, be narrowed, as even in relation to LDTs, health institutions, among others, are required to provide information upon request on the use of such devices to their competent authority and each health institution will have to draw up a declaration which it will make publicly available.

If these conditions are not met and/or diagnostic tests are manufactured and used only within health institutions but “on an industrial scale,” such tests will qualify as in vitro diagnostic medical devices with the full applicability of the EU IVDR.

LDTs regulated by the EU IVDR will be subject to conformity assessments and inspections by the relevant competent authority, who will also review the declarations and statements made by the health institutions in relation to their LDTs.

Our current and future tests will need to be analyzed as to whether any or all of them would qualify for an exemption under Article 5 of EU IVDR or otherwise.

We will be required to comply with various certification and documentation criteria, and we may be subject to conformity assessments and inspections.

Given that the EU IVDR has not yet come into effect, it remains to be seen how it, and particularly the exemptions it grants under Article 5 of EU IVDR, may be further interpreted and clarified in the future.

The aforementioned EU rules are generally applicable in the European Economic Area (EEA) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.

The Impact of Brexit

The EU IVDR will not be applicable in Great Britain (England, Scotland and Wales) due to Brexit.

Existing EU directives governing all medical devices, including in vitro diagnostic medical devices have been given effect in domestic law through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended).

This means that from January 1, 2021, the Great Britain route to market is still based on the requirements derived from the pre-existing EU legislation.

As a standalone regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices in Great Britain.

The MHRA may choose to align with the EU IVDR going forward with respect to LDTs, respectively, or retain regulatory flexibility through domestic legislation which will continue to be monitored.

The UK government has introduced a new Medicines and Medical Devices bill which allows the secretary of state to amend or supplement the Medical Devices Regulations 2002 (SI 2002/618).

In addition, the Trade Deal between the UK and the EU generally provides for cooperation and exchange of information between the parties in the areas of product safety and compliance, including market surveillance, enforcement activities and measures, standardization related activities, exchanges of officials, and coordinated product recalls.

As such, processes for compliance and reporting should reflect requirements from regulatory authorities.

CE Marks issued by EU-recognized notified bodies will continue to be valid in Great Britain, until June 30, 2023.

For medical devices placed on the Great Britain market after this period, the UK Conformity Assessment (UKCA) marking will be mandatory.

The EU no longer recognizes conformity assessment activities performed by UK notified bodies for medical devices placed on the market since January 1, 2021.

Notified bodies must be located in an European Union member state, or territory where there is a mutual recognition agreement (MRA);

there is currently no such MRA between the UK and the EU.

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Other Health Care Regulation

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A claim includes “any request or demand” for money or property presented to the U.S.

In addition, a claim including items or

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services resulting from a violation of the federal Anti-Kickback Statute or Stark Law constitutes a false or fraudulent claim for purposes of the federal False Claims Act.

In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute or Stark Law constitutes a false or fraudulent claim for purposes of the federal False Claims Act.

The federal Health Insurance Portability and Accountability Act of 1996 also created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items, or services.

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Also, many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

In addition, the federal government, as part of the Affordable Care Act (the ACA), as well as certain state governments have enacted laws aimed at increasing transparency in relationships between medical device companies and health care professionals.

We are now required by the federal Physician Payments Sunshine Act and similar state and foreign laws to report annually many types of payments made and items of value provided to licensed health care professionals and teaching hospitals, as well as certain ownership and investment interests held by physicians (as defined by statute) and their immediate family members.

In addition, the federal government, as part of the Patient Protection and Affordable Care Act (the ACA), as well as certain state governments have enacted laws aimed at increasing transparency in relationships between medical device companies and health care professionals.

We are now required by the federal Physician Payments Sunshine Act and similar state and foreign laws to report annually many types of

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payments made and items of value provided to licensed health care professionals and teaching hospitals, as well as certain ownership and investment interests held by physicians (as defined by statute) and their immediate family members.

Certain states also mandate implementation of commercial compliance programs, impose restrictions on device manufacturer marketing practices and tracking and/or require the reporting of gifts, compensation and other remuneration to physicians.

In addition, certain foreign jurisdictions have adopted, or are currently acting to implement, similar laws.

In the EU, many member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices (including IVDs), in particular vis-à-vis healthcare professionals and organizations.

Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities.

In addition, many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the United States, on medical device manufacturers.

Certain countries also mandate implementation of commercial compliance programs.

Violations of these laws may be punishable by criminal and civil sanctions, including fines and civil monetary penalties, the possibility of exclusion from federal healthcare programs (including Medicare and Medicaid), disgorgement and corporate integrity agreements, which impose, among other things, rigorous operational and monitoring requirements on companies.

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Failure by physicians, hospitals, surgery centers, fertility clinics and other users of our products to obtain sufficient coverage and reimbursement from third-party payors for procedures in which our products are used, or adverse changes in government and private third-party payors’ coverage and reimbursement policies.

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We believe the overall escalating cost of medical products and services being paid for by the government and private health insurance has led to, and will continue to lead to, increased pressures on the healthcare and medical device industry to reduce the costs of products and services.

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These updates could directly impact the demand for our products.

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With respect to drug coverage and reimbursement, third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of drugs, in addition to their safety and efficacy.

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Additionally, decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product.

In international markets including the EU, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific product lines and procedures.

There can be no assurance that procedures using our products will be covered for a specific indication, that our products 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 products profitably.

For example, in the EU, member states impose controls on whether products are reimbursable by national or regional health service providers and on the prices at which devices are reimbursed under state-run healthcare schemes.

More and more, local, product specific reimbursement law is applied as an overlay to medical device regulation, which has provided an additional layer of clearance requirement.

Healthcare Reform

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Among policy makers and payors in the United States, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.

In March 2010, the Patient Protection and Affordable Care Act, or ACA, was passed, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical, medical device and clinical laboratory industries.

Passed in March 2010, the ACA substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical, medical device and clinical laboratory industries.

Among other things, the ACA increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1%;

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and established a Center for Medicare Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

Since its enactment, there have been judicial and political challenges to certain aspects of the ACA.

On June 17, 2021, the U.S.

Supreme Court rejected a challenge by a group of states and individuals to the constitutionality of the ACA.

However, it is still unclear how other efforts to challenge, repeal or replace the ACA will impact the law.

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Since its enactment, there have been judicial and political challenges to certain aspects of the Affordable Care Act.

On March 2, 2020, the U.S.

Supreme Court granted the petitions for writs of certiorari to review the constitutionality of the ACA, although it is unclear when or how the Supreme Court will rule.

It is also unclear how other efforts to challenge, repeal or replace the ACA will impact the law.

In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted.

These changes included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through December 31, 2020, unless additional Congressional action is taken.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted.

These changes included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of the temporary suspension from May 1, 2020 through December 31, 2021, unless additional Congressional action is taken.

In addition, on January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

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Further, entities that knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA covered entity in a manner that is not authorized or permitted by HIPAA may be subject to criminal penalties.

Even when HIPAA does not apply, according to the Federal Trade Commission (FTC), violating consumers’ privacy rights or failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act.

The FTC expects a company’s data security measures to be reasonable

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The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

In addition, certain state and non-U.S.

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The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.

In Europe, the GDPR went into effect in May 2018 and imposes strict requirements for processing the personal data of individuals within the EEA and the United Kingdom.

In Europe, the GDPR went into effect in May 2018 and imposes strict requirements for processing the personal data of individuals within the EEA and the UK.

In addition, the GDPR increases the scrutiny of transfers of personal data from clinical trial sites located in the EEA to the United States and other jurisdictions that the European Commission does not recognize as having “adequate” data protection laws;

in July 2020, the Court of Justice of the European Union limited how organizations could lawfully transfer personal data from the EEA to the United States by invalidating the EU-US Privacy Shield and imposing further restrictions on use of the standard contractual clauses, which could increase our costs and our ability to efficiently process personal data from the EEA.

in July 2020, the Court of Justice of the EU (CJEU) limited how organizations could lawfully transfer personal data from the EEA to the United States by invalidating the EU-US Privacy Shield and imposing further restrictions on use of the standard contractual clauses, which could increase our costs and our ability to efficiently process personal data from the EEA.

Indeed, while the CJEU upheld the adequacy of the standard contractual clauses (a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism, and potential alternative to the Privacy Shield), it made clear that reliance on them alone may not necessarily be sufficient in all circumstances.

Use of the standard contractual clauses must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular applicable surveillance laws and rights of individuals and additional measures and/or contractual provisions may need to be put in place.

However, the nature of these additional measures is currently uncertain.

The CJEU went on to state that if a competent supervisory authority believes that the standard contractual clauses cannot be complied with in the destination country and the required level of protection cannot be secured by other means, such supervisory authority is under an obligation to suspend or prohibit that transfer.

The European Commission has published revised standard contractual clauses for data transfers from the EEA:

the revised clauses must be used for relevant new data transfers starting September 27, 2021;

existing standard contractual clauses arrangements must be migrated to the revised clauses by December 27, 2022.

There is some uncertainty around whether the revised clauses can be used for all types of data transfers, particularly whether they can be relied on for data transfers to non-EEA entities subject to the GDPR.

Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater.

Additionally, following the United Kingdom’s withdrawal from the EEA and the EU, and the expiry of the transition period, companies will have to comply with the GDPR and the GDPR as incorporated into the United Kingdom national law, the latter regime having the ability to separately fine up to the greater of £17.5 million or 4% of global turnover.

The relationship between the United Kingdom and the EU in relation to certain aspects of data protection law remains unclear, for example around how data can lawfully be transferred between each jurisdiction, which exposes us to further compliance risk.

Additionally, following the UK’s withdrawal from the EEA and the EU, and the expiry of the transition period, companies will have to comply with the GDPR and the GDPR as incorporated into the UK national law, the latter regime having the ability to separately fine up to the greater of £17.5 million or 4% of annual global turnover.

The European Commission has adopted an adequacy decision in favor of the UK, enabling data transfers from EU member states to the UK without additional safeguards.

However, the UK adequacy decision will automatically expire in June 2025 unless the European Commission re-assesses and renews/extends that decision, and remains under review by the Commission during this period.

The relationship between the UK and the EU in relation to certain aspects of data protection law remains unclear, and it is unclear how UK data protection laws and regulations will develop in the medium to long term, and how data transfers to and from the UK will be regulated in the long term.

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RAW MATERIALS

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To support the sale and use of CooperVision products, CooperVision engages in various activities and offers a variety of services.

These include clinical training, digital marketing for the customer, e-commerce, telemarketing, social media, and

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journal advertisements.

These include clinical training, digital marketing for the customer, e-commerce, telemarketing, social media, and journal advertisements.

CooperVision also invested in tools that allow our customers to offer their patients monthly purchase and delivery subscriptions.

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DEPENDENCE ON CUSTOMERS

No customers accounted for 10% or more of our consolidated net revenue in fiscal 2020 and 2019.

No customer accounted for 10% or more of our consolidated net revenue in fiscal 2021 and 2020.

Business Segment Information of the Consolidated Financial Statements for additional information.

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Neither of our business units is materially subject to profit renegotiation or termination of contracts or subcontracts at the election of the United States government.

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CooperVision and CooperSurgical net sales in the fiscal first quarter, which runs from November 1 through January 31, are typically lower than subsequent quarters, as patient traffic to practitioners' offices, fertility clinics, and hospitals/surgical centers for surgical procedures is relatively light during the holiday season.

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Federal, state and local provisions that regulate the discharge of materials into the environment, or relate to the protection of the environment, do not currently materially affect Cooper's capital expenditures, earnings or competitive position.

In addition, the Company continues to monitor and comply with environmental health and safety regulations in countries in which it operates throughout the world, in particular, EU and China

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Restrictions on the use of certain Hazardous Substances in electrical and electronic equipment (RoHS) and Registration, Evaluation, Authorization and Restriction of Chemical substances, or REACH.

In addition, the Company continues to monitor and comply with environmental health and safety regulations in countries in which it operates throughout the world, in particular, EU and China Restrictions on the use of certain Hazardous Substances in electrical and electronic equipment (RoHS) and Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH).

HUMAN CAPITAL RESOURCES

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We believe we have good relations with our workforce.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees.

The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the granting of stock-based compensation awards.

Our employees are located around the world, with 48% in Americas, 47% in EMEA and 5% in Asia Pacific.

Human capital management areas of focus include a people-focused culture;

embedding diversity and inclusion;

fostering an environment of health, safety, and well-being;

investing in and developing our employees through training and engagement.

In addition, we regularly conduct an employee survey to gauge employee engagement.

The Chart below shows percentage of employees located in Americas, EMEA and Asia Pacific as of October 31, 2021.

Additional information is included in our annual ESG Report (located on our website at www.coopercos.com/esg-report-2020).

Information on our website, including the ESG Report, shall not be deemed incorporated by reference into this Annual Report.

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NEW YORK STOCK EXCHANGE CERTIFICATION

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The SEC maintains a website that contains such reports, proxy and information statements and other information whose Internet address is http://www.sec.gov.

The Company's Corporate Governance Principles, Ethics and Business Conduct Policy and charters of each standing committee of the Board of Directors are also posted on the Company's website.

The Company's Corporate Governance Principles, Code of Conduct and charters of each standing committee of the Board of Directors are also posted on the Company's website.

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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.

What changed 10-K

Item 1. Business