What changed in this filing

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Item 1. Business

2022-12-09 compared with 2021-12-10 · 255 added, 215 removed, 394 unchanged (54% of the section changed)

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CooperVision develops, manufactures and markets a broad range of single-use, two-week and monthly contact lenses, featuring advanced materials and optics.

CooperVision designs its products to solve vision challenges such as astigmatism, presbyopia, myopia, ocular dryness and eye fatigues;

CooperVision designs its products to solve vision challenges such as astigmatism, presbyopia and myopia;

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

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.

CooperSurgical's business competes in the general health care market with a focus on advancing the health of women, babies and families through a diversified portfolio of products and services including medical devices, fertility, diagnostics and contraception.

CooperVision also manufactures and markets myopia management and specialty eyecare products which it gained through a series of orthokeratology (ortho-k) and scleral lens acquisitions.

In November 2019, CooperVision's internally developed MiSight® 1 day lens became first and only approved product by the United States Food and Drug Administration (FDA) for myopia control and is indicated to slow the progression of myopia in children when treatment is initiated between the ages of 8-12.

The MiSight 1 day lens became available in the U.S.

in fiscal 2020 and 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 UK and the U.S., with other smaller locations also existing in multiple locations around the world.

CooperSurgical's business competes in the general health care market with a focus on advancing the health of women, babies and families through a diversified portfolio of products and services.

Our fertility portfolio encompasses medical device coverage of the in vitro fertilization (IVF) cycle, egg and sperm donation, and cryopreservation.

Our office and surgical platform encompasses more than 600 clinically-relevant medical devices used in gynecology and obstetrics, including contraception and labor & delivery, as well as cord blood and cord tissue storage services.

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

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and fertility products/equipment and genetic testing services used primarily in fertility clinics and laboratories.

CooperSurgical's major manufacturing and distribution facilities are located in Costa Rica, the Netherlands, the United Kingdom and the United States, with other smaller locations also existing in multiple locations around the world.

CooperSurgical's major manufacturing, cryostorage and distribution facilities are located in Costa Rica, the Netherlands, the United Kingdom and the United States, with other smaller locations also existing in multiple locations around the world.

CooperVision and CooperSurgical each operate in highly competitive environments.

Both of Cooper's businesses compete predominantly on the basis of product quality and differentiation, technological benefit, price, service and reliability.

Both of Cooper's businesses compete predominantly on the bases of product quality and differentiation, technological benefits, price, service levels and reliability.

CooperVision competes in the worldwide soft contact lens market and services three primary regions:

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• Spherical lenses including lenses that correct near- and farsightedness uncomplicated by more complex visual defects.

• 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.

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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.

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

Myopia management contact lenses slow the progression of myopia in children 8 to 12 years of age at initiation of the treatment.

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 frequent replacement (FRP) lenses, which are designed for two-week and monthly replacement.

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

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• 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, custom toric lenses for patients with a high degree of astigmatism, and myopia management contact lenses.

single-use, two-week and monthly 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, and myopia management contact lenses.

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

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Silicone hydrogel lenses represent a significant portion of CooperVision's contact lens sales and our Biofinity ® brand is CooperVision's leading product line in terms of sales.

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, toric and multifocal 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.

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

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

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

We believe the global market for single-use contact lenses will continue to grow and that our competitive silicone hydrogel and traditional hydrogel product offerings represent an opportunity for our business.

In addition to its silicone hydrogel product offerings, CooperVision competes in the contact lens market with other traditional hydrogel products.

CooperVision believes that our key accounts which include optical chains, global retailers, certain buying groups and mass merchandisers are growing faster than the overall market.

We are focused on supporting the growth of all our customers by investing in selling, promotional and advertising activities.

CooperVision focuses on supporting the growth of all customers including key accounts (optical chains, global retailers, certain buying groups and mass merchandisers) by investing in selling, promotional and advertising activities.

Further, we are increasing investment in our distribution and packaging capabilities to support the growth of our business and to continue providing quality service with our industry leading SKU range and customized offerings.

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

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

With MiSight, CooperVision offers the only FDA approved 1 and first Chinese NMPA approved product to control the progression of myopia in age-appropriate children.

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

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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.

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

In fiscal 2022, CooperVision acquired a privately-held Denmark-based ortho-k contact lens distributor.

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.

1 Indications for use of MiSight® 1 day (omafilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism.

The lens is to be discarded after each removal.

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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

Single-use spheres – This includes Biomedics 1 day, clariti 1 day, MyDay, MiSight and Proclear 1 day

Toric – This includes Avaira Vitality toric, Biomedics toric, Biofinity toric, clariti 1 day toric, MyDay toric and Proclear toric

Multifocal – This includes Biofinity multifocal, Biofinity toric multifocal, clariti 1 day multifocal, MyDay multifocal and Proclear 1 day multifocal

Non single-use sphere, other – This includes our Avaira Vitality spheres, frequent replacement product (FRP) lens portfolio (Biofinity spheres, Biofinity Energys, Biomedics, Proclear spheres, clariti spheres), ortho-k, scleral and custom lenses, contact lens solutions and other

CooperVision Competition

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and Bausch Health Companies Inc.

CooperVision's competitors may have greater financial resources, larger research and development budgets, larger sales forces, greater market penetration and/or larger manufacturing volumes.

Certain of CooperVision's competitors may have greater financial resources, larger research and development budgets, larger sales forces, greater market penetration and/or larger manufacturing volumes.

CooperVision seeks to offer a high level of customer service through its direct sales organizations around the world and through telephone sales and technical service representatives who consult with eye care professionals about the use of our lens products.

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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:

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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.

CooperVision offers both branded and private label options in contact lenses.

CooperVision offers both branded and private label/store brand options in contact lenses.

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 as well as ortho-k and scleral lenses.

It also competes in the specialty contact lens space with its FDA approved MiSight 1 day contact lens for myopia management in age-appropriate children 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

CooperSurgical offers a broad array of products and services focused on advancing the health of women, babies and families through a diversified portfolio of products and services including medical devices, fertility, genomics, diagnostics and contraception.

We offer quality products, innovative technologies and superior services to health care professionals and patients worldwide.

CooperSurgical collaborates with health care professionals to identify products and new technologies from disposable products to diagnostic tests to sophisticated instruments and equipment, to bring new products to market.

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.

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

A focus area for CooperSurgical 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 these 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 2022, CooperSurgical acquired both a private cryopreservation services company and Generate Life Sciences (Generate), a privately-held leading provider of donor egg and sperm for fertility treatments, fertility cryopreservation services and newborn stem cell storage (cord blood & cord tissue).

In fiscal 2021, CooperSurgical acquired three privately-held medical device companies and one privately-held IVF cryostorage software solutions company.

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

CooperSurgical participates in the market for family health care with its diversified product lines in three major categories based on the point of health care delivery:

In April 2022, CooperSurgical entered into an asset purchase agreement to acquire Cook Medical's Reproductive Health business, a manufacturer of minimally invasive medical devices focused on the fertility, obstetrics and gynecology markets.

The aggregate consideration is $875.0 million in cash, with $675.0 million payable at the closing and the remaining $200.0 million payable in $50.0 million installments following each of the first, second, third and fourth anniversaries of the closing.

The transaction is subject to customary closing conditions, such as receipt of required regulatory approvals.

Market for Women's and Family Health Care

CooperSurgical participates in the market for women's and family health care with its diversified product lines in three major categories based on the point of health care delivery:

hospitals and surgical centers, OB/GYN medical offices and fertility clinics.

CooperSurgical expects patient visits to Women’s Health provider offices in the United States to increase over the next decade.

From adolescent care to geriatrics, there is increased awareness of women’s health issues.

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

In recent years, including with the acquisition of Generate in fiscal 2022, CooperSurgical’s business increasingly includes marketing and selling to end consumers of healthcare technology and reproductive planning products and services.

CooperSurgical expects patient visits to women’s health provider offices in the U.S.

to increase over the next decade.

From adolescent care to geriatrics, there is increasing global awareness of women’s health issues.

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

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

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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.

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

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 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.

Recent trends of patient-centered, value-based care 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:

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The OB/GYN market encompasses the following significant points of healthcare delivery:

• Routine office visits:

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Approximately a third of gynecology office visits are related to abnormal uterine bleeding.

• Office-based procedures are increasing given high patient satisfaction, reduction of health system cost and comparative clinical outcomes.

Trends in the OB/GYN market include:

• Office-based and outpatient procedures are increasing given high patient satisfaction, reduction of health system cost and comparative clinical outcomes.

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

• 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:

• Pregnancy and childbirth complications are on the rise.

• The obstetrician is a key contributor to stem cell storage, facilitating the collection of cord blood and cord tissue following delivery in most markets.

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

With respect 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.

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

• Improved product offerings such as donor activity and cryopreservation services

• Technology improvements for both male and female infertility challenges

• Greater worldwide disposable income

Women's and Family Health Care Product Sales

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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

Office/Surgical – This includes Endosee endometrial imaging products, Fetal Pillow cephalic elevation devices for use in Cesarean sections, illuminated speculum products, Lone Star retractor systems, loop electrosurgical excision procedure (LEEP) products, Mara water ablation systems, newborn stem cell storage, PARAGARD contraceptive IUDs, point-of-care products and uterine positioning products.

Fertility – Our significant fertility products and services include cryostorage, donor gamete services, fertility consumables and equipment and genomic services (including preimplantation genetic testing).

CooperSurgical Competition

CooperSurgical focuses on selected segments of the family and women's health care market with a diversified portfolio of products and services including medical devices in outpatient and operating room settings, fertility and contraception.

In some instances, CooperSurgical offers all the items needed for a complete procedure.

CooperSurgical believes that opportunities exist for continued market consolidation.

Competitive factors in these segments in which CooperSurgical competes include technological and scientific advances, product quality and availability, price, customer service including response time and effective communication of product information to physicians, fertility clinics and hospitals.

CooperSurgical focuses on selected segments of the women's and family health care market with a diversified portfolio of products and services including medical devices in outpatient and operating room settings, fertility, contraception and healthcare technology services.

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 solutions.

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, Hologic and Medtronic.

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

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 competes in categories across women’s health, including routine care, diagnostics and medical devices used in outpatient care, surgical procedures and labor and delivery.

Larger companies such as Johnson & Johnson, Medtronic and Hologic have offerings that compete with our products.

CooperSurgical offers private cord blood and cord tissue cryostorage services in the U.S., Canada and Australia.

In that field, we compete primarily with ViaCord, a division of Perkin Elmer, in the U.S., as well as other smaller companies globally.

CooperSurgical also offers PARAGARD, which is the only FDA approved, non-hormonal Intrauterine Device (IUD) contraceptive option in the U.S.

and has a 10-year use indication.

With PARAGARD, we compete with manufacturers of hormonal IUDs including Bayer and AbbVie, Long Acting Reversible Contraceptives (LARCs), including Organon, and other forms of birth control.

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.

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 and manufacturers of other forms of birth control.

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

Currently, PARAGARD is not sold outside of the United States.

Additionally, services offered to clinics and families undergoing assisted reproductive technologies include genomics, donor gametes and cryostorage.

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

RESEARCH AND DEVELOPMENT

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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.

CooperSurgical's research and development activities include the design and improvement of surgical procedure devices, and the advancement and expansion of CooperSurgical's portfolio of fertility and general OB/GYN offerings.

GOVERNMENT 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.

Most of our products are medical devices subject to extensive regulation by the FDA in the U.S.

and other regulatory bodies abroad.

The Federal Food, Drug, and Cosmetic Act (FDCA) and FDA regulations govern, among other things, medical device design and development, testing, manufacturing, labeling, storage, record keeping, premarket clearance or approval, advertising and promotion, and sales and distribution.

Unless an exemption applies, each medical device we wish to distribute commercially in the United States will require either premarket notification to the FDA requesting clearance for commercial distribution under Section 510(k) of the FDCA, or premarket approval (PMA) from the FDA.

Unless an exemption applies, each medical device we

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wish to distribute commercially in the U.S.

will require either premarket notification to the FDA requesting clearance for commercial distribution under Section 510(k) of the FDCA, or premarket approval (PMA) from the FDA.

A majority of the medical devices we currently market have received FDA clearance through the 510(k) process or approval through the PMA process.

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

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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).

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).

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

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When we are required to obtain a 510(k) clearance for a Class I or Class II device that we wish to market, we must submit a premarket notification to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device.

A predicate device is a legally marketed device that is not subject to a PMA, a device that was legally marketed in commercial distribution in the United States before May 28, 1976 (a pre-amendments device) and, for which the FDA has not yet called for the submission of a PMA, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) premarket notification process.

A predicate device is a legally marketed device that is not subject to a PMA, a device that was legally marketed in commercial distribution in the U.S.

before May 28, 1976 (a pre-amendments device) and, for which the FDA has not yet called for the submission of a PMA, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) premarket notification process.

The FDA aims to make substantial equivalence determinations following receipt of a 510(k) premarket notification within 90 days of submission of the notification, but as a practical matter, clearance can take significantly longer.

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The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer's determination.

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

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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.

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.

Over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products.

For example, in November 2018, FDA officials announced forthcoming steps that the FDA intends to take to modernize the premarket notification pathway under Section 510(k) of the FDCA.

For example, in November 2018, FDA officials announced steps that the FDA intended to take to modernize the premarket notification pathway under Section 510(k) of the FDCA.

Among other things, the FDA announced that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates.

These proposals included plans to potentially sunset certain older devices that were used as predicates under the 510(k) clearance pathway, and to potentially publish a list of devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old.

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

These proposals have not yet been finalized or adopted.

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.

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

Premarket Approval Pathway

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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-

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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 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 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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New PMA applications or PMA application supplements are required for significant modifications to the manufacturing process, labeling and design of a device that is approved through the PMA process.

PMA supplements often require submission of the same type of information as a PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application, and may not require as extensive clinical data or the convening of an advisory panel.

PMA supplements often require submission of the same type of information as a PMA application, except that the supplement is limited to information needed to support any changes

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from the device covered by the original PMA application, and may not require as extensive clinical data or the convening of an advisory panel.

Clinical Trials for Medical Devices

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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

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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 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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We provide certain genetic testing laboratory services.

In the United States, Under the FDCA and the FDA’s regulatory framework, in vitro diagnostic devices (IVDs) are a type of medical device that can be used in the diagnosis or detection of diseases, such as cancer, or other conditions.

In the U.S., under the FDCA and the FDA’s regulatory framework, in vitro diagnostic devices (IVDs) are a type of medical device that can be used in the diagnosis or detection of diseases, such as cancer, or other conditions.

The FDA considers Laboratory Developed Tests (LDTs) to be a subset of IVDs, which are intended for clinical use and are designed, manufactured, and used within a single laboratory.

Although the FDA has statutory authority to assure that medical devices, including IVDs, are safe and effective for their intended uses, the FDA has historically exercised its enforcement discretion and not enforced certain applicable provisions of the FDCA and regulations with respect to LDTs.

Even under its current enforcement discretion policy, the FDA has issued warning letters to IVD manufacturers for commercializing laboratory tests that were purported to be LDTs but that the FDA alleged failed to meet the definition of an LDT or otherwise were not subject to the FDA’s policy on enforcement discretion because they presented a potential safety risk.

Although the FDA has statutory authority to assure that medical devices, including IVDs, are safe and effective for their intended uses, the FDA

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has historically exercised its enforcement discretion and not enforced certain applicable provisions of the FDCA and regulations with respect to certain LDTs.

Additionally, the FDA could change its policy of enforcement discretion for LDTs, even without legislation.

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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

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

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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Depending on the approach adopted under any potential legislation, certain LDTs could become subject to some form of premarket review, potentially with a transition period for compliance and a grandfathering provision.

Moreover, in August 2020, the U.S.

Department of Health and Human Services issued a rescission order stating that the FDA will not require premarket review of LDTs absent changes in policy implemented through formal notice-and-comment rulemaking procedures.

The degree to which this rescission order will affect FDA’s enforcement discretion policy or its oversight over LDTs remains unclear.

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.

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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.

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FDA Regulation of HCT/Ps

We currently operate a provider of donor egg and sperm for fertility treatments, fertility cryopreservation services and newborn stem cell storage.

Donated reproductive tissue (eggs or sperm) are regulated by the FDA as human cells, tissues, and cellular and tissue-based products (HCT/Ps).

In addition, Section 361 of the Public Health Service Act (PHSA) authorizes the FDA to issue regulations to prevent the introduction, transmission or spread of communicable disease with respect to HCT/Ps.

HCT/Ps regulated as “361 HCT/Ps” are subject to requirements relating to registering facilities and listing products with the FDA, and stringent requirements for processing, storing, labeling and distributing HCT/Ps, including required labeling information, screening and testing for tissue donor eligibility, record keeping and adverse event reporting, among other applicable requirements and laws.

361 HCT/Ps do not require 510(k) clearance, PMA approval, submission of a Biologics License Application, or other premarket authorization from the FDA before marketing.

However, to be regulated as a 361 HCT/P, the product must, among other things, be “minimally manipulated,” which for structural tissue products means that the manufacturing processes do not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement, and for cells or nonstructural tissue products, means that the manufacturing processes do not alter the relevant biological characteristics of cells or tissues.

A 361 HCT/P must also be intended for “homologous use,” which refers to use in the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.

HCT/Ps that do not meet the criteria of Section 361 are regulated under Section 351 of the PHSA.

Unlike 361 HCT/Ps, HCT/Ps regulated as “351 HCT/Ps” are subject to premarket review and/or approval by the FDA, as required.

We believe our HCT/Ps are regulated as 361 HCT/Ps.

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.

In the United States, the FDA regulates drugs under the FDCA and its implementing regulations.

In the U.S., the FDA regulates drugs under the FDCA and its implementing regulations.

The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

Failure to comply with the applicable U.S.

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.

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.

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

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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

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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.

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.

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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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 or notified bodies in other countries must approve or certify new products before they may be marketed there.

Even if the FDA has cleared or approved a product in the U.S., 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.

There is a trend towards harmonization of quality system standards among the European Union (EU), U.S., 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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If the Company does not maintain compliance with regulatory standards or if problems occur after marketing, product approval may be withdrawn.

In addition to FDA regulatory requirements, CooperVision maintains ISO 13485 certification and CE Mark approvals for its products and CooperSurgical maintains ISO 13485 certification for medical devices and ISO 15189 certification for the Genomics laboratories.

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 Regulation and must be maintained for all products intended to be sold in the European market.

In addition to FDA regulatory requirements, CooperVision maintains ISO 13485 certification and CE marks for its products and CooperSurgical maintains ISO 13485 certification for medical devices and ISO 15189 certification for the Genomics laboratories.

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

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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).

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

Similarly, until May 25, 2022, IVDs were regulated by Directive 98/79/EC (the EU IVDD) which has been repealed and replaced by Regulation (EU) 2017/746 of the European Parliament and of the Council (the EU IVDR).

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.

The European Parliament and Council adopted the proposed regulation on December 15, 2021.

The EU IVDR became applicable on May 26, 2022 but there is 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.

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

Both regulations were adopted to establish a modernized and more robust EU legislative framework, with the aim of ensuring better protection of public health and patient safety.

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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:

Our current certificates have been granted under the EU MDD and the EU IVDD.

Devices lawfully placed on the market pursuant to the EU MDD prior to May 26, 2021 may generally continue to be made available on the market or put into service until May 26, 2025, provided that the requirements of the transitional provisions are fulfilled.

In particular, the certificate in question must still be valid.

Similarly, with respect to IVDs, they may generally continue to be made available provided that the requirements of the transitional provisions are fulfilled.

However, respectively as of May 26, 2021 and May 26, 2022 some of the EU MDR and EU IVDR requirements apply in place of the corresponding requirements of the former directives with regard to registration of economic operators and of devices, post-market surveillance and vigilance requirements.

Pursuing marketing of medical devices (including IVDs) in the EU will notably require that our devices be certified under the new regimes set forth in the EU MDR and the EU IVDR when our current certificates expire.

Both the EU MDR and the EU IVDR seek to:

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

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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.

However, all medical devices (including IVDs) placed on the EU market must meet general safety and performance requirements , 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.

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

To demonstrate compliance with the 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 (Class A), where the manufacturer can self-assess the conformity of its products with the 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.

If satisfied that the relevant product conforms to the 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.

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

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

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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.

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 EU MDR and IVDR.

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.

According to the former Article 1(5) of the EU 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 provided that this exemption did not affect the right of an EU member state from imposing “appropriate protection requirements.” In order to fall within this exemption under the EU IVDD, medical devices, including laboratory developed tests, had to 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 EU IVDD to laboratory developed tests was not entirely clear, as the EU IVDD did not specify what non-industrial scale would be.

Since the EU IVDR became applicable, 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.

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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.

However, compared to the previous regulatory regime, the exemptions for LDTs have, overall, been 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 IVDs with the full applicability of the EU IVDR.

LDTs regulated by the EU IVDR are 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 the 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.

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.

Following a national referendum and enactment of legislation by the government of the UK, the UK formally withdrew from the EU on January 31, 2020, commonly referred to as “Brexit”, and, following the expiry of the Brexit transitional period on December 31, 2020, the UK now operates under a distinct regulatory regime and certain EU laws now only

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apply to the UK in respect of Northern Ireland (as laid out in the Protocol on Ireland and Northern Ireland).

The Medicines and Healthcare products Regulatory Agency (MHRA) is now the UK’s standalone regulator.

Although the UK and EU have now reached an agreement on its future trading relationship (implemented in the EU-UK Trade and Cooperation Agreement from January 1, 2021, or the TCA), the agreement does not cover all regulatory areas regarding medical devices (including IVDs), which may be subject to future bilateral discussions going forward and could further change the relationship between the UK and the EU in this regard.

EU laws which were directly applicable before the end of the transitional period or have been transposed into UK law through secondary legislation continue to be applicable as “retained EU law.” However, new legislation such as the EU MDR and EU IVDR will not be applicable.

The UK government has introduced a new Medicines and Medical Devices Act which seeks to address regulatory gaps through implementing regulations and delegated powers covering the fields of human medicines, clinical studies of human medicines, and medical devices.

Significantly, under the TCA there is no mutual recognition of regulatory regimes and certifications between the EU and the UK.

Post-Brexit, amendments have been made to the existing UK medical devices legislation which require medical devices to be registered with the MHRA before being placed on the Great Britain market.

Manufacturers based outside of the UK need to appoint a UK Responsible Person to register devices with the MHRA.

Following a government consultation on changes to the UK’s medical device regulations, the response to which was published on June 26, 2022, it is anticipated that amendments to the legislation will soon be published by the government and should become applicable by July 1, 2023 so that medical devices placed on the market in Great Britain (England, Scotland, and Wales) will require a UK Conformity Assessment (UKCA) mark.

However, within the government’s consultation response, it has proposed that transition periods will be included in the revised legislation so that products with existing and valid conformity assessments (CE mark or UKCA mark) could continue to be placed on the Great Britain market for a maximum of 3-5 years after July 1, 2023, depending on which legislation the medical device has been certified under.

IVDs with valid certification can continue to be placed on the market until the earlier of certificate expiry or for a period of five years following publication of the new regulations.

However, UKCA marking alone will not be recognized in the EU.

The rules for placing medical devices on the Northern Ireland market will differ from those in the Great Britain.

These modifications may have an effect on the way we intend to conduct our business in these countries.

Other Health Care Regulation

We may be subject to various federal, state and foreign laws pertaining to health care fraud and abuse, including anti-kickback laws and physician self-referral, false claims laws and physician payment transparency laws and regulations.

In the United States, the federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting, or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering, or arranging for the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs.

In the U.S., the federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting, or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering, or arranging for the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs.

The term remuneration has been interpreted broadly to include anything of value.

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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.

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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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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.

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.

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.

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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.

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Market acceptance and sales of our CooperSurgical products to our customers, who primarily consist of hospitals and surgical centers, OB/GYN medical offices and fertility clinics, will depend on the availability of payor coverage and the adequacy of reimbursement, for the procedures using our products, by government insurance programs and other third-party payors.

Payor coverage and reimbursement for procedures using medical devices in the United States and international markets vary significantly by country.

In the United States, our currently approved products are commonly treated as general supplies utilized in surgical procedures and if covered by third-party payors, are paid for as part of the procedure.

Outside of the United States, there are many reimbursement programs through private payors as well as government programs.

Payor coverage and reimbursement for procedures using medical devices in the U.S.

and international markets vary significantly by country.

In the U.S., our currently approved products are commonly treated as general supplies utilized in surgical procedures and if covered by third-party payors, are paid for as part of the procedure.

Outside of the U.S., there are many reimbursement programs through private payors as well as government programs.

In some countries, government reimbursement is the predominant program available to patients and hospitals.

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Healthcare Reform

In the United States, there has been, and continues to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect the profitable sale of product candidates.

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 the U.S, there has been, and continues to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect the profitable sale of product candidates.

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

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.

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required manufacturers to participate in a coverage gap discount program, in which manufacturers must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs, implemented a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected;

imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs, introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected;

expanded eligibility criteria for Medicaid programs;

creates a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

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.

created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

and established a Center for Medicare & Medicaid 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.

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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.

Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for pharmaceutical products.

Most recently, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law.

Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap;

imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);

and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).

Individual states in the U.S.

have also become increasingly active in implementing regulations designed to control pharmaceutical 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.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine which drugs and suppliers will be included in their healthcare programs.

Furthermore, there has been increased interest by third-party payors and governmental authorities in reference pricing systems and publication of discounts and list prices.

In foreign countries where we market our products, recent healthcare reform has taken place as well.

For instance in December 2021, the EU Regulation No 2021/2282 on Health Technology Assessment (HTA) amending Directive

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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.

Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical 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.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine which drugs and suppliers will be included in their healthcare programs Furthermore, there has been increased interest by third-party payors and governmental authorities in reference pricing systems and publication of discounts and list prices.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressures.

Data Privacy and Security

2011/24/EU, was adopted.

This regulation, which became effective in January 2022, intends to boost cooperation among EU member states in assessing health technologies, including some medical devices, and providing the basis for cooperation at the EU level for joint clinical assessments in these areas.

The regulation foresees a three-year transitional period and will permit EU member states to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the most potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.

Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement.

We expect that additional state, federal and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that state, federal and foreign governments will pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressures.

Data Privacy and Security Laws and Regulations

Numerous state, federal and foreign laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of personal information, including health-related information.

In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy laws, and federal and state consumer protection laws and regulations, that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners.

In the U.S., numerous federal and state laws and regulations, including data breach notification laws, health information privacy laws, and federal and state consumer protection laws and regulations, that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners.

For example, the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and regulations implemented thereunder (collectively, HIPAA) imposes privacy, security and breach notification obligations on certain health care providers, health plans, and health care clearinghouses, known as covered entities, as well as their business associates that perform certain services that involve creating, receiving, maintaining or transmitting individually identifiable health information for or on behalf of such covered entities.

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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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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.

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.

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

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For example, the California Consumer Privacy Act (CCPA) went into effect on January 1, 2020.

The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to access and delete their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used.

The CCPA, among other things, creates data privacy obligations for covered companies and provides certain privacy rights to California residents, including the right to access and delete their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used.

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 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 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.

Further, the California Privacy Rights Act (CPRA), which will go into effect on January 1, 2023, significantly amends the CCPA and will impose additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data.

It will also create a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement.

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

The GDPR imposes comprehensive data privacy compliance obligations in relation to collection, processing, sharing, disclosure, transfer and other use of data relating to an identifiable living individual or “personal data,” including a principal of accountability and the obligation to demonstrate compliance through policies, procedures, training and audit.

In addition, the GDPR increases the scrutiny of transfers of personal data from the EEA, including clinical trial sites located in the EEA to the U.S.

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 EU (CJEU) limited how organizations could lawfully transfer personal data from the EEA to the U.S.

by invalidating the EU-US Privacy Shield and imposing further

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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 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.

Subsequent European court and regulator decisions have taken a restrictive approach to international data transfers.

Additionally, following the UK’s withdrawal from 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.

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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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CooperSurgical augments its sales and marketing activities by participating in national and regional industry trade shows, professional educational programs and internet promotions including e-commerce, social media and collaborative efforts with professional organizations, telemarketing, direct mail and advertising in professional journals.

Since the acquisition of PARAGARD, CooperSurgical has expanded its awareness campaigns to include direct to consumer elements including print, internet/social media, radio and television.

Since the addition of PARAGARD and cord blood and cord tissue storage services, CooperSurgical has also expanded its awareness campaigns to include direct to consumer elements including print, internet/social media, radio and television.

PATENTS, TRADEMARKS AND LICENSING AGREEMENTS

Cooper owns or licenses a variety of domestic and foreign patents, which, in total, are material to our overall business.

The names of certain Cooper's products are protected by trademark registrations in the United States Patent and Trademark Office and, in some cases, also in foreign trademark offices.

The names of certain Cooper's products are protected by trademark registrations in the U.S.

Patent and Trademark Office and, in some cases, also in foreign trademark offices.

Applications are pending for additional trademark and patent registrations.

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In addition to trademarks and patent licenses, we own certain trade secrets, copyrights, know-how and other intellectual property.

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Aquaform ® , Avaira ® , Avaira Vitality ® , Biofinity ® , Biofinity Energys ® , MyDay ® , MiSight ® , ActivControl ® , Proclear ® and Biomedics ® are registered trademarks of The Cooper Companies, Inc., its affiliates and/or subsidiaries.

PC Technology™ and FIPS™ are trademarks of The Cooper Companies, Inc., its affiliates and/or subsidiaries.

The clariti ® mark is a registered trademark of The Cooper Companies, Inc., its affiliates and/or subsidiaries worldwide except in the U.S.

where the use of clariti ® is licensed.

PARAGARD ® , Mara ® , Fetal Pillow ® and Endosee ® are registered trademarks of CooperSurgical, Inc.

DEPENDENCE ON CUSTOMERS

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GOVERNMENT CONTRACTS

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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Neither of our business units is materially subject to profit renegotiation or termination of contracts or subcontracts at the election of the U.S.

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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The Chart below shows percentage of employees located in Americas, EMEA and Asia Pacific as of October 31, 2022.

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

We submitted our 2021 annual Section 12(a) CEO certification with the New York Stock Exchange.

The certification was not qualified in any respect.

Additionally, we filed with the Securities and Exchange Commission as exhibits to this Annual Report on Form 10-K for the year ended October 31, 2021, the CEO and CFO certifications required under Section 302 of the Sarbanes-Oxley Act of 2002.

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

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

CYBERSECURITY

In the normal course of business, we may collect and store personal information and other sensitive information, including proprietary and confidential business information, trade secrets, intellectual property, information regarding trial participants in connection with clinical trials, sensitive third-party information and employee information.

To protect this information, our existing cybersecurity policies require continuous monitoring and detection programs, network security precautions, and in-depth security assessment of vendors.

We maintain various protections designed to safeguard against cyberattacks, including firewalls and virus detection software.

We have established and regularly test our disaster recovery plan and we protect against business interruption by backing up our major systems.

In addition, we periodically scan our environment for any vulnerabilities, perform penetration testing and engage third parties to assess effectiveness of our data security practices.

A third-party security consultant conducts regular network security reviews, scans and audits.

In addition, we maintain insurance that includes cybersecurity coverage.

Our cybersecurity program is led by a team of highly skilled cybersecurity professionals, including 10 dedicated internal cybersecurity resources.

Four members of the security team currently have CISSP credentials, five members hold one or more GIAC/SANS cybersecurity certificates, and in total the team has over 40 security and network certifications.

In addition to our internal security staff, we partner with various third-party security service providers, including two 24/7 SOC teams, to augment our staffing, expertise, and hours of operation.

The program incorporates industry-standard frameworks, policies and practices designed to protect the privacy and security of our sensitive information.

The program also includes a suite of best-in-breed security technologies and tools to implement and automate security protections for our networks, employees, and customers.

Our cybersecurity team reports to the Audit Committee quarterly on information security and cybersecurity matters, or as needed.

Our Audit Committee, which is comprised of several members from our Board of Directors, has oversight responsibility for our data security practices and we believe the committee has the requisite skills and visibility into the design and operation of our data security practices to fulfill this responsibility effectively.

Despite the implementation of our cybersecurity program, our security measures cannot guarantee that a significant cyberattack will not occur.

A successful attack on our information technology systems could have significant consequences to the business.

While we devote resources to our security measures to protect our systems and information, these measures cannot provide absolute security.

See “Risk Factors – Risks Relating to Our Business” for additional information about the risks to our business associated with a breach or compromise to our information security systems.

AVAILABLE INFORMATION

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What changed 10-K

Item 1. Business