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Item 1. Business

2023-12-08 compared with 2022-12-09 · 282 added, 550 removed, 99 unchanged (89% of the section changed)

The Cooper Companies, Inc.

(Cooper, we or the Company), a Delaware corporation organized in 1980, is a global medical device company publicly traded on the NYSE (NYSE:

Cooper operates through two business units, CooperVision and CooperSurgical.

(Cooper, we or the Company), is a global medical device company with a mission to improve lives one person at a time.

We partner with health care providers worldwide to improve patient outcomes and deliver practice-building resources and training.

By listening closely to the healthcare providers and patients, we fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment.

Cooper operates through two business segments, CooperVision and CooperSurgical.

Our two business segments elevate standards of care with products and services in the fields of vision, fertility and women’s health.

For financial information relating to these business segments, refer to Note 12.

Business Segment Information in Item 8.

Financial Statements and Supplementary Data of this Annual Report.

CooperVision is a global manufacturer providing products for contact lens wearers.

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 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™.

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.

CooperVision designs its products to address vision challenges such as astigmatism, presbyopia and myopia with a broad collection of spherical, toric and multifocal contact lenses.

CooperVision offers contact lenses in materials like silicone hydrogel Aquaform technology.

CooperVision also manufactures and markets myopia management products, including the internally developed MiSight 1 day lens, as well as other specialty eyecare products such as orthokeratology (ortho-k) and scleral lenses.

In November 2019, the MiSight 1 day lens became the first and only product approved by the United States Food and Drug Administration (FDA) for slowing the progression of myopia in children aged 8-12 at the initiation of treatment, and in August 2021, CooperVision received Chinese National Medical Products Administration (NMPA) approval for use of the MiSight 1 day lens 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 facilities in multiple locations around the world.

CooperSurgical offers a broad array of products and services focused on fertility and women's health.

We categorize CooperSurgical product sales based on the point of health care delivery, which includes:

products used in medical offices, ambulatory surgical centers and hospitals primarily by Obstetricians/Gynecologists (OB/GYN);

and fertility products and services used primarily in fertility clinics.

Our portfolio encompasses more than 600 products and services.

Our medical devices are used in gynecology and obstetrics, including but not limited to contraception and labor and delivery as well as cord blood and cord storage services.

Our fertility portfolio encompasses medical devices supporting the in vitro fertilization (IVF) cycle, egg and sperm donation, cryopreservation, and genomic services (including genetic testing).

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

We categorize CooperSurgical product sales based on the point of health care delivery, which includes products used in medical office and surgical procedures, primarily by Obstetricians/Gynecologists (OB/GYN);

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

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 bases of product quality and differentiation, technological benefits, price, service levels and reliability.

SEGMENT INFORMATION

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

the Americas, EMEA (Europe, Middle East and Africa) and Asia Pacific.

The contact lens market has two major product categories:

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

The two major product categories of contact lenses sold by CooperVision are:

• Spherical lenses, including lenses that correct near- and farsightedness uncomplicated by more complex visual defects, myopia management lenses, which slow the progression of and correct myopia in age-appropriate children, and other specialty lenses.

• 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.

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

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

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

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

single-use, two-week 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.

In order to achieve a comfortable and healthier lens wearing experience, products are sold with recommended wearing and replacement schedules, often referred to as modalities, with the primary modalities being single-use lenses designed for one-day use and frequent replacement (FRP) lenses designed for two-week and monthly replacement.

CooperVision offers spherical, toric, multifocal and toric multifocal lens products in most modalities and in a wide range of lens parameters.

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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 for 8 to 12 years (age-appropriate) children.

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

Silicone hydrogel materials supply a higher level of oxygen to the cornea, as measured by the transmissibility of oxygen through a given thickness of material, or “dk/t,” than traditional hydrogel lenses.

We believe our ability to compete successfully with a full range of silicone hydrogel products is an important factor to achieving success in our business.

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, 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 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 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.

CooperVision Product Modalities

Frequent replacement lenses

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

Our Biofinity brand is CooperVision's highest grossing product.

CooperVision also markets two-week silicone hydrogel spherical and toric lenses under the Avaira Vitality brand.

Single-use lenses

CooperVision markets single-use silicone hydrogel lenses under our MyDay brand and our clariti 1 day brand.

The MyDay brand is our softest line of 1-day silicone hydrogel lenses and offers spherical (including MyDay Energys ), toric, and multifocal lenses.

The clariti 1-day brand is our most affordable line of silicone hydrogel 1-day lenses and offers spherical, toric, and multifocal lenses.

CooperVision also offers traditional single-use hydrogel lenses under our Proclear and Biomedics brands.

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

Market for Contact Lenses

The market for spherical lenses is growing with the addition of new value-added products, such as spherical lenses that may provide improved comfort for contact lens related dryness during lens wear and that add aspherical optical properties, more higher oxygen permeable lenses such as silicone hydrogels, and myopia management contact lenses for children aged 8 to 12 years old.

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.

We believe that myopia management opens up an attractive new market for contact lenses.

With MiSight, we offer the only FDA approved 1 and first Chinese NMPA approved product to slow the progression of, and correct, myopia in age-appropriate children.

This is a critical differentiator as the proactive management of myopia becomes standard-of-care within the eye care community to help reduce the progression of myopia in children, along with reducing the risks of long-term eye health problems associated with myopia such as cataracts, retinal detachment, and macular degeneration.

We are investing to develop this new market by educating eye care practitioners, patients and their families, which increases awareness.

CooperVision is focused on greater worldwide market penetration of recently introduced products, and we continue to expand our presence in existing and emerging markets, 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 2023, CooperVision acquired a private U.S.-based company that provides a broad portfolio of technologically advanced contact lens products, including scleral and hybrid lenses.

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

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

CooperSurgical

CooperSurgical focuses on advancing fertility and women's health through a diversified portfolio including fertility products and services, medical devices, cryostorage (such as cord blood and cord tissue storage) 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 to bring to market.

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

CooperSurgical distributes its products and services through OB/GYN and medical offices, hospital and ambulatory surgery centers and fertility clinics, as well as direct-to-consumer.

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 help increase our share of business within these key account groups.

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.

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Contact Lens Product Sales

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

The contact lens market is highly competitive.

CooperVision's largest competitors in the worldwide market and its primary competitors in the spherical, toric and multifocal lens categories of that market are Johnson & Johnson Vision Care, Inc., Alcon Inc.

and Bausch Health Companies Inc.

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.

CooperVision also competes with manufacturers of eyeglasses and with refractive surgical procedures that correct visual defects including laser vision correction.

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.

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

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

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

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

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

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 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.

We also compete based on our customer and professional services.

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, cryostorage, contraception and healthcare technology services (such as cord blood and cord tissue storage and genomic testing).

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 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.

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 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.

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.

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.

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

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

This 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.

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 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.

In fiscal 2022, CooperSurgical acquired both a private cryopreservation services company and Generate Life Sciences (Generate), a private leading provider of donor egg and sperm for fertility treatments, fertility cryopreservation services and newborn stem cell storage (cord blood and cord tissue).

We expect to continue investing in CooperSurgical's business, including through strategic transactions, with the goal of expanding our integrated solutions model within the areas of fertility and women's health.

CooperSurgical Product Categories

Office/Surgical

CooperSurgical sells a wide variety of innovative medical devices and services used in gynecology and obstetrics, including in labor and delivery, as well as to screen, diagnose and treat women's health and reproductive issues.

CooperSurgical offers the cryostorage of newborn cord blood and cord tissue, which are potent sources of stem cells that have the potential for treatment and healing.

Our newborn stem cell storage services are available in the United States, Canada and Australia.

PARAGARD is a hormone-free intrauterine device (IUD) offered by CooperSurgical that prevents pregnancy for up to ten years using copper as the only active ingredient.

It is the only FDA approved non-hormonal IUD contraceptive option and is exclusively sold in the United States.

CooperSurgical has broad product offerings for fertility evaluations and IVF procedures by OB/GYN professionals, reproductive endocrinologists and embryologists.

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

Additionally, CooperSurgical offers services to clinics and families undergoing assisted reproductive technologies including donor gametes, cryostorage, and genomic services.

Market for Fertility and Women's Health Care

CooperSurgical participates in the market for women's and family health care with its diversified product lines at various points of health care delivery:

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

In recent years, including with the acquisition of Generate in fiscal 2022, CooperSurgical’s business increasingly includes marketing and selling to end consumers through our cryostorage (such as cord blood and cord tissue storage) and reproductive planning products and services.

CooperSurigcal expects that OB/GYN medical offices and fertility clinics will continue to move away from private practice ownership and toward group practices and networks.

As the consolidation trend continues it will have increased influence over supply chain control, group purchases, value analysis committees, product evaluation and procurement.

We believe CooperSurgical's broad product portfolio can benefit in this changing environment as customers look to standardize and consolidate vendors.

Trends specific in the OB/GYN market include:

• The increase in office-based and outpatient procedures, given high patient satisfaction, reduction of healthcare costs and comparative clinical outcomes.

• A focus on reducing pregnancy and childbirth complications.

• The obstetrician being 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), beginning with the OB/GYN and then transitioning to fertility clinics.

Trends specific in the fertility market include:

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

• The maternal age is increasing.

• Patient awareness of, and access to, services is increasing.

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

• Routine office visits:

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

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

assessment of menstrual disorders, pelvic infections, urinary incontinence, abnormal Pap smears, fertility concerns, pregnancy and menopause.

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

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.

• 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.

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

• The number of fertility clinics is rising worldwide.

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

• 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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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).

• Single parents by choice and LGBTQIA+ individuals are starting families.

• Improved product offerings such as donor activity and cryopreservation services are becoming available.

• Technology improvements are being developed for both male and female infertility challenges.

• Worldwide disposable income is increasing.

The markets in which we participate are highly competitive and involve the continual search for technological and scientific innovations.

Competitive factors in these markets include technological and scientific advances, product quality and availability, price, customer service including response time and effective communication of product information to clinicians and consumers, and manufacturing processes.

Competitors may have greater financial resources, larger research and development budgets, larger sales forces, greater market penetration and/or larger manufacturing capacity.

Both CooperVision and CooperSurgical compete predominantly on the basis of product quality and differentiation, technological benefits, price, service levels and reliability.

CooperVision Competition

and Bausch + Lomb.

To a lesser extent, CooperVision also competes with manufacturers of eyeglasses and providers of other forms of vision correction including ophthalmic surgery.

CooperVision competes in its markets by producing high, medium and low-volume lenses made with a variety of materials for a broader range of market niches, as well as offering a wide range of lens parameters, leading to a higher rate of successful fitting for practitioners and better visual acuity for patients.

Our ability to compete successfully with a full range of silicone hydrogel products is an important factor to achieving success in our business.

We also compete based on our customer and professional services.

CooperSurgical Competition

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.

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, consumers, fertility clinics and hospitals.

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 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.

CooperSurgical focuses on selected segments of the fertility and women's health care market with a diversified portfolio including fertility products and services, medical devices, cryostorage (such as cord blood and cord tissue storage) and contraception.

CooperSurgical's strategy includes developing and acquiring new solutions to complement our current offerings.

In the fertility market, CooperSurgical competes against Vitrolife Group, FujiFilm-Irvine Scientific, Cook Medical, Hamilton Thorne, and Fairfax Cryobank and Fairfax EggBank.

We also compete with fertility clinics offering their own services.

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

In the stem cell storage field, we compete primarily with ViaCord, a division of Revvity, in the United States, as well as other smaller companies globally.

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.

We have broad product offerings for fertility evaluations and IVF procedures by OB/GYN, reproductive endocrinologists and embryologists.

These include products for use by the OB/GYN in their offices for initial evaluations with office-based hysteroscopy and first line treatments such as intrauterine insemination.

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

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.

We are aware of a non-hormonal IUD under development, which may compete with PARAGARD in the future.

RESEARCH AND DEVELOPMENT

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

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

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

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

CooperSurgical conducts research and development in-house, and works with external specialists when necessary, in mechanical, electrical, biomedical and software engineering, as well as life sciences.

CooperSurgical research and development activities are focused on innovating, improving, and advancing our products and services including, instruments, devices, consumables, digital services, and manufacturing technologies.

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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.

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

Device Classification

The FDA classifies medical devices into one of three classes—Class I, II or III—depending on the degree of risk associated with each medical device and the extent of control needed to ensure its safety and effectiveness.

Both CooperVision and CooperSurgical develop and market medical devices subject to different levels of FDA regulation depending on the classification of the device.

Class III devices, such as flexible and extended wear contact lenses, require extensive premarket testing and approval, while Class I and II devices require lower levels of regulation.

GOVERNMENT REGULATION

Our products are subject to extensive regulation by the FDA in the United States and a variety of regulatory agencies in other countries.

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.

These regulations govern, among other things, the design and development, testing, manufacturing, labeling, storage, record keeping, premarket clearance, approval or certification, post-market vigilance reporting, advertising and promotion, and sales and distribution of medical devices and pharmaceutical products.

Failure to comply with the applicable regulations, which are subject to established and new legislation and change, could result in enforcement action by the FDA, or other U.S.

or foreign government agencies which may include, among other things, any of the following consequences:

warning letters, civil penalties, refusal or withdrawal of approvals or certifications, license suspension or revocation, product recalls, operating restrictions, suspension or shutdown of production, and criminal prosecution.

Regulation in the United States

Medical Devices

Most of our products are medical devices, which must comply with the Federal Food, Drug and Cosmetic Act (FDCA) and the regulations promulgated by the FDA thereunder.

Both CooperVision and CooperSurgical develop and market medical devices subject to different levels of FDA regulation depending on the classification and risk profile of the device.

Class III devices, such as extended wear contact lenses, require extensive premarket testing and approval, while Class I and II devices require lower levels of regulation.

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

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

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

Class II devices are moderate risk devices, which are subject to the FDA's General Controls, and any other special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device, such as performance standards, post-market surveillance, FDA guidelines or particularized labeling requirements.

Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification procedure.

Pursuant to the Medical Device User Fee and Amendments to the FDA Reauthorization Act (MDUFA IV), unless a specific exemption applies, 510(k) premarket notification submissions require payment of user fees.

Certain Class II devices are exempt from this premarket review process.

Class III devices are those devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or certain implantable devices, or which have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device.

The safety and effectiveness of Class III devices cannot be assured solely by the General Controls and other special controls such as those listed above.

These devices almost always require formal clinical studies to demonstrate safety and effectiveness and must be approved through the PMA process described below.

PMA applications (and supplemental PMA applications) are subject to substantially higher user fees under MDUFA IV than are 510(k) premarket notifications.

510(k) Clearance Pathway

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 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.

Although many 510(k) pre-market notifications are cleared without clinical data, in some cases, the FDA requires additional information to support substantial equivalence.

If the FDA agrees that the device is substantially equivalent to a predicate device, it will grant 510(k) clearance to commercially market the device.

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

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

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

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.

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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 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.

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 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

A PMA application must be submitted if the device cannot be cleared through the 510(k) premarket notification procedures or if the device has been previously classified as Class III (unless otherwise 510(k) exempt).

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, a premarket approval (PMA) from the FDA, or a de novo classification and request for marketing authorization submitted to and granted by the FDA.

If we are required to obtain a 510(k) clearance for a device that we wish to market, we must submit a premarket notification to the FDA demonstrating that the device is substantially equivalent to a device commercially distributed in the United States before May 28, 1976 (a pre-amendments device), or to a device that was found to be substantially equivalent to a pre-amendments device.

If the FDA agrees that the device is substantially equivalent, it will grant 510(k) clearance to commercially market the device.

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

The sponsor of a device automatically designated as Class III must either fulfill more rigorous PMA requirements or request a risk-based classification determination for the device in accordance with the de novo process.

The de novo process is a pathway to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

A PMA application must be submitted if the device cannot be cleared through the 510(k) premarket notification procedures, or if the device has been previously classified as Class III.

The PMA process is much more demanding than the 510(k) premarket notification process.

A PMA application must be supported by extensive data including, but not limited to, technical, non-clinical, clinical trials, manufacturing and labeling to demonstrate to the FDA's satisfaction the safety and effectiveness of the device for its intended use.

Following receipt of a PMA application, the FDA conducts an administrative review to determine whether the application is sufficiently complete to permit a substantive review.

If it is not, the agency will refuse to file the PMA.

If it is, the FDA will accept the application for filing and begin the review.

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

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

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

Also, during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.

In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure compliance with the QSR, which, among other things requires manufacturers to implement and follow elaborate design, testing, control, documentation and other quality assurance procedures in the device design and manufacturing process.

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

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

The FDA may 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.

In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients.

Failure to comply with the conditions of approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval.

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

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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

A clinical trial is almost always required to support a PMA application and is sometimes required to obtain clearance of a 510(k) premarket notification.

These trials may require submission of an application for an investigational device exemption (IDE) to the FDA depending on the device.

If the device under evaluation does not present a significant risk to human health, then the device sponsor is not required to submit an IDE application to the FDA before initiating human clinical trials, but must still comply with abbreviated IDE requirements when conducting such trials.

A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject.

If the device presents a “significant risk” to human health, the sponsor must submit an IDE application to the FDA and obtain IDE approval prior to commencing the human clinical trials.

The IDE application, which includes a clinical study protocol, must be supported by appropriate data, such as animal and laboratory testing results, showing that the potential benefits of testing the device in humans and the importance of the knowledge to be gained outweighs the risks to human subjects from the proposed investigation that the testing protocol is scientifically sound and there is reason to believe that the device as proposed for use will be effective.

The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the company that the investigation may not begin.

If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval.

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

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

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

Additionally, after a trial begins, the FDA may place it on hold or terminate it if, among other reasons, it concludes that the clinical subjects are exposed to unacceptable health risks that outweigh the benefits of participation in the study.

During a study, we are required to comply with the FDA's IDE requirements for investigator selection, trial monitoring, reporting, record keeping and prohibitions on the promotion of investigational devices or making safety or efficacy claims for them.

We are also responsible for the appropriate labeling and distribution of investigational devices.

Continuing FDA and Other Government Agency Regulation of Medical Devices

A PMA application must be supported by extensive data including, but not limited to, technical, pre-clinical, clinical trials, manufacturing and labeling to demonstrate to the FDA's satisfaction the safety and effectiveness of the device for its intended use.

Prior to commencing human clinical trials, submission of an application for an investigational device exemption (IDE) and receipt of IDE approval from the FDA is required if the device under evaluation presents a significant risk to human health.

The process of gathering supporting information leading up to PMA application, and the subsequent FDA review, can take several years.

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

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

After a device is placed on the market, numerous regulatory requirements apply.

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establishment registration and device listing with the FDA;

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

the FDA's Quality System Regulation (QSR), which requires manufacturers to follow design, testing, production, control, complaint handling, documentation and other quality assurance procedures during the manufacturing process;

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

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

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

and medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur.

The FDA has broad post-market and regulatory enforcement powers.

We are subject to unannounced inspections for cause by the FDA to determine our compliance with the QSR and other regulations.

Failure to comply with applicable regulatory requirements, which are subject to new legislation and change, can result in enforcement action by the FDA, or other federal and state government agencies which may include, but may not be limited to, any of the following sanctions or consequences:

warning letters or untitled letters;

fines, injunctions and civil penalties;

recall, seizure or import holds of our products;

operating restrictions, suspension or shutdown of production;

refusing to issue certificates to foreign governments needed to export products for sale in other countries;

refusing our request for 510(k) clearance or premarket approval of new or modified products;

withdrawing 510(k) clearance or premarket approvals that are already granted;

and criminal prosecution.

Laboratory Developed Tests

We provide certain genetic testing laboratory services.

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

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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.

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 over LDTs because they presented a potential safety risk or because they were marketed directly to consumers without the involvement of a health care professional.

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

For example, in recent years, the FDA has stated its intention to modify its enforcement discretion policy with respect to LDTs.

Specifically, on July 31, 2014, the FDA notified Congress of its intent to modify, in a risk-based manner, its policy of enforcement discretion with respect to LDTs.

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

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

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

The FDA halted finalization of this guidance in November 2016 to allow for further public discussion on an appropriate oversight approach for LDTs and to give congressional authorizing committees the opportunity to develop a legislative solution.

In January 2017, the FDA issued a discussion paper on possible approaches to LDT regulation.

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

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

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

If passed in its current form, the VALID Act would create a new category of medical products separate from medical devices called “in vitro clinical tests,” or IVCTs.

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

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

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

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.

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.

broad post-market and regulatory enforcement powers.

We are subject to unannounced inspections for cause by the FDA to determine our compliance with the QSR and other regulations.

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.

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

Furthermore, in October 2023, the FDA published a proposed rule to amend its regulations to make explicit that LDTs are devices under the FDCA.

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

Under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, we are required to hold a certificate applicable to the type of laboratory tests we perform and to comply with standards applicable to our operations, including test processes, personnel, facilities administration, equipment maintenance, recordkeeping, quality systems and proficiency testing.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, we are required to hold a certificate applicable to the type of laboratory tests we perform and to comply with standards applicable to our operations, including test processes, personnel, facilities administration, equipment maintenance, recordkeeping, quality systems and proficiency testing.

We have current certification under CLIA to perform testing at our New Jersey facility.

To renew our CLIA certificate, we are subject to survey and inspection every two years to assess compliance with program standards.

The regulatory and compliance standards applicable to the testing we perform may change over time, and any such changes could have a material effect on our business.

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

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

Such laws establish standards for the day-to-day operation of a clinical reference laboratory, including the training and skills required of personnel and quality control.

In addition, state laws mandate proficiency testing, which involves testing of specimens that have been specifically prepared for the laboratory.

In addition, certain states require licensing of out-of-state laboratories in order to receive and test specimens from those tests.

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.

Human cells, tissues, and cellular and tissue-based products

We currently operate a provider of donated reproductive tissue (eggs and sperm) for fertility treatments, fertility cryopreservation services and newborn stem cell storage.

Eggs and 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 with respect to HCT/Ps.

To be regulated as a "361 HCT/P", the product must, among other things, be minimally manipulated and intended only for homologous uses.

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

Failure to comply with the applicable U.S.

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

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.

After approval, most changes to the approved product, such as adding new indications or other labeling claims are subject to further testing to new clinical investigation requirements and prior FDA review and approval.

There also are continuing, annual program fee requirements for any approved products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.

Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and to list their drug products and are subject to periodic announced and unannounced inspections by the FDA and these state agencies for compliance with Good Manufacturing Practices, or cGMPs, and other requirements, which impose procedural and documentation requirements upon us and our third-party manufacturers.

Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented, or FDA notification.

FDA regulations also require investigation and correction of any deviations from cGMPs specifications and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use.

Pharmaceutical Products

In the United States, the FDA regulates pharmaceutical products under the FDCA and its implementing drug regulations.

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

The process required by the FDA before a drug may be marketed in the United States generally involves numerous and time-consuming steps, including preclinical laboratory tests, human clinical trials, FDA reviews, inspections and audits and compliance with post-approval requirements.

Any drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA as the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.

Drug manufacturers and their subcontractors are required to be in compliance with Good Manufacturing Practices, or cGMPs, and other requirements.

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

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

A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA.

Physicians, in their independent professional medical judgement, may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA.

We, however, are prohibited from marketing or promoting drugs for uses outside of the approved labeling.

In addition, the distribution of prescription pharmaceutical products, including samples, is subject to the Prescription Drug Marketing Act (PDMA), which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states.

Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.

The Drug Supply Chain Security Act also imposes obligations on manufacturers of pharmaceutical products related to product and tracking and serialization.

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

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

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.

Any of these sanctions could result in adverse publicity, among other adverse consequences.

In addition, the FDA closely regulates the marketing, promotion and distribution of pharmaceutical products.

Foreign Regulation

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

The regulations vary widely from country to country.

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

The Japanese quality and regulatory standards remain stringent even with the more recent harmonization efforts and updated Japanese regulations.

China is also updating its regulations and is requiring rigorous in-country product testing.

These regulatory procedures require a considerable investment in time and resources and usually result in a substantial delay between new product development and marketing.

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 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.

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 and product modifications before they may be marketed in those countries.

The regulations vary widely from country to country, although there is a trend towards harmonization of quality system standards among the European Union (EU), United States, Canada and various other industrialized countries.

Medical devices marketed or sold in the EU must meet the CE mark requirements and maintain certain certifications.

CooperVision maintains ISO 13485 certification and CE marks for its products and CooperSurgical maintains ISO 13485 certification and CE marks for medical devices and ISO 15189 certification for the genomics laboratories.

The ISO 13485 Quality Management System certification is now also required for registration of products in Asia Pacific and Latin American countries, among many other requirements for registration in these countries.

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

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

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

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.

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.

The EU rules below are generally applicable in the European Economic Area (EEA) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland, while the majority of the United Kingdom now operates under a separate regulatory regime following the United Kingdom's withdrawal from the EU on January 31, 2020.

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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;

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

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

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

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

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

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

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

However, all medical devices (including IVDs) placed on the EU market must 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 Device and In Vitro Diagnostic Medical Device Regulation in the EU

Until May 25, 2021, medical devices sold in the EU were regulated by the Medical Device Directive (the EU MDD), which has been repealed and replaced by the Medical Device Regulation (the EU MDR).

Similarly, the EU has adopted the In Vitro Diagnostic Medical Device Regulation (the EU IVDR), which repealed and replaced the In Vitro Diagnostic Medical Device Directive (the EU IVDD) and became applicable on May 26, 2022.

The majority of 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 and EU IVDD may generally continue to be made available on the market or put into service provided that the requirements of transitional provisions are fulfilled.

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

In the EU, the safety and performance of medical devices (including IVDs) are evaluated by the designated Notified Bodies via the submission of Technical Dossiers, depending on the product classifications.

A Declaration of Conformity to the Medical Device Directive (MDD) or Medical Device Regulation (MDR) is drawn out as a basis for European conformity marking (CE Mark).

All medical devices placed on the EU market must meet general safety and performance requirements, including the requirement 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 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.

Compliance with the general safety and performance requirements is also a prerequisite for 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 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.

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

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

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

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

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

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

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

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

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

Specific requirements are defined at the national level.

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

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

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

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

Regulation of Laboratory Developed Tests in the European Union

With certain exceptions, a conformity assessment procedure requires the intervention of notified bodies, which are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market.

Typically, satisfactory completion of an audit and examinations of a product’s technical dossiers and the manufacturer’s quality system is required before the issuance of a certificate by the notified body.

This certificate, along with the Declaration of Conformity, are then used by the manufacturer as basis for CE mark.

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

In addition, all manufacturers placing medical devices on the market in the EU are subject to various other regulations, including compliance with the EU medical device vigilance system, directives and requirements regarding the advertisement and promotion of medical devices and inspections rights of regulatory authorities.

Laboratory Developed Test Regulation in the EU

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

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.

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

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

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

However, compared to the previous regulatory regime, the exemptions for LDTs 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

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

In order to fall within this exemption under the EU IVDD, medical devices, including LDTs, had to be designed and used within such health institutions (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.

While the legal framework for applying the exemption under the EU IVDD to LDTs was not entirely clear, the EU IVDR may provide greater clarity on the regulation of 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 EU IVDR;

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

Medical Devices and In Vitro Diagnostic Medical Devices Regulations in the United Kingdom

Following the United Kingdom’s withdrawal from the EU, commonly referred to as Brexit, EU laws no longer apply directly in Great Britain (England, Wales and Scotland).

Under the terms of the Ireland/Northern Ireland Protocol agreed between the EU and United Kingdom, many EU laws, including those relating to medical devices and IVDs do still apply in Northern Ireland.

In Great Britain, the legislative regime currently continues to be based on the requirements set out in the EU MDD, the Active Implantable Medical Devices Directive (EU AIMDD), and the EU IVDD.

However, the Government is currently developing substantial reforms to the Great Britain regulatory regime for medical devices and IVDs.

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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.

Medical Device and In Vitro Diagnostic Medical Device Regulation in Asia Pacific

As in other regions, securing regulatory approvals in Asia Pacific is a critical aspect of commercializing our products.

While medical device regulations in the Asia Pacific are based on similar regulatory fundamentals (such as risk-based classification of devices) as other regions, navigating the regulatory landscape in Asia Pacific is extremely complex.

Medical device regulation in Asia Pacific differs significantly country by country, requiring specific regulatory affairs expertise in each country, as well as country-based regulatory strategies.

The regulatory framework maturity in Asia Pacific is widely varied ranging from well-established to emerging, approval timelines can be lengthy and unpredictable and there is less access to and engagement with regulators compared to other markets.

Several key Asia Pacific markets require regulatory approval in other countries prior to registration, increasing the time from completion of product development to product launch.

For example, in China, manufacturers must provide proof of home country approval (such as the United States or EU) as part of the regulatory registration/approval process.

The National Medical Products Administration (NMPA) regulates medical devices in China.

Medical devices in China are classified by risk into Class I (lowest risk), Class II or Class III (highest risk).

China requires physical testing (known as ‘type testing’) of medical device samples by in-country testing centers to confirm compliance with specifications and standards, both pre- and post-market.

Additionally, NMPA generally requires in-country clinical trials to support new product registrations, rather than relying on foreign clinical data.

In Japan, the primary regulation governing medical devices is the Pharmaceutical and Medical Device Act (PMD Act).

The Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceutical and Medical Device Agency (PMDA) regulate medical devices.

The PMDA evaluates the safety and effectiveness of medical devices prior to granting marketing authorization or approval, and monitors post-market safety of approved devices.

The PMDA is also the Quality Management System (QMS) Inspection Authority.

Medical devices are placed into one of four risk classes based on potential risk, with Class I being the lowest potential risk and Class IV being the highest.

Contact lenses, for example, are regulated as Class III devices and require premarket approval (registration), an expensive and lengthy process depending on the application category.

A novel or new medical device application will generally require local clinical trial data, extending the time to approval.

The registration process in Japan requires a QMS application and inspection.

Additionally, separate from the registration process, a Foreign Manufacturer Registration is required before a company can import medical devices manufactured outside Japan.

Japan and Australia participate in the Medical Device Single Audit Program, which allows for the acceptance of QMS audit reports from other participating Regulatory Authorities, including the FDA.

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 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.

There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution.

The exceptions and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be intended to induce prescribing, purchasing, or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor.

Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute.

Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances.

In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

The federal physician self-referral prohibitions, commonly known as the Stark Law, generally prohibit entities from billing a patient or the Medicare or Medicaid programs for certain designated health services, including clinical laboratory services, when the physician ordering the service, or any member of such physician’s immediate family, has a financial interest, such as an ownership or investment interest in or compensation arrangement with us, unless the arrangement meets an exception to the prohibition.

These prohibitions apply regardless of any intent by the parties to induce or reward referrals or the reasons for the financial relationship and the referral.

The federal False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to, or approval by, the federal government or knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.

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

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.

Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

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

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

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

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

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

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

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

Certain countries also mandate implementation of commercial compliance programs.

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

Similar sanctions and penalties, as well as imprisonment, also can be imposed upon executive officers and employees of such companies.

We are subject to various federal, state and foreign laws to prevent fraud and abuse in the healthcare industry and protect personal health-related information, including the following:

• state, federal and similar foreign anti-kickback laws, which generally prohibit payments and other forms of remuneration to induce or in return for the purchase, lease, order or arranging for the purchase, lease or order of a product or service;

• the federal physician self-referral law, known as the Stark Law, which generally prohibits physicians from referring Medicare or Medicaid patients to receive designated health services from an entity which the physician, or a member of the physician's immediate family, has a financial interest in;

• the federal False Claims Act, which prohibits any individual or entity from presenting or causing to be presented false claims for payment to the federal government;

• federal and state laws that prohibit executing, or attempting to execute, a scheme to obtain money from any healthcare benefit program under false pretenses;

• the Physician Payments Sunshine Act and similar state and foreign laws that require medical device and pharmaceutical manufacturers to disclose financial relationships with health care professionals and teaching hospitals;

• data privacy and security laws and regulations, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the EU General Data Protection Regulation (GDPR), which are intended to protect the collection, use, access to, confidentiality and security of health-related and other personal information.

Coverage and Reimbursement

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 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.

Our commercial success depends in part on the extent to which governmental authorities, private health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for the procedures during which our products are used.

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

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

All third-party reimbursement programs are developing increasingly sophisticated methods of controlling healthcare costs through prospective reimbursement and capitation programs, group purchasing, redesign of benefits, requiring second opinions prior to major surgery, careful review of bills, encouragement of healthier lifestyles and other preventative services and exploration of more cost-effective methods of delivering healthcare.

In addition to uncertainties surrounding coverage policies, there are periodic changes to reimbursement levels.

Third-party payors regularly update reimbursement amounts and also from time to time revise the methodologies used to determine reimbursement amounts.

This includes routine updates to payments to physicians, hospitals and ambulatory surgery centers for procedures during which our products are used.

These updates could directly impact the demand for our products.

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party payors.

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

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

Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of PARAGARD or any other drug product that receives approval.

Third-party payors may not consider our products to be medically necessary or cost-effective compared to other available therapies, or the rebate percentages required to secure favorable coverage may not yield an adequate margin over cost or may not enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development.

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

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

There can be no assurance that procedures using our products will be covered for a specific indication, that our products will be considered cost-effective by third-party payors, that an adequate level of reimbursement will be available or that the third-party payors’ reimbursement policies will not adversely affect our ability to sell our products profitably.

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

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

Healthcare Reform

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.

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

required collection of rebates for drugs paid by Medicaid managed care organizations;

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, 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;

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.

On June 17, 2021, the U.S.

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

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.

In the United States and foreign countries, 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.

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.

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.

Passed in March 2010, the Patient Protection and Affordable Care Act (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.

Additionally, there has recently been heightened scrutiny by governmental authorities, individual hospitals, and third-party payors over product prices, which has resulted in 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.

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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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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.

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 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.

Entities that are found to be in violation of HIPAA as the result of a breach of unsecured protected health information, a complaint about privacy practices or an audit by HHS, may be subject to significant civil, criminal and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance.

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

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

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

laws, such as the EU General Data Protection Regulation (GDPR), govern the privacy and security of personal data, including health-related data in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation.

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

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.

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

In the EU, regulations have been adopted which are intended to boost cooperation among EU member states in assessing health technologies, including certain high-risk medical devices, and providing the basis for cooperation at the EU level for joint clinical assessments in these areas.

Other Laws and Regulations

We are subject to numerous federal, state, local and foreign environmental laws, including provisions that regulate the discharge of materials into the environment, laws applicable to our facilities, products or manufacturing processes, including evolving regulations regarding the use of hazardous substances or chemicals in our products, and laws related to the protection of the environment, environmental health and safety regulations, Restriction of Hazardous Substances (RoHS) in electrical and electronic equipment in the EU, and Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH).

We are subject to various other federal, state and foreign laws related to the manufacturing and distribution of our products and to our international operations, including export control and trade compliance laws.

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 skilled cybersecurity professionals, including dedicated internal cybersecurity resources.

The security team currently has CISSP credentials, GIAC/SANS cybersecurity certificates, and other security and network certifications.

In addition to our internal security staff, we partner with various third-party security service providers 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.

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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.

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

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 undertaking, whichever is greater.

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.

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

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

program also includes a suite of 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.

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.

RAW MATERIALS

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In certain smaller countries, CooperVision often uses distributors and leverages our distributors' sales and marketing resources to attract major customers to CooperVision.

With the addition of MiSight, CooperVision has expanded the breadth and depth of its sales support by adding myopia management specialists while it has expanded awareness campaigns to include direct to consumer elements including print, internet/social media, radio and television.

With the addition of MiSight, CooperVision has expanded the breadth and depth of its sales capabilities by adding myopia management specialists while expanding awareness campaigns to include direct-to-consumer elements including print, internet/social media, radio and television.

CooperSurgical's products are marketed by a network of dedicated field sales representatives, independent agents and distributors.

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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 U.S.

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

Applications are pending for additional trademark and patent registrations.

Cooper intends to protect our intellectual property rights aggressively.

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.

INTELLECTUAL PROPERTY

We protect our products through patents and trademark registrations, both in the United States and in international markets.

We monitor competitive products trademark use worldwide and, when determined appropriate, we have enforced and plan to continue to enforce and defend our patent and trademark rights.

We also rely upon trade secrets, licenses, technical know-how and continuing technological innovation to develop and maintain our competitive position.

CooperVision, CooperSurgical, and other trade names, trademarks or service marks of Cooper and its subsidiaries appearing in this report are the property of Cooper and its subsidiaries.

Trade names, trademarks and service marks of the other companies appearing in this report are the property of their respective holders.

DEPENDENCE ON CUSTOMERS

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

GOVERNMENT CONTRACTS

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.

COMPLIANCE WITH ENVIRONMENTAL LAWS

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

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

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HUMAN CAPITAL RESOURCES

As of October 31, 2023, we had a workforce of more than 15,000.

We believe we have good relations with our workforce.

Our employees are located around the world, with 53% in Americas, 42% in EMEA and 5% in Asia Pacific.

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investing in and developing our employees through training and engagement.

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

Our employees are a key differentiator in our overall strategy.

We believe we have good relations with our workforce, and we invest in our workforce to meet current and future business objectives, always driving towards our goal of being a global employer of choice.

The Chart below shows percentage of employees located in Americas, EMEA and Asia Pacific as of October 31, 2023.

Diversity and Inclusion

We believe that an inclusive work environment that truly appreciates the diversity of employees’ talents, experiences, and ideas leads to more innovation and progress.

Through our Diversity & Inclusion (D&I) strategy, we drive a culture where individual qualities and backgrounds are highly valued and respected, and our employees feel a sense of belonging.

Our D&I strategy includes initiatives to promote D&I conversations and training to inform and educate our workforce, forming communities of advocates and allies to help advance our culture of inclusion, and completion of various reviews of our programs to minimize the impact of unconscious bias on our reward decisions.

Our commitment to D&I starts with our executives and is further executed through local initiatives in order to create sustainable change.

Health, Safety and Well-being

Our culture of health, safety, and well-being helps our people and businesses thrive.

We comply with applicable health and safety laws and regulations and help protect our employees through continuous improvement, education, engagement, and risk management.

Our Environmental, Health, and Safety (EHS) Global Policies formalize our commitment to high standards of EHS performance for employees, consultants, contract workers, and temporary staff worldwide.

Our employee handbooks specify health and safety expectations, working condition policies, and other relevant topics.

We encourage an open reporting culture and require any unsafe conditions or potential hazards be reported immediately.

Wellness is an important part of our culture.

Our global Mind & Body Well-being Employee Resource Group focuses on enhancing physical wellness and raising the importance of mental health through virtual and in-person events.

We offer on- and off-site fitness and wellness facilities and programs, an assortment of team-building activities, and have a robust offering of physical, social, nutritional and mental health resources.

Training, Development and Engagement

We empower employees to succeed and grow, reward great thinking, results and hard work, and engage our employees.

Across our businesses, we offer job-specific training, certifications, mentoring, developmental assignments, and other opportunities to help our employees develop the skills needed to achieve long-term success.

We conduct regular formal and informal surveys to proactively seek out employee feedback, ideas, and collect data on

the employee experience.

We encourage candid participation, and these insights help us develop targeted strategies to

enhance our workplace and culture.

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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

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.

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.

Compensation and Benefits

We provide competitive compensation and benefits in order to attract and retain talent.

We regularly review our pay practices to confirm there are no significant pay disparities across gender or race, and we conduct an annual market assessments to provide consistency in rewards we offer.

We have implemented robust processes for setting personal goals, individual development actions and review employees’ performance and pay on an annual basis.

We also offer comprehensive and continually evolving benefits to help employees balance their work lives and personal lives.

AVAILABLE INFORMATION

The Cooper Companies, Inc.

Internet address is http://www.coopercos.com.

Internet address is https://www.coopercos.com.

The information on the Company's website is not part of this or any other report we file with, or furnish to, the Securities and Exchange Commission (SEC).

Our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, along with all other reports and amendments filed with or furnished to the SEC, are publicly available free of charge on our website as soon as reasonably practicable.

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

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

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

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business