ONTARIO SUPERIOR COURT OF JUSTICE. -and-

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1 Court File No.370t1 c 7;/J'-\ ONTARIO SUPERIOR COURT OF JUSTICE MARIE ANNE TONASKET DENOMMEE Plaintiff -and- ENDO PHARMACEUTICALS SOLUTIONS INC., ENDO INTERNATIONAL PLC, ENDO PHARMACEUTICALS, INC., V ALEANT PHARMACEUTICALS INTERNATIONAL, INC., VALEANT CANADA LIMITED, VALEANT CANADA LP (aka VALEANT CANADA S.E.C.), VALEANT INTERNATIONAL BERMUDA (formerly Valeant International (Barbados) SRL), ROGAN HOLDING CORPORATION, BROOKWA TER VENTURES INC. (formerly Meta Health Services Inc.), THERAMED CORPORATION, INDEVUS PHARMACEUTICALS INC., SAB PHARMA INC., NOV ARTIS PHARMA CANADA INC., SANDOZ CANADA INC., SAVIENT PHARMACEUTICALS INC., BRISTOL-MYERS SQUIBB CANADA CO., BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION, and BRISTOL MYERS SQUIBB COMPANY Defendants (Proceeding under the Class Proceedings Act, 1992, SO 1992, c C.6) TO THE DEFENDANTS STATEMENT OF CLAIM A LEGAL PROCEEDING HAS BEEN COMMENCED AGAINST YOU by the plaintiff. The claim made against you is set out in the fo ll owing pages. Ir YOU WISH TO DEFEND THIS PROCEEDING, you or an Ontario lawyer acting for you must prepare a statement of defence in Form 18A prescribed by the Rules of Civil Procedure, serve it on the plaintiffs lawyer or, where the plaintiff does not have a lawyer, serve it on the plaintiff, and file it, with proof of service, in this court office, WITHIN TWENTY DAYS after this statement of claim is served on you, if you are served in Ontario. If you are served in another province or territory of Canada or in the United States of America, the period for serving and filing your statement of defence is forty days. If you are served outside Canada and the United States of America, the period is sixty days.

2 - 2- Instead of serving and filing a statement of defence, you may serve and file a notice of intent to defend in Form 18B prescribed by the Rules of Civil Procedure. This will entitle you to ten more days within which to serve and fi le yom statement of defence. IF YOU FAIL TO DEFEND THIS PROCEEDING, JUDGMENT MAY BE GIVEN AGAINST YOU IN YOUR ABSENCE AND WITHOUT FURTHER NOTICE TO YOU. IF YOU WISH TO DEFEND THIS PROCEEDING BUT ARE UNABLE TO PAY LEGAL FEES, LEGAL AID MAY BE AVAILABLE TO YOU BY CONTACTING A LOCAL LEGAL AID OFFICE. Date July 22, 2014 Issued by ~ Local registrar Address of 80 Dundas Street court office London, Ontario N6A 6A3 TO: ENDO PHARMACEUTICALS SOLUTIONS INC. Glandore Business Centres, No. 33 Fitzwilliam Square Dublin 2, Ireland ENDO INTERNATIONAL PLC Glandore Business Centres, No. 33 Fitzwilliam Square Dublin 2, Ireland ENDO PHARMACEUTICALS, INC Atwater Drive Malvern, Pennsylvania 19355, USA V ALEANT PHARMACEUTICALS INTERNATIONAL, INC. 700 West Georgia Street, Floor Vancouver, British Columbia V7Y 1B3 VALEANT CANADA LIMITED 2150 St-Elzear Boulevard West Laval, Quebec H7L 4A8 Canada

3 - 3 - VALEANT CANADA LP (aka Valcant Canada S.E.C.) 2150 St-Elzear Boulevard West Laval, Quebec H7L 4A8 Canada V ALEANT INTERNATIONAL BERMUDA (formerly Valeant International (Barbados) SRL) Welches Christ Church, BB Barbados ROGAN HOLDING CORPORATION 298 Russell Hill Road Toronto, Ontario M4V 2T6 Canada BROOKWATER VENTURES INC. (formerly Meta Health Services Inc.) 65 Queen Street West Suite 805 and 815 Toronto, Ontario M5H 2M5 Canada THERAMED CORPORATION 6891 Edwards Boulevard Mississauga, Ontario L5T 2T9 Canada INDEVUS PHARMACEUTICALS INC. 33 Hayden Avenue #110 Lexington, Massachusetts United States of America SAB-PHARMA INC. 145 rue Jules-Leger Boucherville, QC J4B 7K8 Canada NOV ARTIS PHARMA CANADA INC boul. Bouchard Dorval, Quebec H9S 1A9 Canada SANDOZ CANADA INC. 145 rue Jules-Leger Boucherville, Quebec J4B 7K8 Canada

4 - 4- SA VIENT PHARMACEUTICALS INC. 400 Crossing Boulevard #3 Bridgewater, New Jersey United States of America BRISTOL-MYERS SQUIBB CANADA CO Upper Water St. Ste 900 Halifax, Nova Scotia B3J 3N2 Canada BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION 345 Park Avenue New York, New York United States of America BRISTOL-MYERS SQUIBB COMPANY 345 Park Avenue New York, New York United States of America

5 - 5- CLAIM I. The Plaintiff, Marie Anne Tonasket Denommee, claims on behalf of herself and others similarly situated in Canada: (a) (b) (c) (d) (e) (f) (g) (h) (i) an order certifying this proceeding and appointing her representative plaintiff for the class, to be further defined in the motion for certification; a declaration that the Defendants were negligent in the design, development, testing, research, manufacture, licensing, labelling, warning, marketing, distribution, and sale of Delatestryl (as defined in paragraph 28); a declaration that the Defendants are vicariously liable for the acts and omissions of their officers, directors, agents, employees and representatives; general damages in the amount of $30,000,000 or such other sum as this Honourable Court deems just; special damages in the amount of $15,000,000 or such other smn as this Honourable Comi deems just; alternatively, an accounting or other such restitutionary remedy disgorging the revenues realized by the Defendants from the sales of Delatestryl in Canada; damages pursuant to the Family Law Act, RSO 1990, C F.3, s. 61 and similar legislation and common law in other provinces and territories, as applicable, in the amount of $100,000 for each Plaintiff family member; punitive, aggravated and exemplary damages in the amount of $5,000,000; the costs of distributing all monies received to the class members;

6 -6- G) pre-judgment and post-judgment interest pursuant to section 128 and 129 of the Courts o.f Justice Act, RSO 1990, c C.43; (k) (l) the costs of this action on a substantial indemnity basis, together with H.S.T. and other applicable taxes thereon; and such further and other relief as this Honourable Court deems just. NATURE OF THE ACTION 2. This action involves the prescription drug Delatestryl, a form of testosterone replacement therapy. This action arises out of the Defendants' unlawful, negligent, inadequate, improper, unfair and deceptive practices and misrepresentations related to, inter alia, their design, development, testing, research, manufacture, licensing, labelling, warning, marketing, distribution and sale of their testosterone replacement therapy drug, Delatestryl. 3. The Defendants misrepresented that Delatestryl is a safe and effective treatment for low testosterone levels, also known as hypogonadism or "low-t", when in fact this drug causes serious Cardiovascular Events and Conditions (as defined in paragraph 36). 4. Consumers of the Defendants' drug were misled as to the drug's safety and efficacy, and as a result have suffered serious Cardiovascular Events and Conditions. THE PLAINTIFF 5. Marie Am1e Tonasket Denommee ("Ms. Denommee") is a resident of Kelowna, British Columbia. 6. Ms. Denommee is the wife of Jean Jacques Denommee ("Mr. Denommee"), an individual who was treated with Delatestryl and subsequently passed away after suffering an acute myocardial infarction (heart attack) as a result of using Delatestryl. THE DEFENDANTS 7. The rights to the manufacturing, distribution and sale of Deletestryl have changed hands several times since the drug was first introduced in the market.

7 - 7- A. Bristol-Myers Squibb 8. The Defendant, Bristol-Myers Squibb Company (formerly known as E.R. Squibb & Sons Ltd.), and the Defendant, Bristol-Myers Squibb International Corporation, are international business corporations with their headquarters in New York, New York, U.S.A. The Defendant, Bristol-Myers Squibb Canada Co. (formerly known as Squibb Canada Inc.), is a wholly owned subsidiary of the Defendant, Bristol-Myers Squibb Company, incorporated pursuant to the laws of Canada, with its head office in Halifax, Nova Scotia. These Defendants were engaged in the design, development, testing, research, manufacturing, licensing, labelling, warning, marketing, distribution and sale of Delatestryl from approximately 1953 (when Delatestryl was first introduced in the market). 9. The business of each of Bristol-Myers Squibb Company, Bristol-Myers Squibb International Corporation, and Bristol-Myers Squibb Canada Co. (collectively "Bristol Myers Squibb") are inextricably interwoven with that of the other and each is the agent of the other for the purposes of design, development, testing, research, manufacture, licensing, labelling, warning, marketing, distribution and/or sale for a profit, either directly or indirectly through an agent, affiliate or subsidiary, of Delatestryl. B. Theramed 10. In or around May 2000, the Defendant, Theramed Corporation, a corporation incorporated pursuant to the laws of Canada, based in Mississauga, Ontario, became engaged in the design, development, testing, research, manufacturing, licensing, labelling, warning, marketing, distribution and sale of Delatestryl. At that time, the Defendant, Theramed Corporation, was a wholly owned subsidiary of Brookwater Ventures Inc. (known at the time as Meta Health Services Inc.), which is a corporation incorporated pursuant to the laws of Canada, based in Toronto, Ontario. When Brookwater Ventures Inc. was known as Meta Health Services Inc., it was based in Mississauga, Ontario.

8 - 8 - II. In or around April 2008, the Defendant, Theramed Corporation, was sold to the Defendant, Rogan Holdings Corporation, a corporation incorporated pursuant to the laws of Canada, based in Toronto, Ontario. C. Valeant 12. The Defendant, Valeant International Bermuda (formerly Valeant International (Barbados) SRL), is an international corporation operating as a subsidiary of Valeant Pharmaceuticals International, Inc., based in Christ Church, Barbados. 13. The Defendant, Valeant Pharmaceuticals International, Inc., is a multinational speciality pharmaceutical company with its principal place of business in Laval, Quebec. 14. The Defendant, Valeant Canada Limited, has its principal place of business in Laval, Quebec. The Defendant, Valeant Canada Limited, is a wholly owned subsidiary of the Defendant, Valeant Pharmaceuticals International, Inc. 15. The Defendant, Valeant Canada LP, also known as Valeant Canada S.E.C., has its principal place of business in Laval, Quebec. The Defendant, Valeant Canada LP, is a wholly owned subsidiary of the Defendant, Valeant Pharmaceuticals International, Inc., operating as a limited partnership. 16. The business of each of Valeant International Bermuda (formerly Valeant International (Barbados) SRL), Valeant Pharmaceuticals International, Inc., Valeant Canada Limited, and Valeant Canada LP (aka Valeant Canada S.E.C.) (collectively "Valeant") are inextricably interwoven with that of the other and each is the agent of the other for the purposes of design, development, testing, research, manufacture, licensing, labelling, warning, marketing, distribution and/or sale for a profit, either directly or indirectly through an agent, affiliate or subsidiary, ofdelatestryl in Canada. 17. In or around July 2011, the Valeant Defendants became engaged in the design, development, testing, research, manufacturing, licensing, labelling, warning, marketing, distribution and sale of Delatestryl in Canada.

9 -9- D. Savicnt 18. In or around March 1992, Gynex Pharmaceuticals Inc., a corporation based in Bridgewater, New Jersey, U.S.A., became engaged in the design, development, testing, research, manufacturing, licensing, labelling, waming, marketing, distribution and sale of Delatestryl. Gynex Pharmaceuticals Inc. was subsequently acquired by and carried on business as part of what is now known as the Defendant, Savient Pharmaceuticals, Inc. (formerly known as Bio-Technology General Corporation), a corporation based in Bridgewater, New Jersey, U.S.A. 19. In or around September 2003, the Defendant, Savient Pharmaceuticals, Inc., engaged Sabex Inc., in the, inter alia, manufacturing, of Delatestryl. Sabex Inc. was subsequently acquired by and carried on business as the Defendant, Sandoz Canada Inc., a corporation incorporated pursuant to the laws of Canada, based in Boucherville, Quebec and a wholly owned subsidiary of the Defendant, Novatiis Pharma Canada Inc., a corporation incorporated pursuant to the laws of Canada, based in Dorval, Quebec. E. SAB-Pharma 20. In or around 2007, the Defendant, SAB-Pharma Inc., a corporation incorporated pursuant to the laws of Canada, based in Boucherville, Quebec, became engaged in, inter alia, the manufacturing ofdelatestryl. F. Indevus 21. In or around January 2006, the Defendant, Indevus Pharmaceuticals Inc., a corporation based in Lexington, Massachusetts, U.S.A., became engaged in the design, development, testing, research, manufacturing, licensing, labelling, warning, marketing, distribution and sale ofdelatestryl. G. Endo 22. The Defendants, Endo Pharmaceuticals Solutions Inc. and Endo Intemational pic, are corporations with their principal place of business based in Dublin, Ireland.

10 - I The Defendant, Endo Pharmaceuticals, Inc., has its principal place of business in Malvern, Pennsylvania. The Defendant, Endo Pharmaceuticals, Inc., is a wholly owned subsidiary of the Defendant, Endo International pic. 24. The business of each of the Defendants, Endo Pharmaceuticals Solutions Inc., En do International pic and Endo Pharmaceuticals Inc. (collectively "Endo") are inextricably interwoven with that of the other and each is the agent of the other for the purposes of design, development, testing, research, manufacture, licensing, labelling, warning, marketing, distribution and/or sale for a profit, either directly or indirectly through an agent, affiliate or subsidiary, of Delatestryl in Canada. 25. Subsequently, the Endo Defendants, became engaged in the design, development, testing, research, manufacturing, licensing, labeling, warning, marketing, distribution and sale of Delatestryl. THE DEFENDANTS' TESTOSTERONE THERAPY A. Bacl<ground 26. Testosterone is a primary androgenic hormone responsible for normal growth, development of the male sex organs, and maintenance of secondary sex characteristics. The hormone plays a role in sperm production, fat distribution, maintenance of muscle strength and mass, and sex drive. 27. In men, testosterone levels normally begin a gradual decline after the age of thirty. The slow, but steady, decrease of testosterone levels is a normal part of the aging process. 28. Delatestryl, a form of testosterone replacement therapy, provides testosterone enanthate for intramuscular injections and belongs to the class of drugs known as Androgens. 29. Delatestryl was approved by the U.S. Food and Drug Administration ("FDA") in De1atestry1 has been available in Canada since 1956.

11 - II Delatestryl injections are self-administered by the patient on a weekly basis, or as recommended by their physician or other health care provider. The testosterone is released into the bloodstream over several days. 31. Delatestryl is just one form of testosterone replacement therapy. Other forms of testosterone replacement therapy include prescription injections, transdennal patches, buccal systems (applied to upper gum and inner cheek), and pills. Testosterone injections, gels, patches, buccal systems, and pills are collectively referred to herein as "Testosterone Therapy". 32. Testosterone Therapy is indicated for treating conditions in adult males associated with a deficiency or absence of endogenous testosterone. This deficiency or absence of testosterone is often associated with hypogonadism. Hypogonadism is a specific and recognized condition of the endocrine system, which in men may involve the severely diminished production or non-production of testosterone. Hypogonadism can be the result of a medical condition, taking certain medications, or a consequence of an injury. Hypogonadism can also begin during fetal development, before puberty, or during adulthood. 33. There are two basic types of hypogonadism: pnmary hypogonadism and secondary hypogonadism. Primary hypogonadism is the result of a condition in the testicles while secondary hypogonadism is the result of a condition in the hypothalamus or pituitary glands. Either type may be the result of an inherited trait or something that occurs later in life, such as injury or an infection. Delatestryl was developed for and approved by the FDA for treatment of primary hypogonadism and hypogonadotropic hypogonadism (a form of secondary hypogonadism) and approved by Health Canada for treatment of all forms of hypogonadism. 34. It is estimated that 20-30% of men over sixty years-of-age and 30-40% of men over eighty years-of-age are affected by hypogonadism.

12 Delatestryl is not medically indicated for treatment of non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated and if other etiologies responsible for the symptoms have not been excluded. B. TheRisks 36. Testosterone Therapy, including Delatestryl, carries the risk of undesirable cardiovascular-related events and conditions in patients who use the drug. The "Cardiovascular Events and Conditions" suffered due to Testosterone Therapy include but are not limited to increased or irregular heart rate, myocardial infarction (heart attack), stroke, deep vein thrombosis, pulmonary embolism and death. There have been a number of studies suggesting that Testosterone Therapy in men increases the risk of certain Cardiovascular Events and Conditions. 37. In 2010, a New England Joumal of Medicine study entitled "Adverse Events Associated with Testosterone Administration," whose participants received testosterone gel, was discontinued early after an exceedingly high number of men in the testosterone test group suffered cardiovascular-related adverse events. 38. In November 2013, a study entitled "Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with low Testosterone Levels" was published in the Joumal of the American Medical Association. The study indicated that Testosterone Therapy raised the risk of death, heart attack, and stroke by approximately 30%. 39. On January 29, 2014, a study was released in PLOS ONE entitled "Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men" that indicated use of Testosterone Therapy doubled the risk of heart attacks in men over sixty-five years of age and men younger than sixty-five with a previous diagnosis of heart disease. 40. On January 31,2014, the FDA announced it was investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products and

13 monitoring the risk in addition to reassessing the safety issues raised in the Journal of the American Medical Association and PLOS ONE studies described herein. 41. On June 19, 2014, the FDA announced it was requiring manufacturers of Testosterone Therapy products to include a general warning in the drug labelling of such products about the risk of blood clots in the veins. Blood clots in the veins are also known as venous thromboembolism, including deep vein thrombosis and pulmonary embolism. The previous warning warned of venous blood clots as a possible result of polycythemia (an abnormal increase in the number of red blood cells). The labels require modification because there were postmarket reports of venous blood clots umelated to polycythemia. The FDA further mmounced that this new warning was not related to the FDA's ongoing evaluation of the possible risk of stroke, heart attack and death in patients using Testosterone Therapy. 42. On July 15, 2015, Health Canada issued an Information Update regarding testosterone hormone replacement products, including Delastestryl. Health Canada advised that following a safety review on testosterone replacement products, they found a growing body of evidence for serious and possible life-threatening heart and blood vessel problems, including heart attacks, strokes and blood clots in the lungs or legs, as well as increased or irregular heart rate with the use of testosterone replacement products. 43. Notwithstanding the important cardiovascular findings in numerous studies and other data and information that was being collected worldwide by the Defendants, the Defendants concealed the cardiovascular risks of Testosterone Therapy. 44. In addition, despite the publicity surrounding reports by third parties, the Defendants continued to market and distribute Testosterone Therapy as being safe and effective, without undettaking their own cardiovascular studies in order to either confirm or dispute the findings reported by others.

14 Testosterone Therapy's product monograph in Canada does not provide any real precaution about cardiovascular risk, merely outlining that it may increase blood pressure and misrepresented that cardiovascular event rates are "unknown." THE PLAINTIFF'S EXPERIENCE 46. Mr. Denommee was prescribed Delatestryl by his physician and commenced using Delatestryl on or about August 13, On December 6, 2009, while on vacation with Ms. Denommee in Mexico, Mr. Denommee died after suffering a myocardial infarction (hemt attack). 48. Mr. Denommee used Delatestryl in accordance with the package label and consumer information pamphlet, and in the mam1er it was intended to be used. 49. Mr. Denommee had no heart -related conditions or problems prior to his use of Delatestryl. 50. In the time period before and during Mr. Denommee's use of Delatestryl, he received no or inadequate warnings about the increased risk of Cardiovascular Events and Conditions. 51. Had Mr. Denommee been aware of the increased risk of Cardiovascular Events and Conditions from the use of Delatestryl, he would never have used Delatestryl. But for the Defendants' wrongful conduct, Mr. Denommee would not have suffered the myocardial infarction and died. 52. Ms. Denommee first became aware of the link between Cardiovascular Events and Conditions and the use ofdelatestryl in early 2014, after the media brought to light the conclusions of the scientific studies outlined and FDA investigation above. It was not possible for Ms. Denommee to have known that her husband's heart attack was caused by Delatestryl prior to these events. 53. Ms. Denommee has suffered and will continue to suffer damages including loss of care, guidance and companionship as well as financial expenses and special damages.

15 CAUSES OF ACTION A. Duty of Care 54. The Defendants, at all material times, owed a duty of care to the Plaintiff to: (a) (b) (c) (d) (e) (f) ensure that Delatestryl was fit for its intended or reasonably foreseeable use; conduct appropriate research and testing to determine whether and to what extent use of Delatestryl posed serious health risks, including the risk of Cardiovascular Events and Conditions; properly, adequately, and fairly warn the Plaintiff, other putative class members, and their prescribing physicians or other health care providers that use of Delatestryl carries a risk of Cardiovascular Events and Conditions; ensure that prescribing physicians and other health care providers were kept fully and completely warned and informed regarding all risks associated with Delatestryl; monitor, investigate, evaluate and follow-up on adverse reaction to the use ofdelatestryl; and properly inform Health Canada and other regulatory agencies of the increased risks of Cardiovascular Events and Conditions associated with the use of Delatestryl. B. Negligence 55. The Defendants negligently breached their duty of care.

16 The Plaintiff states that her damages and the damages of other putative class members were caused by the negligence of the Defendants. Such negligence includes but is not limited to the following: (a) (b) (c) (d) (e) (f) (g) (h) (i) the Defendants failed to ensure that Delatestryl was not dangerous to recipients during the course of its use and that the drug was fit for its intended purpose; the Defendants failed to adequately test Delatestryl in a manner that would fully disclose the magnitude of the risks associated with its use, including but not limited to the increased risk of Cardiovascular Events and Conditions; the Defendants failed to maintain and manage an adverse incident repmiing system for Delatestryl; the Defendants failed to give Health Canada complete and accurate information as that information became available; the Defendants failed to conduct any or any adequate follow-up studies on the efficacy and safety of Delatestryl; the Defendants failed to conduct any or any adequate long-term studies of the increased risk of continued use ofdelatestryl; the Defendants failed to properly supervise their employees, their subsidiaries and their affiliated corporations; in all of the circumstances of this case, the Defendants applied callous and reckless disregard for the health and safety of persons using Delatestryl; and the Defendants breached other duties of care to persons using Delatestryl, details of which breaches are known only to the Defendants.

17 - 17- C. Failure to Warn 57. The Defendants failed to wam of the risks associated with Delatestryl. 58. The Plaintiff states that her damages and the damages of other putative class members were caused by the Defendants' failure to warn, which includes, but is not limited to, the following: (a) (b) (c) (d) (e) (f) the Defendants failed to provide persons using Delatestryl, their physicians or other health care providers, and Health Canada with proper, adequate, and/or fair warning of the increased risks associated with the use of Delatestryl, including but not limited to the increased risk of Cardiovascular Events and Conditions; the Defendants failed to warn persons using Delatestryl, their physicians or other health care providers, and Health Canada about the need for comprehensive regular monitoring to ensure the early discovery of side effects related to using Delatestryl; the Defendants failed to adequately monitor, evaluate and act upon reports of adverse reactions to Delatestryl in Canada and elsewhere; the Defendants failed to provide any or any adequate updated and/or current information to persons using Delatestryl, their physicians or other health care providers, and Health Canada respecting the increased risks of Delatestryl as such information became available from time to time; the Defendants failed to provide adequate warnings of the potential increased risks associated with Delatestryl on package labels; the Defendants failed to provide adequate warnings of the increased risks associated with Delatestryl, including the increased risk of Cardiovascular Events and Conditions in persons using Delatestryl, on the customer information pamphlets in Canada;

18 - 18- (g) (h) (i) the Defendants, after noticing problems with Delatestryl, failed to issue adequate warnings, timely recall of the drug, publicize the problem and othetwise act properly and in a timely manner to alert the public, including adequately warning persons using Delatestryl and their physicians or other health care providers of the drug's inherent dangers, including but not limited to the danger of developing Cardiovascular Events and Conditions in persons using Delatestryl; the Defendants failed to establish any adequate procedures to educate their sales representatives and prescribing physicians or other health care providers respecting the increased risks associated with using Delatestryl; and the Defendants failed to conform with applicable disclosure and reporting requirements pursuant to the Food and Drugs Act, RSC 1985, c F-27 and its associated regulations. D. Negligent Design 59. The Defendants were negligent in designing Delatestryl. 60. The Plaintiff states that her damages and the damages of other putative class members were caused by the Defendants' negligent design of Delatestryl, which includes but is not limited to the following: (a) (b) (c) any benefit from using Delatestryl was outweighed by the serious and undisclosed risks of its use, when used as intended; there are no individuals for whom the benefits of Delatestryl outweigh the risks, given that there are many alternative products that are at least as efficacious as Delatestryl and carry far less and/or less serious risks than Delatestryl; the Defendants knew, or ought to have known, that the foreseeable risks of Delatestryl exceeded the benefits associated with its design;

19 - 19- (d) (e) (f) (g) (h) the Defendants knew, or ought to have known, that Delatestryl was more dangerous than persons using Delatestryl and their physicians or other health care providers, as reasonably prudent consumers and health care providers, would expect when used in an intended or reasonably foreseeable manner; the Defendants failed to warn persons using Delatestryl and their physicians or other health care providers that Delatestryl, as designed, could result in adverse health or medical conditions, including Cardiovascular Events and Conditions; the Defendants failed to conduct any or any adequate follow-up studies on the efficacy and safety of Delatestryl as designed; the Defendants failed to conduct any or any adequate long-term studies of the increased risk of continued use of Delatestryl as designed; and the Defendants, throughout the events described herein, had the economic and technical means to provide a safer alternative design that would have prevented the health and medical conditions described herein and prevented the injuries and damages suffered by persons using Delatestryl. E. Negligent Distribution, Marketing and Sale 61. The Defendants were negligent in the distribution, marketing and sale of Delatestryl. 62. The Plaintiff states that her damages and the damages of other putative class members were caused by the Defendants' negligent distribution, marketing and sale of Delatestryl, which includes, but is not limited to, the following: (a) (b) Delatestryl is either defective in its design or, although non-defective, still has the propensity to injure under its intended and ordinary use; any benefit from using Delatestryl was outweighed by the serious and undisclosed risks of its use, when used as intended;

20 -20- (c) (d) (e) (f) (g) (h) there are no individuals for whom the benefits ofdelatestryl outweigh the risks, given that there are many alternative products that are at least as efficacious as Delatestryl and carry far less and/or less serious risks than Delatestryl; the Defendants knew, or ought to have known, that Delatestryl was either defective in its design or, although non-defective, still had the propensity to injure under its intended and ordinary use; the Defendants sought to increase the usage of Delatestryl despite the known safety concerns; the Defendants actively promoted Delatestryl as suitable for use in general without regard for severe health risks; the Defendants, when distributing the drug, failed to provide persons using Delatestryl, their physicians or other health care providers, and Health Canada with proper, adequate, and/or fair warning ofdelatestryl's design defect or propensity to injure when used as intended; and the Defendants failed to timely cease the manufacture, marketing and/or distribution of Delatestryl when they knew, or ought to have known, that Delatestryl was either defective in its design, or although non-defective, still had the propensity to injury under its intended and ordinary use. F. Waivet of Tort 63. The Plaintiff and other putative class members are entitled to elect, at the end of the trial of the common issues, to waive the tort and require the Defendants to account for all or part of the revenue they received from the sale of Delatestryl in Canada. 64. The Plaintiff pleads that such an election may be appropriate for the following reasons, among others: (a) such revenue was acquired in such circumstances that the Defendants may not, in good conscience, retain it;

21 (b) (c) (d) the integrity of the pharmaceutical regulations and marketplace would be undermined if the court did not require an accounting; Delatestryl could not have been marketed, and the Defendants would not have received any or part of the revenue from its sale in Canada, absent the Defendants' tmtious conduct; and the Defendants engaged in wrongful conduct by putting into the marketplace a pharmaceutical product that causes or has the potential to cause serious risks of cardiovascular injury. DAMAGES AND SUBROGATED CLAIMS 65. The risks associated with the use of Delatestryl, including the risk of Cardiovascular Events and Conditions, were in the exclusive knowledge and control of the Defendants. 66. The extent of the risks were not known to, and could not have been known by, the Plaintiff or other putative class members. 67. The injuries of the Plaintiff and other putative class members would not have occurred but for the negligence of the Defendants in failing to ensure that Delatestryl was safe for use or, in the alternative, for failing to provide adequate warning of the risks associated with using Delatestryl to persons using Delatestryl and their physicians or other health care providers. 68. As a result of the Defendants' conduct, putative class members have suffered and will continue to suffer damages and loss, including, but not limited to: (a) (b) personal injury; out-of-pocket expenses incurred, including those connected with hospital stays, medical treatment, medication and the cost of Delatestryl or, alternatively, the incremental cost of Delatestryl as paid for by putative class members;

22 - 22- (c) (d) (e) compensation for the loss of guidance, care and companionship; costs of future care and future services; and loss of income and loss of future income. 69. As a result of the Defendants' conduct, putative class members suffered and will continue to suffer expenses and special damages, of a nature and amount to be particularized prior to trial. 70. As a result of the Defendants' negligence, putative class members are entitled to damages pursuant to Tort-feasors Act, RSA 2000 c T-5, Fatal Accidents Act, RSA 2000, c F-8, Family Law Act, RSO 1990, c F.3, Civil Code of Quebec (1991) art 1457 (1991), The Fatal Accidents Act, CSSM c F50, Fatal Accidents Act, RSNB 1973, c F-7, as repealed by Fatal Accidents Act, SNB 2012, c 104, Fatal Accidents Act, RSNL 1990, c F-6, Fatal Injuries Act, RSNS 1989, c 163, Fatal Accidents Act, RSPEI 1988, c F-5, as amended by SPEI 2008, c 8, s II, The Fatal Accidents Act, RSS 1978, c F-11, Fatal Accidents Act, RSNWT 1988, c F-3, Fatal Accidents Act, RSNWT (Nu) 1988, c F-3, Fatal Accidents Act, RSY 2002, c 86, Family Compensation Act, RSBC 1996, c 126, and the regulations thereunder and amendments thereto. 71. Some of the expenses related to the medical treatment that putative class members have undergone, and will continue to undergo, have been borne by the various provincial health insurers. 72. As a result of the Defendants' negligence, the various provincial health insurers have suffered and will continue to suffer damages for which they are entitled to be compensated by virtue of their right of subrogation in respect of all past and future insured services. A claim is hereby advanced by the Plaintiff for the cost of such services under the applicable Provincial and Territorial Legislation including the Health Care Costs Recovety Act, SBC 2008, c 27, Health Services Insurance Act, CCSM c H35, Health Services Act, RSNB 1973, c H-3, Health Services and Insurance Act, RSNS 1989, c 197, Health Insurance Act, RSO 1990, c H-6, Health Insurance Act, RSQ c A- 29, and The Department of Health Act, RSS 1978, c D-17, Health Care Insurance Plan

23 -23- Act, RSY 2002, c I 07, Hospital Insurance and Health and Social Services Administration Act, RSNWT 1988, c.t-3, Ho:,pital Insurance and Health and Social Services Administration Act, RSNWT (Nu) 1988, c.t-3, Crown's Right of Recove1y Act, SA 2009, c C-35, Hmpital and Diagnostic Services Insurance Act, RSPEI 1988, c H-8, Hospital Insurance Agreement Act, RSNL 1990, c H-7, and the regulations thereunder and amendments thereto. PUNITIVE DAMAGES 73. The Plaintiff pleads that the Defendants' conduct, as particularized above, in the design, development, testing, manufacturing, licensing, distribution, marketing, sale and promotion of Delatestryl and the delayed withdrawal or recall and/or the failure to withdraw or recall was high-handed, outrageous, reckless, wanton, entirely without care, deliberate, callous, disgraceful, willful, in intentional disregard of the rights and safety of the Plaintiff and the rights and safety of the other putative class members, indifferent to the consequences and motivated by economic considerations, such as the maintenance of profits and market share. Such conduct renders the Defendants liable to pay punitive damages to the putative class members. 74. The Plaintiff claims on behalf of herself and other putative class members punitive, aggravated and exemplary damages for the Defendants' reckless and unlawful conduct. SERVICE OUTSIDE OF ONTARIO 75. The Plainti!T pleads and relies on section 17 (g) and (p) of the Rules of Civil Procedure, RRO 1990, Reg 194, allowing for service ex juris of the foreign Defendants. Specifically, this originating process may be served without court order outside Ontario in that the claim is (a) in respect of a tort committed in Ontario (rule 17.02(g)); (b) against a person carrying on business in Ontario (rule 17.02(p )). PLACE OF TRIAL 76. The Plaintiff proposes that this action be tried in London, Ontario.

24 -24- July 22, 2014 Siskinds LLP Barristers & Solicitors 680 Waterloo Street P.O. Box 2520 London, ON N6A 3V8 Charles M. Wright LSUC#: 36599Q Linda J. Visser LSUC#: Jill S. McCmtney LSUC#: 50632S Tel: (519) Fax: (519) Lawyers for the Plaintiff

25 DENOMMEE d ENDO INTERNATIONAL PLC eta! Plaintiff an Defendants Court File No: ONTARIO SUPERIOR COURT OF JUSTICE Proceeding commenced at London STATEMENT OF CLAIM Siskinds LLP Barristers & Solicitors 680 Waterloo Street P.O. Box 2520 London, ON N6A 3V8 Charles M. Wright LSUC#: 36599Q Linda J. Visser LSUC#: Jill S. McCartney LSUC#: 50632S Tel: (519) Fax: (519) Lawyers for the Plaintiff