Definitions

“Approval Hearing” means the hearing of the motion for final approval of the Settlement Agreement.
“Approved Claimant” means a Settling Claimant that the Claims Administrator determines is eligible for compensation under the Compensation Protocol.
“Certification and Hearing Notice Orders” means the Court orders certifying the Ontario Proceeding, Saskatchewan Proceeding, and Quebec Proceeding and approving the Hearing Notice and Hearing Notice Plan, in a form agreed to by the Parties, attached hereto as Schedule “A”;
“Claim Deadline” means one hundred and twenty (120) days after the first day on which the Settlement Approval Notice is published;
“Claim Form” means the claim form developed by the Claims Administrator in consultation with Class Counsel and approved by the Court.
“Claims Administration Costs” means all costs, other than Class Counsel Legal Fees, required to implement this Settlement Agreement, including without limitation, costs required to satisfy the notice provisions;
“Claims Administrator” means the firm proposed by Class Counsel and appointed by the Courts to administer the Settlement Amount in accordance with the provisions of this Settlement Agreement and the Compensation Protocol, and any employees of such firm.
“Classes” means the Ontario Class, Saskatchewan Class, and Quebec Class;
“Class Counsel Legal Fees” means all legal fees, disbursements and applicable taxes in respect of all legal services provided by Class Counsel or any other law firm for the benefit of the Class(es) and the Provincial Health Insurers, as approved by the Court, but does not include fees for legal services for the benefit of particular Settling Claimants (which are payable by the Settling Claimant);“Class Counsel” means Merchant Law Group, Siskinds LLP and Siskinds Desmeules, Avocats;
“Class Member” means a member of any of the Ontario Class, Saskatchewan Class, and Quebec Class, but, for greater certainty, does not include any Opt Out or Provincial Health Insurer. “Class Members” means members of those three classes, with the same exceptions;
“Compensation Protocol” means the Court-approved plan for administering this Settlement Agreement and distributing the Settlement Amount to Class Members;
“Courts” means the Court of Queen’s Bench for Saskatchewan, the Ontario Superior Court of Justice, and the Superior Court of Quebec;
“Defendants’ Counsel” means the law firm of Blake, Cassels & Graydon LLP;
“Defendants” means Janssen Inc., Janssen Pharmaceuticals, Inc., Janssen Ortho LLC, Johnson & Johnson, and Johnson & Johnson Inc.;
“Dismissal Order” means the Order of the Ontario Superior Court of Justice dismissing the Other Class Proceedings with no costs against either the Plaintiffs or Defendants, and alternatively dismissing the Joudry Action and converting the Rosevear Action into an individual proceeding if the named plaintiff opts out of the applicable Class;
“Effective Date” means the date on which all of the following have occurred: (i) each Provincial Health Insurer has provided all statutorily required consents or approvals and executed a Provincial Health Insurer Release; (ii) copies of all the Provincial Health Insurer Releases have been provided to counsel for the Defendants; (iii) the Settlement Approval Orders and Dismissal Order become Final Orders and (iv) the Settlement Agreement has not been and can no longer be terminated pursuant to Section 5;
“Eligible Injury(s)” means:
1. a diagnosis of acute kidney injury or acute renal failure occurring on or before April 25, 2016;
2. a diagnosis of diabetic ketoacidosis occurring on or before August 31, 2016; or
3. amputation of a lower limb (i.e. leg, foot, or toe(s)) occurring on or before December 6, 2017
“Final Order” means any order contemplated by this Settlement Agreement from which no appeal lies, in respect of which any right of appeal has expired without the initiation of proceedings in respect of that appeal, or proposed appeal, such as the delivery of a notice of appeal or application for leave to appeal, or, in respect of any order from which an appeal is taken, that appeal and any subsequent appeal are dismissed;
“Hearing Notice Plan” means the method by which the Hearing Notice is disseminated, in a form agreeable to the Parties and approved by the Court;
“Hearing Notice” means the notice (in long, abridged and press release form) approved by the Court, substantially in the form of Schedule “B”, in English and French, which advises Class Members of the certification of the Saskatchewan, Ontario and Quebec Proceedings (for settlement purposes only), the opt out process, and the hearings to approve the settlement provided for in this Settlement Agreement;
“Injury Evidence” means proof, by way of medical records, which may include contemporaneous physician or hospital records supplemented by a letter from the physician providing any needed clarification of the contents of the records, of each Eligible Injury claimed.
“Invokana Product(s)” means Invokana^®, Invokamet^®, and/or Invokamet XL^®;
“Net Settlement Proceeds” means the Settlement Amount less the amounts payable in respect of Claims Administration Costs, Class Counsel Legal Fees and any other costs associated with claims administration and notice of settlement approval hearing and, where the settlement is approved, notice of settlement approval;
“Non-Refundable Expenses” means the costs of publishing and distributing the Hearing Notice, including the associated professional fees (but expressly excluding Class Counsel Legal Fees), and any Claims Administration Costs incurred prior to any termination of this Settlement Agreement pursuant to section 5, limited to a maximum of $50,000 pursuant to section 3.2(2);
“Ontario Class” means:
1. All persons resident in Canada (at the time of the certification order), with exception of Saskatchewan Class Members and Quebec Class Members, who were prescribed and used Invokana^®, Invokamet^®, and/or Invokamet XR^® in Canada at any time on or before the date of the certification order; and
2. All persons, with exception of Saskatchewan Class Members and Quebec Class Members, who by virtue of a personal relationship to one or more of such persons described in (i) above have claims for common law or statutory damages;
“Ontario Court” means the Ontario Superior Court of Justice;
“Ontario Proceeding” means Raymond Duck v Janssen Inc., Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Johnson & Johnson Inc.; commenced in the Toronto office of the Ontario Court under Court File No.CV-18- 00000570-00CP;
“Opt Out Deadline” means the date sixty (60) days after the date on which the Hearing Notice is first published, or such other date as the Parties agree and is approved by the Court;
“Opt Out Form” means the form for requesting exclusion from the Classes, substantially in the form of Schedule “D”;
“Opt Out Threshold” shall mean the threshold agreed upon by the Plaintiffs and Defendants, delivered to the Court under seal and kept confidential by the Plaintiffs, the Defendants and the Court;
“Opt Out” means a person who would have been a Class Member but for her timely and valid request for exclusion pursuant to the opt out procedures set out in the Certification and Hearing Notice Orders;
“Other Class Proceedings” means
1. Amanda Evelyn Rosevear v Janssen Inc., Janssen Pharmaceuticals, Inc., Janssen Ortho LLC, and Johnson & Johnson; commenced in the Toronto office of the Ontario Court under Court File No. CV-16-551-20100CP (“Rosevear Action”); and
2. Rosalba Joudry v Janssen Inc., Janssen Pharmaceuticals, Inc., Janssen Ortho LLC, Johnson & Johnson and Johnson & Johnson Inc.; commenced in the Toronto office of the Ontario Court under Court File No. CV-15- 536111CP (“Joudry Action”);
“Parties” means the Plaintiffs and the Defendants;
“Plaintiffs” means the Plaintiffs in the Saskatchewan Proceeding, the Ontario Proceeding, and the Quebec Proceeding;
“Prescription Evidence” means the documentation that must be provided to:
1. Establish proof of Invokana Product prescription for treatment of a diagnosis of diabetes through medical records or documentation from the prescribing or treating physician;
2. Establish proof of prescription for an Invokana Product(s), namely:
  1. contemporaneous medical and/or pharmacy records demonstrating consumption of an Invokana Product;
  2. contemporaneous insurance benefit records demonstrating coverage for an Invokana Product; or
  3. documentation from the prescribing or treating physician confirming consumption of an Invokana Product;
3. Establish the requisite length of time of Invokana Product usage for each Eligible Injury claimed, as follows:
  1. 7 days of continuous usage, including within 48 hours prior to the event, for a diagnosis of acute kidney injury or acute renal failure;
  2. 7 days of continuous usage, including within 48 hours prior to the event, for a diagnosis of diabetic ketoacidosis;
  3. 30 days of continuous usage, including within 30 days of the procedure, for amputation of a lower limb;
Proof of usage to be established with contemporaneous medical and/or pharmacy records, or contemporaneous insurance benefit records, or documentation from the prescribing or treating physician. Absent clear evidence to the contrary, it will be presumed that the Invokana Product prescription was filled and taken in accordance with the prescription.
“Proceedings” means the Saskatchewan Proceeding, the Ontario Proceeding, and the Quebec Proceeding;
“Provincial Health Insurer Release” means the form of Release attached hereto as Schedule “H”;
“Provincial Health Care Recovery Fund” means a separate fund allocated to the Provincial Health Insurers as compensation for the Provincial Health Insurer Rights of Recovery.
“Provincial Health Insurer Rights of Recovery” means all statutory authority for the recovery of costs of insured health or medical services, as defined in the empowering legislation of each jurisdiction and listed in Schedule “G”;
“Provincial Health Insurers” means all provincial and territorial Ministries of Health or equivalents, and/or provincial and territorial plans funding medical and health care services and costs throughout Canada as listed in Schedule “G”;
“Quebec Class” means:
1. All persons resident in Quebec (at the time of the authorization) who were prescribed and used Invokana^®, Invokamet^®, and/or Invokamet XR^® in Quebec at any time on or before the date of the certification order; and
2. All persons, who by virtue of a personal relationship to one or more of such persons described in (i) above have claims for common law or statutory damages;
“Quebec Proceeding” means Steven Varnai and Joanne Giroux v Janssen Inc., Janssen Pharmaceuticals, Inc., Janssen Ortho LLC, Johnson & Johnson, and Johnson & Johnson Inc. filed under Court File No. 500-06-000906-186;
“Referee” means the person, selected by Class Counsel and approved by the Court, that will hear appeals from decisions of the Claims Administrator.
“Released Claims” means:
1. For all Releasors, other than the Provincial Health Insurers, any and all legal, equitable, administrative or other claims of any kind, regardless of the legal, equitable, statutory or other theory on which they are based, including all existing, future, known, and unknown claims, actions, demands, causes of action, cross-claims, counterclaims, obligations, contracts, indemnity, contribution, suits, debts, sums, accounts, controversies, rights, damages, costs, lawyers’ fees, administration costs, losses, expenses, and all liabilities whatsoever existing now or arising in the future, whether class, individual or otherwise in nature, including direct, contingent or absolute, accrued, mature, derivative, subrogated, personal, assigned, discovered, undiscovered, suspected, unsuspected, disclosed, undisclosed, asserted, unasserted, known, unknown, inchoate, or otherwise, relating in any way to any conduct anywhere: 1) that arise directly or indirectly out of, relate to, or are in any way connected with Invokana Product(s); 2) that have been brought or could have been brought by the Class that relate to Invokana Product(s); 3) relating to the creation, design, manufacture, testing, distribution, promotion, advertising, sale, administration, research, development, efficacy, inspection, clinical investigation, licensing, regulatory approval or authorization, packaging, labelling, use, marketing, recommendation, ingestion, compliance with regulatory obligations or reporting requirements, warnings and post-sale warnings, packaging, instructions for use, condition, promises, and any other matter arising out of, relating to, resulting from, or in any way connected with or related to Invokana Product(s), including by way of example but without limitation, alleged failure to warn, negligence in design or manufacturing, and/or labeling, of Invokana Product(s); and/or 4) relating to any alleged representations, promises, statements, warranties (express or implied) or guarantees given or made by anyone affiliated with or representing the Released Parties relating to Invokana Product(s). Subject to the foregoing, the “Released Claims” include all claims for damages or remedies of whatever kind or character, known or unknown, that are now recognized or that may be created or recognized in the future by statute, regulation, judicial decision, or in any other manner, for or in respect of, arising out of or relating to any Invokana Product(s).
2. For the Provincial Health Insurers, any and all manner of claims which a Provincial Health Insurer ever had, now has or hereafter can, shall or may have pursuant to Provincial Health Insurer Rights of Recovery arising out of or in any way related to Class Members’ use of Invokana Products whether known or unknown, direct or indirect, subrogated or otherwise, relating in any way to the design, manufacture, sale, distribution, labelling, and/or use, of Invokana Product(s) in Class Members during the Class Period, and including, without limitation and by way of example, all subrogated and/or direct claims in respect of Class Members that were or could have been brought by or on behalf of the Provincial Health Insurers for the cost of medical care and treatment provided to Class Members, as well as medical screening and monitoring, arising from the facts alleged in the Proceedings.
“Released Parties” means, jointly and severally, individually and collectively, the Defendants, and any and all of their present, future and former, direct and indirect, parents, subsidiaries, divisions, affiliates, controlling persons, general or limited partners, insurers, vendors, contractors, agents and assigns, and all other persons, partnerships or corporations with whom any of the former have been, or are now, affiliated or related, and all of their respective past, present and future officers, directors, employees, agents, shareholders, attorneys, trustees, servants and representatives, and the predecessors, successors, purchasers, heirs, executors, estate administrators, assigns and personal representatives (or equivalent thereto) of each of the foregoing; any and all suppliers of materials, components, and services used in the manufacture of any Invokana Product(s), including the labelling, packaging, marketing and selling thereof, along with any and all of their present, future and former, direct and indirect, parents, subsidiaries, divisions, affiliates, controlling persons, general or limited partners, insurers, vendors, contractors and assigns, and all other persons, partnerships or corporations with whom any of the former have been, or are now, affiliated or related, and all of their respective past, present and future officers, directors, employees, agents, shareholders, attorneys, trustees, servants and representatives, and the predecessors, successors, purchasers, heirs, executors, estate administrators, assigns and personal representatives (or equivalent thereto) of each of the foregoing; any and all distributors of Invokana Product(s), including those involved in the labelling, packaging, marketing and selling of Invokana Product(s), wholesale distributors, private label distributors, retail distributors, hospitals and clinics, and all of their present, future and former, direct and indirect, parents, subsidiaries, divisions, affiliates, controlling persons, general or limited partners, insurers, vendors, contractors and assigns, and all other persons, partnerships or corporations with whom any of the former have been, or are now, affiliated or related, and all of their respective past, present and future officers, directors, employees, agents, shareholders, attorneys, trustees, servants and representatives, and the predecessors, successors, purchasers, heirs, executors, estate administrators, assigns and personal representatives (or equivalent thereto) of each of the foregoing;
“Releasors” shall mean, jointly and severally, individually and collectively, the Plaintiffs and the Class Members and all of their present, future and former representatives, predecessors, successors, heirs, executors, administrators, insurers and assigns;
“Saskatchewan Class” means:
1. All persons resident in Saskatchewan (at the time of the certification order) who were prescribed and used Invokana^®, Invokamet^®, and/or Invokamet XR^® in Saskatchewan at any time on or before the date of the certification order; and
2. All persons who by virtue of a personal relationship to one or more of such persons described in (i) above have claims for common law or statutory damages;
“Saskatchewan Proceeding” means Ronald Allen Fiddler v Janssen Inc., Janssen Pharmaceuticals, Inc., Janssen Ortho LLC, Johnson & Johnson, and Johnson & Johnson Inc., commenced in the Court of Queen’s Bench for Saskatchewan under Court File Number Q.B.G. 2809 of 2015;
“Settlement Agreement” means this agreement, including the recitals, exhibits and schedules;
“Settlement Amount” means CAD $1,500,000.00 inclusive, including without limitation all interest, taxes, costs, Class Counsel Legal Fees, other legal fees and Claims Administration Costs;
“Settlement Approval Notice” means the notice (in long, abridged and press release form) approved by the Courts, substantially in the form of Schedule “F”, in English and French, which advises Class Members of the approval of the settlement provided for in this Settlement Agreement;
“Settlement Approval Notice Plan” means the method by with the Settlement Approval Notice is disseminated, in a form agreeable to the Parties and approved by the Courts;
“Settlement Approval Orders” means the orders or judgments issued by the Courts substantially in the form of Schedule “E” hereto.
“Settling Claimant” (collectively, the “Settling Claimants”) means each Class Member who files a claim pursuant to the Compensation Protocol;
“Trust Account” means a guaranteed investment vehicle, liquid money market account or equivalent security with a rating equivalent to or better than that of a Canadian Schedule I bank (a bank listed in Schedule I of the Bank Act, S.C. 1991, c. 46) held at a Canadian financial institution under the control of Class Counsel or the Claims Administrator, once appointed, for the benefit of the Settlement Claimants, as provided for in this Settlement Agreement.