In re Prograf Antitrust Litigation
www.PrografIndirectPurchaserSettlement.com

Frequently Asked Questions

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1. Why Did I Get The Notice?

You received the Notice because you requested it or because records indicate that you might be a member of the Settlement Class. The Settlement has been approved, and Astellas denies any wrongdoing. You are not being sued.

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2. What is the Lawsuit About?

The Action was approved by Judge Rya W. Zobel for the United States District Court for the District of Massachusetts. The Action claims that Astellas violated state antitrust, unfair competition, consumer protection, and unjust enrichment laws of the Class States by unlawfully delaying the introduction of generic versions of the prescription drug Prograf into the United States market, causing injury to the Plaintiffs and some members of the Settlement Class by causing them to pay higher prices for Prograf than they would have paid for its generic versions. The Action claims that Astellas filed a baseless petition with the FDA, which delayed the FDA’s approval of generic versions of Prograf. Plaintiffs argue that, as a result of its petition, Astellas willfully maintained monopoly power in a market for tacrolimus in the United States, thereby maintaining the price of Prograf above competitive levels, resulting in overcharges to Plaintiffs and some members of the Settlement Class. Astellas denies these claims and denies that it did anything wrong. Astellas asserts that the petition it filed with the FDA properly requested that the FDA modify its policies concerning the testing required for the approval of generic versions of immunosuppressants and raised legitimate medical concerns about the substitutability of different versions of tacrolimus. Astellas asserts that these requests had scientific merit and reflected the concerns of the relevant medical community. Astellas asserts that it filed the petition with the FDA for appropriate reasons and that the petition is entitled to First Amendment protection. Astellas also denies that the petition delayed the market entry of generic versions of Prograf.

No Court or a jury has determined that any of the allegations against Astellas have been proven.

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3. What is a Class Action Lawsuit?

In a class action lawsuit, one or more people (called “class representatives”) sue on behalf of themselves and other people who have similar claims. All of the people who have the right kind of claims form a “class” together, and after approval (or “certification”) of a class by the court, the court’s rulings apply to the class as a whole.

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4. What Has Happened in this Action?

Extensive fact and expert discovery has been taken in this case. On June 10, 2014, the Court certified this Action under Fed. R. Civ. P. 23(c)(4) as an issue-specific class action lawsuit only to address the issue of Astellas’s alleged antitrust misconduct. Because the Court certified an issue-specific class (“Issue Class”), a trial in this Action would address only the question of whether Astellas violated the law and if so, the period of time during which the market for Prograf (tacrolimus) was impacted. If Plaintiffs were to prove that Astellas violated the law, individual Issue Class members would then have to file their independent lawsuits to prove that they were injured as a result of Astellas’s conduct and if so, by how much.

Astellas has appealed the Court’s certification of an Issue Class to the United States Court of Appeals for the First Circuit. The parties had fully briefed the appeal, held oral argument, and were awaiting a ruling from the Court of Appeals when they reached this Settlement. To facilitate settlement of this Action, the parties asked the Court to certify the Settlement Class under Fed. R. Civ. P. 23(b)(3) for settlement purposes only. The Court certified the Settlement Class on April 29, 2016. A full description of the “Settlement Class Members” – the Consumers and Third Party Payors who are part of the certified Settlement Class in this lawsuit – is provided in Questions 6 through 8.

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5. Why is there a settlement with Defendant?

The Court did not decide in favor of either party to this Action. Instead, the lawyers for both sides of the lawsuit negotiated a Settlement, which they believe is in the best interests of their respective clients. The Settlement allows both sides to avoid the risks and cost of lengthy and uncertain litigation and the uncertainty of a trial and appeals, and permits Settlement Class Members to be compensated without undue delay. Plaintiffs and their attorneys think the Settlement is fair and in the best interests of Settlement Class Members.

The terms of the Settlement approved by the Court are set forth in the written Settlement Agreement. The Settlement Agreement provides that Defendants will pay a total of $13,250,000.00 (Thirteen Million Two Hundred Fifty Thousand Dollars and no/100), plus interest earned during escrow, in exchange for a release of all claims against the Released Parties (as defined in the Settlement Agreement) arising out of or related to the conduct alleged or that could have been alleged in the Action. The Settlement Agreement, including the full text of the release, is available for review here.

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6. I am an Individual Who Purchased or Paid for Prograf. How Do I Know if I am a Settlement Class Member?

As a Consumer, you are a member of the Settlement Class if:

  • Between April 15, 2008 and December 31, 2010 (the “Class Period”), you purchased or paid for some or all of the purchase price for Prograf and/or its generic equivalent in Arizona, California, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Vermont, West Virginia, and/or Wisconsin in capsule form, for consumption by yourself or a member of your family.
  • You are NOT a Settlement Class Member if:
    • During the Class Period, your insurance plan always required you to pay the same co-payment for a prescription regardless of whether it is a branded or generic drug; or
    • You are an officer, director, manager, employee, subsidiary or affiliate of Astellas; or
    • During the Class Period, you purchased Prograf directly from Astellas or its affiliates; or
    • During the Class Period, you purchased Prograf and/or its generic equivalent only for resale purposes; or
    • During the Class Damage Period, your only purchases of Prograf were subsidized through Astellas’ Patient Assistance Program (PAP) and/or the Astellas Prograf Value Card program; or
    • You are an immediate family member of the Judge in this lawsuit.

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7. How do I know if I am a Third Party Payor for the purposes of this case?

Third Party Payors include all health insurance companies, health maintenance organizations, health and welfare plans that make payments from their own funds, and other health benefit providers and entities with self-funded plans that contract with a health insurer or administrator to administer their prescription drug benefits.

Third Party Payors include such private entities that may provide prescription drug benefits for current or former public employees and/or public benefits programs, but – for the purposes of this Action – only to the extent that such a private entity purchased or paid for Prograf and/or its generic equivalent for consumption by its members, employees, insureds, participants, or beneficiaries during the Class Period.

For purposes of this definition, an entity “purchased” or “paid for” Prograf and/or its generic equivalent if it paid, or reimbursed someone who paid, some or all of the dispensing pharmacy’s price for such drug.

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8. I am a Third Party Payor. How Do I Know if I am a Settlement Class Member?

As a Third Party Payor, you are a member of the Settlement Class if:

  • Between April 15, 2008 and December 31, 2010 (the “Class Period”) you purchased or paid for some or all of the purchase price for Prograf and/or its generic equivalent in Arizona, California, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Vermont, West Virginia, and/or Wisconsin in capsule form for consumption by your members, employees, insureds, participants, or beneficiaries and not for resale.
  • You are NOT a Settlement Class Member if:
    • During the Class Period, you were a fully insured health plan (i.e., a plan that purchased insurance from another entity covering 100% of your plan’s reimbursement obligations to your members); or
    • During the Class Period, you were a government entity that is not a government-funded employee benefit plan; or
    • You are an officer, director, manager, employee, subsidiary or affiliate of Astellas; or
    • During the Class Period, you purchased Prograf directly from Astellas or its affiliates; or
    • During the Class Period, you purchased Prograf and/or its generic equivalent only for resale purposes.

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9. What Does the Settlement with the Defendant Provide?

Defendant has agreed to pay $13,250,000.00 (Thirteen Million Two Hundred Fifty Thousand Dollars and no/100) as the Settlement Amount. In exchange, Plaintiffs and the Settlement Class Members will release Astellas from all claims that were brought or could have been brought in this Action, including antitrust, unfair competition, consumer protection, consumer fraud, and unjust enrichment claims. This Notice provides a summary of the release and the Settlement. All information related to the Settlement, including the full text of the release, is included in the Settlement Agreement, which is available for review here.

Defendant will deposit the Settlement Amount into an escrow account. The Settlement Amount plus interest earned in the escrow account, less taxes, costs and expenses associated with the administration of the escrow account is the “Settlement Fund.” The “Net Settlement Fund” is the amount of money available for distribution to the Settlement Class Members upon final Court approval of the Settlement. The Net Settlement Fund is the Settlement Fund less deductions for costs, fees and expenses including:

  • Reasonable attorneys’ fees, costs and expenses approved by the Court (See Question 18);
  • Any Court-approved incentive award to the Plaintiffs that served as class representatives in this Action (“Class Representatives”);
  • Taxes payable on the Settlement Fund;
  • Costs and expenses associated with administration of the Settlement; and
  • Costs of notifying Settlement Class members, including the costs of printing and mailing this Notice and the cost of publishing newspaper notice.

The Net Settlement Fund will be divided among all Settlement Class Members whose claims for recovery have been allowed pursuant to the terms of the Settlement Agreement and who send in valid claim forms (“Authorized Claimants”).

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10. How Much Will My Payment Be?

Your share of the Net Settlement Fund will depend on whether you are a Consumer or a Third Party Payor. The Court has preliminarily approved Class Counsel’s proposal that 35% of the Net Settlement Fund be distributed to Settlement Class members who are individual Consumers and 65% be distributed to Third Party Payor members of the Settlement Class (the “Allocation Agreement”). Further, at least 30 days before the Fairness Hearing (defined in Question 12), Class Counsel will propose a plan for final allocation of the Settlement Fund, including a method by which the Net Settlement Fund will be distributed among the Consumer members of the Settlement Class and among the Third Party Payor members of the Settlement Class (the “Allocation Plan”).

Your share of the Net Settlement Fund will depend on the amount of Prograf you purchased and/or the amount you paid for Prograf during the Class Damage Period of September 3, 2008 to December 31, 2010. If you did not purchase Prograf during the Class Damage Period, your share of the Net Settlement Fund may be zero. Generally, those who purchased or paid for more Prograf during the Class Damage Period will get a higher recovery.

Your share of the Net Settlement Fund will also depend on the number of valid claim forms that Settlement Class members submit. If less than 100% of the Settlement Class sends in a claim form, you could get a larger pro rata share.

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11. How Can I Get a Payment?

To be eligible for a payment, you must have submitted a claim form, postmarked no later than December 6, 2016.

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12. When Will I Get a Payment?

On November 2, 2016, the Court approved the Settlement. However, there may be appeals. It is always uncertain whether these appeals can be resolved favorably, and resolving them can take time, perhaps more than a year. During the course of an appeal, interest will accrue on the Settlement Fund and will be included, pro rata, in the amount paid to the Settlement Class Members. It also takes time for all the claim forms to be processed. If there are no appeals and depending on the number of claims submitted, the Claims Administrator could distribute the Net Settlement Fund as early as nine months after the Fairness Hearing. Please be patient.

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13. What Happens if the Settlement is terminated?

It is possible the Settlement may be terminated by one of the parties as outlined in the Settlement Agreement. If the Settlement is terminated, the certification of the Settlement Class will be vacated, and the Action will proceed as if the Settlement Agreement had not been entered into.

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14. How Do I Stay in the Settlement Class?

You will be a member of the Settlement Class unless you asked to be excluded and your exclusion request was deemed valid by the Court. All of the Court’s Orders in the Action will apply to you and legally bind you. You are also bound by the Settlement with the Defendant. To be eligible for a payment from the Settlement Fund, you must have submitted a claim form, postmarked no later than December 6, 2016.

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15. How Do I Exclude Myself from the Settlement?

The exclusion deadline was on September 8, 2016. You had the right to exclude yourself from the Settlement Class and sue Defendant for these claims at your own expense. If you did so, you will not receive any payment from the Settlement of this Action.

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16. As a Settlement Class Member, do I have a lawyer representing my interests in this Class Action?

The Court has appointed lawyers to represent you and other Settlement Class Members for purposes of the Settlement Class that has been certified. These lawyers are called Class Counsel. The following lawyers are the lead attorneys representing the Settlement Class for purposes of the approved Settlement:

J. Gerard Stranch, IV Joe P. Leniski, Jr. BRANSTETTER, STRANCH & JENNINGS, PLLC The Freedom Center 223 Rosa L. Parks Avenue, Suite 200 Nashville, TN 37203 Tel: (615) 254-8801 James R. Dugan, II Douglas Plymale, Ph.D. David Franco DUGAN LAW FIRM One Canal Place 365 Canal St., Suite 1000 New Orleans, LA 70130 Tel: (504) 648-0180

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17. How will the lawyers for the Settlement Class be compensated?

On November 2, 2016 the Court approved counsel’s request for Attorneys’ Fees and Expenses and Representative Plaintiff incentive award. Class Counsel asked the Court to reimburse them from the Settlement Fund for the costs and expenses they have incurred in the Action. You will not have to pay these fees, costs, and expenses out of your own pocket. These amounts will be deducted from the Settlement Fund. The incentive or service awards to the Plaintiffs who brought the Action for their service as Class Representatives will be $10,000 each.

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18. How Do I Tell the Court That I Do Not Like the Settlement With Defendant?

The objection deadline was on October 21, 2016. If you did not exclude yourself from the Settlement Class, you had the right object to or comment on the Settlement at the Fairness Hearing held on November 2, 2016.

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19. When and Where Will the Court Decide Whether to Approve The Settlement?

On November 2, 2016, the Court approved the Settlement, Attorneys’ Fees and Expenses award, Representative Plaintiff Incentive award, and Plan of Allocation.

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20. Is there a list of NDC codes available for the Settlement?

Yes, the NDC codes are:

0179-0079-70 43353-178-80 55154-8705-8 55111-526-78 0469-0657-11
0378-2045-01 0781-2102-01 55111-525-01 55111-527-01 0469-0657-73
0378-2046-01 0781-2103-01 55111-525-05 55111-527-05 51079-028-20
0378-2046-05 0781-2104-01 55111-525-30 55111-527-30 51079-817-01
0378-2047-01 21695-170-00 55111-525-78 55111-527-78 51079-818-01
43353-178-09 55154-5430-2 55111-526-01 0469-0607-73 0591-3359-01
43353-178-53 55154-5438-8 55111-526-05 0469-0617-11 0591-3359-30
43353-178-60 55154-8705-2 55111-526-30 0469-0617-73 0469-3016-01
378204505 378204705 469060767 469061710 469061771
469065710 469065771 51079002801 51079081720 51079081820
54569662800 55111052701 68084044901 68084045001 68084045101
68258909901

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21. What is the difference between the Class Period and Class Damage Period?

Please note that there is a “Class Period” (Between April 15, 2008 and December 31, 2010) and “Class Damage Period” (September 3, 2008 to December 31, 2010) for the Prograf Indirect Purchaser Settlement. Settlement Class Members include those individuals that purchased Prograf during the Class Period, within the Class States. However, the potential award to each Settlement Class Member will be based on the purchases and/or amount paid for Prograf during the Class Damage Period.

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