STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 

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Bradley S. Albert, Admitted in Md. 

600 Pennsylvania Avenue, N.W. 

Washington, D.C. 20580 

(202) 326-3670; (202) 326-3384 (fax) 

balbert@ftc.gov 

Attorney for Plaintiff Federal Trade Commission 

George G. Gordon 

DECHERT LLP 

Cira Centre, 2929 Arch Street 

Philadelphia, PA 19104 

(215) 994-4000; (215) 655-2382 (fax) 

george.gordon@dechert.com 

Attorney for Defendants Endo International plc and 

Endo Pharmaceuticals, Inc. 

UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF CALIFORNIA 

SAN FRANCISCO DIVISION 

FEDERAL TRADE COMMISSION, 

Plaintiff, 

v. 

ENDO PHARMACEUTICALS INC., 

and 

ENDO INTERNATIONAL PLC, 

Defendants. 

Case No 17-cv-00312 

STIPULATED ORDER FOR 

PERMANENT INJUNCTION 

The Federal Trade Commission (“Commission”) filed its Complaint for Injunctive Relief 

(“Complaint”) in this matter pursuant to Section 13(b) of the Federal Trade Commission Act 

(“FTC Act”), 15 U.S.C. § 53(b). The Commission and Defendants Endo Pharmaceuticals Inc. 

and Endo International plc, by their respective attorneys, have reached an agreement to resolve 

this case through settlement, and without trial or final adjudication of any issue of fact or law, 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

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and stipulate to entry of this Stipulated Order for Permanent Injunction (“Order”) to resolve all 

matters in dispute in this action. 

FINDINGS 

1. This Court has jurisdiction over the parties and the subject matter of this action. 

Defendants have stipulated that, for purposes of this Order alone, the Court has 

jurisdiction over Endo Pharmaceuticals Inc. and Endo International plc. 

2. Venue for these matters is proper in this Court under 15 U.S.C. § 22 and 28 U.S.C. § 

1391(b) and (c), and under Section 13(b) of the FTC Act, 15 U.S.C. § 53(b). 

3. The Complaint alleges that Defendants engaged in anticompetitive acts that constitute an 

unfair method of competition in violation of Sections 5(a) and 13(b) of the FTC Act, 15 

U.S.C. §§ 45(a) and 53(b), and an acquisition in violation of Section 7 of the Clayton 

Act, 15 U.S.C. § 18, by entering an agreement that foreclosed competition from generic 

equivalents of the brand-name drug Lidoderm® and later reduced competition between 

sellers of generic lidocaine patches. 

4. Defendants admit the facts necessary to establish the personal and subject matter 

jurisdiction of this Court in this matter only. 

5. Defendants deny the charges in the Complaint and dispute that the Commission is 

entitled to obtain relief. 

6. This Order does not constitute any evidence against Defendants, or an admission of 

liability or wrongdoing by Defendants, in this case or in any other litigation involving 

Lidoderm® or Opana ER®. This Order shall not be used in any way, as evidence or 

otherwise, in any other litigation or proceeding; provided that, nothing in this provision 

prevents the Commission or Defendants from using this Order in any proceeding 

regarding enforcement or modification of this Order or as otherwise required by law. 

7. Defendants waive any claim that they may have under the Equal Access to Justice Act, 

28 U.S.C. § 2412, concerning the prosecution of this action through the date of this 

Order, and agree to bear their own costs and attorney fees in this action and the Federal 

Court Actions. 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

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8. Entry of this Order is in the public interest. The Commission and Defendants have 

agreed to stipulate to entry of this Order to finally resolve the claims and litigations 

between them in the FTC Litigation and the Federal Court Actions. 

STIPULATIONS 

1. Defendants stipulate that venue for this matter is proper in this Court under 15 U.S.C. § 

22 and 28 U.S.C. § 1391(b) and (c), and under Section 13(b) of the FTC Act, 15 U.S.C. § 

53(b). 

2. Defendants waive all rights to appeal or otherwise challenge or contest the validity of this 

Order. 

3. Defendants stipulate that they shall comply with the provisions of this Order pending its 

entry by the Court. 

4. Defendants and the Commission have agreed to entry of this Order to finally resolve all 

claims and litigations between the Commission and Defendants in the FTC Litigation and 

the Federal Court Actions. 

5. The Commission stipulates that it will not file litigation or any other proceedings against 

Defendants asserting, or seeking remedies based on, Resolved Claims, other than any 

legal proceeding regarding enforcement or modification of this Order. 

6. The parties stipulate that the Commission’s dismissal of the Federal Trade Commission 

v. Endo Pharmaceuticals Inc., Civ Action No. 16-cv-1440 (E.D. Pa.) shall be treated for 

all purposes as being with prejudice with respect to any claims asserted in that action 

against Defendants. 

7. Defendants stipulate that they shall bear their own costs in the Federal Court Actions and 

shall not make any claims against the Commission for attorneys’ fees or costs in the 

Federal Court Actions. 

8. Defendants stipulate that, within one day of the entry of this Order, they will file a 

voluntary dismissal with prejudice of their claims in the Declaratory Judgment Actions in 

the form provided in Exhibit 1 to this Order. 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

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9. The Commission stipulates that, within one day of the entry of this Order, the 

Commission will file a motion for voluntary dismissal with prejudice of its claims against 

Defendants, including but not limited to Par Pharmaceutical Companies, Inc., as well as 

Paddock Holdings, LLC and Paddock Laboratories, Inc., in Federal Trade Commission v. 

Actavis, Inc., Civ. Action No. 09-cv-955 (N.D. Ga.), in the form provided in Exhibit 2 to 

this Order. 

I. 

IT IS ORDERED that, as used in this Order, the following definitions shall apply: 

A. “Commission” means the United States Federal Trade Commission. 

B. “Endo Pharmaceuticals” means Endo Pharmaceuticals Inc., any joint venture, subsidiary, 

division, group, or affiliate Controlled currently or in the future by Endo Pharmaceuticals Inc., 

their successors and assigns, and the respective directors, officers, employees, agents, and 

representatives acting on behalf of each. 

C. “Endo International” means Endo International plc, any joint venture, subsidiary, 

division, group, or affiliate Controlled currently or in the future by Endo International plc, their 

successors and assigns, and the respective directors, officers, employees, agents, and 

representatives acting on behalf of each. 

D. “Defendant” means either Endo Pharmaceuticals or Endo International. 

E. “Defendants” means Endo Pharmaceuticals and Endo International. 

F. “505(b)(2) Application” means an application filed with the United States Food and Drug 

Administration pursuant to Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, 21 

U.S.C. § 355(b)(2). 

G. “ANDA” means an Abbreviated New Drug Application filed with the United States Food 

and Drug Administration pursuant to Section 505(j) of the Federal Food, Drug and Cosmetic 

Act, 21 U.S.C. § 355(j). 

H. “Authorized Generic” means a Drug Product that is manufactured pursuant to an NDA 

and Marketed in the United States under a name other than the proprietary name identified in the 

NDA. 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

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I. “Brand/Generic Settlement” means any agreement or understanding that settles a Patent 

Infringement Claim in or affecting Commerce in the United States. 

J. “Brand/Generic Settlement Agreement” means a written agreement that settles a Patent 

Infringement Claim in or affecting Commerce in the United States. 

K. “Branded Subject Drug Product” means a Subject Drug Product Marketed in the United 

States under the proprietary name identified in the NDA for the Subject Drug Product. 

L. “Commerce” has the same definition as it has in 15 U.S.C. § 44. 

M. “Control” or “Controlled” means the holding of more than fifty percent (50%) of the 

common voting stock or ordinary shares in, or the right to appoint more than fifty percent (50%) 

of the directors of, or any other arrangement resulting in the right to direct the management of, 

the said corporation, company, partnership, joint venture, or entity. 

N. “Contingent Supply Agreement” means a Supply Agreement that: (i) is contingent on the 

Generic Filer’s inability to market the Generic Subject Drug Product on or after the Generic 

Entry Date because (x) the FDA has not granted final approval of the Generic Filer’s ANDA or 

505(b)(2) Application for the Generic Subject Drug Product and/or (y) the Generic Filer cannot 

manufacture commercial quantities of the Generic Subject Drug Product; and (ii) terminates 

within thirty (30) days after the Generic Filer has final FDA approval and can manufacture 

commercial quantities of the Generic Subject Drug Product using good faith, commercially 

reasonable efforts, 

provided, however, the Generic Filer may take delivery of, market, and sell quantities of 

Authorized Generic ordered prior to termination of the Supply Agreement so long as the total 

quantity of Authorized Generic delivered to the Generic Filer following termination of the 

Supply Agreement: (i) does not exceed the total quantity needed by the Generic Filer (as 

reflected in forecasts provided to the NDA Holder prior to termination of the Supply Agreement) 

during the eight (8) months following (x) termination of the Supply Agreement, if termination 

occurs after the Generic Entry Date, or (y) the Generic Entry Date, if termination occurs before 

the Generic Entry Date; and (ii) is delivered within eight (8) months of termination of the Supply 

Agreement. 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

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O. “Declaratory Judgment Actions” means Endo Pharmaceuticals Inc., et al. v. Federal 

Trade Commission, Civ. Action No. 16-cv-5599 (E.D. Pa.) and Endo Pharmaceuticals Inc., et al. 

v. Federal Trade Commission, Civ. Action No. 16-cv-5600 (E.D. Pa.). 

P. “Drug Product” means a finished dosage form (e.g., tablet, capsule, solution, or patch), as 

defined in 21 C.F.R. § 314.3(b), approved under a single NDA, ANDA or 505(b)(2) Application, 

that contains a drug substance, generally, but not necessarily, in association with one or more 

other ingredients. 

Q. “Exception” means the following in a Brand/Generic Settlement: 

1. compensation for saved future litigation expenses, but only if the total 

compensation the NDA Holder agrees to provide to the Generic Filer during the 

sixty (60) day period starting thirty (30) days before and ending thirty (30) days 

after executing the Brand/Generic Settlement Agreement does not exceed a 

maximum limit, which is initially set at seven million dollars ($7,000,000) and 

shall be increased (or decreased) as of January 1 of each year following entry of 

this Order by an amount equal to the percentage increase (or decrease) from the 

previous year in the annual average Producer Price Index for Legal Services 

(Series Id. PCU5411--5411--) published by the Bureau of Labor Statistics of the 

United States Department of Labor or its successor; 

2. the right to Market, as of an agreed upon Generic Entry Date: (i) Generic 

Product(s) in the United States under an ANDA or 505(b)(2) Application (x) that 

is controlled by the Generic Filer and was not transferred to the Generic Filer by 

the NDA Holder, or (y) to which the Generic Filer has a license from a party other 

than the NDA Holder; or (ii) an Authorized Generic of the Subject Drug Product; 

provided that this Exception shall apply regardless of whether or not the Generic 

Filer must pay for the right to Market and, if so, the terms and conditions 

governing such payment; 

3. provisions to facilitate, by means other than the transfer of goods or money, the 

Generic Filer’s ability to secure or maintain final regulatory approval, or 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

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commence or continue the Marketing, of a Generic Product, by, inter alia, 

providing covenants, waivers, permissions, releases, dismissals of claims, and/or 

authorizations; 

4. waiver or limitation of a claim for damages or other monetary relief based on 

prior Marketing of the Generic Subject Drug Product, but only if the NDA Holder 

and the Generic Filer do not agree, and have not agreed, to another Brand/Generic 

Settlement for a different Drug Product during the sixty (60) day period starting 

thirty (30) days before and ending thirty (30) days after the execution of the 

Brand/Generic Settlement Agreement; or 

5. a continuation or renewal of a pre-existing agreement between an NDA Holder 

and a Generic Filer but only if: (i) the pre-existing agreement was entered into at 

least 90 days before the relevant Brand/Generic Settlement Agreement, (ii) the 

terms of the renewal or continuation, including the duration and the financial 

terms, are substantially similar to those in the pre-existing agreement, and (iii) 

entering into the continuation or renewal is not expressly contingent on agreeing 

to a Brand/Generic Settlement. 

R. “Exempted Agreement” means a Materials Agreement or Supply Agreement that meets 

all of the following conditions: 

1. the price is above the Fully Allocated Manufacturing Cost, meaning: 

a. if the Agreement is a Materials Agreement, the Materials Price charged by the 

NDA Holder for Materials provided through the Materials Agreement is at or 

above the Fully Allocated Manufacturing Cost incurred by the NDA Holder 

per unit of the relevant Materials, or 

b. if the Agreement is a Supply Agreement, the Supply Price charged by the 

NDA Holder for the Authorized Generic of the Subject Drug Product is at or 

above the Fully Allocated Manufacturing Cost incurred by the NDA Holder 

per unit of the Authorized Generic of the Subject Drug Product provided 

under the agreement; 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

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2. the Brand/Generic Settlement Agreement containing or incorporating the 

Materials Agreement or Supply Agreement is the only Brand/Generic Settlement 

Agreement that the NDA Holder and the Generic Filer have entered, or agreed to 

enter, during the sixty (60) day period starting thirty (30) days before and ending 

thirty (30) days after the execution of the Brand/Generic Settlement Agreement; 

3. within fourteen (14) days after signing the Brand/Generic Settlement Agreement 

containing or incorporating the Materials Agreement or Supply Agreement, 

Defendants Submitted to the Monitor a full and complete copy of the 

Brand/Generic Settlement Agreement, including any Materials Agreement and/or 

Supply Agreement; 

4. within fourteen (14) days after the NDA Holder provides to the Generic Filer the 

Materials Price or Supply Price, as applicable, Defendants Submitted to the 

Monitor notification of the relevant Materials Price or Supply Price; 

5. within thirty (30) days after beginning supply under the relevant Materials 

Agreement or Supply Agreement, the NDA Holder Submitted to the Monitor: 

a. if a Materials Agreement, a verified written statement containing (i) the Fully 

Allocated Manufacturing Cost per unit for the Materials and (ii) a detailed 

calculation of the Fully Allocated Manufacturing Cost for the Materials, stated 

separately by cost component and on a per-unit basis; and 

b. if a Supply Agreement, a verified written statement containing (i) the Fully 

Allocated Manufacturing Cost per unit for the relevant Authorized Generic of 

the Subject Drug Product and (ii) a detailed calculation of the Fully Allocated 

Manufacturing Cost for the Authorized Generic of the Subject Drug Product, 

stated separately by cost component and on a per-unit basis; and 

6. if the NDA Holder is not a Defendant, the Materials Agreement or Supply 

Agreement, as applicable, requires the NDA Holder to (i) provide the notification 

required by subparagraphs I.S.(5) and (ii) cooperate with any reasonable request 

by the Monitor or staff of the Commission for documents and information to 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

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determine the relevant Fully Allocated Manufacturing Cost, including without 

limitation and subject to any demonstrated legally recognized privilege, providing 

the Monitor reasonable access to personnel, books, documents, and records kept 

in the ordinary course of business; 

provided that, notwithstanding subparagraph I.S(5) or subparagraph I.S(6), a Materials 

Agreement or Supply Agreement in which a Defendant is the Generic Filer shall also be 

considered an Exempted Agreement if it complies with subparagraphs I.S(1) to (4) and: 

a. if a Materials Agreement, Defendants Submit to the Monitor within thirty (30) 

days of beginning to receive the Materials, a verified written statement containing 

(i) Defendants’ best estimate of what would be the Fully Allocated Manufacturing 

Cost per unit for the Materials if manufactured or sourced by the Generic Filer, 

including a separate estimate of each cost component on a per-unit basis, and (ii) 

a description of the terms and conditions of any agreement(s), offer(s), purchase 

order(s), or price quote(s) a Defendant has entered into or received for supply of 

the Materials in connection with manufacture of the Subject Drug Product and 

other facts and circumstances, if any, that Defendants deem relevant to 

understanding such terms and conditions; and 

b. if a Supply Agreement, it is a Contingent Supply Agreement and Defendants 

Submit to the Monitor within thirty (30) days of beginning to receive the 

Authorized Generic, a verified written statement containing (i) Defendants’ best 

estimate of what would be the Fully Allocated Manufacturing Cost per unit for 

the Subject Drug Product if manufactured by the Generic Filer and (ii) a detailed 

calculation of the estimated Fully Allocated Manufacturing Cost, including an 

estimate of each cost component on a per-unit basis. 

S. “Federal Court Actions” means the Declaratory Judgment Actions, Federal Trade 

Commission v. Endo Pharmaceuticals Inc., Civ. Action No. 16-cv-1440 (E.D. Pa.), which was 

dismissed without prejudice by the Commission on October 25, 2016; and Federal Trade 

Commission v. Actavis, Inc., Civ. Action No. 09-cv-955 (N.D. Ga.). 

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T. “FTC Investigation” means the pre-complaint investigation conducted by FTC staff under 

File No. 141-0004. 

U. “FTC Litigation” means any legal proceeding brought by the Commission that alleges the 

Lidoderm Settlement Agreement and/or the Opana Settlement Agreement violates the law(s) 

enforced by the Commission. 

V. “Fully Allocated Manufacturing Cost” means: (1) direct costs incurred to produce or, if 

applicable, to acquire, the Subject Drug Product or Materials, determined in accordance with 

GAAP, as consistently applied in accordance with past practice and in the ordinary course of 

business, including, but not limited to (x) acquisition costs or (y) if applicable, materials, labor, 

manufacturing costs, packaging, labeling, testing, quality control, storage, insurance, and product 

maintenance; (2) the cost to ship the Subject Drug Product or Materials to the Generic Filer, and 

(3) administrative and overhead expenses associated with production or, if applicable, the 

acquisition of the Subject Drug Product or Materials, including, but not limited to, administrative 

labor costs, maintenance, information technology, quality assurance, insurance, depreciation of 

the equipment, and depreciation of the facility, allocated in accordance with past practice and in 

the ordinary course of business. To the extent the NDA Holder does not allocate administrative 

and overhead expenses associated with the Subject Drug Product to the Subject Drug Product, 

the NDA Holder shall do so at a proportion of the NDA Holder’s COGS of the Subject Drug 

Product to the NDA Holder’s total COGS (for purposes of this definition, COGS means the 

NDA Holder’s cost of goods sold, determined in accordance with GAAP, as consistently applied 

in accordance with past practice and in the ordinary course of business). 

W. “Generic Entry Date” shall mean the date in a Brand/Generic Settlement Agreement, 

whether certain or contingent, on or after which a Generic Filer is authorized by the NDA Holder 

to begin manufacturing, using, importing or Marketing the Generic Subject Drug Product. 

X. “Generic Filer” means a party to a Brand/Generic Settlement who controls an ANDA or 

505(b)(2) Application for the Subject Drug Product or has the exclusive right under such ANDA 

or 505(b)(2) Application to distribute the Subject Drug Product. 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

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Y. “Generic Product” means a Drug Product manufactured and/or sold under an ANDA or 

pursuant to 505(b)(2) Application. 

Z. “Generic Subject Drug Product” means the Generic Product that is the subject of the 

Patent Infringement Claim being resolved by the Brand/Generic Settlement. 

AA. “Lidoderm Settlement Agreement” means the Settlement and License Agreement 

between Endo Pharmaceuticals Inc. and Watson Laboratories, Inc. resolving the ANDA patent 

litigation involving the brand-name drug Lidoderm that is the subject of the Complaint in this 

action. 

BB. “Market,” “Marketed,” or “Marketing” means the promotion, offering for sale, sale, or 

distribution of a Drug Product. 

CC. “Materials” means components or ingredients used in the manufacturing of a Subject 

Drug Product, including, but not limited to, hard-to-source excipients, hard-to-source active 

pharmaceutical ingredients, hard-to-source packaging, devices, or kits for injectables. 

DD. “Materials Agreement” means provisions in, or incorporated into, a Brand/Generic 

Settlement Agreement providing for the supply of Materials to the Generic Filer by the NDA 

Holder for securing and/or maintaining regulatory approval, or manufacturing and Marketing by 

the Generic Filer of the Subject Drug Product, including the terms and conditions of any such 

supply. 

EE. “Materials Price” means the total actual per-unit price charged by the NDA Holder for 

Materials provided through a Materials Agreement, including any transfer price and royalty to be 

paid by the Generic Filer, net of any discounts, allowances, rebates, or other reductions. 

FF. “Monitor” means an individual appointed pursuant to the terms of Section IV below. 

GG. “NDA” means a New Drug Application filed with the United States Food and Drug 

Administration pursuant to Section 505(b) of the Federal Food, Drug and Cosmetic Act, 21 

U.S.C. § 355(b), including all changes or supplements thereto that do not result in the submission 

of a new NDA. 

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HH. “NDA Holder” means a party to a Brand/Generic Settlement that controls the NDA for 

the Subject Drug Product or has the exclusive right to distribute the Branded Subject Drug 

Product in the United States. 

II. “No-AG Commitment” means any agreement with, or commitment or license to, the 

Generic Filer that prohibits, prevents, restricts, requires a delay of, or imposes a condition 

precedent upon the research, development, manufacture, regulatory approval, or Marketing of an 

Authorized Generic, 

provided however, that agreement by the Generic Filer to pay royalties to the NDA 

Holder for the right to Market the Generic Subject Drug Product or an Authorized Generic of the 

Subject Drug Product, including agreement on the terms and conditions governing payment of 

such royalties, shall not be considered a No-AG Commitment. 

JJ. “Opana Settlement Agreement” means the Settlement and License Agreement and 

Development and Co-Promotion Agreement between Endo Pharmaceuticals Inc. and Impax 

Laboratories, Inc. resolving the ANDA patent litigation involving the brand-name drug Opana 

ER that is the subject of the FTC Investigation. 

KK. “Patent Infringement Claim” means any allegation threatened in writing or included in a 

complaint filed with a court of law that a Generic Product may infringe one or more U.S. Patents 

held by, or licensed to, an NDA Holder. 

LL. “Payment by the NDA Holder to the Generic Filer” means a transfer of value, other than 

a No-AG Commitment, by the NDA Holder to the Generic Filer (including, but not limited to, 

money, goods, or services), regardless of whether the Generic Filer purportedly transfers value in 

return, where such transfer is either (i) expressly contingent on entering a Brand/Generic 

Settlement Agreement, or (ii) agreed to during the sixty (60) day period starting thirty (30) days 

before and ending thirty (30) days after executing a Brand/Generic Settlement Agreement. 

MM. “Resolved Claims” means antitrust claims, or other claims based on the competitive 

impact of the conduct alleged in Federal Trade Commission v. Endo Pharmaceuticals Inc., Civ. 

Action No. 16-cv-1440 (E.D. Pa.) (the “Original Action”), including but not limited to claims 

alleging unfair methods of competition under § 5 of the FTC Act, that were or could have been 

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included in the Original Action or which arise from or are related to allegations, claims, or 

remedies included in the Original Action. 

NN. “Submit to the Commission” or “Submitted to the Commission” means to file with the 

Office of the Secretary of the Commission and send an electronic copy to the Compliance 

Division of the Commission at bccompliance@ftc.gov. 

OO. “Submit to the Monitor” or “Submitted to the Monitor” means to deliver to the Monitor 

appointed pursuant to the Order or, if no Monitor is appointed under this Order, to Submit to the 

Commission. 

PP. “Subject Drug Product” means the Drug Product for which one or more Patent 

Infringement Claims are settled under a given Brand/Generic Settlement. For purposes of this 

Order, the Drug Product of the NDA Holder and the Generic Filer to the same Brand/Generic 

Settlement shall be considered to be the same Subject Drug Product. 

QQ. “Supply Agreement” means provisions in, or incorporated into, a Brand/Generic 

Settlement Agreement providing for the supply of the Subject Drug Product to the Generic Filer 

by the NDA Holder for the Marketing by the Generic Filer of an Authorized Generic on or after 

the Generic Entry Date, including the terms and conditions of any such supply. 

RR. “Supply Price” means the total actual per-unit price charged by the NDA Holder for 

supply provided through a Supply Agreement, including any transfer price and royalty to be paid 

by the Generic Filer for the right to sell an Authorized Generic of the Subject Drug Product, net 

of any discounts, allowances, rebates, or other reductions. 

SS. “U.S. Patent” means any patent issued by the United States Patent and Trademark Office, 

including all renewals, derivations, divisions, reissues, continuations, continuations-in part, 

modifications, or extensions thereof. 

II. 

IT IS FURTHER ORDERED that, in connection with any actions in or affecting 

Commerce, 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 14 

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A. Defendants shall cease and desist from, either directly or indirectly, or through any 

corporate or other device, individually or collectively entering into a Brand/Generic Settlement 

that includes: 

1. (i) a No-AG Commitment and (ii) an agreement by the Generic Filer not to 

research, develop, manufacture, or Market the Subject Drug Product for any 

period of time; or 

2. (i) any Payment by the NDA Holder to the Generic Filer that is not an Exception 

or an Exempted Agreement and (ii) an agreement by the Generic Filer not to 

research, develop, manufacture, or Market the Subject Drug Product for any 

period of time, 

provided that any agreement entered into by an entity prior to that entity becoming part 

of a Defendant is not subject to the terms of this Order. 

III. 

IT IS FURTHER ORDERED that: 

A. Nothing in this Order shall prohibit a Defendant from entering a written agreement, 

including a Brand/Generic Settlement, for which Defendant has Submitted to the Commission a 

request for prior approval of the agreement so long as: 

1. within thirty (30) days of the Commission’s receipt of the request for prior 

approval under this paragraph, the Director of the Bureau of Competition (or his 

or her designee) has not notified the Defendant in writing that, after considering 

the request in good faith, Commission staff believes the relevant agreement raises 

substantial questions regarding violation of Section 5 of the FTC Act or any other 

applicable law that the FTC has authority to enforce and of the reasons for such a 

belief; or 

2. the Defendant has received the prior approval of the Commission, 

provided, however, nothing in Paragraph II shall prohibit a Defendant 

from executing a written agreement so long as such agreement contains a 

provision or provisions expressly stating: (1) the Defendant will Submit to the 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 15 

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Commission a request for prior approval of the agreement, and (2) the agreement 

is not effective, and shall not become effective, until and unless (i) thirty (30) 

days have passed since the request for prior approval was Submitted to the 

Commission and the Director of the Bureau of Competition (or his or her 

designee) has not notified the Defendant in writing that Commission staff believes 

the agreement raises substantial questions regarding violation of Section 5 of the 

FTC Act or any other applicable law that the FTC has authority to enforce, or (ii) 

the Commission has approved of the agreement. 

B. Nothing in this Order shall prohibit a Defendant from purchasing, merging with, or 

otherwise acquiring or being acquired by any party with which the Defendant has entered into a 

Brand/Generic Settlement. 

IV. 

A. The Commission may appoint a Monitor to ensure that any Materials Agreement or 

Supply Agreement that a Defendant asserts is an Exempted Agreement meets the requirements 

of Paragraph I.S of this Order. The Monitor shall serve, without bond or other security, at the 

expense of Defendants, on such reasonable and customary terms and conditions to which the 

Monitor and Defendants agree and that the Commission approves. 

B. The Commission shall select the Monitor, subject to the consent of Defendants, which 

consent shall not be unreasonably withheld. If Defendants have not opposed, in writing and 

identifying the reasons for opposing, the selection of any proposed Monitor within fourteen (14) 

days after notice by the staff of the Commission of the identity of any proposed Monitor, 

Defendants shall be deemed to have consented to the selection of the proposed Monitor. 

C. The Monitor’s duties and responsibilities shall include the following: 

1. the Monitor shall act in a fiduciary capacity for the benefit of the Commission; 

2. the Monitor shall have the power and authority to perform his/her duties under 

this Paragraph. The Monitor shall exercise his/her power and authority and carry 

out his/her duties and responsibilities in a manner consistent with the purposes of 

this Order and in consultation with the Commission; 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 16 

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3. the Monitor shall have authority to employ, at the expense of Defendants, such 

consultants, accountants, attorneys, and other representatives and assistants as are 

reasonably necessary to carry out the Monitor’s duties and responsibilities; 

4. the Monitor shall evaluate reports Submitted to the Monitor pursuant to the 

requirements of Paragraph V and within thirty (30) days from the date the 

Monitor receives a report, report in writing to the Commission concerning 

whether any Materials Agreement or Supply Agreement that Defendants assert is 

an Exempted Agreement meets the requirements of Paragraph I.S of this Order. 

D. Defendants shall grant and transfer to the Monitor, and such Monitor shall have, all 

rights, powers, and authority necessary to carry out the Monitor’s duties and responsibilities 

under this Order, including but not limited to, the following: 

1. Defendants shall cooperate with any reasonable request of the Monitor and shall 

take no action to interfere with or impede the Monitor's ability to perform his/her 

duties as provided in this Paragraph; 

2. subject to any demonstrated legally recognized privilege, Defendants shall 

provide the Monitor full and complete access to personnel, books, documents, 

records kept in the ordinary course of business, facilities and technical 

information, and such other relevant information as the Monitor may reasonably 

request to perform his/her duties under this Paragraph; 

3. Defendants shall indemnify the Monitor and hold the Monitor harmless against 

any losses, claims, damages, liabilities, or expenses arising out of, or in 

connection with, the performance of the Monitor’s duties, including all reasonable 

fees of counsel, and other reasonable expenses incurred in connection with the 

preparations for, or defense of, any claim, whether or not resulting in any liability, 

except to the extent that such losses, claims, damages, liabilities, or expenses 

result from gross negligence, willful or wanton acts, or bad faith by Monitor; and 

4. Defendants may require the Monitor and each of the Monitor’s consultants, 

accountants, attorneys, and other representatives and assistants to sign an 

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 16 of 34
STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 17 

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appropriate confidentiality agreement related to Defendants’ materials and 

information received in connection with the performance of the Monitor’s duties, 

provided however, such agreement shall not restrict the Monitor from 

providing any information to the Commission or require the Monitor to report to 

Defendants the substance of communications to or from the Commission or any 

party to a Brand/Generic Settlement Agreement other than Defendants. 

E. The Commission may require the Monitor and each of the Monitor’s consultants, 

accountants, attorneys, and other representatives and assistants to sign an appropriate 

confidentiality agreement related to Commission materials and information received in 

connection with the performance of the Monitor’s duties. 

F. The Commission may, on its own initiative or at the request of the Monitor, issue such 

additional orders or directions as may be necessary or appropriate. 

G. If the Commission determines that the Monitor has ceased to act or failed to act 

diligently, the Commission may appoint a substitute Monitor. The Commission shall select the 

substitute Monitor, subject to the consent of Defendants, which consent shall not be 

unreasonably withheld. If Defendants have not opposed, in writing and identifying the reasons 

for opposing, the selection of any proposed substitute Monitor within fourteen (14) days after 

notice by the staff of the Commission to Defendants of the identity of any proposed substitute 

Monitor, Defendants shall be deemed to have consented to the selection of the proposed 

substitute Monitor. 

V. 

IT IS FURTHER ORDERED that: 

A. Defendants shall Submit to the Commission a verified written report within sixty (60) 

days after the date this Order is entered, one (1) year after the date this Order is entered, and 

annually for nine (9) years thereafter, setting forth in detail the manner and form in which they 

have complied and are complying with this Order. So long as Defendants are under common 

ownership, their reports may be filed jointly. If the Commission has appointed a Monitor, and if 

Defendants are providing or receiving product under an Exempted Agreement, Defendants shall 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 18 

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Submit to the Monitor a copy of the report. Among other things and without limitation, 

Defendants shall include in each report: 

1. a copy of each agreement a Defendant has entered with any party to a 

Brand/Generic Settlement signed by a Defendant if: (i) the Brand/Generic 

Settlement Agreement includes an agreement by the Generic Filer not to research, 

develop, manufacture, or Market the Subject Drug Product for any period of time; 

and (ii) the agreement was entered within six (6) months of executing the 

Brand/Generic Settlement Agreement, provided that, Defendants do not need to 

submit any agreement that was submitted with a prior verified written report; and 

2. if, during the period covered by the report, an NDA Holder has supplied 

Authorized Generic to a Defendant pursuant to a Contingent Supply Agreement 

that Defendants assert is an Exempted Agreement, identify the Contingent Supply 

Agreement; if Defendants have not obtained FDA approval for the Generic 

Subject Drug Product, provide a statement describing the status of their efforts 

and planned actions to obtain approval; and if Defendants are not able to 

manufacture commercial quantities of the Generic Subject Drug Product, provide 

a statement describing the status of their efforts and what steps they are taking to 

develop commercial manufacturing capability. 

B. This Order does not alter the reporting requirements of Defendants pursuant to Section 

1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. 

VI. 

IT IS FURTHER ORDERED that for the purpose of determining or securing 

compliance with this Order, subject to any legally recognized privilege, and upon written request 

and upon reasonable notice to Defendants, Defendants shall, without restraint or interference, 

permit any duly authorized representative of the Commission: 

1. access, during office hours and in the presence of counsel, to all facilities and 

access to inspect and copy all non-privileged business records and documentary 

material related to compliance with this Order, including without limitation 

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 18 of 34
STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 19 

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electronically stored information as defined in Rule 2.7(a)(1) and (2), 16 C.F.R. § 

2.7(a)(1), and books, ledgers, accounts, correspondence, memoranda, and other 

records and documents (in whatever form such records and documents are kept) 

in the possession or under the control of a Defendant, which copying services 

shall be provided by Defendants at the request of the authorized representative(s) 

of the Commission and at the expense of Defendants; and 

2. to interview officers, directors, or employees of Defendants, who may have 

counsel present, regarding any such matters. 

VII. 

IT IS FURTHER ORDERED that Defendants shall notify the Commission at least 

thirty (30) days prior to: 

A. Any proposed dissolution of Endo Pharmaceuticals Inc. or Endo International plc; or 

B. Any proposed acquisition, merger, or consolidation of Endo Pharmaceuticals Inc. or 

Endo International plc; or 

C. Any other change in a Defendant, including, but not limited to, assignment and the 

creation, sale or dissolution of subsidiaries, if such change might affect the compliance 

obligations arising out of this Order. 

VIII. 

IT IS FURTHER ORDERED that: 

A. In connection with any FTC Litigation, Defendants shall: 

1. agree to service of process of all Commission subpoenas issued under Rule 45 of 

the Federal Rules of Civil Procedure or Rule 3.34 of the Commission Rules of 

Practice; 

2. respond to the Commission’s requests for production of documents as though 

Defendants were parties to the FTC Litigation and shall limit objections to those 

available to a party to such litigation; 

3. not object to or file a motion to quash, on the grounds that the depositions are 

unduly burdensome because Defendants are third parties, subpoenas from the 

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 19 of 34
STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 20 

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Commission for the deposition testimony of up to seven (7) of their officer(s), 

director(s), agent(s), or employee(s), or corporate representative(s) (designated 

under Federal Rule of Civil Procedure 30(b)(6) or Rule 3.33(c)(1) of the 

Commission Rules of Practice). Such depositions shall be scheduled at mutuallyagreeable dates, times, and locations in the United States; 

4. not object to any discovery request on the grounds that the requested documents 

are not located in the United States; 

5. not object on grounds of timeliness to any motion(s) to compel the production of 

documents that Defendants withheld as privileged or protected by the work 

product doctrine during the FTC Investigation; and 

6. negotiate in good faith with the Commission to provide a declaration, affidavit, 

and/or sponsoring witness, if necessary, to establish the authenticity and 

admissibility of any documents and/or data that Defendants produce or have 

produced to the Commission. 

IX. 

IT IS FURTHER ORDERED that: 

A. No information or documents submitted under this Order shall be disclosed by the 

Commission to any person other than an authorized representative of the Commission, including 

without limitation any Monitor appointed pursuant to this Order, except in the course of a legal 

proceeding regarding enforcement or modification of this Order, or as otherwise required by law. 

B. In the event of a material change in the law governing the antitrust implications of 

Brand/Generic Settlements, the Commission will consider, in good faith, modifications to this 

Order proposed by Defendants. 

X. 

IT IS FURTHER ORDERED that this Court shall retain jurisdiction over these matters 

for purposes of construction, modification, and enforcement of this Order. 

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 20 of 34
STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 21 

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XI. 

IT IS FURTHER ORDERED that this Order shall terminate ten (10) years from the 

date on which the Order is issued. 

XII. 

IT IS FURTHER ORDERED that this action shall be dismissed with prejudice. Each 

party shall bear its own costs. 

SO ORDERED this ____ day of _____, 2017 

 ____________________________ 

 The Honorable William H. Orrick

 

 

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STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 22 

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 22 of 34
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STIPULATED ORDER FOR PERMANENT INJUNCTION 

Case No. 17-cv-00312 22 

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 23 of 34
Exhibit 1 

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 24 of 34
UNITED STATES DISTRICT COURT 

FOR THE EASTERN DISTRICT OF PENNSYLVANIA 

ENDO PHARMACEUTICALS INC., et. al., 

Plaintiffs, 

v. Case No: 16-cv-5599

FEDERAL TRADE COMMISSION, 

Defendant. 

NOTICE OF VOLUNTARY DISMISSAL WITH PREJUDICE 

 Pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(i), Plaintiffs Endo 

Pharmaceuticals Inc. and Endo International plc hereby give notice that their claims against 

Defendant in the above-captioned action are voluntarily dismissed with prejudice. The 

Defendant has not filed an answer or motion for summary judgment in this case. 

 

Exhibit 1 to Stipulated Order for Permanent Injunction - Page 1

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 25 of 34
2 

Dated: Respectfully Submitted, 

 

 																																						_____________

George G. Gordon 

Christine C. Levin 

Jennings F. Durand 

DECHERT LLP 

Cira Centre, 2929 Arch Street 

Philadelphia, PA 19104 

Tel.: (215) 994-4000 

Fax: (215) 994-2222 

george.gordon@dechert.com 

christine.levin@dechert.com 

jennings.durand@dechert.com 

																																	_______________

Steven G. Reade (pro hac vice) 

Ryan Z. Watts (pro hac vice) 

Charles B. Weinograd (pro hac vice) 

Jonathan L. Stern (pro hac vice) 

ARNOLD & PORTER LLP 

601 Massachusetts Avenue NW 

Washington, DC 20001 

Tel.: (202) 942-5000 

Fax: (202) 942-5999 

steven.reade@aporter.com 

ryan.watts@aporter.com 

charles.weinograd@aporter.com 

jonathan.stern@aporter.com 

Counsel for Defendants Endo 

Pharmaceuticals Inc. and Endo International 

plc 

Exhibit 1 to Stipulated Order for Permanent Injunction - Page 2

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 26 of 34
UNITED STATES DISTRICT COURT 

FOR THE EASTERN DISTRICT OF PENNSYLVANIA 

ENDO PHARMACEUTICALS INC., et. al., 

Plaintiffs, 

v. Case No: 16-cv-5600

FEDERAL TRADE COMMISSION, 

Defendant. 

NOTICE OF VOLUNTARY DISMISSAL WITH PREJUDICE 

 Pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(i), Plaintiffs Endo 

Pharmaceuticals Inc. and Endo International plc hereby give notice that their claims against 

Defendant in the above-captioned action are voluntarily dismissed with prejudice. The 

Defendant has not filed an answer or motion for summary judgment in this case. 

 

Exhibit 1 to Stipulated Order for Permanent Injunction - Page 3

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 27 of 34
2 

Dated: Respectfully Submitted, 

 

 																																						_____________

George G. Gordon 

Christine C. Levin 

Jennings F. Durand 

DECHERT LLP 

Cira Centre, 2929 Arch Street 

Philadelphia, PA 19104 

Tel.: (215) 994-4000 

Fax: (215) 994-2222 

george.gordon@dechert.com 

christine.levin@dechert.com 

jennings.durand@dechert.com 

																																	_______________

Steven G. Reade (pro hac vice) 

Ryan Z. Watts (pro hac vice) 

Charles B. Weinograd (pro hac vice) 

Jonathan L. Stern (pro hac vice) 

ARNOLD & PORTER LLP 

601 Massachusetts Avenue NW 

Washington, DC 20001 

Tel.: (202) 942-5000 

Fax: (202) 942-5999 

steven.reade@aporter.com 

ryan.watts@aporter.com 

charles.weinograd@aporter.com 

jonathan.stern@aporter.com 

Counsel for Defendants Endo 

Pharmaceuticals Inc. and Endo International 

plc 

Exhibit 1 to Stipulated Order for Permanent Injunction - Page 4

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 28 of 34
Exhibit 2 

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 29 of 34
IN THE UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF GEORGIA 

ATLANTA DIVISION 

FEDERAL TRADE 

COMMISSION, 

 Plaintiff, 

 vs. 

ACTAVIS, INC., et al., 

 Defendants. 

Case Number: 1:09-cv-955-TWT 

Unopposed Motion for Voluntary Dismissal with Prejudice as to Defendants 

Par Pharmaceutical Companies, Inc. and Paddock Holdings, LLC 

Pursuant to Federal Rule of Civil Procedure 41(a)(2), Plaintiff Federal Trade 

Commission (“FTC”) moves this Court to enter an order dismissing the abovecaptioned case as against defendants Par Pharmaceutical Companies, Inc. (“Par”) 

and Paddock Laboratories, Inc. now known as Paddock Holdings, LLC 

(“Paddock”). As grounds for this request, the FTC states as follows: 

1. On January [ ], 2017, Judge Orrick in the Northern District of 

California entered a Stipulated Order for Permanent Injunction in the case styled, 

Federal Trade Commission v. Endo Pharmaceuticals Inc. et. al, No. [ ] (N.D. 

Exhibit 2 to Stipulated Order for Permanent Injunction - Page 1

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 30 of 34
2 

Cal.). A copy of the Stipulated Order for Permanent Injunction (“Permanent 

Injunction”) is attached as Exhibit A. 

2. As of September 28, 2015, Par is a wholly owned indirect subsidiary 

of Endo International plc. (“Endo”). 

3. Under the Permanent Injunction, Endo and its subsidiaries (including 

Par) are prohibited from entering into agreements similar to those challenged in 

this case. (Permanent Injunction at § II.) The scope of this prohibition is consistent 

with the relief the FTC seeks in this case. See Federal Trade Commission’s Third 

Supplemental Response to Actavis Inc.’s First Set of Interrogatories (Sept. 8, 

2016). Entry of the Permanent Injunction, therefore, adequately addresses the 

alleged anticompetitive conduct at issue here with respect to Par. 

4. In light of the Permanent Injunction, the FTC also seeks voluntary 

dismissal against Paddock, Par’s generic AndroGel joint venture partner. Paddock 

is no longer engaged in the manufacture or sale of pharmaceutical products, and no 

longer controls the assets or entities involved in the alleged anticompetitive 

conduct. 

5. The FTC, Par, and Paddock have reached agreement on costs and 

cooperation in this case. A copy of the letter agreement is attached as Exhibit B. 

6. “[I]n most cases, a voluntary dismissal should be granted unless the 

defendant will suffer clear legal prejudice.” Pontenberg v. Boston Scientific Corp., 

Exhibit 2 to Stipulated Order for Permanent Injunction - Page 2

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 31 of 34
3 

252 F.3d 1253, 1255 (11th Cir. 2001) (quoting McCants v. Ford Motor Co., Inc., 

781 F.2d 855, 856–57 (11th Cir. 1986)). Here, Par and Paddock agree that they 

suffer no prejudice as a result of a dismissal with prejudice. For the foregoing 

reasons, therefore, the FTC respectfully requests that the Court dismiss this case as 

to Defendants Par and Paddock. 

Date: January [ ], 2017 Respectfully submitted, 

___________________ 

Saralisa C. Brau 

Randall M. Weinsten 

Federal Trade Commission 

600 Pennsylvania Avenue, NW 

Washington, DC 20580 

sbrau@ftc.gov 

Telephone: (202) 326-2774 

Facsimile: (202) 326-3384 

Counsel for Plaintiff Federal Trade 

Commission

 

Exhibit 2 to Stipulated Order for Permanent Injunction - Page 3

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 32 of 34
IN THE UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF GEORGIA 

ATLANTA DIVISION 

FEDERAL TRADE 

COMMISSION, 

 Plaintiff, 

 vs. 

ACTAVIS, INC., et al., 

 Defendants. 

Case Number: 1:09-cv-955-TWT 

[Proposed] Order of Dismissal with Prejudice 

 Before this Court is Plaintiff Federal Trade Commission’s Unopposed 

Motion for Voluntary Dismissal with Prejudice as to Defendants Par 

Pharmaceutical Companies, Inc. and Paddock Laboratories now known as Paddock 

Holdings, LLC. After consideration of the Motion, the Court is of the opinion that 

the motion should be GRANTED. 

 IT IS HEREBY ORDERED that Plaintiff Federal Trade Commission’s 

claims in the above-captioned action against Defendants Par Pharmaceutical 

Companies, Inc. and Paddock Laboratories now known as Paddock Holdings, LLC 

are hereby dismissed with prejudice pursuant to Rule 41(a)(2) of the Federal Rules 

of Civil Procedure and each party is to bear its own attorneys’ fees and costs. 

Exhibit 2 to Stipulated Order for Permanent Injunction - Page 4

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 33 of 34
ENTERED and ORDERED this ____ day of ________________, 2017. 

 Honorable Thomas W. Thrash, Jr. 

Exhibit 2 to Stipulated Order for Permanent Injunction - Page 5

Case 3:17-cv-00312-WHO Document 25 Filed 02/02/17 Page 34 of 34