Appendix 12

• Author: Kenneth Dorsney
• Pages: 613-615

613

PLA IN TI FF ’S REQ UE ST S FO R AD MI SS IO NS

IN THE UNITED STATES DISTRICT COURT

[Name of District]

[DISTRICT COURT CAPTION]

PLAINTIFF’S FIRST SET OF REQUESTS FOR ADMISSIONS TO DEFENDANT

Pursuant to Rule 36 of the Federal Rules of Civil Procedure, and the applicable

Local Rules of the United States District Court for the District of [Name of District],

plaintiff [Name of Plaintiff] hereby requests that defendant [Name of Defendant]

separately admit or deny each of the following requests, in accordance with those rules

and the following Definitions and Instructions by serving written responses to the offices

of [Name of Counsel for Plaintiff] at [Address of Counsel for Plaintiff], on or within thirty

(30) days of service of this set of requests for admissions.

DEFINITIONS

1. "GenX" means the chemical compound [active ingredient] including

without limitation any salt thereof, or any preparation, formulation, pharmaceutical, or

product comprised of or containing [active ingredient].

2. "FDA" means the United States Food and Drug Administration.

3. "ANDA" means Abbreviated New Drug Application as used in 21 U.S.C.

§ 355(j) and regulations issued by the FDA pursuant thereto.

4. "Drug Product" has the meaning set forth in 35 U.S.C. § 156(f)(2).

5. "Defendant" means collectively, jointly, and severally [Name of

Defendant], and each of their officers, directors, representatives, employees, agents,

partners, corporate parents, subsidiaries, affiliates, predecessors and successors, including

any entities or persons acting on behalf of [Name of Defendant].

6. "Defendant's ANDA" means ANDA No. 00-001 and any

supplements or amendments thereto.

7. "Defendant's ANDA Products" means the GenX _____ Tablets, which are

the subject of Defendant's ANDA.

8. "HPMC" means hydroxypropyl methylcellulose.

9. "DEFENDANT 1," "DEFENDANT 2," and "DEFENDANT 3" mean

and refer to documents produced in this action by Defendant bearing those Production

Numbers.

10. Any reference to a corporation or business entity includes all

entities and persons acting on the entity's behalf as well as all affiliates, divisions,

parents, subsidiaries, predecessors and successors thereof

11. The terms "and" and "or" shall be interpreted liberally as conjunctive,

disjunctive, or both so that the fullest disclosure of information is achieved.

17. The term "all" means all and each and the term "each" means each and all

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