Appendix 40

• Author: Kenneth Dorsney
• Pages: 763-764

763

STI P U L A T I O N AN D ORDER OF IN F R I N G E M E N T

IN THE UNITED STATES DISTRICT COURT

[Name of District]

[DISTRICT COURT CAPTION]

STIPULATION AND ORDER OF INFRINGEMENT

IT IS HEREBY STIPULATED AND AGREED, between [Name of Plaintiff] and

[Name of Defendant] by their undersigned counsel, that:

1. The [active ingredient] products described in Defendant's Abbreviated

New Drug Application No. 1 ("Defendant's ANDA") fall within the scope of Claims 24

and 25 of United States Patent 1 ("the ‘001 patent") and Claim 12 of United States Patent

No. 2 ("the ‘002 patent") (collectively, "the asserted claims").

2. If the asserted claims are found to be not invalid, the making, using,

offering for sale, selling, or importation into the United States of the [active ingredient]

products described in Defendant's ANDA would constitute infringement of the asserted

claims.

3. In light of this Stipulation, Plaintiffs agree that they will not seek any fact

discovery from Defendant and Defendant agrees that it will not seek any fact discovery

solely related to infringement from Plaintiffs.

4. Defendant further agrees that it will not rely on any documents generated

by any individual formerly employed or currently employed by Defendant or any

testimony (oral or written) of any individual formerly employed or currently employed by

Defendant in support of any defense, by counterclaim or otherwise.

5. Defendant also agrees that it will not assert or pursue any defense, by

counterclaim or otherwise, that was not expressly identified in Defendant's Notice Letter

dated [Date], which relies on documents or information generated by any individual

formerly employed or currently employed by Defendant or any testimony (oral or

written) of any individual formerly employed or currently employed by Defendant,

except as provided for as follows: Should Defendant seek to pursue any additional

defense, by counterclaim or otherwise that relies on documents or information generated

by any individual formerly employed or currently employed by Defendant or any

testimony (oral or written) of any individual formerly employed or currently employed by

Defendant, Defendant agrees that Plaintiffs may seek discovery related to that defense.

To the extent Plaintiffs seek discovery from Defendant related to any such defense, the

parties agree to confer in good faith regarding a schedule for discovery related to any

such defense.

6. Plaintiffs agree that, except for the asserted claims, they shall not assert

any of the claims of the ‘001 and ‘002 patents against Defendant, its manufacturers,

customers, distributors, successors, assigns or anyone in privity therewith, in connection

with the [active ingredient] products that are described in Defendant's ANDA as

produced to Plaintiffs.

A–40