Document Authenticity Stipulation

• Author: Kenneth L. Dorsney
• Pages: 781-782

Document Authenticity Stipulation

IN THE UNITED STATES DISTRICT COURT

[Name of District]

—

[DISTRICT COURT CAPTION]

STI PUL AT ION WI TH RES PEC T TO T HE AU THEN TI CI TY AN D

AD MI SSI BI LIT Y OF C ER TAI N REC ORD S

Plaintiff Brand, Inc. (“Brand”) and Defendant Generic, Inc. (“Generic”), by their

undersigned counsel, hereby stipulate and agree to the matters set forth below regarding

infringement of U.S. Patent No. 1 in this action:

1. Any document produced in this matter by Brand or Generic that constitutes

a regulatory filing before the U.S. Food and Drug Administration (“FDA”) (including

New Drug Applications (“NDA”), Investigational New Drug Applications (“IND”),

Abbreviated New Drug Applications (“ANDA”), Drug Master Files (“DMF”), and any

supplements or amendments thereto), and any document produced in this matter by Brand

or Generic that constitutes correspondence with the FDA concerning any such regulatory

filing, shall be deemed prima facie authentic for purposes of admissibility at trial, with no

need for additional proof of authenticity at trial, provided that the trial exhibit appears to

be unaltered from the condition in which the document was submitted to or received from

the FDA and provided that the trial exhibit appears to be unaltered from the condition in

which the document was produced by that party.

2. Any document produced in this matter by Brand or Generic that

constitutes a regulatory filing before the FDA (including NDAs, INDs, ANDAs, DMFs,

and any supplements or amendments thereto), and any document produced in this matter

by Brand or Generic that constitutes correspondence with the FDA concerning any such

regulatory filing, shall be deemed a “business record” that meets the requirements of

Federal Rule of Evidence 803(6) and therefore is not subject to exclusion from evidence

at trial on grounds of hearsay, provided that the trial exhibit appears to be unaltered from

the condition in which the document was submitted to or received from the FDA and

provided that the trial exhibit appears to be unaltered from the condition in which the

document was produced by that party.

3. The parties agree that it is the producing party’s burden to come forward

with evidence of the lack of authenticity of its own documents, as described above. A

denial of a document’s authenticity or business record status by counsel or a witness,

without further corroboration or evidence of non-authenticity or non-business record

status, shall not be a valid basis for objecting to the document’s admissibility.

4. The parties agree to meet and confer in good faith regarding any disputes

regarding documents presumed to be authentic and within the scope of Fed. R. Evid.

803(6) under the terms of this Stipulation.

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