Free Reply Brief - District Court of Delaware - Delaware

Case 1:07-cv-00754-GMS

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Exhibit A

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OFFER OF CONFIDENTIAL ACCESS AND CONFIDENTIALITY AGREEMENT

OFFER OF CONFIDENTIAL ACCESS AND CONFIDENTIALITY AGREEMENT ("Agreement"), by and between BANNER PHARMACAPS INC., a corporation having a place

of business at 4125 Premier Drive, High Point, NC 27265 ("Banner") on the one hand, and ABBOTT LABORATORIES, a corporation having a place of business at 100 Abbott Park Road,
Abbott Park, Illinois 60064-3500 ("Abbott") on the other hand, effective upon the date of a request by Abbott for access to Banner's Section 505(b)(2) New Drug Application for valproic

acid 125,250 and 500 mg delayed release capsules (Banner's NDA") filed with the U.S. Food
and Drug Administration ("FDA").

WL1NESSETH:

WHEREAS, in accordance with Section 505(j)(5XC)(i)(III) of the Federal Food, Drug,

and Cosmetic Act ("the Act"), as amended by Title XI of the Medicare Prescription Drug,
Improvement and Modernization Act of 2003, Banner offers to make certain "Information" (as

defined below) concerning Banner's NDA available to Abbott subject to the terms and
conditions of this Agreement;

NOW, THEREFORE, in consideration of the foregoing premises, the sufficiency of which is hereby acknowledged, and intending to be legally bound hereby, the parties agree as
follows:

1.

DEFINITIONS

(a)

"Information" means any and all information that the Providing Party (as

00486649.DOC

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hereafter defined) or its representatives provides or furnishes to the Receiving Party (as hereafter

defined) or its representatives, regardless of whether: (i) such Information is specifically marked

or designated as "confidential" or "proprietary", (ii) such Information is patentable,
copyrightable or otherwise protected by law, or (iii) such Information is furnished verbally, in
writing or in electronic form. "Information" includes, but is not limited to, any and all notes, memoranda, analyses, compilations, studies or other documents (whether in hard copy or

electronic media) prepared by either party which contain or otherwise reflect such Information,
and any and all copies, extracts or other reproductions of any of the same. In addition, for

avoidance of doubt, "Information" includes Banner's NDA, and related Drug Master File
established at FDA.

(b)

Notwithstanding the foregoing, the term "Information" does not include

information that: (i) is or becomes available to the public through no wrongful act of the

Receiving Party or its representatives; (ii) is known to the Receiving Party on the date of this Agreement, as evidenced by written records of the Receiving Party existing on said date; (iii) is

received from a third party who has the right to disclose the same to the Receiving Party; (iv) is
in the rightful possession of the Receiving Party free of any obligation of confidentiality; or (v) is
independently developed by the Receiving Party without reference to, or misuse of, information furnished by the Providing Party.

(c)

"Providing Party" means the party furnishing Information, and includes its

subsidiary and affiliated corporations.

(d)

"Receiving Party" means the party receiving Information, and includes its

subsidiary and affiliated corporations.

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(e)

"Representatives" means any party's employees, agents or other representatives,

including advisors, attorneys, accountants, financial advisors and potential financing sources.

2.

CONFIDENTIALITY

(a)

The parties are authorized to provide Information to each other for the sole and

limited purpose of evaluating possible infringement of the patents that are the subject of Banner's Paragraph IV certification pursuant to Section 505(b)(2)(A)(iv) of the Act in connection with Banner's NDA (U.S. Patent Nos. 4,988,731 and 5,212,326 ("the Listed Patents")).
(b) Persons entitled to access to the Information on the part of the Receiving Party are

restricted to (i) outside counsel engaged or employed by the Receiving Party to represent them

and the staff of such outside counsel, including paralegal, secretarial and clerical personnel who are engaged in assisting such counsel, provided that such outside counsel has been identified to the Providing Party in writing; (ii) no more than five in-house counsel; and (iii) independent

consultants and experts assisting in the evaluation of the Information for the Receiving Party and
any employees and assistants under the control of such consultant or expert. Each such

consultant and expert shall be identified by the Receiving Party to the Providing Party, and shall
execute an Undertaking, in the form in Attachment A hereto, agreeing to be bound by the terms of this Agreement.

(c)

Persons with access to the Information (i) shall be identified to the Providing

Party before Information is provided under this Agreement; (ii) shall keep Information furnished
to them by the Providing Party strictly confidential and not disclose it to other employees or

agents of the Receiving Party; (iii) shall take all reasonable precautions to safeguard such Information against unauthorized disclosure; and (iv) shall not take any action inconsistent with
the Providing Party's ownership of such Information.

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(d)

Except to the extent required by law or judicial process and in accordance with

paragraph 4 below, the Receiving Party and its Representatives shall not disclose to any third person or entity (other than those provided for in paragraph 2(b)): (i) the Providing Party's
Information; (ii) the fact that such Information was disclosed to the Receiving Party; or (iii) the fact that an evaluation is taking place with respect to the Information, including the status
thereof, unless exempted from one or more of these prohibitions by the express prior written consent or authorization of the Providing Party.

(e)

The Receiving Party and its Representatives shall not copy, reproduce, or reduce

to writing any part of the Information furnished to it by the Providing Party except as is
reasonably necessary to accomplish the purpose of this Agreement. Any such copies,

reproductions or reductions to writing shall become the property of the Providing Party. (f) The Receiving Party shall be responsible for any breach of this Agreement by its

officers, directors, employees or other representatives, and shall take all reasonable measures to
restrain such persons from the unauthorized use or disclosure of the Information.

3.

USE OF INFORMATION

The Abbott and its Representatives shall use the Information provided to them solely for
the limited purpose of determining whether to initiate an action against Banner for infringement
of the Listed Patents.

4.

GOVERNMENTAL REQUESTS FOR DISCLOSURE In the event that the Receiving Party or any of its Representatives receives a request or is

required by applicable law to disclose to a court or government agency of competent jurisdiction
all or any part of the Providing Party's Information, the Receiving Party or its representatives

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shall promptly notify the Providing Party of the request, and shall to the extent requested, consult

with and assist the Providing Party in seeking a protective order or other appropriate protective
remedy. If such order or other remedy is not obtained or the Providing Party waives compliance with the terms hereof, the Receiving Party or its representatives, as the case may be, shall disclose only that portion of the Information which, in the reasonable opinion of its counsel, is legally required to be disclosed, and shall exercise their respective best efforts to assure that confidential treatment will be accorded such Information by the persons or entities receiving it.
The Providing Party shall be given a reasonable opportunity to review the Information prior to its
disclosure.

5.

RETURN OF INFORMATION

(a)

If Abbott does not commence an action against Banner alleging infringement of

the Listed Patents within forty-five (45) days of its receipt of Banner's notice of its Paragraph IV
certification against those patents (the "45-day period") which accompanies this Offer of
Confidential Access and Agreement, Abbott shall cause persons entitled to access to the

Information to return immediately to Banner (a) all Information that Banner has provided under
this Agreement, and (b) all non-privileged notes, analyses, studies or other documents to the

extent that they contain information in Banner's NDA, and shall notify Banner that this has been
done.

(b)

If Abbott commences an action against Banner alleging infringement of the

Listed Patents within the 45-day period: (1) while the litigation is pending, the portions of Banner's NDA provided and all

notes, analyses, studies or other documents to the extent that they contain information in the AND A, shall be treated as information under the highest level of confidentiality under any

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protective order entered in the action brought against Banner, and until such a protective order is
entered subsections (2)(c)(ii)-(iv) of this Agreement continue to apply; and

(2)

Abbott shall cause persons entitled to access to the Information to return the

portions of Banner's NDA provided, and all notes, analyses, studies or other documents prepared to the extent that they contain information in Banner's NDA, within thirty (30) days after the

final determination of the action brought against Banner.

6.

INJUNCTIVE RELIEF The parties agree that money damages will not be a sufficient remedy for any breach of

this Agreement by the Receiving Party or its representatives, and that the Providing Party is
entitled to injunctive relief and specific performance as remedies for any such breach. Such

remedies shall not be deemed to be the exclusive remedies for a breach of this Agreement but
shall be in addition to all other remedies available at law or in equity.

7.

TERM; TERMINATION

This Agreement shall be effective upon a request by Abbott for access to Banner's NDA, and until such time as the Information is returned pursuant to Paragraph 5 above. This
Agreement may be renewed upon such terms as may be agreed upon by the parties. Upon

termination of this Agreement, the Receiving Party shall fulfill its obligations to return the
Providing Party's Information pursuant to above paragraph 5 of this Agreement. The Receiving

Party's obligations of confidentiality pursuant to above paragraph 2 shall survive the termination
of this Agreement.

8.

SEVERABILITY

The invalidity or unenforceability of any provision of this Agreement shall not affect the

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validity or enforceability of any other provision, all of which shall remain in iull force and effect.

9.

ASSIGNMENT

This Agreement shall not be assigned without the prior written consent of the Providing
Party.
10. NOTICES

All notices and other communications sent under any provision of this Agreement
shall be addressed to Banner and Abbott at the addresses set forth below:

For Banner:
Charles L. Cain

For Abbott:
Name

Global Vice President, Legal & Public Affairs
Banner Pharmacaps Inc.

Title Address

4100 Mendenhall Oaks Pkwy, Suite 301 High Point, NC 27265
All notices shall be in writing, and shall be effective when received.

11.

GOVERNING LAW

This Agreement shall be construed in accordance with the laws of the State of North
Carolina, without regard to conflict of laws principles.

12.

HEADINGS

The section headings in this Agreement are for convenience only, and shall not alter or affect the meaning or interpretation of any provision of this Agreement.

13.

COUNTERPARTS

This Agreement may be executed in one or more counterparts, all of which shall be
considered one and the same Agreement.

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14.

COMMUNICATIONS

Delivery of any counterpart signature page of this Agreement, written communication or
notice hereunder by facsimile shall be equally as effective as delivery of a manually executed

original of such counterpart signature page, communication or notice. Any party delivering a
counterpart signature page, written communication or notice hereunder by facsimile shall also
deliver a confirmatory hand-signed original.

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed upon a
request by Abbott for Access to Banner's NDA.

BANNER PHARMACAPS INC. By:
Title:

ABBOTT LABORATORIES

By:
Title:

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ATTACHMENT A

I,
1. My present residential address is

, declare and state as follows:

2.

My present employer is
.

, and the address of my present

employer is

3.

My present occupation or job is

.

4.

I have received and carefully read the foregoing Offer of Confidential Access and

Confidentiality Agreement, and understand its provisions.

5.

In accordance with paragraphs 2(b) - 2(d) of the Agreement, I hereby undertake to abide

by all provisions of the Agreement. Particularly, I undertake: (a) to hold in confidence and not to disclose any Information (as defined in paragraph 1 of the Agreement), which is provided to me by a party to the Agreement, to any individual or entity other than the persons permitted in the
Agreement; (b) to use Information provided to me solely for the purpose of evaluating

Information provided to me by any party; and (c) to return any Information in accordance with
paragraph 5 of the Agreement.

Dated:

Signature

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Exhibit B

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Jason G. Winchester/JonesDay Extension 54373 03/18/2008 12:19 PM

To [email protected] cc Melissa B Hirst/JonesDay@JonesDay bcc Subject Fw: Offer of Confidential Access Agreement

Charlie To move our discussions forward on getting access to the CMC section of the NDA, I am resending to you below the few changes that Abbott proposed to the original OCA proffered by Banner in the paragraph IV notice . With these changes, Abbott would be willing to sign the OCA and take any materials Banner is willing to share pursuant to the OCA, pending entry of a protective order in the case. In addition to the OCA, is Banner willing to provide us with a copy of its proposed labeling at this stage? Given that Banner has selected Depakote as the RLD, we believe that the product labeling Banner has submitted to FDA will likely contain relevant information. Obviously we will be seeking the labeling and all other portions of the NDA in discovery, and we believe it will speed the case along if Banner would produce this material now. I will be tied up in depositions tomorrow and Thursday, but can make time to talk today until about 4 EST. Otherwise, I may be able to take a break tomorrow to talk if there is a convenient time for you, or perhaps we could talk after hours on Thursday. I should be cooling my jets at LaGuardia at 6 EST or so. I do not want to let me schedule delay this effort, however, so perhaps you and Melissa can talk about the OCA issues without me. JGW Jason G. Winchester JONES DAY 77 W. Wacker Dr., Suite 3500 Chicago, IL 60601-1692 312.269.4373 (Direct) 312.782.8585 (Facsimile)
----- Forwarded by Jason G. Winchester/JonesDay on 03/18/2008 11:47 AM ----Jason G. Winchester/JonesDay Extension 54373 10/26/2007 09:06 AM To [email protected] cc Subject Re: Offer of Confidential Access Agreement

Charles Thanks for getting back to me. Here are Abbott's proposed changes to the Offer of Confidential Access: 1. Paragraph 5(a). In the fifth line, insert "or destroy" after "Banner" and before "(a) all Information . . ." Also, at the end of subparagraph 5(a), add the following sentence: "Notwithstanding the foregoing, Abbott's outside counsel shall be permitted to retain one copy of all Information that Banner has provided under this Agreement and all associated notes, analyses, studies or other documents relating to Banner's NDA." 2. Paragraph 5(b)(2). In the first line, add "to Banner or destroy" after "return" and before "the" 3. In paragraph 10, Abbott designates Perry C. Siatis, Senior Counsel, Abbott Laboratories, 100 Abbott Park Road., Dept. 324, Bldg. AP6A, Abbott Park, IL 60064.

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If these changes are acceptable, we would like to obtain relevant portions of Banner's NDA for review under the terms of the OCA. Specifically, Abbott requests: 1. The Chemistry Manufacturing and Controls section of the ANDA, and any other portions sufficient to show the precise details about the proposed formulation, manufacturing instructions, batch records, and composition statements. 2. The proposed labeling and package insert. 3. Any information describing the physical, chemical, or structural properties of the active ingredient, including any statements regarding whether the active ingredient is an oligomer. 4. Any comparisons in the NDA of Banner's proposed product to Depakote, other than the actual BA/BE studies, which we are not asking for at this time. I am available today to discuss any of these issues. Thanks. JGW

Jason G. Winchester Jones Day 77 W. Wacker Dr., Suite 3500 Chicago, Illinois 60601-1692 312.269.4373 (direct) 312.782.3939 (main) 312.782.8585 (fax) [email protected]
[email protected] To [email protected] 10/26/2007 07:44 AM cc Subject Offer of Confidential Access Agreement

Jason, I received your voice mail and do not anticipate a problem with your requested changes. Would you like to forward me language to address them, or would you prefer me to revise? Charles Charles L. Cain Global Vice President, Legal and Public Affairs Banner Pharmacaps Inc. 4100 Mendenhall Oaks Parkway, Suite 301 High Point, NC 27265 336.812.7010/ Fax 336.812.7054 [email protected]

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Exhibit C

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