Collaborative Development Agreement

Exhibit 10.34


COLLABORATIVE DEVELOPMENT AGREEMENT


This Agreement is made and entered into this 30 th day of August, 2000 by and between PHARMANETICS, INC., a North Carolina corporation ("PharmaNetics"), and AVENTIS PHARMACEUTICALS PRODUCTS INC., a Delaware corporation ("Aventis"). PharmaNetics and Aventis are sometimes referred to herein individually as a "Party" and collectively as the "Parties".


RECITALS

WHEREAS , PharmaNetics is an in-vitro diagnostic manufacturer that markets analyzer test cards for certain blood markers to be used with card analyzer instrumentation systems; and


WHEREAS, Aventis is a global pharmaceutical company that desires to have PharmaNetics develop and gain approval of an enoxaparin test card and analysis devices and to manufacture and supply such test cards and devices to exclusively support Lovenoxae in the Territory .

NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in this Agreement, the Parties agree as follows:


ARTICLE 1


DEFINITIONS.

As used herein, the following terms shall have the following meanings: 1.1 " Act" means the Federal Food, Drug and Cosmetic Act of 1938, as the same may be amended or re-enacted from time to time. 1.2 " Affiliate" means a corporation, partnership, trust or other entity that directly, or indirectly through one or more intermediates, controls, is controlled by or is under common control with a Party to this Agreement. For such purposes, "control," "controlled by" and "under common control with" shall mean the possession of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting stock or partnership interest, by contract or otherwise. In the case of a corporation, the direct or indirect ownership of more than fifty percent (50%) of its outstanding voting shares shall in any event be deemed to confer control, it being understood that the direct or indirect ownership of a lesser percentage of such shares shall not necessarily preclude the existence of control. 1.3 " Agreement" shall mean this document and any annex, addendum, exhibit, attachment, schedule or modification hereto.

Confidential 1.4 " Aventis Know-how" means all Information that is (a) owned or Controlled by Aventis at any time during the Term of this Agreement and (b) useful or necessary in the Field.

1.5 " Control" or " Controlled" when used in connection with intellectual property rights, means that the Party owns or has a license to such intellectual property rights and has legal authority, right and ability to grant to the other Party access, a license, or a sublicense to such intellectual property rights or to otherwise disclose proprietary or trade secret information to such other Party, as provided for in this Agreement, without violating any agreement with or the rights of a third party.

1.6 " FDA" means the United States Food and Drug Administration or any successor entity thereto. 1.7 " Field" means the development, manufacture, use and sale of the Products that are or could be developed and sold under this Agreement. 1.8 " First Commercial Sale" means, with respect to any Product, the first sale for end use or consumption of such Product in the United States after all applicable required Regulatory Approvals have been granted in the United States.

1.9 " GMP" means Good Manufacturing Practices as promulgated under the Act at 21 CFR (chapters 210, 211, 600 and 610), as the same may be amended or re-enacted from time to time.

1.10 " Improvement" means any enhancement of or improvement to Product and/or its use or indication, whether or not patentable, developed by or for, invented or acquired by, or coming under the Control of, PharmaNetics during the term of this Agreement.

1.11 " Information" means (i) techniques and data relating to the Field, including, but not limited to, ideas (including patentable inventions), inventions, practices, methods, knowledge, know-how, trade secrets, skill, experience, documents, apparatus, clinical and regulatory strategies, test data, including pharmacological, toxicological and clinical test data, analytical and quality control data, manufacturing, patent and legal data or descriptions and (ii) devices, algorithms, chemical formulations, compositions of matter, product samples and assays relating to the Field.

1.12 " Lovenoxae" means both the Lovenoxae and Clexaneae (enoxaparin sodium) Injection brand prescription pharmaceutical product for which Aventis Pharmaceuticals Products Inc. (then known as Rhone-Poulenc Rorer Pharmaceuticals Inc.) filed an NDA on July 26, 1991 which was re-filed on


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Page 2 December 30, 1991 and received FDA approval on March 29, 1993.

1.13 " NDA" means the new drug applications related to Product, submitted to the FDA under Sections 505, 507 or 512 of the Act and applicable regulations related thereto.

1.14 " PharmaNetics Know-how" means all Information that is (a) owned or Controlled by PharmaNetics at any time during the Term of this Agreement and (b) useful or necessary in the Field. PharmaNetics Know-how does not include PharmaNetics Patents.

1.15 " PharmaNetics Patent(s)" means all U.S. patents and patent applications, including all additions, divisions, continuations, continuations-in-part, substitutions, extensions, patent term extensions and renewals, and patents issued thereon generally directed to one or more aspects of Product that are or become owned or Controlled by PharmaNetics prior to or during the term of this Agreement.

1.16 " Product" means an enoxaparin test card and test card system that are approved and labeled exclusively for use with Lovenoxae .

1.17 " Regulatory Approval" means (a) in the United States, approval by the FDA of all authorizations, licenses or permits required and satisfaction of any related applicable FDA registration and notification requirements (if any) and (b) in any country other than the United States, approval by regulatory authorities having jurisdiction over such country of a single application or set of applications filed by PharmaNetics for approval of all authorizations, licenses or permits required and satisfaction of any related applicable regulatory and notification requirements, if any, together with any other approval necessary to make and sell commercially the Product in such country, including, where applicable, satisfactory labeling and pricing approval.

1.18 " Term of this Agreement" means the period of time during which this Agreement is in effect under Article 11. 1.19 " Territory" means all the countries in the world.

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ARTICLE 2


DEVELOPMENT

2.1 Joint Development Committee .

2.1.1 Organization . On the Effective Date, the Parties shall organize a Joint Development Committee ("JDC") consisting of three members from each Party. Each Party will elect one of its three members to serve as a co-chairperson. The JDC shall be dissolved as soon as practicable after First Commercial Sale of Product in the United States.

2.1.2 Function . The function of the JDC shall be to plan, coordinate and manage the clinical development of Product until the First Commercial Sale of Product and to serve as a forum for communication between the Parties. Each co-chairperson of the JDC will be responsible for keeping the Party he or she represents informed of the status of the development activities. The JDC is not intended to replace any internal management procedures of either Party.

2.1.3 Decision Making . The JDC will operate by consensus, with the representatives of each party having one vote in total, except as set forth in Section 2.1.5.

2.1.4 Governing Rules . The rules governing the JDC shall include the following:

(a) The timing, agenda and minutes of each JDC meeting will be the responsibility of the co-chairperson hosting the meeting. (b) The location of the JDC meeting will alternate between PharmaNetics' facility and one of Aventis' facilities. (c) The JDC will meet no less than four times annually.

(d) Non-members of the JDC are welcome to participate provided prior notice is given.

(e) Minutes of each JDC meeting will be summarized within two weeks after the meeting and will not be official until the non-drafting co-chairperson has agreed to them.

(f) Each Party will bear its own travel and lodging expenses associated with the JDC and its meetings.

(g) JDC members reporting to a Party may be changed from time to time at the sole discretion of the Party with notice to the other Party.

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Page 4 2.1.5 Dispute Resolution . If the JDC fails to reach consensus on any matter within its jurisdiction, the parties shall refer the matter to the Chief Executive Officer of PharmaNetics and to a Senior Executive Officer of Aventis. If the executive officers can not reach a decision on any material matter, including but not limited to the design of registration enabling trials, within five (5) business days of the matter being referred to them, then either Party shall have the right to provide notice of termination of this Agreement to be effective sixty (60) days from the date of the end of such period. If and only if PharmaNetics terminates this Agreement pursuant to the terms of this Section 2.1.5 and such termination is subsequent to completion of registration enabling trials for the Product designed for the purpose of obtaining Regulatory Approval in the United States, PharmaNetics shall be subject to a term of non-completion in accordance with Section 11.4. If and only if Aventis terminates this Agreement pursuant to the terms of this Section 2.1.5 and such termination is subsequent to completion of registration enabling trials for Product designed for the purpose of obtaining Regulatory Approval in the United States, Aventis shall be subject to a term of non-competition in accordance with Section 11.4 2.2 Development Studies .

2.2.1 PharmaNetics shall be responsible for, and shall use reasonable efforts to conduct, all work and perform all studies necessary for, obtaining Regulatory Approval for the Products. Notwithstanding the foregoing, Aventis shall provide reasonable assistance to PharmaNetics with respect to any issues or questions relating to Lovenoxae and use reasonable efforts to provide access to those clinical trial sites and related data required to collect the information necessary to obtain regulatory approval for the Product.

2.2.2 Aventis hereby grants to PharmaNetics a limited, nonexclusive, worldwide license to Aventis Know-how in the Field for the sole purpose of conducting studies for the development of Product.

2.2.3 PharmaNetics shall record, to the extent practicable, all Information relating to the development of Product, in standard laboratory notebooks, which shall be signed, dated and witnessed. To the extent practicable, such notebooks shall be kept separately from notebooks documenting other development activities of PharmaNetics. PharmaNetics shall require its employees and consultants to disclose any inventions relating to the Product in writing promptly after conception.

2.3 Manufacturing .

2.3.1 PharmaNetics shall be responsible for manufacturing testing, release and supply of all Product at its sole cost and expense. The Product will be manufactured and tested in accordance with GMPs, and all other laws,


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Page 5 guidelines and regulations applicable to the manufacture of Product within the Territory and the terms and requirements set forth in this Agreement. 2.3.2 The Product will be provided free of charge to Aventis by PharmaNetics as requested by Aventis for use in those development studies being conducted to provide the information required to obtain regulatory approval of the Product. Should Aventis request Product for use in additional developmental studies, then PharmaNetics will provide the Product at the prices specified in Exhibit A. 2.4 Inspection and Regulatory Compliance .

2.4.1 During regular business hours and upon reasonable notice, Aventis personnel shall be permitted to inspect the facilities of PharmaNetics to observe manufacturing activities and review Product relevant documentation including complaint history and on time delivery performance, for the extent necessary for assessing compliance with applicable regulatory, environmental and other governmental regulations and identifying safety and occupational risks (if any) associated with the manufacturing activities.

2.4.2 PharmaNetics will inform Aventis of the outcome of all regulatory compliance inspections or regulatory action that impact the Product within two (2) business days. PharmaNetics will make copies of all pertinent inspection reports, regulatory action letters and corrective action submissions available to Aventis within one week of receipt/submission.

2.4.3 PharmaNetics will inform Aventis of all recalls regarding the Product within forty-eight (48) hours of recall commencement.

ARTICLE 3


REGULATORY AND LABELING

3.1 Regulatory Filings . PharmaNetics shall be responsible for the preparation of suitable applications for Regulatory Approval in the Territory and shall be the owner and party of record of all such applications.

3.2 Ownership of the Data and Regulatory Approvals . PharmaNetics will be the sole owner of (a) all the data generated by the testing of the Product, (b) the database for such data, and (c) all Regulatory Approval submissions filed for clinical studies of the Product and any comparable regulatory filings outside the United States.


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Page 6 3.3 Review of Materials. PharmaNetics shall provide Aventis with drafts of any documents or other correspondence to be submitted to the FDA or such similar regulatory authority outside of the United States, as well as all communications with investigators, including but not limited to all protocols and presentations to investigators. Aventis shall have ten (10) business days to review and comment on such materials before submission or other communication may be made. PharmaNetics will use reasonable efforts to accommodate Aventis' comments prior to submission, presentation or publication of the materials. 3.4 Labeling .

3.4.1 The labeling for the Product will be such that the only approved drug or pharmaceutical product with which the Product is approved for usage is Lovenoxae .

3.4.2 PharmaNetics shall be responsible for all costs associated with labeling the Products; provided, however, that should Aventis have any special requirements with respect to labeling, then Aventis will be responsible for any excess charges over and above PharmaNetics' standard costs .

3.4.3 Aventis shall supply PharmaNetics with all camera ready artwork and trademarks of Aventis to be applied to the Product and the labels. 3.4.4 Aventis shall have 15 days to review and comment on all labeling of Product and any submissions to the FDA or applicable regulatory authority with respect to such labeling, and PharmaNetics will use reasonable efforts to accommodate Aventis' comments prior to submission


ARTICLE 4


COMMERCIALIZATION

4.1 Joint Commercialization Committee . Not later than the commencement of the registration enabling trials for the Product, the Parties shall organize a Joint Commercialization Committee ("JCC") consisting of three members from each Party. Each Party will elect one of its three members to serve as a co-chairperson.

4.1.1 Function . The function of the JCC shall be to establish the overall strategy and oversee the commercialization of Product in the Territory. The JCC will have the opportunity to review and advise the Parties on, with respect to the Product, all market research plans and research results and similar items, as well as PharmaNetics' proposed marketing and sales budget for Product, for the purpose of advising and assisting in establishing a U.S. commercialization strategy in the Territory. The JCC is not intended to replace any internal management procedures of either Party. The JCC


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shall be organized hereunder for consultative purposes only and shall have no decision-making authority binding on either Party.

4.1.2 Decision Making . The objective of the JCC shall be to reach agreement by consensus on all matters falling within its authority hereunder, including, but not limited to the design, claims and content of promotional materials and the timing of launch of the Product with the Territory. The representatives of each party shall have one vote in total on the JCC. 4.1.3 Exception to Joint Decision Making . Except with respect to registration enabling trials, which shall be governed by the principles set forth in Article 2, Aventis, in its sole discretion, shall have the option to incorporate the Product into any of its ongoing clinical studies involving Lovenoxae . PharmaNetics shall provide reasonable assistance to Aventis with respect to any issues of questions related to the Product. Aventis agrees to make the results of such clinical studies, to the extent that such results relate to the Product, available to PharmaNetics. Neither Party shall initiate, conduct, or enable a third party to conduct clinical studies for the development of the Product except pursuant to this Agreement.

4.2 Dispute Resolution .

4.2.1 Referral of Unsolved Matters to Executive Officers . In the event of a deadlock on the JCC, then the Parties shall refer the matter to the Chief Executive Officer of PharmaNetics and to a Senior Executive Officer of Aventis to be resolved by negotiation in good faith as soon as is practicable but in no event later than five (5) business days after referral. Such resolution, if any, of a referred issue by the executive officers shall be final and binding on the parties. If resolution of the deadlock is not achieved within such five (5) day period, then this Agreement shall automatically terminate at the end of sixty (60) days from such date; provided, however, the parties shall be entitled to continue to attempt to resolve the deadlock during such period, in which case the parties may mutually terminate the automatic sixty (60) day termination. 4.2.2 Independent Experts . Such executive shall have the right to engage the services of any number of independent experts in the field in question (the individuals) so engaged by each executive officer to be engaged under obligations of confidentiality) to assist the executive officer in making a determination on the unresolved matter, and each executive officer shall be obligated to consider in good faith the analysis and opinions of any such independent experts engaged by either of them in making a determination.

4.3 Efforts . PharmaNetics will use reasonable efforts to commercialize and sell Product in the Territory.

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Page 8 4.4 Limitations to Field of Commercialization . Except for those particular patient subgroups approved by the JCC (i.e., patients such as those with obesity and renal impairment that could potentially span the full range of Lovenoxae indications), neither Party will promote the Product in the fields of oncology or venous thromboembolism prophylaxis or treatment.

4.5 Advertising/Marketing/Sales Costs . PharmaNetics and Aventis shall each bear their own advertising, marketing and sales costs associated with Product distribution, promotion and education.

4.6 Packaging . PharmaNetics shall be responsible for all costs of packaging the Product; provided, however, that any additional costs incu ...