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SUPPLY AGREEMENT

Supply Agreement

SUPPLY AGREEMENT | Document Parties: AVI BIOPHARMA, INC. | WHEREAS, Company You are currently viewing:
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AVI BIOPHARMA, INC. | WHEREAS, Company

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Title: SUPPLY AGREEMENT
Governing Law: Oregon     Date: 4/11/2006
Industry: Biotechnology and Drugs     Law Firm: Ice Miller;Davis Wright     Sector: Healthcare

SUPPLY AGREEMENT, Parties: avi biopharma  inc. , whereas  company
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Exhibit 10.50

 

NOTE :  Portions of this document marked “***” have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment of the omitted and separately filed portions.

 

SUPPLY AGREEMENT

 

THIS SUPPLY AGREEMENT (the “Agreement”) is made and entered into as of March 10, 2006, (the “Effective Date”) between AVI BIOPHARMA, INC. (as defined below, “Supplier”), an Oregon corporation, and COOK GROUP INCORPORATED (as defined below, “Company”), an Indiana corporation.

 

WITNESSETH:

 

WHEREAS, Supplier is establishing manufacturing facilities to manufacture drugs such as the Drug (as defined below);

 

WHEREAS, Company and Supplier have entered into a License and Development Agreement of even date herewith with respect to the Drug (the “License and Development Agreement”);

 

WHEREAS, Company and Supplier have entered into an Investment Agreement of even date herewith with respect to the Drug (the “Investment Agreement”);

 

WHEREAS, Supplier and Company wish to enter into this Agreement regarding Supplier’s supplying the Drug (as defined below) to Company;

 

AGREEMENTS:

 

NOW THEREFORE, in consideration of the representations, warranties, covenants and agreements contained herein, and for other valuable consideration, the receipt and adequacy of which is hereby acknowledged, the parties mutually agree as follows:

 

ARTICLE 1.

 

DEFINITIONS

 

1.1.                                                      Specific Definitions . As used in this Agreement, the following terms shall have the meanings set forth or as referenced below:

 

Actual Cost ” means the cost of non-manufacturing activities performed by AVI personnel pursuant to this Agreement, including direct labor, materials, travel, and allocated overhead costs.

 

Affiliate ” of a specified person (natural or juridical) means a person that directly, or

 



 

indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, the person specified. “ Control ” shall mean ownership of more than 50% of the shares of stock entitled to vote for the election of directors in the case of a corporation, and more than 50% of the voting power in the case of a business entity other than a corporation.

 

Agreement ” means this Agreement and all Exhibits and Schedules hereto.

 

Company ” means Cook Group Incorporated and its Affiliates.

 

Confidential Information ” means know-how, trade secrets, and unpublished information disclosed (whether before or during the term of this Agreement) by one of the parties (the “disclosing party”) to the other party (the “receiving party”) or generated under this Agreement, excluding information which:

 

(a)                        was already in the possession of receiving party prior to its receipt from the disclosing party (provided that the receiving party is able to provide the disclosing party with reasonable documentary proof thereof and, if received from a third party, that such information was acquired without any party’s breach of a confidentiality or non-disclosure obligation to the disclosing party related to such information);

 

(b)                       is or becomes part of the public domain by reason of acts not attributable to the receiving party;

 

(c)                        is or becomes available to receiving party from a source other than the disclosing party which source, has rightfully obtained such information and has no obligation of non-disclosure or confidentiality to the disclosing party with respect thereto; or

 

(d)                       has been independently developed by the receiving party without breach of this Agreement or use of any Confidential Information of the other party.

 

Drug ” has the meaning given such term in the License and Development Agreement.

 

Effective Date ” has the meaning set forth in the recitals hereto.

 

FDA ” means the United States Food and Drug Administration.

 

Force Majeure ” means any event or condition, not existing as of the date of this Agreement, not reasonably foreseeable as of such date and not reasonably within the control of either party, which prevents in whole or in material part the performance by one of the parties of its obligations hereunder, such as an act of government, war or related actions, civil insurrection, act of terrorism, riot, sabotage, strike, epidemic, fire, flood, windstorm, and similar events.

 

GMP ” means Good Manufacturing Practices as defined in 21 CFR Parts 210 through 226 and Parts 600 through 680 and any successor provisions thereof that apply to production of the Drug under this Agreement.

 

Intellectual Property ” means U.S. and foreign patents and patent applications, trademarks, service marks and registrations thereof and applications therefor, copyrights and

 

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copyright registrations and applications, mask works and registrations thereof, know-how, trade secrets, inventions, discoveries, ideas, technology, data, information, processes, drawings, designs, licenses, computer programs and software, and technical information including but not limited to information embodied in material specifications, processing instructions, equipment specifications, product specifications, confidential data, electronic files, research notebooks, invention disclosures, research and development reports and the like related thereto and all amendments, modifications, and improvements to any of the foregoing.

 

Indemnifiable Losses ” has the meaning set forth in Section 7.1 .

 

Indemnitee ” has the meaning set forth in Section 7.3 .

 

Indemnitor ” has the meaning set forth in Section 7.3 .

 

Investment Agreement ” has the meaning set forth in the recitals hereto.

 

License and Development Agreement ” has the meaning set forth in the recitals hereto.

 

Product Liability Damages ” means any liability, claim or expense, including but not limited to reasonable attorneys’ fees and medical expenses, arising in whole or in part out of claims of third parties for personal injury or loss of or damage to property relating to or arising out of the Products, whether based on strict liability in tort, negligent manufacture of product, or any other allegation of liability arising from the design, testing, manufacture, packaging, labeling (including instructions for use), or sale of the Products.

 

Product ” means the final formulation or configuration of the Drug with or without a device or delivery mechanism such as a stent, catheter, or microbubble formulation.

 

Specifications ” means the specifications and formulations for the Products as agreed to by the parties. Within sixty (60) days of the Effective Date, the parties will agree in writing to initial Specifications for each Product to be developed. Thereafter, Specifications for a particular Product may be amended from time to time upon mutual agreement of the parties. Specifications specifically developed by Company or included in any FDA approval of the Drug, but excluding in either case Supplier Specifications (as defined herein), shall be referred to as “ Company Specifications .”  “ Supplier Specifications ” shall mean specifications developed by Supplier and incorporated into the Specifications without modification by Company.

 

Supplier ” means AVI BioPharma, Inc. and its Affiliates.

 

Term ” has the meaning set forth in Section 8.1 .

 

Warranty Exclusions ” has the meaning set forth in Section 5.1 .

 

1.2.                                                      Other Terms . Other terms may be defined elsewhere in the text of this Agreement and shall have the meaning indicated throughout this Agreement.

 

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1.3.                                                      Definitional Provisions .

 

(a)                        The words “hereof,” “herein,” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provisions of this Agreement.

 

(b)                       The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.

 

(c)                        References to an “Exhibit” or to a “Schedule” are, unless otherwise specified, to one of the Exhibits or Schedules attached to or referenced in this Agreement, and references to an “Article” or a “Section” are, unless otherwise specified, to one of the Articles or Sections of this Agreement.

 

(d)                       The term “person” includes any individual, partnership, joint venture, corporation, trust, unincorporated organization or government or any department or agency thereof.

 

ARTICLE 2.

 

SUPPLY

 

2.1.                                                      Supply of Drug . Commencing upon the closing of transactions contemplated by the Investment Agreement, Supplier shall manufacture, or have manufactured, and supply to Company all of Company’s orders for Drug made under Article 3 , in accordance with the Specifications in effect at the time of order for each Product and with Company’s schedule for deliveries. In the event of any Drug or material shortages or temporary or long-term production capacity restraints or Force Majeure events, Supplier may allocate production capacity among customers, but, in all events will supply Company on a priority basis over supplying any other customers.

 

2.2.                                                      Promotion and Training . Upon a reasonable request by Company and subject to staff and support availability, Supplier will assist Company in preparing promotional, marketing and training literature and instructions for the Products, including any artwork,  will conduct training courses and seminars to educate medical professionals on the use of Products and their use in connection with Company’s medical devices and for training its marketing, sales, and distribution groups, and will provide Company with training related to the sale of Products. Company shall reimburse Supplier’s Actual Costs in providing all services and support pursuant to this Section 2.2. Within thirty (30) days of the end of each calendar quarter in which costs were incurred, Supplier will send Company an invoice specifying the Actual Cost of services and support provided in the just-ended quarter and the payment due. Within thirty (30) days of receiving each such invoice, Company will make a payment to Supplier for the full amount due.

 

2.3.                                                      Packaging and Labeling . Supplier shall package and label the Drug in accordance with packaging and labeling specifications to be mutually agreed upon by Company and Supplier and approved by the FDA.

 

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2.4.                                                      Compliance With Laws and Regulations .

 

(a)                        Supplier shall be responsible for compliance with present and future applicable statutes, laws, ordinances and regulations of national, federal, state and local governments now or hereafter in effect materially relating to its manufacture of the Drug. If required or necessary in connection with sales of Products by Company, Supplier shall have its manufacturing facilities become ISO 9001 certified. Without limitation of the foregoing, Supplier represents and warrants to Company that all Drugs sold and delivered to Company under this Agreement will have been manufactured, labeled and packaged in accordance with applicable FDA GMP requirements and, if applicable, Supplier’s ISO 9001 certifications, and that continually during the term of this Agreement no Drugs delivered by Supplier to Company shall be adulterated or misbranded at the time of delivery within the meaning of the U.S. Food, Drug and Cosmetic Act and regulations thereunder or any similar law or regulation. Supplier shall cause Company’s regulatory personnel to be provided with reasonable access from time to time to the facilities and records of Supplier for the purpose of confirming Supplier’s compliance with any applicable FDA GMP and all other applicable requirements noted in this Article 2 . Supplier agrees to provide Company with reasonable prior written notice of any FDA inspection of Supplier’s facilities or records prior to such FDA inspection, or if such prior written notice is not feasible, then within three business days thereafter. Supplier also agrees to provide Company with written notice of its receipt of any claim by the FDA or other governmental agency of any actual or alleged violation by Supplier of any GMP or other applicable requirements as soon as practicable following receipt of such notice (but in no event more than 5 business days thereafter). Company shall have the right, at any time and from time-to-time upon not less than 72 hours prior notice to the Supplier, to inspect Supplier’s manufacturing facilities in order to examine all phases of the manufacturing process and inspect or audit any or all of the Supplier’s data and records related thereto and the Products compliance with the terms and conditions hereunder or with respect to any applicable law, rule or regulation. In the event Supplier uses a sub-contractor or third party to perform any part of the manufacturing, Supplier shall obtain the agreement of such sub-contractor or third party that Company shall have similar inspection rights.

 

(b)                       Company and Supplier (except where Supplier has the responsibility under Section 2.4(a)  or elsewhere herein) shall comply with all applicable laws, rules, regulations, codes, and standards of all federal, state, local and municipal government agencies which affect their respective performance and activities under this Agreement. Notwithstanding anything contained herein, Company shall be responsible for compliance with present and future applicable statutes, laws, ordinances and regulations of national, federal, state and local governments now or hereafter in effect including applicable import and export laws materially relating to its purchase, distribution or sale of the Products.

 

2.5.                                                      Exclusivity . During the term of this Agreement, or if longer, the term of the License and Development Agreement, (a) Supplier shall not promote, make, have made, market or sell the Drug for use in the Field (as defined in the License and Development Agreement) to any person or entity other than Company, and (b) Company shall purchase 100% of its requirements for the Drug for use in the Field from Supplier. Prior to any sale, transfer or other disposition to any third party of Drug for use outside the Field, Supplier shall obtain the agreement of such third party that it will not use, promote, market or sell the Drug in the Field or resell the Drug for use in the Field.

 

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2.6.                                                      Complaints and Adverse Events . Each party agrees to inform the other party promptly (but in no event no later than forty-eight (48) hours after becoming aware of same) of any information concerning any complaint involving the Products or that might be applicable to the Products or adverse drug experience (as defined in 21 C.F.R. § 314.80), injury, toxicity, or sensitivity reaction associated with the use of the Products or that might be applicable to the Products, provided that:

 

(a)                        if the adverse drug experience is serious, as defined in 21 C.F.R. § 314.80 (including any adverse drug reaction that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer or overdose), then each party shall notify the other party within twenty-four (24) hours;

 

(b)                       all notifications to Company shall be by facsimile and on Company’s designated adverse event forms; and

 

(c)                        all notifications to Supplier shall be by facsimile and on Supplier’s designated adverse event forms.

 

2.7.                                                      Records and Recall . Company shall maintain complete and accurate records of all Products sold by Company in sufficient detail to enable Supplier to conduct an effective recall of Drugs purchased by Company under this Agreement if Supplier determines that such a recall is required or otherwise necessary or appropriate. In the event of a recall of any of the Drugs by Supplier, Company will cooperate with and assist Supplier in effecting such recall, including promptly contacting any purchasers that Supplier reasonably desires to be contacted and promptly communicating to such purchasers the information or instructions Supplier reasonably desires to be transmitted relating to such recall. Company shall be responsible for all costs of effecting such recall of Products, including any shipping costs related to returning recalled Drugs to Supplier and replacing such recalled Drugs with new Drugs, except, such costs shall instead be paid by Supplier (directly or through reimbursement of Company for costs reasonably incurred by Company) where the recall relates to a matter for which Supplier would be required to indemnify Company under Article 7 of this Agreement. Notwithstanding the foregoing, Company shall control any recall of any products sold by Company to third parties that may incorporate the Drug.

 

2.8.                                                      Certain Responsibilities . Notwithstanding anything contained herein, Supplier shall not be responsible for any loss or damage , including Products Liability Damages, from the use or performance of the Drugs manufactured under this Agreement where (a) such use or performance did not result from a breach of this Agreement by Supplier, including, without limitation, Supplier’s warranties, (b) the Drugs complied with the description and form described in any documents used for all governmental approvals, applications, submissions, and approvals filed by Company with the FDA, or given to Company by the FDA, and (c) the Drugs complied with the packaging, shipping, and labeling for the Drugs. Company further agrees that no Products will be released for public use or consumption until all requisite governmental approvals therefore have been obtained for such use and consumption.

 

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2.9.                                                      Supply . Supplier agrees:  (i) to have in place prior to the first regulatory approval of the commercial sale of the Product an agreed upon reserve supply of the Drug to support the Product and maintain during the term of this Agreement a commercially reasonable supply for the Drug and (ii) to produce commercially reasonable quantities of the Drug in compliance with FDA GMP requirements and other regulatory requirements. The Company agrees to pay for the agreed upon reserve supply of Drug prior to the first regulatory approval. Supplier agrees to store in a safe and secure off-site location a reserve supply of the Drug and Supplier agrees to exercise commercially reasonable efforts to replenish such supply if it is used. The Drugs shall be stored in compliance with the Specifications and any applicable law or regulation.

 

ARTICLE 3.

 

ORDERS AND DELIVERY

 

3.1.                                                      Purchase Orders . To assist the Supplier in determining the reserve supply of Drug to be maintained, the Company will make its commercially reasonable efforts to forecast its requirements for Drugs six (6) months in advance of ordering Drugs and updating a rolling forecast at three (3) month intervals. Such rolling forecasts by Company shall be used for purposes of facilitating Company’s clinical, sales and marketing plans and meeting the lead times required by certain of Supplier’s suppliers, but they are not legally binding on Company in any manner. Company shall submit purchase orders for the Drugs to Supplier in writing, whether by mail, facsimile, email or otherwise, which shall, at a minimum, set forth the product numbers, quantities, delivery dates, and shipping instructions and shipping addresses for all Drugs ordered. Each purchase order shall constitute a contract between Company and Supplier for the sale of the Drugs ordered and shall be subject to and governed by the terms of this Agreement. The terms and conditions of this Agreement shall so govern and supersede any additional or contrary terms set forth in Company’s purchase order or any Supplier or Company acceptance, confirmation, invoice or other document unless duly signed by an officer of Company and an executive officer of Supplier and expressly stating and identifying which specific additional or contrary terms shall supersede the terms and conditions of this Agreement. With respect to all purchase orders submitted at least sixty (60) days in advance of the earliest scheduled delivery date set forth in such order, Supplier shall fill such orders in accordance with the scheduled delivery dates set forth therein, and with respect to all other purchase orders, Supplier shall exercise commercially reasonable efforts to fill such orders in accordance with the scheduled delivery dates set forth therein.

 

3.2.                                                      Modification of Orders . No purchase order shall be modified or canceled except upon the mutual agreement of the parties; provided, however, that Company may cancel a purchase order based upon actions of a regulatory authority and Company may make changes to a purchase order in quantities that do not exceed ten (10)&nbs


 
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