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DISTRIBUTION AGREEMENT

Distribution Agreement

DISTRIBUTION AGREEMENT | Document Parties: BioMimetic Therapeutics, Inc | Joint Solutions Alliance Corporation You are currently viewing:
This Distribution Agreement involves

BioMimetic Therapeutics, Inc | Joint Solutions Alliance Corporation

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Title: DISTRIBUTION AGREEMENT
Governing Law: Tennessee     Date: 8/11/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

DISTRIBUTION AGREEMENT, Parties: biomimetic therapeutics  inc , joint solutions alliance corporation
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EXHIBIT 10.1

DISTRIBUTION AGREEMENT

     This Agreement (“Agreement”) is entered into as of the last date executed below (the “Effective Date”) and is by and among BioMimetic Therapeutics, Inc. having its principal office located at 389 Nichol Mill Lane, Franklin, TN 37067 USA (“Manufacturer”), and Joint Solutions Alliance Corporation having its principal office located at 975 Fraser Drive, Unit 18, Burlington, ON L7L 4X8 Canada (“Distributor”)(each, individually a “Party” and collectively the “Parties”).

RECITALS

     WHEREAS Manufacturer is engaged in the business of manufacturing bio-active drug-device combination products for the healing of musculoskeletal injuries and disease, including orthopedic, spine and sports injury applications, including the Products (as hereinafter defined); and

     WHEREAS Distributor is engaged in the business of selling and marketing goods manufactured by others in the Territory (as hereinafter defined), including products similar or related to the Products; and

     WHEREAS Distributor is desirous of being appointed an exclusive distributor of the Products in the Territory.

     NOW THEREFORE, In consideration of the mutual covenants and agreements herein contained, Manufacturer and Distributor do hereby agree as follows:

1. Definitions.

      1.01. Approval Date. The term “Approval Date” shall mean the date that Manufacturer is granted marketing authorization within the Territory to market and sell the Products.

      1.02. Products. The term “Products” shall include the products listed in EXHIBIT A. Manufacturer shall have the right to modify, alter, improve, change, add to or discontinue any or all the Products, but Manufacturer shall only discontinue a Product upon ** days’ prior written notice to Distributor.

      1.03. Specifications. The term “Specification” as to any Product shall refer to the specifications set forth for such product in EXHIBIT A.

      1.04. Territory. The term “Territory” shall include the country of Canada.

      1.05. Field. The term “Field” shall include Products for treating indications within or below the neck in humans, and shall expressly exclude all veterinary applications.

 

 

 

 

**

 

REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 


 

2. Exclusive Distributorship.

      2.01. Grant of Distributorship. Manufacturer hereby grants to Distributor the exclusive right to sell the Products within the Field during the Term (as hereinafter defined) to customers located within the Territory for delivery in the Territory all in accordance with the terms and conditions set forth herein and subject to the Sales Restriction set forth below. Distributor is not authorized to sell the Products for delivery outside the Territory or outside the Field unless Distributor has received the prior written consent of Manufacturer.

      2.02. Sales Restriction. Distributor shall only be permitted to market and sell Products (directly or indirectly) to customers who do not have a valid dental or veterinary license (“Sales Restriction”). Manufacturer may terminate this Agreement with cause upon ** days notice if Distributor violates this Sales Restriction, provided that Distributor fails to cure such breach within such ** day notice period. Notwithstanding the foregoing, Manufacturer may terminate this Agreement with cause ** if Distributor or Distributor’s subdistributor or subdealer violates the Sales Restriction ** times within any ** period. Distributor shall indemnify Manufacturer for ** that they may be required to pay as a result of Distributor’s or any of its subdistributor’s or subdealer’s violation of the Sales Restriction.

3. Orders and Performance.

      3.01. Rolling Forecasts . Upon a mutually agreed upon date upon the anticipation of the Approval Date, Distributor will provide to Manufacturer an initial forecast of its requirements for the Products during each of the six (6) calendar quarters beginning with the anticipated Approval Date. On the first day of the third month of each calendar quarter thereafter during the term of this Agreement, Distributor shall update the forecasted requirements for each of the calendar quarters covered by the previous forecast and shall include forecasted requirements for an additional calendar quarter. Each forecast provided in accordance herewith shall specify the number of units of the Products required by Distributor in each covered calendar quarter by month in the form set forth in EXHIBIT B. The requirements for the first two quarters covered by each forecast shall be binding. Distributor shall be obligated to purchase and pay for one hundred percent (100%) of the forecasted requirements for such binding calendar quarters, whether or not Distributor issues purchase orders for the forecasted amounts of the Products in accordance with Section 3.02.

      3.02. Purchase Orders . A minimum of ** days prior to Distributor’s requested shipment date for any order of the Products, Distributor shall submit a purchase order to Manufacturer specifying the number of units of Products to which the order relates, the address to which the order should be shipped, and the requested delivery date. No purchase order shall be binding on Manufacturer unless such purchase order conforms to the terms of this Agreement and is acknowledged and accepted in writing by Manufacturer. Manufacturer will use commercially reasonable efforts to fill any purchase order for quantities of the Products that exceed the forecasted requirements for the month in which delivery is requested as promptly as

 

 

 

 

**

 

REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 


 

practicable, but Manufacturer cannot guarantee that it will be able to fill any such order by the requested delivery date.

      3.03. Terms of Delivery and Shipment. The terms and conditions of sale shall be those set forth in EXHIBIT D, as modified or supplemented by additional terms of this Agreement. The terms set forth in this Agreement and in EXHIBIT D shall prevail over any inconsistent or additional terms set forth in Distributor’s purchase order. The Products sold to Distributor by Manufacturer shall be shipped ** from the Manufacturer’s manufacturing facility for the Products **, to the destination in the Territory designated by Distributor in the purchase order, unless otherwise agreed by the Parties. Title to the Products shall transfer from the Manufacturer to the Distributor upon delivery to ** at the **. Distributor shall pay all ** associated with shipment, export or import of the Products.

      3.04. Annual Sales Quota . If the Approval Date occurs within the first three (3) quarters of the year, within ** days of the Approval Date, Manufacturer and Distributor shall agree upon a sales quota for the Distributor for the then current calendar year. If the Approval Date occurs within the last quarter of the year, within ** days of the Approval Date, Manufacturer and Distributor shall agree upon a sales quota for the Distributor that shall apply from the Approval Date through the end of the calendar year following the Approval Date. Thereafter, on or before ** of each year, Manufacturer and Distributor shall agree upon a sales quota for the Distributor for the following calendar year. If the Parties are unable to agree upon a sales quota or **. If Distributor fails to achieve ** of its sales quota during any given year, Manufacturer shall have the right, at its sole discretion, to either: (1) terminate this Agreement at anytime thereafter upon ** days notice; (2) **; or (3) **.

      3.05. Addressee of Rolling Forecasts and Firm Orders . All rolling forecasts and purchase orders shall be sent by Distributor to the person at the address identified on EXHIBIT B as such exhibit may be amended from time to time by Manufacturer.

      3.06. Additional or Different Terms. Any rolling forecasts, purchase orders, confirmations, acceptances, advices and similar documents submitted by Distributor in conducting the activities contemplated under this Agreement are for administrative purposes only and any legal terms that may be included on such forms shall not add to or modify the provisions of this Agreement. To the extent there are any conflicts or inconsistencies between this Agreement and any such document, the provisions of this Agreement shall control as to a particular order unless otherwise agreed to in writing by the Parties.

      3.07. Distributor License Responsibilities . Distributor shall be responsible for obtaining all licenses, permits or authorizations required for importing or exporting (returns) of Products.

4. Prices, Payment Terms and Security Interest.

      4.01. Prices. Attached hereto as Exhibit C is Manufacturer’s anticipated price schedule for the Products. Manufacturer shall provide Distributor with a final price schedule following the Approval Date. All prices are exclusive of all **. Said prices shall be subject to change by

 

 

 

 

**

 

REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 


 

Manufacturer from time to time by ** days’ prior written notice to Distributor, provided, however, that no such price change shall affect purchase orders accepted by Manufacturer prior to notifying Distributor of such price change or for Products that are delivered prior to the effective date of the price change. The prices at which the Products are resold in the Territory shall be determined **.

      4.02. Terms of Payment. Unless otherwise agreed by the Parties in writing, Manufacturer shall invoice Distributor upon shipping Products. Payment shall be made by Distributor separately for each purchase order accepted by Manufacturer, and Distributor shall remit payment for Products in US Dollars within ** days of the invoice date. In the event such remittance is not made in full within said period, interest shall accrue on moneys outstanding from the due date to the date of payment at the rate of ** (or the maximum legal rate allowed, whichever is less).

      4.03. Security Interest. Manufacturer shall retain title to and a security interest in the Products until all moneys payable hereunder are paid in full. At Manufacturer’s request, Distributor will execute such documents deemed necessary or desirable by Manufacturer to perfect its security interest.

5. Marketing and Advertising.

      5.01. Distributor’s Undertaking. Distributor shall exert its best efforts to promote the sale of the Products in the Territory and to develop a market demand for the same in the Territory. Distributor will market the Products in a professional and ethical manner. Distributor will not sell or market any Products in any part of the Territory where proper regulatory approval has not been obtained, unless approval is not required. Distributor shall advertise the Products throughout the Territory in appropriate advertising media and in a manner insuring proper and adequate publicity for the Products. Distributor shall maintain a sales organization which can be best utilized for the promotion of the sales of the Products, which shall include at least 5 sales representatives assigned to promote the Products.

      5.02. Right to Appoint Subdealers. Distributor shall have the right, at its own discretion, to appoint a subdealer or subdealers to exploit the Products in the Territory in accordance with the grant of the distributorship pursuant to Section 2.01 above; provided that (1) any subdealer shall only sell the Products to end-user customers, and not to any third party for the purpose of resale by such third party; (2) Distributor provides Manufacturer with notice thereof prior to any such appointment that includes (i) the identity of the subdealer; (ii) a description of the products, and the rights being granted to the subdealer; and (iii) the Territory in which the products will be sold by subdealer and (iv) a copy of the subdealer agreement; (3) the subdealer agreement shall be consistent with all the terms and conditions of this Agreement, and shall include Field, Territory and Sales Restrictions consistent with this Agreement; and (4) Distributor shall remain responsible to Manufacturer for the compliance of each such subdealer with the financial and other obligations under this Agreement. Distributor shall not, nor cause or permit any subdealer to, directly or indirectly, sell, solicit orders for or otherwise deal in products which, in the reasonable discretion of Manufacturer, are competitive with the Products.

 

 

 

 

**

 

REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 


 

      5.03. Sales Materials. Manufacturer agrees to provide Distributor, at no cost to Distributor, such sales materials with respect to Products as Manufacturer generally makes available to its distributors, including technical specifications, drawings, advertisements and samples, and Distributor may reproduce such materials as reasonably required, provided that all copyright, trademark and other property markings are reproduced. Such materials remain the property of Manufacturer and, except insofar as they are distributed by Distributor in the course of its performance of its duties under this Agreement, must be promptly returned to Manufacturer upon the expiration or termination of this Agreement.

      5.04. Trade Fairs and Exhibitions. Distributor agrees to participate in trade fairs and exhibitions to market the Products in the Territory, including, but not limited to, those designated by Manufacturer in its sole discretion. The cost of the fairs or exhibitions and displays, and the responsibility therefor, shall be determined by the Parties in writing prior to each trade fair or exhibition.

      5.05. Sales Force and Customer Service. Beginning upon the Approval Date, Distributor will maintain a sales force of full-time sales representatives in Canada, who are trained on the Product as well as enough customer service representatives reasonably necessary to support the Product sales in the Territory.

      5.06 Product Specialist. Manufacturer shall be permitted to provide Product Specialists (at Manufacture’s expense) who are trained specialist in the technical aspects of the Products, including the Product design and methods of use. The Product Specialist shall be permitted to work with the Distributor’s sales representatives in promoting the Product, and shall be permitted to attend and participate in sales calls, sales meetings, and sales training sessions.

6. Training.

      6.01. Training for Distributor Personnel. At a mutually agreed upon time following the Effective Date and in advance of an anticipated Approval Date, Manufacturer shall provide Distributor, a technical sales training session for qualified personnel designated by Distributor, provided that Distributor shall be responsible for all expenses for its personnel attending such training session. After the completion of such training, Manufacturer shall provide, at a time mutually convenient for the Parties, without charging any consultation fees to Distributor, one (1) qualified employee of Manufacturer to conduct annual technical sales training at Distributor’s facility in Burlington, Ontario.

7. Product Notifications and Recall.

      7.01. Notification by Distributor. Distributor will: (a) notify Manufacturer in writing of any claim or proceeding involving the Products within five (5) calendar days after Distributor learns of such claim or proceeding; and (b) report promptly to Manufacturer all claimed or suspected defects in the Products. Distributor will notify Manufacturer of all potential adverse experiences and/or injuries, serious and non-serious, no later than five (5) calendar days from the date that Distributor learns of the event. It will be Manufacturer’s sole responsibility to report all

 


 

adverse experience reports and other pharmacovigilance information to regulatory bodies, worldwide.

      7.02. Recalls. If a product investigation by a party or government office or agency results in a potential product recall or correction of the Products, Manufacturer shall retain full authority and responsibility for decisions on such recall or correction. If Manufacturer decides to conduct a recall or correction, Manufacturer will provide written notice to Distributor that includes a summary of the reason for and implementation of such action. Manufacturer shall provide such information as Distributor may reasonably require to prepare any customer notification of such recall or correction, which notification shall be issued by Distributor.

      7.03. Procedure. Any recall, correction or notification shall be handled in accordance with the recall, correction and customer notification policy and procedures maintained by Manufacturer. Manufacturer shall retain full authority and responsibility for communication with regulatory bodies, worldwide, as it relates to any recall or product notification.

      7.04. Quality Agreement. Prior to the Approval Date, the Parties shall enter into a Quality Agreement which shall set forth each Party’s responsibilities regarding quality matters relating to the Products, and shall include the terms set forth in the attached Exhibit E which describes Distributor’s responsibilities relating to the Canadian Medical Device Regulations (CMDR) and the Global Harmonization Task Force (GHTF) guidance document on Device Adverse Reporting Systems for Canada. Manufacturer shall have the right to perform a pre-qualification audit and subsequent annual audits of Distributor’s facilities to ensure compliance with the above regulations and Manufacturer’s SOPs for storage and handling of the Products. Manufacturer shall provide Distributor with at least two (2) weeks notice in advance of such audit.

8. Confidentiality.

      8.01. Definition. As used in this Agreement, “Confidential Information” means any proprietary or confidential information, technical data, trade secrets or know-how of a Party (the “Disclosing Party”), including, without limitation, product formulations, research, product plans, products, manufacturing techniques, service plans, services, business plans, customer lists and customers, markets, software, developments, inventions, processes, formulas, technology, designs, drawings, engineering, marketing, distribution and sales methods and systems and profit figures, finances and other business information disclosed to the other Party hereto (the “Receiving Party”) by or on behalf of the Disclosing Party, either directly or indirectly, in writing, orally or by drawings or inspection of documents or other tangible property; provided that (a) any Confidential Information disclosed in tangible form will be marked as confidential and/or proprietary information by the Disclosing Party and (b) any Confidential Information disclosed in intangible form will be identified as confidential and/or proprietary information of the Disclosing Party at the time of disclosure and summarized in writing to the Receiving Party within thirty (30) days of its disclosure. The Parties agree that the provisions of this Agreement shall be considered the Confidential Information of both Parties and shall not be disclosed by either Party except as set forth in this Section 8.01.

 


 

      8.02. Duties of Confidentiality and Non-Use. During the Term, and for a period of ten (10) years thereafter, the Receiving Party will maintain in confidence all Confidential Information disclosed to it by the Disclosing Party. The Receiving Party shall not use, disclose or grant use of the Disclosing Party’s Confidential Information except as required under this Agreement. To the extent that disclosure is authorized by this Agreement, the Disclosing Party shall obtain prior agreement from its employees, agents, consultants, Affiliates, subcontractors and sublicensees (collectively, the “Representatives”) to whom disclosure is to be made to hold in confidence and not make use of such information for any purpose other than those permitted by this Agreement. Each Receiving Party shall use at least the same standard of care as it uses to protect its own Confidential Information to ensure that its Representatives do not disclose or make any unauthorized use of such Confidential Information. Each Receiving Party shall promptly notify the other upon discovery of any unauthorized use or disclosure of Confidential Information.

      8.03. Exceptions. The obligations regarding “Confidential Information” set forth in this Section 8.03 shall not apply to:

     (a) information that, at the time of disclosure, was published, known publicly, or otherwise in the public domain;

     (b) information that after disclosure, is published, becomes known publicly, or otherwise becomes part of the public domain through no fault of the Receiving Party;

     (c) information that, prior to the time of disclosure, is known to the Receiving Party, as evidenced by its written records, and is not then subject to an obligation of confidentiality to any third party;

     (d) information that, after disclosure, is made available to the Receiving Party by a third party under no obligation of confidentiality and without restriction on its further disclosure by the Receiving Party; and

     (e) information that is required to be disclosed pursuant to the order of any court or governmental agency with competent jurisdiction or where disclosure is otherwise required by law (provided, however, that (i) any such disclosure shall not otherwise relieve the Receiving Party of its continuing confidentiality and non-use obligations hereunder with respect to all of the Confidential Information, including the information disclosed by it to the court or agency under this clause, and (ii) the Receiving Party shall give the Disclosing Party reasonable advance notice of any such disclosure and cooperate reasonably with the Disclosing Party in the Disclosing Party’s efforts to object to such disclosure and to obtain the recipient’s agreement to maintain the confidentiality of the Confidential Information disclosed under this clause).

      8.04. Permitted Disclosure. Each Party and its Representatives may disclose Confidential Information to the extent such disclosure is reasonably necessary for the purpose of the implementation of this Agreement to individuals or entities bound by the same terms of this Section 8.04. Each Party may also disclose Confidential Information for purposes of complying with any applicable statute or governmental regulation, and any required disclosure to Health Canada or any other governmental regulatory authority, provided however that such disclosing

 


 

Party gives reasonable notice thereof to the nondisclosing Party so that the nondisclosing Party may to appear, object and obtain a protective order or other appropriate relief regarding such disclosure.

9. Representations and Warranties, Limitation of Liability .

      9.01. Authority. Each Party represents and warrants to the other that (a) such Party is a corporation duly organized and validly existing under the laws of the state or other jurisdiction of incorporation or formation; (b) the execution and performance of this Agreement by such Party has been duly authorized by all requisite corporate action; and (c) the execution and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and, to its knowledge, will not violate any law, rule or regulation applicable to such Party.

      9.02. Limited Warranty. Manufacturer grants to Distributor the warranty with respect to the Products set forth in Article 6 of the Statement of Terms and Conditions attached hereto as EXHIBIT D.

      9.03. Exclusive Remedy. In the event of any failure by a shipment of the Products to conform, in any material respect, to the warranty set forth in Article 6 of EXHIBIT D, the only liability of Manufacturer to Distributor, and Distributor’s sole and exclusive remedy, shall be Manufacturer’s use of commercially reasonable efforts to replace the shipment. Only in the event that the Products received by Distributor do not conform to the Warranty and after the use of commercially reasonable efforts to replace the shipment is unsuccessful, Manufacturer shall refund payment to Distributor.

      9.04. Disclaimer of Warranties. EXCEPT AS OTHERWISE SET FORTH HEREIN, MANUFACTURER DISCLAIMS ANY WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

10. Indemnification.

      10.01. Indemnification by Manufacturer. Manufacturer shall defend Distributor and its directors, officers and employees and any Affiliate from and against any and all claims and suits broug


 
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