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JOINT DEVELOPMENT AGREEMENT

Development Agreement

JOINT DEVELOPMENT AGREEMENT | Document Parties: ALYNX, CO. | Offray Specialty Narrow Fabrics, Inc You are currently viewing:
This Development Agreement involves

ALYNX, CO. | Offray Specialty Narrow Fabrics, Inc

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Title: JOINT DEVELOPMENT AGREEMENT
Governing Law: Delaware     Date: 2/8/2008
Law Firm: Sills Cummis    

JOINT DEVELOPMENT AGREEMENT, Parties: alynx  co. , offray specialty narrow fabrics  inc
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EXHIBIT 10.30

JOINT DEVELOPMENT AGREEMENT

This JOINT DEVELOPMENT AGREEMENT (the “ Agreement ”) is entered into by MiMedx, Inc. , a Florida corporation, having a principal place of business located at 1234 Airport Road, Suite 105, Destin, FL 32541 (“ MiMedx ”) and Offray Specialty Narrow Fabrics, Inc. , a New York corporation having a principal place of business located at 360 Route 24, P.O. Box 421, Chester, NJ 07930-0421 (“ Offray ”) (with MiMedx and Offray hereinafter collectively referred to as the “ Parties ,” each a “ Party ”).

RECITALS

WHEREAS, MiMedx has technical expertise in producing NDGA-treated collagen fibers suitable for medical implants, such as braided or woven collagen implants, and owns or has exclusive rights to patents and patent applications covering NDGA-treated collagen and implants;

WHEREAS, Offray has technical expertise in woven textile production and manufacturing; and

WHEREAS, the Parties desire to collaborate to jointly develop commercial production processes for fabricating woven and/or braided NDGA-treated collagen fiber bioprostheses.

NOW, THEREFORE, in consideration of the foregoing and such other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties , intending to be legally bound, agree and covenant as follows:

AGREEMENT

 

1.

DEVELOPMENT ACTIVITIES

1.1 Development Activities; Defined.

The Parties shall cooperate and use all reasonable diligence to: (i) jointly research and develop, for a period of one (1) year from the date of the last signature to this Agreement (the “Effective Date”), commercial production processes and equipment for fabricating woven and/or braided NDGA-treated collagen fibers into bioprostheses (the “First Phase”); and (ii), upon successful completion of the First Phase, the Parties shall cooperate to develop, for a period of eighteen (18) months after completion of the First Phase, a manufacturing process that reliably

 

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produces at least one (1) woven NDGA-treated collagen fiber bioprosthesis and which, as determined and mutually agreed upon by the Parties in writing, is suitable for commercial medical product production (collectively, the “Second Phase”) (with (i) and (ii) collectively referred to as the “Development Activities”).

1.2 First Phase.

Offray shall perform feasibility testing by weaving MiMedx collagen fibers at Offray’s Watsontown, Pennsylvania facility (the “Watsontown Facility”). The Parties recognize that successful testing conducted during the First Phase may require multiple fabrication and/or test iterations. MiMedx shall evaluate whether the feasibility testing conducted during the First Phase is successful using its own material testing and validation of a woven collagen fiber product made by Offray , and may, upon prior written notice to, and the prior written consent of, Offray , which consent shall not be unreasonably withheld, conduct an audit of Offray’s Watsontown Facility and the work conducted by Offray during the First Phase, including all laboratory notebooks, equipment and prototypes made to arrive at any tested specimens developed as part thereof.

1.3 Offray Employees.

Offray agrees that each employee and consultant who performs any services in any way relating to the First Phase or Second Phase (as defined below) shall be appropriately informed of the terms of this Agreement , and that each such employee and consultant shall be under legal obligation to Offray by contract or otherwise sufficient to impose on such employee or consultant a legal obligation to comply with the terms and conditions of this Agreement , including, without limitation, the confidentiality obligations of Section 8 of this Agreement , and, for each employee, consultant or consultant’s entity for individuals that may be an inventor, a legal obligation to assign to Offray all rights to and in all intellectual property, including, without limitation, all inventions, copyrights, patents and trademarks, created by such employee or consultant during their employment by or with Offray .

1.4 Second Phase.

Upon successful completion of the First Phase, as determined by MiMedx in its sole discretion, the Parties shall cooperate and use all reasonable diligence to conduct the Second Phase. During the Second Phase, MiMedx scientists shall travel to Offray’s Watsontown Facility at MiMedx’s expense and assist as needed for the design and development of the

 

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manufacturing process to be developed during the Second Phase. During the Second Phase, and upon Offray’s request, MiMedx shall assist Offray in analyzing any prototype bioprosthesis products. Notwithstanding the foregoing, MiMedx may, at its sole discretion, request a sample woven bioprosthesis product produced by Offray in order to conduct its own material testing and validation of any such woven bioprosthesis product produced by Offray during the Second Phase, MiMedx will use all reasonable efforts to promptly return any test analysis of prototypes of woven bioprosthesis products within two (2) weeks of receipt of any such materials and/or products to be tested, unless agreed otherwise by the Parties . During the Second Phase, MiMedx may, upon prior written notice to, and the prior written consent of, Offray , which consent shall not be unreasonably withheld, perform an onsite quality control, manufacturing and regulatory audit of the Watsontown Facility to assess compliance with the United States Food and Drug Administration guidelines or other similar foreign regulatory authority.

1.5 Monthly Evaluation and Reporting.

During the First and Second Phase, the Parties shall communicate with each other at least monthly to evaluate ongoing Development Activities. Offray shall also provide bi-monthly progress reports regarding the status and progress of the First Phase and, if initiated, the Second Phase. The progress reports shall include a brief written review of the work performed during the previous two (2) weeks containing the following: (i) a summary of the work performed on the Development Activities; (ii) an overview of any progress made towards completion of the First or Second Phase, as the case may be; and (iii) recommendations for any proposed alterations in or to the Development Activities. MiMedx shall review each progress report and provide any response to Offray in writing within one (1) week of MiMedx’s receipt thereof. Notwithstanding the foregoing, the Parties , may, if mutually agreed upon, also routinely confer with regard to the Development Activities in-person or by telephone.

1.6 Salaries of Employees.

All salaries, benefits, and insurance in any way relating to this Agreement , including, without limitation, any work performed on the Development Activities, shall be paid by each Party for its own employees. Any overtime hours expended, or additional staff hired, by a Party for the purposes of this Agreement , including, without limitation, any work performed on the Development Activities, shall be paid by each Party with no cost, obligation, or liability to the other Party .

 

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1.7 Manufacturing and Supply Agreement.

If the First and Second Phase of the Development Activities are successful, as mutually agreed upon by the Parties , MiMedx agrees to consider Offray as a potential commercial supplier if Offray is able to demonstrate that it can meet or exceed reasonable and customary United States medical supplier standards for delivery, manufacturing capacity, competitive cost and ability to meet all quality and manufacturing regulatory requirements.

 

2.

MIMEDX SUPPORT AND PAYMENTS

2.1 Equipment.

In support of the First Phase, MiMedx shall purchase a handloom of Offray’s choosing with a cost not to exceed $4,000 (US). This and any other equipment purchased by MiMedx for use in the Development Activities shall be owned by MiMedx and, upon request, returned to MiMedx , regardless of the outcome of the Development Activities, unless each Party agrees otherwise in writing. MiMedx shall not be obligated to pay for any other equipment used in the Development Activities unless approved by MiMedx in advance in writing.

2.2 Payment for Development Activities.

In addition to the royalty payments set forth in Section 3.4, MiMedx shall pay Offray for the First Phase in accordance with the Fee Schedule dated June 18, 2007 (not to exceed $15,200 US, without prior written consent of MiMedx ) between the Parties , attached hereto as Exhibit A. If the first Phase is successful and MiMedx decides to pursue the Second Phase, the Parties shall mutually agree upon reimbursement of and/or payment for reasonable expenses to be paid to Offray for the Second Phase, such Agreement to be in wring and signed by the Party to be charged.

2.3 Supply of Collagen Fibers/Assistance.

MiMedx shall supply Offray with NDGA-treated collagen fibers or NDGA to treat collagen fibers to be used in the Development Activities in reasonable amounts and meeting appropriate product specifications as necessary to properly conduct the Development Activities, and shall provide technical assistance to Offray with regard to the Development Activities as reasonably requested by Offray .

2.4 Travel and travel costs.

MiMedx shall, upon proper documentation provide by Offray , refund or reimburse Offray for all reasonable travel costs, including, without limitation, coach class airfare and

 

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reasonable living (i.e. room and board) expenses, for Offray employees and consultants who, at the request of MiMedx , travel to MiMedx’s Destin, Florida location or other specified location for meetings relating in any way to the Development Activities.

 

3.

OWNERSHIP OF INTELLECTUAL PROPERTY

3.1 Definitions.

For purposes of this Agreement :

(a) “Intellectual Property” means any and all intellectual property, including, but not limited to, inventions, copyrights, copyright applications or registrations, original works of authorship, developments, improvements, patents, patent applications, Patent Rights (as defined in Section 3.1(e)) trademarks, trademark applications, trade names, trade secrets, designs, technical information, formulations, processes, know-how, data, specifications, test results, drawings, manufacturing equipment and other information, whether or not patented or patentable, or otherwise subject to protection under any applicable laws, rules and regulations, which in any way relate to, or arise from, this Agreement , including, without limitation, the Development Activities.

(b) “Joint Intellectual Property” means Intellectual Property having at least one (1) co-creator who is an employee, agent, servant, representative or consultant of Offray and one co-creator who is an employee, agent, servant, representative or consultant of MiMedx .

(c) “ MiMedx Intellectual Property” means Intellectual Property having as creators only employees, agents, servants, representatives or consultants of MiMedx .

(d) “ Offray Intellectual Property” means Intellectual Property having as creators only employees, agents, servants, representatives or consultants of Offray .

(e) “Patent Rights” means all rights under any patent or patent application in any country, including any substitution, extension or supplementary protection certificate, reissue, reexamination, renewal, division, continuation or continuations-in-part thereof which in any way relate to, or arise from, this Agreement , including, without limitation, the Development Activities. “Joint

 

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Patent” means any patent from the Patent Rights that is jointly owned such that the patent has at least one inventor who is an employee, agent, servant, representative or consultant of Offray and at least one inventor who is an employee, agent, servant, representative or consultant of MiMedx . “ Offray Patent” means any patent from the Patent Rights with all inventors being only employees, agents, servants, representatives or consultants of Offray . “ MiMedx Patent’ means any patent from the Patent Rights with all inventors being only employees, agents, servants, representatives or consultants of MiMedx .

3.2 Ownership of Joint Intellectual Property/Royalty.

MiMedx and Offray shall jointly own all Joint Intellectual Property.

3.3 Ownership of MiMedx Intellectual Property.

MiMedx shall own all MiMedx Intellectual Property.

3.4 Ownership of Offray Intellectual Property/Royalty/License.

Offray shall own all Offray Intellectual Property.

Offray hereby grants to MiMedx an exclusive, irrevocable, right and license, with the right to sublicense the Offray Intellectual Property and the Joint Intellectual Property, including the right to use or have used, make or have made, market, have marketed, offer for sale, import for sale, and sell and have sold any product of process covered by Offray Patent(s) and/or any Joint Patent(s) in the field of medical collagen bioprosthesis (the Field).

MiMedx hereby covenants and agrees to pay Offray a two percent (2%) royalty on gross sales revenues of any products covered by or products produced by processes covered by an Offray Patent. MiMedx hereby covenants and agrees to pay a 1 percent (1%) royalty on gross sales revenues of any products covered by or products produced by processes covered by a Joint Patent. However, to be clear, no multiple royalties shall be due or payable because any product and/or method to produce such product is covered by or more than one Offray Patent and/or Joint Patent. For example, in the situation where a product and/or method to produce such product is covered by both at least one Offray Patent(s) and at least one Joint Patent(s) or two or more Offray Patents, the royalty due shall still remain at 2% and in the situation where a product and/or method to produce such product is covered by one or more Jointly Owned Patents, the royalty due shall be 1%. Terms for payment of and accountability for sales will be defined by a later drafted Agreement should a Joint Patent(s) or Offray Patent issue and the Parties agree to

 

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act in good faith to establish such implementing details and definitions as reasonable and customary.

3.5 Patent Prosecution and Maintenance.

MiMedx shall, at its sole discretion, have the right, but not the obligation, to prepare, file prosecute and maintain at its own expense any patent applications and/or patents relating to the Joint Intellectual Property. If, after ninety (90) days written notice from either Party to the other Party that there exists Joint Intellectual Property that a Party reasonably believes should be protected, MiMedx declines to fund or prepare and file a patent application relating thereto, then Offray shall have the right, at Offray s expense, to prepare, file, prosecute and maintain any patent application(s) relating to such Joint Intellectual Property. If MiMedx declines to fund and Offray decides to do so for a particular Joint Patent, then the exclusive license under Section 3.4 converts to a non-exclusive license for that Joint Patent.

Each Party shall be responsible for protecting any Intellectual Property solely owned by that Party , unless agreed otherwise in writing.

3.6 Laboratory Notebooks.

Each Party agrees to use its reasonable efforts to have its employees and/or consultants timely and promptly record, date and witness any and all Intellectual Property in bound laboratory notebooks. Intellectual Property shall be disclosed and reported to the other Party within thirty (30) days of the date indicated for the same in the laboratory notebook.

 

4.

INFRINGEMENT OF INTELLECTUAL PROPERTY

4.1 Notice of Infringement.

Upon becoming aware of any alleged infringement of Intellectual Property, each Party shall promptly notify the other Party of any and all available evidence of infringement, and the Parties shall cooperate to diligently investigate and determine, in the exercise of reasonable judgment and good practice, whether the activities in question in fact constitute an infringement of In


 
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