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EXHIBIT 10.31
COLLABORATIVE RESEARCH AND EVALUATION AGREEMENT
This Collaborative Research and Evaluation Agreement (" Agreement" ), effective on the date the last Party executes this Agreement (" Effective Date" ), is by and between MiMedx, Inc., a Florida corporation having its principal address at 1234 Airport Rd., Suite 105, Destin, FL 32541 (" MIMEDX" ), and Regeneration Technologies, Inc., a Delaware corporation having its principal address at 11621 Research Circle, Alachua, FL 32615 (" RTI" ). As used herein, RTI and MIMEDX may be referred to collectively as " the Parties" or individually as a " Party."
WHEREAS , MIMEDX holds an exclusive, worldwide license with Shriners Hospitals for Children and the University of South Florida Research Foundation for intellectual property covering the polymerization chemistry of NDGA as applied to biological materials, bioprostheses, or devices created through its application, as defined in United States Patent Nos. 6,565,960, 6,821,530, and other pending applications;
WHEREAS , RTI is a processor of orthopedic and other biologic matrix surgical implants, and has experience in, and certain proprietary technology related to, the generation and characterization of efficacious and safe in-vivo applications of biomaterials for the repair and natural healing of human bone and other human tissues;
WHEREAS , RTI and MIMEDX previously executed a Mutual Confidentiality and Nondisclosure Agreement having an effective date of June 22, 2007;
WHEREAS , RTI and MIMEDX anticipate that this Agreement will allow them to jointly determine the feasibility of creating a commercially viable methodology for combining MIMEDX' s NDGA technology with RTI' s biological matrix surgical implants and cleaning and sterilization technologies; and
WHEREAS , it is the intent of RTI and MIMEDX that the work performed as a result of this Agreement, and any intellectual property derived therefrom, shall be afforded the prior art protections provided for by the CREATE Act of 2004, as codified by 35 USC 103 (c).
NOW, THEREFORE , in view of the foregoing premises, and in consideration of the mutual covenants, terms and conditions hereinafter set forth, the Parties hereto agree as follows:
1. Definitions 1.1 " MIMEDX" Technology" shall mean patents, patent applications, know-how, trade secrets, and all technology owned, controlled, or licensed by MIMEDX as of the Effective Date or thereafter during the Term of this Agreement, that relates specifically to biomaterials for soft tissue repair, such as tendons, ligaments and cartilage, as well as the production of polymerized collagen for medical and/or surgical use, devices and/or components, including, but not limited to, the polymerization chemistry of NDGA as applied to biological materials, bioprostheses, or devices created through its application. This includes, but is not necessarily
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limited to, the technology as covered in US patents 6,565,960 and 6,821,530 and all immediate extensions thereof, past, present and future. 1.2 " RTI Technology/Biomaterials" shall mean patents, patent applications, know-how, trade secrets and all technology owned, controlled, or licensed by RTI as of the Effective Date or thereafter during the Term of this Agreement, that relates specifically to RTI Biomaterials, specifically including RTI' s proprietary allograft, xenograft and biological matrix technologies, cleansing, sterilization, packaging and distribution of RTI proprietary allograft, xenograft and biological matrix implants, as well as technology useful in manufacturing, and clinical and other uses of RTI Biomaterials. 1.3 " Project Technology" shall mean every technology, material, process, device, or article of manufacture which is newly discovered, developed, made, perfected, improved, designed, engineered, devised, acquired, produced, conceived, or first reduced to practice by MIMEDX and/or RTI or any of their employees or agents in the course of performing their obligations hereunder, whether tangible or intangible, including without limitation each and every invention, work of authorship, trade secret, formula, process, routine, subroutine, technique, concept, method, idea and algorithm, and all software and related documentation in any source of development (including but not limited to source code, objects code, flow charts, diagrams and other materials of any type whatsoever) and all rights of any kind in or to any of the foregoing (including without limitation copyrights, trade secret rights and patent rights) regardless of whether any or all of the foregoing constitutes copyrightable or patentable subject matter.
1.4 " Confidential Information" shall be given the meaning as defined in Article 4, below. Unless expressly stated to the contrary, or as may be otherwise clearly gleaned from the context, the term " Confidential Information" as used throughout this Agreement shall be deemed to include information as to trade secrets that have been designated as " Confidential ad infinitum ," as defined in Section 4.3, below.
1.5 " Protocol" shall mean a detailed scientific plan to explore the feasibility of the synergistic combination of RTI Technology/Biomaterials and MIMEDX Technology (as outlined in the Statement Of Work, attached hereto and incorporated by reference as Exhibit A ). 1.6 " Project" shall mean the research, experimentation and evaluation performed and to be performed by RTI and MIMEDX pursuant to this Agreement as outlined in Exhibit A to determine the feasibility of using the MIMEDX Technology to enhance RTI' s Biomaterials for use in healthcare settings, to determine the feasibility of using the RTI Technology to enhance MIMEDX Biomaterials for use in healthcare settings, and/or to facilitate the use of MIMEDX Technology in healthcare settings.
1.7 " Project Results" shall mean all tangible outputs produced in relation to the Project, including Project Technology, data, results or any other information generated or
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developed by either RTI or MIMEDX, or their respective employees, agents or consultants, in conducting the Project. 2. Description of the Project
2.1 Work to be Performed by RTI and MIMEDX . RTI and MIMEDX shall perform the work contemplated by the Project in accordance with the desired project characteristics and guidelines set forth in Exhibit A . 2.2 Description of Research and Evaluation Procedures
2.2.1 The Project described in the Statement of Work, Exhibit A , shall be conducted by both Parties as a collaborative effort under the direction of the Project Managers, to be appointed as set forth in Section 5.1.
2.2.2 Both Parties shall provide scientific personnel and technical expertise to carry out the Project. Both Parties shall bear their own expenses associated with the scientific personnel and technical expertise it provides, as further described in Exhibit A . 2.2.3 To the extent necessary to carry out the collaborative research and evaluation contemplated by the Project, or as may be necessary to obtain governmental and regulatory approvals for Protocols, the Parties shall exchange all necessary technical information, including all preclinical and clinical information, and shall provide all necessary technical assistance and training to the other. All information transferred, provided or exchanged under this Section 2.2.3 shall be subject to the confidentiality requirements set forth in Article 4. 2.2.4 Each Party agrees to make its employees and non-employee consultants reasonably available at their respective places of employment to consult with the other Party on issues arising during the Project and in connection with any request from any regulatory agency, including, without limitation, regulatory, scientific, technical and clinical testing issues.
2.2.5 Representatives of RTI and MIMEDX may, upon reasonable notice and at times reasonably acceptable to the other Party (a) visit the facilities where the Project is being conducted and (b) consult informally with personnel of the other Party performing work on the Project during such visits, by telephone, by facsimile or electronic transmission, or in any other manner as the Parties shall agree. If requested by the other Party, RTI and MIMEDX shall cause appropriate individuals working on the Project to be available for meetings at the location of the facilities where such individuals are employed at times reasonably convenient to the Party responding to such request.
2.2.6 RTI and MIMEDX shall each maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes and as will properly reflect all work done and results achieved in the performance of the Project (including all data in the form required under any applicable governmental regulations). RTI and MIMEDX shall each provide the other the right to inspect and copy all such records to the extent reasonably required
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for the performance of its obligations under this Agreement; provided that each Party shall maintain such records and the information of the other contained therein in confidence in accordance with Article 4 below and shall not use such records or information except to the extent otherwise permitted by this Agreement.
2.3 Exclusivity of Research Engagement.
2.3.1 Allograft Tissue . During the term of this Agreement, the Parties agree that they will not engage in research or collaborative efforts with non-parties on matters involving: (i) NDGA treatment of musculoskeletal allograft tissue constructs, whether with or without combination with MiMedx collagen fibers.
2.3.1.1 For purposes of Section 2.3.1.1, " musculoskeletal allograft tissue constructs" means (i) substantially intact or minimally manipulated allograft tissue implants comprising bone, muscle, fascia, cartilage, ligaments, tendons, and/or menisci, and (ii) biological matrices containing demineralized bone matrix " DBM." The Parties recognize and agree that sterilization and/or aseptic processing of musculoskeletal allograft tissue constructs is essential to the creation of safe implants. As such, sterilization and/or aseptic processing of musculoskeletal allograft tissue shall not, by itself, be deemed manipulation of the allograft tissue.
2.3.2 This exclusivity provision does not apply to any other NDGA collagen fiber constructs and shall not be interpreted to include stand-alone NDGA fibers that are not in combination with either allograft tissue constructs as defined above.
3. Deliverables
The Deliverables under this Agreement are set forth in Exhibit A .
4. Confidential Information
4.1 MIMEDX Confidential Information . With respect to MIMEDX, the term " Confidential Information" refers to its specialized and proprietary trade secrets, formulas, processes, methods, technology, know-how, customer and vendor information and lists, financial data, undisclosed and unreleased products, and other items or information related to its xenograft tissue, surgical implants, collagen for human implants, NDGA-polymerized collagen technology and any laboratory and clinical testing and research methodologies or models that when furnished, shown, or disclosed to RTI is designated, whether in writing or orally (followed by a written confirmation and summary) as " Confidential," or which is of such nature and character that a reasonable person in the trade would understand it to be confidential without the necessity of it being so designated. All Confidential Information disclosed by MIMEDX, except for jointly owned Confidential Information as set forth in Section 4.4, shall remain the exclusive property of MIMEDX.
4.2 RTI Confidential Information . With respect to RTI, the term " Confidential Information" refers to its specialized and proprietary trade secrets, formulas, processes, methods,
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technology, know-how, customer and vendor information and lists, financial data, undisclosed and unreleased tissue lines or products, and other items or information related to its allograft tissue, xenograft tissue, surgical implants, collagen for human implants, associated processing and sterilization technologies for each, and any laboratory and clinical testing and research methodologies or models that when furnished, shown, or disclosed to MIMEDX is designated, whether in writing or orally (followed by a written confirmation and summary), as " Confidential," or which is of such nature and character that a reasonable person in the trade would understand it to be confidential without the necessity of it being so designated. All Confidential Information disclosed by RTI, except for jointly owned Confidential Information as set forth in Section 4.4, shall remain the exclusive property of RTI.
4.3 Confidential ad infinitum . The Parties recognize and agree that the other Party may possess certain trade secrets that will likely continue to have commercial and competitive value for an indeterminate period of time, and perhaps in perpetuity. Therefore, a Party may in its sole discretion designate as " Confidential ad infinitum" those certain trade secrets it reasonably believes fit such criteria. Any provision of this Agreement to the contrary not withstanding, trade secrets must be designated orally or in writing as " Confidential ad infinitum" at the time of disclosure. In the event of an oral designation, the disclosing Party must confirm the designation in writing to the receiving Party within one (1) week following disclosure. Trade secrets that are Confidential ad infinitum shall at a minimum be given all the same protections as Confidential Information, with certain added or heightened requirements as further described below. Election not to designate a trade secret as Confidential ad infinitum , or failure to so designate, shall not be deemed to erode or abrogate a trade secret' s underlying status as Confidential Information.
4.4 Jointly Owned Confidential Information . With respect to this Agreement, the Project Results, negotiations between the Parties, financial and prospective financial data, and any other information jointly generated by the Parties as a result of this Agreement, including the existence of this Agreement and the fact that a relationship between the Parties exists, shall be " Confidential Information" jointly owned by the Parties. Subject to Sections 4.4 and 4.7 and except for the use of Joint Inventions under Section 8.2.2, a Party wishing to disclose any part of this jointly owned Confidential Information must first obtain written permission from the other Party by contacting the designated corporate representative for such purpose as set forth in Section 4.7.
4.5 Protection of Confidential Information . To the maximum extent permitted by applicable law, and except as otherwise expressly permitted pursuant to any other provision of this Agreement, RTI and MIMEDX, their employees and consultants, agree to observe complete confidentiality with regard to the Confidential Information; not to disclose or otherwise permit any third parson or entity access to the Confidential Information or any portion thereof without the other Party' s prior written permission (except that such disclosure or access shall be permitted to an employee of the Party to the extent required by such employee in order to perform duties consistent with the terms of this Agreement, so long as the disclosure is not inconsistent with, where applicable, Section 4.5.1); to ensure that the Party' s employees who
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receive access to the Confidential Information or any portion thereof are advised of the confidential and proprietary nature of the Confidential Information and to ensure by agreement pursuant to Section 4.7 hereof that they are prohibited from copying or revealing, for any purpose whatsoever, the Confidential Information (or any part thereof) or from taking any action prohibited under this Agreement (except that such copying or revealing shall be permitted to an employee to the extent required by such employee in order to perform duties not inconsistent with the terms of this Agreement); to notify the other Party promptly and in writing of any circumstances relating to any possession or use of the Confidential Information (or any part thereof) by any person or entity other than those authorized under this Section 4.5; and to take any and all other actions reasonably deemed necessary or appropriate by the other Party from time to time to ensure the continued confidentiality and protection of the Confidential Information.
4.5.1 Protection of Information Designated as Confidential ad infinitum . All protection provided to Confidential Information under Section 4.5 shall apply to trade secrets that have been designed as Confidential ad infinitum , with the following additional items and limitations: (i) in advance of disclosure to an employee or consultant (hereinafter " Employee" ) of the receiving Party, and regardless of whether disclosure has already been made to another Employee of the receiving Party, the receiving Party shall identify to the disclosing Party the Employee it wishes to receive the trade secret information; (ii) the disclosing Party may in its sole discretion approve or disapprove of the receiving Party' s selected Employee; (iii) the receiving Party' s act of identifying the aforementioned selected Employee to the disclosing Party serves as an express and/or implied warranty by the ...
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