GLOBAL SIGHT NETWORK A Service of the Alabama Eye Bank PROCESSOR

Transcription

1 GLOBAL SIGHT NETWORK A Service of the Alabama Eye Bank PROCESSOR AGREEMENT FOR RECEIPT AND GLYCEROL PRESERVATION OF CORNEAL (OCULAR) TISSUE INTENDED FOR HUMAN TRANSPLANTION This agreement is made and entered into this day of, between Global Sight Network, a service of the Alabama Eye Bank, located at 500 Robert Jemison Road, Birmingham, Alabama (hereinafter GSN, or PROCESSOR ) and the (hereinafter SOURCE BANK ). RECITALS WHEREAS, GSN operating as a service of the Alabama Eye Bank is an FDAregistered establishment and is accredited by the Eye Bank Association of America that provides services related to the recovery, testing, processing, storage, labeling, packaging, and distribution of human corneal (ocular) tissue for human transplantation and the screening of donors; WHEREAS, SOURCE BANK is an FDA-registered establishment and is accredited by the Eye Bank Association of America that provides services related to the recovery, testing, processing, storage, labeling, packaging, and distribution of human corneal (ocular) tissue for human transplantation and the screening of donors; WHEREAS, SOURCE BANK desires to maximize its utilization of donated corneal tissue by providing to surgeons and associated qualified personnel glycerolpreserved corneal tissue (herein GPC ): WHEREAS, SOURCE BANK desires to provide to GSN corneal tissue that has been tested, determined to be from an eligible donor, and has met predetermined release criteria established by GSN, for the purpose of glycerol-preservation; WHEREAS, GSN desires to process said corneal tissue by transferring it into long-term corneal storage medium (glycerol), for distribution by SOURCE BANK for the purpose of transplantation to those in need throughout the United States and the world; WHEREAS, GSN desires to further the scientific basis of GPC by consolidating data on its usage for the purposes of publication in the peer-reviewed medical science literature; NOW, THEREFORE, in consideration of the foregoing and of the conditions herein contained, GSN and SOURCE BANK agree as follows: ARTICLE I DUTIES Page 1 of 11

2 A. General 1. SOURCE BANK shall make available to GSN, the PROCESSOR, corneal tissue that has been recovered, donor-screened, tested, and determined by SOURCE BANK to be from an eligible donor, and released by SOURCE BANK for human transplantation (referred to hereafter as Tissue ) in accordance with all applicable Federal and State laws and regulations, requirements of Eye Bank Association of America (EBAA) Medical Standards and U.S. Food and Drug Administration (FDA) PART GSN shall accept Tissue from SOURCE BANK for additional processing that includes the transfer of Tissue into long-term preservation media in accordance with all applicable Federal and State laws and regulations, requirements of EBAA Medical Standards and FDA PART GSN and SOURCE BANK shall each comply with all applicable Federal and State laws and regulations as well as EBAA medical standards related to the performance of their responsibilities under this Agreement, including but not limited to regulations for human cells, tissue, and cellular and tissue-based products (HCT/Ps) as set forth in 21 C.F.R. Part 1271, as these regulations may be amended periodically, including FDA guidance applicable to their respective obligations under this Agreement. 4. GSN reserves the right to accept or decline tissue for processing from Source Banks. GSN reserves the right to alter, amend or change GSN preservation procedures without notifying Source Banks. B. SOURCE BANK Responsibilities 1. SOURCE BANK shall be responsible for Tissue from donors in compliance with all applicable Federal and State requirements, EBAA medical standards and FDA PART 1271, and for making donor eligibility determinations, in accordance with all applicable Federal and State laws. No tissue for which donor eligibility is unknown at the time of shipping to GSN will be accepted. 2. SOURCE BANK shall be responsible for retaining and maintaining all records related to donor eligibility determinations for all Tissue and shall make such records promptly available to GSN upon request or to FDA pursuant to an authorized inspection or upon FDA s request. 3. SOURCE BANK shall ensure that the labeling for Tissue contains all relevant and required information, including but not limited to warning statements, a description of the tissue, and applicable storage requirements and is accompanied by all required records, including records which shall include but not be limited to a distinct identification code affixed to the container, the Page 2 of 11

3 donor s eligibility determination, and the name and address of SOURCE BANK as the establishment making the eligibility determination. Processed tissue shall be returned to SOURCE BANK in GSN packaging material (labels, box, documents), which shall include the appropriate documentation to be supplied to end user, as specified by EBAA. 4. SOURCE BANK shall ensure that Tissue has met all established release criteria and is available for processing by GSN in accordance with EBAA medical standards and FDA PART 1271 before shipment to GSN. 5. SOURCE BANK shall package, store, and ship Tissue to GSN under conditions that will ensure the Tissue is not damaged and is protected from communicable disease contamination, in accordance with EBAA medical standards and FDA PART SOURCE BANK shall be responsible for maintaining all records of its activities with respect to Tissue in accordance with applicable Federal and State laws and regulations for the recovery, screening, testing, processing, labeling, storage, packaging, and distribution of corneal tissue as set forth in EBAA Medical Standards and FDA PART SOURCE BANK will be solely responsible for any and all shipping costs incurred in connection with shipping Tissue to GSN. 8. SOURCE BANK will be responsible for the final distribution approval of those GPCs processed and sent back to SOURCE BANK. Final distribution approval is comprised of the SOURCE BANK s donor eligibility determination, GSN s tissue suitability confirmation, and the SOURCE BANK s review of processing documentation. 9. SOURCE BANK will distribute GPCs within SOURCE BANK service area. 10. SOURCE BANK shall be responsible for investigating all adverse reactions involving Tissue that SOURCE BANK provided to GSN for processing and for submitting reportable adverse reaction reports to FDA as required, and SOURCE BANK shall notify GSN as soon as possible but in no event later than 15 calendar days after SOURCE BANK discovers or becomes aware of a deviation and shall report any follow-up information to GSN within fifteen (15) days after SOURCE BANK receives or becomes aware of such information. 11. SOURCE BANK shall promptly notify GSN of any notices of FDA Inspection and provide GSN with copies of any and all observations, correspondence, and submissions resulting from any such inspection. Page 3 of 11

4 12. SOURCE BANK will perform appropriate marketing activities in the service area to acquaint surgeons, surgical facilities, and employees (herein called Customers ) with GPC products and usage. i. To distribute exclusively GPC obtained from GSN. ii. To not distribute GPC to entities located outside of the service area or to entities within the service area for resale to third parties located outside of the service area. iii. To use its best efforts to further the promotion, marketing, sales and other distribution of GPCs in the service area. iv. To utilize GSN trademarks and service marks at all times in all promotional materials, subject to prior written approval of GSN. 13. SOURCE BANK shall diligently advertise GPC in the service area. All promotional materials created by the SOURCE BANK for use with GSN tissues must be approved by GSN prior to use. All expenses incurred by SOURCE BANK with respect to creating advertising materials and advertising GPC shall be borne by SOURCE BANK. 14. SOURCE BANK agrees to provide feedback to GSN, both positive and negative, on the use of GSN tissues. SOURCE BANK agrees to cooperate with GSN in dealing with any customer complaints concerning GPC. 15. SOURCE BANK will provide data on usage of GPC as requested by GSN. Data may include, but not be restricted to, database entries, written comments, testimonials, still images, or videos. Data will be requested for the purposes of improving internal processes, contributing to peer-review literature that improves the scientific basis of GPC usage, and developing material for publicity, marketing, training, motivation, or fundraising. SOURCE BANK may mask surgeon and/or patient identities. C. GSN Responsibilities 1. GSN shall accept only Tissue from SOURCE BANK that meets GSN acceptance criteria, including the following criteria: a. Tissue must be properly packaged, stored, and shipped and not damaged; b. Tissue must have proper labeling, which shall include but not be limited to a unique identification, the name and address of SOURCE BANK, an all other relevant and required information pursuant to federal and EBAA regulations. c. Tissue must conform to all applicable CGTP requirements for tissue that is available for distribution; and d. Tissue must meet all other acceptance criteria as set forth in GSN s standard operating procedure for receipt of tissue. Page 4 of 11

5 2. GSN shall reject tissue that is received but does not meet acceptance criteria and notify SOURCE BANK immediately. Rejected tissue will be disposed on site unless otherwise requested by SOURCE BANK. Return shipping is a cost of SOURCE BANK. 3. GSN shall ensure that its handling of any Tissue after acceptance, including any processing is in compliance with applicable CGTP requirements set forth under FDA PART GSN shall evaluate Tissue received from SOURCE BANK to determine whether it is suitable for the purpose(s) stated by SOURCE BANK (e.g., glaucoma drainage device cover). Tissue determined to be suitable for the stated purpose shall be processed by GSN in accordance with CGTP requirements and current GSN Policies and Procedures. 5. GSN reserves the right to distribute medically eligible tissues with high cell counts to international accounts for surgeries to take place within the expiration date of intermediate-term storage medium, in consultation with the SOURCE BANK. 6. GSN shall establish and be responsible for ensuring return criteria for any Tissue that is processed by GSN in accordance with FDA PART 1271 and released for return to SOURCE BANK. 7. GSN shall be responsible for ensuring that the labeling for any GSN processed Tissue is in accordance with regulations at FDA PART 1271 and contains all relevant and required information, including but not limited to: the unique identification code established by SOURCE BANK, information about the donor eligibility determination made by SOURCE BANK, and the name and address of GSN as the establishment that has determined that the processed Tissue meets GSN s tissue suitability criteria. 8. GSN reserves the right to arrange shipments of tissue to SOURCE BANK in a manner that reduces costs (e.g., ship in batches). 9. GSN shall be responsible for maintaining all records of its activities with respect to Tissue from the time GSN receives the Tissue, in accordance with applicable Federal and State laws and regulations for the receipt, storage, processing, labeling, packaging, and distribution of corneal tissue, including CGTP regulations, and provide to SOURCE BANK such documentation and information as required by SOURCE BANK, so that SOURCE BANK may determine whether GPC meets criteria for release for distribution. Page 5 of 11

6 10. GSN shall in no case make final donor eligibility determinations for tissue processed pursuant to this agreement. Final responsibility for use of transplanted GSN tissue rests with the surgeon. 11. GSN shall be responsible for investigating and submitting reportable deviations to FDA as required for any deviation occurring during the performance of any GSN responsibility under this Agreement. 12. GSN shall promptly notify SOURCE BANK of any notices of FDA Inspection and provide SOURCE BANK with copies of any and all observations, correspondence, and submissions resulting from any such inspection. 13. GSN shall furnish SOURCE BANK with marketing support, including a reasonable quantity of GSN brochures, flyers, and electronic media in the English language. GSN shall provide SOURCE BANK with existing art work, logos, photography and similar materials for the production of sales aids, advertising, brochures, trade exhibits and related items that SOURCE BANK will produce to support its marketing and usage activities. SOURCE BANK may utilize such advertising materials to promote usage of GPC and in preparing its own advertising materials. 14. GSN will provide SOURCE BANK with technical assistance concerning GPC to a reasonable extent. SOURCE BANK agrees to an initial training session about GPC and the marketing materials and tools. GSN may also provide SOURCE BANK s personnel with training in product information, clinical applications, study results and sales techniques, via telephone conference or web-based conference, or at any mutually agreeable location. 15. GSN will provide customer support, including a Frequently Asked Questions file, incorporating feedback from the SOURC BANK and other sources, and make this file available to the SOURCE BANK. GSN will ensure that the GSN website contains current GSN product lists and promotional and instructional material in downloadable form. D. Audits 1. GSN shall allow representatives from SOURCE BANK to audit GSN s compliance with applicable requirements, including access to GSN s facilities and records relevant to the performance of its responsibility under this Agreement. Such audits shall be scheduled at mutually agreeable times upon reasonable advance written notice to GSN. The number of SOURCE BANK auditors and the length of such audit shall be reasonable in light of the type of audit. GSN may provide SOURCE BANK an audit report performed by a third party is available upon request. Page 6 of 11

7 2. SOURCE BANK shall allow representatives from GSN to audit SOURCE BANK S compliance with applicable requirements, including access to SOURCE BANK s facilities and records relevant to the performance of its responsibility under this Agreement. Such audits shall be scheduled at mutually agreeable times upon reasonable advance written notice to SOURCE BANK. The number of GSN auditors and the length of such audit shall be reasonable in light of the type of audit. ARTICLE II PAYMENT For services that GSN provides to SOURCE BANK under this agreement, the SOURCE BANK shall pay GSN according to the fee schedule attached hereto as Exhibit A. Said fees shall be paid by the SOURCE BANK to GSN monthly, due and payable within twenty (20) days following the end of each month during the term of this agreement. ARTICLE III TERM A. This Agreement shall become effective on the and, except as otherwise provided herein, and shall apply only to such Tissue recovered on or after B. This Agreement shall renew automatically on the yearly anniversary of the signatory date, or upon request for re- negotiation by thirty (30) days written notice of either party. C. Either GSN or SOURCE BANK may terminate this Agreement for any reason by giving the other party thirty (30) days written notice. D. Either party may terminate this Agreement immediately upon providing written notice to the other party in the event (i) the terminating party has a reasonable belief that the other party is not in compliance with applicable CGTP requirements or (ii) the other party has breached a material term of this Agreement. E. In the event of a termination of this Agreement, the provisions of Article I.C.6 (records retention) and Article IV ( Indemnification ) shall survive for a period of ten (10) years. ARTICLE IV INDEMNIFICATION A. GSN and SOURCE BANK agree to indemnify and hold each other and their respective affiliates, officers, directors, employees, and agents harmless against any and all damages, liabilities, losses, claims, diminution in value, obligations, liens, assessments, judgments, taxes, fines, penalties, reasonable costs and expenses (including, without limitation, reasonable fees of legal counsel representing the indemnified party), as the same are incurred, of any kind or Page 7 of 11

8 nature whatsoever (whether or not arising out of third-party claims and including all amounts paid in investigation, defense or settlement of the foregoing and consequential damages) which may be sustained or suffered by any such indemnified party based upon, arising out of, or by reason of for (a) any actual or alleged breach of such party s representations or obligations contained in this Agreement; (b) such party s breach of its obligations with respect to Article V; (c) the acts or omissions of any personnel performing any acts under this Agreement; (d) the acts or omissions of any of such party s subcontractors; and (e) any actual, alleged, threatened or potential violation or contravention of any laws by such party or their personnel. B. If any third party claim for which indemnity is, or may be, sought is made, or appears reasonably possible, the indemnified party agrees (a) promptly to notify the indemnifier in writing; (b) to cooperate with the indemnifier, and to allow the indemnifier sole authority to control the defense and settlement of such claim; provided, however, that (i) no settlement or compromise affecting the financial or legal obligations of the indemnified party shall be entered into or agreed to without the indemnified party s prior written approval (such approval not to be unreasonably withheld); and (ii) the indemnified party has the right to participate, at its own expense, in the defense and/or settlement of any such claim or action in order to protect its own interests. ARTICLE V INSURANCE GSN and SOURCE BANK each agree during the term of this Agreement to obtain and keep in effect, at its sole cost, comprehensive and liability insurance to cover performance of their respective obligations or an indemnification obligation under Article IV under the terms of this Agreement. Should either GSN or SOURCE BANK request copies of the insurance coverage, it shall be provided. ARTICLE VI ENTIRE AGREEMENT This contains the entire agreement between the parties and no statements, promises or inducements made by either GSN or SOURCE BANK or their agents that are not contained in this written contract shall be valid or binding. ARTICLE VII WAIVER No failure on the part of either party to exercise, and no delay in exercising, and no course of dealing with respect to, any right, power, or privilege under this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise of any right, power, or privilege under this Agreement preclude any other or further exercise thereof or the exercise of any other right, power, or privilege, ARTICLE VIII AMENDMENTS Page 8 of 11

9 No provision of this Agreement may be modified or supplemented, except by an instrument in writing signed by GSN and SOURCE EYE BANK. ARTICLE IX ASSIGNMENT This Agreement shall insure to the benefit and be binding on the parties, their assignees and successors. GSN and SOURCE BANK agree to provide the other party with written notice of any such assignment at least thirty (30) days prior to such assignment; the written consent of the other party, which shall not be unreasonably withheld, is required prior to such assignment. ARTICLE X SEVERABILITY In the event any provision of this Agreement is held to be invalid or unenforceable, the valid or enforceable portion thereof and the remaining provisions of this Agreement will remain in full force and effect. ARTICLE XI NOTICES Any and all notices or other communications required or permitted under this Agreement must be in written form, and be deemed to have been given upon receipt of facsimile or to the notified party (followed by hard copy of document) addressed to: GSN: Global Sight Network Doyce V. Williams, President 500 Robert Jemison Road Birmingham, Alabama SOURCE BANK: Insert contact and address ARTICLE XII- HEADINGS The Article headings appearing herein are included only for the convenience of reference and are not intended to affect the interpretation of any provision of this Agreement. ARTICLE XIII GOVERNING LAW This Agreement will be governed and construed in accordance with the laws of the State of Alabama. IN WITNESS WHEREOF the parties have executed this Agreement this day of, {year}. Page 9 of 11

10 GLOBAL SIGHT NETWORK SOURCE EYE BANK A Service of the Alabama Eye Bank An Alabama non-profit organization Birmingham, Alabama Page 10 of 11

11 Agreement for Processing Corneal (Ocular) Tissue Exhibit A GLYCEROL-PRESERVED CORNEA PROCESSING SERVICES AGREEMENT: SOURCE BANK and GLOBAL SIGHT NETWORK (GSN) SOURCE BANK agrees to pay GSN according to the following fee schedule: 1. $125 fee per cornea transferred to glycerol as two cornea halves, according to protocol. 2. Shipping charges If a change in the fee schedule is deemed necessary by GSN, the Source Eye Bank will be notified by GSN at least 30 days in advance. SOURCE BANK By: Name: Title: Date: GLOBAL SIGHT NETWORK By: Name: Doyce V. Williams Title: President and Chief Executive Officer Date: Page 11 of 11