RUCDR Infinite Biologics

Transcription

1 RUCDR Infinite Biologics Induced Pluripotent Stem (ips) Cell Material Transfer Agreement For For-Profit Entities For Research Use This Material Transfer Agreement ( AGREEMENT ), between REPOSITORY and REPOSITORY CUSTOMER as defined below (each a PARTY, jointly the PARTIES ), regarding a transfer for use is effective as of ( EFFECTIVE DATE ): The Parties agree to the following terms and conditions and hereby enter into this Agreement: I. Definitions: 1. REPOSITORY: RUCDR Infinite Biologics 2. REPOSITORY CUSTOMER: 3. REPOSITORY CUSTOMER SCIENTIST: 4. PROVIDER: Target ALS Foundation To clarify, Target ALS owns right title and interest to NCRM1-tdT, NCRM1-tdT VAChT-iCre, SalvaRED, FA tdT, HB9-Cre Corneo, SalvaGREEN, and 15ViCre Materials being shipped to RUCDR from Columbia University on behalf of the Target ALS program. 5. PROVIDER SCIENTIST: Dr. Neil Schneider, an employee of The Trustees Of Columbia In The City of New York, who is preparing Materials for shipping on behalf of the Target ALS program. In the event REPOSITORY CUSTOMER publishes information resulting from the use of any of the followingncrm1-tdt, NCRM1-tdT VAChT-iCre, SalvaRED, FA tdT, HB9-Cre Corneo, SalvaGREEN, and 15ViCre, REPOSITORY CUSTOMER shall additionally acknowledge the Columbia Stem Cell Core and its investigators, Dr. Barbara Corneo, Dr. Hynek Wichterle and Alejandro Garcia Diaz. 6. COMMERCIAL PURPOSES: The sale, lease, license, or transfer of a substance to a for-profit organization. COMMERCIAL PURPOSES shall RUCDR 1 of 9

2 also include uses of the substance by any organization to produce or manufacture products for general sale, or to conduct research activities that result in any sale, lease, license, or transfer of the substance to a forprofit organization. For clarity, industrially sponsored research performed by an academic, government or not-for-profit entity in such entity s own laboratories shall not be considered use of the substance for COMMERCIAL PURPOSES. 7. INDUCED PLURIPOTENT STEM CELLS ( ips CELLS ): Human cells (such as skin cells or lymphoblasts) reprogrammed to, and stably maintained in, a primordial state over a prolonged period of time and multiple cell divisions without differentiating, and which are capable of developing into cells and tissues of the three primary germ layers (endoderm, ectoderm and mesoderm). 8. MATERIAL(S): MATERIAL, PROGENY, and UNMODIFIED DERIVATIVES; the ownership is retained by PROVIDER. 9. MODIFIED DERIVATIVES: Substances that are not intact cells and that REPOSITORY CUSTOMER has isolated or derived from NON- PLURIPOTENT MODIFICATIONS or PLURIPOTENT MODIFICATIONS and that are not UNMODIFIED DERIVATIVES. 10. NON-PLURIPOTENT MODIFICATIONS: Cells that are created by the REPOSITORY CUSTOMER from MATERIAL, PROGENY or PLURIPOTENT MODIFICATIONS, but only if such cells are NOT capable of responding to extrinsically acting cues (such as growth factors, changing media conditions, and other similar cues) to differentiate into various cell types from each of the three primary germ layers (endoderm, ectoderm, mesoderm). For clarity, NON- PLURIPOTENT MODIFICATIONS may be multipotent, restricted progenitor cells, or may be terminally differentiated cells, but are NOT pluripotent. NON- PLURIPOTENT MODIFICATIONS may or may not have been manipulated by the REPOSITORY CUSTOMER in the manner described in the definition of PLURIPOTENT MODIFICATIONS. 11. ORIGINAL MATERIAL(S): The ips CELLS of PROVIDER for distribution by the REPOSITORY to the REPOSITORY CUSTOMER, as described in Appendix ONE. 12. PLURIPOTENT MODIFICATIONS: ips CELLS that are created by the REPOSITORY CUSTOMER from MATERIAL or PROGENY. PLURIPOTENT MODIFICATIONS differ from MATERIAL and PROGENY as a result of a manipulation (genetic or otherwise) to the MATERIAL or PROGENY performed by the REPOSITORY CUSTOMER. Some examples of such genetic manipulations include: integration of a reporter gene, or correction of a genetic defect of the MATERIAL. For clarity, PLURIPOTENT MODIFICATIONS are capable of self-renewal in culture and of responding to extrinsically acting cues (such as growth factors, changing media conditions, and other similar cues) to differentiate into various cell types from each of the three primary germ layers (endoderm, ectoderm, mesoderm). RUCDR 2 of 9

3 II. USE 13. PROGENY: Unmodified descendant ips CELLS from the MATERIAL. PROGENY retain the ability to self-replicate and the ability to differentiate into cell types from the three primary germ layers (endoderm, ectoderm, mesoderm). 14. THIRD PARTY or THIRD PARTIES: With the exception of Provider, any person or entity that is not a PARTY to this AGREEMENT and is not a REPOSITORY CUSTOMER. 15. UNMODIFIED DERIVATIVES: Substances that are not intact cells and that REPOSITORY CUSTOMER either: (a) isolated or derived from MATERIAL, PROGENY or other UNMODIFIED DERIVATIVES or (b) isolated or derived from NON-PLURIPOTENT MODIFICATIONS, PLURIPOTENT MODIFICATIONS or MODIFIED DERIVATIVES that are indistinguishable from substances that could have been isolated or derived from MATERIAL, PROGENY or other UNMODIFIED DERIVATIVES. 1. The REPOSITORY CUSTOMER agrees that the MATERIAL: (a) will not be used in human subjects, or administered to human subjects in clinical trials, or for diagnostic purposes involving human subjects without the prior written consent of PROVIDER; (b) will be used only in compliance with applicable laws and regulations, and in compliance with REPOSITORY CUSTOMER s applicable policies on human subject research; (c) will, in the case of entities receiving funding from agencies of the United States to conduct human stem cell research, be used only in compliance with applicable National Institutes of Health Guidelines on Human Stem Cell Research: (d) will not be used in research in which the MATERIALS are introduced into nonhuman primate blastocysts; (e) will not be used in research involving the breeding of animals where the introduction of the MATERIALS may contribute to the germ line; and (f) is subject to the additional terms and conditions in Appendix TWO attached hereto. 2. The REPOSITORY CUSTOMER acknowledges that the MATERIAL may be the subject of a patent application or covered by patent rights in one or more countries. Except as provided in this Agreement, no express or implied licenses to such patent rights are provided. Unless specifically indicated, no license or right to use any third party patent, technology or intellectual property is conveyed to REPOSITORY CUSTOMER under this Agreement. It is the sole responsibility of the REPOSITORY CUSTOMER to obtain from third parties that may have a proprietary interest in the MATERIAL, or modification or derivatives thereof, any permissions necessary that are consistent with REPOSITORY CUSTOMER s intended use of the MATERIAL, modifications or derivatives. 3. The REPOSITORY CUSTOMER AND REPOSITORY CUSTOMER RUCDR 3 of 9

4 SCIENTIST agree that the MATERIAL: (i) is to be used only at the REPOSITORY CUSTOMER organization and only in the REPOSITORY CUSTOMER SCIENTIST S laboratory under the direction of the REPOSITORY CUSTOMER SCIENTIST or others working under his/her direct supervision; and (ii) will not be transferred to anyone else without REPOSITORY S prior written consent, provided however, the MATERIAL may be used by service providers and/or research collaborators under contract to conduct research and development on behalf of Repository Customer. 4. REPOSITORY CUSTOMER shall have the right to nonexclusively distribute PLURIPOTENT MODIFICATIONS, subject to Appendix TWO and Appendix THREE restrictions, if any, and the following terms: (a) In the event that REPOSITORY CUSTOMER desires to enter into negotiations to provide or license to a PLURIPOTENT MODIFICATION to a THIRD PARTY for COMMERCIAL PURPOSES, REPOSITORY CUSTOMER will first notify the THIRD PARTY of PROVIDER s ownership of MATERIALS that are contained or incorporated within the PLURIPOTENT MODIFICATION. REPOSITORY CUSTOMER s h a l l s e n d T HI R D P A RT Y t o P R O VI D E R t o d i s c u s s a c o m m e r c i a l l i c e n s e. It is recognized by the REPOSITORY CUSTOMER that such COMMERCIAL PURPOSES may require a license from PROVIDER, who has no obligation to grant a license to any ownership interest in MATERIAL incorporated in the PLURIPOTENT MODIFICATION. 5. Except for any PROVIDER or THIRD PARTY such as but not limited to those rights stated in Appendix TWO, and Appendix THREE and any express labels shipped with Material(s) notifying REPOSITORY CUSTOMERS of rights owned by THIRD PARTIES such as Takara to contact them for a commercial license, the REPOSITORY CUSTOMER will own and may freely distribute for research purposes: (a) NON-PLURIPOTENT MODIFICATIONS, (b) MODIFIED DERIVATIVES, and (c) those substances created through the use of the MATERIAL, MODIFIED DERIVATIVES, NON-PLURIPOTENT MODIFICATIONS or PLURIPOTENT MODIFICATIONS, but which are not PROGENY or UNMODIFIED DERIVATIVES. REPOSITORY CUSTOMER may transfer the substances described in (a) through (b) (c) of this article, and sufficient rights to use them, to other academic and governmental research institutions for their internal research purposes at nominal cost, which is solely intended to reimburse the REPOSITORY CUSTOMER for the reasonable expenses REPOSITORY CUSTOMER incurred in producing, storing and shipping such substances, and will implement arrangements to effect such transfers. 6. REPOSITORY does not have access to, and will not provide REPOSITORY CUSTOMER with personally identifiable information or the key code to personally identifiable information that is coded related to the MATERIAL. REPOSITORY CUSTOMER and REPOSITORY CUSTOMER SCIENTIST agree not to attempt to identify or contact the human donor from whom the MATERIAL was or may have been derived. RUCDR 4 of 9

5 III. MISCELLANSOUS 1. Any MATERIAL delivered pursuant to this Agreement is provided as is and is understood to be experimental in nature and may have hazardous properties and its use may require acquisition of rights from THIRD PARTIES. The REPOSITORY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF THE MATERIAL, ITS SOURCE, MERCHANTABILITY, TRANSFER OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT,TRADEMARK, OR OTHER PROPRIETARY RIGHTS. 2. REPOSITORY CUSTOMER hereby agrees to defend, to hold harmless and to indemnify PROVIDER, REPOSITORY, and THIRD PARTY s who own rights to Material(s) against any claim arising from the REPOSITORY CUSTOMER's receipt, storage, disposition and/or use of the MATERIAL 3. This Agreement shall not be interpreted to prevent or delay publication or oral presentation of research findings resulting from the use of the MATERIAL. The REPOSITORY CUSTOMER SCIENTIST agrees that appropriate acknowledgement of the source of the MATERIAL from PROVIDER and PROVIDER SCIENTIST will be provided in all publications or oral presentation of such research findings. 4. Prohibition Against Use of Name. With the exception of the requirements of section 3, REPOSITORY CUSTOMER and/or REPOSITORY CUSTOMER SCIENTIST shalll not use the name, insignia, or symbols of PROVIDER OR PROVIDER SCIENTIST OR REPOSITORY, its faculties or departments, or any variation or combination thereof, or the name of any trustee, faculty member, other employee, or student of that Party for any purpose whatsoever without prior written consent. SIGNATURES BEGIN ON THE NEXT PAGE. RUCDR 5 of 9

6 FOR REPOSITORY CUSTOMER: The Authorizing Official signing this Agreement on behalf of the REPOSITORY CUSTOMER certifies and affirms that he or she has the authority to do so. Authorized Official: [Name] [Title] [Institution] Date Address: I, Repository Customer Scientist have read and understand the terms of this agreement. Repository Customer Scientist Name and Title and Date FOR REPOSITORY: The Authorizing Official signing this Agreement on behalf of the REPOSITORY certifies and affirms that he or she has the authority to do so. Authorized Official: 9/20/18 Jennifer C. Moore Director Stem Cell Services and Technologies RUCDR 145 Bevier Rd, Piscataway Township, NJ Date RUCDR 6 of 9

7 Appendix ONE Detailed Description of MATERIAL PROVIDED TO REPOSITORY CUSTOMER [Article II.6] List of ipsc lines transferred under this Agreement: Name or Designation Description ipsc Reprogramming Method Starting Material RUCDR 7 of 9

8 Appendix TWO Summary of Use and Re-distribution Restrictions and Additional Terms and Conditions for Repository Customer s Use [Articles III.1(f), III.3, III.4, III.5] MATERIAL, PROGENY, and UNMODIFIED DERIVATIVES PLURIPOTENT MODIFICATIONS NON- PLURIPOTENT MODIFICATIONS MODIFIED DERIVATIVES USE BY RC IS SUBJECT TO THE OTHER ADDITIONAL TERMS BELOW x x x x RC may use the Material under RC Scientist direct supervision, only for noncommercial use, at its nonprofit organization or government agency. RC may not transfer within RC s nonprofit organizations or government agency for noncommercial use. RC may not use for COMMERCIAL PURPOSE and may not or redistribute to any THIRD PARTY for COMMERCIAL PURPOSES. x x x x Re-distribution by RC requires RC notice to the THIRD PARTY of terms associated with use of Cytotune IPS Sendai Reprogramming Kit adfa 3th X x x x RUCDR 8 of 9

9 A license with Provider is required for all use and transfer to a commercial entity or for a Third Party s commercial use. X x x x Before RC re-distributing to a Third Party for Commercial Purpose, Third Party must obtain permission from Repository, which may require Third Party to execute a license with Provider. X x x x RC may transfer Material to service providers and / or research collaborators under contract, to conduct research and development on behalf of RC, only in accord with Section III/ Paragraph 3. X RUCDR 8 of 9

10 Appendix THREE Cytotune - ips Sendai Reprogramming Kit License Terms for Repository Customer s use of MATERIAL Non-For-Profit Institutions Non-for-profit entities may use the intellectual properties without payment solely for research and educational purposes, provided that any sort of commercial purposes are not involved. This, however, does not mean a grant of license. Further, it is prohibited to provide for-profit entities with ips cells or their derivatives without prior written consent of ips Academia Japan, Inc. For-Profit Entities For Profit entities must have the appropriate license for use from ips Academia Japan, Inc or DNAVEC. The information below lists contact details for obtaining a license from ips Academia Japan, Inc. ips Academia Japan, Inc Licensing Inquiry Phone: Fax: Licensing Inquiry license@ips-ac.co.jp RUCDR 9 of 9