RUCDR Infinite Biologics

Transcription

1 RUCDR Infinite Biologics ips DISTRIBUTION MATERIAL TRANSFER AGREEMENT For use by REPOSITORY to Transfer CRM ips CELLS to REPOSITORY CUSTOMERS [Articles 1.3, 3.5] Induced Pluripotent Stem (ips) Cell Material Transfer Agreement I. 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 ): 1. REPOSITORY: RUCDR Infinite Biologics 2. REPOSITORY CUSTOMER: 3. REPOSITORY CUSTOMER SCIENTIST: II. Definitions: 1. COMMERCIAL PURPOSES: The sale, lease, license, or transfer of a substance to a for-profit organization. COMMERCIAL PURPOSES shall 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 for-profit organization. For clarity, industrially sponsored research performed by an academic, government or notfor-profit entity in such entity s own laboratories shall not be considered use of the substance for COMMERCIAL PURPOSES. 2. 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). 3. MATERIAL(S): ORIGINAL MATERIAL, PROGENY, and UNMODIFIED DERIVATIVES. 4. 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. 5. NIH CENTER FOR REGENERATIVE MEDICINE ( NIH-CRM ), a trans-nih initiative administratively housed within the National Institute of Arthritis and Musculoskeletal and Skin Diseases and located in Bethesda, MD. Rutgers Infinite Biologics 145 Bevier Road Piscataway NJ Tel: Fax: RUCDR 1 of 10

2 6. NON-PLURIPOTENT MODIFICATIONS: Cells that are created by the REPOSITORY CUSTOMER from ORIGINAL 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. 7. ORIGINAL MATERIAL(S): The ips CELLS provided by the REPOSITORY to the REPOSITORY CUSTOMER, as described in Appendix ONE. 8. PLURIPOTENT MODIFICATIONS: ips CELLS that are created by the REPOSITORY CUSTOMER from ORIGINAL MATERIAL or PROGENY. PLURIPOTENT MODIFICATIONS differ from ORIGINAL MATERIAL and PROGENY as a result of a manipulation (genetic or otherwise) to the ORIGINAL 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 ORIGINAL 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). 9. PROGENY: Unmodified descendant ips CELLS from the ORIGINAL 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). 10. THIRD PARTY or THIRD PARTIES: Any person or entity that is not a PARTY to this AGREEMENT and is not a REPOSITORY CUSTOMER. 11. UNMODIFIED DERIVATIVES: Substances that are not intact cells and that REPOSITORY CUSTOMER either: (a) isolated or derived from ORIGINAL 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 ORIGINAL MATERIAL, PROGENY or other UNMODIFIED DERIVATIVES. III. Terms and Conditions of this Agreement: 1. The REPOSITORY CUSTOMER agrees that the MATERIAL: RUCDR 2 of 10

3 (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 written consent of the NIH-CRM; (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 ORIGINAL 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 ORIGINAL MATERIAL, or modification or derivatives thereof, any permissions necessary that are consistent with REPOSITORY CUSTOMER s intended use of the ORIGINAL MATERIAL, modifications or derivatives. 3. The REPOSITORY CUSTOMER may NOT transfer ORIGINAL MATERIAL or PROGENY to other non-profit, commercial or governmental parties for their internal non-commercial or commercial research purposes without written permission of the REPOSITORY. 4. REPOSITORY CUSTOMER shall have the right to nonexclusively distribute PLURIPOTENT MODIFICATIONS, subject to Appendix TWO restrictions, if any, and the following term: (a) In the event that REPOSITORY CUSTOMER enters into negotiations to provide or license a PLURIPOTENT MODIFICATION to a THIRD PARTY for COMMERCIAL PURPOSES, then REPOSITORY CUSTOMER will notify that THIRD PARTY of NIH-CRM s ownership of MATERIALS that RUCDR 3 of 10

4 are contained or incorporated within the PLURIPOTENT MODIFICATION. It is recognized by the REPOSITORY CUSTOMER that such COMMERCIAL PURPOSES may require a license from NIH-CRM, who has no obligation to grant a license to any ownership interest in MATERIAL incorporated in the PLURIPOTENT MODIFICATION. 5. Except for any NIH-CRM or THIRD PARTY rights that may exist by virtue of Appendix TWO, the REPOSITORY CUSTOMER will own and may freely distribute: (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 (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 ORIGINAL MATERIAL was or may have been derived. 7. Any MATERIAL delivered pursuant to this Agreement 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. RUCDR 4 of 10

5 8. Except to the extent prohibited by law and except for U.S. Government and State agencies (which may not agree to an indemnification obligation), the REPOSITORY CUSTOMER hereby agrees to hold harmless and indemnify NIH-CRM and REPOSITORY against any claim arising from the REPOSITORY CUSTOMER s receipt, storage, disposition and/or use of the MATERIAL, including patent infringement. 9. 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 will be provided in all publications or oral presentation of such research findings. SIGNATURES BEGIN ON THE NEXT PAGE. RUCDR 5 of 10

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 have read and understand the terms of this agreement. 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: [Name] [Title] [Institution] Date Address: I have read and understand the terms of this agreement. Date RUCDR 6 of 10

7 Appendix ONE Detailed Description of ORIGINAL MATERIAL PROVIDED TO REPOSITORY CUSTOMER [Article II.6] List of ipsc lines transferred under this Agreement: # Name or Designation Description 1 NCRM-5 ipsc control ipsc Reprogramming Method Episomal plasmid Starting Material CD34+ cord blood (Attach info sheet for each ips cell line including source and IRB-approved Protocol #, if applicable.) RUCDR 7 of 10

8 Appendix TWO Summary of Use and Re-distribution Restrictions and Additional Terms and Conditions for RECIPIENT s Use of MATERIALS [Articles III.1(f), III.3, III.4, III.5] ORIGINAL MATERIAL, PROGENY, and UNMODIFIED DERIVATIVES PLURIPOTENT MODIFICATIONS NON- PLURIPOTENT MODIFICATIONS MODIFIED DERIVATIVES Use by RECIPIENT is subject to the other additional terms below. RECIPIENT may not use or redistribute to THIRD PARTIES for COMMERCIAL PURPOSES. Re-distribution by RECIPIENT requires notice to the THIRD PARTY of applicable restrictions. 1 Before re-distributing to a THIRD PARTY for COMMERCIAL PURPOSES, THIRD PARTY must obtain permission from NIH, which may require THIRD PARTY to execute a license with NIH. 1 Note: except as expressly modified by the provisions of this Appendix TWO, use or distribution by RECIPIENT is subject to the restrictions set forth in Article III.1 (a)-(f) and distribution to THIRD PARTIES shall be accompanied by notice of the restrictions on use set forth in Article III.1(a)-(f). Other additional terms and conditions: If this box is checked, MATERIAL is derived from human samples collected under a protocol approved and overseen by an NIH intramural IRB (or else was subject to an exemption by the NIH Office of Human Subjects Research) and NIH-CRM will not provide RECIPIENT with personally identifiable information or the code to personally identifiable information. RUCDR 8 of 10

9 Notification to RECIPIENT (internal research) Definitions: LONZA: Lonza Walkersville, Inc. and any of its affiliates. CLIENT: The person or entity purchasing MATERIAL from LONZA. RECIPIENT: CLIENT and/or any party receiving the MATERIAL or ALTERED CELLS either directly or indirectly from CLIENT. MATERIAL: Pluripotent cells, derivatives of pluripotent cells, genetic modifications of pluripotent cells, partially-differentiated cells, and terminally-differentiated cells. ALTERED CELLS: Changes made to the MATERIAL made only by a RECIPIENT. COMMERCIAL PURPOSES: The sale, lease, license, or other transfer of MATERIAL or ALTERED CELLS to a for-profit organization. COMMERCIAL PURPOSES shall also include uses of MATERIAL or ALTERED CELLS by a for-profit organization, to perform contract research, to perform screening of compound libraries to produce or manufacture products for general sale, or to conduct research activities that result in any sale, lease, license, or transfer of MATERIAL or ALTERED CELLS. However, industrially sponsored academic research shall not be considered a use of MATERIAL or ALTERED CELLS for COMMERCIAL PURPOSES per se, unless any of the above conditions of this definition are met. NOR WILL SENDING THE MATERIAL OR ALTERED CELLS TO A FOR-PROFIT ORGANIZATION TO PERFORM SERVICES ON BEHALF OF THE RECIPIENT SUCH AS KARYOTYPING, HYBRIDIZATION, ARRAY AND GENOME ANALYSIS UNLESS THE ABOVE CONDITIONS ARE MET. 1. RECIPIENT shall have the right, without restriction, to distribute MATERIAL or ALTERED CELLS to academic organizations or to academic core laboratories for their internal non-commercial purpose only, which may include generation of data. RECIPIENT may also distribute MATERIAL or ALTERED CELLS to for-profit organizations under appropriate license from any third party(ies) required for such distribution. 2. RECIPIENT shall acknowledge that the MATERIAL and ALTERED CELLS is or may be the subject of an issued patent or pending patent application. Except as provided in this Notification, no express or implied licenses or other rights are provided to RECIPIENT under any patents, patent applications, trade secrets, licenses or other proprietary rights( INTELLECTUAL PROPERTY ) of LONZA, or any third parties, including any altered forms of the MATERIAL made by LONZA. In particular, no express or implied licenses or other rights are provided to use the MATERIAL, or any related patents of LONZA, or any third parties, for COMMERCIAL PURPOSES. 3. If RECIPIENT desires to use or license the MATERIAL or ALTERED CELLS for COMMERCIAL PURPOSES, RECIPIENT agrees, in advance of such use, to negotiate in good faith with parties holding applicable intellectual property rights to establish the terms of a commercial license. It is understood by RECIPIENT that LONZA or any third party shall have no obligation to grant such a license to RECIPIENT, and may grant exclusive or non-exclusive commercial licenses to others, or sell or assign all or part of the rights in the MATERIAL or ALTERED CELLS to any third party(ies), subject to any pre-existing rights held by others and obligations to the Federal Government. For clarity, any terminally-differentiated cells made and sold by LONZA may be used by RECIPIENT for COMMERCIAL PURPOSES. RUCDR 9 of 10

10 Nothing in this paragraph, however, shall prevent RECIPIENT from granting commercial licenses under RECIPIENT s intellectual property rights claiming ALTERED CELLS, or methods of their manufacture or their use. 4. Any MATERIAL and ALTERED CELLS delivered pursuant to this Notification is understood to be experimental in nature and may have hazardous properties. LONZA MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL AND ALTERED CELLS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. 5. Except to the extent prohibited by law, RECIPIENT assumes all liability for damages which may arise from its use, storage or disposal of the MATERIAL or ALTERED CELLS. LONZA will not be liable to RECIPIENT for any loss, claim or demand made by RECIPIENT, or made against RECIPIENT by any other party, due to or arising from the use of the MATERIAL or ALTERED CELLS by RECIPIENT, except to the extent permitted by law when caused by the gross negligence or willful misconduct of LONZA. 6. RECIPIENT agrees to use MATERIAL and ALTERED CELLS in compliance with all applicable statutes and regulations and agrees to notify RECIPIENT of same. For the removal of doubt, RECIPIENT shall not use MATERIAL and ALTERED CELLS for application and use for human/animal therapeutic, diagnostic and/or prophylactic purposes including but not limited to clinical applications, cell therapy, transplantation, and /or regenerative medicine without appropriate license. 7. RECIPIENT shall be required to convey a copy of this Notification to RECIPIENT to any person or party receiving MATERIAL or ALTERED CELLS from RECIPIENT. 8. LONZA has obtained its rights to manufacture the MATERIAL pursuant to a non-exclusive license agreement ( the AJ agreement ) with ips Academia Japan, Inc. ( AJ ). No rights, either express or implied, obtained by LONZA in the AJ agreement are provided to RECIPIENT to use the MATERIAL or ALTERED CELLS. 9. If RECIPIENT desires to use or license the MATERIAL or ALTERED CELLS for COMMERCIAL PURPOSES, RECIPIENT is not required to obtain further license or other rights from LONZA resulting from its manufacturing of the MATERIAL. Notwithstanding, the RECIPIENT is still required to meet the obligations of any other party (which may include AJ) provided for in this notification for use of the MATERIAL or ALTERED CELLS for COMMERCIAL PURPOSES. (as of August 2014) RUCDR 10 of 10