Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by LHI pursuant to any applicable Statement of Work, LHI will prepare the SOW Documentation for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI of any specific requirements CLIENT may have relating to the SOW Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI intends to include in the SOW Documentation the use of any assay, medium, or other technology that is not commercially available, LHI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch. 3.2 CLIENT will cooperate with LHI to assist LHI to develop the SOW Documentation and Process, including, without limitation, by providing LHI with additional information and procedures as may be required to create the SOW Documentation, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information. 3.3 LHI will deliver a draft version of the SOW Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 3.4 The Process, SOW Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI Operating Documents, LHI Inventions or LHI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Process, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which shall not be unreasonably withheld.
Appears in 2 contracts
Sources: Manufacturing Services Agreement (Vascular Biogenics Ltd.), Manufacturing Services Agreement (Vascular Biogenics Ltd.)
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by LHI LWI pursuant to any applicable Statement of Work, LHI LWI will prepare the SOW Documentation Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI LWI of any specific requirements CLIENT may have relating to the SOW DocumentationMaster Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI LWI intends to include in the SOW Documentation Master Production Record the use of any assay, medium, or other technology that is not commercially available, LHI LWI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI LWI to assist LHI LWI to develop the SOW Documentation Master Production Record and Process, including, without limitation, by providing LHI LWI with additional information and procedures as may be required to create the SOW DocumentationMaster Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI LWI will deliver a draft version of the SOW Documentation Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW DocumentationMaster Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation Master Production Record within fifteen ten (1510) working business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW DocumentationMaster Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI LWI Operating Documents, LHI Inventions New General Application Intellectual Property or LHI LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and Master Production Record to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation Master Production Record incorporates or contains any LHI LWI Background Intellectual Property or LHI Property, LWI Confidential Information that does not solely relate to Product or ProcessNew General Application Intellectual Property, then prior to any disclosure of such LHI LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client CLIENT shall obtain LHI prior approvalLWI’s written consent to such disclosure, which consent shall not be unreasonably withheld.
Appears in 2 contracts
Sources: Manufacturing Services Agreement, Manufacturing Services Agreement (Heat Biologics, Inc.)
Technology Transfer. 3.1 Based on (a) Sublicensee acknowledges and agrees that ECC has delivered and made to Sublicensee a disclosure of a general introduction to the Technology and to its commercial feasibility prior to the execution of this Agreement. Except to the extent such information provided falls within one or more of the exceptions to the definition of "Confidential Information", all information disclosed by CLIENT ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and including process changes developed shall be deemed to be confidential. The timing and extent of additional disclosure by LHI pursuant ECC to any applicable Statement of Work, LHI will prepare the SOW Documentation for the Process in accordance with the schedule Sublicensee shall be as set forth in the Statement of Work. CLIENT will inform LHI of any specific requirements CLIENT may have relating to the SOW Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI intends to include in the SOW Documentation the use of any assay, medium, or other technology that is not commercially available, LHI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batchsubparagraph 22(b) hereof.
3.2 CLIENT will cooperate with LHI to assist LHI to develop the SOW Documentation and Process, including, without limitation, by providing LHI with additional information and procedures as may be required to create the SOW Documentation, Process, and/or any of the following: (ib) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI will deliver a draft version of the SOW Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW Documentation, Specifications, and any improvements or modifications thereto developed during the term execution of this Agreement, but excluding any LHI Operating Documents, LHI Inventions or LHI Confidential Information included in any ECC shall provide Sublicensee with copies of the foregoingpatents listed in Section B of Exhibit "B" hereto. Beyond that, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Process, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which ECC shall not be unreasonably withheldrequired to provide additional information concerning, or disclosure of, the Technology to Sublicensee until Sublicensee provides to ECC (i) written notice of Sublicensee's intent to commercialize a Product, which written notice shall include detailed specifications for the designated Product, and (ii) evidence, reasonably satisfactory to ECC, of Sublicensee's intent to commercialize the designated Product in the form of written documentation of orders placed by Sublicensee of the equipment needed by Sublicensee to produce and commercialize the designated Product or in the form of written documentation from Sublicensee confirming the dedication and/or modification of existing equipment necessary to produce the designated Product. Within ninety (90) days after ECC's receipt of the items described in the preceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (w) a Product specific recipe for the production of the designated Product; (x) Product specific process specifications for the production of the designated Product; (y) copies of all patent applications listed in the Exhibits hereto that ECC deems relevant to the production of the designated Product; and (z) a list of known raw materials suppliers and preferred equipment vendors.
Appears in 2 contracts
Sources: Sublicense Agreement (Earthshell Container Corp), Sublicense Agreement (Earthshell Container Corp)
Technology Transfer. 3.1 Based on (a) As promptly as possible but no later than [***], Micromet will identify to MedImmune a contract manufacturing organization that will manufacture Licensed Product for Micromet. Subject to such contract manufacturing organization executing an agreement pursuant to Section 5.4, MedImmune will provide Micromet and such identified manufacturer (to the information extent not previously provided by CLIENT MedImmune) with the Know-How in its possession as of the Effective Date that is MedImmune Process Technology, which includes, but is not limited to, and in each case that exists as of the Effective Date, technical reports and materials for process development activities that are relevant to and would be required for Micromet or its contract manufacturing organization to perform such Manufacturing Process (including but not limited to any master cell banks, working cell banks, fermentation processes, recovery steps established, process changes developed validation, product identity assays, in-process-control assays, relevant standard operating procedures, as well as samples of the working cell bank prepared at MedImmune, and technical methods for assays required for the applicable process. For clarity, all Know-How within MedImmune Process Technology in tangible form (except for biological, chemical, or physical materials) to be provided under this Section 5.1(a) are listed in Exhibit E-3. In addition, MedImmune will have the right to redact the documents to the extent they contain information that is not related to Manufacturing Process or information related to the recipe of Media Materials.
(b) Promptly after the Effective Date, the MedImmune Project Manager, his counterpart at Micromet, and other appropriate personnel of MedImmune and Micromet will meet to establish a plan for the transfer of the Manufacturing Process and the MedImmune Process Technology as is reasonable and customary in the industry for the transfer of manufacturing processes and designed to complete the transfer of the Manufacturing Process and the MedImmune Process Technology within the timeframe set forth in subsection (c) below (the “Transfer Plan”), which Transfer Plan will be deemed part of this Agreement and incorporated herein by LHI reference. Within [***]([***])[***] from the date on which MedImmune is informed of the contract manufacturing organization (“CMO”) selected by Micromet for the manufacture of the Licensed Product, MedImmune will make appropriate personnel available to meet with the CMO to initiate such process transfer. *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(c) MedImmune will use commercially reasonable efforts to complete transfer of the Manufacturing Process and the MedImmune Process Technology to such manufacturer within [***]([***])[***] from that first meeting. Such timelines will be extended for delays that are reasonably outside the control of MedImmune, including but not limited to delays related to the performance of Micromet, its contract manufacturer, or licensees. Upon completion of the transfer of the Manufacturing Process and the MedImmune Process Technology, MedImmune will not have any applicable Statement further obligations to provide additional MedImmune Process Technology to Micromet or its manufacturer.
(d) MedImmune's obligation with respect to the Manufacturing Process and the MedImmune Process Technology is limited to transfer of Work, LHI will prepare the SOW Documentation for the Manufacturing Process Technology in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI of any specific requirements CLIENT may have relating this Section 5.1 and providing consulting services pursuant to the SOW Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI intends to include in the SOW Documentation the use of any assay, medium, or other technology that is not commercially available, LHI will inform CLIENT of such intention Section 5.6 and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI to assist LHI to develop the SOW Documentation and Process, including, without limitation, by providing LHI with additional information and procedures as may be required to create the SOW Documentation, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI will deliver a draft version of the SOW Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Documentation, or in the event that CLIENT MedImmune does not submit a written notice setting forth CLIENT’s objections to covenant, warrant or represent that the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI Operating Documents, LHI Inventions or LHI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Manufacturing Process and/or the SOW Documentation MedImmune Process Technology when used by or on behalf of Micromet or its sublicensees will be suitable for any research or commercial purpose solely related producing Clinical Materials and/or Licensed Product. *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Product or Process Securities Exchange Act of 1934, as amended. Under 17 C.F.R. §§ 200.80(b)(4), and to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Process, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which shall not be unreasonably withheld.240.24b-2
Appears in 1 contract
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process definition or changes developed by LHI LONZA pursuant to any applicable Statement of Work, LHI LONZA will [***] prepare the SOW Project Documentation for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI LONZA of any specific requirements CLIENT may have relating to the SOW Project Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein[***]. If LHI intends to include [***], LONZA will [***]. The applicable Project Documentation, as set forth in the SOW Documentation the use of any assaySOW, medium, or other technology that is not commercially available, LHI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI LONZA to CLIENT at completion of a Batch.
3.2 CLIENT will cooperate with LHI LONZA to assist LHI LONZA to develop the SOW Project Documentation and Process, including, without limitation, by providing LHI LONZA with additional information and procedures as may be required to create the SOW Project Documentation, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI LONZA will deliver a draft version of the SOW applicable portions of the Project Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI LONZA in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI LONZA and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Project Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENT[***], such draft will be deemed approved by CLIENT.
3.4 The Process, SOW Project Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI LONZA Operating Documents, LHI LONZA Inventions existing on or LHI prior to the Effective Date, or LONZA Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2Subject to Article 11, CLIENT shall be permitted the sole owner of each Process developed by the Parties hereunder and shall be free to use the Process and/or the SOW Project Documentation either alone or with or for the benefit of any research or commercial purpose solely related to the Product or Process Third Party and to manufacture transfer or license the Process to any Third Party manufacturer(s), without any restrictions, payments or other obligations owed to LONZA, to use, manufacture, have manufactured and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Project Documentation incorporates or contains any LHI LONZA Background Intellectual Property or LHI LONZA Confidential Information that does not solely relate to Product or Processas agreed by the Parties under Section 3.1, then prior to any disclosure of such LHI LONZA Background Intellectual Property or LHI LONZA Confidential Information to, or use by, a Third Party manufacturer, Client CLIENT shall obtain LHI prior approval, which shall not be unreasonably withheldLONZA’s written consent to such disclosure.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Affinia Therapeutics Inc.)
Technology Transfer. 3.1 Based on (a) Sublicensee acknowledges and agrees that ECC has delivered and made to Sublicensee a disclosure of a general introduction to the Technology and to its commercial feasibility prior to the execution of this Agreement. Except to the extent such information provided falls within one or more of the exceptions to the definition of "Confidential Information", all information disclosed by CLIENT ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and including process changes developed shall be deemed to be confidential. The timing and extent of additional disclosure by LHI pursuant ECC to any applicable Statement of Work, LHI will prepare the SOW Documentation for the Process in accordance with the schedule Sublicensee shall be as set forth in the Statement of Work. CLIENT will inform LHI of any specific requirements CLIENT may have relating to the SOW Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI intends to include in the SOW Documentation the use of any assay, medium, or other technology that is not commercially available, LHI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batchsubparagraph 22(b) hereof.
3.2 CLIENT will cooperate with LHI to assist LHI to develop the SOW Documentation and Process, including, without limitation, by providing LHI with additional information and procedures as may be required to create the SOW Documentation, Process, and/or any of the following: (ib) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI will deliver a draft version of the SOW Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW Documentation, Specifications, and any improvements or modifications thereto developed during the term execution of this Agreement, but excluding any LHI Operating Documents, LHI Inventions or LHI Confidential Information included in any ECC shall provide Sublicensee with copies of the foregoingpatents listed in Section B of Exhibit "B" hereto. Beyond that, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Process, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which ECC shall not be unreasonably withheldrequired to provide additional information concerning, or disclosure of the Technology to Sublicensee until Sublicensee provides to ECC (i) written notice of Sublicensee's intent to commercialize a Product, which written notice shall include detailed specifications for the designated Product, and (ii) evidence, reasonably satisfactory to ECC, of Sublicensee's intent to commercialize the designated Product in the form of written documentation of orders placed by Sublicensee of the equipment needed by Sublicensee to produce and commercialize the designated Product or in the form of written documentation from Sublicensee confirming the dedication and/or modification of existing equipment necessary to produce the designated Product. Within ninety (90) days after ECC's receipt of the items described in the preceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (w) a Product specific recipe for the production of the designated Product; (x) Product specific process specifications for the production of the designated Product; (y) copies of all patent applications listed in the Exhibits hereto that ECC deems relevant to the production of the designated Product; and (z) a list of known raw materials suppliers and preferred equipment vendors.
Appears in 1 contract
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by LHI L WI pursuant to any applicable Statement of Work, LHI L WI will prepare the SOW Documentation Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI L WI of any specific requirements CLIENT may have relating to the SOW DocumentationMaster Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI LWI intends to include in the SOW Documentation Master Production Record the use of any assay, medium, or other technology that is not commercially available, LHI L WI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI L WI to assist LHI L WI to develop the SOW Documentation Master Production Record and Process, including, without limitation, by providing LHI L WI with additional information and procedures as may be required to create the SOW DocumentationMaster Production Record, Process, and/or ancl/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI L WI will deliver a draft version of the SOW Documentation Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI L WI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s 's written acceptance of the draft SOW DocumentationMaster Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s 's objections to the draft SOW Documentation Master Production Record within fifteen ten (1510) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW DocumentationMaster Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI L WI Operating Documents, LHI L WI Inventions or LHI L WI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject subj ect to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or ancl/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and Master Production Record to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation Master Production Record incorporates or contains any LHI L WI Intellectual Property or LHI L WI Confidential Information that does not solely relate to Product or ProcessInformation, then prior to any disclosure of such LHI LWI Intellectual Property or LHI L WI Confidential Information to, or use by, a Third Party manufacturer, Client CLIENT shall obtain LHI prior approval, which shall not be unreasonably withheldL WI's written consent to such disclosure. * Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment and those portions have been filed separately with the Securities and Exchange Commission.
Appears in 1 contract
Sources: Know How License and Stock Purchase Agreement (Regenicin, Inc.)
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by LHI LWI pursuant to any applicable Statement of Work, LHI LWI will prepare the SOW Documentation Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI LWI of any specific requirements CLIENT may have relating to the SOW DocumentationMaster Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI LWI intends to include in the SOW Documentation Master Production Record the use of any assay, medium, or other technology that is not commercially available, LHI LWI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and delivered by LHI at completion Exchange Commission pursuant to Rule 406 of a Batchthe Securities Act of 1933, as amended.
3.2 CLIENT will cooperate with LHI LWI to assist LHI LWI to develop the SOW Documentation Master Production Record and Process, including, without limitation, by providing LHI LWI with additional information and procedures as may be required to create the SOW DocumentationMaster Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI LWI will deliver a draft version of the SOW Documentation Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI LWI and CLIENT will meet promptly (whether in person or by teleconference) to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW DocumentationMaster Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation Master Production Record within fifteen (15) working [*] days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW DocumentationMaster Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI LWI Operating Documents, LHI LWI Inventions or LHI LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating [*].
3.5 Any subsequent transfer of documentation, specifications, and production process [*] from Section 11.2.2LWI’s facility in Walkersville, CLIENT Maryland to another Facility for the manufacturing of the Product [*] shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product, either alone or by a Third Party on its behalf[*]; provided, however, that if any such transfer [*], shall be [*]. For the Process and/or avoidance of doubt, in the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Processevent a subsequent transfer is [required for commercial manufacturing purposes], then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which shall not be unreasonably withheldthe Parties will [*].
Appears in 1 contract
Sources: Manufacturing Services Agreement (Gamida Cell Ltd.)
Technology Transfer. 3.1 Based on (a) As promptly as possible but no later than [***], Micromet will identify to MedImmune a contract manufacturing organization that will manufacture Licensed Product for Micromet. Subject to such contract manufacturing organization executing an agreement pursuant to Section 5.4, MedImmune will provide Micromet and such identified manufacturer (to the information extent not previously provided by CLIENT MedImmune) with the Know-How in its possession as of the Effective Date that is MedImmune Process Technology, which includes, but is not limited to, and in each case that exists as of the Effective Date, technical reports and materials for process development activities that are relevant to and would be required for Micromet or its contract manufacturing organization to perform such Manufacturing Process (including but not limited to any master cell banks, working cell banks, fermentation processes, recovery steps established, process changes developed validation, product identity assays, in-process-control assays, relevant standard operating procedures, as well as samples of the working cell bank prepared at MedImmune, and technical methods for assays required for the applicable process. For clarity, all Know-How within MedImmune Process Technology in tangible form (except for biological, chemical, or physical materials) to be provided under this Section 5.1(a) are listed in Exhibit E-3. In addition, MedImmune will have the right to redact the documents to the extent they contain information that is not related to Manufacturing Process or information related to the recipe of Media Materials. *** Certain confidential information contained in this document, marked by LHI brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to any applicable Statement Rule 24b-2 of Workthe Securities Exchange Act of 1934, LHI as amended.
(b) Promptly after the Effective Date, the MedImmune Project Manager, his counterpart at Micromet, and other appropriate personnel of MedImmune and Micromet will prepare the SOW Documentation meet to establish a plan for the transfer of the Manufacturing Process and the MedImmune Process Technology as is reasonable and customary in the industry for the transfer of manufacturing processes and designed to complete the transfer of the Manufacturing Process and the MedImmune Process Technology within the timeframe set forth in subsection (c) below (the “Transfer Plan”), which Transfer Plan will be deemed part of this Agreement and incorporated herein by reference. Within [***] from the date on which MedImmune is informed of the contract manufacturing organization (“CMO”) selected by Micromet for the manufacture of the Licensed Product, MedImmune will make appropriate personnel available to meet with the CMO to initiate such process transfer.
(c) MedImmune will [***] to complete transfer of the Manufacturing Process and the MedImmune Process Technology to such manufacturer within [***] from that first meeting. Such timelines will be extended for delays that are reasonably outside the control of MedImmune, including but not limited to delays related to the performance of Micromet, its contract manufacturer, or licensees. Upon completion of the transfer of the Manufacturing Process and the MedImmune Process Technology, MedImmune will not have any further obligations to provide additional MedImmune Process Technology to Micromet or its manufacturer.
(d) MedImmune's obligation with respect to the Manufacturing Process and the MedImmune Process Technology is limited to transfer of the Manufacturing Process Technology in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI of any specific requirements CLIENT may have relating this Section 5.1 and providing consulting services pursuant to the SOW Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI intends to include in the SOW Documentation the use of any assay, medium, or other technology that is not commercially available, LHI will inform CLIENT of such intention Section 5.6 and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI to assist LHI to develop the SOW Documentation and Process, including, without limitation, by providing LHI with additional information and procedures as may be required to create the SOW Documentation, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI will deliver a draft version of the SOW Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Documentation, or in the event that CLIENT MedImmune does not submit a written notice setting forth CLIENT’s objections to covenant, warrant or represent that the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI Operating Documents, LHI Inventions or LHI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Manufacturing Process and/or the SOW Documentation MedImmune Process Technology when used by or on behalf of Micromet or its sublicensees will be suitable for any research or commercial purpose solely related producing Clinical Materials and/or Licensed Product. *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Product or Process and to manufacture and sell ProductSecurities Exchange Act of 1934, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Process, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which shall not be unreasonably withheldas amended.
Appears in 1 contract
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by LHI LWI pursuant to any applicable Statement of Work, LHI LWI will prepare the SOW Documentation Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI LWI of any specific requirements CLIENT may have relating to the SOW DocumentationMaster Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI LWI intends to include in the SOW Documentation Master Production Record the use of any assay, medium, or other technology that is not commercially available, LHI LWI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI LWI to assist LHI LWI to develop the SOW Documentation Master Production Record and Process, including, without limitation, by providing LHI LWI with additional information and procedures as may be required to create the SOW DocumentationMaster Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI LWI will deliver a draft version of the SOW Documentation Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW DocumentationMaster Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation Master Production Record within fifteen ten (1510) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW DocumentationMaster Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI LWI Operating Documents, LHI LWI Inventions or LHI LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 1010 . Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and Master Production Record to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation Master Production Record incorporates or contains any LHI LWI Intellectual Property or LHI LWI Confidential Information that does not solely relate to Product or ProcessInformation, then prior to any disclosure of such LHI LWI Intellectual Property or LHI LWI Confidential Information to, or use by, a Third Party manufacturer, Client CLIENT shall obtain LHI prior approval, which shall not be unreasonably withheldLWI’s written consent to such disclosure.
Appears in 1 contract
Sources: Know How License and Stock Purchase Agreement (Regenicin, Inc.)
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by LHI LWI pursuant to any applicable Statement of Work, LHI LWI will prepare the SOW Documentation Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI LWI of any specific requirements CLIENT may have relating to the SOW DocumentationMaster Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI LWI intends to include in the SOW Documentation Master Production Record the use of any assay, medium, or other technology that is not commercially available, LHI LWI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI LWI to assist LHI LWI to develop the SOW Documentation Master Production Record and Process, including, without limitation, by providing LHI LWI with additional information and procedures as may be required to create the SOW DocumentationMaster Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406
3.3 LHI LWI will deliver a draft version of the SOW Documentation Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI LWI and CLIENT will meet promptly (whether in person or by teleconference) to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW DocumentationMaster Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation Master Production Record within fifteen (15) working [*] days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW DocumentationMaster Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI LWI Operating Documents, LHI LWI Inventions or LHI LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating [*].
3.5 Any subsequent transfer of documentation, specifications, and production process [*] from Section 11.2.2LWI’s facility in Walkersville, CLIENT Maryland to another Facility for the manufacturing of the Product [*] shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product, either alone or by a Third Party on its behalf[*]; provided, however, that if any such transfer [*], shall be [*]. For the Process and/or avoidance of doubt, in the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Processevent a subsequent transfer is required for commercial manufacturing purposes, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which shall not be unreasonably withheldthe Parties will [*].
Appears in 1 contract
Sources: Manufacturing Services Agreement (Gamida Cell Ltd.)
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by LHI XXXX pursuant to any applicable Statement of Work, LHI XXXX will prepare the SOW Documentation Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI XXXX of any specific requirements CLIENT may have relating to the SOW DocumentationMaster Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI XXXX intends to include in the SOW Documentation Master Production Record the use of any assay, medium, or other technology that is not commercially available, LHI XXXX will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI XXXX to assist LHI XXXX to develop the SOW Documentation Master Production Record and Process, including, without limitation, by providing LHI XXXX with additional information and procedures as may be required to create the SOW DocumentationMaster Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI XXXX will deliver a draft version of the SOW Documentation Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI XXXX in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI XXXX and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW DocumentationMaster Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation Master Production Record within fifteen ten (1510) working business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW DocumentationMaster Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI XXXX Operating Documents, LHI Inventions New General Application Intellectual Property or LHI XXXX Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and Master Production Record to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation Master Production Record incorporates or contains any LHI XXXX Background Intellectual Property or LHI Property, XXXX Confidential Information that does not solely relate to Product or ProcessNew General Application Intellectual Property, then prior to any disclosure of such LHI XXXX Background Intellectual Property, XXXX Confidential Information or New General Application Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client CLIENT shall obtain LHI prior approvalXXXX’s written consent to such disclosure, which consent shall not be unreasonably withheld.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Heat Biologics, Inc.)
Technology Transfer. 3.1 Based on Prior to manufacturing the Product, a technology transfer of the manufacturing process will be performed from Purchaser to SWI. Purchaser shall disclose (and provide copies, as applicable) to SWI all information provided by CLIENT and including process changes developed by LHI pursuant related to any applicable Statement the manufacture of Workthe Product in Purchaser’s possession, LHI will prepare the SOW Documentation that is required for the Process manufacture of the Product by SWI (collectively “Manufacturing Technology”); provided that any such information is used solely for the purpose of manufacturing the Product in accordance with this Agreement. SWI acknowledges that such Manufacturing Technology is and shall remain the schedule sole property of Purchaser and/or its Affiliates, and nothing herein shall be deemed to convey to SWI any right therein except as required for the purpose of manufacturing the Product in accordance with this Agreement. The steps, planning and obligations of the Parties regarding the transfer of the Manufacturing Technology for such Product are set forth in the Statement technology transfer master plan attached in Exhibit D (the “Technology Transfer Master Plan”). Provided that Purchaser supply SWI with the needed amount of WorkCompound at *** to SWI, SWI will manufacture the required number of Batches as outlined in the Technology Transfer Master Plan and a minimum of *** validation Batches of Product. CLIENT will inform LHI of Purchaser shall be responsible for any specific and all regulatory requirements CLIENT may have relating with respect to the SOW DocumentationProduct. SWI shall provide to Purchaser data required by Purchaser to qualify SWI’s facility as per the Technology Transfer Master Plan. Upon request, includingPurchaser will provide SWI with, without limitation, any information assistance or procedures CLIENT wishes to have incorporated therein. If LHI intends to include in the SOW Documentation the use of any assay, medium, or other technology that is not commercially available, LHI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such nonon-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI to assist LHI to develop the SOW Documentation and Process, including, without limitation, by providing LHI with additional information and procedures site support as may be reasonably required to create by SWI in connection with the SOW Documentation, Process, and/or any transfer of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI technology. Such assistance will deliver be provided *** for a draft version number of the SOW Documentation to CLIENT for its review and approval in accordance with the schedule days as set forth in the Statement of WorkTechnology Transfer Master Plan. CLIENT will notify LHI Purchaser shall support the one-time costs as described in writing of the Technology Transfer Master Plan and purchase from SWI each validation Batch that meets the Specifications at the Price set forth in Exhibit B. If any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Documentationvalidation Batches of a Product does not comply with the Specifications, or Supplier shall have *** (***) months to re-manufacture and deliver the number of validation Batch(es) that failed to meet the Specifications. If SWI is unable within that *** (***)-month period to manufacture and deliver to Purchaser the validation Batch(es), Section 9.2(c) shall apply. Purchaser will be reimbursed for *** any validation Batches that fail to meet the Specifications, in the event that CLIENT does not submit a written notice setting forth CLIENTsuch failure is due to SWI’s objections mistake, negligence or failure to follow Purchaser’s instructions. In the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENTevent any validation batches fail to meet the Specifications for any other reason, such draft will be deemed approved by CLIENT.
3.4 The Processexcept for Purchaser’s mistake, SOW Documentation, Specifications, and negligence or failure to provide SWI with any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI Operating Documents, LHI Inventions or LHI Confidential Information included in any portion of the foregoingManufacturing Technology, SWI will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Process, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which shall not be unreasonably withheld***.
Appears in 1 contract
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by LHI LWI pursuant to any applicable Statement of Work, LHI LWI will prepare the SOW Documentation Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI LWI of any specific requirements CLIENT may have relating to the SOW DocumentationMaster Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI LWI intends to include in the SOW Documentation Master Production Record the use of any assay, medium, or other technology that is not commercially available, LHI LWI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI LWI to assist LHI LWI to develop the SOW Documentation Master Production Record and Process, including, without limitation, by providing LHI LWI with additional information and procedures as may be required to create the SOW DocumentationMaster Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI LWI will deliver a draft version of the SOW Documentation Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW DocumentationMaster Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation Master Production Record within fifteen ten (1510) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW DocumentationMaster Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI LWI Operating Documents, LHI Inventions New General Application Intellectual Property or LHI LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and Master Production Record to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation Master Production Record incorporates or contains any LHI LWI Intellectual Property or LHI LWI Confidential Information that does not solely relate to Product or ProcessInformation, then prior to any disclosure of such LHI LWI Intellectual Property or LHI LWI Confidential Information to, or use by, a Third Party manufacturer, Client CLIENT shall obtain LHI prior approval, which shall not be unreasonably withheldLWI’s written consent to such disclosure.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Genesis Biopharma, Inc)
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process the Process definition or changes developed by LHI LONZA pursuant to any applicable Statement of Work, LHI will LONZA shall use commercially reasonable efforts to prepare the SOW Project Documentation for the Process in accordance with the schedule set forth in the relevant Statement of Work. CLIENT will shall inform LHI LONZA of any specific requirements CLIENT may have relating to the SOW Project Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated incorporate therein. If LHI LONZA intends to include in the SOW Project Documentation the use of any assay, medium, or other technology that is not commercially available, LHI will LONZA shall inform CLIENT of such intention and the Parties will shall meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials Materials or technology in the Process. The SOW Documentation applicable Project Documentation, as set forth in the SOW, shall be completed and delivered by LHI LONZA at completion of a Batch.
3.2 CLIENT will shall reasonably cooperate with LHI LONZA to assist LHI LONZA to develop the SOW Project Documentation and Process, including, without limitation, by providing LHI LONZA with additional information and procedures as LONZA may be required reasonably require to create the SOW Project Documentation, Process, and/or any of the following: (i) manufacturing process information, SOPs, and development reports, (ii) quality control assays, (iii) Specifications of raw material specifications Materials (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing packaging and shipping instructions, (v) Product Product-specific cleaning and decontamination information.
3.3 LHI will LONZA shall deliver a draft version of the SOW applicable portions of the Project Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will shall notify LHI LONZA in writing of any objections it has to the such draft Master Production RecordProject Documentation, and upon such notification, representatives of LHI LONZA and CLIENT will shall meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Project Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Project Documentation within fifteen (15) working [***] business days following the receipt of such draft by CLIENT, such draft will shall be deemed to have been approved by CLIENT.
3.4 The Process, SOW Project Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI LONZA Operating Documents, LHI Inventions Documents or LHI Confidential Information of LONZA included in any of the foregoing, will shall be deemed CLIENT CLIENT’s property and Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Project Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Project Documentation incorporates or contains any LHI Intellectual Property of LONZA or LHI Confidential Information that does not solely relate to Product or Processof LONZA, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information of LONZA to, or use by, a Third Party manufacturer, Client CLIENT shall obtain LHI prior approvalLONZA’s written consent to such disclosure, which consent shall not be unreasonably withheld, delayed or conditioned.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Gracell Biotechnologies Inc.)
Technology Transfer. 3.1 Based Without limitation to MTEM’s obligations under Section 3.9, at Takeda’s request, for each Licensed Product, MTEM shall, at Takeda’s expense (subject to a mutually agreed reasonable budget with internal time to be calculated on an FTE basis based on a rate that reflects MTEM's actual costs for such FTE), transfer the Manufacturing process for such Licensed Product and any ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components thereof to Takeda or its designee (the “Technology Recipient”) as set forth in this Section 5.2, which transfer will comprise all necessary and available Know-How, documentation, methods, reagents, processes and other components to enable Takeda or its designee to independently Manufacture Licensed Products (such transfer, the “Technology Transfer”).
5.2.1 Within [***] after Takeda notifies MTEM that it is exercising Technology Transfer rights under this Section 5.2 with respect to a Licensed Product, MTEM shall deliver to the Technology Recipient copies of the then-current Manufacturing process for and any other information provided reasonably required in order to Manufacture such Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and other Components contained therein, including master batch records and any other manufacturing records (collectively, the “Technology Transfer Documentation”).
5.2.2 During such [***] and upon Takeda’s reasonable request with at least [***] notice to MTEM, MTEM shall also find a convenient time to permit representatives of the Technology Recipient or Takeda, as applicable, (the “Representatives”) to access the Facility during normal business hours to observe the Manufacturing of the Licensed Product and ▇▇▇▇ ▇▇▇-▇ Fusion Proteins included therein. While the Representatives are at the Facility, MTEM shall make available to the Representatives employees of MTEM (or its Affiliates or subcontractors) for consultation with respect to the Technology Transfer Documentation and the Manufacturing process for the Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein.
5.2.3 At Takeda’s request, MTEM shall use commercially reasonable efforts to effect assignments of any existing contract to the extent relating to one or more of the Licensed Products or the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein, or to obtain for Takeda substantially all of the practical benefit and burden under such agreement to the extent applicable to Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein, including by CLIENT entering into appropriate and including process changes developed reasonable alternative arrangements on terms agreeable to Takeda. Unless otherwise agreed by LHI pursuant the Parties, any agreement with any Contract Manufacturing Organization or other service provider entered into by MTEM on or after the Effective Date that relates to any applicable Statement Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein shall be assignable or otherwise transferable to Takeda without the consent of Workthe counterparty thereto to the extent related to any Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein.
5.2.4 Following the completion of the Technology Transfer, LHI will prepare MTEM shall, for a period of up to [***] thereafter, provide the SOW Documentation Technology Recipient with reasonable access to MTEM’s employees for telephone or in person consultations regarding the Process Manufacture of the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and, if applicable, the Licensed Products.
5.2.5 Without limiting the foregoing, MTEM shall take, and shall cause its Affiliates and subcontractors to take, all action and to do all things necessary, proper or advisable to complete the Technology Transfer in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI of any specific requirements CLIENT may have relating to the SOW Documentationthis Section 5.2, including, without limitationas applicable, any information or procedures CLIENT wishes obtaining and making available such information, personnel, products, materials, services, facilities and other resources as reasonably necessary to have incorporated therein. If LHI intends enable the Technology Recipient to include Manufacture the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and the Licensed Products.
5.2.6 Takeda shall pay MTEM for its reasonable, out-of-pocket costs and expenses incurred in the SOW Documentation performance of its activities under this Section 5.2 (in which case such amounts paid shall be included as Co-Development Costs), unless the use Technology Transfer is a response by Takeda to a material breach by MTEM of any assay, medium, or other technology its supply obligations hereunder that is not commercially available, LHI will inform CLIENT of such intention and the Parties will meet cured by MTEM pursuant to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will cooperate with LHI to assist LHI to develop the SOW Documentation and Process, including, without limitation, by providing LHI with additional information and procedures as may be required to create the SOW Documentation, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI will deliver a draft version of the SOW Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI Operating Documents, LHI Inventions or LHI Confidential Information included in any which case MTEM shall bear all of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Process, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which shall not be unreasonably withheldown expenses.
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Sources: Development Collaboration and Exclusive License Agreement (Molecular Templates, Inc.)
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process definition or changes developed by LHI LONZA pursuant to any applicable Statement of Work, LHI LONZA will use commercially reasonable efforts to prepare the SOW Project Documentation for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI LONZA of any specific requirements CLIENT may have relating to the SOW Project Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI LONZA intends to include in the SOW Project Documentation the use of any assay, medium, or other technology that is not commercially available, LHI LONZA will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation applicable Project Documentation, as set forth in the SOW, shall be completed and delivered by LHI LONZA at completion of a Batch.
3.2 CLIENT will cooperate with LHI LONZA to assist LHI LONZA to develop the SOW Project Documentation and Process, including, without limitation, by providing LHI LONZA with additional information and procedures as may be required to create the SOW Project Documentation, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LHI LONZA will deliver a draft version of the SOW applicable portions of the Project Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI LONZA in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI LONZA and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Project Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Project Documentation within fifteen (15) working [***] days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW Project Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI LONZA Operating Documents, LHI Inventions LONZA Inventions, Lonza New IP, or LHI LONZA Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 109. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Project Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product; [***]. [***] = Certain information contained in this document, either alone or marked by a brackets, has been omitted because it is both not material and would be competitively harmful if publicly disclosed.
3.5 All CLIENT Materials shall remain the sole property of CLIENT and are the Confidential Information of CLIENT. LONZA shall use the CLIENT Materials solely to perform its obligations under this Agreement and shall not transfer the CLIENT Materials to any Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does without CLIENT’s prior written consent. The CLIENT Materials supplied under this Agreement must be used a) with prudence and appropriate caution because not solely relate to Product or Process, then prior to any disclosure all of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approvaltheir characteristics may be known and b) ) in accordance with CLIENT’s information and instructions, which shall not be unreasonably withheldinclude a statement of content/formulation/ingredients, storage conditions, expiration information and safety and hazard information. Except as expressly set forth in this Agreement, THE CLIENT MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, OTHER THAN AS TO THE ACCURACY AND CORRECTNESS OF THE INFORMATION AND INSTRUCTIONS PROVIDED PURSUANT TO THIS SECTION, AND CLIENT EXPRESSLY DISCLAIMS ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE.
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