Common use of Technology Transfer Clause in Contracts

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.

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.

Technology Transfer. 3.1 Based on the information provided by CLIENT TiGenix 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 TiGenix will inform LHI LWI of any specific requirements CLIENT TiGenix may have relating to the SOW DocumentationMaster Production Record, including, without limitation, any information or procedures CLIENT TiGenix 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 TiGenix of such intention and intention. If TiGenix agrees with such intention, 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 TiGenix 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; in each case, to the extent such information and procedures are in TiGenix’s possession or control, or can be procured by TiGenix without material time and cost expenditures. 3.3 LHI LWI will deliver a draft version of the SOW Documentation Master Production Record to CLIENT TiGenix for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. CLIENT TiGenix 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 TiGenix will meet promptly to resolve such objections. Upon CLIENTTiGenix’s written acceptance of the draft SOW DocumentationMaster Production Record, or in the event that CLIENT TiGenix does not submit a written notice setting forth CLIENTTiGenix’s objections to the draft SOW Documentation Master Production Record within fifteen ten (1510) working days Business Days following receipt of such draft by CLIENTTiGenix, such draft will be deemed approved by CLIENTTiGenix. 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 TiGenix Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT TiGenix 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 Confidential Information that does not solely relate Property, the terms of Section 11 shall apply. 3.5 Any subsequent transfer of documentation, specifications, and production process by LWI from LWI’s facility in Walkersville, Maryland to another Facility for the manufacturing of the Product or Processspecifically for TiGenix shall be at TiGenix’s expense, then prior to any disclosure if such transfer is at the request 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 withheldTiGenix.

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.

Technology Transfer. 3.1 Based on SEATTLE GENETICS possesses confidential and proprietary technical information not in the information public domain that is necessary to the process of manufacturing the Product, including without limitation in process assays, methods, formulas, specifications, processes and know-how (the "SEATTLE GENETICS Information"), that is the subject of various patents, patents applications and Know-How owned or controlled by SEATTLE GENETICS ("the "SEATTLE GENETICS Intellectual Property", and collectively with the SEATTLE GENETICS Information, the "SEATTLE GENETICS Technology"). SEATTLE GENETICS Information shall be included in a technology transfer dossier to be shared with Gensia Sicor. 2.2.1 Gensia Sicor and SEATTLE GENETICS will mutually develop a Master Batch Record for the Product following the technical specifications, methods and know-how provided by CLIENT SEATTLE GENETICS. 2.2.2 SEATTLE GENETICS will transfer to Gensia Sicor appropriate methods and including in process changes developed assays for manufacturing the Product. Such methods and in process assays, being reviewed and agreed to by LHI SEATTLE GENETICS, will be confirmed, or if requested, validated by Gensia Sicor for their application to the finished Product. 2.2.3 A protocol describing distribution of Product will be provided to Gensia Sicor by SEATTLE GENETICS for review and acceptance prior to commencement of the manufacturing of finished dosage Product. Distribution of clinical Product will be coordinated between Gensia Sicor and SEATTLE GENETICS. 2.2.4 SEATTLE GENETICS hereby grants Gensia Sicor a non-exclusive, non-transferable right under the SEATTLE GENETICS Intellectual Property to use the SEATTLE GENETICS Information solely for the purpose of manufacturing the Product 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 this Agreement. Gensia Sicor (a) acknowledges that SEATTLE GENETICS and/or its licensors retain all ownership rights in and to the SEATTLE GENETICS Technology and (b) agrees not to use the SEATTLE GENETICS Technology for any purpose other than manufacturing the Product for SEATTLE GENETICS hereunder. Gensia Sicor agrees to treat all of such the SEATTLE GENETICS Technology as "Confidential Information" pursuant to Article VIII hereof. [***] Confidential treatment requested 2.2.5 Either party may jointly or independently make or otherwise acquire rights to non-commercially available materials patentable discoveries, improvements, ideas and other intellectual property rights (including without limitation processes and methods) or technology Know-How useful in the Processmanufacture of the Product ("Developments"). The SOW Documentation Any Developments conceived, fashioned or acquired solely by Gensia Sicor shall be completed owned solely by Gensia Sicor. Gensia Sicor shall promptly disclose all such Developments, in writing, to SEATTLE GENETICS, and delivered by LHI at completion of hereby grants to SEATTLE GENETICS a Batch. 3.2 CLIENT will cooperate with LHI to assist LHI to develop the SOW Documentation and Processnon-exclusive, includingworldwide, without limitationperpetual, by providing LHI with additional information and procedures as may be required to create the SOW Documentationroyalty-free license, 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 right to sublicense, to use each such Development for the Statement development and manufacture of WorkSEATTLE GENETICS' products. CLIENT will notify LHI in writing of any objections it has to the draft Master Production RecordAny Developments conceived, 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, fashioned 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 acquired solely by CLIENT, such draft will be deemed approved by CLIENT. 3.4 The Process, SOW Documentation, Specifications, and any improvements or modifications thereto developed SEATTLE GENETICS during the term of this AgreementAgreement shall be owned solely by SEATTLE GENETICS. Any Developments conceived, but excluding fashioned or acquired jointly by employees of Gensia Sicor and employees of SEATTLE GENETICS shall be jointly owned by both parties. 2.2.6 The parties do not expect that any LHI Operating Documentspatentable inventions, LHI Inventions discoveries, improvements or LHI Confidential Information included in any ideas relating to the manufacture of the foregoing, Product ("Product Inventions") will be deemed CLIENT Confidential Information and subject made, conceived or reduced to practice during the provisions set forth in Article 10course of the work performed under this Agreement. Without derogating from Section 11.2.2However, CLIENT any Product Inventions that are developed or acquired solely by Gensia Sicor shall be permitted owned solely by Gensia Sicor ("Gensia Sicor Product Inventions"). Gensia Sicor shall not use or incorporate any Gensia Sicor Product Inventions in the course of the work performed under this Agreement without first disclosing such Gensia Sicor Product Inventions to use SEATTLE GENETICS and obtaining prior written approval from SEATTLE GENETICS, upon which the Process and/or parties agree to negotiate in good faith the SOW Documentation terms of a license agreement on commercially reasonable terms for such Gensia Sicor Product Inventions. Any Product Inventions developed or acquired solely by SEATTLE GENETICS during the term of this Agreement shall be owned solely by SEATTLE GENETICS. Any Product Inventions developed or acquired jointly by employees of Gensia Sicor and employees of SEATTLE GENETICS shall be jointly owned by both parties. With respect to any research or commercial purpose solely filings related to jointly owned Inventions, the Product or Process parties shall work together to identify mutually agreeable intellectual property counsel and shall share equally in all costs of filing any applications and maintaining intellectual property protection. Inventorship shall be determined under U.S. patent law. 2.2.7 During the Term, Gensia Sicor agrees not 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[***].

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.

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.

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.