Common use of Technology Transfer Clause in Contracts

Technology Transfer. 3.1 Based on the information provided by TiGenix and including process changes developed by LWI pursuant to any applicable Statement of Work, LWI will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix will inform LWI of any specific requirements TiGenix may have relating to the Master Production Record, including, without limitation, any information or procedures TiGenix wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix of such 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. 3.2 TiGenix will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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 LWI will deliver a draft version of the Master Production Record to TiGenix for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix will meet promptly to resolve such objections. Upon TiGenix’s written acceptance of the draft Master Production Record, or in the event that TiGenix does not submit a written notice setting forth TiGenix’s objections to the draft Master Production Record within ten (10) Business Days following receipt of such draft by TiGenix, such draft will be deemed approved by TiGenix. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed TiGenix Confidential Information and subject to the provisions set forth in Article 10. TiGenix shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or Master Production Record incorporates or contains any LWI Intellectual 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 specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.

Appears in 2 contracts

Sources: Manufacturing Services Agreement (TiGenix NV), Manufacturing Services Agreement (TiGenix NV)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process changes developed by LWI pursuant to any applicable Statement of Work, LWI will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI of any specific requirements TiGenix CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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. 3.2 TiGenix CLIENT will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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 LWI will deliver a draft version of the Master Production Record to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix CLIENT will meet promptly to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production Record, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenixCLIENT’s objections to the draft Master Production Record within ten (10) Business Days business days following receipt of such draft by TiGenixCLIENT, such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject to the provisions set forth in Article 10. TiGenix CLIENT shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or the Master Production Record incorporates or contains any LWI Background Intellectual Property, the terms LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of Section 11 such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall apply. 3.5 Any subsequent transfer of documentation, specifications, and production process by LWI from obtain LWI’s facility in Walkersvillewritten consent to such disclosure, Maryland to another Facility for the manufacturing of the Product specifically for TiGenix which consent shall not be at TiGenix’s expense, if such transfer is at the request of TiGenixunreasonably withheld.

Appears in 2 contracts

Sources: Manufacturing Services Agreement, Manufacturing Services Agreement (Heat Biologics, Inc.)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process changes developed by LWI LHI pursuant to any applicable Statement of Work, LWI LHI will prepare the Master Production Record SOW Documentation for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI LHI of any specific requirements TiGenix CLIENT may have relating to the Master Production RecordSOW Documentation, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated therein. If LWI LHI intends to include in the Master Production Record SOW Documentation the use of any assay, medium, or other technology that is not commercially available, LWI LHI will inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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 TiGenix CLIENT will cooperate with LWI LHI to assist LWI LHI to develop the Master Production Record SOW Documentation and Process, including, without limitation, by providing LWI LHI with additional information and procedures as may be required to create the Master Production RecordSOW 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; 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 LWI LHI will deliver a draft version of the Master Production Record SOW Documentation to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI LHI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI LHI and TiGenix CLIENT will meet promptly to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production RecordSOW Documentation, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenixCLIENT’s objections to the draft Master Production Record SOW Documentation within ten fifteen (1015) Business Days working days following receipt of such draft by TiGenixCLIENT, such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production RecordSOW Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI LHI Operating Documents, LWI LHI Inventions or LWI LHI Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject to the provisions set forth in Article 10. TiGenix Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the Master Production Record 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 Master Production Record the SOW Documentation incorporates or contains any LWI LHI Intellectual PropertyProperty or LHI Confidential Information that does not solely relate to Product or Process, the terms then prior to any disclosure of Section 11 such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall applyobtain LHI prior approval, which shall not be unreasonably withheld. 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 specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.

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 TiGenix CLIENT and including process changes developed by LWI L WI pursuant to any applicable Statement of Work, LWI L WI will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI L WI of any specific requirements TiGenix CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI L WI will inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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. 3.2 TiGenix CLIENT will cooperate with LWI L WI to assist LWI L WI to develop the Master Production Record and Process, including, without limitation, by providing LWI L WI with additional information and procedures as may be required to create the Master 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; 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 LWI L WI will deliver a draft version of the Master Production Record to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI L WI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix CLIENT will meet promptly to resolve such objections. Upon TiGenix’s CLIENT's written acceptance of the draft Master Production Record, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenix’s CLIENT's objections to the draft Master Production Record within ten (10) Business Days days following receipt of such draft by TiGenixCLIENT, such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI L WI Operating Documents, LWI L WI Inventions or LWI L WI Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject subj ect to the provisions set forth in Article 10. TiGenix CLIENT shall be permitted to use the Process and/or ancl/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or the Master Production Record incorporates or contains any L WI Intellectual Property or L WI Confidential Information, prior to any disclosure of such LWI Intellectual PropertyProperty or L WI Confidential Information to, or use by, a Third Party manufacturer, CLIENT shall obtain L 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 terms of Section 11 shall applySecurities and Exchange Commission. 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 specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.

Appears in 1 contract

Sources: Know How License and Stock Purchase Agreement (Regenicin, 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 TiGenix and including process changes developed by LWI pursuant related to any applicable Statement the manufacture of Workthe Product in Purchaser’s possession, LWI will prepare the Master Production Record 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. TiGenix will inform LWI of Purchaser shall be responsible for any specific and all regulatory requirements TiGenix may have relating with respect to the Product. SWI shall provide to Purchaser data required by Purchaser to qualify SWI’s facility as per the Technology Transfer Master Production RecordPlan. Upon request, includingPurchaser will provide SWI with, without limitation, any information assistance or procedures TiGenix wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix of such 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 nonon-commercially available materials or technology in the Process. 3.2 TiGenix will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures site support as may be reasonably required to create by SWI in connection with the Master Production Record, 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; in each case, to the extent such information and procedures are in TiGenix’s possession or control, or can technology. Such assistance will be procured by TiGenix without material time and cost expenditures. 3.3 LWI will deliver provided *** for a draft version number of the Master Production Record to TiGenix for its review and approval in accordance with the schedule days as set forth in the relevant Statement of WorkTechnology Transfer Master Plan. TiGenix will notify LWI 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 LWI and TiGenix will meet promptly to resolve such objections. Upon TiGenix’s written acceptance of the draft Master Production Recordvalidation 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 TiGenix does not submit a written notice setting forth TiGenixsuch failure is due to SWI’s objections mistake, negligence or failure to follow Purchaser’s instructions. In the draft Master Production Record within ten (10) Business Days following receipt of such draft by TiGenixevent any validation batches fail to meet the Specifications for any other reason, such draft will be deemed approved by TiGenix. 3.4 The Processexcept for Purchaser’s mistake, Master Production Record, Specifications, and negligence or failure to provide SWI with any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any portion of the foregoingManufacturing Technology, SWI will be deemed TiGenix Confidential Information and subject to the provisions set forth in Article 10. TiGenix shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or Master Production Record incorporates or contains any LWI Intellectual 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 specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.

Appears in 1 contract

Sources: Manufacturing and Supply Agreement (Vivus Inc)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process changes developed by LWI XXXX pursuant to any applicable Statement of Work, LWI XXXX will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI XXXX of any specific requirements TiGenix CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated therein. If LWI XXXX intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI XXXX will inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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. 3.2 TiGenix CLIENT will cooperate with LWI XXXX to assist LWI XXXX to develop the Master Production Record and Process, including, without limitation, by providing LWI XXXX with additional information and procedures as may be required to create the Master 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 LWI XXXX will deliver a draft version of the Master Production Record to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI XXXX in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI XXXX and TiGenix CLIENT will meet promptly to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production Record, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenixCLIENT’s objections to the draft Master Production Record within ten (10) Business Days business days following receipt of such draft by TiGenixCLIENT, such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI XXXX Operating Documents, LWI Inventions New General Application Intellectual Property or LWI XXXX Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject to the provisions set forth in Article 10. TiGenix CLIENT shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or the Master Production Record incorporates or contains any LWI XXXX Background Intellectual Property, the terms XXXX Confidential Information or New General Application Intellectual Property, prior to any disclosure of Section 11 such XXXX Background Intellectual Property, XXXX Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall applyobtain XXXX’s written consent to such disclosure, which consent shall not be unreasonably withheld. 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 specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Heat Biologics, Inc.)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process changes developed by LWI pursuant to any applicable Statement of Work, LWI will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI of any specific requirements TiGenix CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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. 3.2 TiGenix CLIENT will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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 LWI will deliver a draft version of the Master Production Record to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix CLIENT will meet promptly to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production Record, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenixCLIENT’s objections to the draft Master Production Record within ten (10) Business Days days following receipt of such draft by TiGenixCLIENT, such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject to the provisions set forth in Article 1010 . TiGenix CLIENT shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or the Master Production Record incorporates or contains any LWI Intellectual PropertyProperty or LWI Confidential Information, the terms prior to any disclosure of Section 11 such LWI Intellectual Property or LWI Confidential Information to, or use by, a Third Party manufacturer, CLIENT shall apply. 3.5 Any subsequent transfer of documentation, specifications, and production process by LWI from obtain LWI’s facility in Walkersville, Maryland written consent to another Facility for the manufacturing of the Product specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenixdisclosure.

Appears in 1 contract

Sources: Know How License and Stock Purchase Agreement (Regenicin, Inc.)

Technology Transfer. 3.1 Based on the information provided by TiGenix (a) Sublicensee acknowledges and including process changes developed by LWI pursuant agrees that ECC has delivered and made to any applicable Statement Sublicensee a disclosure of Work, LWI will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix will inform LWI of any specific requirements TiGenix may have relating a general introduction to the Master Production Record, including, without limitation, any information or procedures TiGenix wishes Technology and to have incorporated thereinits commercial feasibility prior to the execution of this Agreement. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix of such 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. 3.2 TiGenix will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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, Except to the extent such information and procedures are in TiGenix’s possession falls within one or control, or can be procured by TiGenix without material time and cost expenditures. 3.3 LWI will deliver a draft version more of the Master Production Record exceptions to TiGenix for its review the definition of "Confidential Information", all information disclosed by ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and approval in accordance with the schedule shall be deemed to be confidential. The timing and extent of additional disclosure by ECC to Sublicensee shall be as set forth in the relevant Statement of Work. TiGenix will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix will meet promptly to resolve such objections. Upon TiGenix’s written acceptance of the draft Master Production Record, or in the event that TiGenix does not submit a written notice setting forth TiGenix’s objections to the draft Master Production Record within ten (10subparagraph 22(b) Business Days following receipt of such draft by TiGenix, such draft will be deemed approved by TiGenixhereof. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term (b) Upon execution of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI 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 ECC shall not be deemed TiGenix Confidential Information required 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 subject (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 provisions set forth in Article 10. TiGenix shall be permitted to use production of the Process and/or the Master Production Record to manufacture and sell designated Product; provided, however, that if the Process and/or Master Production Record incorporates or contains any LWI Intellectual Property, the terms and (z) a list of Section 11 shall applyknown raw materials suppliers and preferred equipment vendors. 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 specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.

Appears in 1 contract

Sources: Sublicense Agreement (Earthshell Container Corp)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process definition or changes developed by LWI LONZA pursuant to any applicable Statement of Work, LWI LONZA will [***] prepare the Master Production Record Project Documentation for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI LONZA of any specific requirements TiGenix CLIENT may have relating to the Master Production RecordProject Documentation, including, without limitation, any information or procedures TiGenix wishes to have incorporated therein[***]. If LWI intends to include [***], LONZA will [***]. The applicable Project Documentation, as set forth in the Master Production Record the use SOW, shall be completed and delivered by LONZA to CLIENT at completion of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix of such 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 Processa Batch. 3.2 TiGenix CLIENT will cooperate with LWI LONZA to assist LWI LONZA to develop the Master Production Record Project Documentation and Process, including, without limitation, by providing LWI LONZA with additional information and procedures as may be required to create the Master Production RecordProject 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; 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 LWI LONZA will deliver a draft version of the Master Production Record applicable portions of the Project Documentation to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI LONZA in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI LONZA and TiGenix CLIENT will meet promptly to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production Record, or in the event that TiGenix does not submit a written notice setting forth TiGenix’s objections to the draft Master Production Record within ten (10) Business Days following receipt of such draft by TiGenixProject Documentation[***], such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production RecordProject Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI LONZA Operating Documents, LWI LONZA Inventions existing on or LWI prior to the Effective Date, or LONZA Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject to the provisions set forth in Article 10. TiGenix Subject 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 Master Production Record Project Documentation either alone or with or for the benefit of any 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; provided, however, that if the Process and/or Master Production Record the Project Documentation incorporates or contains any LWI LONZA Background Intellectual PropertyProperty or LONZA Confidential Information as agreed by the Parties under Section 3.1, the terms prior to any disclosure of Section 11 such LONZA Background Intellectual Property or LONZA Confidential Information to, or use by, a Third Party manufacturer, CLIENT shall applyobtain LONZA’s written consent to such disclosure. 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 specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Affinia Therapeutics Inc.)

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 TiGenix 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 LWI 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, LWI will prepare the Master Production Record for the Manufacturing Process Technology in accordance with the schedule set forth in the Statement of Work. TiGenix will inform LWI of any specific requirements TiGenix may have relating this Section 5.1 and providing consulting services pursuant to the Master Production Record, including, without limitation, any information or procedures TiGenix wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix of such intention. If TiGenix agrees with such intention, the Parties will meet to discuss Section 5.6 and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 TiGenix will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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 LWI will deliver a draft version of the Master Production Record to TiGenix for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix will meet promptly to resolve such objections. Upon TiGenix’s written acceptance of the draft Master Production Record, or in the event that TiGenix MedImmune does not submit a written notice setting forth TiGenix’s objections to covenant, warrant or represent that the draft Master Production Record within ten (10) Business Days following receipt of such draft by TiGenix, such draft will be deemed approved by TiGenix. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed TiGenix Confidential Information and subject to the provisions set forth in Article 10. TiGenix shall be permitted to use the Manufacturing Process and/or the Master Production Record MedImmune Process Technology when used by or on behalf of Micromet or its sublicensees will be suitable for 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 manufacture and sell Product; providedRule 24b-2 of the Securities Exchange Act of 1934, however, that if the Process and/or Master Production Record incorporates or contains any LWI Intellectual Property, the terms of Section 11 shall apply. 3.5 Any subsequent transfer of documentation, specificationsas amended. Under 17 C.F.R. §§ 200.80(b)(4), and production process by LWI from LWI’s facility in Walkersville, Maryland to another Facility for the manufacturing of the Product specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.240.24b-2

Appears in 1 contract

Sources: Termination and License Agreement (Micromet, 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 TiGenix entering into appropriate and including process changes developed reasonable alternative arrangements on terms agreeable to Takeda. Unless otherwise agreed by LWI 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, LWI will prepare MTEM shall, for a period of up to [***] thereafter, provide the Master Production Record 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. TiGenix will inform LWI of any specific requirements TiGenix may have relating to the Master Production Recordthis Section 5.2, including, without limitationas applicable, any information or procedures TiGenix wishes obtaining and making available such information, personnel, products, materials, services, facilities and other resources as reasonably necessary to have incorporated therein. If LWI 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 Master Production Record 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, LWI will inform TiGenix of such intention. If TiGenix agrees with such intention, 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. 3.2 TiGenix will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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 LWI will deliver a draft version of the Master Production Record to TiGenix for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix will meet promptly to resolve such objections. Upon TiGenix’s written acceptance of the draft Master Production Record, or in the event that TiGenix does not submit a written notice setting forth TiGenix’s objections to the draft Master Production Record within ten (10) Business Days following receipt of such draft by TiGenix, such draft will be deemed approved by TiGenix. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any which case MTEM shall bear all of the foregoing, will be deemed TiGenix Confidential Information and subject to the provisions set forth in Article 10. TiGenix shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or Master Production Record incorporates or contains any LWI Intellectual Property, the terms of Section 11 shall applyits own expenses. 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 specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.

Appears in 1 contract

Sources: Development Collaboration and Exclusive License Agreement (Molecular Templates, Inc.)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process changes developed by LWI pursuant to any applicable Statement of Work, LWI will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI of any specific requirements TiGenix CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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. 3.2 TiGenix CLIENT will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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 LWI will deliver a draft version of the Master Production Record to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix CLIENT will meet promptly to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production Record, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenixCLIENT’s objections to the draft Master Production Record within ten (10) Business Days days following receipt of such draft by TiGenixCLIENT, such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject to the provisions set forth in Article 10. TiGenix CLIENT shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or the Master Production Record incorporates or contains any LWI Intellectual PropertyProperty or LWI Confidential Information, the terms prior to any disclosure of Section 11 such LWI Intellectual Property or LWI Confidential Information to, or use by, a Third Party manufacturer, CLIENT shall apply. 3.5 Any subsequent transfer of documentation, specifications, and production process by LWI from obtain LWI’s facility in Walkersville, Maryland written consent to another Facility for the manufacturing of the Product specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenixdisclosure.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Genesis Biopharma, Inc)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process the Process definition or changes developed by LWI LONZA pursuant to any applicable Statement of Work, LWI will LONZA shall use commercially reasonable efforts to prepare the Master Production Record Project Documentation for the Process in accordance with the schedule set forth in the relevant Statement of Work. TiGenix will CLIENT shall inform LWI LONZA of any specific requirements TiGenix CLIENT may have relating to the Master Production RecordProject Documentation, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated incorporate therein. If LWI LONZA intends to include in the Master Production Record Project Documentation the use of any assay, medium, or other technology that is not commercially available, LWI will LONZA shall inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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 applicable Project Documentation, as set forth in the SOW, shall be completed and delivered by LONZA at completion of a Batch. 3.2 TiGenix will CLIENT shall reasonably cooperate with LWI LONZA to assist LWI LONZA to develop the Master Production Record Project Documentation and Process, including, without limitation, by providing LWI LONZA with additional information and procedures as LONZA may be required reasonably require to create the Master Production RecordProject 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; 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 LWI will LONZA shall deliver a draft version of the Master Production Record applicable portions of the Project Documentation to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix will CLIENT shall notify LWI LONZA in writing of any objections it has to the such draft Master Production RecordProject Documentation, and upon such notification, representatives of LWI LONZA and TiGenix will CLIENT shall meet promptly to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production RecordProject Documentation, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenixCLIENT’s objections to the draft Master Production Record Project Documentation within ten (10) Business Days [***] business days following the receipt of such draft by TiGenixCLIENT, such draft will shall be deemed to have been approved by TiGenixCLIENT. 3.4 The Process, Master Production RecordProject Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI LONZA Operating Documents, LWI Inventions Documents or LWI Confidential Information of LONZA included in any of the foregoing, will shall be deemed TiGenix CLIENT’s property and Confidential Information and subject to the provisions set forth in Article 10. TiGenix CLIENT shall be permitted to use the Process and/or the Master Production Record Project Documentation to manufacture and sell Product; provided, however, that if the Process and/or Master Production Record the Project Documentation incorporates or contains any LWI Intellectual PropertyProperty of LONZA or Confidential Information of LONZA, the terms prior to any disclosure of Section 11 such Intellectual Property or Confidential Information of LONZA to, or use by, a Third Party manufacturer, CLIENT shall applyobtain LONZA’s written consent to such disclosure, which consent shall not be unreasonably withheld, delayed or conditioned. 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 specifically for TiGenix shall be at TiGenix’s expense, if such transfer is at the request of TiGenix.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Gracell Biotechnologies Inc.)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process changes developed by LWI pursuant to any applicable Statement of Work, LWI will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI of any specific requirements TiGenix CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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. 3.2 TiGenix CLIENT will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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 each casethis document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the extent such information Securities Act of 1933, as amended. Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and procedures are in TiGenix’s possession or control, or can be procured by TiGenix without material time and cost expenditures.230.406 3.3 LWI will deliver a draft version of the Master Production Record to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix CLIENT will meet promptly (whether in person or by teleconference) to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production Record, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenixCLIENT’s objections to the draft Master Production Record within ten (10) Business Days [*] days following receipt of such draft by TiGenixCLIENT, such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject to the provisions set forth in Article 10. TiGenix shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or Master Production Record incorporates or contains any LWI Intellectual 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 specifically for TiGenix [*] shall be at TiGenix’s expense[*]; provided, if however, that any such transfer [*], shall be [*]. For the avoidance of doubt, in the event a subsequent transfer is at required for commercial manufacturing purposes, the request of TiGenixParties will [*].

Appears in 1 contract

Sources: Manufacturing Services Agreement (Gamida Cell Ltd.)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process changes developed by LWI pursuant to any applicable Statement of Work, LWI will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI of any specific requirements TiGenix CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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. [*] = 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. 3.2 TiGenix CLIENT will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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 LWI will deliver a draft version of the Master Production Record to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix CLIENT will meet promptly (whether in person or by teleconference) to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production Record, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenixCLIENT’s objections to the draft Master Production Record within ten (10) Business Days [*] days following receipt of such draft by TiGenixCLIENT, such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject to the provisions set forth in Article 10. TiGenix shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or Master Production Record incorporates or contains any LWI Intellectual 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 specifically for TiGenix [*] shall be at TiGenix’s expense[*]; provided, if however, that any such transfer [*], shall be [*]. For the avoidance of doubt, in the event a subsequent transfer is at [required for commercial manufacturing purposes], the request of TiGenixParties 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 TiGenix 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 LWI 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, LWI 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 Master Production Record 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. TiGenix will inform LWI of any specific requirements TiGenix may have relating this Section 5.1 and providing consulting services pursuant to the Master Production Record, including, without limitation, any information or procedures TiGenix wishes to have incorporated therein. If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform TiGenix of such intention. If TiGenix agrees with such intention, the Parties will meet to discuss Section 5.6 and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 TiGenix will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master 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 LWI will deliver a draft version of the Master Production Record to TiGenix for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix will meet promptly to resolve such objections. Upon TiGenix’s written acceptance of the draft Master Production Record, or in the event that TiGenix MedImmune does not submit a written notice setting forth TiGenix’s objections to covenant, warrant or represent that the draft Master Production Record within ten (10) Business Days following receipt of such draft by TiGenix, such draft will be deemed approved by TiGenix. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed TiGenix Confidential Information and subject to the provisions set forth in Article 10. TiGenix shall be permitted to use the Manufacturing Process and/or the Master Production Record MedImmune Process Technology when used by or on behalf of Micromet or its sublicensees will be suitable for 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 manufacture and sell Product; provided, however, that if the Process and/or Master Production Record incorporates or contains any LWI Intellectual 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 Rule 24b-2 of the Product specifically for TiGenix shall be at TiGenix’s expenseSecurities Exchange Act of 1934, if such transfer is at the request of TiGenixas amended.

Appears in 1 contract

Sources: Termination and License Agreement (Micromet, Inc.)

Technology Transfer. 3.1 Based on the information provided by TiGenix CLIENT and including process definition or changes developed by LWI LONZA pursuant to any applicable Statement of Work, LWI LONZA will use commercially reasonable efforts to prepare the Master Production Record Project Documentation for the Process in accordance with the schedule set forth in the Statement of Work. TiGenix CLIENT will inform LWI LONZA of any specific requirements TiGenix CLIENT may have relating to the Master Production RecordProject Documentation, including, without limitation, any information or procedures TiGenix CLIENT wishes to have incorporated therein. If LWI LONZA intends to include in the Master Production Record Project Documentation the use of any assay, medium, or other technology that is not commercially available, LWI LONZA will inform TiGenix CLIENT of such intention. If TiGenix agrees with such intention, 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 applicable Project Documentation, as set forth in the SOW, shall be completed and delivered by LONZA at completion of a Batch. 3.2 TiGenix CLIENT will cooperate with LWI LONZA to assist LWI LONZA to develop the Master Production Record Project Documentation and Process, including, without limitation, by providing LWI LONZA with additional information and procedures as may be required to create the Master Production RecordProject 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; 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 LWI LONZA will deliver a draft version of the Master Production Record applicable portions of the Project Documentation to TiGenix CLIENT for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix CLIENT will notify LWI LONZA in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI LONZA and TiGenix CLIENT will meet promptly to resolve such objections. Upon TiGenixCLIENT’s written acceptance of the draft Master Production RecordProject Documentation, or in the event that TiGenix CLIENT does not submit a written notice setting forth TiGenixCLIENT’s objections to the draft Master Production Record Project Documentation within ten (10) Business Days [***] days following receipt of such draft by TiGenixCLIENT, such draft will be deemed approved by TiGenixCLIENT. 3.4 The Process, Master Production RecordProject Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI LONZA Operating Documents, LWI Inventions LONZA Inventions, Lonza New IP, or LWI LONZA Confidential Information included in any of the foregoing, will be deemed TiGenix CLIENT Confidential Information and subject to the provisions set forth in Article 109. TiGenix CLIENT shall be permitted to use the Process and/or the Master Production Record Project Documentation to manufacture and sell Product; provided[***]. [***] = Certain information contained in this document, howevermarked by brackets, that has been omitted because it is both not material and would be competitively harmful if the Process and/or Master Production Record incorporates or contains any LWI Intellectual Property, the terms of Section 11 shall applypublicly disclosed. 3.5 Any subsequent 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 without CLIENT’s prior written consent. The CLIENT Materials supplied under this Agreement must be used a) with prudence and appropriate caution because not all of documentationtheir characteristics may be known and b) ) in accordance with CLIENT’s information and instructions, specificationswhich shall include a statement of content/formulation/ingredients, storage conditions, expiration information and production process by LWI from LWI’s facility safety and hazard information. Except as expressly set forth in Walkersvillethis Agreement, Maryland to another Facility for the manufacturing of the Product specifically for TiGenix shall be at TiGenix’s expenseTHE CLIENT MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, if such transfer is at the request of TiGenixEXPRESS 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.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Vaxart, Inc.)