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 Without limitation to MTEM’s obligations under Section 3.10, at Takeda’s request, for each Takeda Target, MTEM shall transfer the Manufacturing process for the SLT-A Fusion Proteins and the Licensed Products 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, MTEM shall deliver to the Technology Recipient copies of the then-current Manufacturing process for and any other information reasonably required in order to Manufacture the SLT-A Fusion Proteins and the Licensed Products, 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 SLT-A Fusion Proteins and the Licensed Products. 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 SLT-A Fusion Proteins and, if applicable, the Licensed Products.
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 the SLT-A Fusion Proteins and the Licensed Products, or to obtain for Takeda substantially all of the practical benefit and burden under such agreement to the extent applicable to the SLT-A Fusion Proteins and the Licensed Products, including by entering into appropriate and reasonable alternative arrangements on terms agreeable to Takeda. Unless otherwise agreed by the information provided Parties, any agreement with any contract manufacturing organization or other service provider entered into by TiGenix and including process changes developed by LWI pursuant MTEM on or after the Effective Date that relates to any applicable Statement SLT-A Fusion Protein or any Licensed Product shall be assignable or otherwise transferable to Takeda without the consent of Workthe counterparty thereto to the extent related to such SLT-A Fusion Protein or, LWI will prepare if applicable, Licensed Product.
5.2.4 Following the Master Production Record delivery of the Technology Transfer Documentation, MTEM shall provide the Technology Recipient with reasonable access to MTEM’s employees for telephone or in person consultations regarding the Process Manufacture of the SLT-A 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 SLT-A 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 unless the use Technology Transfer is a response by Takeda to a breach by MTEM of any assayits supply obligations hereunder, medium, or other technology that is not commercially available, LWI will inform TiGenix in which case MTEM shall bear all 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 Processits own expenses.
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: Multi Target Collaboration and License Agreement (Molecular Templates, Inc.), Multi Target Collaboration and License Agreement (Molecular Templates, Inc.)
Technology Transfer. 3.1 Based 30.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the information provided by TiGenix expected date of expiry or termination of this Agreement and including process changes developed by LWI the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to any the Technology Transfer Plan does not place CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable Statement of Workrecords, LWI will prepare the Master Production Record for the Process documentation, GSK Know-How and GSK Intellectual Property in accordance with the schedule Technology Transfer Plan and the timelines, formats, and other guidelines 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 Except for a Technology Transfer pursuant to include in Clause 30.1(C) or 30.1(D), the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will inform TiGenix of reimburse GSK for such intentionservices pursuant to Clause 12 (Invoice and Payment). If TiGenix agrees with such intentionthere is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, the Parties Technology Transfer Plan will meet to discuss and attempt to agree in good faith on survive for [***] from such termination or expiration date. For clarity, 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 Purchaser shall not be required to create the Master Production Record, Process, and/or reimburse GSK for 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 controlTechnology Transfer support services, or can be procured direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by TiGenix without material time and cost expendituresthe Purchaser pursuant to Clause 30.1(C) or 30.1(D).
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 30.2 A Technology Transfer may be implemented in the relevant Statement circumstances contemplated by Clause 30.1(A) either in anticipation of Work. TiGenix will notify LWI in writing expiry 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, this Agreement 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 termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the foregoing, notification by GSK that it will be deemed TiGenix Confidential Information and subject unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the provisions set forth part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in Article 10. TiGenix accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be permitted relieved of its obligation under Clause 4.1 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 purchase [***] of Section 11 shall applyits requirements for Products from GSK.
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: Clinical Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Clinical Manufacturing and Supply Agreement (Dermavant Sciences 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.
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 During the period beginning on the Effective Date until the date that is [***] ([***]) days following the Completion of the Required Studies (or such later date as is set out in Schedule 2.5 (the “Technology Transfer Period”), the Parties shall complete their respective activities under the Technology Transfer Plan, including S▇▇▇▇’▇ transfer to GSK of such Know-How and materials, as set out in Schedule 2.5; provided that either Party may propose amendments to the Technology Transfer Plan at any time during the Technology Transfer Period by delivering a notice to the other Party for review and discussion; provided, further, that the Technology Transfer Plan may only be amended by mutual agreement of the Parties. In furtherance of the foregoing, within [***] ([***]) Business Days following the Effective Date, the Parties will establish a technology transfer committee comprised of representatives of each Party (which representatives may be replaced by the appointing Party at any time upon giving notice to the other Party) (the “Technology Transfer Committee”) to oversee and coordinate the implementation of the Technology Transfer Plan. For clarity, the Technology Transfer Committee will have no responsibility or decision-making authority except as expressly provided in this Section 2.5 or otherwise expressly agreed by the Parties in writing. Subject to the terms of this Agreement (including the Technology Transfer Plan), (i) no later than [***], S▇▇▇▇ will deliver to GSK (or its designee), at S▇▇▇▇’▇ reasonable cost and expense, all such Know-How and materials set forth in Schedule 2.5 as were in existence as of the Effective Date (including but not limited to, information provided by TiGenix and copies of documents related to the Compound or any Product (including process changes developed by LWI pursuant CMC data and information and all non-clinical studies and Clinical Trial data and results)), (ii) no later than [***] ([***]) days following the Completion of the Required Studies, S▇▇▇▇ shall provide to any applicable Statement GSK (or its designee) a copy of Work, LWI will prepare all such Know-How and materials set forth in Schedule 2.5 as were generated in the Master Production Record for period between the Process Effective Date and the date of Completion of the Required Studies (including but not limited to Clinical Trial data and results from such Required Studies in accordance with the schedule set forth in Technology Transfer Plan), save that following the Statement of Work. TiGenix will inform LWI completion 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 individual phase(s) of the following: (iRequired Studies, S▇▇▇▇ shall provide GSK with copies of all relevant Clinical Trial data and results from any such individual phase(s) manufacturing process information, SOPs, development reports, (ii) quality control assaysas soon as possible following the relevant completion date, (iii) raw material specifications (including vendorS▇▇▇▇ shall use Commercially Reasonable Efforts to ensure that all information, grade documentation, data and sampling/testing requirements)materials to be provided to GSK in accordance with this Section 2.5 and the Technology Transfer Plan shall be provided in a format that is well-structured and well-indexed and that all relevant documents and files are clearly labelled, and (iv) S▇▇▇▇ shall make available to GSK qualified S▇▇▇▇ Personnel having the necessary skill, expertise and experience to accomplish the activities set forth in such Technology Transfer Plan and to answer any questions or provide instruction as reasonably requested by GSK during the Technology Transfer Period. The S▇▇▇▇ Human Biological Samples will not be delivered to GSK. GSK will have the right to request, at GSK’s direction, that S▇▇▇▇ conduct analysis of the S▇▇▇▇ Human Biological Samples and provide GSK (or its designee) with any data, results and reports associated with such analysis. If GSK identifies items that were not included in the original Technology Transfer Plan but are useful or necessary to research, Develop, Manufacture or Commercialize the Compound and any Product and sample packing and shipping instructionsin the Field in the GSK Territory, (v) Product specific cleaning and decontamination information; in each case, S▇▇▇▇ will use Commercially Reasonable Efforts to the extent such information and procedures are in TiGenix’s possession or controldeliver to GSK, or can be procured provide GSK with access to, such items. S▇▇▇▇ shall use Commercially Reasonable Efforts to ensure that all data, results and other information provided by TiGenix without material time S▇▇▇▇ to GSK pursuant to this Section 2.5 and cost expenditures.
3.3 LWI will deliver a draft version of the Master Production Record to TiGenix for its review Technology Transfer Plan is true and approval accurate and was generated in accordance with the schedule Data Integrity Practices 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 TiGenixSchedule 4.11(b).
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 2. Other than as specifically provided 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 PropertySection 1 above, the terms and conditions of Section 11 shall applythe Agreement are not being modified by this Amendment 1 and will remain in full force and effect.
3.5 Any subsequent transfer 3. This Amendment 1 contains the Parties’ entire agreement with respect to the subject matter of documentation, specifications, and production process this Amendment 1.
4. This Amendment shall be governed by LWI from LWI’s facility in Walkersville, Maryland to another Facility for the manufacturing laws of the Product specifically for TiGenix State of Delaware, without regard to the conflicts of law principles that would require application of different law.
5. This Amendment may be executed in counterparts, each of which shall constitute an original, but all of which when taken together shall constitute a single instrument. Delivery of an executed counterpart of a signature page to this Amendment by telecopier or other electronic means (e.g., via PDF) shall be at TiGenix’s expense, if such transfer is at the request effective delivery of TiGenixa manually executed counterpart of this Amendment.
Appears in 2 contracts
Sources: Exclusive License Agreement (Spero Therapeutics, Inc.), Exclusive License Agreement (Spero Therapeutics, 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 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 the information provided by TiGenix and including process changes developed by LWI If ▇▇▇▇▇▇ elects option (a) pursuant to Section 3.7, or at any applicable Statement time thereafter if ▇▇▇▇▇▇ determines to establish its own commercial scale manufacturing, then MERRIMACK shall perform a technology transfer of Work, LWI will prepare the Master Production Record MERRIMACK’s manufacturing process for the Process Drug Product and/or Licensed Product to ▇▇▇▇▇▇ (or its designated Affiliate or CMO), which technology transfer shall be performed in accordance with a mutually agreed technology transfer plan, timeline and budget.
(a) As part of such technology transfer to ▇▇▇▇▇▇ (or ▇▇▇▇▇▇’▇ designated Affiliate or CMO), MERRIMACK shall:
(i) subject to ▇▇▇▇▇▇’▇ prior approval of a budget, transfer to ▇▇▇▇▇▇ (or ▇▇▇▇▇▇’▇ designated Affiliate or CMO) copies of Regulatory Filings and other Licensed Technology that are necessary or useful for ▇▇▇▇▇▇ (or the schedule Affiliate or CMO identified by ▇▇▇▇▇▇) to manufacture the Drug Product and/or Licensed Product, including manufacturing processes, analytical methods, specifications, protocols, assays, batch records, quality control data, transportation and storage requirements, and other manufacturing documentation or files (collectively, “Manufacturing Technology”); and
(ii) provide technical assistance to ▇▇▇▇▇▇ (or ▇▇▇▇▇▇’▇ Affiliate or designated CMO) with respect to the use and implementation of such Manufacturing Technology as may be mutually agreed by the Parties.
(b) ▇▇▇▇▇▇ shall pay MERRIMACK, within [**] days following MERRIMACK’s invoice, for (i) all internal costs of MERRIMACK personnel at the [**] FTE Rate, plus (ii) all out-of-pocket costs and expenses incurred by MERRIMACK, to the extent incurred in performing the technology transfer activities contemplated hereunder, and provided that all aforesaid costs and expenses do not exceed the amounts 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 corresponding budget set forth in the relevant Statement agreed technology transfer plan, it being understood that such approved budget shall incorporate into the budget an allowance of Work. TiGenix [**] percent ([**]%) for cost overruns, provided that such overruns, upon their occurrence, are appropriately documented and justified.
(c) The Parties will notify LWI cooperate in writing of any objections it has good faith in undertaking all such technology transfer activities, including with respect to the draft Master Production Record, scheduling and upon such notification, representatives planning 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 TiGenixassociated meetings.
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 1 contract
Sources: License and Collaboration Agreement (Merrimack Pharmaceuticals 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 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 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 [***] following the information provided by TiGenix and including process changes developed by LWI pursuant Effective Date (the “Technology Transfer Period”), L▇▇▇▇ shall, at L▇▇▇▇’▇ expense, transfer to any applicable Statement of WorkLicensee, 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 intentioncurrent “as-is” form and format, 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 reportstechnical information and processes as existing and as set forth on Schedule C, (ii) quality control assaysregulatory filings or applications in L▇▇▇▇’▇ name for the Product as set forth on Schedule C, and (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 other information and procedures are in TiGenix’s possession or control, or can be procured reasonably requested by TiGenix without material time and cost expenditures.
3.3 LWI will deliver a draft version Licensee within [***] of the Master Production Record to TiGenix for its review Technology Transfer Period 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 used exclusively for the manufacturing Development of the Product by L▇▇▇▇; provided that such information exists in the form requested at the time of such request and is controlled by and reasonably available to Lilly, and L▇▇▇▇ is under no obligation to keep such information confidential. For clarity, except for the foregoing clause (iii), L▇▇▇▇ will only provide the items specifically for TiGenix listed on Schedule C and there shall be at TiGenix’s expenseno further obligation by L▇▇▇▇ to provide any technical information, if materials, processes, regulatory filings or applications beyond those listed therein. For the avoidance of doubt, the foregoing shall not include, and Licensee shall have no rights to use, any manufacturing technology (including any expression vector, cell-line, cell-based media or any of its components) or processes or device technology or processes, or any other technology, of Lilly and its Affiliates. The technology transfer shall occur in an orderly fashion and in a manner such that the value, usefulness and confidentiality of the transferred Licensed Know-How and regulatory documentation are preserved in all material respects. The implementation and transfer of information pursuant hereto shall be conducted through electronic, email and teleconference consultation between the Parties; provided that L▇▇▇▇ shall not be required to conduct any on-site or in-person consultation in connection therewith unless Licensee reimburses Lilly for any travel expenses. For clarity, Licensee shall be responsible for any Development or Manufacturing related costs associated with such technology transfer, including lab runs, pilot scale testing and demo batches and Lilly will not be obligated to provide any assistance, support, advice, guidance, technology transfer, information, data, or cooperation to Licensee other than what is at the request of TiGenixspecifically described in this Agreement.
Appears in 1 contract
Sources: License, Development and Commercialization Agreement (Zura Bio LTD)
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 (i) In the information provided by TiGenix and including process changes developed by LWI pursuant to any applicable Statement of Work, LWI will prepare event GSK has exercised the Master Production Record for the Process Option in accordance with Section 3 (d) (ii) of this Amendment, then, subject to the schedule terms and conditions of this Section 3 (e), Corixa shall transfer to GSK on a co-exclusive basis all Manufacturing Know-How for GSK's use solely in connection with the practice of the license set forth in Section 3 (d) (i).
(ii) GSK shall have the Statement right to request the foregoing transfer of WorkManufacturing Know-How by providing written notice to Corixa therefor during the period that commences upon exercise of the Option and terminates on the later of December 31, 2007 and the date the CSC determines that the Work Plan is fully completed (the "Transfer Request Period"). TiGenix will inform LWI GSK shall have no right to a transfer 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 Manufacturing Know-How if GSK has not provided Corixa a written request therefore during the Transfer Request Period.
(iii) In the event GSK requests such transfer 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 writing in accordance with such intentionSection 3 (e) (ii), the Parties will meet to discuss and attempt to agree parties shall negotiate in good faith on a Manufacturing Know-How transfer work plan, which work plan shall include the terms of use of FTE rate for Corixa's FTEs who will perform such non-commercially available materials or technology in the Processwork plan and which work plan will be appended to this Amendment as Exhibit V and thereupon shall be incorporated into this Amendment. *CONFIDENTIAL TREATMENT REQUESTED.
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, Following agreement to the extent such information and procedures are in TiGenix’s possession or controlManufacturing Know-How transfer work plan, 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 Corixa shall transfer to TiGenix for its review and approval GSK all then existing Manufacturing Know-How in accordance with the schedule such work plan. GSK shall fund ▇▇▇▇▇▇'s efforts in performing such work plan 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 Recordtherein, 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 which funding 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 applypayable quarterly in advance based upon ▇▇▇▇▇▇'s invoice therefore.
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: MPL Agreements (Corixa 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 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 Promptly after Closing, the information Seller shall disclose and make available to Buyer all documentation of any kind possessed by it relating to the Purchased Intellectual Property to enable Buyer to exercise its rights and perform its obligations under this Agreement and to take full ownership in and practice all of the Purchased Intellectual Property. In addition, during the three (3)-month period after Closing, the Seller shall provide to a limited number of Buyer’s personnel, physical access (by telephone, facsimile, email and through personal visits) at reasonable times during regular business hours to a reasonable number of the Seller’s personnel to assist in transfer of all Purchased Intellectual Property. The Seller agrees to retain the consulting services of ▇▇▇▇▇▇ ▇▇▇▇▇ (or such other person as may be reasonably acceptable to Buyer), at no cost to Buyer (except for reimbursable travel expenses as provided by TiGenix and including process changes developed by LWI pursuant below), to any applicable Statement of Work, LWI will prepare perform the Master Production Record following services during the two (2) year period following the Closing Date: assist Buyer to manufacture coils for the Process benefit of Buyer at the same or higher productivity and quality levels as existed during the one-year period prior to the Closing Date; assist the Seller and Buyer in accordance with the schedule prompt and orderly transfer of the Purchased Intellectual Property to Buyer; and assist the Seller and Buyer to accomplish the tasks described in this Section 6.11. Any reasonable and supportable travel costs incurred by ▇▇▇▇▇▇ ▇▇▇▇▇ in providing these consulting services shall be reimbursed by Buyer. Provided that the Seller (by providing the services of ▇▇. ▇▇▇▇▇ or by such other means as may be reasonably acceptable to Buyer) has (a) assisted Buyer to establish a parallel coil winding capability making Honeywell Trident program coils at Buyer’s East Granby, CT plant, and (b) further provided that this condition is accomplished prior to the first anniversary of the Closing Date and (c) further provided that the Seller is not in material breach of this Agreement, then not later than five (5) days after the date each of the conditions in clauses (a), (b) and (c) are satisfied, Buyer and the Seller shall issue joint instructions to the Escrow Agent to pay to the Seller one-half of the Escrow Amount, including interest accrued on that amount. Provided that (i) the Seller has satisfied the condition set forth in clause (a) above, and (ii) further provided that such coil winding operation is manufacturing coils qualified under the Statement of Work. TiGenix will inform LWI of any specific requirements TiGenix may have relating to the Master Production RecordHoneywell Trident missile retrofit program, 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 and (iii) further provided 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 both of the following: conditions set forth in clauses (i) manufacturing process informationand (ii) above are accomplished prior to the second anniversary of the Closing Date, SOPsand (iv) further provided that the Seller is not in material breach of this Agreement, development reportsthen not later than five (5) days after the date each of the conditions in clauses (i), (ii) quality control assays), (iii) raw material specifications and (iv) are satisfied, Buyer and the Seller shall issue joint instructions to the Escrow Agent to pay to the Seller all of the remaining Escrow Amount, including vendor, grade and sampling/testing requirementsinterest accrued on that amount. If the conditions in clauses (i), (ii), (iii) and (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information; in each case, are not satisfied prior 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 second anniversary of the Master Production Record to TiGenix for its review Closing Date, Buyer 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 Seller shall issue joint instructions to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix will meet promptly Escrow Agent to resolve such objections. Upon TiGenix’s written acceptance pay to the Buyer all of the draft Master Production Recordremaining Escrow Amount, or in the event including interest accrued on 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 TiGenixamount.
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 1 contract