Common use of Technology Transfer Clause in Contracts

Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by 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. CLIENT will inform LWI of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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. 3.3 LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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, LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheld.

Appears in 2 contracts

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

Technology Transfer. 3.1 Based on the information provided by 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. CLIENT will inform LWI LHI of any specific requirements CLIENT may have relating to the Master Production RecordSOW Documentation, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch. 3.2 CLIENT will cooperate with 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. 3.3 LWI LHI will deliver a draft version of the Master Production Record SOW Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. 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 CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production RecordSOW Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record SOW Documentation within ten fifteen (1015) business working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property LHI Inventions or LWI LHI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the 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 the Master Production Record SOW Documentation incorporates or contains any LWI Background LHI Intellectual Property, LWI Property or LHI Confidential Information that does not solely relate to Product or New General Application Intellectual PropertyProcess, then prior to any disclosure of such LWI Background LHI Intellectual Property, LWI Property or LHI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT Client shall obtain LWI’s written consent to such disclosureLHI prior approval, which consent shall not be unreasonably withheld.

Appears in 2 contracts

Sources: Manufacturing Services Agreement (Vascular Biogenics Ltd.), Manufacturing Services Agreement (Vascular Biogenics Ltd.)

Technology Transfer. 3.1 Based 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 CLIENT 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. CLIENT will inform LWI completion of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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 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) Product S▇▇▇▇ shall make available to GSK qualified S▇▇▇▇ Personnel having the necessary skill, expertise and sample packing experience to accomplish the activities set forth in such Technology Transfer Plan and shipping instructionsto 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, (v) Product specific cleaning and decontamination information. 3.3 LWI will deliver a draft version at GSK’s direction, that S▇▇▇▇ conduct analysis of the Master Production Record 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 CLIENT for its review research, Develop, Manufacture or Commercialize the Compound and approval any Product in the Field in the GSK Territory, S▇▇▇▇ will use Commercially Reasonable Efforts to deliver to GSK, or provide GSK with access to, such items. S▇▇▇▇ shall use Commercially Reasonable Efforts to ensure that all data, results and other information provided by S▇▇▇▇ to GSK pursuant to this Section 2.5 and the Technology Transfer Plan is true and accurate and was generated in accordance with the schedule Data Integrity Practices set forth in Schedule 4.11(b). 2. Other than as specifically provided in Section 1 above, the Statement terms and conditions of Workthe Agreement are not being modified by this Amendment 1 and will remain in full force and effect. 3. CLIENT will notify LWI in writing of any objections it has This Amendment 1 contains the Parties’ entire agreement with respect to the draft Master Production Record, and upon such notification, representatives subject matter of LWI and CLIENT will meet promptly to resolve such objectionsthis Amendment 1. 4. Upon CLIENT’s written acceptance This Amendment shall be governed by the laws of the draft Master Production RecordState of Delaware, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections without regard to the draft Master Production Record within ten (10) business days following receipt conflicts of such draft by CLIENT, such draft will be deemed approved by CLIENTlaw principles that would require application of different law. 3.4 The Process5. This Amendment may be executed in counterparts, Master Production Recordeach of which shall constitute an original, Specificationsbut 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., and any improvements or modifications thereto developed during the term via PDF) shall be effective delivery of a manually executed counterpart of this Agreement, but excluding any LWI Operating Documents, New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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, LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheldAmendment.

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 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. CLIENT will inform LWI LONZA of any specific requirements CLIENT may have relating to the Master Production RecordProject Documentation, including, without limitation, any information or procedures CLIENT 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Processa Batch. 3.2 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. 3.3 LWI LONZA will deliver a draft version of the Master Production Record applicable portions of the Project Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI LONZA in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI LONZA and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENTProject Documentation[***], such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property LONZA Inventions existing on or LWI prior to the Effective Date, or LONZA Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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 the Master Production Record Project Documentation incorporates or contains any LWI LONZA Background Intellectual Property, LWI Property or LONZA Confidential Information or New General Application Intellectual Propertyas agreed by the Parties under Section 3.1, prior to any disclosure of such LWI LONZA Background Intellectual Property, LWI Property or LONZA Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWILONZA’s written consent to such disclosure, which consent shall not be unreasonably withheld.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Affinia Therapeutics Inc.)

Technology Transfer. 3.1 Based on the information provided by 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. CLIENT will inform LWI XXXX of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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. 3.3 LWI XXXX will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI XXXX in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI XXXX and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property or LWI XXXX Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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, LWI XXXX Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI XXXX Background Intellectual Property, LWI XXXX Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWIXXXX’s written consent to such disclosure, which consent shall not be unreasonably withheld.

Appears in 1 contract

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

Technology Transfer. 3.1 Based on (i) In the information provided by CLIENT 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 Work. CLIENT will inform LWI Manufacturing Know-How by providing written notice to Corixa therefor during the period that commences upon exercise of any specific requirements CLIENT may have relating to the Master Production RecordOption and terminates on the later of December 31, including, without limitation, any information or procedures 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 CLIENT of such intention 2007 and the Parties will meet date the CSC determines that the Work Plan is fully completed (the "Transfer Request Period"). GSK shall have no right to discuss and attempt to agree a transfer of the 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 writing in accordance with Section 3 (e) (ii), the 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 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 instructionsFollowing agreement to the Manufacturing Know-How transfer work plan, (v) Product specific cleaning and decontamination information. 3.3 LWI will deliver a draft version of the Master Production Record Corixa shall transfer to CLIENT 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 Statement of Work. CLIENT will notify LWI in writing of any objections it has to the draft Master Production Recordtherein, and upon such notification, representatives of LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. CLIENT 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 the Master Production Record incorporates or contains any LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheldpayable quarterly in advance based upon ▇▇▇▇▇▇'s invoice therefore.

Appears in 1 contract

Sources: MPL Agreements (Corixa Corp)

Technology Transfer. 3.1 Based During the period beginning on the Effective Date until the date set out in Schedule ‎4.3 (the “Technology Transfer Period”), the Parties shall complete their respective activities under the Technology Transfer Plan, including Scynexis’s transfer to GSK of such Scynexis Know-How and specified quantities of such materials, as set out in Schedule ‎4.3; provided that either Party may propose amendments to the Technology Transfer Plan at any time during the Technology Transfer Period by delivering a written notice to the other Party for review and discussion; provided, further, that the Technology Transfer Plan may only be amended by mutual written agreement of the Parties. In furtherance of the foregoing, within [***] ([***]) Business Days following the Effective Date, the Parties will establish a technology transfer subcommittee 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 ‎4.3 or otherwise expressly agreed by the Parties in writing. Subject to the terms and conditions of this Agreement (including the Technology Transfer Plan), (a) during the [***] ([***]) period following the Effective Date (or such shorter or longer period as may be mutually agreed by the Parties to enable product release or execution of any studies), ▇▇▇▇▇▇▇▇ will deliver to GSK (or its designee) all such Know-How and specified quantities of such materials set forth in Schedule ‎4.3 as were in existence as of the Effective Date (including information and copies of documents related to any Compound or any Product (including Scynexis Regulatory Documentation for such Compounds and Products and CMC data and information and all non-clinical studies and Clinical Trial data and results referenced therein)), (b) Scynexis shall use Commercially Reasonable Efforts to (i) ensure that all information, documentation, data and quantities of materials to be provided to GSK in accordance with this Section ‎4.3 and the Technology Transfer Plan shall be provided in a format that is structured and indexed in a manner designated by GSK and that all relevant documents and files are clearly labelled and (ii) deliver to GSK (or its designee) copies of any and all documentation and source data (A) in Scynexis’s or its Affiliates’ possession and Control or (B) residing with any Third Party contractors of Scynexis or any of its Affiliates which Scynexis can reasonably obtain from them, in each case, used to generate such documents and files, (c) Scynexis shall make available to GSK qualified Scynexis Personnel having the necessary skill, expertise and experience to accomplish the activities set forth in such Technology Transfer Plan to answer any questions or provide instruction as reasonably requested by GSK during the Technology Transfer Period, (d) Scynexis shall use reasonable efforts to provide GSK with access to its CMOs involved in the Manufacture of any Compound or any Product, subject to customary confidentiality obligations, for purposes of facilitating the activities contemplated by the Technology Transfer Plan and (e) at GSK’s written request, Scynexis or its Affiliates shall assign to GSK or its designee any commitment or agreement set forth on Schedule ‎9.2(x) to the extent such commitments or agreements are assignable provided that Scynexis shall use good faith efforts to obtain any necessary consents for such assignment, and GSK or its designee shall assume all of Scynexis’s post-Effective Date obligations thereunder. Scynexis shall perform its obligations under the Technology Transfer Plan at its sole cost and expense, provided that any and all reasonable and documented FTE Costs incurred by Scynexis or its Representatives under this Section ‎4.3 to convert any information, documentation, data or quantities of materials into the format designated by GSK as contemplated above, and any and all Out-of-Pocket Costs incurred by Scynexis or its Representatives under this Section ‎4.3 except to the extent that such Out-of-Pocket Costs are incurred by Scynexis or its Representatives in connection with CMC activities required to be conducted to remedy any identified errors in existence as of the Effective Date that are necessary to be remedied in order to obtain or maintain the applicable Regulatory Approval) shall be reimbursed by GSK, and shall be due and payable within [***] ([***]) from the date on which GSK receives a Valid Invoice; provided further that (1) a good faith estimate of such Out-of-Pocket Costs and any good faith material updates of these good faith estimates of such Out-of-Pocket Costs shall be approved by GSK prior to such Out-of-Pocket Costs being incurred and if GSK does not provide such approval within [***] ([***]) of receipt from Scynexis of the estimate or updated estimate of the relevant Out-of-Pocket Costs, then Scynexis shall not be obligated to perform the applicable activity, and (2) to the extent GSK approves such estimate or updated estimate, GSK shall be obligated to pay the amount set forth in such Valid Invoice so long as such amount does not exceed such approved estimate or updated estimate, as applicable, by more than [***] percent ([***]%). Upon GSK’s request, the Scynexis Human Biological Samples and reasonable quantities of any and all fermentation strains being used by Scynexis or any of its Affiliates as of the Effective Date in the Manufacture of any Compound or any Product shall promptly be delivered by Scynexis to GSK to the extent permitted by any informed consent forms or applicable Law. If GSK identifies items Controlled by Scynexis or any of its Affiliates that were not included in the original Technology Transfer Plan but were being used by Scynexis or any of its Affiliates as of the Effective Date to Exploit any Compound and any Product in the Field in the GSK Territory, Scynexis will use Commercially Reasonable Efforts to deliver to GSK, or provide GSK with access to, copies or reasonable quantities of such items. Scynexis shall use Commercially Reasonable Efforts to ensure that all data, results and other information provided by CLIENT and including process changes developed by LWI Scynexis to GSK pursuant to any applicable Statement of Work, LWI will prepare this Section ‎4.3 and the Master Production Record for the Process Technology Transfer Plan is true and accurate in all material respects and was generated in accordance with the schedule Data Integrity Practices set forth in Schedule ‎4.10(b). Use of the Statement of Work. CLIENT will inform LWI of any specific requirements CLIENT may have relating Product Trademarks by Scynexis or its Affiliates during the Technology Transfer Period in connection with domain names, website materials, and social media handles shall be included in the Scynexis Retained Rights as contemplated in Section ‎2.3 solely to the Master Production Record, including, without limitation, any information extent such use is permitted or procedures CLIENT wishes to have incorporated therein. If LWI intends to include in required by the Master Production Record the use of any assay, medium, Technology Transfer Plan or other technology that is not commercially available, LWI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials otherwise as permitted or technology in the Processrequired hereunder. 3.2 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. 3.3 LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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, LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheld.

Appears in 1 contract

Sources: Exclusive License Agreement (Scynexis Inc)

Technology Transfer. 3.1 Based on the information provided by 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. CLIENT will shall inform LWI LONZA of any specific requirements CLIENT may have relating to the Master Production RecordProject Documentation, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will shall meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials Materials or technology in the Process. The applicable Project Documentation, as set forth in the SOW, shall be completed and delivered by LONZA at completion of a Batch. 3.2 CLIENT will 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. 3.3 LWI will LONZA shall deliver a draft version of the Master Production Record applicable portions of the Project Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will shall notify 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 CLIENT will shall meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production RecordProject Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record Project Documentation within ten (10) [***] business days following the receipt of such draft by CLIENT, such draft will shall be deemed to have been approved by CLIENT. 3.4 The Process, 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, New General Application Intellectual Property Documents or LWI Confidential Information of LONZA included in any of the foregoing, will shall be deemed CLIENT CLIENT’s property and Confidential Information and subject to the provisions set forth in Article 10. 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 the Master Production Record Project Documentation incorporates or contains any LWI Background Intellectual Property, LWI Property of LONZA or Confidential Information or New General Application Intellectual Propertyof LONZA, prior to any disclosure of such LWI Background Intellectual Property, LWI Property or Confidential Information or New General Application Intellectual Property of LONZA to, or use by, a Third Party manufacturer, CLIENT shall obtain LWILONZA’s written consent to such disclosure, which consent shall not be unreasonably withheld, delayed or conditioned.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Gracell Biotechnologies Inc.)

Technology Transfer. 3.1 Based Without limitation to MTEM’s obligations under Section 3.9, at Takeda’s request, for each Licensed Product, MTEM shall, at Takeda’s expense (subject to a mutually agreed reasonable budget with internal time to be calculated on an FTE basis based on a rate that reflects MTEM's actual costs for such FTE), transfer the Manufacturing process for such Licensed Product and any ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components thereof to Takeda or its designee (the “Technology Recipient”) as set forth in this Section 5.2, which transfer will comprise all necessary and available Know-How, documentation, methods, reagents, processes and other components to enable Takeda or its designee to independently Manufacture Licensed Products (such transfer, the “Technology Transfer”). 5.2.1 Within [***] after Takeda notifies MTEM that it is exercising Technology Transfer rights under this Section 5.2 with respect to a Licensed Product, MTEM shall deliver to the Technology Recipient copies of the then-current Manufacturing process for and any other information provided reasonably required in order to Manufacture such Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and other Components contained therein, including master batch records and any other manufacturing records (collectively, the “Technology Transfer Documentation”). 5.2.2 During such [***] and upon Takeda’s reasonable request with at least [***] notice to MTEM, MTEM shall also find a convenient time to permit representatives of the Technology Recipient or Takeda, as applicable, (the “Representatives”) to access the Facility during normal business hours to observe the Manufacturing of the Licensed Product and ▇▇▇▇ ▇▇▇-▇ Fusion Proteins included therein. While the Representatives are at the Facility, MTEM shall make available to the Representatives employees of MTEM (or its Affiliates or subcontractors) for consultation with respect to the Technology Transfer Documentation and the Manufacturing process for the Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein. 5.2.3 At Takeda’s request, MTEM shall use commercially reasonable efforts to effect assignments of any existing contract to the extent relating to one or more of the Licensed Products or the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein, or to obtain for Takeda substantially all of the practical benefit and burden under such agreement to the extent applicable to Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein, including by CLIENT entering into appropriate and including process changes developed reasonable alternative arrangements on terms agreeable to Takeda. Unless otherwise agreed by 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. CLIENT will inform LWI of any specific requirements CLIENT may have relating to the Master Production Recordthis Section 5.2, including, without limitationas applicable, any information or procedures CLIENT wishes obtaining and making available such information, personnel, products, materials, services, facilities and other resources as reasonably necessary to have incorporated therein. If 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 CLIENT of such intention and the Parties will meet cured by MTEM pursuant to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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. 3.3 LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property or LWI Confidential Information included in any which case MTEM shall bear all of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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, LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheldits own expenses.

Appears in 1 contract

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

Technology Transfer. 3.1 Based on the information provided by 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. CLIENT will inform LWI of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. [*] = 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 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. 3.3 LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly (whether in person or by teleconference) to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business [*] days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. CLIENT [*]. 3.5 Any subsequent transfer of documentation, specifications, and production process [*] from LWI’s facility in Walkersville, Maryland to another Facility for the manufacturing of the Product [*] shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product[*]; provided, however, that if any such transfer [*], shall be [*]. For the Process and/or avoidance of doubt, in the Master Production Record incorporates or contains any LWI Background Intellectual Propertyevent a subsequent transfer is [required for commercial manufacturing purposes], LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheldthe Parties will [*].

Appears in 1 contract

Sources: Manufacturing Services Agreement (Gamida Cell Ltd.)

Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by 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. CLIENT will inform LWI of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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 this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406 3.3 LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly (whether in person or by teleconference) to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business [*] days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. CLIENT [*]. 3.5 Any subsequent transfer of documentation, specifications, and production process [*] from LWI’s facility in Walkersville, Maryland to another Facility for the manufacturing of the Product [*] shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product[*]; provided, however, that if any such transfer [*], shall be [*]. For the Process and/or avoidance of doubt, in the Master Production Record incorporates or contains any LWI Background Intellectual Propertyevent a subsequent transfer is required for commercial manufacturing purposes, LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheldthe Parties will [*].

Appears in 1 contract

Sources: Manufacturing Services Agreement (Gamida Cell Ltd.)

Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by 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. CLIENT will inform LWI of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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. 3.3 LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule corresponding budget set forth in the Statement agreed technology transfer plan, it being understood that such approved budget shall incorporate into the budget an allowance of Work. CLIENT [**] 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 CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENTassociated 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, New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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, LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheld.

Appears in 1 contract

Sources: License and Collaboration Agreement (Merrimack Pharmaceuticals Inc)

Technology Transfer. 3.1 Based on the information provided by 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. CLIENT will inform LWI L WI of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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. 3.3 LWI L WI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI L WI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s 's written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s 's objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property L WI Inventions or LWI L WI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject subj ect to the provisions set forth in Article 10. 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 LWI Background L WI Intellectual Property, LWI Property or L WI Confidential Information or New General Application Intellectual PropertyInformation, prior to any disclosure of such LWI Background Intellectual Property, LWI Property or L WI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s L WI's written consent to such disclosure, which consent shall not be unreasonably withheld. * Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment and those portions have been filed separately with the Securities and Exchange Commission.

Appears in 1 contract

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

Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by 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. CLIENT will inform LWI of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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. 3.3 LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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, Property or LWI Confidential Information or New General Application Intellectual PropertyInformation, prior to any disclosure of such LWI Background Intellectual Property, Property or LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheld.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Genesis Biopharma, Inc)

Technology Transfer. 3.1 Based on 2.1 Within 2 weeks after the information provided by CLIENT signature of this Agreement, and including process changes developed by LWI pursuant prior to any applicable Statement of WorkManufacturer’s obligations to Manufacture the Product hereunder arising, LWI Cambridge will prepare supply and transfer to Manufacturer all the Master Production Record for Technical Information that it has in its possession or control to enable Manufacturer to Manufacture and adequately transport the Process Product, the Raw Materials and the Active Substance in accordance with the schedule set forth Specifications, GMP and this Agreement and more generally to fulfil all of its obligations hereunder. 2.2 As from the date of signature hereof and throughout the Validation process, Cambridge will promptly provide such technical assistance as may reasonably be requested to enable the effective transfer of the Technical Information referred to in clause 2.1 and to enable the Statement of Work. CLIENT will inform LWI of any specific requirements CLIENT may have relating Manufacturer to carry out the Master Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LWI intends to include in Validation and Manufacture the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform CLIENT Product. 2.3 Upon receipt of such intention Technical Information 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 CLIENT will cooperate with LWI to assist LWI to develop the Master Production Record and Processtechnical assistance, 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 Manufacturer shall carry out Validation of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information. 3.3 LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval Manufacture in accordance with the schedule set forth Protocol. 2.4 In accordance with the Protocol, Manufacturer shall Manufacture three (3) Validation Batches of the Product in accordance with the Specifications for use in the Statement of WorkValidation process. CLIENT will notify LWI in writing of any objections it has This Validation process may include Stability Studies to the draft Master Production Recordcurrent ICH standards. 2.5 Notwithstanding anything else herein contained, and upon such notification, representatives of LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance should (i) Validation of the draft Master Production Recordprocess of Manufacture not be proven in accordance with the Protocol; (ii) should Manufacturer be unable for whatever reason to Manufacture the Product in accordance with the Technical Conditions, the Specifications, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding or (iii) the Regulatory Authorities not approve the Product, the parties shall meet and discuss the issues and the means by which any LWI Operating Documentsproblems may be resolved. If the issues preventing the Validation are not able to be overcome to the satisfaction of Cambridge, New General Application Intellectual Property or LWI Confidential Information included in any Cambridge may terminate this Agreement on provision of the foregoing, will be deemed CLIENT Confidential Information at least 1 month’s written notice and subject to the provisions set forth in Article 1013 shall apply. CLIENT Manufacturer may terminate this Agreement during or at the end of the Validation process in the event that Validation is not carried out to Manufacturer’s satisfaction and the provisions set forth in Article 13 shall be permitted to use apply. 2.6 Cambridge shall pay Manufacturer for the Process and/or Validation in accordance with Part A of Schedule 3. For the Master Production Record to manufacture and sell Product; providedsake of clarity, however, that if the Process and/or Validation is unsuccessful Cambridge shall only be required to pay for those modules of the Master Production Record incorporates or contains any LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property, Validation process that were completed by Manufacturer prior to any disclosure of such LWI Background Intellectual Propertythe failure, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheldplus those other costs as set forth in Article 13 hereof.

Appears in 1 contract

Sources: Contract Manufacture Agreement (Biovail Corp International)

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 CLIENT 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. CLIENT will inform LWI of any specific requirements CLIENT may have relating to the Master Production RecordHoneywell Trident missile retrofit program, including, without limitation, any information or procedures 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 and (iii) further provided that is not commercially available, LWI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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 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. 3.3 LWI will deliver a draft version are not satisfied prior to the second anniversary of the Master Production Record to CLIENT for its review Closing Date, Buyer and approval in accordance with the schedule set forth in the Statement of Work. CLIENT 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 CLIENT will meet promptly Escrow Agent to resolve such objections. Upon CLIENT’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 CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENTamount. 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, New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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, LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheld.

Appears in 1 contract

Sources: Asset Purchase Agreement (Optelecom-Nkf, Inc.)

Technology Transfer. 3.1 Based on the information provided by 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. CLIENT will inform LWI of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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. 3.3 LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 1010 . 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, Property or LWI Confidential Information or New General Application Intellectual PropertyInformation, prior to any disclosure of such LWI Background Intellectual Property, Property or LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be unreasonably withheld.

Appears in 1 contract

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

Technology Transfer. 3.1 Based on [***] following the information provided by CLIENT 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. CLIENT will inform LWI of any specific requirements CLIENT may have relating to current “as-is” form and format, the Master Production Record, including, without limitation, any information or procedures 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 CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 3.2 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 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 other information reasonably requested by Licensee within [***] of the Technology Transfer Period and used exclusively for the 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 listed on Schedule C and there shall be no further obligation by L▇▇▇▇ to provide any technical information, 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 vendorany expression vector, grade cell-line, cell-based media or any of its components) or processes or device technology or processes, or any other technology, of Lilly and sampling/testing requirements)its Affiliates. The technology transfer shall occur in an orderly fashion and in a manner such that the value, (iv) Product usefulness and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information. 3.3 LWI will deliver a draft version confidentiality of the Master Production Record to CLIENT for its review transferred Licensed Know-How and approval regulatory documentation are preserved in accordance with the schedule set forth in the Statement all material respects. The implementation and transfer of Work. 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 CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT. 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, New General Application Intellectual Property or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. CLIENT information pursuant hereto shall be permitted to use conducted through electronic, email and teleconference consultation between the Process and/or the Master Production Record to manufacture and sell ProductParties; provided, however, provided that if the Process and/or the Master Production Record incorporates or contains any LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent L▇▇▇▇ shall not be unreasonably withheldrequired 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 specifically described in this Agreement.

Appears in 1 contract

Sources: License, Development and Commercialization Agreement (Zura Bio LTD)