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 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. CLIENT TiGenix will inform LWI of any specific requirements CLIENT TiGenix may have relating to the Master Production Record, including, without limitation, any information or procedures CLIENT 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 CLIENT TiGenix of such intention and intention. If TiGenix agrees with such intention, the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process.
3.2 CLIENT 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 CLIENT TiGenix for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. CLIENT 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 CLIENT TiGenix will meet promptly to resolve such objections. Upon CLIENTTiGenix’s written acceptance of the draft Master Production Record, or in the event that CLIENT TiGenix does not submit a written notice setting forth CLIENTTiGenix’s objections to the draft Master Production Record within ten (10) business days Business Days following receipt of such draft by CLIENTTiGenix, such draft will be deemed approved by CLIENTTiGenix.
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 TiGenix Confidential Information and subject to the provisions set forth in Article 10. CLIENT 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 the Master Production Record incorporates or contains any LWI Background Intellectual Property, the terms of Section 11 shall apply.
3.5 Any subsequent transfer of documentation, specifications, and production process by 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 from LWI’s written consent facility in Walkersville, Maryland to another Facility for the manufacturing of the Product specifically for TiGenix shall be at TiGenix’s expense, if such disclosure, which consent shall not be unreasonably withheldtransfer is at the request of TiGenix.
Appears in 2 contracts
Sources: Manufacturing Services Agreement (TiGenix NV), Manufacturing Services Agreement (TiGenix NV)
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process definition or changes developed by LWI LONZA pursuant to any applicable Statement of Work, LWI LONZA will use commercially reasonable efforts to prepare the Master Production Record Project Documentation for the Process in accordance with the schedule set forth in the Statement of Work. 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 LONZA intends to include in the Master Production Record Project Documentation the use of any assay, medium, or other technology that is not commercially available, LWI LONZA will inform 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 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 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 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 receipt of such draft by CLIENT, 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, LONZA Inventions, Lonza New General Application Intellectual Property IP, or LWI LONZA Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 109. CLIENT shall be permitted to use the Process and/or the Master Production Record Project Documentation to manufacture and sell Product; provided[***]. [***] = Certain information contained in this document, howevermarked by brackets, that has been omitted because it is both not material and would be competitively harmful if publicly disclosed.
3.5 All CLIENT Materials shall remain the Process and/or sole property of CLIENT and are the Master Production Record incorporates or contains any LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property, prior of CLIENT. LONZA shall use the CLIENT Materials solely to perform its obligations under this Agreement and shall not transfer the CLIENT Materials to any disclosure of such LWI Background Intellectual Property, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, without CLIENT’s prior written consent. The CLIENT shall obtain LWIMaterials supplied under this Agreement must be used a) with prudence and appropriate caution because not all of their characteristics may be known and b) ) in accordance with CLIENT’s written consent to such disclosureinformation and instructions, which consent shall not be unreasonably withheldinclude a statement of content/formulation/ingredients, storage conditions, expiration information and safety and hazard information. Except as expressly set forth in this Agreement, THE CLIENT MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, OTHER THAN AS TO THE ACCURACY AND CORRECTNESS OF THE INFORMATION AND INSTRUCTIONS PROVIDED PURSUANT TO THIS SECTION, AND CLIENT EXPRESSLY DISCLAIMS ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE.
Appears in 1 contract
Technology Transfer. 3.1 Based on Prior to manufacturing the Product, a technology transfer of the manufacturing process will be performed from Purchaser to SWI. Purchaser shall disclose (and provide copies, as applicable) to SWI all information provided by CLIENT and including process changes developed by LWI pursuant related to any applicable Statement the manufacture of Workthe Product in Purchaser’s possession, LWI will prepare the Master Production Record that is required for the Process manufacture of the Product by SWI (collectively “Manufacturing Technology”); provided that any such information is used solely for the purpose of manufacturing the Product in accordance with this Agreement. SWI acknowledges that such Manufacturing Technology is and shall remain the schedule sole property of Purchaser and/or its Affiliates, and nothing herein shall be deemed to convey to SWI any right therein except as required for the purpose of manufacturing the Product in accordance with this Agreement. The steps, planning and obligations of the Parties regarding the transfer of the Manufacturing Technology for such Product are set forth in the Statement technology transfer master plan attached in Exhibit D (the “Technology Transfer Master Plan”). Provided that Purchaser supply SWI with the needed amount of WorkCompound at *** to SWI, SWI will manufacture the required number of Batches as outlined in the Technology Transfer Master Plan and a minimum of *** validation Batches of Product. CLIENT will inform LWI of Purchaser shall be responsible for any specific and all regulatory requirements CLIENT may have relating with respect to the Product. SWI shall provide to Purchaser data required by Purchaser to qualify SWI’s facility as per the Technology Transfer Master Production RecordPlan. Upon request, includingPurchaser will provide SWI with, without limitation, any information assistance or procedures 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 nonon-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 site support as may be reasonably required to create by SWI in connection with the Master Production Record, Process, and/or any transfer of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 LWI technology. Such assistance will deliver be provided *** for a draft version number of the Master Production Record to CLIENT for its review and approval in accordance with the schedule days as set forth in the Statement of WorkTechnology Transfer Master Plan. CLIENT will notify LWI Purchaser shall support the one-time costs as described in writing of the Technology Transfer Master Plan and purchase from SWI each validation Batch that meets the Specifications at the Price set forth in Exhibit B. If any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Master Production Recordvalidation Batches of a Product does not comply with the Specifications, or Supplier shall have *** (***) months to re-manufacture and deliver the number of validation Batch(es) that failed to meet the Specifications. If SWI is unable within that *** (***)-month period to manufacture and deliver to Purchaser the validation Batch(es), Section 9.2(c) shall apply. Purchaser will be reimbursed for *** any validation Batches that fail to meet the Specifications, in the event that CLIENT does not submit a written notice setting forth CLIENTsuch failure is due to SWI’s objections mistake, negligence or failure to follow Purchaser’s instructions. In the draft Master Production Record within ten (10) business days following receipt of such draft by CLIENTevent any validation batches fail to meet the Specifications for any other reason, such draft will be deemed approved by CLIENT.
3.4 The Processexcept for Purchaser’s mistake, Master Production Record, Specifications, and negligence or failure to provide SWI with any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, New General Application Intellectual Property or LWI Confidential Information included in any portion of the foregoingManufacturing Technology, SWI will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. 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
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 on (a) As promptly as possible but no later than [***], Micromet will identify to MedImmune a contract manufacturing organization that will manufacture Licensed Product for Micromet. Subject to such contract manufacturing organization executing an agreement pursuant to Section 5.4, MedImmune will provide Micromet and such identified manufacturer (to the information extent not previously provided by CLIENT MedImmune) with the Know-How in its possession as of the Effective Date that is MedImmune Process Technology, which includes, but is not limited to, and in each case that exists as of the Effective Date, technical reports and materials for process development activities that are relevant to and would be required for Micromet or its contract manufacturing organization to perform such Manufacturing Process (including but not limited to any master cell banks, working cell banks, fermentation processes, recovery steps established, process changes developed validation, product identity assays, in-process-control assays, relevant standard operating procedures, as well as samples of the working cell bank prepared at MedImmune, and technical methods for assays required for the applicable process. For clarity, all Know-How within MedImmune Process Technology in tangible form (except for biological, chemical, or physical materials) to be provided under this Section 5.1(a) are listed in Exhibit E-3. In addition, MedImmune will have the right to redact the documents to the extent they contain information that is not related to Manufacturing Process or information related to the recipe of Media Materials.
(b) Promptly after the Effective Date, the MedImmune Project Manager, his counterpart at Micromet, and other appropriate personnel of MedImmune and Micromet will meet to establish a plan for the transfer of the Manufacturing Process and the MedImmune Process Technology as is reasonable and customary in the industry for the transfer of manufacturing processes and designed to complete the transfer of the Manufacturing Process and the MedImmune Process Technology within the timeframe set forth in subsection (c) below (the “Transfer Plan”), which Transfer Plan will be deemed part of this Agreement and incorporated herein by LWI reference. Within [***]([***])[***] from the date on which MedImmune is informed of the contract manufacturing organization (“CMO”) selected by Micromet for the manufacture of the Licensed Product, MedImmune will make appropriate personnel available to meet with the CMO to initiate such process transfer. *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(c) MedImmune will use commercially reasonable efforts to complete transfer of the Manufacturing Process and the MedImmune Process Technology to such manufacturer within [***]([***])[***] from that first meeting. Such timelines will be extended for delays that are reasonably outside the control of MedImmune, including but not limited to delays related to the performance of Micromet, its contract manufacturer, or licensees. Upon completion of the transfer of the Manufacturing Process and the MedImmune Process Technology, MedImmune will not have any applicable Statement further obligations to provide additional MedImmune Process Technology to Micromet or its manufacturer.
(d) MedImmune's obligation with respect to the Manufacturing Process and the MedImmune Process Technology is limited to transfer of Work, LWI will prepare the Master Production Record for the Manufacturing Process Technology in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LWI of any specific requirements CLIENT may have relating this Section 5.1 and providing consulting services pursuant 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 Section 5.6 and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process.
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 MedImmune does not submit a written notice setting forth CLIENT’s objections to covenant, warrant or represent that 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 Manufacturing Process and/or the Master Production Record MedImmune Process Technology when used by or on behalf of Micromet or its sublicensees will be suitable for producing Clinical Materials and/or Licensed Product. *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to manufacture Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Under 17 C.F.R. §§ 200.80(b)(4), 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.240.24b-2
Appears in 1 contract
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process definition or changes developed by 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 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 (a) As promptly as possible but no later than [***], Micromet will identify to MedImmune a contract manufacturing organization that will manufacture Licensed Product for Micromet. Subject to such contract manufacturing organization executing an agreement pursuant to Section 5.4, MedImmune will provide Micromet and such identified manufacturer (to the information extent not previously provided by CLIENT MedImmune) with the Know-How in its possession as of the Effective Date that is MedImmune Process Technology, which includes, but is not limited to, and in each case that exists as of the Effective Date, technical reports and materials for process development activities that are relevant to and would be required for Micromet or its contract manufacturing organization to perform such Manufacturing Process (including but not limited to any master cell banks, working cell banks, fermentation processes, recovery steps established, process changes developed validation, product identity assays, in-process-control assays, relevant standard operating procedures, as well as samples of the working cell bank prepared at MedImmune, and technical methods for assays required for the applicable process. For clarity, all Know-How within MedImmune Process Technology in tangible form (except for biological, chemical, or physical materials) to be provided under this Section 5.1(a) are listed in Exhibit E-3. In addition, MedImmune will have the right to redact the documents to the extent they contain information that is not related to Manufacturing Process or information related to the recipe of Media Materials. *** Certain confidential information contained in this document, marked by LWI brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to any applicable Statement Rule 24b-2 of Workthe Securities Exchange Act of 1934, LWI as amended.
(b) Promptly after the Effective Date, the MedImmune Project Manager, his counterpart at Micromet, and other appropriate personnel of MedImmune and Micromet will prepare the Master Production Record meet to establish a plan for the transfer of the Manufacturing Process and the MedImmune Process Technology as is reasonable and customary in the industry for the transfer of manufacturing processes and designed to complete the transfer of the Manufacturing Process and the MedImmune Process Technology within the timeframe set forth in subsection (c) below (the “Transfer Plan”), which Transfer Plan will be deemed part of this Agreement and incorporated herein by reference. Within [***] from the date on which MedImmune is informed of the contract manufacturing organization (“CMO”) selected by Micromet for the manufacture of the Licensed Product, MedImmune will make appropriate personnel available to meet with the CMO to initiate such process transfer.
(c) MedImmune will [***] to complete transfer of the Manufacturing Process and the MedImmune Process Technology to such manufacturer within [***] from that first meeting. Such timelines will be extended for delays that are reasonably outside the control of MedImmune, including but not limited to delays related to the performance of Micromet, its contract manufacturer, or licensees. Upon completion of the transfer of the Manufacturing Process and the MedImmune Process Technology, MedImmune will not have any further obligations to provide additional MedImmune Process Technology to Micromet or its manufacturer.
(d) MedImmune's obligation with respect to the Manufacturing Process and the MedImmune Process Technology is limited to transfer of the Manufacturing Process Technology in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LWI of any specific requirements CLIENT may have relating this Section 5.1 and providing consulting services pursuant 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 Section 5.6 and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process.
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 MedImmune does not submit a written notice setting forth CLIENT’s objections to covenant, warrant or represent that 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 Manufacturing Process and/or the Master Production Record MedImmune Process Technology when used by or on behalf of Micromet or its sublicensees will be suitable for producing Clinical Materials and/or Licensed Product. *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to manufacture and sell Product; providedRule 24b-2 of the Securities Exchange Act of 1934, however, that if the Process and/or 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 withheldas amended.
Appears in 1 contract
Technology Transfer. 3.1 Based on (a) Sublicensee acknowledges and agrees that ECC has delivered and made to Sublicensee a disclosure of a general introduction to the Technology and to its commercial feasibility prior to the execution of this Agreement. Except to the extent such information provided falls within one or more of the exceptions to the definition of "Confidential Information", all information disclosed by CLIENT ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and including process changes developed shall be deemed to be confidential. The timing and extent of additional disclosure by LWI pursuant ECC to any applicable Statement of Work, LWI will prepare the Master Production Record for the Process in accordance with the schedule Sublicensee shall be as 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 Processsubparagraph 22(b) hereof.
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: (ib) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 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 execution of this Agreement, but excluding any LWI Operating Documents, New General Application Intellectual Property or LWI Confidential Information included in any ECC shall provide Sublicensee with copies of the foregoingpatents listed in Section B of Exhibit "B" hereto. Beyond that, will 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 ECC shall not be unreasonably withheldrequired to provide additional information concerning, or disclosure of the Technology to Sublicensee until Sublicensee provides to ECC (i) written notice of Sublicensee's intent to commercialize a Product, which written notice shall include detailed specifications for the designated Product, and (ii) evidence, reasonably satisfactory to ECC, of Sublicensee's intent to commercialize the designated Product in the form of written documentation of orders placed by Sublicensee of the equipment needed by Sublicensee to produce and commercialize the designated Product or in the form of written documentation from Sublicensee confirming the dedication and/or modification of existing equipment necessary to produce the designated Product. Within ninety (90) days after ECC's receipt of the items described in the preceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (w) a Product specific recipe for the production of the designated Product; (x) Product specific process specifications for the production of the designated Product; (y) copies of all patent applications listed in the Exhibits hereto that ECC deems relevant to the production of the designated Product; and (z) a list of known raw materials suppliers and preferred equipment vendors.
Appears in 1 contract
Technology Transfer. 3.1 Based on the information provided by CLIENT and including process changes developed by 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 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 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 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 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.)