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 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 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.. [*] = 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 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 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 SEATTLE GENETICS possesses confidential and proprietary technical information not in the information provided public domain that is necessary to the process of manufacturing the Product, including without limitation in process assays, methods, formulas, specifications, processes and know-how (the "SEATTLE GENETICS Information"), that is the subject of various patents, patents applications and Know-How owned or controlled by CLIENT SEATTLE GENETICS ("the "SEATTLE GENETICS Intellectual Property", and including process changes developed by LWI pursuant collectively with the SEATTLE GENETICS Information, the "SEATTLE GENETICS Technology"). SEATTLE GENETICS Information shall be included in a technology transfer dossier to any applicable Statement of Work, LWI be shared with Gensia Sicor.
2.2.1 Gensia Sicor and SEATTLE GENETICS will prepare the mutually develop a Master Production Batch Record for the Process Product following the technical specifications, methods and know-how provided by SEATTLE GENETICS.
2.2.2 SEATTLE GENETICS will transfer to Gensia Sicor appropriate methods and in accordance with process assays for manufacturing the schedule set forth Product. Such methods and in the Statement of Work. CLIENT process assays, being reviewed and agreed to by SEATTLE GENETICS, will inform LWI of any specific requirements CLIENT may have relating be confirmed, or if requested, validated by Gensia Sicor for their application to the Master Production Recordfinished Product.
2.2.3 A protocol describing distribution of Product will be provided to Gensia Sicor by SEATTLE GENETICS for review and acceptance prior to commencement of the manufacturing of finished dosage Product. Distribution of clinical Product will be coordinated between Gensia Sicor and SEATTLE GENETICS.
2.2.4 SEATTLE GENETICS hereby grants Gensia Sicor a non-exclusive, including, without limitation, any information or procedures CLIENT wishes non-transferable right under the SEATTLE GENETICS Intellectual Property to have incorporated therein. If LWI intends use the SEATTLE GENETICS Information solely for the purpose of manufacturing the Product pursuant 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 this Agreement. Gensia Sicor (a) acknowledges that SEATTLE GENETICS and/or its licensors retain all ownership rights in and to the SEATTLE GENETICS Technology and (b) agrees not to use the SEATTLE GENETICS Technology for any purpose other than manufacturing the Product for SEATTLE GENETICS hereunder. Gensia Sicor agrees to treat all of such the SEATTLE GENETICS Technology as "Confidential Information" pursuant to Article VIII hereof. [***] Confidential treatment requested
2.2.5 Either party may jointly or independently make or otherwise acquire rights to non-commercially available materials patentable discoveries, improvements, ideas and other intellectual property rights (including without limitation processes and methods) or technology Know-How useful in the 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 manufacture of the following: Product (i) manufacturing process information"Developments"). Any Developments conceived, SOPsfashioned or acquired solely by Gensia Sicor shall be owned solely by Gensia Sicor. Gensia Sicor shall promptly disclose all such Developments, development reportsin writing, (ii) quality control assaysto SEATTLE GENETICS, (iii) raw material specifications (including vendorand hereby grants to SEATTLE GENETICS a non-exclusive, grade and sampling/testing requirements)worldwide, (iv) Product and sample packing and shipping instructionsperpetual, (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 royalty-free license, with the schedule set forth in right to sublicense, to use each such Development for the Statement development and manufacture of WorkSEATTLE GENETICS' products. CLIENT will notify LWI in writing of any objections it has to the draft Master Production RecordAny Developments conceived, 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, fashioned 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 acquired solely 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 SEATTLE GENETICS during the term of this AgreementAgreement shall be owned solely by SEATTLE GENETICS. Any Developments conceived, but excluding fashioned or acquired jointly by employees of Gensia Sicor and employees of SEATTLE GENETICS shall be jointly owned by both parties.
2.2.6 The parties do not expect that any LWI Operating Documentspatentable inventions, New General Application Intellectual Property discoveries, improvements or LWI Confidential Information included in any ideas relating to the manufacture of the foregoing, Product ("Product Inventions") will be deemed CLIENT Confidential Information and subject made, conceived or reduced to practice during the provisions set forth in Article 10course of the work performed under this Agreement. CLIENT However, any Product Inventions that are developed or acquired solely by Gensia Sicor shall be permitted owned solely by Gensia Sicor ("Gensia Sicor Product Inventions"). Gensia Sicor shall not use or incorporate any Gensia Sicor Product Inventions in the course of the work performed under this Agreement without first disclosing such Gensia Sicor Product Inventions to use SEATTLE GENETICS and obtaining prior written approval from SEATTLE GENETICS, upon which the Process and/or parties agree to negotiate in good faith the Master Production Record to manufacture terms of a license agreement on commercially reasonable terms for such Gensia Sicor Product Inventions. Any Product Inventions developed or acquired solely by SEATTLE GENETICS during the term of this Agreement shall be owned solely by SEATTLE GENETICS. Any Product Inventions developed or acquired jointly by employees of Gensia Sicor and 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 employees of SEATTLE GENETICS shall be jointly owned by both parties. With respect to any disclosure filings related to jointly owned Inventions, the parties shall work together to identify mutually agreeable intellectual property counsel and shall share equally in all costs of such LWI Background Intellectual Propertyfiling any applications and maintaining intellectual property protection. Inventorship shall be determined under U.S. patent law.
2.2.7 During the Term, LWI Confidential Information or New General Application Intellectual Property to, or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent Gensia Sicor agrees not to such disclosure, which consent shall not be unreasonably withheld[***].
Appears in 1 contract
Sources: Clinical Supply Agreement (Seattle Genetics Inc /Wa)
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.
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Sources: Manufacturing Services Agreement (Genesis Biopharma, Inc)