Technology Transfer. 31.1 If: (A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) Clause 31.3 applies; or (C) Clause 32.3 applies where Purchaser is the Terminating Party; or (D) Clause 32.5 applies; or (E) Clause 32.6(B) applies; or (F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property in accordance with the Technology Transfer Plan and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F). 31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK. 31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of: (A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser. 31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein. 31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that: (A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products; (B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and (C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 2 contracts
Samples: Commercial Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Commercial Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is 3.1 Based on the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production information provided by CLIENT and including process employed changes developed by GSK in the Manufacture of the Products and (unless initiated LWI pursuant to Clause 31.2) shall be developed based on any applicable Statement of Work, LWI will prepare the expected date of expiry or termination of this Agreement and Master Production Record for the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan 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 timelinesParties 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, formatsincluding, without limitation, by providing LWI with additional information and other guidelines set forth therein. Except for a Technology Transfer pursuant procedures as may be required to Clause 31.1(C)create the Master Production Record, 31.1(D)Process, 31.1(E) or 31.1(F), and/or any of the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is following: (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or 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 is terminated by Agreement, but excluding any LWI Operating Documents, New General Application Intellectual Property or LWI Confidential Information included in any of the Purchaser pursuant foregoing, will be deemed CLIENT Confidential Information and subject to Clause 32.3(A) 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 Clause 37.2contains any LWI Background Intellectual Property, the Technology Transfer Plan will survive for [***] from LWI Confidential Information or New General Application Intellectual Property, prior to any disclosure of such termination LWI Background Intellectual Property, LWI Confidential Information or expiration date. For clarityNew General Application Intellectual Property to, the Purchaser or use by, a Third Party manufacturer, CLIENT shall obtain LWI’s written consent to such disclosure, which consent shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F)unreasonably withheld.
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 2 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Heat Biologics, Inc.)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is 3.1 Based on the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production information provided by TiGenix and including process employed changes developed by GSK in the Manufacture of the Products and (unless initiated LWI pursuant to Clause 31.2) shall be developed based on any applicable Statement of Work, LWI will prepare the expected date of expiry or termination of this Agreement and Master Production Record for the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan and the timelines, formats, and other guidelines schedule set forth in the Statement of Work. TiGenix will inform LWI of any specific requirements TiGenix may have relating to the Master Production Record, including, without limitation, any information or procedures TiGenix wishes to have incorporated therein. Except for a Technology Transfer pursuant If LWI intends to Clause 31.1(C)include in the Master Production Record the use of any assay, 31.1(D)medium, 31.1(E) or 31.1(F)other technology that is not commercially available, LWI will inform TiGenix of such intention. If TiGenix agrees with such intention, the Purchaser shall reimburse GSK for Parties will meet to discuss and attempt to agree in good faith on the terms of use of such Technology Transfer support services [***]. The Purchaser non-commercially available materials or technology in the Process.
3.2 TiGenix will reimburse GSK for such services pursuant cooperate with LWI to Clause 13 (Invoice assist LWI to develop the Master Production Record and Payment). If there is 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) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information; in each case, to the extent such information and procedures are in TiGenix’s possession or control, or can be procured by TiGenix without material time and cost expenditures.
3.3 LWI will deliver a draft version of the Master Production Record to TiGenix for its review and approval in accordance with the schedule set forth in the relevant Statement of Work. TiGenix will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and TiGenix will meet promptly to resolve such objections. Upon TiGenix’s written acceptance of the draft Master Production Record, or in the event that TiGenix does not submit a written notice setting forth TiGenix’s objections to the draft Master Production Record within ten (10) Business Days following receipt of such draft by TiGenix, such draft will be deemed approved by TiGenix.
3.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement is terminated by Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the Purchaser pursuant foregoing, will be deemed TiGenix Confidential Information and subject to Clause 32.3(A) the provisions set forth in Article 10. TiGenix shall be permitted to use the Process and/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or Master Production Record incorporates or Clause 37.2contains any LWI Intellectual Property, the Technology Transfer Plan will survive terms of Section 11 shall apply.
3.5 Any subsequent transfer of documentation, specifications, and production process by LWI from LWI’s facility in Walkersville, Maryland to another Facility for [***] from such termination or expiration date. For clarity, the Purchaser manufacturing of the Product specifically for TiGenix shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transferat TiGenix’s expense, if such Technology Transfer has been initiated by transfer is at the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F)request of TiGenix.
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 2 contracts
Samples: Manufacturing Services Agreement (TiGenix NV), Manufacturing Services Agreement (TiGenix NV)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is 3.1 Based on the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production information provided by CLIENT and including process employed changes developed by GSK in the Manufacture of the Products and (unless initiated LHI pursuant to Clause 31.2) shall be developed based on any applicable Statement of Work, LHI will prepare the expected date of expiry or termination of this Agreement and SOW Documentation for the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan schedule set forth in the Statement of Work. CLIENT will inform LHI of any specific requirements CLIENT may have relating to the SOW Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI intends to include in the SOW Documentation the use of any assay, medium, or other technology that is not commercially available, LHI will inform CLIENT of such intention and the timelines, formats, Parties will meet to discuss and other guidelines set forth therein. Except for a Technology Transfer pursuant attempt to Clause 31.1(C), 31.1(D), 31.1(E) agree in good faith on the terms of use of such non-commercially available materials or 31.1(F), technology in the Purchaser shall reimburse GSK for such Technology Transfer support services [***]Process. The Purchaser SOW Documentation shall be completed and delivered by LHI at completion of a Batch.
3.2 CLIENT will reimburse GSK for such services pursuant cooperate with LHI to Clause 13 (Invoice assist LHI to develop the SOW Documentation and Payment). If there is Process, including, without limitation, by providing LHI with additional information and procedures as may be required to create the SOW Documentation, Process, and/or any of the following: (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or 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 LHI will deliver a draft version of the SOW Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
3.4 The Process, SOW Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement is terminated Agreement, but excluding any LHI Operating Documents, LHI Inventions or 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 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 Purchaser pursuant Process and/or the SOW Documentation incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Clause 32.3(A) Product or Clause 37.2Process, the Technology Transfer Plan will survive for [***] from then prior to any disclosure of such termination LHI Intellectual Property or expiration date. For clarityLHI Confidential Information to, the Purchaser or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F)unreasonably withheld.
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Vascular Biogenics Ltd.), Manufacturing Services Agreement (Vascular Biogenics Ltd.)
Technology Transfer. 31.1 30.1 If:
(A) Clause 31.2 appliesGSK will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.or
(B) Clause 31.3 30.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party31.6 applies; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B36.2(ii) applies; or
(F) Clause 37.2(ii) applies; , GSK shall, subject to Clause 31.5, shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products Products, and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property in accordance with the Technology Transfer Plan and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E30.1(C) or 31.1(F30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 12 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A31.3(A) or Clause 37.236.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E30.1(C) or 31.1(F30.1(D).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a 30.2 A Technology Transfer to a Second Source pursuant to may be implemented in the circumstances contemplated by Clause 31.1(A30.1(A) at any time by notice either in writing to GSKanticipation of expiry of this Agreement or in the event of termination of this Agreement.
31.3 30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial APINew Clinical Product; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. or
(B) a material or repeated failure on the part of GSK to Manufacture Commercial New Clinical Product or Commercial API (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
31.4 30.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B30.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)30.1(C), Purchaser shall be relieved of its obligations obligation under Clause 4.1 to purchase certain [***] of its requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 2 contracts
Samples: Clinical Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Clinical Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. 31.1 If:Without limitation to MTEM’s obligations under Section 3.10, at Takeda’s request, for each Takeda Target, MTEM shall transfer the Manufacturing process for the SLT-A Fusion Proteins and the Licensed Products to Takeda or its designee (the “Technology Recipient”) as set forth in this Section 5.2, which transfer will comprise all necessary and available Know-How, documentation, methods, reagents, processes and other components to enable Takeda or its designee to independently Manufacture Licensed Products (such transfer, the “Technology Transfer”).
5.2.1 Within [***] after Takeda notifies MTEM that it is exercising Technology Transfer rights under this Section 5.2, MTEM shall deliver to the Technology Recipient copies of the then-current Manufacturing process for and any other information reasonably required in order to Manufacture the SLT-A Fusion Proteins and the Licensed Products, including master batch records and any other manufacturing records (A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTcollectively, MARKED BY the “Technology Transfer Documentation”).
5.2.2 During such [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaserand upon Takeda’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property in accordance reasonable request with the Technology Transfer Plan and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, the Technology Transfer Plan will survive for least [***] from such termination notice to MTEM, MTEM shall also find a convenient time to permit representatives of the Technology Recipient or expiration dateTakeda, as applicable, (the “Representatives”) to access the Facility during normal business hours to observe the Manufacturing of the SLT-A Fusion Proteins and the Licensed Products. For clarityWhile the Representatives are at the Facility, MTEM shall make available to the Representatives employees of MTEM (or its Affiliates or subcontractors) for consultation with respect to the Technology Transfer Documentation and the Manufacturing process for the SLT-A Fusion Proteins and, if applicable, the Purchaser Licensed Products.
5.2.3 At Takeda’s request, MTEM shall not use commercially reasonable efforts to effect assignments of any existing contract to the extent relating to the SLT-A Fusion Proteins and the Licensed Products, or to obtain for Takeda substantially all of the practical benefit and burden under such agreement to the extent applicable to the SLT-A Fusion Proteins and the Licensed Products, including by entering into appropriate and reasonable alternative arrangements on terms agreeable to Takeda. Unless otherwise agreed by the Parties, any agreement with any contract manufacturing organization or other service provider entered into by MTEM on or after the Effective Date that relates to any SLT-A Fusion Protein or any Licensed Product shall be required assignable or otherwise transferable to reimburse GSK for any Takeda without the consent of the counterparty thereto to the extent related to such SLT-A Fusion Protein or, if applicable, Licensed Product.
5.2.4 Following the delivery of the Technology Transfer support servicesDocumentation, MTEM shall provide the Technology Recipient with reasonable access to MTEM’s employees for telephone or direct costs or expenses associated with such Technology Transferin person consultations regarding the Manufacture of the SLT-A Fusion Proteins and, if such applicable, the Licensed Products.
5.2.5 Without limiting the foregoing, MTEM shall take, and shall cause its Affiliates and subcontractors to take, all action and to do all things necessary, proper or advisable to complete the Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or this Section 5.2, including, as applicable, obtaining and making available such information, personnel, products, materials, services, facilities and other resources as reasonably necessary to enable the applicable Specifications, provided that (in each case) such failure is not due Technology Recipient to any act or omission of PurchaserManufacture the SLT-A Fusion Proteins and the Licensed Products.
31.4 Following a 5.2.6 Takeda shall pay MTEM for its reasonable, out-of-pocket costs and expenses incurred in the performance of its activities under this Section 5.2 unless the Technology Transfer undertaken pursuant is a response by Takeda to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved breach by MTEM of its supply obligations under Clause 4.1 to purchase certain requirements for Products from GSKhereunder, as set out thereinin which case MTEM shall bear all of its own expenses.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 2 contracts
Samples: Multi Target Collaboration and License Agreement (Molecular Templates, Inc.), Multi Target Collaboration and License Agreement (Molecular Templates, Inc.)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is 3.1 Based on the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production information provided by CLIENT and including process employed changes developed by GSK in the Manufacture of the Products and (unless initiated LWI pursuant to Clause 31.2) shall be developed based on any applicable Statement of Work, LWI will prepare the expected date of expiry or termination of this Agreement and Master Production Record for the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan 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 timelinesParties 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, formatsincluding, without limitation, by providing LWI with additional information and other guidelines set forth therein. Except for a Technology Transfer pursuant procedures as may be required to Clause 31.1(C)create the Master Production Record, 31.1(D)Process, 31.1(E) or 31.1(F), and/or any of the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is following: (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or manufacturing process information, SOPs, development reports, (ii) this Agreement is terminated by 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 Purchaser pursuant Master Production Record to Clause 32.3(A) or Clause 37.2CLIENT 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 Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support servicesdraft Master Production Record, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
(A) a material 3.4 The Process, Master Production Record, Specifications, and any improvements or repeated failure on modifications thereto developed during the part term of GSK this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to meetthe 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 Intellectual Property or LWI Confidential Information, prior to any disclosure of such LWI Intellectual Property or LWI Confidential Information to, or notification by GSK that it will be unable to meetuse by, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant manufacturer, CLIENT shall obtain LWI’s written consent to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1)disclosure.
Appears in 1 contract
Samples: Know How License and Stock Purchase Agreement (Regenicin, Inc.)
Technology Transfer. 31.1 30.1 If:
(A) Clause 31.2 appliesGSK will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.or
(B) Clause 31.3 30.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party31.6 applies; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B36.2(ii) applies; or
(F) Clause 37.2(ii) applies; , GSK shall, subject to Clause 31.5, shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products Products, and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place [***] = 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. an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property in accordance with the Technology Transfer Plan and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E30.1(C) or 31.1(F30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 12 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A31.3(A) or Clause 37.236.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E30.1(C) or 31.1(F30.1(D).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a 30.2 A Technology Transfer to a Second Source pursuant to may be implemented in the circumstances contemplated by Clause 31.1(A30.1(A) at any time by notice either in writing to GSKanticipation of expiry of this Agreement or in the event of termination of this Agreement.
31.3 30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial APINew Clinical Product; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. or
(B) a material or repeated failure on the part of GSK to Manufacture Commercial New Clinical Product or Commercial API (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
31.4 30.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B30.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)30.1(C), Purchaser shall be relieved of its obligations obligation under Clause 4.1 to purchase certain [***] of its requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 1 contract
Samples: Clinical Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; 3.1 Based on the information provided by CLIENT and including process definition or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTchanges developed by LONZA pursuant to any applicable Statement of Work, MARKED BY LONZA will [***] prepare the Project Documentation for the Process in accordance with the Statement of Work. CLIENT will inform LONZA of any specific requirements CLIENT may have relating to the Project Documentation, [***]. If [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property in accordance with the Technology Transfer Plan and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services LONZA will [***]. The Purchaser applicable Project Documentation, as set forth in the SOW, shall be completed and delivered by LONZA to CLIENT at completion of a Batch.
3.2 CLIENT will reimburse GSK for such services pursuant cooperate with LONZA to Clause 13 (Invoice assist LONZA to develop the Project Documentation and Payment). If there is Process, including, without limitation, by providing LONZA with additional information and procedures as may be required to create the Project Documentation, Process, and/or any of the following: (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or manufacturing process information, SOPs, development reports, (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(Aquality control assays, (iii) or Clause 37.2raw material specifications (including vendor, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(Cgrade and sampling/testing requirements), 31.1(D)(iv) Product and sample packing and shipping instructions, 31.1(E(v) or 31.1(F)Product specific cleaning and decontamination information.
31.2 Subject 3.3 LONZA will deliver a draft version of the applicable portions of the Project Documentation to Clause 4.1 CLIENT for its review and without prejudice to Clause 2.3, approval in accordance with the Purchaser may utilize one or more Third Parties to act as second source(s) schedule set forth in the Statement of manufacture for Products (each, a “Second Source”)Work. The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice CLIENT will notify LONZA in writing of any objections it has to GSK.
31.3 The Purchaser may elect the draft Master Production Record, and upon such notification, representatives of LONZA and CLIENT will meet promptly to implement a Technology Transfer pursuant to Clause 31.1(B) in resolve such objections. Upon CLIENT’s written acceptance of the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY draft Project Documentation[***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable such draft will be deemed approved by CLIENT.
3.4 The Process, Project Documentation, Specifications, provided that (and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LONZA Operating Documents, LONZA Inventions existing on or 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 the sole owner of each case) such failure is not due Process developed by the Parties hereunder and shall be free to use the Process and/or the Project Documentation either alone or with or for the benefit of any Third Party and to transfer or license the Process to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)Third Party manufacturer(s), Purchaser shall be relieved 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 Project Documentation incorporates or contains any LONZA Background Intellectual Property or LONZA Confidential Information as agreed by the Parties under Section 3.1, prior to any disclosure of its obligations under Clause 4.1 to purchase certain requirements for Products from GSKsuch LONZA Background Intellectual Property or LONZA Confidential Information to, as set out therein.
31.5 For the avoidance of doubtor use by, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient a Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant manufacturer, CLIENT shall obtain LONZA’s written consent to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1)disclosure.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Affinia Therapeutics Inc.)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is 3.1 Based on the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production information provided by CLIENT and including process employed changes developed by GSK in the Manufacture of the Products and (unless initiated L WI pursuant to Clause 31.2) shall be developed based on any applicable Statement of Work, L WI will prepare the expected date of expiry or termination of this Agreement and Master Production Record for the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan schedule set forth in the Statement of Work. CLIENT will inform 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, L WI will inform CLIENT of such intention and the timelinesParties 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 L WI to assist L WI to develop the Master Production Record and Process, formatsincluding, without limitation, by providing L WI with additional information and other guidelines set forth therein. Except for a Technology Transfer pursuant procedures as may be required to Clause 31.1(C)create the Master Production Record, 31.1(D)Process, 31.1(E) ancl/or 31.1(F), any of the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is following: (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or manufacturing process information, SOPs, development reports, (ii) this Agreement is terminated by 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 L WI will deliver a draft version of the Purchaser pursuant Master Production Record to Clause 32.3(A) or Clause 37.2CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify 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 written acceptance of the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support servicesdraft Master Production Record, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:that CLIENT does not submit a written notice setting forth CLIENT's objections to the draft Master Production Record within ten (10) days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
(A) a material 3.4 The Process, Master Production Record, Specifications, and any improvements or repeated failure on modifications thereto developed during the part term of GSK this Agreement, but excluding any L WI Operating Documents, L WI Inventions or L WI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subj ect to meetthe provisions set forth in Article 10. CLIENT shall be permitted to use the Process ancl/or the Master Production Record to manufacture and sell Product; provided, however, that if the Process and/or the Master Production Record incorporates or contains any L WI Intellectual Property or L WI Confidential Information, prior to any disclosure of such LWI Intellectual Property or L WI Confidential Information to, or notification by GSK that it will be unable to meetuse by, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site manufacturer, CLIENT shall obtain L WI's written consent to such disclosure. * Certain portions of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has this exhibit have been initiated in respect of Commercial API omitted pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to request for confidential treatment and those portions have been filed separately with the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1)Securities and Exchange Commission.
Appears in 1 contract
Samples: Know How License and Stock Purchase Agreement (Regenicin, Inc.)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT2.1 Within 2 weeks after the signature of this Agreement, MARKED BY [***]and prior to Manufacturer’s obligations to Manufacture the Product hereunder arising, HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology Cambridge will supply and transfer to Manufacturer all the Purchaser (Technical Information that it has in its possession or Purchaser’s designee) (control to enable Manufacturer to Manufacture and adequately transport the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to Product, the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry or termination of this Agreement Raw Materials and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Active Substance in accordance with the Technology Transfer Plan Specifications, GMP and this Agreement and more generally to fulfil all of its obligations hereunder.
2.2 As from the timelinesdate of signature hereof and throughout the Validation process, formatsCambridge will promptly provide such technical assistance as may reasonably be requested to enable the effective transfer of the Technical Information referred to in clause 2.1 and to enable the Manufacturer to carry out the Validation and Manufacture the Product.
2.3 Upon receipt of such Technical Information and technical assistance, and other guidelines set forth thereinManufacturer shall carry out Validation of the process of Manufacture in accordance with the Protocol.
2.4 In accordance with the Protocol, Manufacturer shall Manufacture three (3) Validation Batches of the Product in accordance with the Specifications for use in the Validation process. Except for a Technology Transfer pursuant This Validation process may include Stability Studies to Clause 31.1(C)current ICH standards.
2.5 Notwithstanding anything else herein contained, 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is should (i) an ongoing Technology Transfer at the time of expiration or termination Validation of the Agreement or process of Manufacture not be proven in accordance with the Protocol; (ii) should Manufacturer be unable for whatever reason to Manufacture the Product in accordance with the Technical Conditions, the Specifications, or this Agreement, or (iii) the Regulatory Authorities not approve the Product, the parties shall meet and discuss the issues and the means by which any problems may be resolved. If the issues preventing the Validation are not able to be overcome to the satisfaction of Cambridge, Cambridge may terminate this Agreement on provision of at least 1 month’s written notice and the provisions set forth in Article 13 shall apply. Manufacturer may terminate this Agreement during or at the end of the Validation process in the event that Validation is terminated by not carried out to Manufacturer’s satisfaction and the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, provisions set forth in Article 13 shall apply.
2.6 Cambridge shall pay Manufacturer for the Technology Transfer Plan will survive for [***] from such termination or expiration dateValidation in accordance with Part A of Schedule 3. For the sake of clarity, if the Purchaser Validation is unsuccessful Cambridge shall not only be required to reimburse GSK pay for any Technology Transfer support servicesthose modules of the Validation process that were completed by Manufacturer prior to the failure, or direct plus those other costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out thereinforth in Article 13 hereof.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 1 contract
Samples: Contract Manufacture Agreement (Biovail Corp International)
Technology Transfer. 31.1 If:
(Ai) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION In the event GSK has exercised the Option in accordance with Section 3 (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designeed) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products and (unless initiated pursuant to Clause 31.2ii) shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (Amendment, then, subject to the terms and conditions of the licences granted in the Purchase Agreement) applicable recordsthis Section 3 (e), documentation, Corixa shall transfer to GSK on a co-exclusive basis all Manufacturing Know-How for GSK's use solely in connection with the practice of the license set forth in Section 3 (d) (i).
(ii) GSK shall have the right to request the foregoing transfer of Manufacturing Know-How by providing written notice to Corixa therefor during the period that commences upon exercise of the Option and terminates on the later of December 31, 2007 and the date the CSC determines that the Work Plan is fully completed (the "Transfer Request Period"). GSK Intellectual Property shall have no right to a transfer of the Manufacturing Know-How if GSK has not provided Corixa a written request therefore during the Transfer Request Period.
(iii) In the event GSK requests such transfer in writing in accordance with Section 3 (e) (ii), the Technology Transfer Plan parties shall negotiate in good faith a Manufacturing Know-How transfer work plan, which work plan shall include the FTE rate for Corixa's FTEs who will perform such work plan and which work plan will be appended to this Amendment as Exhibit V and thereupon shall be incorporated into this Amendment. *CONFIDENTIAL TREATMENT REQUESTED.
(iv) Following agreement to the timelinesManufacturing Know-How transfer work plan, formats, and other guidelines Corixa shall transfer to GSK all then existing Manufacturing Know-How in accordance with such work plan. GSK shall fund Xxxxxx's efforts in performing such work plan as set forth therein. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser which funding shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out thereinpayable quarterly in advance based upon Xxxxxx's invoice therefore.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 1 contract
Samples: MPL Agreements (Corixa Corp)
Technology Transfer. 31.1 If:
Within a reasonable period of time (Anot to exceed [REDACTED: Term] after the Effective Date, Thera will provide SA with: (i) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTone copy of all the electronic documentation in CTD format filed with the Food and Drug Administration of the United States of America for the Product, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer except with respect to the Purchaser documentation listed in Schedule 2.3, (ii) all the documentation exchanged with Regulatory Authorities in each of the Countries, and (iii) if requested by the Regulatory Authorities of a Country, samples of the Product, the Product in semi-finished form and/or the Compound or Purchaser’s designeeexcipients . The subsections (i), (ii) and (iii) of this Article 2.3 shall be altogether referred to as the “Technology TransferTransferred Technology”). The Parties documentation exchanged with Regulatory Authorities in each of the Countries, if any, will not be provided to SA in CTD format and SA shall use Commercially Reasonable Efforts be responsible to create convert such documentation in such format or any other format at the sole cost and expense of SA. Further, SA shall be solely responsible for the translating or having translated any of the documentation transferred to SA correctly. SA shall bear all responsibility for the accuracy of the translation and all of the costs and expenses of translating any document provided by Thera under this Article 2.3 for the purpose of making Regulatory Filings with Regulatory Authorities. Thera, or a technology transfer plan relating Third Party designated by Thera and acting on behalf of Thera, shall make certain of its employees who are knowledgeable about the Product and the Licensed Technology reasonably available to SA for scientific and technical explanations, advice and related on-site support, if and to the extent reasonably requested by SA, supporting the filing of a MAA in connection with SA’s exercise of its rights and obligations under this Agreement. All such Licensed Technology Transfer provided to SA and all information and materials (in whatever form or medium), including the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to electronic documentation in CTD format filed with the production process employed by GSK in the Manufacture Food and Drug Administration of the Products and (unless initiated pursuant to Clause 31.2) United States of America for the Product, transferred, disclosed by or on behalf of Thera hereunder shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (remain Thera’s Confidential Information, subject to the terms and conditions of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property in accordance with the Technology Transfer Plan and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F)Article 11.
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 1 contract
Samples: Distribution and Licensing Agreement (Theratechnologies Inc.)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; 3.1 Based on the information provided by CLIENT and including the Process definition or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTchanges developed by LONZA pursuant to any applicable Statement of Work, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties LONZA shall use Commercially Reasonable Efforts commercially reasonable efforts to create a technology transfer plan relating to prepare the Technology Transfer (Project Documentation for the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan relevant Statement of Work. CLIENT shall inform LONZA of any specific requirements CLIENT may have relating to the Project Documentation, including, without limitation, any information or procedures CLIENT wishes to incorporate therein. If LONZA intends to include in the Project Documentation the use of any assay, medium, or other technology that is not commercially available, LONZA shall inform CLIENT of such intention and the timelinesParties shall 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, formats, and other guidelines as set forth therein. Except for in the SOW, shall be completed and delivered by LONZA at completion of a Technology Transfer pursuant Batch.
3.2 CLIENT shall reasonably cooperate with LONZA to Clause 31.1(C)assist LONZA to develop the Project Documentation and Process, 31.1(D)including, 31.1(E) or 31.1(F)without limitation, providing LONZA with additional information and procedures as LONZA may reasonably require to create the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is Project Documentation, Process, and/or any of the following: (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or manufacturing process information, SOPs, and development reports, (ii) this Agreement is terminated by quality control assays, (iii) Specifications of raw Materials (including vendor, grade and sampling/testing requirements), (iv) Product and sample packaging and shipping instructions, (v) Product-specific cleaning and decontamination information.
3.3 LONZA shall deliver a draft version of the Purchaser pursuant applicable portions of the Project Documentation to Clause 32.3(A) CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT shall notify LONZA in writing of any objections it has to such draft Project Documentation, and upon such notification, representatives of LONZA and CLIENT shall meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft Project Documentation, or Clause 37.2, in the Technology Transfer Plan will survive for event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Project Documentation within [***] from business days following the receipt of such termination draft by CLIENT, such draft shall be deemed to have been approved by CLIENT.
3.4 The Process, Project Documentation, Specifications, and any improvements or expiration datemodifications thereto developed during the term of this Agreement, but excluding any LONZA Operating Documents or Confidential Information of LONZA included in any of the foregoing, shall be deemed CLIENT’s property and Confidential Information and subject to the provisions set forth in Article 10. For clarityCLIENT shall be permitted to use the Process and/or the Project Documentation to manufacture and sell Product; provided, however, that if the Purchaser Process and/or the Project Documentation incorporates or contains any Intellectual Property of LONZA or Confidential Information of LONZA, prior to any disclosure of such Intellectual Property or Confidential Information of LONZA to, or use by, a Third Party manufacturer, CLIENT shall obtain LONZA’s written consent to such disclosure, which consent shall not be required to reimburse GSK for any Technology Transfer support servicesunreasonably withheld, delayed or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F)conditioned.
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 1 contract
Samples: Manufacturing Services Agreement (Gracell Biotechnologies Inc.)
Technology Transfer. 31.1 If:
During the period beginning on the Effective Date until the date set out in Schedule 4.3 (A) Clause 31.2 appliesthe “Technology Transfer Period”), the Parties shall complete their respective activities under the Technology Transfer Plan, including Scynexis’s transfer to GSK of such Scynexis Know-How and specified quantities of such materials, as set out in Schedule 4.3; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTprovided that either Party may propose amendments to the Technology Transfer Plan at any time during the Technology Transfer Period by delivering a written notice to the other Party for review and discussion; provided, MARKED BY further, that the Technology Transfer Plan may only be amended by mutual written agreement of the Parties. In furtherance of the foregoing, within [***] ([***]) Business Days following the Effective Date, HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate Parties will establish a one-time technology transfer subcommittee comprised of representatives of each Party (which representatives may be replaced by the appointing Party at any time upon giving notice to the Purchaser (or Purchaser’s designeeother Party) (the “Technology TransferTransfer Committee”) to oversee and coordinate the implementation of the Technology Transfer Plan. For clarity, the Technology Transfer Committee will have no responsibility or decision-making authority except as expressly provided in this Section 4.3 or otherwise expressly agreed by the Parties in writing. Subject to the terms and conditions of this Agreement (including the Technology Transfer Plan). The , (a) during the [***] ([***]) period following the Effective Date (or such shorter or longer period as may be mutually agreed by the Parties to enable product release or execution of any studies), Xxxxxxxx will deliver to GSK (or its designee) all such Know-How and specified quantities of such materials set forth in Schedule 4.3 as were in existence as of the Effective Date (including information and copies of documents related to any Compound or any Product (including Scynexis Regulatory Documentation for such Compounds and Products and CMC data and information and all non-clinical studies and Clinical Trial data and results referenced therein)), (b) Scynexis shall use Commercially Reasonable Efforts to create a technology transfer plan relating (i) ensure that all information, documentation, data and quantities of materials to be provided to GSK in accordance with this Section 4.3 and the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed be provided in a format that is structured and indexed in a manner designated by GSK and that all relevant documents and files are clearly labelled and (ii) deliver to GSK (or its designee) copies of any and all documentation and source data (A) in Scynexis’s or its Affiliates’ possession and Control or (B) residing with any Third Party contractors of Scynexis or any of its Affiliates which Scynexis can reasonably obtain from them, in each case, used to generate such documents and files, (c) Scynexis shall make available to GSK qualified Scynexis Personnel having the necessary skill, expertise and experience to accomplish the activities set forth in such Technology Transfer Plan to answer any questions or provide instruction as reasonably requested by GSK during the Technology Transfer Period, (d) Scynexis shall use reasonable efforts to provide GSK with access to its CMOs involved in the Manufacture of the Products and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry any Compound or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (any Product, subject to customary confidentiality obligations, for purposes of facilitating the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property in accordance with activities contemplated by the Technology Transfer Plan and (e) at GSK’s written request, Scynexis or its Affiliates shall assign to GSK or its designee any commitment or agreement set forth on Schedule 9.2(x) to the timelines, formatsextent such commitments or agreements are assignable provided that Scynexis shall use good faith efforts to obtain any necessary consents for such assignment, and other guidelines set forth thereinGSK or its designee shall assume all of Scynexis’s post-Effective Date obligations thereunder. Except for a Scynexis shall perform its obligations under the Technology Transfer pursuant Plan at its sole cost and expense, provided that any and all reasonable and documented FTE Costs incurred by Scynexis or its Representatives under this Section 4.3 to Clause 31.1(C)convert any information, 31.1(D)documentation, 31.1(Edata or quantities of materials into the format designated by GSK as contemplated above, and any and all Out-of-Pocket Costs incurred by Scynexis or its Representatives under this Section 4.3 except to the extent that such Out-of-Pocket Costs are incurred by Scynexis or its Representatives in connection with CMC activities required to be conducted to remedy any identified errors in existence as of the Effective Date that are necessary to be remedied in order to obtain or maintain the applicable Regulatory Approval) or 31.1(F)shall be reimbursed by GSK, the Purchaser and shall reimburse GSK for such Technology Transfer support services be due and payable within [***] ([***]. The Purchaser will reimburse ) from the date on which GSK for receives a Valid Invoice; provided further that (1) a good faith estimate of such services pursuant Out-of-Pocket Costs and any good faith material updates of these good faith estimates of such Out-of-Pocket Costs shall be approved by GSK prior to Clause 13 (Invoice such Out-of-Pocket Costs being incurred and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, the Technology Transfer Plan will survive for if GSK does not provide such approval within [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***]) of receipt from Scynexis of the estimate or updated estimate of the relevant Out-of-Pocket Costs, HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTDthen Scynexis shall not be obligated to perform the applicable activity, and (2) to the extent GSK approves such estimate or updated estimate, GSK shall be obligated to pay the amount set forth in such Valid Invoice so long as such amount does not exceed such approved estimate or updated estimate, as applicable, by more than [***] percent ([***]%). HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material Upon GSK’s request, the Scynexis Human Biological Samples and reasonable quantities of any and all fermentation strains being used by Scynexis or repeated failure on any of its Affiliates as of the part Effective Date in the Manufacture of any Compound or any Product shall promptly be delivered by Scynexis to GSK to Manufacture Commercial the extent permitted by any informed consent forms or applicable Law. If GSK identifies items Controlled by Scynexis or any of its Affiliates that were not included in the original Technology Transfer Plan but were being used by Scynexis or any of its Affiliates as of the Effective Date to Exploit any Compound and any Product in the Field in the GSK Territory, Scynexis will use Commercially Reasonable Efforts to deliver to GSK, or Commercial API provide GSK with access to, copies or reasonable quantities of such items. Scynexis shall use Commercially Reasonable Efforts to ensure that all data, results and other information provided by Scynexis to GSK pursuant to this Section 4.3 and the Technology Transfer Plan is true and accurate in all material respects and was generated in accordance with cGMP the Data Integrity Practices set forth in Schedule 4.10(b). Use of the Product Trademarks by Scynexis or its Affiliates during the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant Period in connection with domain names, website materials, and social media handles shall be included in the Scynexis Retained Rights as contemplated in Section 2.3 solely to Clause 31.1(B) the extent such use is permitted or Clause 31.1(C) (but not a required by the Technology Transfer undertaken pursuant to Clause 31.1(A) Plan or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, otherwise as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated permitted or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1)hereunder.
Appears in 1 contract
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is 3.1 Based on the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production information provided by CLIENT and including process employed changes developed by GSK in the Manufacture of the Products and (unless initiated LWI pursuant to Clause 31.2) shall be developed based on any applicable Statement of Work, LWI will prepare the expected date of expiry or termination of this Agreement and Master Production Record for the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan 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 timelinesParties 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, formatsmarked 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 other guidelines 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 [*] 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, 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 thereinin Article 10. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [*].
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 [*]; provided, however, that any such transfer [*], shall be [*]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be in the event a subsequent transfer is [required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Productsfor commercial manufacturing purposes], such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1)Parties will [*].
Appears in 1 contract
Samples: Manufacturing Services Agreement (Gamida Cell Ltd.)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is 3.1 Based on the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production information provided by CLIENT and including process employed changes developed by GSK in the Manufacture of the Products and (unless initiated LWI pursuant to Clause 31.2) shall be developed based on any applicable Statement of Work, LWI will prepare the expected date of expiry or termination of this Agreement and Master Production Record for the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan 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 timelinesParties 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, formatsincluding, without limitation, by providing LWI with additional information and other guidelines set forth therein. Except for a Technology Transfer pursuant procedures as may be required to Clause 31.1(C)create the Master Production Record, 31.1(D)Process, 31.1(E) or 31.1(F), and/or any of the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is following: (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or manufacturing process information, SOPs, development reports, (ii) this Agreement is terminated by 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 Purchaser pursuant Master Production Record to Clause 32.3(A) or Clause 37.2CLIENT 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 Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support servicesdraft Master Production Record, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within ten (10) days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.
(A) a material 3.4 The Process, Master Production Record, Specifications, and any improvements or repeated failure on modifications thereto developed during the part term of GSK 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 meetthe 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 Intellectual Property or LWI Confidential Information, prior to any disclosure of such LWI Intellectual Property or LWI Confidential Information to, or notification by GSK that it will be unable to meetuse by, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant manufacturer, CLIENT shall obtain LWI’s written consent to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1)disclosure.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Genesis Biopharma, Inc)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is 3.1 Based on the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production information provided by CLIENT and including process employed changes developed by GSK in the Manufacture of the Products and (unless initiated LWI pursuant to Clause 31.2) shall be developed based on any applicable Statement of Work, LWI will prepare the expected date of expiry or termination of this Agreement and Master Production Record for the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan 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 timelinesParties 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, formatsincluding, 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 other guidelines 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 [*] 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, 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 thereinin Article 10. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [*].
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 [*]; provided, however, that any such transfer [*], shall be [*]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be in the event a subsequent transfer is required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Productsfor commercial manufacturing purposes, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1)Parties will [*].
Appears in 1 contract
Samples: Manufacturing Services Agreement (Gamida Cell Ltd.)
Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is 3.1 Based on the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production information provided by CLIENT and including process employed changes developed by GSK in the Manufacture of the Products and (unless initiated XXXX pursuant to Clause 31.2) shall be developed based on any applicable Statement of Work, XXXX will prepare the expected date of expiry or termination of this Agreement and Master Production Record for the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property Process in accordance with the Technology Transfer Plan schedule set forth in the Statement of Work. CLIENT will inform 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 XXXX intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, XXXX will inform CLIENT of such intention and the timelinesParties 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 XXXX to assist XXXX to develop the Master Production Record and Process, formatsincluding, without limitation, by providing XXXX with additional information and other guidelines set forth therein. Except for a Technology Transfer pursuant procedures as may be required to Clause 31.1(C)create the Master Production Record, 31.1(D)Process, 31.1(E) or 31.1(F), and/or any of the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is following: (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or 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 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 XXXX in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of 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 is terminated by Agreement, but excluding any XXXX Operating Documents, New General Application Intellectual Property or XXXX Confidential Information included in any of the Purchaser pursuant foregoing, will be deemed CLIENT Confidential Information and subject to Clause 32.3(A) 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 Clause 37.2contains any XXXX Background Intellectual Property, the Technology Transfer Plan will survive for [***] from XXXX Confidential Information or New General Application Intellectual Property, prior to any disclosure of such termination XXXX Background Intellectual Property, XXXX Confidential Information or expiration date. For clarityNew General Application Intellectual Property to, the Purchaser or use by, a Third Party manufacturer, CLIENT shall obtain XXXX’s written consent to such disclosure, which consent shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F)unreasonably withheld.
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such that:
(A) the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) if any such Technology Transfer has been initiated in respect of Commercial Products pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 1 contract
Samples: Manufacturing Services Agreement (Heat Biologics, Inc.)
