Technology Transfer. 30.1 If: (A) GSK will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or (B) Clause 30.3 applies; or (C) Clause 31.6 applies; or (D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D). 30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement. 30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of: (A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or (B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure: (i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and (ii) is not due to any act or omission of Purchaser. 30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 2 contracts
Sources: Clinical Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Clinical Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. 30.1 31.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing and Supply AgreementClause 31.2 applies; oror 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 30.3 31.3 applies; or
(C) Clause 31.6 applies32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 36.2(ii32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, 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, 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 30.1(C31.1(C), 31.1(D), 31.1(E) or 30.1(D31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 12 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 31.3(A32.3(A) or Clause 36.237.2, 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 30.1(C31.1(C), 31.1(D), 31.1(E) or 30.1(D31.1(F).
30.2 A 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 may be implemented to a Second Source pursuant to Clause 31.1(A) at any time by notice in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreementwriting to GSK.
30.3 31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B31.1(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 New Clinical ProductCommercial Product or Commercial API; or
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 New Clinical Commercial Product (or, if applicable, New Clinical API) or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) failure is not due to any act or omission of Purchaser.
30.4 31.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B31.1(B) or Clause 30.1(C31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be relieved of its obligation obligations under Clause 4.1 to purchase [***] of its 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
Sources: Commercial Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Commercial Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. 30.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant Beginning on the Effective Date, Manufacturer and Purchaser shall use commercially reasonable and diligent efforts to the Commercial Manufacturing initiate, implement and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate complete a one-time technology transfer to the Purchaser (or Purchaser’s designee) Facility (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts ) to create enable Purchaser to manufacture (or have manufactured) each Product on a technology transfer plan relating commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer (shall include the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failurefollowing activities:
(i) has caused Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2;
(or is reasonably likely ii) Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date;
(iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products;
(iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term;
(v) Manufacturer’s transfer of all manufacturing know-how and technical information related to causeProducts, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License;
(vi) a material delay if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA;
(vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement;
(viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity;
(ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility;
(x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility;
(xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country;
(xii) the Parties’ development of Clinical Productsa transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and
(iixiii) is not due Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to any act or omission obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Purchaser.
30.4 Following a Technology Transfer undertaken Section 4.2(d) and be performed using API supplied to Purchaser pursuant to Clause 30.1(B) or Clause 30.1(C)the API Supply Agreement; provided, Purchaser however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be relieved provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of its obligation under Clause 4.1 to purchase [***] Seller Products for Distribution in the Seller Countries and is also required for the manufacture of its requirements Products for Products from GSKDistribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity.
Appears in 2 contracts
Sources: Transitional Supply Agreement (Depomed Inc), Transitional Supply Agreement (Depomed Inc)
Technology Transfer. 30.1 If:
3.1 WAKUNAGA shall transfer as promptly after the Effective Date as possible to MELINTA on an “as is” basis (Ai) GSK will not be supplying Products complete copies of all of its files relating to the Wakunaga Patents, (ii) copies of written documentation relating to the Wakunaga Proprietary Information that is reasonably necessary or useful for Commercialisation MELINTA to perform its obligations or exercise its rights under this Agreement, and, to the extent that Abbott transfers same to WAKUNAGA with the right to disclose to MELINTA, (iii) copies of all files relating to the Abbott Patents, and (iv) copies of all Abbott Proprietary Information received pursuant to the Commercial Manufacturing and Supply Termination Agreement; or.
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies3.2 WAKUNAGA shall, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (extent within 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 scope of the ProductsWakunaga Patents, and shall be developed based on Wakunaga Proprietary Information, Abbott Patents and/or Abbott Proprietary Information, provide MELINTA with technical support during the expected date of expiry or termination term of this Agreement and under the availability conditions set forth in this Section 3.2. WAKUNAGA personnel shall not be required to provide MELINTA or any Sublicensee of GSK Personnel and resources to MELINTA in excess of ten (10) days of support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant with respect to the Technology Transfer Plan does not place CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTsubject matter of this Agreement which may occur at any time following the Effective Date. In the event that, 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 WAKUNAGA’s prior consent after negotiation between the terms Parties, which consent shall not be unreasonably withheld, WAKUNAGA will provide support in excess of the licences granted in the Purchase Agreementten (10) applicable recordsdays of support, 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 MELINTA hereby agrees to Clause 30.1(C) pay or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 12 (Invoice and Payment). If there is (i) an ongoing Technology Transfer have MELINTA Sublicensee pay WAKUNAGA at the time rate of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] from (or such termination other reasonable rate as notified by WAKUNAGA upon thirty (30) days’ prior written notice) for time spent by WAKUNAGA personnel in connection with any support services requested by MELINTA or expiration dateany MELINTA Sublicensee. For clarity, WAKUNAGA personnel for the Purchaser shall not be required foregoing technical support may include up to reimburse GSK for any Technology Transfer support servicesforty (40) hours of time of AbbVie personnel at WAKUNAGA’s sole discretion, or direct costs or expenses associated with such Technology Transferother amount as agreed by AbbVie, if and all such Technology Transfer has been initiated personnel shall sign reasonable and customary confidentiality agreements as reasonably agreed by the Purchaser pursuant to Clause 30.1(C) or 30.1(D)Parties.
30.2 A Technology Transfer may be implemented in 3.3 WAKUNAGA shall, and shall use reasonable efforts to cause AbbVie to, take all commercially reasonable steps necessary to provide declarations, consents and signatures, as well as perform all other activities reasonably required for the circumstances contemplated by Clause 30.1(A) either in anticipation transfer of expiry of this Agreement or in the event of termination of this AgreementProprietary Information as per Sections 3.1 and 3.2 above. The Parties recognize that WAKUNAGA cannot assure MELINTA that AbbVie will comply with all such requests.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 2 contracts
Sources: License Agreement (Melinta Therapeutics, Inc. /New/), License Agreement (Melinta Therapeutics, Inc. /New/)
Technology Transfer. 30.1 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 (Athe “Technology Recipient”) GSK as set forth in this Section 5.2, which transfer will not be supplying 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 for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) appliessuch transfer, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties .
5.2.1 Within [***] after Takeda notifies MTEM that it is exercising Technology Transfer rights under this Section 5.2, MTEM shall use Commercially Reasonable Efforts to create a technology transfer plan relating deliver to the Technology Transfer Recipient copies of the then-current Manufacturing process for and any other information reasonably required in order to Manufacture the SLT-A Fusion Proteins and the Licensed Products, including master batch records and any other manufacturing records (collectively, the “Technology Transfer PlanDocumentation”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support .
5.2.2 During 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 upon Takeda’s 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, 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 be required use commercially reasonable efforts to reimburse GSK for effect assignments of any Technology Transfer support servicesexisting contract to the extent relating to the SLT-A Fusion Proteins and the Licensed Products, or direct costs or expenses associated with to obtain for Takeda substantially all of the practical benefit and burden under such Technology Transferagreement to the extent applicable to the SLT-A Fusion Proteins and the Licensed Products, if such Technology Transfer has been initiated including by entering into appropriate and reasonable alternative arrangements on terms agreeable to Takeda. Unless otherwise agreed by the Purchaser pursuant to Clause 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meetParties, any Firm Order for New Clinical Product; or
(B) a material agreement with any contract manufacturing organization or repeated failure other service provider entered into by MTEM on or after the part Effective Date that relates to any SLT-A Fusion Protein or any Licensed Product shall be assignable or otherwise transferable to Takeda without the consent of GSK the counterparty thereto to Manufacture New Clinical Product (the extent related to such SLT-A Fusion Protein or, if applicable, New Clinical API) Licensed Product.
5.2.4 Following the delivery of the Technology Transfer Documentation, MTEM shall provide the Technology Recipient with reasonable access to MTEM’s employees for telephone or in person consultations regarding the Manufacture of the SLT-A Fusion Proteins and, if applicable, the Licensed Products.
5.2.5 Without limiting the foregoing, MTEM shall take, and shall cause its Affiliates and subcontractors to take, all action and to do all things necessary, proper or advisable to complete the Technology Transfer in accordance with 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:
(i) has caused (or is reasonably likely Technology Recipient to cause) a material delay in Purchaser’s development of Clinical Manufacture the SLT-A Fusion Proteins and the Licensed Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 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 30.1(B) or Clause 30.1(C), Purchaser shall be relieved a breach by MTEM of its obligation under Clause 4.1 to purchase [***] supply obligations hereunder, in which case MTEM shall bear all of its requirements for Products from GSKown expenses.
Appears in 2 contracts
Sources: Multi Target Collaboration and License Agreement (Molecular Templates, Inc.), Multi Target Collaboration and License Agreement (Molecular Templates, Inc.)
Technology Transfer. 30.1 If:
(Aa) GSK will not be supplying Products for Commercialisation pursuant Sublicensee acknowledges and agrees that ECC has delivered and made to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate Sublicensee a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create disclosure of a technology transfer plan relating general introduction to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely and to its commercial feasibility prior to the production process employed by GSK in execution of this Agreement. Except to the Manufacture extent such information falls within one or more of the Productsexceptions to the definition of "Confidential Information", all information disclosed by ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and shall be developed based on the expected date deemed to be confidential. The timing and extent of expiry or termination additional disclosure by ECC to Sublicensee shall be as set forth in subparagraph 22(b) hereof.
(b) Upon execution of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK Agreement, ECC 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 provide Sublicensee with copies of the licences granted patents listed in the Purchase Agreement) applicable recordsSection B of Exhibit "B" hereto. Beyond that, 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser ECC shall not be required to reimburse GSK for any Technology Transfer support servicesprovide additional information concerning, or direct costs or expenses associated with such disclosure of, the Technology Transferto Sublicensee until Sublicensee provides to ECC (i) written notice of Sublicensee's intent to commercialize a Product, if such Technology Transfer has been initiated by which written notice shall include detailed specifications for the Purchaser pursuant designated Product, and (ii) evidence, reasonably satisfactory to Clause 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented ECC, of Sublicensee's intent to commercialize the designated Product in the circumstances contemplated form of written documentation of orders placed by Clause 30.1(A) either in anticipation Sublicensee of expiry of this Agreement the equipment needed by Sublicensee to produce and commercialize the designated Product or in the event form of termination written documentation from Sublicensee confirming the dedication and/or modification of this Agreement.
30.3 The Purchaser may elect existing equipment necessary to implement a Technology Transfer pursuant to Clause 30.1(Bproduce the designated Product. Within ninety (90) days after ECC's receipt of the items described in the event of:
preceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (Aw) a material or repeated failure on Product specific recipe for the part production of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical the designated Product; or
(Bx) Product specific process specifications for the production of the designated Product; (y) copies of all patent applications listed in the Exhibits hereto that ECC deems relevant to the production of the designated Product; and (z) a material or repeated failure on the part list of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaserknown raw materials suppliers and preferred equipment vendors.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 2 contracts
Sources: Sublicense Agreement (Earthshell Container Corp), Sublicense Agreement (Earthshell Container Corp)
Technology Transfer. 30.1 If:
(Upon determination by the Development Committee that a Product based on a Feasible Prototype is ready for commercialization, C▇▇▇ will have the option but not the obligation to manufacture such Product, or to have such Product manufactured by a third party. Cardica will continue to supply to C▇▇▇, upon C▇▇▇’▇ request and at a cost of [*] per unit, such additional units of the Product over the [*] units described in Section 5.2(C) above as C▇▇▇ may reasonably request for the further testing [*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A) GSK , SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. and development of the Product. Upon the first FDA Approval of a Product in the Field that is based on a Feasible Prototype that the Development Committee determines is ready for commercialization, C▇▇▇ will have the sole responsibility for manufacturing such Product, or having such Product manufactured, at its sole expense. Upon C▇▇▇’▇ request, to enable C▇▇▇ to assume such responsibility, Cardica will transfer to C▇▇▇, at no additional cost, all equipment, including all pre-production tooling, and Cardica Know-How, including but not be supplying Products for Commercialisation pursuant limited to, all trade secret, manufacturing and supplier information included therein, related to the Commercial Manufacturing and Supply Agreement; or
Products that is reasonably necessary for C▇▇▇ to manufacture such Product (B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology TransferTransferred Product”). The Parties shall use Commercially Reasonable Efforts Upon request from C▇▇▇, Cardica will provide, at no additional cost, reasonable technical assistance to create a technology transfer plan relating to C▇▇▇ for the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed Transferred Product based on the expected date of expiry or termination of this Agreement and the mutual availability of GSK Personnel the parties, which assistance may include: i) training of C▇▇▇ personnel in connection with the manufacture of Transferred Product, ii) advice concerning the manufacture of Transferred Product, and resources iii) testing of sample Transferred Product to support verify that such transferTransferred Product complies with applicable specifications established by the Development Committee to confirm successful transfer of technology to C▇▇▇ hereunder. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to Additionally, on C▇▇▇’▇ request, 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 parties will negotiate the terms of the licences granted under which Cardica may provide engineering services to assist C▇▇▇ in the Purchase Agreement) applicable records, documentation, GSK Know-How design and GSK Intellectual Property in accordance with the Technology Transfer Plan modification of Transferred Product to meet customer and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D)regulatory requirements.
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 1 contract
Sources: License, Development and Commercialization Agreement (Cardica Inc)
Technology Transfer. 30.1 If:
The Parties acknowledge that as of the Amendment Effective Date, Zymeworks has transferred to BeiGene certain Zymeworks Know-How existing as of the Effective Date (Athe “Initial Technology Transfer”). Upon Completion of the Phase 1 Clinical Trial for the Licensed Product, Zymeworks shall promptly notify BeiGene in writing, including a copy of the results and other existing information relevant thereto (the “Clinical Trial Results”) GSK (collectively, the “Trial Completion Notice”). Upon Completion of the Dose Escalation Study Zymeworks will not be supplying Products promptly notify BeiGene in writing of Completion of the Dose Escalation Study, including a copy of the results and the recommended dose for Commercialisation pursuant to the Commercial Manufacturing Licensed Product (collectively, the “Dose Identification Notice”). Within […***…] of the earlier of BeiGene’s receipt of (a) the Trial Completion Notice or (b) Dose Identification Notice, Zymeworks will provide and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to BeiGene, […***…], the Purchaser Zymeworks Know-How that exists as of the date of such Trial Completion Notice or Dose Identification Notice and was not previously provided to BeiGene by providing copies or samples of relevant documentation, materials and other embodiments of such Zymeworks Know-How, including data within reports, and electronic files, that exists on the Effective Date (the “Secondary Technology Transfer”). During the Term, Zymeworks shall (i) at each meeting of the JSC (and, in any event, on […***…] if any JSC meeting is not held in a particular […***…]), provide BeiGene with a summary of additional Zymeworks Know-How, if any, developed since the last meeting of the JSC, (ii) transfer any such Zymeworks Know-How to BeiGene promptly following BeiGene’s reasonable request, (iii) transfer a copy of the results of the Zymeworks Territory Studies to BeiGene, promptly after completion of each such study; and (iv) provide BeiGene with reasonable access to Zymeworks personnel involved in the research and Development of Licensed Products, either in-person at Zymeworks’ facility or Purchaser’s designee) by teleconference (the “Continuing Technology Transfer,” and together with the Initial Technology Transfer and the Secondary Technology Transfer, the “Technology Transfer”). The Parties For the avoidance of doubt, Zymeworks’ personnel shall use Commercially Reasonable Efforts not be obligated to create a technology travel to BeiGene’s facilities, and Zymeworks’ transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan obligations under this Section 4.1 shall relate apply solely to the production process employed by GSK in extent the Manufacture of the Products, and 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 Zymeworks 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely necessary to cause) a material delay in Purchasersupport BeiGene’s development of Clinical Products; and
(ii) is not due to any act or omission of PurchaserDevelopment and 1 Competitive Information – Commercially Sensitive Terms.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 1 contract
Technology Transfer. 30.1 IfWithout prejudice to the Supplier’s rights under this Agreement, Prestige may in its sole discretion and at any time elect to implement the transfer of Know-how (save to the extent such Know-how comprises Intellectual Property that is made solely by the Supplier and/or its Affiliates and which is capable of being used independently of Prestige’s Intellectual Property and which shall remain the property of the Supplier (or its Affiliates) pursuant to Clause 20.10) relating to the Manufacture of the Products (“Manufacturing Know-How”) from the Supplier (or its Affiliates) to Prestige or one of Prestige’s Affiliates or a designated contract manufacturer by providing written notification to the Supplier at any time. Following such notice the Supplier (or its Affiliates) shall fully cooperate with Prestige with regard to the transfer and provide all necessary, reasonably required and customary assistance to Prestige to enable Prestige to complete the transfer in a timely and effective manner. Without limitation to the foregoing the following provisions shall apply in the event of a transfer contemplated by this Clause 26:
(A) GSK will not be supplying Products upon notice of transfer under this Clause 26 Prestige and the Supplier shall (or shall procure that its Affiliates will) agree a transfer plan which addresses, if required, reduction of production volumes and draw down of any Materials, any remaining Product and all other issues requiring consideration for Commercialisation pursuant to the Commercial Manufacturing completion of such transfer in a timely and Supply Agreement; oreffective manner;
(B) Clause 30.3 applies; orthe Supplier shall (or shall procure that its Affiliates will) provide all such reasonable assistance with respect to the transfer of processes equivalent to those employed by the Supplier (or its Affiliates) during the Term of this Agreement (i.e., on a “like-for-like” basis);
(C) Clause 31.6 applies; orPrestige will be responsible for all activities related to the development and preparation of data for use in regulatory submissions in connection with such transfer and the Supplier shall (or shall procure that its Affiliates will) without charge provide Prestige with copies of all documentation held by the Supplier (or its Affiliates) and necessary or otherwise reasonably requested by Prestige for such purpose;
(D) Clause 36.2(iithe Supplier (and its Affiliates) applies, GSK shall facilitate a onereasonably co-time technology transfer operate with Prestige in transferring the Manufacturing Know-How including making available to Prestige appropriate employees of the Purchaser Supplier (or Purchaser’s designeeits Affiliates) (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 who are engaged in the Manufacture of Product to provide information and guidance for the Productstransfer process, including consulting services, to the extent reasonably necessary for the completion of the transfer of the Manufacturing Know-How in a timely and efficient manner; and
(E) Prestige shall be developed based on pay the expected date reasonable and properly incurred actual incremental costs of expiry or termination the Supplier and its Affiliates in providing Prestige with assistance pursuant to sub-Clauses (B) and (D) above. Notwithstanding the transfer of any Product under this Clause 26, the Supplier shall remain fully liable under the terms of this Agreement and (including liability to any Governmental Entity) for all Products which 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 Supplier (Ior its Affiliates) 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 has Manufactured for Prestige under 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 1 contract
Sources: Transitional Manufacturing and Supply Agreement (Prestige Brands Holdings, Inc.)
Technology Transfer. 30.1 If:If ▇▇▇▇▇▇ elects option (a) pursuant to Section 3.7, or at any time thereafter if ▇▇▇▇▇▇ determines to establish its own commercial scale manufacturing, then MERRIMACK shall perform a technology transfer of MERRIMACK’s manufacturing process for the Drug Product and/or Licensed Product to ▇▇▇▇▇▇ (or its designated Affiliate or CMO), which technology transfer shall be performed in accordance with a mutually agreed technology transfer plan, timeline and budget.
(Aa) GSK will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time As part of such technology transfer to the Purchaser ▇▇▇▇▇▇ (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the expected date of expiry ▇▇▇▇▇▇’▇ designated Affiliate 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 30.1(C) or 30.1(DCMO), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failureMERRIMACK shall:
(i) has caused subject to ▇▇▇▇▇▇’▇ prior approval of a budget, transfer to ▇▇▇▇▇▇ (or is reasonably likely ▇▇▇▇▇▇’▇ designated Affiliate or CMO) copies of Regulatory Filings and other Licensed Technology that are necessary or useful for ▇▇▇▇▇▇ (or the Affiliate or CMO identified by ▇▇▇▇▇▇) to cause) a material delay in Purchaser’s development of Clinical Productsmanufacture the Drug Product and/or Licensed Product, including manufacturing processes, analytical methods, specifications, protocols, assays, batch records, quality control data, transportation and storage requirements, and other manufacturing documentation or files (collectively, “Manufacturing Technology”); and
(ii) is not due provide technical assistance to any act ▇▇▇▇▇▇ (or omission ▇▇▇▇▇▇’▇ Affiliate or designated CMO) with respect to the use and implementation of Purchasersuch Manufacturing Technology as may be mutually agreed by the Parties.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B(b) or Clause 30.1(C)▇▇▇▇▇▇ shall pay MERRIMACK, Purchaser shall be relieved of its obligation under Clause 4.1 to purchase within [**] days following MERRIMACK’s invoice, for (i) all internal costs of MERRIMACK personnel at the [**] FTE Rate, plus (ii) all out-of-pocket costs and expenses incurred by MERRIMACK, to the extent incurred in performing the technology transfer activities contemplated hereunder, and provided that all aforesaid costs and expenses do not exceed the amounts set forth in the corresponding budget set forth in the agreed technology transfer plan, it being understood that such approved budget shall incorporate into the budget an allowance of its requirements [**] percent ([**]%) for Products from GSKcost overruns, provided that such overruns, upon their occurrence, are appropriately documented and justified.
(c) The Parties will cooperate in good faith in undertaking all such technology transfer activities, including with respect to the scheduling and planning of associated meetings.
Appears in 1 contract
Sources: License and Collaboration Agreement (Merrimack Pharmaceuticals Inc)
Technology Transfer. 30.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to discuss and agree in writing in an executable proposal the exact scope of the Technology Transfer (services Patheon is to provide and the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely costs to the production process employed be charged by GSK Patheon in the Manufacture of the Products, and shall be developed providing these services based on the expected date rates set out below pursuant to Section 2.1 (p). All Fees stated in this Schedule F are fees applicable as at 1st November 2012. Accordingly, the fees applicable as 1st November 2013 shall be those fees stated in this Schedule F adjusted to reflect the increase or decrease in the United Kingdom Retail Price Index (All Items) published by the National Institute for Statistics (as published at: ▇▇▇.▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇) in respect of expiry or termination the period from 1st November 2012 to 30 October 2013. Examples of this Agreement and activities here might include but are not limited to: •Support for the availability generation 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 Protocols •Support for cross-organization technology transfer (subject to the terms teams •Support implementation 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 technology transfer activities Patheon will invoice Zogenix at a Technology Transfer pursuant to Clause 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 12 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time rate of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] from such termination or expiration dateper hour for these activities. For clarity, the Purchaser shall Examples of activities here might include but are not be required to reimburse GSK for any Technology Transfer limited to: •Review and update applicable process development reports •Suggest parameters and metrics that 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation successful tech transfer •Provide on-site assistance at third party as necessary Patheon will invoice Zogenix at a rate of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] per hour for all onsite activities. Patheon will invoice Zogenix at a rate of its requirements [***] per day for Products all off site activities. In addition all documented travel expenses will be paid that are approved by Zogenix in advance in writing and are in accord with Patheon’s company travel policy for travel for a similar purpose by the same employee Examples of activities here might include but are not limited to: •Escorting agreed Zogenix or third party visitors to observe the at Patheon •Supply master batch records, SOPs maintenance and use logs and provide in machine-readable formats •Provide recommendation for changes •Assist with process fit analyses •Input into summaries of manufacturing experience to date –Supply in process results to date *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. –Supply processing parameters from GSKcGMPs runs •Identify any critical process parameters Patheon will invoice Zogenix at a rate of [***] per hour all activities related to the provision of copies of documents. Patheon will invoice Zogenix [***] per hour for all escorting duties. Patheon will invoice Zogenix at a rate of [***] per hour for all other on site activities. Patheon will invoice Zogenix at a rate of [***] per day for all off site activities. In addition all documented travel expenses will be paid by Zogenix that are approved in advance in writing and are in accord with Patheon’s company travel policy for travel for a similar purpose by the same employee. Examples of activities here might include but are not limited to: • Provide ▇▇▇▇ of materials, resources and routings in machine-readable formats –Current and for manufactured batches •List of raw material vendors and current specifications •List of any Patheon-specific materials •List of any proprietary reagents •List of any supply agreements Patheon will invoice Zogenix at a rate of [***] per hour all activities related to the provision of copies of documents. Patheon will invoice Zogenix at a rate of [***] per hour for all other activities. Examples of activities here might include but are not limited to: •Support generation of assay transfer package –Assay methods –Qualification protocols –Reagent list, including sources •Collaborate on assay transfer protocol •Allow on site observation of methods •Perform necessary practical assay transfer assistance at third party Patheon will invoice Zogenix at a rate of [***] per hour all activities related to the provision of copies of documents. Patheon will invoice Zogenix at a rate of [***] per hour for all other activities. Examples of activities here might include but are not limited to: *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. •Review of all documents to ensure that they are the latest version –Process description –Batch records, assay methods, –Raw material specifications •Identification of any ancillary documents •Change control of Technology Transfer protocol –Assay transfer protocol review and approval Patheon will invoice Zogenix at a rate of [***] per hour for these activities.
Appears in 1 contract
Technology Transfer. 30.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant Beginning on the Effective Date, Manufacturer and Purchaser shall use commercially reasonable and diligent efforts to the Commercial Manufacturing initiate, implement and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate complete a one-time technology transfer to the Purchaser (or Purchaser’s designee) Facility (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts ) to create enable Purchaser to manufacture (or have manufactured) each Product on a technology transfer plan relating commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer (shall include the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 12 (Invoice and Payment). If there is following activities:
(i) an ongoing Technology Transfer Purchaser’s installation of ER Line 2 promptly following receipt at the time of expiration or termination of the Agreement or Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2;
(ii) this Agreement is terminated Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date;
(iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products;
(iv) Manufacturer’s provision of a forecast of Seller’s and its Confidential Information indicated by the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] has been omitted from this filing and filed separately with the Securities Exchange Commission. Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term;
(v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such termination or expiration date. For clarityknow-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License;
(vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the Purchaser shall not be DEA of all documentation required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated register Purchaser’s Facility with such Technology Transferrespect to tapentadol or, if such Technology Transfer has been initiated by no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA;
(vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to Clause 30.1(Cthe API Supply Agreement;
(viii) or 30.1(D).
30.2 A Technology Transfer may be implemented Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meetSeller Countries, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Clinical Products; and
(iiSection 4.2(d) is not due and shall be performed using API supplied to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken Purchaser pursuant to Clause 30.1(B) or Clause 30.1(C)the API Supply Agreement; provided, Purchaser however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be relieved provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of its obligation under Clause 4.1 to purchase Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission. appropriate allocation of its requirements the costs of such activity;
(ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility;
(x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility;
(xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country;
(xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and
(xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the Confidential Information indicated by [***] has been omitted from GSKthis filing and filed separately with the Securities Exchange Commission. costs of such activity.
Appears in 1 contract
Sources: Transitional Supply Agreement
Technology Transfer. 30.1 If:
3.1 As soon as reasonably practicable following the date hereof, but in any event no later than [***] after the date hereof, the Parties will in good faith (Aeach acting reasonably) GSK will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate agree on a one-time technology transfer to the Purchaser (or Purchaser’s designee) formal written plan (the “Technology TransferTT Plan”) for the transitioning of the Manufacturing Know-How to Buyer or to its Third Party manufacturer or manufacturers by way of [***] customary technology transfer for packaging (including serialization), and [***] for formulation of the Licensed Product, in each case to [***] designated by Buyer (which may be the same or different facilities for packaging and formulation and which may in each case be owned or operated by Buyer or any contractor or other Third Party designee thereof).
3.2 Each Party shall perform the activities allocated to it in the TT Plan. The Parties shall use Commercially Reasonable Efforts methods that will be used to create a technology transfer plan relating to effect the Technology Transfer for Packed Tablets and Bulk Tablets, will include:
3.2.1 the provision of copies of all relevant documentation and data maintained by AstraZeneca in electronic form and in the control of, or reasonably obtainable by, AstraZeneca which record the Manufacturing Know-How, including (a) a list of all equipment, components and materials needed for the “Technology Transfer Manufacture of the Licensed Product, (b) a step-by-step description of the Manufacturing process for the Licensed Product, and (c) validated analytical methods for the Licensed Product;
3.2.2 the provision of reasonable technical assistance to Buyer or its nominated Third Party manufacturer or manufacturers to ensure a timely transition of the Manufacture of the Product as set forth in the TT Plan”;
3.2.3 access to employees of AstraZeneca and its Affiliates who have knowledge of such steps at AstraZeneca’s (or its Affiliates’) premises or, where reasonably required, at the applicable Buyer facility (but subject to the limitations set forth in this Article 3); and
3.2.4 upon reasonable advance notice and upon a date mutually agreed, support reasonable, scheduled site visits in accordance with the TT Plan subject to AstraZeneca’s then current standards applicable to visitors by appropriate Personnel of Buyer or any of its Affiliates, contractors or Third Party manufacturers.
3.3 Each Party will complete the activities allocated to it in the TT Plan within any timelines set out therein (or for activities for which a timeline has not been allocated, within a reasonable time frame). The Technology Transfer shall be completed as soon as reasonably practicable by the Parties, each acting in an expeditious and commercially reasonable manner. In any event, the TT Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and 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 require that supporting such Technology Transfer pursuant to the Technology Transfer be completed within the Term and, if the Technology Transfer for Packed Tablets is not completed within the Packaging Term or if the Technology Transfer for Bulk Tablets is not completed within the Bulk Supply Term, the obligations of AstraZeneca pursuant to this Article 3 with respect to the applicable Technology Transfer shall terminate in all respects; provided that if the applicable Technology Transfer will not be completed within the Packaging Term or Bulk Supply Term, as applicable, due to a breach by AstraZeneca of any of its obligations under this Article 3, the Packaging Term or Bulk Supply Term, as applicable, shall be extended by the number of days of delay in the completion that is attributable to such breach upon notice in writing from Buyer to AstraZeneca.
3.4 The Parties acknowledge that (a) the Parties will be jointly responsible for the development of the TT Plan, (b) Buyer will lead the process for the implementation of the TT Plan does for the transitioning of the Manufacturing Know-How to Buyer or to its Third Party manufacturer or manufacturers, and (c) the role of AstraZeneca will be to support Buyer in such implementation activities, in each case as specified in the TT Plan.
3.5 AstraZeneca shall, during the Term, provide up to [***] hours of support for the Packaging Technology Transfer and the Formulation Techology Transfer, collectively, pursuant to this Article 3 [***] (“Support Hours”). As of the Execution Date, the Support Hours shall be provisionally allocated as follows: up to [***] Support Hours for the Packaging Technology Transfer and up to [***] Support Hours for the Formulation Technology Transfer; provided that Buyer may, at any time and from time to time during the Packaging Term or the Bulk Supply Term, reallocate Support Hours from the Packaging Technology Transfer to the Formulation Technology Transfer, or vice versa, upon written notice to AstraZeneca. If ▇▇▇▇▇, acting reasonably, requires time in addition to complete the Packaging Technology Transfer or the Formulation Technology Transfer, AstraZeneca and Buyer will discuss in good faith Buyer’s requirements and AstraZeneca will use its reasonable efforts to accommodate such request; provided, that the other manufacturing operations of AstraZeneca and its Affiliates are not place CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTunduly disrupted by the provision of such additional support. The Parties shall agree in writing to the terms of any additional support to be provided by AstraZeneca, MARKED BY including the total number of additional hours of support and the time period over which such additional support shall be provided. All such additional support will be provided at Buyer’s cost, [***].
3.6 In respect of all Technology Transfer services provided pursuant to this Supply Agreement, Buyer shall reimburse AstraZeneca for all reasonable (a) [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (Ib) IS NOT MATERIAL AND [***] and (IIc) 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***], in each case, reasonably incurred by or on behalf of AstraZeneca and its Affiliates in providing such services. The Purchaser will reimburse GSK Buyer shall be responsible for such services pursuant the costs of all API or other materials used in connection with any Technology Transfer.
3.7 In no event shall AstraZeneca be required to Clause 12 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination provide technology transfer assistance for any element of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for Manufacturing Know-How more than [***] from such termination during the Technology Transfer process.
3.8 Subject to Sections 3.1 through 3.5, and Section 3.11, Buyer shall be responsible for providing, making available or expiration date. For clarity, the Purchaser shall not be obtaining in sufficient time as required to reimburse GSK for any meet the TT Plan, all facilities, materials, personnel, consents, approvals, information and other resources necessary to carry out and complete the Technology Transfer. As the success of the implementation of the Technology Transfer support servicesprocess will primarily depend on Buyer or its Third Party manufacturer, subject to compliance with AstraZeneca’s obligations under this Supply Agreement, AstraZeneca provides no assurances or direct costs guarantees that the formulation or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 30.1(C) or 30.1(D).
30.2 A Technology Transfer may other Manufacturing processes can be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] transitioned to Buyer or any Third Party.
3.9 In addition to the Technology Transfer, which for clarity does not include a technology transfer for the API, AstraZeneca shall provide such Manufacturing Know-How in its possession and control to the extent requested by Buyer and such information is necessary or reasonably useful in order to assist Buyer in establishing its own supply chain for API.
3.10 While on site at the facilities of the other Party (or a Third Party designated by the other Party), each Party will ensure that it and its requirements for Products from GSK.Affiliates (and their respective personnel) conduct themselves in such manner as would be reasonably expected in the circumstances and comply with: (a) such of the other Party’s (or relevant Third Party’s) normal and reasonable codes of conduct and security practice (including those related to data protection, health and safety, operational and technical security, occupancy, acceptable use and access to buildings) as are brought to the relevant person’s attention; (b) the other Party’s (or relevant Third Party’s) reasonable instructions; and (c)
Appears in 1 contract
Technology Transfer. 30.1 If:
(Aa) GSK will not be supplying Products Toshiba shall use all reasonable efforts to develop, and, in exchange for Commercialisation pursuant the payments made by SanDisk under the Common R&D Agreement, upon successful development of 0.21, 0.16, 0.13 * micron process technology applicable to the Commercial Manufacturing manufacturing and Supply Agreement; or
testing of NAND Flash Memory Products (B"NAND PROCESS TECHNOLOGY") Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) appliesthat can be implemented in a commercially viable manner, GSK Toshiba shall facilitate a one-time deliver such technology transfer to and all improvements thereto * developed by Toshiba during 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 term of the ProductsCommon R&D Agreement, to each of the DSC and Yokkaichi foundry facilities and such other manufacturing facilities as may hereafter be agreed upon by the Parents. Timing of the delivery of technology transfers shall be based on, among other things, available capacity and 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 decision to be made from time to time by the Management Committee. The * INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. parties intend that the Yokkaichi and DSC facilities should run the same technologies in similar time frames.
(b) Whenever a technology transfer is required hereunder, Toshiba shall deliver such level of NAND Process Technology Transfer Plan to the applicable manufacturing facility as would be normal practice by the Toshiba Semiconductor Company whenever it transfers a technology to a new manufacturing facility or transfers a new or advanced technology to an existing manufacturing facility in order to achieve successful implementation of the newly transferred technology.
(c) A technology transfer hereunder shall be deemed complete when the transferred technology passes a reasonable qualification procedure to be mutually agreed upon by Toshiba and SanDisk.
(d) Following the timelinesClosing, formatsToshiba shall use its best efforts to assist DSC in achieving the same productivity in the manufacturing of Products as achieved at the Yokkaichi facility. However, the parties understand and agree that Toshiba does not warrant that the DSC facility will be able to manufacture the same quality and yield as experienced at the Yokkaichi facility.
(e) The costs of all technology transfers described in this Section 7.01 shall be borne by Toshiba or by DSC as set forth in SCHEDULE 7.01, and other guidelines set forth therein. Except for a Technology Transfer pursuant such expenses to Clause 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 be borne by the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser DSC shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSKincluded in Start-Up Costs as defined in Section 7.02.
Appears in 1 contract
Sources: Master Agreement (Sandisk Corp)
Technology Transfer. 30.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the 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, HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED IS FILED WITH THE INFORMATION (I) IS NOT MATERIAL SECURITIES AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM EXCHANGE COMMISSION PURSUANT TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSEDRULE 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 1 contract
Sources: Clinical Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. 30.1 If:
(Aa) GSK will not be supplying Products for Commercialisation pursuant Sublicensee acknowledges and agrees that ECC has delivered and made to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate Sublicensee a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create disclosure of a technology transfer plan relating general introduction to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely and to its commercial feasibility prior to the production process employed by GSK in execution of this Agreement. Except to the Manufacture extent such information falls within one or more of the Productsexceptions to the definition of "Confidential Information", all information disclosed by ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and shall be developed based on the expected date deemed to be confidential. The timing and extent of expiry or termination additional disclosure by ECC to Sublicensee shall be as set forth in subparagraph 22(b) hereof.
(b) Upon execution of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK Agreement, ECC 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 provide Sublicensee with copies of the licences granted patents listed in the Purchase Agreement) applicable recordsSection B of Exhibit "B" hereto. Beyond that, 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser ECC shall not be required to reimburse GSK for any Technology Transfer support servicesprovide additional information concerning, or direct costs or expenses associated with such disclosure of the Technology Transferto Sublicensee until Sublicensee provides to ECC (i) written notice of Sublicensee's intent to commercialize a Product, if such Technology Transfer has been initiated by which written notice shall include detailed specifications for the Purchaser pursuant designated Product, and (ii) evidence, reasonably satisfactory to Clause 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented ECC, of Sublicensee's intent to commercialize the designated Product in the circumstances contemplated form of written documentation of orders placed by Clause 30.1(A) either in anticipation Sublicensee of expiry of this Agreement the equipment needed by Sublicensee to produce and commercialize the designated Product or in the event form of termination written documentation from Sublicensee confirming the dedication and/or modification of this Agreement.
30.3 The Purchaser may elect existing equipment necessary to implement a Technology Transfer pursuant to Clause 30.1(Bproduce the designated Product. Within ninety (90) days after ECC's receipt of the items described in the event of:
preceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (Aw) a material or repeated failure on Product specific recipe for the part production of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical the designated Product; or
(Bx) Product specific process specifications for the production of the designated Product; (y) copies of all patent applications listed in the Exhibits hereto that ECC deems relevant to the production of the designated Product; and (z) a material or repeated failure on the part list of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaserknown raw materials suppliers and preferred equipment vendors.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 1 contract
Technology Transfer. 30.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant to Consistent with the Commercial Manufacturing principle of avoiding supply disruption and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the 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 transition plan established pursuant to Section 15.3, Pfizer shall provide Adolor with any then-existing documentation, technical information and other Know-How, in the timelinesform and format in which such materials are maintained by Pfizer in the ordinary course of its business (provided that Pfizer shall use commercially reasonable efforts to provide such materials in a form and format useable by Adolor), formatsthat are necessary for the manufacture of Named Compounds and Licensed Products. Such documentation, technical information and other Know-How shall include: (a) copies of flow charts of the manufacturing procedures and work instructions related to manufacturing Named Compounds and Licensed Products, (b) a list of all equipment, including the source of the equipment, utilized in the production of Named Compounds and Licensed Products, (c) copies of all current specifications for Named Compounds and Licensed Products, (d) copies of all standard operating procedures for the manufacturing procedures to be transferred, (e) all environmental conditions necessary to manufacture Named Compounds and Licensed Products and copies of any existing external environmental impact studies based on the materials or methods employed in the manufacturing method to be transferred, and (f) such other guidelines documentation as the Parties may mutually agree, in each case of the foregoing subsections (a) through (f), that are necessary to manufacture Named Compounds and Licensed Products. In addition, prior to the effective date of termination, and for up to ** thereafter, Pfizer shall make available to Adolor, the reasonable assistance of Pfizer’s employees, and shall request that any external Third Party manufacturers be available, to support the transfer of the manufacturing technology to Adolor. Pfizer shall use commercially reasonable best efforts to ensure that these personnel will cooperate with Adolor in the implementation of the manufacturing technology until such implementation has been completed successfully. Adolor shall reimburse Pfizer or any of Pfizer’s Third Party manufacturers for all reasonable Out-of-Pocket Costs and Expenses incurred pursuant to this Section 15.3.1. Pfizer shall continue to supply Adolor after the effective date of termination with Adolor’s requirements of clinical and commercial quantities of Named Compounds and Licensed Products, pursuant to a supply agreement to be negotiated in good faith by the Parties on “commercially reasonable terms” which agreement will remain in effect until the earlier of (a) the ** of the effective date of termination, and (b) such time as Adolor or a Third Party manufacturer engaged by Adolor is capable of supplying Adolor with its requirements of clinical and commercial quantities of Named Compounds and Licensed Products, provided, however, that Adolor must use its commercially reasonable best efforts to supply or have supplied by a Third Party, Named Compounds and Licensed Products as soon as reasonably practicable after the effective date of such termination. Solely for purposes of this Section 15.3.1, “commercially reasonable terms” means, with respect to clinical supplies of Named Compounds and Licensed Products, Pfizer’s Manufacturing Costs for such supplies, and with respect to commercial supplies means Pfizer’s Manufacturing Costs plus a reasonable ▇▇▇▇-up, which ▇▇▇▇-up shall not exceed ** prior to the first anniversary of effective date of termination, ** for the next year and ** the second anniversary of the effective date of termination, to be set forth therein. Except for a Technology Transfer pursuant to Clause 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in supply agreement between the event of termination of this AgreementParties.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 1 contract
Technology Transfer. 30.1 If:
Upon Completion of the Phase 1 Clinical Trial for the Licensed Product, Zymeworks shall promptly notify BeiGene in writing, including a copy of the results and other existing information relevant thereto (Athe “Clinical Trial Results”) GSK (collectively, the “Trial Completion Notice”). Within […***…] of BeiGene’s receipt of the Clinical Trial Results, Zymeworks will not be supplying Products for Commercialisation pursuant to the Commercial Manufacturing provide and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to BeiGene, […***…], the Purchaser Zymeworks Know-How that exists on the Effective Date and was not previously provided to BeiGene by providing copies or samples of relevant documentation, materials and other embodiments of such Zymeworks Know-How, including data within reports, and electronic files, that exists on the Effective Date (the “Initial Technology Transfer”). Thereafter, during the Term, Zymeworks shall (a) at each meeting of the JSC (and, in any event, on […***…] if any JSC meeting is not held in a particular […***…]), provide BeiGene with a summary of additional Zymeworks Know-How, if any, developed since the last meeting of the JSC, (b) transfer any such Zymeworks Know-How to BeiGene promptly following BeiGene’s reasonable request, and (c) provide BeiGene with reasonable access to Zymeworks personnel involved in the research and Development of Licensed Products, either in-person at Zymeworks’ facility or Purchaser’s designee) by teleconference (the “Continuing Technology Transfer,” and together with the Initial Technology Transfer, the “Technology Transfer”). The Parties For the avoidance of doubt, Zymeworks’ personnel shall use Commercially Reasonable Efforts not be obligated to create a technology travel to BeiGene’s facilities, and Zymeworks’ transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan obligations under this Section 4.1 shall relate apply solely to the production process employed by GSK in extent the Manufacture of the Products, and 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 Zymeworks Know-How is reasonably necessary to support BeiGene’s Development and GSK Intellectual Property Commercialization of the Licensed Product in the Field in the Territory in accordance with this Agreement. Notwithstanding the Technology Transfer Plan and foregoing, Zymeworks’ technology transfer obligations hereunder shall not include the timelinesobligation to transfer manufacturing-related Know-How, formats, and other guidelines except as set forth therein. Except for a Technology Transfer pursuant to Clause 30.1(C) in Section 7.2 or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 unless otherwise mutually agreed by the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented Parties in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.writing.42
Appears in 1 contract
Sources: License and Collaboration Agreement (Zymeworks Inc.)
Technology Transfer. 30.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant After the Development Transfer Date, Lpath shall use Commercially Reasonable Efforts to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology promptly transfer to Merck as soon as reasonably practical, ***, all Lpath Know-How, including any preclinical data, clinical data, assays and associated materials, protocols, procedures and any other information in Lpath’s possession or control, that is reasonably necessary or useful to continue or initiate Development of, or in seeking Regulatory Approval for, Licensed Products. For clarity, Lpath shall at all times have the Purchaser right to retain reasonable quantities of tangible materials (if any) within such Lpath Know-How, and may use them, and authorize others to use them, in connection with Ocular Products or Purchaser’s designee) (other products outside the “Technology Transfer”)Field. The Merck shall use Commercially Reasonable Efforts to cooperate and facilitate such transfer, and the Parties shall use Commercially Reasonable Efforts to create complete such transfer within *** after the Development Transfer Date. Details shall be set forth in a technology transfer plan relating to be agreed upon by the Technology Transfer Parties (the “Technology Transfer Plan”) which plan shall set forth agreed-upon steps for an adequate technology transfer and timelines therefore, an outline of which is attached to this Agreement as Schedule 3.7. In addition, and without limiting the generality of the foregoing, upon Merck’s request Lpath shall (i) promptly assign to Merck all applications and filings made with any Regulatory Authority solely applicable to the Development or Commercialization of Licensed Products in and for the Field (and not applicable to any Ocular Product or other product outside the Field), including any applicable IND and orphan drug designations with respect thereto, (ii) use ***CONFIDENTIAL PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. The Technology Transfer Plan shall relate Commercially Reasonable Efforts to assign to Merck all agreements related solely to the production process employed by GSK conduct of any Clinical Trial in and for the Field with respect to Licensed Product and to seek any required Third Party consents therefor (provided that such Commercially Reasonable Efforts shall not require Lpath to make payments or provide other consideration to any Third Party in consideration therewith), and (iii) assign to Merck all agreements, if any, related solely to the manufacture, supply or distribution of clinical supplies of Licensed Product for Clinical Trials in the Manufacture of Field (to the Productsextent such agreement is specific to Clinical Trials in the Field, and shall be developed based on not related to Ocular Products or other products outside 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 30.1(C) or 30.1(DField), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, notwithstanding the Purchaser foregoing, Lpath shall have the right to retain, and shall not be required to reimburse GSK for any Technology Transfer support servicesassign to Merck, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK any applications and filings made with any Regulatory Authority related to meetOcular Products (including IND number 100786), or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material any agreements which relate to clinical trials of Ocular Products, or repeated failure on (C) any agreement related to the part of GSK to Manufacture New Clinical Product (ormanufacture, if applicablesupply or distribution of, New Clinical API) in accordance with cGMP or which otherwise relate to, Ocular Products or other products outside the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of PurchaserField.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 1 contract
Sources: License Agreement (Lpath, Inc)
Technology Transfer. 30.1 If:(a) Upon Lavvan’s written request and at Amyris’ cost and expense with regard to Amyris employees and contractors and Lavvan’s cost and expense with regard to all non-Amyris employee costs, including all Contract Manufacturer costs, Amyris shall transfer to Lavvan or an applicable Contract Manufacturer (i) the Commercial Strain and the Technology necessary to produce each applicable Collaboration Cannabinoid; and (ii) all documentation, specifications, approvals, permits, consents and materials related to the Technology, including process design schematics and manuals, necessary for Lavvan or such Contract Manufacturer to manufacture the applicable Collaboration Cannabinoid.
(Ab) GSK will not be supplying Products for Commercialisation pursuant Amyris shall cooperate in good faith with Lavvan and/or a Contract Manufacturer to the Commercial Manufacturing bring about and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate complete 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 smooth and orderly transition of the Technology Transfer (with respect to each Collaboration Cannabinoid and other information and materials described in Section 3.4.3(a) to enable an applicable Contract Manufacturer to successfully produce the “applicable Collaboration Cannabinoid utilizing the Technology. Each Technology Transfer Plan”). The Technology Transfer Plan shall relate solely include reasonable travel to Lavvan and/or the production process employed by GSK in the Manufacture Contract Manufacturer, and Amyris shall ensure that Lavvan and/or its Contract Manufacturer(s) have reasonable access to qualified scientists and Representatives of Amyris reasonably necessary to support an efficient and effective transfer of the Products, and 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 transferTechnology. 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 All Know-How and GSK Intellectual Property documentation to be transferred to Lavvan and/or a Contract Manufacturer hereunder shall be provided in accordance electronic form, to the extent such Know-How and documentation is available in electronic form.
(c) Amyris shall be responsible as Lavvan’s designee for the management of such Contract Manufacturer for the period beginning with the Technology Transfer Plan delivery of the initial technology transfer report in respect of such Collaboration Cannabinoid to Lavvan or the applicable Contract Manufacturer and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 12 (Invoice and Payment). If there is ending (i) an ongoing Technology Transfer at with respect to CBD one (1) year following the time achievement of expiration or termination of the Agreement or Milestone 6, (ii) this Agreement is terminated by with respect to SCC1, one (1) year following the Purchaser pursuant achievement of Milestone 8, or (iii) for each Collaboration Cannabinoid other than CBD and SCC1, upon the achievement of the Commercial Scale Milestone in respect of such Collaboration Cannabinoid (“Amyris Management Period”) with respect to Clause 31.3(A) or Clause 36.2manufacturing ramp-up and scaling of commercial production; provided that Amyris must receive consent from Lavvan, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser which consent shall not be required unreasonably withheld, delayed or conditioned, before making or agreeing to reimburse GSK make any capital expenditures, other expenditures or commitments exceeding $100,000 USD individually or $1,000,000 USD in the aggregate), and Lavvan shall be responsible for any Technology Transfer support servicesthe management of such Contract Manufacturer after the expiration of the Amyris Management Period. Notwithstanding the foregoing, or direct costs or expenses associated nothing in this Section 3.4.3 shall derogate from Lavvan’s ability to visit and/or maintain a presence at a Contract Manufacturer’s facility, to observe and inspect operations (with such Technology Transferrights to be at least as expansive as those set forth in Section 3.4.2, if such Technology Transfer has been initiated by the Purchaser pursuant mutatis mutandis), and to Clause 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of otherwise exercise its rights under this Agreement or in and its agreement with the event of termination of this AgreementContract Manufacturer.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 1 contract
Sources: Research, Collaboration and License Agreement (Amyris, Inc.)
Technology Transfer. 30.1 If:
Without limitation to MTEM’s obligations under Section 3.9, at Takeda’s request, for each Licensed Product, MTEM shall, at Takeda’s expense (Asubject to a mutually agreed reasonable budget with internal time to be calculated on an FTE basis based on a rate that reflects MTEM's actual costs for such FTE), transfer the Manufacturing process for such Licensed Product and any ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components thereof to Takeda or its designee (the “Technology Recipient”) GSK as set forth in this Section 5.2, which transfer will not be supplying 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 for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) appliessuch transfer, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for .
5.2.1 Within [***] from after Takeda notifies MTEM that it is exercising Technology Transfer rights under this Section 5.2 with respect to a Licensed Product, MTEM shall deliver to the Technology Recipient copies of the then-current Manufacturing process for and any other information reasonably required in order to Manufacture such termination or expiration date. For clarityLicensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and other Components contained therein, including master batch records and any other manufacturing records (collectively, 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 30.1(C) or 30.1(DDocumentation”).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) 5.2.2 During such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] and upon Takeda’s reasonable request with at least [***] notice to MTEM, MTEM shall also find a convenient time to permit representatives of the Technology Recipient or Takeda, as applicable, (the “Representatives”) to access the Facility during normal business hours to observe the Manufacturing of the Licensed Product and ▇▇▇▇ ▇▇▇-▇ Fusion Proteins included therein. While the Representatives are at the Facility, MTEM shall make available to the Representatives employees of MTEM (or its Affiliates or subcontractors) for consultation with respect to the Technology Transfer Documentation and the Manufacturing process for the Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein.
5.2.3 At Takeda’s request, MTEM shall use commercially reasonable efforts to effect assignments of any existing contract to the extent relating to one or more of the Licensed Products or the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein, or to obtain for Takeda substantially all of the practical benefit and burden under such agreement to the extent applicable to Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein, including by 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 Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein shall be assignable or otherwise transferable to Takeda without the consent of the counterparty thereto to the extent related to any Licensed Product and the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and components contained therein.
5.2.4 Following the completion of the Technology Transfer, MTEM shall, for a period of up to [***] thereafter, provide the Technology Recipient with reasonable access to MTEM’s employees for telephone or in person consultations regarding the Manufacture of the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and, if applicable, the Licensed Products.
5.2.5 Without limiting the foregoing, MTEM shall take, and shall cause its Affiliates and subcontractors to take, all action and to do all things necessary, proper or advisable to complete the Technology Transfer in accordance with 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 Technology Recipient to Manufacture the ▇▇▇▇ ▇▇▇-▇ Fusion Proteins and the Licensed Products.
5.2.6 Takeda shall pay MTEM for its reasonable, out-of-pocket costs and expenses incurred in the performance of its requirements for Products from GSKactivities under this Section 5.2 (in which case such amounts paid shall be included as Co-Development Costs), unless the Technology Transfer is a response by Takeda to a material breach by MTEM of its supply obligations hereunder that is not cured by MTEM pursuant to this Agreement, in which case MTEM shall bear all of its own expenses.
Appears in 1 contract
Sources: Development Collaboration and Exclusive License Agreement (Molecular Templates, Inc.)
Technology Transfer. 30.1 If:
3.1 Initial Technology Transfer. Schedule D, attached hereto, identifies specific components of technology Controlled by Alnylam or its Affiliates that Alnylam believes may be reasonably required or useful to effect the transfer to Monsanto (Aor its designated Affiliate(s)) GSK will not be supplying Products of Licensed Intellectual Property that is reasonably necessary or useful for Commercialisation the exercise of Monsanto’s rights under the licenses granted pursuant to Section 2.1(a). Within a period of [**] following the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) Effective Date (the “Technology TransferIdentification Period”), Monsanto shall identify which specific components of technology listed in Schedule D that Monsanto wishes to receive under the technology transfer process described in this Section 3.1 and shall notify Alnylam thereof by identifying such desired components of technology in Schedule I attached hereto. The Parties As soon as reasonably practical, but in no event later than [**] after the end of the Technology Identification Period (the “Initial Technology Transfer Period”), Alnylam shall use Commercially Reasonable Efforts to create a deliver the technology transfer plan relating documentation for each item as set forth in Schedule I (which may be amended from time to time by mutual agreement of the Technology Transfer (Parties, the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to During the production process employed by GSK in the Manufacture of the Products, and 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 [***]] day period following the Initial Technology Transfer Period (the “Technology Transfer Definition Period”), 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 the Parties will discuss and mutually agree upon the training processes and activities, and the requisite number of Alnylam personnel and other resources. GSK shall transfer (subject to the terms of the licences granted conduct such activities, for each item set forth 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 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 31.3(A) or Clause 36.2, amend the Technology Transfer Plan will survive to include such training processes and activities and personnel commitment and budget for such activities (as described in Section 3.2 below). During the [***] from such termination or expiration date. For clarity, month period following the Purchaser shall not be required to reimburse GSK for any completion of the Technology Transfer support servicesDefinition Period (“Technology Training Period”), or direct costs or expenses associated with Alnylam shall use Commercially Reasonable Efforts to make available to Monsanto such Technology Transfer, if such number of technical personnel as may be set forth in the Technology Transfer has been initiated by Plan to answer any questions or provide training and instruction as set forth in the Purchaser Technology Transfer Plan concerning the items delivered pursuant to Clause 30.1(C) or 30.1(D).
30.2 A this Section 3.1, in connection with Monsanto’s Discovery, Development, Commercialization and Manufacture of Licensed Products hereunder. Upon Alnylam’s belief that it has completed its technology transfer activities under the Technology Transfer may be implemented Plan, Alnylam shall so notify Monsanto in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase writing and no later than [**] days after receipt of such notice from Alnylam Monsanto shall notify Alnylam in writing as to whether or not Monsanto agrees that Alnylam has completed its technology transfer activities under the Technology Transfer Plan. If Monsanto fails to provide such notice to Alnylam within such time period, then Monsanto shall be deemed to agree that Alnylam’s activities under the Technology Transfer Plan are completed. In the event that Monsanto notifies Alnylam in writing within such time period that it does not agree that such activities have been completed, then the Parties will discuss the items in dispute and work in good faith to amicably resolve the situation as promptly as possible, but in no event later than [**] days after Alnylam’s receipt of its requirements for Products from GSKMonsanto’s notice.
Appears in 1 contract
Sources: License and Collaboration Agreement
Technology Transfer. 30.1 If:
(Aa) GSK Seller shall reasonably cooperate with and shall make its personnel available at all reasonable times to ensure the prompt and complete transfer to Buyer of all Transferred Know-How, up to a maximum combined resource commitment of {*} until a maximum of {*} from Closing Date (the “Tech Transfer Period”). In connection with the foregoing, Seller shall, at its sole cost and expense (except for the payment required pursuant to Section 6.3(b)) during the Tech Transfer Period: (i) {*}, (ii) make introductions to, arrange for site visits with and, as appropriate, audits of any of Seller’s vendors and/or suppliers vending to and supplying the Business, and (iii) undertake such other activities as are necessary to effect the transfer of the Transferred Know-How (collectively, the activities referred to in the first two (2) sentences of this Section 6.3(a) are hereinafter referred to as the “Tech Transfer Process”). Buyer acknowledges that Seller has publicly announced a lay-off, and that Seller has informed Buyer that the layoff includes scientific personnel familiar with the Acquired Assets, who will not be supplying Products for Commercialisation pursuant to employed by Seller beyond January 2009. While Seller will {*} assist Seller in the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time completion of any remaining technology transfer to {*} and only during an additional {*}, the Purchaser (or Purchaser’s designee) parties intend that barring unforeseen circumstances the technology transfer should be completed within Tech Transfer Period. During the Tech Transfer Period, Buyer shall compile a reasonably detailed written list (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the 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 Transferred Know-How List”) of the Know-How that falls within the definition of ‘Transferred Know-How Category’ and GSK Intellectual Property is either (a) reflected in accordance the documentation Seller is required to provide to Buyer under this Agreement (or has been provided to Buyer as part of the due diligence process prior to the Closing Date) or (b) provided to Buyer through the Tech Transfer Process. Buyer shall provide such Transferred Know-How List to Seller {*}. {*}. The Transferred Know-How List shall not be deemed final until agreed to in writing by Buyer and Seller.
(b) In connection with the Technology Transfer Plan foregoing, Buyer shall pay to Seller an amount equal to {*} of which {*} shall be paid at the Closing and {*} shall be paid on the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 12 (Invoice and Payment). If there is earlier of: (i) an ongoing Technology Transfer at the time of expiration or termination {*} anniversary of the Agreement Closing or (ii) this Agreement is terminated by the Purchaser pursuant date that Buyer provides written notice to Clause 31.3(A) or Clause 36.2, Seller that it no longer requires 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 30.1(C) or 30.1(Dtechnology transfer services of Seller as set forth in Section 6.3(a).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for Products from GSK.
Appears in 1 contract
Technology Transfer. 30.1 If:5.1 Transfer of Vicuron Know-how and Materials.
(Aa) GSK will not be supplying Products for Commercialisation pursuant to Within thirty (30) days of the Commercial Manufacturing Effective Date, Vicuron shall deliver and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time technology transfer to the Purchaser (Oscient, or PurchaserOscient’s designee, all Vicuron Know-how and Materials, Vicuron Licensed Know-how and Materials, and Regulatory Filings to a location designated by Oscient and in accordance with commercially reasonable procedures for a transfer of this type. Vicuron will provide Oscient with all reasonable assistance required to transfer the Vicuron Know-how and Materials, Vicuron Licensed Know-how and Materials, Regulatory Filings and Vicuron Regulatory Approvals, and the benefit thereof, to Oscient or Oscient’s designee. Without limiting the generality of the foregoing, (a) Vicuron shall provide Oscient or its designee with all Information and Materials in its possession necessary to enable it to manufacture the Bulk Compound and Product, and (b) if visits with personnel of Vicuron and its Affiliates are reasonably requested by Oscient for purposes of transferring the “Technology Transfer”)Vicuron Know-how and Materials, Vicuron Licensed Know-how and Materials, Regulatory Filings and Vicuron Regulatory Approvals to Oscient or its designee, or for purposes of Oscient’s acquiring expertise on the practical application and use of the Vicuron Know-how and Materials, Vicuron Licensed Know-how and Materials, Regulatory Filings or Vicuron Regulatory Approvals or of assisting Oscient or its designee on issues arising during such transfer and transition, then, on a reasonable schedule to be agreed upon by the Parties, qualified personnel from each Party with appropriate technical or regulatory expertise who are familiar with all aspects of the Vicuron Know-how and Materials, Vicuron Licensed Know-how and Materials, Regulatory Filings and Vicuron Regulatory Approvals shall meet at such facilities or locations as may be mutually agreed upon, and shall participate in telephone conference calls so that the personnel from Vicuron can transfer knowledge to Oscient personnel about manufacture of the Products. The Parties now anticipate that these in-person meetings shall use Commercially Reasonable Efforts to create occur at mutually agreed locations and that telephone conference calls shall occur regularly for 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 period of the Products, and 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 [at least ***]** months from 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. an undue burden on GSK personnel and other resources. GSK it being agreed that there 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 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [be no more than ***]. The Purchaser will reimburse GSK for ** days of in-person meetings during such services pursuant to Clause 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 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] from such termination **-month period unless the Parties agree to additional meetings. Notwithstanding the foregoing, until Oscient 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [designee ***] **, Vicuron shall make available to Oscient Vicuron’s then-current employees or then-current consultants who have expertise or knowledge relevant to the manufacture of Bulk Compound on a reasonable schedule to be agreed upon by the Parties. The transfer of Vicuron Know-how and Materials and Vicuron Licensed Know-how and Materials to Oscient shall be complete only upon Vicuron’s * Confidential information has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. satisfaction of the foregoing requirements. Vicuron and its requirements Affiliates agree to cooperate with Oscient and applicable regulatory authorities to the extent reasonably necessary to effect the successful transfer of Regulatory Filings and Vicuron Regulatory Approvals.
(b) As of the Effective Date, Vicuron has designated ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ as its primary contact person and Oscient has designated ▇▇▇▇▇ ▇▇▇▇▇▇▇ as its primary contact person. The primary contact persons shall be responsible for Products from GSKoversight of the interactions and activities described in Section 5.1(a) and shall attempt to resolve any questions that arise during the course of such transfer.
Appears in 1 contract
Sources: Assignment and Termination Agreement
Technology Transfer. 30.1 If:
(A) GSK will not be supplying Products On or promptly after the Effective Date, ViroPharma shall arrange for Commercialisation pursuant to the Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, GSK shall facilitate a one-time complete technology transfer to Schering or its designated Affiliate (a) such data and information in ViroPharma’s possession reasonably requested by Schering related to the Purchaser processes and procedures for the manufacture, testing, handling, storage, formulation and packaging of the bulk active Compound and the finished Products, (or Purchaserb) the specifications and release testing for the Compound and Products, (c) complete copies of the CMC sections for all of ViroPharma’s designeeINDs for the Compound and/or Products, and (d) samples of all available reference standards for the Compound and Products, including any known impurities and/or metabolites (the “Technology TransferTransfer Materials”). The Parties Within seven (7) business days after delivery of the Transfer Materials by ViroPharma to Schering, Schering shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology inform ViroPharma of whether additional Transfer (the “Technology Materials are required, and if so, shall describe with particularity such additionally required Transfer Plan”)Materials. The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of the Products, and shall be developed based on the 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 immediately preceding sentence shall also apply to any later deliveries of Transfer Plan and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant Materials delivered to Clause 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 12 (Invoice and Payment)Schering at their request. If there is Schering does not provide such notice to ViroPharma within such seven (i7) an ongoing Technology business day period, then Schering shall be deemed to have such received such Transfer at Materials required for it to make the time of expiration or termination of determination regarding the Agreement or (ii) this Agreement is terminated by Specifications described in Section 5.2 below. During the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarityperiod immediately following the Effective Date, ViroPharma shall, upon request, transfer to Schering any additional information described in Section 5.1(a) above not previously provided to Schering, and ViroPharma shall also, upon request by Schering, make reasonably available ViroPharma’s employees to Schering to discuss matters relating to the Purchaser processes and procedures for the manufacture, testing, handling, storage, formulation and packaging of the bulk active Compound and the finished Products, and shall not be required assist Schering in contacting ViroPharma’s Third Party manufacturing contractors involved with the manufacture of the Compound and/or Product, all as reasonably necessary 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 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the circumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be relieved of its obligation under Clause 4.1 to purchase [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. advise and assist Schering or its designated Affiliate in the technology transfer, and the start-up and validation of the manufacturing process for the Compound and/or Products. Such access to personnel shall be during normal business hours and Schering shall pay ViroPharma for the reasonable travel costs and other out-of-pocket expenses incurred by such personnel, as well as a reasonable hourly rate to be agreed to by the Parties for the time of such personnel in excess of two hundred (200) hours during such [***] period, at Schering’s request in providing such advice and assistance. Following the successful completion of the technology transfer provided for under this Section 5.1, Schering (or its designated Affiliate or Third Party contractor) shall be responsible for the manufacture of all of Schering’s requirements for Products from GSK.supplies of the Compound and the Product for the Territory in excess of the initial supplies to be provided by ViroPharma under Section 5.2
Appears in 1 contract
Sources: License Agreement (Viropharma Inc)