Common use of Manufacturing Technology Transfer Clause in Contracts

Manufacturing Technology Transfer. Except as the Committee ------------ --------------------------------- may otherwise agree in writing, in order to effectuate an orderly transition of the uninterrupted availability of Product to LILLY for purposes contemplated under this Agreement, MEGABIOS, at least ninety (90) days prior to completion of the Project or completion of Phase I Clinical Trials, whichever is earlier, shall transfer to LILLY all information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form of consultation) to LILLY with respect to manufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will be referred to herein as the "Manufacturing Transfer." All such information, methods and instructions transferred to LILLY under this Section 4.3 shall be referred to herein as the "Manufacturing Information," and shall be maintained in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the manufacture of the Products and shall not disclose or transfer such Manufacturing Information to any third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, and bear its costs for, up to [ * ] FTEs for a period of up to [ * ] months [ * ] in aggregate) to accomplish the Manufacturing Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities by MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and that MEGABIOS is able to provide, for up to [ * ] after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to such additional assistance.

Manufacturing Technology Transfer. Except Without limiting the provisions of Section 3.1, as soon as reasonably practicable following the Committee ------------ --------------------------------- may otherwise agree Effective Date (but in writingall cases within thirty (30) days after Chimerix’s receipt of the upfront payment pursuant to Section 5.1), Chimerix shall transfer or cause to be transferred (including from its Third Party contract manufacturers) to Merck, or a Third Party manufacturer designated by Merck, copies in English (in writing and in an electronic format, or in written format to the extent that electronic format is not available) of all data, information and other Know-How Controlled by Chimerix (or any of its Affiliates or its Third Party contract manufacturers) that is related to the manufacture of the Compounds and/or Products, in order to effectuate enable Merck (or its designee) to manufacture the Compounds and Products, including to replicate the process employed by or on behalf of Chimerix to manufacture Compounds and Products. In addition, at the request of Merck from time to time during the eighteen (18) month period following the Effective Date, Chimerix shall make its (and its Affiliates’) employees and consultants (including personnel of its Third Party contract manufacturers) available to Merck to provide consultation and technical assistance in order to ensure an orderly transition of the uninterrupted availability manufacturing technology and operations to Merck (or its designee) and to assist Merck (or its designee) in the start-up of its manufacture of Compound and Product (such consultation, the “Manufacturing Consultation”). For clarity, the Manufacturing Consultation shall be at no cost or expense to LILLY for purposes contemplated under this AgreementMerck during the Transfer Period; provided, MEGABIOShowever, that Merck shall at least ninety all times (90including during the Transfer Period) reimburse Chimerix (within thirty (30) days after a receipt of an itemized invoice from Chimerix) for those reasonable out-of-pocket costs payable by Chimerix to its Third Party contract manufacturer for the use of such Third Party contract manufacturer’s personnel in providing such Manufacturing Consultation to Merck to the extent applicable (but solely to the extent that Merck has agreed to the amount of such costs in writing prior to completion of the Project or completion of Phase I Clinical Trialssuch Manufacturing Consultation, whichever is earlierand for clarity, shall transfer to LILLY all information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form of consultation) to LILLY with respect to manufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will be referred to herein as the "Manufacturing Transfer." All such information, methods and instructions transferred to LILLY under this Section 4.3 Chimerix shall be referred to herein as the "Manufacturing Information," and shall be maintained solely responsible for any costs incurred in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence excess of such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the manufacture of the Products and agreed upon amount but shall not disclose or transfer be obligated to incur such Manufacturing Information to any third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, and bear its excess costs for, up to [ * ] FTEs for a period of up to [ * ] months [ * ] in aggregate) to accomplish the Manufacturing Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities by MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and that MEGABIOS is able to provide, for up to [ * ] after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to such additional assistanceMerck’s benefit).

Manufacturing Technology Transfer. Except Other than in connection with a termination by AstraZeneca pursuant to Clause 18.4(a) (Termination by AstraZeneca for Material Breach by Buyer) or Clause 18.4(b) (Termination by AstraZeneca for Buyer Insolvency), as a result of which AstraZeneca is not required to take the Committee ------------ --------------------------------- actions described in this Clause 19.7 pursuant to the terms set forth in Clause 19.2(c), or a termination by Buyer pursuant to Clause 18.3(a) (Termination by Buyer following the [***] Anniversary), promptly following notice of termination of this Supply Agreement in accordance with any of the terms hereof, or if required pursuant to Clause 19.6 [***], or if Buyer has the right to source alternative sources of supply and Manufacture of the Supplied Product pursuant to Clause 2.1, and subject to the limitations of Clause 19.8 (Technology Transfer Limitations) and the other terms of this Agreement, the Parties shall work together to agree to a plan for transitioning the Manufacturing Know-How (a “Technology Transfer”) to Buyer or its Third Party manufacturer (Buyer or such Third Party, the “Technology Recipient”), including a targeted completion date for such Technology Transfer, and the Parties shall, and shall otherwise cause their Affiliates to, use commercially reasonable efforts to assist and cooperate in respect of any Technology Transfer. Such assistance shall include AstraZeneca providing such information, data and documentation in respect of the Supplied Products, the materials and the Manufacturing process in respect thereof as Buyer may reasonably request, supplier information with respect to the Supplied Product, batch records in respect of any Supplied Product and artwork, logos and the like in respect thereof) and such other information and data as may be reasonably necessary to qualify the Technology Recipient with any Regulatory Authority for purposes of Manufacturing and supplying the Supplied Product (including as to any information, data or documentation that such Technology Recipient may be required to provide to, or include in any filing or application made to, any Regulatory Authority in respect of the qualification of such Technology Recipient for the Manufacturing and supply of Supplied Products). Each Party shall, and Buyer shall use Commercially Reasonable Efforts to cause any selected Third Party manufacturer to use Commercially Reasonable Efforts to perform its obligations under such plan in accordance with the timelines set out therein. All documents transmitted to the Technology Recipient in connection with a Technology Transfer shall be transmitted electronically unless otherwise agree in writing, required by applicable Law in order to effectuate an orderly transition of effect the uninterrupted availability of Product Technology Transfer. Neither AstraZeneca nor its Affiliates will be required to LILLY for purposes contemplated under this Agreement, MEGABIOS, at least ninety (90) days prior to completion of the Project or completion of Phase I Clinical Trials, whichever is earlier, shall transfer to LILLY all the Technology Recipient any data, information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but or documents not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form possession of consultation) to LILLY with respect to manufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will AstraZeneca or its Affiliates or that cannot be referred to herein as the "Manufacturing Transferreasonably obtained thereby." All such information, methods and instructions transferred to LILLY under this Section 4.3 shall be referred to herein as the "Manufacturing Information," and shall be maintained in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the manufacture of the Products and shall not disclose or transfer such Manufacturing Information to any third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, and bear its costs for, up to [ * ] FTEs for a period of up to [ * ] months [ * ] in aggregate) to accomplish the Manufacturing Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities by MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and that MEGABIOS is able to provide, for up to [ * ] after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to such additional assistance.