Manufacturing Know-How. Within ten (10) business days of (1) PPD exercising its PPD Option pursuant to Section 5.2(a), (2) a written request made by PPD during the PPD Option Period in connection with PPD’s Development of Licensed Product during the PPD Option Period, or (3) a written request from PPD in the event PPD has terminated the Master Services Agreement pursuant to Section 6.04 and PPD is continuing with Development of Licensed Product, Xxxxxxx shall initiate the transfer, to PPD or any designee thereof if designated in writing by PPD prior to the initiation of such transfer all Manufacturing Know-How reasonably required to (i) synthesize and manufacture, and enable or qualify PPD or any designee thereof to synthesize or manufacture, a Compound, API, CTM or Finished Product, (ii) complete the chemistry, manufacturing, and controls portion of any Regulatory Filings, in a form and format reasonably acceptable to PPD, or (iii) enable PPD or any designee thereof to continue activities related to any of the foregoing, such as development, optimization, testing, or shipping, and upon PPD’s reasonable request Xxxxxxx shall provide reasonable access to and assistance [*] as necessary to effect the purposes of the foregoing for a period of up to [*] ([*]) months. If after the two month time period, PPD requests additional assistance, PPD will pay all reasonable, documented out of pocket expenses incurred by Xxxxxxx in transferring the Manufacturing Know-How and performing any requested consultation services, provided that Xxxxxxx shall itself remain responsible for the costs of all personnel required to make such transfer or provide such assistance.
Manufacturing Know-How. Subject to Clause 4, UCLB hereby grants to Autolus for the full duration of the Term and throughout the Territory a non-exclusive licence under the Manufacturing Know-How (including the right to sub-license through multiple tiers) within the Field to use the same:
Manufacturing Know-How. Welichem shall disclose to GSK, GSK’s Affiliates and any of GSK’s Third Party contract manufacturers, and shall cause any other relevant Third Party to disclose any and all, of its Know-How relating to the development and manufacture of the Compound, any Backup Compound or the Product.
Manufacturing Know-How. Welichem shall disclose to GSK, GSK’s Affiliates and any of GSK’s Third Party contract manufacturers, and shall cause any other relevant Third Party (including Celestial and BWTP) to disclose any and all, of its Know-How relating to the development and manufacture of the Compound or any Backup Compound in the China Territory.
Manufacturing Know-How. For clarity, except as provided in Section 3.2.4 (Manufacturing Matters) above, the Manufacturing Lead shall not be obligated to share with the other Party or provide the other Party access to Know-How related to the manufacture of a Product unless and until such Party becomes the Manufacturing Lead with respect to such aspect of manufacturing of such Product, in which case the Manufacturing Lead shall promptly provide the other Party with access to such manufacturing Know-How within the Product Intellectual Property as is reasonably necessary for such Party to fulfill its obligations as Manufacturing Lead with respect to such Product. All such transfer of manufacturing Know-How shall be overseen and facilitated by the JPT for the applicable Product.
Manufacturing Know-How. Only if the Default Model becomes applicable as per Clause 2.2 above, SSI shall, [****] the Manufacturing Know How to [****] as per Clause 3.2 above, by means of SSI executing a Technology Transfer as per Clause 5 below. [****] shall mean that were a further Technology Transfer[****], then Evaxion is authorised to contractually obligate [****] to carry out such Technology Transfer on Evaxion’s behalf without involving SSI, whether resource wise or financially, it being noted that SSI by then may no longer possess the required competencies to participate in a Technology Transfer.
Manufacturing Know-How. “Manufacturing Know-How” means the Specifications and information, including without limitation engineering designs, xxxx of materials, drawings, and the like, necessary to manufacture the Products, as well as the names and contact information for all of Supplier’s then-current suppliers and manufacturers with respect to the Products.
Manufacturing Know-How. In addition to the obligations of confidentiality applicable to the Confidential Information of Biogen Idec pursuant to this Article X, until such time as Biogen Idec ceases to maintain the Manufacturing Know-How as a trade secret, Xxxxxxx (a) shall maintain in confidence all Manufacturing Know-How, and (b) shall not use such Manufacturing Know-How for any purpose except in manufacturing or having manufactured Products or Services under the license granted under Section 2.2 of this Agreement or pursuant to the sublicense rights of Section 2.4 of this Agreement.
Manufacturing Know-How. 2.8.1. Xxxxxx acknowledges and agrees that, as of the Effective Date, Dermira has completed its obligations to transfer Manufacturing Know-How and provide any related assistance pursuant to Sections 2.7.1 and 2.7.2 of the First A&R Agreement.
Manufacturing Know-How. Without limiting either Party’s obligations under Section 2.4 (Technology, Data, and Regulatory Transfer) or Section 8.1.2 (Local Manufacturing), within a reasonable time period following the engagement by Sobi of an applicable contract manufacturing organization or supplier reasonably acceptable to Apellis pursuant to Section 8.1 (Sobi Right to Manufacture Drug Substance) (with respect to Drug Substance) or Sobi’s engagement of the Second Source (with respect to Drug Products), as applicable, Apellis shall provide (or cause its relevant Affiliates or subcontractors of Drug Substance or Drug Product, as applicable, to provide) such contract manufacturing organization, supplier, or Second Source (as applicable) with all Apellis Know-How necessary to Manufacture the Drug Substance or the Drug Product, as applicable, (the “Manufacturing Know-How”) that has not previously been transferred in accordance with Section 2.4 (Technology, Data, and Regulatory Transfer) or Section 8.1.2 (Local Manufacturing), to be held in confidence by such contract manufacturing organization, supplier, or Second Source (as applicable) until such time (if any) that Sobi obtains the right to Manufacture Drug Substance or Drug Product (as applicable) pursuant to Section 8.1 (Sobi Right to Manufacture Drug Substance) or Section 8.2 (Sobi Right to Manufacture Drug Product) (as applicable).
