CMC Information. Promptly after the Effective Date, and from time to time, 3SBio will provide all necessary CMC information to Selecta or its designee for incorporation into Regulatory Filings and Regulatory Approvals for the Products in the Field in the Territory. As long as the CMO manufacturing contracts have not been assigned to 3SBio, Selecta shall use Commercially Reasonable Efforts to provide to 3SBio all CMC information and samples from its chosen CMO as necessary for 3SBio’s regulatory filings outside the Territory.
CMC Information. (a) Each Party shall submit to each other Party all CMC information related to the Product as soon as such CMC data becomes available.
CMC Information. Keryx, in its discretion, may provide Vendor with CMC information applicable to Vendor for Vendor to manufacture Product in accordance with this Agreement and the Health Registrations, and Vendor shall comply with all such CMC information in performing its activities hereunder. For clarity, all CMC information shall be considered Confidential Information of Keryx hereunder.
CMC Information. Customer shall provide Corden with CMC information applicable to Corden to the extent necessary for Corden to Manufacture the Product in accordance with this Agreement, and Corden shall comply with all such CMC information in performing its activities hereunder. In the event Customer subsequently modifies any relevant Health Registration (or the CMC) which will affect the Manufacture of the Product hereunder, it shall promptly notify Corden and provide it with necessary information about such Health Registration (or CMC) supplements or amendments to the extent necessary for Corden to Manufacture the Product in accordance with this Agreement, and the provisions of Section 8.3 shall apply.
CMC Information. Upon reasonable request by Incyte, Hengrui shall provide Incyte with any CMC Information necessary or useful or otherwise requested or required by a Regulatory Authority and/or Governmental Authority as a condition or in support of obtaining or maintaining all Regulatory Approvals (including Pricing Approval) for the Licensed Products in the Incyte Territory. All materials provided by Hengrui to Incyte under this Agreement shall be translated into the English language. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
CMC Information. Keryx, in its discretion, may provide BioVectra with CMC information applicable to BioVectra for BioVectra to manufacture Product in accordance with this Agreement and the Health Registrations, and BioVectra shall comply with all such CMC information in performing its activities hereunder. Any changes to CMC section after the effective date of this Agreement, will need to be reviewed for scope changes to the manufacturing schedule, release requirements or quality requirements and associated impact(s), including impacts to costs prior to implementation. For clarity, all CMC information shall be considered Confidential Information of Keryx hereunder.
CMC Information. Notwithstanding anything to the contrary in this Agreement or the Supply Agreement, AMAG shall disclose Information related to CMC for the Product and necessary to support Regulatory Approvals (“CMC Information”) to Takeda only to the extent that Takeda requires such CMC Information to comply with applicable Laws, and only to those certain individuals designated to receive CMC Information on behalf of Takeda (the “CMC Recipients”). The CMC Recipients shall not have the right to disclose CMC Information to any other Takeda personnel. To the extent applicable in any regulatory jurisdiction in the Licensed Territory, AMAG shall have the right to timely file or otherwise provide CMC Information directly to a Regulatory Authority, and Takeda shall reasonably cooperate with AMAG in any such filing. If a regulatory jurisdiction does not provide a procedure whereby AMAG may directly submit such CMC Information, then AMAG shall provide to the CMC Recipients the relevant CMC Information, and Takeda shall have the right to file any such CMC Information to the extent required by applicable Laws, subject to the terms of this Section 5.1(b). To the extent that Takeda provides any such CMC Information to a Regulatory Authority, Takeda shall disclose only what is required to be disclosed, shall take reasonable measures to protect the confidentiality of such Information to the extent permitted by a Regulatory Authority, and shall not disclose any such Information without AMAG’s prior written approval of the form and content of such disclosure except to the extent required by a Regulatory Authority. In addition, notwithstanding Article 12, Takeda shall not have the right to disclose such CMC Information as provided in Section 12.1, and instead shall have the right to disclose such information only to a Regulatory Authority under the terms of this Section 5.1(b).
CMC Information. Subject to Section 2.7 (Development Costs), as long as CG is manufacturing (or having manufactured through a CMO) Product for Kissei pursuant to the Clinical Supply Agreement or Commercial Supply Agreement, CG shall provide to Kissei CG’s then-current CMC Information, to the extent reasonably necessary for Kissei to file and maintain a Marketing Approval Application for Product in the Territory. CG shall permit Kissei to cross-reference such CMC Information in its Regulatory Materials for Product for the Field in the Territory in accordance with this Agreement. “CMC Information” means all technical information regarding a Party’s (or its CMO’s) CMC filed or required to be filed with the FDA or PMDA in connection with the development or commercialization of Product.
CMC Information. Notwithstanding anything to the contrary contained in this Agreement, in no event shall BLS be required to disclose any information related to the Chemistry, Manufacturing and Controls section of any NDA or other Regulatory Approval.
CMC Information. Notwithstanding anything to the contrary contained herein, in no event shall BPI (or its Affiliates) be required to disclose any information related to the Chemistry, Manufacturing and Controls section of any NDA or other regulatory approval for the Product to Kos or any other Person under any circumstances whatsoever.
