Stability Data Sample Clauses

Stability Data. Notwithstanding anything herein to the contrary, Santarus agrees to transfer to GSK all stability data related to the Licensed Products Controlled by Santarus that it may generate from time to time during the Term.
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
Stability Data. Without limiting Santarus’ obligations in Section 5.3.1, GSK shall have the right and be responsible for generating at its expense any stability data necessary to expeditiously file for and obtain Marketing Authorizations throughout the GSK Territory to the extent such data is beyond the current or scheduled Santarus stability programs. In the event that Santarus wishes to use any of this stability data in Regulatory Filings for Licensed Products outside of the GSK Territory and Territory under the Distribution Agreement, excluding uses by Santarus as required by Applicable Law, the Parties shall negotiate in good faith for appropriate compensation by Santarus for the use of such stability data, such compensation to be determined by reference to the anticipated commercial value respectively to GSK and Santarus of using such data.
Sample 1Sample 2
Stability Data. Norgine shall have the right and be responsible for generating at its expense any stability data necessary to file for and obtain Marketing Authorizations throughout the Territory. Santarus shall have the right to use any such stability data generated by Norgine for applications outside the Territory or outside the Field, pursuant to the terms of the license set forth in Section 2.2.
Sample 1
Stability Data. Avigen shall Notify Bayer of any stability failures in routine stability testing of the Product in accordance with the Product Specifications within [...*...] of Avigen confirming such failure if such failure could require notification of a regulatory authority, could prevent release of Product or could warrant recall of Product.
Sample 1
Stability Data. Without limiting Santarus’ obligations in Section 5.3.1, GSK shall have the right and be responsible for generating at its expense any stability data necessary to expeditiously file for and obtain Marketing Authorizations throughout the GSK Territory to the extent such data is beyond the current or scheduled Santarus stability programs. In the event that Santarus wishes to use any of this stability data in Regulatory Filings for Licensed Products outside of the GSK Territory and Territory under the Distribution Agreement, [***]. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Sample 1
Stability Data. DUSA shall annually make available to Schering copies of stability data for the Collaboration Products. Any significant trends should be promptly reported.
Sample 1

Related to Stability Data

  • Stability 14.01 Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures. X 14.02 Data analysis and trending reporting will be performed. X

  • Data To permit evaluation of requests under paragraph (c) of this clause based on unreasonable cost, the Contractor shall include the following information and any applicable supporting data based on the survey of suppliers: Foreign and Domestic Construction Materials Cost Comparison Construction material description Unit of measure Quantity Cost (dollars) * Item 1: Foreign construction material Domestic construction material Item 2 Foreign construction material Domestic construction material [List name, address, telephone number, and contact for suppliers surveyed. Attach copy of response; if oral, attach summary.] [Include other applicable supporting information.] (*Include all delivery costs to the construction site.]

  • Third Party Data Any statistical, industry-related and market-related data, which are included in the Disclosure Package and the Prospectus, is based on or derived from sources that the Company reasonably and in good faith believes to be reliable and accurate, and such data agrees with the sources from which it is derived, and the Company has obtained the written consent for the use of such data from such sources to the extent required.

  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.

  • Global Safety Database Licensee shall establish, hold and maintain (at Licensee’s sole cost and expense) the global safety database for Licensed Products.

  • Product Information EPIZYME recognizes that by reason of, inter alia, EISAI’s status as an exclusive licensee in the EISAI Territory under this Agreement, EISAI has an interest in EPIZYME’s retention in confidence of certain information of EPIZYME. Accordingly, until the end of all Royalty Term(s) in the EISAI Territory, EPIZYME shall keep confidential, and not publish or otherwise disclose, and not use for any purpose other than to fulfill EPIZYME’s obligations, or exercise EPIZYME’s rights, hereunder any EPIZYME Know-How Controlled by EPIZYME or EPIZYME Collaboration Know-How, in each case that are primarily applicable to EZH2 or EZH2 Compounds (the “Product Information”), except to the extent (a) the Product Information is in the public domain through no fault of EPIZYME, (b) such disclosure or use is expressly permitted under Section 9.3, or (c) such disclosure or use is otherwise expressly permitted by the terms and conditions of this Agreement. For purposes of Section 9.3, each Party shall be deemed to be both the Disclosing Party and the Receiving Party with respect to Product Information. For clarification, the disclosure by EPIZYME to EISAI of Product Information shall not cause such Product Information to cease to be subject to the provisions of this Section 9.2 with respect to the use and disclosure of such Confidential Information by EPIZYME. In the event this Agreement is terminated pursuant to Article 12, this Section 9.2 shall have no continuing force or effect, but the Product Information, to the extent disclosed by EPIZYME to EISAI hereunder, shall continue to be Confidential Information of EPIZYME, subject to the terms of Sections 9.1 and 9.3 for purposes of the surviving provisions of this Agreement. Each Party shall be responsible for compliance by its Affiliates, and its and its Affiliates’ respective officers, directors, employees and agents, with the provisions of Section 9.1 and this Section 9.2.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!