Astellas EU Agreement definition

Astellas EU Agreement means the Anemia License and Collaboration Agreement between FibroGen and Astellas with respect to the countries listed on Exhibit A (other than Japan) effective April 28, 2006, as amended from time to time.
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Astellas EU Agreement means the Anemia License and Collaboration Agreement between FibroGen and Astellas effective April 28, 2006, as amended from time to time.
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Astellas EU Agreement means that certain Astellas EU Supply Agreement by and between FibroGen, Inc and Astellas Pharma Europe Ltd., dated January 1, 2021.
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Examples of Astellas EU Agreement in a sentence

  • The Initial Development Plan includes and shall be integrated with those Phase 3 Clinical Trials that are currently being conducted by FibroGen or Astellas under the U.S. and EU plan for conducting Phase3 Clinical Trials of the Product for the CKD Indications under the Astellas EU Agreement (the “Transatlantic Clinical Development Plan” or the “TCDP”).

  • The head of each Executive agency that is responsible for the construction oroperation of Federal facilities outside the United States shall ensure that such construction or operation complies with the environmental pollution control standards of general applicability in the host country or jurisdiction.1–802.

  • Further, only the president or chief executive officer can authorize such agreements and it must be in writing.

  • The Initial Development Plan includes and shall be integrated with those Phase 3 Clinical Trials that are currently being conducted by FibroGen or Astellas under the U.S. and EU plan for conducting Phase 3 Clinical Trials of the Product for the CKD Indications under the Astellas EU Agreement (the “Transatlantic Clinical Development Plan” or the “TCDP”).

  • The Initial Development Plan includes and shall be integrated with those Phase 3 Clinical Trials that are currently being conducted by FibroGen or Astellas under the U.S. and EU plan for conducting Phase 3 Clinical Trials of the Product for the CKD Indications under the Astellas EU Agreement (the “ Transatlantic Clinical Development Plan” or the “TCDP”).

Related to Astellas EU Agreement

  • Collaboration Agreement has the meaning set forth in the Recitals.

  • Sublicense Agreement means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.

  • Research Agreement means a new written contract, grant or cooperative agreement entered into between a person and a college or research corporation for the performance of qualified research; however, all qualified research costs generating a rebate must be spent by the college or research corporation on qualified research undertaken according to a research agreement.

  • License Agreement means the agreement between SAP (or an SAP SE Affiliate, or an authorized reseller) under which Customer procured the rights to use SAP Software or a Cloud Service.

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • Technology License Agreement means the Technology License Agreement dated as of the date hereof between Allergan and ASTI.

  • Novartis shall have the meaning set forth in the Preamble.

  • End User License Agreement means a license grant or end user license agreement governing software as further described in this Agreement or any applicable Appendix.

  • Collaborative agreement means a voluntary, written, or electronic arrangement between one

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Software License Agreement means the particular Software License Agreement to which these Terms and Conditions are attached and incorporated into by reference.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Merck has the meaning set forth in the preamble.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • Development Agreement has the meaning set forth in the Recitals.

  • ISIS means the department’s individualized services information system.

  • Pharmacovigilance Agreement has the meaning set forth in Section 4.3.

  • Company License Agreements means any license agreements granting any right to use or practice any rights under any Intellectual Property (except for such agreements for off-the-shelf products that are generally available for less than $25,000), and any written settlements relating to any Intellectual Property, to which the Company is a party or otherwise bound; and the term “Software” means any and all computer programs, including any and all software implementations of algorithms, models and methodologies, whether in source code or object code.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Cross License Agreement means that certain Cross License Agreement between and among Medarex, Cell Genesys, Inc., Abgenix, Inc., Xenotech, L.P. and Japan Tobacco Inc., dated March 26, 1997.

  • PTI means Preliminary Toxicity Investigation. Up to a 30-day period where the permittee investigates the cause(s) of a whole effluent toxicity exceedance and if the toxicity is known, includes a proposal for its elimination.

  • PTC means the tax credit for electricity produced from certain renewable generation resources described in Section 45 of the Internal Revenue Code of 1986, as it may be amended or supplemented from time to time.

  • License Agreements shall have the meaning set forth in Section 8.11 hereof.

  • Pfizer shall have the meaning set forth in the preamble.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Supply Agreement has the meaning set forth in Section 7.1.