Pharmacovigilance Agreements definition

Pharmacovigilance Agreements means the Pharmacovigilance Agreement for Merck Products and the Pharmacovigilance Agreement for Organon Products to be entered into by and between Merck and Organon or their respective Subsidiaries in connection with the Separation, the Distribution or the other transactions contemplated by this Agreement.
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Pharmacovigilance Agreements has the meaning set forth in Section 5.2.
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Pharmacovigilance Agreements means the written pharmacovigilance agreements entered into by Allos and MICL, dated as of [***], and [***], respectively, and as may be amended from time to time, pursuant to which the parties defined and finalized the actions that the parties shall employ with respect to the Product to protect patients and promote their well-being. The Parties agree to amend and restate the Pharmacovigilance Agreements within [***] of the Amendment Effective Date in order to align them with the provisions of this Agreement and the License Agreement.
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Examples of Pharmacovigilance Agreements in a sentence

  • Xxxxx (facsimile: (000) 000-0000), with a copy to Xxxxx Xxx Xxxxxxxxxxx, KeyBank Institutional Real Estate, 0000 Xxxxxxxx, Xxxxx 000, Xxxxxx Xxxxxxxx 00000 (facsimile: 720-904-4420), or such other address for notice as the Agent shall have last furnished in writing to the Borrower, with a copy to Xxxxxx X.

  • Further details of the Parties’ obligations in regard to safety reporting will be set forth in the Pharmacovigilance Agreements.

  • There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties with respect to the subject matter of this Agreement other than as are set forth in this Agreement, the License Agreement, the Technical Agreement or the Pharmacovigilance Agreements.

  • The Pharmacovigilance Agreements contain provisions relating to adverse drug experiences.

  • The Parties mutually agree to execute one or more separate Pharmacovigilance Agreement(s) as deemed applicable by the Parties specifying the procedures and timeframes for compliance with Applicable Law pertaining to safety reporting of each Licensed Product and their related activities.

  • For the countries where Mylan does not have a local affiliate, Pharmacovigilance Agreements are in place with third parties to ensure that safety information from the territory reaches Mylan Global PSRM in appropriate time and quality.

  • Each of the Pharmacovigilance Agreements shall include mutually acceptable guidelines and procedures for the receipt, investigation, recording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of the Product, and other routine pharmacovigilance reporting requirements.

  • Each Party shall also provide the other Party, on an annual basis and more frequently as reasonably requested by the other Party, a summary report of Adverse Events, as well as those Serious Adverse Events that are not attributable to the use of the Product(s) that are not otherwise subject to Pharmacovigilance Agreements.

  • This License Agreement, together with its Schedules and Exhibits and the Pharmacovigilance Agreement(s) and Quality Agreement(s), sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other prior communications between the Parties with respect to such subject matter.

  • All processes are outlined in Standard Operation Procedures on Affiliate Pharmacovigilance System and Pharmacovigilance Agreements, as summarised in the PSMF.


More Definitions of Pharmacovigilance Agreements

Pharmacovigilance Agreements means the Alcon Pharmacovigilance Agreement, the OTC Pharmacovigilance Agreement, the Pharma Pharmacovigilance Agreement and the Sandoz Pharmacovigilance Agreement. Pharma Pharmacovigilance Agreement means that certain Pharmacovigilance Agreement, to be entered into between the Purchaser and Novartis Pharma AG on the Closing Date, in a form mutually agreeable to the Parties.
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Pharmacovigilance Agreements means the five pharmacovigilance agreements entered into between Sandoz and Novartis on or around the date of this Agreement;
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Related to Pharmacovigilance Agreements

  • Pharmacovigilance Agreement has the meaning set forth in Section 5.1.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Development Agreements means all development, utility or similar agreements included in the Permitted Encumbrances.

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

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

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

  • Regulatory Services Agreement means the agreement between BSEF and the Regulatory Services Provider whereby the Regulatory Services Provider provides market surveillance and trade practice surveillance functions as well as other compliance related services to the SEF operated by BSEF.

  • Third Party Agreements means any Contract between or among a Party (or any member of its Group) and any other Persons (other than the Parties or any member of their respective Groups) (it being understood that to the extent that the rights and obligations of the Parties and the members of their respective Groups under any such Contracts constitute Versum Assets or Versum Liabilities, or Air Products Retained Assets or Air Products Retained Liabilities, such Contracts shall be assigned or retained pursuant to Article II).

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

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

  • Collaborative pharmacy practice agreement means a written and signed

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

  • Alliance Agreement has the meaning given to such term in paragraph 11.2 of Schedule 13 (Information and Industry Initiatives);

  • Implementation Agreement means the Implementation Agreement dated ……… by and between the GOB, PGCB and the Company in connection with the Project, and also includes any amendment of it made from time to time;

  • Master Services Agreement means that master services agreement among the Limited Partnership, the Company, Teekay Corporation and Brookfield XX XXXX L.P. dated as of the date hereof.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

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

  • Third Party Agreement has the meaning provided in Section 5(a) hereof.

  • Marketing Agreement means an agreement entered into, with the director, by producers, distributors, processors, or handlers pursuant to this act and binding only on those signing the agreement.

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

  • Assistance Agreement means a for- mal, written agreement between the CDFI Fund and an Awardee which specifies the terms and conditions of assistance under this part;

  • Transition Services Agreements has the meaning set forth in Section 7.01(h).

  • Collaborative practice agreement means a written agreement

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

  • PJM Agreements means the PJM OATT, PJM Operating Agreement, PJM RAA and any other applicable PJM manuals or documents, or any successor, superseding or amended versions thereof that may take effect from time to time.

  • Services Agreement means an agreement entered into between a Utility and one or more Affiliates for the provision of Shared Services or For Profit Affiliate Services and shall provide for the following matters as appropriate in the circumstances: