Safety Agreement definition

Safety Agreement has the meaning specified in Section 7.4.

Safety Agreement has the meaning set out in Section 4.10(e).

Safety Agreement means the document referred to in Section 8.4 of the BIM44058 Agreement as the “Pharmacovigilance Agreement”, covering operational aspects of the conduct of clinical trials under the BIM 44058 Agreement regarding pharmacovigilance, including but not limited to withdrawal proceedings, complaints handling, definitions of adverse events format of the different reports and reporting procedures between the Parties and vis-à-vis third parties.

Examples of Safety Agreement in a sentence

• Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.

• The Safety Agreement shall be promptly updated if required by changes in legal requirements.

• The Safety Agreement will be promptly updated if required by changes in legal requirements.

• The Technical Specifications, the Manufacturing & Analytical Procedure, the Safety Agreement, form an integral part of this Agreement.

• Each Party shall provide promptly to the other Party any information and data relating to any serious or previously unknown side effects or adverse reactions relating to the Licensed Product that the providing Party receives from any source, as further specified in the Safety Agreement.

More Definitions of Safety Agreement

Safety Agreement means an agreement by that name or any other name agreed between a person, a relevant Church authority or the nominees of that Church authority and the Executive Director of the Office of Professional Standards regulating the manner in which that person has entry and access to the premises and activities of the Church either generally or in a specified location or circumstances;

Safety Agreement has the meaning set forth in Section 6.6.1 (Adverse Events Reporting; Safety Agreements).

Safety Agreement means an agreement in writing approved by the PSC under section 67M(b);

Safety Agreement means the agreement to be entered into by and between the Parties prior to the Commencement Date governing the Parties’ respective responsibilities with respect to Adverse Drug Experiences, pharmacovigilance, complaints and other safety-related matters with respect to the Product.

Safety Agreement means an agreement which outlines the Parties’ respective responsibilities concerning product safety and pharmacovigilence matters relating to Distribution of the Product by Distributor under this Agreement between Teligent Estonia and Distributor.

Safety Agreement means the safety agreement referred to in Section 3.5(c) and, upon execution thereof by the Parties, attached hereto as Schedule 3.5(c).

Safety Agreement means any safety agreements between the Parties regarding adverse event reporting with respect to Products manufactured by Amgen pursuant to this Agreement.