FLU VACCINE definition
Examples of FLU VACCINE in a sentence
Both Parties shall have access to and the right to use for incorporation in any regulatory filing, any pre-clinical and/or clinical data relating to the FLU VACCINE PRODUCTS and developed by either Party in the course of the DEVELOPMENT PROGRAM.
CRUCELL hereby authorizes AvP to (a) provide in any NDA a list of patents that include CRUCELL PATENTS that relate to such FLU VACCINE PRODUCT and such other information, as AvP deems appropriate.
If AvP develops a FLU VACCINE PRODUCT for administration by means other than intramuscular injection ("non-IM"), then AvP shall notify CRUCELL of such PRODUCT and shall have the right to first negotiate with CRUCELL a distribution agreement for such non-IM FLU VACCINE PRODUCT in the CRUCELL TERRITORY.
Subject to the TERM of this Agreement, AvP hereby grants to CRUCELL, and its REGISTERED AFFILIATES, an exclusive, royalty-bearing license to use, register, sell, offer to sell and import FLU VACCINE PRODUCTS in the CRUCELL TERRITORY.
CRUCELL shall participate with AvP in the research and pre-clinical development activities for a pandemic FLU VACCINE PRODUCT, which activities may include generation of antigen, validation of antigen in animal models and isolation of primary influenza strains.
In addition, and subject to the terms of this Agreement, AvP shall have the right to sublicense to third parties the right to sell, offer to sell, import and export, but not the right to develop, make, have made or use FLU VACCINE PRODUCT in the AvP TERRITORY.
AvP shall not be entitled to the royalty on CRUCELL NET SALES of FLU VACCINE PRODUCTS that are not supplied by AvP, unless CRUCELL (or its designated agent or sublicensee or distributor) has not exercised commercially reasonable efforts to register the FLU VACCINE PRODUCT supplied by AvP.
Neither Party shall authorize any such distributors to authorize further distributors to market and sell FLU VACCINE PRODUCTS.
Prior to commencing clinical trials on any FLU VACCINE PRODUCT, the Parties or their authorized agents shall enter into a written agreement concerning policies and procedures for adverse event reporting, which shall be binding on both Parties.
AvP shall provide CRUCELL on an annual basis within thirty (30) days after the anniversary of the EFFECTIVE DATE, with a summary report of the data relating specifically to PER.C6 and/or PER.C8 CELL performance, including specifically any and all substantial positive and/or negative deviations from the standard established operating, culturing and manufacturing parameters found useful in its application of PER.C6 and/or PER.C8 CELLS for the manufacture of FLU VACCINE PRODUCT.