definiens: : means the field of prevention of HIV infection in humans ; : means the final published report based on the Main Master File describing themain objectives of the Phase III Clinical Trial and the outcomes ; : means MRC Grant number G0100137 entitled ‘ Vaginal microbicides for theprevention of HIV transmission ’ ( appended at Schedule 1 to this Agreement ; : means Xx Xxxxxx XxXxxxxxx of the MRC Clinical Trials Unit and Xx Xxxxxxx Xxxxx ofImperial College London ; : means the committee responsible for reviewing the accrued safety and efficacydata during the Phase III Clinical Trial, monitoring the overall progress of the trial, and providing advice on the conduct of the Phase III Clinical Trial to the TrialSteering Committee;:means [COMPANY] ’ investigational new drug application ( as defined in 21 CFR Section312.3 ) number 56962, and any amendments thereto, as filed with the FDA ; : means any patent, copyright, design rights, trademark, Know - How, any rights inrespect of any Confidential Information or other industrial and/or intellectualproperty right ( whether registered or unregistered ) subsisting throughout the world and any application and/or right to apply for any of suchrights that are necessary or useful for the development, manufacture orcommercialization of the Product ; : means the person at each Centre responsible for the conduct of the Programmeat that Centre;:means the brochure relating to the Product ( and matching placebo ) and their use, storage and handling, to be supplied by [COMPANY] to MRC under this Agreement ; : means any confidential know - how, methodologies, formulae, processes, dataand / or expertise ( including but not limited to any relating to manufacture, production, storage, handling and/or use of Products ) that are necessary or usefulfor the development, manufacture or commercialization of the Product;:means a full set of analyses on which the Draft First Full Report and First FullReport for publication shall be based and prepared pursuant to the agreedFirefox https://www.lawinsider.com/contracts/1FxVssTpOwdwizjwcmqH2Q/ind ..