definiens: or sh all mean : ( a ) activities relating to research, pre - clinical and clinical drug developmen t of the Product in the Field, including, test meth od development and stability testing, assay developmen t, toxicology, pharmacology, formulation, quality assurance / quality control development, technology t ransfer, statistical analysis, process development and scale - up, pharmacokinetic studies, data collection and ma nagement, clinical trials ( including research to de sign clinical trials and activities of MSLs to support such clini cal trials prior to the First Commercial Sale in th e U.S. ), regulatory affairs, project management, drug safety surveillan ce activities ( including establishing, holding and maintaining the global safety database prior to the First Comme rcial Sale in the U.S. ) related to clinical trials, the preparation and submission of Registration Filings but excludin g activities ( other than clinical trials in support 7 of Pricing Approvals for the Ex - U.S. Territory, whi ch, for clarity, shall be Ex - U.S. Development Activ ities, and clinical trials in support of Pricing Approvals for the United States, which for clarity, shall be inc luded in the Global Development Plan ) necessary to obtain and ma intain Pricing Approvals, reimbursement or listing on health care providers ’ and payers ’ formularies, ( b ) the de velopment of any device or delivery system that is developed for use with, or otherwise included in, the Finishe d Product, ( c ) the development of any companion dia gnostics for use with the Product, and ( d ) any other researc h and development activities with respect to the Pr oduct in the Field, including, activities to support the discove ry of biomarkers and activities to support new prod uct formulations, delivery technologies or new Indicati ons in the Field, either before or after the First Commercial Sale ; [ * * * * * * * * * * ] . For clarity, the terms and are used herein w ith respect to the Product while the terms and are used herein with corresponding meanings with respect to other produc ts