definiens: means all activities that relate to ( a ) obtaining, maintaining or expanding Regulatory Approval of Product or ( b ) dev eloping the ability to manufacture clinical and com mercial quantities of Product . This includes, without limit ation, ( i ) research, preclinical testing, toxicolog y, formulation, manufacturing - related technology development, and c linical studies of Product ; ( ii ) preparation, submi ssion, review, and development of data or information for the purpose of submission to a governmental authori ty to obtain, maintain and/or expand Regulatory Approval of Product, and outside regulatory services related thereto ; ( iii ) manufacturing process development and scale - u p, bulk production and fill / finish work associated with the supply of Product for preclinical and clinical stud ies, and related quality assurance technical suppor t activities ; ( iv ) post - Regulatory Approval product support for P roduct ( including manufacturing and quality assuran ce technical support, and laboratory and clinical effo rts directed toward the further understanding of th e safety and efficacy of Product ) ; and ( v ) Product - related medic al affairs ( including regulatory support necessary for product maintenance ) . has a correlative meaning