definiens: means any and all activities that relate to the re search and development of Compounds and Products, including ( a ) obtaining, ma intaining or expanding Regulatory Approval of a Pro duct, for one or more Indications ( including preparation, submission, review, and development of data or Inf ormation for the purpose of submission to a Governmental Aut hority to obtain, maintain or expand Regulatory App roval of a Product ), ( b ) CMC Development, ( c ) Non - Clinica l Studies, toxicology and Clinical Trials ( includin g Phase 4 Clinical Trials ( other than Voluntary Phase 4 Cli nical Trials ) ), or ( d ) manufacturing in support of any of the foregoing activities, provided, however, that Devel opment will exclude Commercialization activities, i ncluding manufacture of commercial inventory of Product or t he building or construction of any manufacturing fa cilities