definiens: means all activities that relate to ( a ) obtaining, maintaining or expanding RegulatoryApproval or Pricing Approval of Licensed Product or ( b ) developing the ability to Manufacture clinical and commercialquantities of Licensed Product . Development includes ( i ) research, preclinical testing, toxicology, formulation, Manufacturing - related technology development, product characterization, analytical development, validation andtransfer, and clinical studies of Licensed Product ; ( ii ) preparation, submission, review, and development of data orinformation for the purpose of submission to a governmental authority to obtain, maintain or expand RegulatoryApproval or Pricing Approval of Licensed Product, and outside counsel regulatory legal services related thereto ; ( iii)Manufacturing process development, transfer and scale - up, and validation, including for preclinical and non - clinicalstudies, clinical studies and commercial supply ; ( iv ) bulk production and fill / finish work CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HASBEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONPURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED