definiens: , and shall mean with respect to a product, all activitiesrelated to or in furtherance of the creation or scientific improvement of such product, or are related to or in furtherance of theRegulatory Approval of such product, whether such activities are conducted prior to the filing of a regulatory application forsuch product in any country in the Territory or thereafter . Development Activities may include : ( a ) Characterization of suchproduct ; ( b ) creation and selection of a cell line ; ( c ) preclinical and, if applicable, clinical ( in human ) studies, bioequivalencestudies, development of analytical assays, stability studies and quality analysis / quality control development, datamanagement, review and engagement of CROs, document preparation, and other administrative activities associated with aclinical testing program ; ( d ) development and implementation of a regulatory and legal strategy to address whether to file abiologics application under Section 351(a ) or an abbreviated application under Section 351 ( k ) of the BPCI Act, anddepending on the pathway selected, whether and how the Parties plan to utilize the patent resolution process under the 351(k)pathway ; ( e ) development and implementation of the Product manufacturing process and strategy, including selection ofmanufacturing facilities at each scale ( including Commercial Scale ) ; ( f ) development and implementation of a processvalidation strategy ; ( g ) formulation ( for drug substance and drug product, as well as associated stability studies ) ; ( h)development and design of a delivery device for the Product ; ( i ) development and design of the Product packaging ; ( j)statistical analysis ; ( k ) pre - launch regulatory affairs ; and ( l ) research and development expenses associated with Productdevelopment after Regulatory Approval ( such as post - marketing studies )