Confidential
1.15 “Calendar Year” means (a) the period beginning on the Effective Date and ending on December 31 of the calendar year in which the Effective Date falls, and (b) thereafter each successive period of twelve (12) consecutive calendar months beginning on January 1 and ending on December 31; provided, that the final Calendar Year of the Term shall end on the last day of the Term.
1.16 “CEO” means the Chief Executive Officer of each Party.
1.17 “CMC Development” means the Development activities related to the composition, manufacture, and specification of the drug substance or biologic molecule and the drug product or biologic molecule (including combination products) intended to assure the proper identification, quality, purity and strength of the drug, including site transfer (as conducted pursuant to and in accordance with this Agreement), test method development and stability testing, process development, process improvements (i.e., improving product robustness or manufacturing efficiencies), drug substance or biologic molecule development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control activities.
1.18 “Commercialize” or “Commercialization” means the conduct of all activities undertaken before and after Marketing Approval relating to the promotion, sales, marketing, and distribution for sale of Licensed Products (including selling, offer for sale, have sold, importing, exporting, transporting, customs clearance, warehousing, invoicing, handling, and delivering the Licensed Products to customers), including sales force efforts, detailing, advertising, market research, market access (including price and reimbursement activities), medical education and information services, publication, scientific and medical affairs, medical support, advisory and collaborative activities with opinion leaders and professional societies including symposia, marketing, sales force training, and sales (including receiving, accepting, and filling the Licensed Product orders) and distribution for sale.
1.19 “Commercialization Plan” means the commercialization strategy, as may be amended from time to time, between the Parties detailing the commercial activities and obligations of the Parties, which shall include [
]to Commercialize Licensed Products in the Licensed Territory.
1.20 “Commercially Reasonable Efforts” means, with respect to a Party’s obligation under this Agreement to Develop, Manufacture, Commercialize or seek intellectual property protection for the Licensed Drug Substance and/or Licensed Product, the level of efforts required to carry out such obligation in a sustained manner consistent with the efforts that a similarly situated company devotes to a product of similar market potential at a similar stage in its development or product life within such party’s portfolio, taking into account the competitiveness of the marketplace, the proprietary position of the product, the regulatory environment, the profitability of the product, and other relevant factors. In evaluating whether a Party has used Commercially Reasonable Efforts, due consideration will be given to any delays by the other Party in performing its obligations under this Agreement that adversely impact the first Party’s ability to perform its obligations under this Agreement.
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