definiens: is hereby deleted in its entirety and replaced with the following : means the activities to be performed by [COMPANY] which are related to product development for NDA or ANDA products or required for the scale­up and/or transfer of a product to [COMPANY] from another site . Initial Term means the peIiod of time commencing on the Effective Date and ending December 31, 2006.Production BaselineProduction Baseline " means 200 million tablets of Products ( excluding Elldocel~ 5 mg ), in any combination, during each Production Year at an average rate of ten Batches per momh . or any equivalent thereof to be determined by mutual agreement of the parties . Production YearProduction Year " means each period of twelve ( 12 ) consecutive months commencing on the FDA Approval Date for the first Initial Product to be approved by the FDA, or any anniversary thereof, during the Telm, and following January 1,2005, means each pel10d of twelve ( 12 ) consecutive months thereafter