definiens: - 5 -means the Technical Conditions setting out or otherwise identifying the Specifications for the Product which are annexed as Schedule 1 hereto . The Technical Conditions may be modified from time to time by mutual written agreement between the parties ; means all know - how, registration data, experience, instructions, standards, methods, test and trial results, manufacturing processes, hazard assessments, quality control standards, formulae, specifications, storage data, samples, drawings, designs, descriptions of packaging materials and all other relevant information relating to the Product, the Raw Materials, the Active Substance or the Manufacture, storage, packaging, shipping, handling or use of the Product, Raw Materials and Active Substance ; means the trade mark(s ) set out in Schedule 4 which are either owned by Cambridge or to which Cambridge has the necessary right of use ; means the process of proving the reproducibility, efficacy, and repeatability of all procedures, processes, equipment, materials, testing equipment, tests, activity or system and the ability thereof to Manufacture the Product in accordance with the principles of GMP, the Specifications and the Protocol to the satisfaction of the Manufacturer ; means Cambridge 's 12 months rolling requirements for supply of the Product for the period of twelve ( 12 ) calendar months as from the date on which it is sent to Manufacturer, and which shall be comprised of a binding Firm Period and a non - binding Forecast . The Vendor Schedule shall specify requirements for both the 12.5 mg and the 25 mg strengths of the Product and the different packaging for the Product