definiens: means, with respect to any Compound or Product ( whether as Bulk Drug Substance, Finished DrugProduct or other form ), any and all processes and activities conducted for the manufacture or other production ( includingfermentation, isolation and purification ) by, for, or on behalf of a Party, or otherwise obtaining the supply of such Compoundor Product under cGMP for Development or Commercialization thereof, including, as applicable, filling, packaging, labelingand other finishing and quality control and assurance testing ; for clarity, Manufacturing shall also include activities for themanufacture of batches of Compound or Product not intended to be under cGMP or intended to be under cGMP but whichfail for any reason . For purposes of this Agreement, Manufacturing includes all production of any Compound or Product inaccordance with applicable cGMP . has a correlative meaning . For clarity, Manufacturing of Compound orProduct in accordance with cGMP related to preparation for commercial launch of such Compound or Product shall beDevelopment, and Manufacturing of commercial supplies of Product shall be Commercialization ( which shall includeCompound or Product from successful cGMP validation lots produced prior to filing of any Marketing Approval to the extentCompound or Product produced from such lots becomes inventory available for Commercialization )