definiens: means [ … * * * … ] 1.76 means, with respect to a product, those manufacturing activities involved in or relatingto ( a ) manufacturing process development, ( b ) CMC activities including analytical development and qualification, formulation development, solubility testing, bulk drug substance manufacturing, stability testing and scale - upactivities, bulk drug product manufacturing and stability 6 * * * Text Omitted and Filed Separately with the Securities and Exchange Commission Confidential TreatmentRequested Under 17 C.F.R. Sections 200.80(b)(4 ) and 230.406 testing, ( c ) quality assurance and quality control activities including validation testing, qualification and audit ofclinical and commercial manufacturing facilities, and ( d ) in the case of either a clinical or commercial supply of suchproduct or supply of such product for any non - clinical study, the manufacturing, processing, formulating, packaging, labeling, holding, quality control testing and release of such product