definiens: means the interactions between [COMPANY] and [COMPANY] in the planningand implementation of the research and development work, toxicology study and/or the manufacture, production and exploitationrelating to any Clinical Product, Drug Product, Bulk Drug Substance, Programme Deliverable, Vaccine Process or any amendment of suchcollaboration as may be agreed in writing between the parties butexcluding the conduct of the Clinical Trials ; means all data, records, analysis, assays, notes regulatoryapplications, approvals, certificates, authorizations, letters anddocuments, inventions, practices, methods, knowledge, know - how, skill, experience, test data including pharmacological, manufacture, stability, safety, toxicological, pre - clinical studies and clinical testdata, analytical and quality control data, marketing, manufacturing, and compounds, compositions of matter, assays and biologicalmaterials related thereto, and any other information stored and / orkept in whatever media produced during the Programme other thanCobra Know How ; means any and all Intellectual Property Rights arising under, developed or resulting from the Programme other than the CobraKnow How ; means any and all Drug Product, Bulk Drug Substance and / orProgramme Deliverable commercially exploited by [COMPANY] which isproduced by any Third Party Product Manufacturer ; means the transfer by [COMPANY] of the [COMPANY] Know - How to a Third PartyProduct Manufacturer solely as necessary to enable the Third PartyProduct Manufacturer to manufacture the Bulk Product for [COMPANY] ; DRAFT for Discussion OnlyConfidentialPage 8 means any third party drug product manufacturer approved in writingby [COMPANY] ( such approval not to be unreasonably withheld or delayed)and [COMPANY] which is to supply Bulk Product to [COMPANY] instead of orin addition to [COMPANY] ; means i ) the end form vaccine made from the Drug Substance and / orthe Drug Product ; ii ) the Master Cell Bank, Working Cell Bank, andCell Bank Characterization, any biological material made ordeveloped under the Programme ; and iii ) Vaccine Process