definiens: does not include any ; Project Co - Leader is defined in Clause 2.2.1 ; Proposed Target is defined in Clause 3.1.2 ; Prosecute or Prosecute and Maintain or Prosecution and Maintenance means, with respect to a Patent, all activities ass ociated with the preparation, filing, prosecution and maintenance of such Patent, as wel l as re- examinations, reissues, applications for patent term adjustments and extens ions, supplementary protection certificates and the like with respect to that Pate nt, together with the conduct of interferences, derivation proceedings, pre- and pos t - grant proceedings, the defense of oppositions and other similar proceedings with r espect to that Patent ; Quality Agreement means, as relevant in the context of this Agreement, a written agreement that documents the responsibilities and quality expectations between ( a ) [COMPANY] and any internal or external supplier, contract manufacture r or service provider ( including, to the extent applicable, [COMPANY] ) or ( b ) Immuno core and any internal or external supplier, contract manufacturer or service provider ; Regulatory Approval means the technical, medical and scientific license s, registrations, authorizations and approvals required for marketing or use of a Pr oduct ( including approvals of, BLAs, investigational new drug applications, pre- a nd post- approvals, and labeling approvals and any supplements and amendments to any of such approvals ) of any national, supra- national, regional, state or local regulatory agenc y, department, bureau, commission, council or other gover nmental entity, necessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of Products in a regulatory jurisdiction . In the US, Regulatory Approval means approval of any Marketing Approval Ap plication or equivalent by the FDA . Regulatory Approval shall no t include obtaining any pricing reimbursement or other pricing approval req uirement ; Release is defined in Clause 17.1 ; Replacement Back - up Compound means, with respect to a given Selected Target, a B ack - up Compound that is being substituted for the Selected Candidate relevant to such Selected Target ; 15 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [ * * * ], HAS BEEN OMITTED BECAUSE IT IS BOTH ( I ) NOT MATERIAL AND ( II ) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTI AL