definiens: shall mean all material information and data relating to or used in connection with themanufacturing of Compounds and/or Products by MG, [COMPANY], Additional Partners, their Affiliates, or othersworking under authority of such entities, including without limitation, such information and data as generated or usedduring process development, stability studies, formulation development, scale - up of manufacturing, production ofpreclinical and clinical product batches, validation studies, development of quality assurance / quality control testing, and related regulatory affairs ; and all information and data contained in the DMF or in the CMC section of an IND orNDA ( or their counterparts in other countries ) with respect to Compounds and/or Products . Without limiting theforegoing, Manufacturing Data shall include information and data described in Exhibit 1.64 . Notwithstanding theforegoing, to the extent MG, [COMPANY], Additional Partners or their Affiliates do not have rights to such know - how, theterm shall exclude any proprietary manufacturing know - how described in a DMF that wasdisclosed by a contract manufacturer of MG, [COMPANY], Additional Partners or their Affiliates directly to the RegulatoryAuthority ( and not to MG, [COMPANY], Additional Partners or their Affiliates ), which know - how had been independentlydeveloped by such contract manufacturer outside of its relationship with MG, [COMPANY], Additional Partners or theirAffiliates ; provided that in the case of a contract manufacturer of MG, MG ensures that, upon the request ofPharmion, such contract manufacturer shall file with Regulatory Authorities in the Territory a similar DMF containingsuch know - how in support of [COMPANY] ’s regulatory filings . In addition, notwithstanding the foregoing, ManufacturingData shall not include information or data generated by a Non - Cancer Partner or MG in collaboration with a Non - Cancer Partner, unless the same is provided to an Additional Partner and is not specific to indications outside theField