definiens: means all Information that ( a ) is necessary or useful for the Development orCommercialization of a Product in the Field and ( b ) is Controlled by [COMPANY] or its Affiliates during the Term and arisesfrom a Shared Study ( including any Incremental Study that becomes an Additional Study upon [COMPANY] ’ exercise of the Opt - InRight under Section 4.4(c)(v ) ) ; provided, the use of in this definition shall exclude any Third Party that becomes anAffiliate of [COMPANY] after the Original Effective Date due to a Change of Control of [COMPANY], except to the extentsuch Third Party ’s Information is Controlled by [COMPANY] ( or its Acquiror ) or any of its other Affiliates and is necessaryfor the Development or Commercialization of the Product and is utilized in respect of the Product or the API in the LicensedTerritory ; and provided further that excludes Information arising from any Incremental Study(with respect to which [COMPANY] does not exercise its Opt - In Right under Section 4.4(c)(v ) ) or Investigator - Sponsored Study