RELIANT Regulatory Obligations. Following transfer of the Registration for the Product (including all documentation related thereto) to RELIANT, RELIANT will for the duration of this Agreement be responsible for the maintenance of the Registration for the Product, and shall cover all necessary costs associated therewith. RELIANT shall be responsible for the filing of supplemental or additional Registrations for the Product and for the Additional Products to be commercialized in the Territory, and PRONOVA shall provide such assistance as may be reasonably required. With respect to any supplemental or additional Registrations that may be filed by RELIANT, PRONOVA may object to any such filing (a) in the event that there have been significant deviations from the development plan, and (b) such deviations are demonstrated by PRONOVA to have a material and detrimental effect on sales of Other Products of PRONOVA outside of the Territory, in which case PRONOVA shall provide a Development Objection Notice to RELIANT of such determination and a description of the basis therefor, and RELIANT shall not be entitled to file such supplemental or additional Registrations. Notwithstanding the foregoing, PRONOVA shall not be entitled to deliver a Development Objection Notice with respect to any proposed supplemental or additional Registrations that cover products or indications that are substantially identical to or claimed by any other product or potential product of PRONOVA (i) the development or commercialization of which is expressly contemplated by this Agreement, or (b) that is then being actively developed or commercialized, whether directly or indirectly, by PRONOVA or any of its Affiliates or other licensees. RELIANT shall provide PRONOVA with reasonable advance written notice of any filing to allow PRONOVA to exercise its rights set forth in the immediately preceding sentence. All costs associated with such supplemental or additional Registrations shall be borne by RELIANT.
Appears in 6 contracts
Samples: Agreement, Agreement (Reliant Pharmaceuticals, Inc.), Agreement (Reliant Pharmaceuticals, Inc.)
