HCV License. (i) Subject to the terms and conditions of this Agreement (including the other subsections of this paragraph (c)), and effective upon (A) the relevant Selection Date for the HCV Product and (B) Idenix' receipt of the payment from Novartis of the fee pursuant to Section 8.1(b), Idenix shall grant to Novartis a right and license (with the right to grant sublicenses only as permitted under Section 6.1(f)) under Idenix' rights in the Idenix Intellectual Property and in the Joint Intellectual Property to use, market and promote, import and export, offer for sale, sell and distribute the HCV Product for treatment of human HCV infection as either a monotherapy and/or as part of a Combination Therapy, within the Territory during the applicable Country Terms for such Product (the "Novartis HCV License").
(ii) The license granted to Novartis in subsection (i) above shall be exclusive (even with respect to Idenix) as to the Novartis Territory and shall be co-exclusive with Idenix with respect to the Co-Commercialization Countries and the Co-Marketing Countries; provided that during the effectiveness of such license on a co-exclusive basis in each Co-Commercialization Country and Co-Marketing Country, Idenix (A) shall use the co-exclusive rights retained by it solely to market, promote, import, export, offer for sale, sell or distribute the HCV Product in such country as permitted in accordance with the provisions of Article 5 or Exhibit K, as applicable, and the Supply Agreement, and (B) shall not authorize, or grant the right to, any Third Party (other than an Affiliate or a sublicensee of Idenix to perform obligations or exercise rights under this Agreement) to market, promote, import, export, offer for sale, sell or distribute the HCV Product in such country, either directly or indirectly, or expressly or by implication.
(iii) Idenix hereby covenants to Novartis that, during the term of each license granted to Novartis pursuant to subsection (i), Idenix shall not, and shall not license Third Parties to, use, market and promote, import and export, offer for sale, sell and distribute the HCV Product for treatment of any indication other than human HCV infection as either a monotherapy and/or as part of a Combination Therapy, within the Territory unless otherwise agreed by the Parties.
(iv) Novartis shall exercise the co-exclusive rights granted to it in subsection (i) above solely to market, promote, import, export, offer for sale, sell, or distribute the HCV Produc...
HCV License. In consideration of the grant by Idenix of the Novartis HCV License, Novartis shall make a license payment to Idenix in the aggregate amount of US$70,000,000. Novartis shall make non-refundable, non-creditable payments of such amount as follows, subject in the case of items (B) and (C) to the occurrence of the event referred to under "Event":
(A) US$[**] Submission by Selection Date Novartis of the Novartis HCV Option Exercise Notice
(B) US$[**] FDA approval to Not later than the later of (i) the proceed with a Phase date that the event has occurred, or III Clinical Trial (ii) 30 days after Novartis receives evaluating the written notice from Idenix that the Selected HCV Drug event has occurred Candidate in refractory HCV patients
(C) US$[**] FDA approval to Not later than the later of (i) the proceed with a Phase date that the event has occurred, or III Clinical Trial (ii) 30 days after Novartis receives evaluating the written notice from Idenix that the Selected HCV Drug event has occurred Candidate in HCV treatment naive patients
6. Exhibit M of the Development Agreement is amended to add the following: With respect to the Initial HCV Drug Candidate, Novartis shall have primary responsibility for clinical drug development activities on Novartis conducted studies, submitting and maintaining parallel investigational new drug applications ("INDs") and CTAs with cross reference to the Idenix INDs while Idenix maintains the INDs and CTAs on Idenix-conducted studies. With respect to the Initial HCV Drug Candidate, Novartis shall hold the database and be the lead on data entry, statistics, quality assurance and writing on all Novartis-conducted studies.
7. The chart in clause (ii) of Section 8.5(a) of the Development Agreement is deleted and replaced in its entirely by the following:
