Common use of Commercial Development Obligation Clause in Contracts

Commercial Development Obligation. (a) Licensee will use best efforts, at its sole expense, to diligently develop, commercialize, promote and sell at least one Product in the Territory in the Field, as promptly as is reasonably and commercially feasible. For purposes of this Section 6.1, the standard of best efforts with respect to development matters shall mean the standard that Licensee uses for similar products of similar potential at a similar stage of development on a worldwide basis. With respect to commercialization, promotion and sale, the standard of best efforts shall be measured on a region by region basis, wherein the regions are (i) the European Union, (ii) the United States, (iii) Japan and (iv) the rest of the world. The standard of best efforts with respect to each region shall mean the standard that Licensee uses for similar products of similar potential and at a similar stage of development in each of those regions, respectively. (b) Licensee will keep the Development Steering Committee generally informed as to Licensee's progress in the development of Products. (c) If Licensor has a reasonable basis to believe that Licensee is not using best efforts under Section 6.1(a) , it may provide written notice to Licensee specifying the basis for such belief. On receiving such notice, Licensee will have the right to reply in writing to Licensor's notice within thirty (30) days. If Licensor does not receive a reply from Licensee within that period, or if the Parties disagree, either Party may refer the matter for dispute resolution pursuant to Article XIII. If the dispute is referred to arbitration, and the arbitrators conclude that Licensee has not fulfilled its obligation under Section 6.1(a), and such failure is not cured within sixty (60) days from the date of the decision, or if Licensee has not taken the requisite steps to cure such failure within such period (if not capable of cure within sixty (60) days), or does not diligently pursue such cure, Licensor may, upon notice to Licensee, (i) convert Licensee's license with respect to such Licensed Patent to a non-exclusive license in any or all countries in the applicable region (but limited to only one additional licensee in any country) or (ii) terminate Licensee's license in any or all countries in the applicable region. (d) Notwithstanding the other provisions of this Section 6.1, the Parties anticipate (without guarantee) the following timelines with respect to the development of the Products: (i) Phase I Clinical Trial - already commenced in the United States by Licensor. (ii) Phase II Clinical Trials - [REDACTED]. (iii) Phase III Clinical Trials - [REDACTED] The Phase III Clinical Trials will be pivotal studies powered to show efficacy and safety and are anticipated to be completed within 24 to 28 months. (iv) Analysis and NDA Submission - should be completed within six months following the conclusion of the Phase III Clinical Trial.

Commercial Development Obligation. (a) Licensee ICN will use best efforts, at its sole expense, to expense diligently develop, commercialize, promote and sell at least one Product Products in the Territory each Major Market Country in the Field, as well as elsewhere in the Territory, as promptly as is reasonably and commercially feasible. For purposes of this Section 6.16.1(a), the standard of best efforts with respect to development matters commercial feasibility shall mean the standard that Licensee uses ICN and companies comparable to ICN use for similar products of similar potential at a similar stage of development on a worldwide basis. With respect to commercialization, promotion and sale, the standard Upon a showing of best efforts shall be measured on a region by region basis, wherein the regions are (i) the European Union, (ii) the United States, (iii) Japan and (iv) the rest lack of the world. The standard of best efforts commercial feasibility with respect to each region any country in the Territory other than a Major Market Country, ICN may upon written notice to Metabasis, without being in violation of its obligations under this Section 6.1(a), elect to cease developing, commercializing, promoting and selling Products in such country; provided that such election shall mean not release ICN from any of its obligations to Metabasis up to the standard that Licensee uses for similar products date of similar potential such notice, including payment of all amounts owed to Metabasis up to such date. If within six months after such written notice ICN shall not have resumed diligently developing, commercializing, promoting and at a similar stage of development selling Products in each of those regionssuch country in accordance with Section 6.1, respectivelyall licenses granted to ICN pursuant to Section 2 with respect to such country shall become non-exclusive and ICN shall make available to Metabasis, to the extent they are available to ICN, all clinical information, data, INDs, NDAs and other Product Registrations applicable to all Licensed Compounds and Products to the extent necessary to permit Metabasis and/or its assignees, sublicensees and distributors to develop, commercialize, promote and sell Products in such country. (b) Licensee Until all of the milestone payments referred to in Section 4.2(a) have been paid, ICN will keep the Development Steering Committee generally fully informed on a reasonable basis as to LicenseeICN's progress in the development of Products, including without limitation in respect of all development, commercialization and marketing efforts undertaken by ICN, its Affiliates and Sublicensees, as applicable, with respect to the Licensed Compound and Products, by providing a written report of such efforts on a semiannual basis. Until all of the milestone payments referred to in Section 4.2(a) have been paid, Metabasis may request, no more often than once every calendar quarter, a meeting at which Metabasis may meet with the principal ICN individuals responsible for such development, commercialization and marketing. ICN agrees to arrange such a meeting promptly following such request. At such meeting the ICN representatives will discuss ICN's commercialization efforts for Products, including answering Metabasis' questions regarding such efforts. ICN may satisfy its obligation to meet with Metabasis under this Section 6.1(b) through meetings of the Development Steering Committee. (c) If Licensor has ICN fails to meet a reasonable basis to believe that Licensee is not using best efforts under Section 6.1(a) , it may provide written notice to Licensee specifying the basis for such belief. On receiving such notice, Licensee will have the right to reply in writing to Licensor's notice within thirty (30) days. If Licensor does not receive a reply from Licensee within that period, or if the Parties disagree, either Party may refer the matter for dispute resolution pursuant to Article XIII. If the dispute is referred to arbitration, and the arbitrators conclude that Licensee has not fulfilled its material obligation under Section 6.1(a), and such failure is not cured within sixty (60) days from the date of the decision, or if Licensee has not taken the requisite steps to cure such failure within such period (if not capable of cure within sixty (60) days), or does not diligently pursue such cure, Licensor may, upon notice to Licensee, (i) convert Licensee's license with respect to such Licensed Patent to a non-exclusive license in any or all countries in the applicable region (but limited to only one additional licensee in any country) or (ii) terminate Licensee's license in any or all countries in the applicable region. (d) Notwithstanding the other provisions of this Section 6.1, the Parties anticipate (without guarantee) the following timelines with respect then Metabasis may terminate this Agreement pursuant to the development of the Products: (i) Phase I Clinical Trial - already commenced in the United States by LicensorSection 12.3. (ii) Phase II Clinical Trials - [REDACTED]. (iii) Phase III Clinical Trials - [REDACTED] The Phase III Clinical Trials will be pivotal studies powered to show efficacy and safety and are anticipated to be completed within 24 to 28 months. (iv) Analysis and NDA Submission - should be completed within six months following the conclusion of the Phase III Clinical Trial.