US Territory. In consideration of a cash payment in the amount of US$500,000, which shall be payable within thirty (30) days following the execution of this Agreement, DAEWOONG hereby grants to Evolus an exclusive option, exercisable at any time prior to December 31, 2018 (the “Option Period”), to expand the permitted uses of the Product to include all therapeutic uses, [***] in the US Territory. Evolus may exercise this option by written notice to DAEWOONG during the Option Period, along with payment within thirty (30) days of such notice, of an option exercise fee of [***].
US Territory. Eyetech shall indemnify, defend and hold the Pfizer Parties harmless from and against [**] percent ([**]%) of the amount of any and all Losses arising out of or resulting from any Third Party Claim involving Product Liability in the US Territory (other than Product Liability Losses for which one Party is obligated to indemnify the other Party pursuant to Section 12.4 or 12.5); Pfizer shall indemnify, defend and hold the Eyetech Parties harmless from and against [**] percent ([**]%) of the amount of any and all Losses arising out of or resulting from any Third Party Claim involving Product Liability in the US Territory (other than Product Liability Losses for which one Party is obligated to indemnify the other Party pursuant to Section 12.4 or 12.5).
US Territory. Eyetech shall indemnify, defend and hold the Pfizer Parties harmless from and against [**] percent ([**]%) of the amount of any and all Losses arising out of or resulting from any Third Party Claims involving any actual or alleged infringement of any trademarks, patent rights or other intellectual property rights, or misappropriation of trade secrets, of any Person in connection with the manufacture, use, sale or importation of the Product in the US Territory or in connection with the manufacture or use of the Product in the ROW Territory for subsequent importation and/or sale in the US Territory (other than Losses for which one Party is obligated to indemnify the other Party pursuant to Section 12.4 or 12.5 and other than Losses relating to Products ultimately sold outside the US Territory, which are governed by Section 12.6(b)(ii)); Pfizer shall indemnify, defend and hold the Eyetech Parties harmless from and against [**] percent ([**]%) of the amount of any and all Losses arising out of or resulting from any Third Party Claims involving any actual or alleged infringement of any trademarks, patent rights or other intellectual property rights, or misappropriation of trade secrets, of any Person in connection with the manufacture, use, sale or importation of the Product in the US Territory or in connection with the manufacture or use of the Product in the ROW Territory for subsequent importation and/or sale in the US Territory (other than Losses for which one Party is obligated to indemnify the other Party pursuant to Section 12.4 or 12.5 and other than Losses relating to Products ultimately sold outside the US Territory, which are governed by Section 12.6(b)(ii)).
US Territory. The Lead US Party shall have lead responsibility for all Regulatory Interactions with Regulatory Authorities in the US Territory for each Shared Product.
US Territory. Subject to the provisions of paragraph (g) below, Idenix shall be the Lead Regulatory Party with respect to each Product in the U.S. Territory, provided, however, that Novartis shall perform the regulatory tasks set forth on Exhibit M with respect to each Product in the U.S. Territory, or as otherwise deemed appropriate by the Joint Operations Committee.
US Territory. Alpharma, at its own cost and expense, shall undertake and perform the Regulatory Activities reasonably necessary or required to timely receive legally valid Regulatory Approvals under the FD&C Act for all Developed Products as set forth on Exhibit A. Shasun shall have prepared, completed and delivered to Alpharma all data and information deemed necessary by Alpharma for the filing of a valid ANDA for each of the Developed Products subject to this subsection in accordance with the requirements set forth on the Milestone Timetable including, without limitation, preparing the Chemistry, Manufacturing and Controls section of the Developed Product ANDA (the "CMC Section"). Shasun shall provide Alpharma a draft of the filing materials prepared in accordance with the templates agreed upon by the parties as required by the Milestone Timetable no less than sixty (60) days prior to the deadline contemplated by the Milestone Timetable, to permit Alpharma to review such materials and assess their adequacy and completeness. Alpharma shall have sole discretion to determine the adequacy and completeness of such materials and Shasun shall use commercially reasonable efforts to comply with Alpharma's determinations to change, amend or otherwise supplement the filing materials, including providing all raw data underlying any reports or data summaries at Alpharma's request. Shasun shall also cooperate with Alpharma, as needed in the preparation and finalization of the ANDA, including providing any supplemental information and additional data needed by Alpharma to facilitate the acceptance and timely approval of the ANDA. Alpharma shall have final control over the wording, format and substance of any Regulatory Filing.
US Territory at its own cost and expense (except as otherwise set forth in this Article 2), shall use its best efforts to undertake and perform the Regulatory Activities for all Products which are to be sold in the U.S. Territory as set forth in Exhibit B. **** shall prepare, complete and file with the FDA the ANDA for each of the Products subject to this subsection in accordance with the requirements of the Milestone Timetable set forth in Exhibit C. **** shall provide **** with a draft of the original ANDA and with copies of all communications to and from the FDA in sufficient tine prior to the date required for filing under the Milestone Timetable to permit **** to review such materials and make comments to ****. Should ****, in its discretion, decide to comment on the ANDA application or FDA communications, it shall do so promptly to ensure **** has sufficient time to meet the Milestone Timetable and any Regulatory Requirements. Upon ****'s receipt of ****'s comments, or at such time as ****, in its discretion, decides that it can no longer wait for comments and maintain its obligations under the Milestone Timetable, **** shall reasonably consider any comments received from **** taking into account the efficiencies, delays, additional expenses and/or cost savings and overall increase in quality of the ANDA resulting from incorporating such comments into the ANDA or communications with the FDA. **** shall thereupon have the full and absolute discretion to reject any or all of ****'s comments or at ****'s expense, incorporate any changes to the ANDA or responses to the FDA suggested by **** to the extent it believes such to be timely, reasonably necessary and practicable.
US Territory. All ANDAs submitted by **** in the US Territory to the FDA and any approvals granted by the FDA shall be in ****'s name and owned by ****. Prior to the Product Termination Date in the US Territory and unless the Product has been made non-exclusive or the Product has been terminated from this Agreement with respect to the U.S. Territory, ****'s ANDAs shall only be used by ****, in connection with fulfilling its obligations under this Agreement. After the Product Termination Date or if the Product has been made non-exclusive, **** shall be permitted to use its ANDAs in the US Territory for any purpose whatsoever.
US Territory. In the US Territory, (a) each Party shall bear its own costs in connection with the Commercialization of Collaboration Products, subject to the payment provisions of Article 6 and the sharing and reconciliation provisions described in Section 7.4, and (b) [*] shall bear [*] of any Pre-Marketing Expenses incurred by the Parties, which shall be reported and reimbursed through the mechanisms set forth in Section 7.4.3.
US Territory. Subject to the terms of this Agreement, New River hereby grants to Shire an exclusive (except as to New River) license, without the right to grant sublicenses (except to Affiliates of Shire), under the Licensed Patents, the Licensed Know-How and New River’s interest in any Joint Collaboration Patents (a) to Commercialize Collaboration Products in the Field in the US Territory and (b) to Develop and use Collaboration Products for Commercialization in the US Territory.
