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. 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. 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. 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.
US Territory. If, during the Term, Momenta intends to begin detailed negotiations regarding key terms and/or enter into any contract, agreement, term sheet, understanding or arrangement (verbal or written) with a Commercial Third Party (other than Controlled Contractors) with respect to a Non-Injectable or Improved Enoxaparin Opportunity in the U.S. Territory, Momenta shall provide written notice of such bona fide present intent to the Sandoz Parties (the “Non-Injectable or Improved Enoxaparin Notice”), which Non-Injectable or Improved Enoxaparin Notice shall include information in reasonable detail sufficient to enable the Sandoz Parties to make an informed decision with respect to such Non-Injectable or Improved Enoxaparin Opportunity; provided, however, that this Section 3.3 shall not prevent Momenta from participating in general discussions or negotiations with Third Parties with respect to a Non-Injectable or Improved Enoxaparin Opportunity in the U.S. Territory. If either (but not both) of the Sandoz Parties notifies Momenta in writing within [**] of receipt of the Non-Injectable or Improved Enoxaparin Notice (the “Non-Injectable or Improved Enoxaparin Response Period”, such notice, the “Non-Injectable or Improved Enoxaparin Response”) that it has a bona fide interest in discussing a collaboration with Momenta with respect to such Non-Injectable or Improved Enoxaparin Opportunity, Momenta and such Sandoz Party shall enter into good faith negotiations on an exclusive basis, on such terms as may be mutually agreeable. If (a) neither Sandoz Party indicates during the Non-Injectable or Improved Enoxaparin Response Period that it is interested in discussing such Non-Injectable or Improved Enoxaparin Opportunity, (b) the Sandoz Parties indicate in writing during the Non-Injectable or Improved Enoxaparin Response Period that they have no interest in such Non-Injectable or Improved Enoxaparin Opportunity, or (c) one of the Sandoz Parties indicates such an interest during the Non-Injectable or Improved Enoxaparin Response Period but Momenta and such Sandoz Party are unable to, after good faith negotiations, reach mutual agreement and execute a definitive agreement with respect to a collaboration with respect to such Non-Injectable or Improved Enoxaparin Opportunity within [**] from the date of the Non-Injectable or Improved Enoxaparin Response (or such extended period as may be approved in writing by Momenta and such Sandoz Party), Momenta shall be free for a period of [**...
US Territory. The term ‘U.S. Territory’ means the United States of America, its territories and possessions (including Puerto Rico).”
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.
