Common use of HAE Development Plan Clause in Contracts

HAE Development Plan. Prior to the Second Amendment Date, Dyax and Defiante have met to review and discuss the activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Original Defiante Territory and the First Additional Defiante Territory. Furthermore, Defiante and Dyax shall jointly complete, and the JSC shall approve [*****], such term to be extended in case of unforeseen circumstances or all relevant HAE Development Data being not available, a formal plan to file for Regulatory Approval for Product for the HAE Indication in the EU and in the Additional Defiante Territory (the "HAE Development Plan"). For the sake of clarity, such HAE Development Plan shall provide for no activities for the Second Additional Defiante Territory to be conducted by Defiante before [*****]. The HAE Development Plan shall set forth all further activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Defiante Territory, strategies and timelines for completing such activities, together with the annual budget for expenses related thereto. The HAE Development Plan shall also allocate responsibility between the Parties for such activities, subject to Section 4.2(c), (d) and (e) below and each Party's financial obligations under Section 7.3. The JSC shall review and monitor the activities conducted by the Parties under the HAE Development Plan, which shall be updated and modified from time to time to include any additional studies required by any Regulatory Authority in the Defiante Territory, up until filing of an application for Regulatory Approval with such Regulatory Authority, and any Post-Filing Activities required to obtain Regulatory Approval for the treatment of HAE in each country of the Defiante Territory, in accordance with the following process: (i) each Party shall review the HAE Development Plan not less frequently than quarterly and shall develop detailed and specific updates to the HAE Development Plan, until the completion of the activities covered thereunder; (ii) each Party shall submit all such updates to the JSC for review and approval at each meeting of the JSC; and (iii) the JSC shall review proposed updates to the HAE Development Plan at the next scheduled meeting of the JSC, or earlier if the JSC so agrees, and may approve such proposed updates in its discretion and, upon such approval by the JSC, the HAE Development Plan shall be amended accordingly.

HAE Development Plan. Prior to As soon as possible after the Second Fourth Amendment Date, STRD and Dyax shall jointly complete, and Defiante have met the JSC shall approve by [*****], a formal document that will detail STRD's [*****] Efforts to review and discuss Commercialize Product in the Field in the STRD Territory (the "HAE Development Plan") in accordance with its obligations under Section 5.1 and, as to Europe, in accordance with the provisions of Section 6.7 hereof. The HAE Development Plan shall include all activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Original Defiante Territory and the First Additional Defiante Territory. Furthermore, Defiante and Dyax shall jointly complete, and the JSC shall approve [*****], such term to be extended in case of unforeseen circumstances or all relevant HAE Development Data being not available, a formal plan to file for Regulatory Approval for Product for the HAE Indication in the EU and Field in the Additional Defiante Territory (the "HAE Development Plan"). For the sake of clarity, such HAE Development Plan shall provide for no activities for the Second Additional Defiante Territory to be conducted by Defiante before [*****]. The HAE Development Plan shall set forth all further activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Defiante STRD Territory, ; strategies and timelines for completing such activities, together with the annual budget for expenses related thereto. For the sake of clarity, the HAE Development Plan shall require STRD to show meaningful progress towards the Commercialization of Product in the Second Additional STRD Territory by [*****]. The HAE Development Plan shall also allocate responsibility between the Parties for such activities, subject to Section 4.2(c), (d) and (e) below and each Party's financial obligations under Section 7.3. The JSC shall review and monitor the activities conducted by the Parties under the HAE Development Plan, which shall be updated and modified from time to time to include any additional studies required by any Regulatory Authority in the Defiante Additional STRD Territory, up until filing of an application for Regulatory Approval with such Regulatory Authority, and any Post-Filing Activities required to obtain Regulatory Approval for the treatment of HAE in each country of the Defiante Additional STRD Territory, in accordance with the following process: (i) each Party shall review the HAE Development Plan not less frequently than quarterly and shall develop detailed and specific updates to the HAE Development Plan, until the completion of the activities covered thereunder; (ii) each Party shall submit all such updates to the JSC for review and approval at each meeting of the JSC; and (iii) the JSC shall review proposed updates to the HAE Development Plan at the next scheduled meeting of the JSC, or earlier if the JSC so agrees, and may approve such proposed updates in its discretion and, upon such approval by the JSC, the HAE Development Plan shall be amended accordingly.

HAE Development Plan. Prior to As soon as practicable after the Second Amendment Effective Date, Dyax and Defiante have met the JSC shall convene to review and discuss the activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Original Defiante Territory Territory. Furthermore, as soon as practicable after the Amendment Date, the JSC shall convene to review and discuss the First activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Additional Defiante Territory. FurthermoreFollowing this process, Defiante and Dyax shall jointly complete, and the JSC shall approve [*****], such term to be extended in case of unforeseen circumstances or all relevant HAE Development Data being not availableapprove, a formal plan to file for obtain Regulatory Approval for Product in the Defiante Territory for the HAE Indication in the EU and in the Additional Defiante Territory (the "“HAE Development Plan"”). For the sake of clarity, such HAE Development Plan shall provide for no activities for the Second Additional Defiante Territory to be conducted by Defiante before [*****]. The HAE Development Plan shall set forth all further activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Defiante Territory, strategies and timelines for completing such activities, together with the annual budget for expenses related thereto. The HAE Development Plan shall also allocate responsibility between the Parties for such activities, subject to Section 4.2(c), (d) and (e) below and each Party's ’s financial obligations under Section 7.3. The parties agree that the portion of the HAE Development Plan covering strategies and timelines for Regulatory Approval for Product in the Additional Defiante Territory shall be approved [*****], such term to be extended in case of unforeseen circumstances or all relevant HAE Development Data being not available. The JSC shall review and monitor the activities conducted by the Parties under the HAE Development Plan, which shall be updated and modified from time to time to include any additional studies required by any Regulatory Authority in the Defiante Territory, up until filing of an application for Regulatory Approval with such Regulatory Authority, and any Post-Filing Activities required to obtain Regulatory Approval for the treatment of HAE in each country of the Defiante Territory, in accordance with the following process: (i) each Party shall review the HAE Development Plan not less frequently than quarterly and shall develop detailed and specific updates to the HAE Development Plan, until the completion of the activities covered thereunder; (ii) each Party shall submit all such updates to the JSC for review and approval at each meeting of the JSC; and (iii) the JSC shall review proposed updates to the HAE Development Plan at the next scheduled meeting of the JSC, or earlier if the JSC so agrees, and may approve such proposed updates in its discretion and, upon such approval by the JSC, the HAE Development Plan shall be amended accordingly.

HAE Development Plan. Prior to As soon as practicable after the Second Amendment Effective Date, Dyax and Defiante have met the JSC shall convene to review and discuss the activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Original Defiante Territory and the First Additional Defiante Territory. FurthermoreFollowing this process, but in any event no later that [*****] after the Effective Date, Defiante and Dyax shall jointly complete, and the JSC shall approve [*****], such term to be extended in case of unforeseen circumstances or all relevant HAE Development Data being not availableapprove, a formal plan to file for obtain Regulatory Approval for Product in the Defiante Territory for the HAE Indication in the EU and in the Additional Defiante Territory (the "HAE Development Plan"). For the sake of clarity, such HAE Development Plan shall provide for no activities for the Second Additional Defiante Territory to be conducted by Defiante before [*****]. The HAE Development Plan shall set forth all further activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Defiante Territory, strategies and timelines for completing such activities, together with the annual budget for expenses related thereto. The HAE Development Plan shall also allocate responsibility between the Parties for such activities, subject to Section 4.2(c), (d) and (e) below and each Party's financial obligations under Section 7.3. The JSC shall review and monitor the activities conducted by the Parties under the HAE Development Plan, which shall be updated and modified from time to time to include any additional studies required by any Regulatory Authority in the Defiante Territory, up until filing of an application for Regulatory Approval with such Regulatory AuthorityApproval, and any Post-Filing Activities required to obtain Regulatory Approval for the treatment of HAE in each country of the Defiante Territory, in accordance with the following process:: * Confidential Treatment Requested. Omitted portions filed with the Commission. (i) each Party shall review the HAE Development Plan not less frequently than quarterly and shall develop detailed and specific updates to the HAE Development Plan, until the completion of the activities covered thereunder; (ii) each Party shall submit all such updates to the JSC for review and approval at each meeting of the JSC; and (iii) the JSC shall review proposed updates to the HAE Development Plan at the next scheduled meeting of the JSC, or earlier if the JSC so agrees, and may approve such proposed updates in its discretion and, upon such approval by the JSC, the HAE Development Plan shall be amended accordingly.

HAE Development Plan. Prior to As soon as possible after the Second Fifth Amendment Date, STRD and Dyax shall jointly complete, and Defiante have met the JSC shall approve by [*****], a formal document that will detail STRD's [*****] Efforts to review and discuss Commercialize Product in the Field in the STRD Territory (the "HAE Development Plan") in accordance with its obligations under Section 5.1 and, as to Europe, in accordance with the provisions of Section 6.7 hereof. The HAE Development Plan shall include all activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Original Defiante Territory and the First Additional Defiante Territory. Furthermore, Defiante and Dyax shall jointly complete, and the JSC shall approve [*****], such term to be extended in case of unforeseen circumstances or all relevant HAE Development Data being not available, a formal plan to file for Regulatory Approval for Product for the HAE Indication in the EU and Field in the Additional Defiante Territory (the "HAE Development Plan"). For the sake of clarity, such HAE Development Plan shall provide for no activities for the Second Additional Defiante Territory to be conducted by Defiante before [*****]. The HAE Development Plan shall set forth all further activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Defiante STRD Territory, ; strategies and timelines for completing such activities, together with the annual budget for expenses related thereto. The HAE Development Plan shall also allocate responsibility between the Parties for such activities, subject to Section 4.2(c), (d) and (e) below and each Party's financial obligations under Section 7.3. The JSC shall review and monitor the activities conducted by the Parties under the HAE Development Plan, which shall be updated and modified from time to time to include any additional studies required by any Regulatory Authority in the Defiante Additional STRD Territory, up until filing of an application for Regulatory Approval with such Regulatory Authority, and any Post-Filing Activities required to obtain Regulatory Approval for the treatment of HAE in each country of the Defiante Additional STRD Territory, in accordance with the following process: (i) each Party shall review the HAE Development Plan not less frequently than quarterly and shall develop detailed and specific updates to the HAE Development Plan, until the completion of the activities covered thereunder; (ii) each Party shall submit all such updates to the JSC for review and approval at each meeting of the JSC; and (iii) the JSC shall review proposed updates to the HAE Development Plan at the next scheduled meeting of the JSC, or earlier if the JSC so agrees, and may approve such proposed updates in its discretion and, upon such approval by the JSC, the HAE Development Plan shall be amended accordingly.