Akcea Regulatory Transfer Cooperation Sample Clauses

Akcea Regulatory Transfer Cooperation. (a) At no cost to Pfizer, as soon as reasonably practicable after the Closing Date (but no earlier than following the Completion of any Clinical Trial Akcea is conducting for the Product that are ongoing as of the Execution Date), Akcea will transfer all INDs, related documentation (including IND/CTA sequences, briefing documents, correspondence from/to FDA and any other Regulatory Authority) and dataset, related to the Product, to Pfizer, including the global safety database. (b) Following such IND transfer under Section 2.8.2(a), if requested by Pfizer, at no cost to Pfizer, Akcea and Ionis will cooperate with and provide reasonable assistance to Pfizer in connection with filings or submission to any Regulatory Authority relating to the Product, including by executing any required documents and providing access to personnel. After the first [***] hours of Akcea’s and Ionis’ time for any assistance under this Section 2.8.2(b), on a Major Market-by-Major Market basis until Regulatory Approval of each Indication in each of the Major Markets, if Pfizer reasonably requests, Akcea and Ionis will provide additional assistance to Pfizer in connection with filings or submission to any Regulatory Authority relating to the Product, and, Pfizer will compensate Akcea at Akcea’s then-applicable Akcea FTE Rate in accordance with Section 8.9 for Akcea’s and its Affiliates’ activities conducted under this Section 2.8.2(b). For the avoidance of doubt, any time spent by Akcea preparing and delivering the Draft Clinical Study Report and the Final Clinical Study Report for the NAFLD Trial pursuant to Section 2.4 shall be excluded from the [***] hours contemplated by this Section 2.8.2(b). Notwithstanding the foregoing, after the Closing Date, Pfizer shall have the right to request copies of any missing/outstanding documents or data of Akcea in Akcea’s or Ionis’ possession and control necessary and for the sole purpose of Exploiting the Compound or the Product and such requests shall not constitute assistance subject to the [***] hour cap.
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Related to Akcea Regulatory Transfer Cooperation

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).

  • Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

  • Company Cooperation The Company hereby covenants and agrees that it will not, and the Stockholder irrevocably and unconditionally acknowledges and agrees that the Company will not (and waives any rights against the Company in relation thereto), recognize any Encumbrance or agreement (other than this Agreement) on any of the Stockholder Securities subject to this Agreement.

  • Economic Cooperation 1. The Parties will encourage the utilization of cooperation instruments and mechanisms with a view to strengthen the processes of economic integration and commercial exchange. 2. The objectives of economic cooperation will be: (a) to build on existing agreements or arrangements already in place for trade and economic cooperation; and (b) to advance and strengthen trade and economic relations between the Parties. 3. The Parties will encourage and facilitate, as appropriate, the following activities, including, but not limited to: (a) dialogue about policies and regular exchanges of information and views on ways to promote and expand trade in goods and services between the Parties; (b) joint elaboration of studies and technical projects of economic interest according to the economic development needs identified by the Parties; (c) keeping each other informed of important economic and trade issues, and any impediments to furthering their economic cooperation; (d) providing assistance and facilities to business persons and trade missions that visit the other Party with the knowledge and support of the relevant agencies; (e) supporting dialogue and exchanges of experience among the respective business communities of the Parties; (f) establishing and developing mechanisms for providing information and identifying opportunities for business cooperation, trade in goods and services, investment, and government procurement; and (g) stimulating and facilitating actions of public and/or private sectors in areas of economic interest.

  • Customer Cooperation 3.2.1. Customer shall provide and make available all Customer personnel as may be further addressed in an applicable Order Form or that SAP reasonably requires in connection with performance of the Services. 3.2.2. Customer shall appoint a contact person with the authority to make decisions and to supply SAP with any necessary or relevant information expeditiously.