Amgen Responsibility Sample Clauses

Amgen Responsibility. Following the Effective Date and at all times during the Term (except as expressly stated otherwise herein), except as set forth in Section 8.1.3 (Preclinical Development Costs), Amgen shall be responsible for, and shall bear all costs associated with, the clinical development and commercialization of Amgen Products, including development, distribution, marketing and sales activities. For clarity, after completion of the Preclinical Development Plan, Amgen shall continue to have the right to conduct preclinical development with respect to all Amgen Products. Subject to the express written terms of this Agreement, all decisions concerning the development, marketing and sales of Amgen Products including the clinical and regulatory strategy, design, sale, price and promotion of Amgen Products covered under this Agreement shall be within the sole discretion of Amgen.
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Amgen Responsibility. Amgen shall have exclusive responsibility for all correspondence and for any official communication (except as Licensee may be required by Law or a Governmental Authority to communicate or as expressly provided in Section 4.12.1 (Licensee Responsibility)) regarding (i) the Licensed Product in Indications with applicable Governmental Authorities in the Amgen Territory, (ii) the Licensed Product in the NSCLC Indication with applicable Governmental Authorities in the Territory (other than Japan), provided that, in the Licensee Territory, such responsibility shall transition to Licensee as of the time that a Regulatory Filing seeking Regulatory Approval has been submitted by Licensee, and further provided that Amgen shall reasonably cooperate with Licensee in such transition in accordance with Section 4.12.1 (Licensee Responsibility) and (iii) regarding the manufacture of the Licensed Product in the Territory. Without prejudice to the time periods relevant to Regulatory Filings pursuant to Section 4.7 (Sharing of Regulatory Filings), Amgen shall supply to Licensee a copy of: (a) all material correspondence and communications to any such Governmental Authority at least [*] days prior to provision of such correspondence or communication to such Governmental Authority (or as promptly as possible where exigent circumstances make such provision impractical); and (b) all material correspondence and communications from any such Governmental Authority within [*] days after receipt of any such correspondence. Amgen shall consider in good faith any comments or suggestions made by Licensee with respect to any such communication. Licensee shall reasonably cooperate with Amgen in responding to any inquiry made by a Governmental Authority in the Amgen Territory regarding Licensed Product in any Indications. Licensee shall be entitled to observe and participate in any discussions between Amgen and any Governmental Authority relating to Licensed Product, and Amgen shall give Licensee at least [*] days prior written notice thereof (or prompt written notice, if [*] days notice is impractical). Should Amgen be unable to solicit Licensee’s participation in any such discussion (as, for example, with respect to a call or visit to Amgen by such Governmental Authority without notice), then Amgen shall provide Licensee prompt written notice of such communication with a summary of the discussion. Notwithstanding the above, Amgen shall not be required to disclose manufacturing informati...
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Amgen Responsibility. Except as provided in Section 6.2 (Manufacturing Matters) and as provided under a Preclinical Development Plan, Amgen will be solely responsible for the preparation, submission and maintenance of all Regulatory Filings and obtaining all Regulatory Approvals (including any Marketing Approvals) with respect to Amgen Products. Kite will cooperate with Amgen, at its reasonable request, with respect to any regulatory matters related to Amgen Products. Amgen will own all right, title and interest in and to any and all Regulatory Filings and Regulatory Approvals directed to Amgen Products and all such Regulatory Filings and Regulatory Approvals will be held in the name of Amgen, and Kite will execute all documents and take all actions as are reasonably requested by Amgen to vest such title in Amgen. To the extent not prohibited by Law, Amgen shall provide correspondence from Regulatory Authorities related to any IND filings in Amgen’s name if such correspondence would reasonably relate to any Kite Products and related Regulatory Filings.
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Amgen Responsibility. Amgen shall own and be solely responsible for filing, obtaining and maintaining all Regulatory Approvals for the Licensed Product in the Indications in the Amgen Territory and any approval for any product labeling or promotional materials in the Amgen Territory with respect thereto; and unless otherwise agreed or required by applicable Law, all such approvals shall be held in the name of Amgen (or its designee). Amgen shall also be responsible for any post-approval activities required to be conducted by any Governmental Authority in the Amgen Territory for any Licensed Product; provided that any post-marketing studies not required by the FDA or any other Governmental Authority in the Amgen Territory, shall be submitted to and approved by the Development Committee prior to commencing any such post-marketing studies (as set forth in Section 4.5 (Voluntary Post-Marketing Studies)), and in any event, Amgen shall submit a proposal detailing such post-marketing studies required by any Governmental Authority in the Amgen Territory to the Development Committee for review (not approval) and shall keep the Development Committee apprised of the progress and results thereof.
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Amgen Responsibility. Amgen shall have exclusive responsibility for all correspondence and for any official communication (except as Licensee may be required by Law or a Governmental Authority to communicate or as expressly provided in Section 4.12.1 (Licensee Responsibility)) regarding manufacture of the Licensed Products and regarding the Licensed Products inside the Territory in Amgen Indications and outside the Territory in all indications. With respect to correspondence and communication with Governmental Authorities relating to Licensed Products, Amgen shall use reasonable efforts to provide Licensee copies of material written correspondence as reasonably necessary to permit Licensee to comply with its relevant regulatory obligations (provided that Amgen shall not be required to disclose competitively sensitive information or manufacturing information).
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Related to Amgen Responsibility

  • Own responsibility Without affecting the responsibility of any Obligor for information supplied by it or on its behalf in connection with any Finance Document, each Secured Party confirms to the Security Agent that it has been, and will continue to be, solely responsible for making its own independent appraisal and investigation of all risks arising under or in connection with any Finance Document including but not limited to:

  • Tax Responsibility The Fund shall be liable for all taxes (including Taxes, as defined below) relating to its investment activity, including with respect to any cash or securities held by the Custodian on behalf of the Fund or any transactions related thereto. Subject to compliance by the Fund with its obligations under Section 7.1, the Custodian shall withhold (or cause to be withheld) the amount of any Tax which is required to be withheld under applicable law in connection with the collection on behalf of the Fund pursuant to this Agreement of any dividend, interest income or other distribution with respect to any security and the proceeds or income from the sale or other transfer of any security held by the Custodian. If any Taxes become payable with respect to any prior payment made to the Fund by the Custodian or otherwise, the Custodian may apply any credit balance in the Fund’s deposit account to the extent necessary to satisfy such Tax obligation. The Fund shall remain liable for any tax deficiency. The Custodian is not liable for any tax obligations relating to the Portfolio or the Fund, other than those Tax services as set out specifically in this Section 7. The Fund agrees that the Custodian is not, and shall not be deemed to be, providing tax advice or tax counsel. The capitalized terms “Tax” or “Taxes” means any withholding or capital gains tax, stamp duty, levy, impost, charge, assessment, deduction or related liability, including any addition to tax, penalty or interest imposed on or in respect of (i) cash or securities, (ii) the transactions effected under this Agreement, or (iii) the Fund.

  • Joint Responsibility If the Seller determines that the Interface Problem is attributable partially to the design of a Warranted Part and partially to the design of any Supplier Part, the Seller will, if so requested by the Buyer, seek a solution to the Interface Problem through cooperative efforts of the Seller and any Supplier involved. The Seller will promptly advise the Buyer of such corrective action as may be proposed by the Seller and any such Supplier. Such proposal will be consistent with any then existing obligations of the Seller hereunder and of any such Supplier towards the Buyer. Such corrective action, unless reasonably rejected by the Buyer, will constitute full satisfaction of any claim the Buyer may have against either the Seller or any such Supplier with respect to such Interface Problem.

  • ALPS’ Responsibilities In connection with its performance of TA Web, ALPS shall:

  • Filing Responsibility PARTICIPANT ACKNOWLEDGES THAT IT IS PARTICIPANT’S SOLE RESPONSIBILITY, AND NOT THE CORPORATION’S, TO FILE A TIMELY ELECTION UNDER CODE SECTION 83(b), EVEN IF PARTICIPANT REQUESTS THE CORPORATION OR ITS REPRESENTATIVES TO MAKE THIS FILING ON HIS OR HER BEHALF.

  • Specific Responsibilities In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:

  • Joint Responsibilities In performing the Development Efforts, each party shall

  • Other Responsibilities The delivery of any notices to, and the obtaining of any consents from, any Permitted Transferee with respect to any provision of this Agreement, including, but not limited to, Sections 7.1 and 7.4, shall be your sole responsibility, unless otherwise agreed to in writing between such Permitted Transferee and the Sponsor. Neither the Company nor the Sponsor shall be liable to any Permitted Transferee for your failure to deliver a notice to, or obtain a consent from, any Permitted Transferee with respect to any provision of this Agreement, including, but not limited to, Sections 7.1 and 7.4.

  • Trust Responsibilities In connection with its use of AVA, the Trust, through its service providers, shall:

  • REPORTING RESPONSIBILITY Any reporting responsibility of the Acquired Fund is and shall remain the responsibility of the Acquired Fund.

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