Roche Responsibility Sample Clauses

Roche Responsibility. Roche shall be solely and exclusively responsible at its own expense for the manufacture and supply of clinical supplies of Product.
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Roche Responsibility. Other than Vividion’s development responsibilities for a Vividion PoC Program pursuant to Section 3.2, Roche, at its sole cost and discretion (subject to cost sharing under the Vividion Sharing Option pursuant to Section 4.4), shall use Commercially Reasonable Efforts to develop Compounds and Products and Shared Products for Licensed Programs. Roche shall use Commercially Reasonable Efforts to conduct the activities for a Shared Product under and in accordance with the Development Plan for such Shared Product. Roche shall submit to the JDC for review any amendment to the Development Plan for a Shared Product after Vividion exercises the Vividion Sharing Option for such Shared Product.
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Roche Responsibility. Subject to Section 10.1.2 Roche shall use Commercially Reasonable Efforts to manufacture and supply Compound and Product for pre-clinical and clinical use for Licensed Programs, at its own cost. Roche shall use Commercially Reasonable Efforts to manufacture and supply Shared Products for non-clinical and clinical use, subject to the Development Cost Share as defined in the Financial Appendix.
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Roche Responsibility. Subject to Section 11.1.3, after the exercise of its Option Right for a Licensed Program: (a) Roche shall be solely responsible [***] for all regulatory affairs related to Compounds and Products and Shared Products in the Territory for the applicable Licensed Program including the preparation and filing of applications for Regulatory Approval as well as any or all governmental approvals required to develop, have developed, make, have made, use, have used, manufacture, have manufactured, import, have imported, sell and have sold Products and Shared Products for such Licensed Program, (b) Roche shall be responsible for pursuing, compiling and submitting all regulatory filing documentation, and for interacting with regulatory agencies, for all Products in all countries in the Territory for the applicable Licensed Program and (c) Roche or its Affiliates shall own and file in their discretion (subject to the terms and conditions of this Agreement) all regulatory filings and Regulatory Approvals for all Products and Shared Products in all countries of the Territory for the applicable Licensed Program.
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Roche Responsibility. 7.1.1 Roche Responsibilities in Roche Retained Field Within the Roche Retained Field with respect to the Compound and Product and until the occurrence of the Roche Reversion, Roche will retain at its sole cost all rights to seek authorization to conduct clinical trials, to obtain applicable regulatory designations (including but not limited to orphan drug designation, breakthrough therapy designation, fast-track designation) and seek regulatory advice following reasonable notification and consultation with Dermira. Roche will retain all decision-making rights over non-safety related prescribing information proposals to Regulatory Authorities, and Dermira will make reasonable accommodations with respect to Roche’s registration strategy in the Roche Retained Field. For clarity, as further described in Section 7.2, Dermira shall have the sole right to file all BLAs for the Product including in the Roche Retained Field.
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Roche Responsibility. Following Clinical PoC for a given Licensed Product (other than Shared Products in the SQZ Territory), Roche shall be solely responsible for all regulatory affairs related to such Licensed Products in the Field in the Territory including preparation and filing of INDs and applications for Regulatory Approvals. Roche shall be responsible for pursuing, compiling and submitting all regulatory filing documentation, and for interacting with regulatory agencies, for all such INDs and Regulatory Approvals. Roche shall consult with SQZ on regulatory matters with regards to such Licensed Products and SQZ shall have observer rights in all interactions with Regulatory Authorities in the US, EU (and individual country Regulatory Authorities in the EU) and China. Prior to Roche’s starting Clinical Study enrollment activities with regard to Licensed Products, SQZ shall transfer to Roche all relevant historical clinical safety data Controlled by SQZ that are necessary for development or Regulatory Approval of such Licensed Products. Any such safety information on serious adverse events shall be provided in CIOMS format and safety information on non-serious adverse events shall be provided in English Line Listing format.
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Roche Responsibility. Other than Dicerna’s rights and obligations for regulatory activities set forth in this Article 9 (and subject to Section 6.3), Roche shall be solely responsible at its own expense for all regulatory affairs related to Compounds and Products in the Territory including the preparation and filing of applications for Regulatory Approval, as well as any or all governmental approvals required to develop, have developed, make, have made, use, have used, manufacture, have manufactured, import, have imported, sell and have sold Products. Roche shall be responsible for pursuing, compiling and submitting all regulatory filing documentation, and for interacting with regulatory agencies, for all Products in all countries in the Territory. Roche or its Affiliates shall own and file in their discretion all regulatory filings and Regulatory Approvals for all Products in all countries of the Territory.
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Related to Roche Responsibility

  • 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.

  • 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.

  • 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:

  • 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.

  • Limitation of Responsibility Notwithstanding any other provisions ---------------------------- hereof, Committee Members shall be liable to the parties only for actions constituting bad faith, gross negligence or breach of an express provision of this Agreement (so long as such breach remains uncured after ten (10) days of receiving notice of the nature of such breach). In all other respects, Committee Members shall not be liable for negligence or mistakes of judgment.

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

  • Primary Responsibility The Company acknowledges that to the extent Indemnitee is serving as a director on the Company’s board of directors at the request or direction of a venture capital fund or other entity and/or certain of its affiliates (collectively, the “Secondary Indemnitors”), Indemnitee may have certain rights to indemnification and advancement of expenses provided by such Secondary Indemnitors. The Company agrees that, as between the Company and the Secondary Indemnitors, the Company is primarily responsible for amounts required to be indemnified or advanced under the Company’s certificate of incorporation or bylaws or this Agreement and any obligation of the Secondary Indemnitors to provide indemnification or advancement for the same amounts is secondary to those Company obligations. To the extent not in contravention of any insurance policy or policies providing liability or other insurance for the Company or any director, trustee, general partner, managing member, officer, employee, agent or fiduciary of the Company or any other Enterprise, the Company waives any right of contribution or subrogation against the Secondary Indemnitors with respect to the liabilities for which the Company is primarily responsible under this Section 15. In the event of any payment by the Secondary Indemnitors of amounts otherwise required to be indemnified or advanced by the Company under the Company’s certificate of incorporation or bylaws or this Agreement, the Secondary Indemnitors shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee for indemnification or advancement of expenses under the Company’s certificate of incorporation or bylaws or this Agreement or, to the extent such subrogation is unavailable and contribution is found to be the applicable remedy, shall have a right of contribution with respect to the amounts paid. The Secondary Indemnitors are express third-party beneficiaries of the terms of this Section 15.

  • Scope of Responsibility Notwithstanding any provision to the contrary, the Escrow Agent is obligated only to perform the duties specifically set forth in this Escrow Agreement, which shall be deemed purely ministerial in nature. Under no circumstances will the Escrow Agent be deemed to be a fiduciary to any Party or any other person under this Escrow Agreement. The Escrow Agent will not be responsible or liable for the failure of any Party to perform in accordance with this Escrow Agreement. The Escrow Agent shall neither be responsible for, nor chargeable with, knowledge of the terms and conditions of any other agreement, instrument, or document other than this Escrow Agreement, whether or not an original or a copy of such agreement has been provided to the Escrow Agent; and the Escrow Agent shall have no duty to know or inquire as to the performance or nonperformance of any provision of any such agreement, instrument, or document. References in this Escrow Agreement to any other agreement, instrument, or document are for the convenience of the Parties, and the Escrow Agent has no duties or obligations with respect thereto. This Escrow Agreement sets forth all matters pertinent to the escrow contemplated hereunder, and no additional obligations of the Escrow Agent shall be inferred or implied from the terms of this Escrow Agreement or any other agreement.

  • No Responsibility Except in the case of fraud, gross negligence, or willful misconduct, neither Agent nor any of its officers, directors, employees, or attorneys shall assume or ever have any liability or responsibility for, any diminution in the value of the Collateral or any part of the Collateral.

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