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. 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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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Related to Roche Responsibility

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  • 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.

  • Limited Responsibility Each Party shall be responsible only for service(s) and facility(ies) which are provided by that Party, its affiliates, authorized agents, subcontractors, or others retained by such parties, and neither Party shall bear any responsibility for the services and facilities provided by the other Party, the other Party’s affiliates, agents, subcontractors, or other persons retained by such parties. No Party shall be liable for any act or omission of another Telecommunications Carrier (other than an affiliate) providing a portion of a service, unless such Telecommunications Carrier is an authorized agent, subcontractor, or other retained by the party providing the service.

  • Employer Responsibility The Employer accepts its responsibility to insure equal opportunity in all aspects of employment for all qualified persons regardless of race, creed, religion, color, national origin, age, disability, reliance on public assistance, sex, marital status, sexual orientation/affectional preference, or any other class or group distinction, as set forth by state or federal anti-discrimination laws, or in Board policy.

  • Customer’s Responsibility The policies in this document apply to the use of Data by Customers, Redistributors and their End Customers. Customers are responsible for compliance with this policy by all members of the Customer’s Group and by all persons to whom they distribute Data where authorised to do so. Turquoise recommends that Customers make this Schedule available to all Subscribers to their services having access to Data which is subject to Charges, reporting requirements or usage restrictions.

  • 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:

  • Customer Responsibility You agree that you are responsible for all access to and use of the Service through your account or password(s) and for any fees incurred for the Service, or for software or other merchandise purchased through the Service, or any other expenses incurred in accordance with the terms of this Agreement. You agree that you are responsible for backing up (a) any data you submit, receive or transfer over the Service, including, without limitation, your email; and (b) any data, files, programs, or applications on any device you connect to the Service. You acknowledge that you are aware that content accessible on or through the Service may contain material that is unsuitable for minors (persons under 18 years of age). You agree to supervise usage of your account by minors. You ratify and confirm any obligations incurred by a minor using your account.

  • Client Responsibility For clarity, the parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.

  • Cost Responsibility Interconnection Customer shall be responsible for and shall pay upon demand all Costs associated with the interconnection of the Customer Facility as specified in the Tariff. These Costs may include, but are not limited to, an Attachment Facilities charge, a Local Upgrades charge, a Network Upgrades charge and other charges. A description of the facilities required and an estimate of the Costs of these facilities are included in Sections 3.0 and 4.0 of the Specifications to this ISA.

  • Your Responsibilities You represent and agree to the following by enrolling for Mobile Banking or by using the Service:

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