Development Responsibility; Diligence Obligations Sample Clauses

Development Responsibility; Diligence Obligations. Subject to the terms of this Agreement, TGTX shall be responsible for, at its sole cost and expense, all Development of the Licensed Product in the Licensed Field in the Territory, including all Clinical Trials and activities that are necessary for or otherwise support obtaining and maintaining Regulatory Approvals in the Licensed Field in the Territory. TGTX shall use Commercially Reasonable Efforts to Develop and seek and obtain Regulatory Approval for the Licensed Product in the Licensed Field in the Territory [***], all in accordance with all Applicable Laws. [***] (such date, as may be extend by clause (a) or (b), the “Initiation Deadline”).
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Development Responsibility; Diligence Obligations. Subject to the terms of this Agreement, Imugene shall be responsible for, at its sole cost and expense, all Development of the Existing Product in Licensed Field in the Territory, including all Clinical Trials and activities that are necessary for or otherwise support obtaining and maintaining Regulatory Approvals in the Licensed Field in the Territory. Imugene shall use Commercially Reasonable Efforts to Develop and seek and obtain Regulatory Approval for each Existing Product in the Licensed Field throughout the Territory in accordance with all Applicable Laws. Without limiting the foregoing, (a) Imugene (i) will initiate the first dosing of a human subject in the Expansion Cohort with the Existing Product that is the subject of the Expansion Cohort Modification (or any adjustment thereof submitted in accordance with Section 4.1.3(a)) by the later of (A) [***], or (B) [***] after the FDA does not object to the Expansion Cohort Modification (or any adjustment thereof submitted in accordance with Section 4.1.3(a)) during the applicable review period therefor, and (ii) will complete the Expansion Cohort in accordance with the study design set forth in the applicable protocol, unless otherwise required by the FDA; and (b) [***].

Related to Development Responsibility; Diligence Obligations

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Development Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.

  • Responsibility of Contractor a. Contractor shall be held strictly responsible for the proper performance of all work covered by the Contract Documents, including all work performed by Subcontractors. All work performed under this Contract shall comply in every respect to the rules and regulations of all agencies having jurisdiction over the Project or any part thereof. b. Contractor shall submit Verified Reports as defined in §§4-336 and 4-343 (c), Group 1, Chapter 4, Part I, Title 24, California Code of Regulations (“CCR”). The duties of the Contractor are as defined in §4-343, Group 1, Chapter 4, Part I, Title 24, of the CCR. Contractor shall keep and make available a copy of Title 24 of the CCR at the job site at all times. c. Where, because of short supply, any item of fabricated materials and/or equipment, indicated on drawings or specified is unobtainable and it becomes necessary, with the consent of the Project Manager, to substitute equivalent items differing in details or design, the Contractor shall promptly submit complete drawings and details indicating the necessary modifications of the work. This provision shall be governed by the terms of the General Conditions regarding Submittals: Shop Drawings, Cuts and Samples. d. With respect to work performed at and near a school site, Contractor shall at all times take all appropriate measures to ensure the security and safety of students and staff, including, but not limited to, ensuring that all of Contractor’s employees, Subcontractors, and suppliers entering school property strictly adhere to all applicable District policies and procedures, e.g., sign-in requirements, visitor badges, and access limitations.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Joint Responsibilities The relationship between SAE ITC, the Activities and its Members shall be, and at all times, advisory only, and no party shall have the authority to enter into any contract or commitment in the name of, or on behalf of, any other party. Nothing in this Agreement shall be construed to confer upon either party the status of employee, agent, partner, joint venturer or legal representative of the other, it being intended by all parties to remain independent legal entities solely responsible for its own actions.

  • Client Responsibilities You are responsible for (a) assessing each participants’ suitability for the Training, (b) enrollment in the appropriate course(s) and (c) your participants’ attendance at scheduled courses.

  • 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.

  • Payment Responsibility The payment obligations of each Participating Manufacturer pursuant to this Agreement shall be the several responsibility only of that Participating Manufacturer. The payment obligations of a Participating Manufacturer shall not be the obligation or responsibility of any Affiliate of such Participating Manufacturer. The payment obligations of a Participating Manufacturer shall not be the obligation or responsibility of any other Participating Manufacturer. Provided, however, that no provision of this Agreement shall waive or excuse liability under any state or federal fraudulent conveyance or fraudulent transfer law. Any Participating Manufacturer whose Market Share (or Relative Market Share) in any given year equals zero shall have no payment obligations under this Agreement in the succeeding year.

  • 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.

  • Responsibility of the Parties The Parties undertake to indemnify each other for any damage (loss) caused by their partial or complete non-performance or improper performance of the Agreement, and the indemnification of damage (loss) does not relieve the Parties from the performance/payment of their obligations under the Agreement. In addition, the Customer shall be liable for any damage (loss) caused to the Bank by its partial or complete non-performance or improper performance of the Agreement. Inter alia, in the event of a breach of the term specified in the subsection 3.3.6. of Annex N1 to the Bank Guarantee Agreement, Bank is entitled to charge the Customer with additional amount of the respective Interest (as the damage (loss) inflicted) for the period of breach of the term or the Bank shall be entitled to repay the above obligations not later than 14 (fourteen) calendar days after the written application. Indemnification of the damage (loss) does not release the Customer from the performance/payment of the obligations under the Agreement. Notwithstanding the guarantees specified in Sections 5.1 and 5.2. of Annex N1 to the Bank Guarantee Agreement, in order to ensure full and proper performance of the Customer’s obligations under the Agreement, and, respectively, to secure the Bank’s rights and claims, the Customer hereby expressly gives its prior consent that the Bank is fully authorized to: In the case of several debt arrears, determine the sequence and order of payments of Bank Guarantee and the payments under it; Block any Account of the Customer without acceptance in the amount of the payment due and in accordance with its applicable rules until any payment is under the Agreement is fully and duly covered; Write off without acceptance all payments due from the any Account of the Customer, and if the payment due and the amount available on the Account are in different currencies, the Bank itself can perform conversion at the commercial rate of exchange applicable at the Bank on the date of payment or the rate of exchange agreed with the Customer (if any), and write off also the conversion cost without acceptance from the Account, and channel the converted amount to cover the appropriate payments. During the period of Force Majeure, the Bank shall not be liable for complete or partial nonfulfillment or improper fulfillment of its obligations under the Agreement. In the event of Force Majeure, the Parties shall be guided by ICC Uniform Rules. Any official communication between the Parties shall be in writing. The written notice intended to the Party may be delivered in person or sent by a courier (including an international courier) or through a post delivery (including by a registered letter). For urgency and subject to the following provisions, except by submitting to the Customer a claim for full performance of its obligations under the Agreement or notifying about the complete or partial termination of the Agreement, it is permissible to notify the other Party by email or other electronic means (including via mobile banking, internet banking) provided that upon request of the other Party, such notice shall also be provided in writing within a reasonable time. The notice shall be deemed to have been accepted by the addressee on the day of its receipt if the receipt of the notice is confirmed by the addressee (including by electronic document, receipt, other appropriate means of notification, etc.). If the receipt of the notice is not confirmed by the addressee, any such notice shall be deemed to have been sent and received accordingly: In case of sending a written message by a courier or registered mail - on the day of confirmation of delivery; In case of sending by email and/or other electronic means - on the second Banking Day after the date of sending; Notice shall be deemed to have been received even if the notice is returned to the notifying Party due to the absence of the addressee of the notification on the sent address/contact data, the addressee refuses to receive the notice or avoids receiving it. The Parties will communicate according to the addresses/contact details specified in the Agreement (or any other address/contact information that one Party will provide in writing to the other). The Party is obliged to notify the other Party on the change of the above address or any of their data in a timely manner, otherwise the communication (notification etc.) carried out to the address indicated by the Party shall be deemed to have been duly performed.

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