Proposal of Additional Studies Sample Clauses

Proposal of Additional Studies. (i) To the extent that either Party wishes to conduct an Additional Study or related series of Additional Studies of a Collaboration Product ([***]) that is not set forth in the Joint Development Plan and Budget for the applicable Program for the purpose of seeking Regulatory Approval for such Collaboration Product, such Party shall prepare a [***] year rolling Development plan and budget for such Additional Study(ies) and propose such Additional Study(ies) to the JDC. Such proposed Development plan and budget shall identify the applicable Collaboration Product, [***] (an “Additional Study Proposal”). Following receipt of the Additional Study Proposal from the proposing Party, the non-proposing Party shall have [***] days to decide whether or not to co-fund such Additional Study, and if such non-proposing Party elects to so co-fund, then such Additional Study will be considered a “Joint Development Study”, and the Parties shall amend and update the Joint Development Plan and Budget for the applicable Program to include such Additional Study as a Joint Development Study as part of the Joint Development Program. (ii) If the non-proposing Party fails to elect to co-fund a proposed Additional Study within such [***] day period, then (1) with respect to such proposed Additional Study for the PCV Program, [***] (2) with respect to a proposed Additional Study for a Joint SAV Program, [***], may independently conduct such Additional Study (an “Independent Additional Study”) subject to the terms and conditions of this Section 4.4 and in accordance with such Additional Study Proposal (thereafter, an “Independent Additional Study Development Plan”); provided, however, that if (A) the Independent Additional Study would involve a Collaboration Product in combination with a Moderna Agent when Moderna is the non-proposing Party or a Merck Agent [***] when Merck is the non-proposing Party, then [***], or (B) the non-proposing Party reasonably and in good faith believes that [***], then the proposing Party shall [***].
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Related to Proposal of Additional Studies

  • Proposal of Corrective Action Plan In addition to the processes set forth in the Contract (e.g., service level agreements), if the Department or Customer determines that there is a performance deficiency that requires correction by the Contractor, then the Department or Customer will notify the Contractor. The correction must be made within a time-frame specified by the Department or Customer. The Contractor must provide the Department or Customer with a corrective action plan describing how the Contractor will address all performance deficiencies identified by the Department or Customer.

  • Scope of Collaboration As part of the collaboration, the Controllers will act as Joint Controller. The roles of the Controller and the associated tasks are specified in more detail in Appendix 1. If one party is solely responsible for a data processing operation, this party will implement all relevant data protection provisions on its own responsibility. However, such data processing procedures are not subject to this Agreement. Joint data processing and the type of Personal Data collected and processed within the framework of collaboration are specified in Appendix 1.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • MOTION FOR FINAL APPROVAL Not later than 16 court days before the calendared Final Approval Hearing, Plaintiff will file in Court, a motion for final approval of the Settlement that includes a request for approval of the PAGA settlement under Labor Code section 2699, subd. (l), a Proposed Final Approval Order and a proposed Judgment (collectively “Motion for Final Approval”). Plaintiff shall provide drafts of these documents to Defense Counsel not later than seven days prior to filing the Motion for Final Approval. Class Counsel and Defense Counsel will expeditiously meet and confer in person or by telephone, and in good faith, to resolve any disagreements concerning the Motion for Final Approval.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • Withdrawal of Consent The Participant understands that the Participant is providing the consents herein on a purely voluntary basis. If the Participant does not consent, or if the Participant later seeks to revoke the Participant’s consent, the Participant’s employment status or service and career with the Employer will not be adversely affected; the only consequence of the Participant’s refusing or withdrawing the Participant’s consent is that the Company would not be able to grant RSUs or other equity awards to the Participant or administer or maintain such awards. Therefore, the Participant understands that refusing or withdrawing the Participant’s consent may affect the Participant’s ability to participate in the Plan. For more information on the consequences of Participant’s refusal to consent or withdrawal of consent, the Participant understands that the Participant may contact the Participant’s local human resources representative.

  • Proposal Proposal means any information supplied by or on behalf of the insured, deemed to be a completed proposal form and medical questionnaire and other relevant information that the insurer may require.

  • New Application for Licensure Any time after the three-month period has lapsed from the Effective Date of this Agreement and Respondent has paid the Administrative Penalty set forth in Section III, Paragraph 1 of this Order, Respondent may apply for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement in any or all of the Participating States with the understanding that each State Mortgage Regulator reserves the rights to fully investigate such application for licensure or petition for reinstatement of an MLO Activity Endorsement and may either approve or deny such application or petition pursuant to the normal process for such licensing or endorsement investigations. No license application or petition described in this paragraph will be denied solely based on the facts, circumstances, or consensual resolution provided for in this Agreement. Respondent further agrees that Respondent must satisfy the Administrative Penalty provision prior to submitting an application for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement.

  • Application for approval 3.1. The application for approval of a vehicle type with regard to the AEBS shall be submitted by the vehicle manufacturer or by his authorised representative. 3.2. It shall be accompanied by the documents mentioned below in triplicate: 3.2.1. A description of the vehicle type with regard to the items mentioned in paragraph 2.4., together with a documentation package which gives access to the basic design of the AEBS and the means by which it is linked to other vehicle systems or by which it directly controls output variables. The numbers and/or symbols identifying the vehicle type shall be specified. 3.3. A vehicle representative of the vehicle type to be approved shall be submitted to the Technical Service conducting the approval tests.

  • Updated Information Submission by Interconnection Customer The updated information submission by the Interconnection Customer, including manufacturer information, shall occur no later than one hundred eighty (180) Calendar Days prior to the Trial Operation. The Interconnection Customer shall submit a completed copy of the Electric Generating Unit data requirements contained in Appendix 1 to the LGIP. It shall also include any additional information provided to the Participating TO and the CAISO for the Interconnection Studies. Information in this submission shall be the most current Electric Generating Unit design or expected performance data. Information submitted for stability models shall be compatible with the Participating TO and CAISO standard models. If there is no compatible model, the Interconnection Customer will work with a consultant mutually agreed to by the Parties to develop and supply a standard model and associated information.

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