Commencement of Phase 2 Activities Sample Clauses

Commencement of Phase 2 Activities. If, following delivery of the Phase 1 Data Package, the JSC determines pursuant to Section 3.3.3 (or Protagonist determines pursuant to Section 2.1.4(c)(2)(iii)) that the results from the Phase 1 Activities support continuation of preparation and conduct of the CD Phase 2 Clinical Trial and related Phase 2 Activities, Protagonist shall use Diligent Efforts to provide to Xxxxxxx all data and information relating to the Initial Compound and Initial Product necessary to prepare the INDs and CTAs for the CD Phase 2 Clinical Trial as soon as practicable after such JSC determination. Xxxxxxx shall use Diligent Efforts to prepare and submit such INDs and CTAs to the applicable Regulatory Authorities as soon as practicable after Protagonist provides such necessary data and information. The Parties will use Diligent Efforts to complete such activities within [ * ] after the date on which the JSC (or Protagonist, as the case may be) makes such determination, and in any event Xxxxxxx shall file the Phase 2 IND within [ * ] of the Phase 1 Completion Date, it being understood that any delay in Protagonist’s delivery to Xxxxxxx of the necessary data and information as required above will result in a day for day increase to such time period.
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Commencement of Phase 2 Activities. (a) Xxxxxxx shall file the Phase 2 IND for the Initial Product within approximately [*] following the First Amendment Effective Date. (b) With respect to 2nd Generation Products, if, following delivery of the Phase 1 Data Package for a 2nd Generation Product, the JSC determines pursuant to Section 3.3.3 that the results from the Phase 1 Activities support continuation of preparation and conduct of the CD Phase 2 Clinical Trial and related Phase 2 Activities, Protagonist shall use Diligent Efforts to provide to Xxxxxxx all data and information relating to the 2nd Generation Compound and 2nd Generation Product necessary to prepare the INDs and CTAs for the CD Phase 2 Clinical Trial for such 2nd Generation Product as soon as practicable after such JSC determination. Xxxxxxx shall use Diligent Efforts to prepare and submit such INDs and CTAs to the applicable Regulatory Authorities after Protagonist provides such necessary data and information. The Parties will use Diligent Efforts to complete such activities within [*] after the date on which the JSC (or Protagonist, as the case may be) makes such determination, and in any event Xxxxxxx shall file the Phase 2 IND for such 2nd Generation Product within [*] of the Phase 1 Completion Date for such 2nd Generation Product, it being understood that any delay in Protagonist’s delivery to Xxxxxxx of the necessary data and information as required above will result in a day for day increase to such time period. (c) Xxxxxxx shall use Diligent Efforts to initiate study site recruitment for each CD Phase 2 Clinical Trial within [*] after submission of the applicable Phase 2 IND, provided that there are no delays caused by the action of a Regulatory [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Authority, and thereafter shall use Diligent Efforts to continue such recruitment and conduct and complete such trial in accordance with the applicable Development Plan, subject to Section 3.8. Notwithstanding the foregoing, if a Regulatory Authority requests or requires any changes to the Phase 2 Activities following submission of an IND or CTA in accordance with Section 3.4.1(a), (i) the JSC shall develop and approve an amendment to the Development Plan to address such request or requirement in accordance with Section 3.2.2 and (ii) Xxxxxxx shall have no obligation to commence the C...
Sample 1

Related to Commencement of Phase 2 Activities

  • Commencement and Completion The Work shall commence on _______________, 20__ and shall be complete in accordance with this Agreement without delay on ______________, 20__. The term “day”, used throughout this Agreement, refers to calendar days. Contractor shall not be entitled to any additional compensation for any Permitted Delays. If this Agreement is not signed and returned to the Owner before any work commences, this Agreement will be considered as accepted as presented to the Contractor.

  • Commencement of Negotiations Within five (5) days of satisfaction of the public notice requirement, and not later than forty-five (45) days following submission of the proposal, negotiations shall commence at a mutually acceptable time and place for the purpose of considering changes in this Agreement.

  • Commencement of Work Engineer shall not commence any field work under this Contract until he/she/it has obtained all required insurance and such insurance has been approved by County. As further set out below, Engineer shall not allow any subcontractor/subconsultant(s) to commence work to be performed in connection with this Contract until all required insurance has been obtained and approved and such approval shall not be unreasonably withheld. Approval of the insurance by County shall not relieve or decrease the liability of Engineer hereunder.

  • Commencement and Completion of Work The professional services to be performed pursuant to this Agreement shall commence within five (5) days from the Effective Date of this Agreement. Failure to commence work in a timely manner and/or diligently pursue work to completion may be grounds for termination of this Agreement.

  • Commencement of Development 5.3.1 In the event that development on the Lands has not commenced within five (5) years from the date of registration of this Agreement at the Registry of Deeds or Land Registry Office, as indicated herein, the Agreement shall have no further force or effect and henceforth the development of the Lands shall conform with the provisions of the Land Use By-law. For the purpose of this section, commencement of development shall mean issuance of a Mobile Home Park Construction Permit. 5.3.2 For the purpose of this section, Council may consider granting an extension of the commencement of development time period through a resolution under Section 4.1 of this Agreement, if the Municipality receives a written request from the Developer at least sixty (60) calendar days prior to the expiry of the commencement of development time period.

  • COMMENCEMENT AND COMPLETION OF THE PROJECT Section 3.01 The Project (a) The Company intends and expects, together with any Sponsor Affiliate, to (i) construct and acquire the Project, and (ii) meet the Contract Minimum Investment Requirement within the Investment Period. The Company anticipates that the first Phase of the Project will be placed in service during the calendar year ending December 31, 2020. (b) Pursuant to the FILOT Act and subject to Section 4.03 hereof, the Company and the County hereby agree that the Company and any Sponsor Affiliates shall identify annually those assets which are eligible for FILOT payments under the FILOT Act and which the Company or any Sponsor Affiliate selects for such treatment by listing such assets in its annual PT-300S form (or comparable form) to be filed with the Department (as such may be amended from time to time) and that by listing such assets, such assets shall automatically become Economic Development Property and therefore be exempt from all ad valorem taxation during the Exemption Period. Anything contained in this Fee Agreement to the contrary notwithstanding, the Company and any Sponsor Affiliates shall not be obligated to complete the acquisition of the Project. However, if the Company, together with any Sponsor Affiliates, does not meet the Contract Minimum Investment Requirement within the Investment Period, the provisions of Section 4.03 hereof shall control. (c) The Company may add to the Land such real property, located in the same taxing District in the County as the original Land, as the Company, in its discretion, deems useful or desirable. In such event, the Company, at its expense, shall deliver an appropriately revised Exhibit A to this Fee Agreement, in form reasonably acceptable to the County.

  • Pre-Commencement Phase Services The services required to be provided by the Contractor for the Pre- Commencement Phase of the Project in accordance with the Contract Documents.

  • Commencement of Services The Services will be commenced immediately upon receipt of the signed Proposal (the “Agreement”). If after commencement of the Services, the Project is delayed for any reason beyond Xxxxxxxxx’x control for more than 60 days, the terms and conditions contained herein will be subject to revision by Xxxxxxxxx. Subsequent modifications to this Agreement must be in writing and signed by the parties to the Agreement.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Project Commencement The Grantee shall begin the grant-funded project <<on or before insert date>> <<within 90 days of the original start date of the grant term or grant execution date, whichever is later,>>, unless otherwise approved by System Agency. If project commencement is delayed, the Grantee must submit in writing to the assigned contract manager, the steps taken to initiate the project, the reasons for the delay, and the expected start date. System Agency may require Grantee to take immediate remedial or corrective action in response to any delay.

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