Notice of Last Patient/Last Visit and Anticipated NDA Filing Sample Clauses

Notice of Last Patient/Last Visit and Anticipated NDA Filing. DS shall give ARQULE written notice of (i) the date of the Last Patient/Last Visit in the last Phase 3 Clinical Trial for a Licensed Product to be conducted for the first Targeted Indication prior to the filing of an NDA for such Licensed Product for such Targeted Indication (“Last Patient/Last Visit Notice”), and (ii) its decision to file the NDA covering each Licensed Product for a second Targeted Indication after the unblinding of the data (if a blinded trial) for such Targeted Indication but at least * (*) days prior to the anticipated date of such anticipated filing (the “NDA Filing Notice”).
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Related to Notice of Last Patient/Last Visit and Anticipated NDA Filing

  • Supplemental Pricing Documents No response Optional. If when completing Pricing Form 1 & Pricing Form 2 you direct TIPS to view additional, alternate, or supplemental pricing documentation, you may upload that documentation.

  • Conformity with EXXXX Filing The Prospectus delivered to the Agent for use in connection with the sale of the Placement Shares pursuant to this Agreement will be identical to the versions of the Prospectus created to be transmitted to the Commission for filing via EXXXX, except to the extent permitted by Regulation S-T.

  • Lobbying Activities - Standard Form - LLL No response Do not upload this form unless Vendor has reportable lobbying activities. There are Attributes entitled, “2 CFR Part 200 or Federal Provision - Xxxx Anti-Lobbying Amendment – Continued.” Properly respond to those Attributes and only upload this form if applicable/instructed. If upload is required based on your response to those Attributes, the Disclosure of Lobbying Activities – Standard Form - LLL must be downloaded from the “Attachments” section of the IonWave eBid System, reviewed, properly completed, and uploaded to this location.

  • Program Requirements Provided At No Charge to the Judicial Council A. The Contractor shall provide the following items during the Program at no charge to the Judicial Council:

  • JOC Pricing of Itemized List of RS Means Non-Prepriced Items No response The Vendor may download the optional Pricing of Itemized List of RS Means Non-Prepriced Items form from the attachment tab, fill in the requested information, and upload the completed spreadsheet. DO NOT UPLOAD encrypted or password protected files. Valid Reference Email addresses are REQUIRED on the spreadsheet. The vendor must download the References spreadsheet from the attachment tab, fill in the requested information and upload the completed spreadsheet. DO NOT UPLOAD encrypted or password protected files.

  • Joint Funded Project with the Ohio Department of Transportation In the event that the Recipient does not have contracting authority over project engineering, construction, or right-of-way, the Recipient and the OPWC hereby assign certain responsibilities to the Ohio Department of Transportation, an authorized representative of the State of Ohio. Notwithstanding Sections 4, 6(a), 6(b), 6(c), and 7 of the Project Agreement, Recipient hereby acknowledges that upon notification by the Ohio Department of Transportation, all payments for eligible project costs will be disbursed by the Grantor directly to the Ohio Department of Transportation. A Memorandum of Funds issued by the Ohio Department of Transportation shall be used to certify the estimated project costs. Upon receipt of a Memorandum of Funds from the Ohio Department of Transportation, the OPWC shall transfer funds directly to the Ohio Department of Transportation via an Intra- State Transfer Voucher. The amount or amounts transferred shall be determined by applying the Participation Percentages defined in Appendix D to those eligible project costs within the Memorandum of Funds. In the event that the Project Scope is for right-of-way only, notwithstanding Appendix D, the OPWC shall pay for 100% of the right-of-way costs not to exceed the total financial assistance provided in Appendix C.

  • Implementation of and Reporting on the Project A. The Grantee shall implement and complete the Project in accordance with Exhibit A and with the plans and specifications contained in its Grant Application, which is on file with the State and is incorporated by reference. Modification of the Project shall require prior written approval of the State. B. The Grantee shall submit to the State written progress reports until the completion of the Project. These reports shall be submitted upon request by the State and shall contain such detail of progress or performance on the Project as is requested by the State.

  • Dissemination of Research Findings and Acknowledgement of Controlled-Access Datasets Subject to the NIH GDS Policy

  • Alternate or Supplemental Pricing Documents No response Optional. If when completing Pricing Form 1 & Pricing Form 2 you direct TIPS to view additional, alternate, or supplemental pricing documentation, you may upload that documentation.

  • Please see the current Washtenaw Community College catalog for up-to-date program requirements Conditions & Requirements

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