RA Complete Data Package Sample Clauses

RA Complete Data Package. Within […***…] after database lock of the Phase 2 Clinical Study for the Lead Compound in the Field of RA pursuant to the Initial Development Plan and Budget, Ablynx shall provide AbbVie with a completion report, which report shall include all Information, Clinical Data, SAS charts and supporting documentation needed to support a decision on whether all Phase 2B RA Success Criteria have been achieved, including, a finalized statistical analysis plan, along with a quality assurance statement certifying no quality issues limiting the validity of the Phase 2 Clinical Study in RA were raised during the Conduct of such Phase 2 Clinical Study, and such other information as AbbVie may reasonably request in connection with its evaluation of such data (“RA Complete Data Package”), all in a form that is in substantial conformity with the template set forth in Schedule 3.1.5.
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RA Complete Data Package. Within […***…] after database lock of the Phase 2 Clinical Study for the Lead Compound in the Field of RA pursuant to the Initial Development Plan and Budget, Ablynx shall provide AbbVie with a completion report, which report shall include all Information, Clinical Data, SAS charts and supporting documentation needed to support a decision on whether all Phase 2B RA Success Criteria have been achieved, including, a finalized statistical analysis plan, along with a quality assurance statement certifying no quality issues limiting the validity of the Phase 2 Clinical Study in RA were raised during the Conduct of such Phase 2 Clinical Study, and such other information as AbbVie may reasonably request in connection with its evaluation of such data (“RA Complete Data Package”), all in a form that is in substantial conformity with the template set forth in Schedule 3.1.5. CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Related to RA Complete Data Package

  • Check and complete if Transferee will take delivery of a beneficial interest in the IAI Global Note or a Restricted Definitive Note pursuant to any provision of the Securities Act other than Rule 144A or Regulation S. The Transfer is being effected in compliance with the transfer restrictions applicable to beneficial interests in Restricted Global Notes and Restricted Definitive Notes and pursuant to and in accordance with the Securities Act and any applicable blue sky securities laws of any state of the United States, and accordingly the Transferor hereby further certifies that (check one): (a) o such Transfer is being effected pursuant to and in accordance with Rule 144 under the Securities Act; (b) o such Transfer is being effected to the Company or a subsidiary thereof; (c) o such Transfer is being effected pursuant to an effective registration statement under the Securities Act and in compliance with the prospectus delivery requirements of the Securities Act; (d) o such Transfer is being effected to an Institutional Accredited Investor and pursuant to an exemption from the registration requirements of the Securities Act other than Rule 144A, Rule 144, Rule 903 or Rule 904, and the Transferor hereby further certifies that it has not engaged in any general solicitation within the meaning of Regulation D under the Securities Act and the Transfer complies with the transfer restrictions applicable to beneficial interests in a Restricted Global Note or Restricted Definitive Notes and the requirements of the exemption claimed, which certification is supported by (1) a certificate executed by the Transferee in the form of Exhibit D to the Indenture and (2) if such Transfer is in respect of a principal amount of Notes at the time of transfer of less than $250,000, an Opinion of Counsel provided by the Transferor or the Transferee (a copy of which the Transferor has attached to this certification), to the effect that such Transfer is in compliance with the Securities Act. Upon consummation of the proposed transfer in accordance with the terms of the Indenture, the transferred beneficial interest or Definitive Note will be subject to the restrictions on transfer enumerated in the Private Placement Legend printed on the IAI Global Note and/or the Restricted Definitive Notes and in the Indenture and the Securities Act.

  • Payment for Material Completion The Contractor may request payment of the remaining contract balance, including retainage, less amounts credited the Owner or incurred as liquidated damages, and less amounts withheld for the Punchlist by reason of Minor Items or Permitted Incomplete Work (See Paragraph 6.5.3.2). Payment for Material Completion shall be made by a check payable jointly to the Contractor and Surety and shall be mailed to the Surety.

  • Project Completion Date It is agreed between the Parties that the Project Completion Date is <END DATE, YEAR>. If the Project is not completed by such date then, subject to an amendment agreed to between the Parties, Alberta Innovates may elect to terminate this Investment Agreement. In such event, Alberta Innovates will notify the Applicant of its decision to terminate as soon as reasonably practical and shall advise the Applicant of the effective date of termination. Alberta Innovates will have no liability or obligation to reimburse the Applicant for any Project Costs incurred after the effective date of termination and may require the Applicant to return any portions of the Investment which were spent on Ineligible Expenses. Additionally, any portion of the Investment not used and accounted for in accordance with this Agreement as of the Project Completion Date or earlier termination is repayable by the Applicant to AI at AI’s request.

  • Project Completion Report At the completion of construction and once a Project is placed in service, the Subrecipient must submit a Project Completion Report that includes the total number of units built and leased, affordable units built and leased, DR-MHP units built and leased, an accomplishment narrative, and the tenants names, demographics and income for each DR-MHP unit.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Program Compliance The School Board shall be responsible for monitoring the program to provide technical assistance and to ensure program compliance.

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

  • CONTRACT COMPLETE This Contract represents the complete agreement between the parties. No other understanding regarding this Contract, whether written or oral, may be used to bind either party. For any conflict between the attached Proposal and the terms set out in Articles 1-22 of this Contract, the terms of Articles 1-22 will govern.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Project Completion The Contractor agrees to schedule a final job walk with the County. If required, the County will prepare a list of incomplete items, the “Punch List”. The Contractor agrees to complete the “Punch List” corrections and schedule a final project completion job walk. The County will sign the “Punch List” as completed when determined, the project is finished. The Contractor agrees to submit the following along with its final payment request:

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