SLE Complete Data Package Sample Clauses

SLE Complete Data Package. Within […***…] after database lock of the Phase 2 Clinical Study for the Lead Compound in the Field of SLE 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 2A SLE 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 SLE 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 (“SLE Complete Data Package”), all in a form that is in substantial conformity with the template set forth in Schedule 3.1.6).
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Related to SLE Complete Data Package

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Complete Release Executive agrees to release EDS from all claims or demands Executive may have against EDS, including, but not limited to, any claims related to Executive's employment with EDS or separation from that employment and any claims for attorney's fees and costs. This Agreement includes, without limitation, a release of any rights or claims Executive may have under the Age Discrimination in Employment Act, as amended, which prohibits age discrimination in employment; Title VII of the Civil Rights Act of 1964, as amended, which prohibits discrimination in employment based on race, color, national origin, religion or sex; the Americans with Disabilities Act, as amended, which prohibits discrimination against individuals with disabilities; the Fair Labor Standards Act, as amended, which regulates matters regarding compensation; the Family and Medical Leave Act, as amended, which regulates matters regarding certain types of leaves; or any other federal, state or local laws or regulations that in any way relate to the employment of individuals and/or prohibit employment discrimination of any form. This Agreement also includes, without limitation, a release by Executive of any related or unrelated wrongful discharge claims, contractual claims, tort claims or any other actions. This Agreement covers both claims that Executive knows about and those he/she may not know about. Executive expressly waives any right to assert after signing this Agreement that any claim, demand, obligation, or cause of action has through ignorance, oversight, or for any other reason, been omitted from the scope of Subsection 5 of Section III of this Agreement. Executive further promises never to file a lawsuit, demand, action or otherwise assert any claims that are released in Subsection 5 of Section III of this Agreement (excluding a lawsuit filed by Executive solely for purposes of challenging the validity of the Age Discrimination in Employment Act waiver). This Agreement does not include a release of (i) Executive's right, if any, to benefits Executive may be entitled to under any EDS plan qualified under Section 401(a) of the Internal Revenue Code, including the EDS Retirement Plan and EDS 401(k) Plan, and COBRA benefits pursuant to Internal Revenue Code section 4980B, (ii) any rights or claims Executive may have under the Age Discrimination in Employment Act which arise after the date Executive signs this Agreement, (iii) any rights pursuant to this Agreement, (iv) Executive's right, if any, to benefits Executive may be entitled to under the EDS Executive Deferral Plan, (v) any rights pursuant to any indemnification agreements between Executive and EDS, or (vi) Executive's right, if any, to benefits Executive may be entitled to under any applicable directors and officers or other liability insurance policies.

  • Project Completion Within five (5) days after the delivery by Supplier to Purchaser of a Commissioning Certificate for the Project’s final Turbine, Supplier shall also deliver to Purchaser a completion certificate for all Turbines in the Project (the “Project Completion Certificate”), in the form attached hereto as Exhibit N, together with a list of any remaining Punch List Work on any Turbine, a schedule for completing the Punch List Work and an estimate of the cost of each item of Punch List Work. Supplier shall thereafter promptly complete all Punch List Work.

  • 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.

  • Shareholder Records, Reports and Services (1) The Transfer Agent shall maintain all shareholder accounts, which shall contain all required tax, legally imposed and regulatory information; shall provide shareholders, and file with federal and state agencies, all required tax and other reports pertaining to shareholder accounts; shall prepare shareholder mailing lists; shall cause to be printed and mailed all required prospectuses, annual reports, semiannual reports, statements of additional information (upon request), proxies and other mailings to shareholders; and shall cause proxies to be tabulated.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Complete Copies of Materials The Company has delivered or made available true and complete copies of each document (or summaries of same) that has been requested by Parent or its counsel.

  • Deliverables Upon completion of each Test for each Reviewable Receivable, the Asset Representations Reviewer shall record a finding based on the issues discovered. Findings categories are listed as follows: • Evidence that the applicable Test was satisfied (“Satisfied Test”); • Evidence that the applicable Test was not satisfied (“Unsatisfied Test”); and • Test incomplete as a result of missing or insufficient documentation (“Unsatisfied Test – Missing Required Documents”).

  • 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).

  • Approval and Completion If any dispute regarding the design of the Tenant Improvements is not settled within 10 business days after notice of such dispute is delivered by one party to the other, Tenant may make the final decision regarding the design of the Tenant Improvements, provided (i) Tenant acts reasonably and such final decision is either consistent with or a compromise between Landlord’s and Tenant’s positions with respect to such dispute, (ii) that all costs and expenses resulting from any such decision by Tenant shall be payable out of the TI Fund (as defined in Section 5(d) below), and (iii) Tenant’s decision will not affect the base Building, structural components of the Building or any Building systems (in which case Landlord shall make the final decision). Any changes to the TI Construction Drawings following Landlord’s and Tenant’s approval of same requested by Tenant shall be processed as provided in Section 4 hereof.

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