Global Safety Database; Clinical Database Sample Clauses

Global Safety Database; Clinical Database. (a) Within [***] days after the later of (i) the execution of the Pharmacovigilance Agreement and (ii) the Completion of the Ongoing Trial, Novartis shall transfer to Pharming data for the Licensed Compound and Licensed Products in Novartis’ global safety database in accordance with the Transition Plan, understanding that certain information will be redacted or retained by Novartis in accordance applicable data privacy laws. (b) To the extent not previously transferred to Pharming or its designee, Novartis shall transfer to Pharming data from Novartis’ clinical database for the Licensed Compound and Licensed Products (“Clinical Database”) in accordance with the Transition Plan, understanding that certain information will be redacted or retained by Novartis in accordance applicable data privacy laws. (c) The Parties acknowledge that the transfer by Novartis of data from its relevant databases will include data residing in such databases, but not any database architecture. Pharming shall be solely responsible for establishing appropriate database structures for receipt of the relevant data, which it shall complete not later than [***] days after execution of the Pharmacovigilance Agreement or such other date as may be mutually agreed by the JCT or Transition Committee. (d) The Transition Committee and the Parties’ Alliance Managers will agree on (i) the format, timing, and process for the transfer of data contemplated by this Section 5.5, and (ii) any access to information in Novartis’ databases reasonably requested by Pharming prior to the completion of such data transfers. For clarity, the Parties may agree to transfer data contained in the Clinical Database, in whole or in part, on a schedule agreed by the JCT or Transition Committee, including on a country-by-country or trial site-by-trial site basis. (e) Following the completion of the transfer of data from Novartis’ global safety database contemplated by this Section 5.5 (the “Safety Database Transfer”), Pharming shall establish, hold and maintain the global safety database(s) for the Licensed Compound and each Licensed Product (the “Global Safety Database”) into which it shall enter information on all adverse events concerning the Licensed Compound and each Licensed Product occurring anywhere in the world in accordance with the Pharmacovigilance Agreement and Applicable Law.
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Related to Global Safety Database; Clinical Database

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • 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.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work. 4.12.2 Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate a material, product or system for some portion of the Work. 4.12.3 Samples are physical examples which illustrate materials, equipment or workmanship and establish standards by which the Work will be judged. 4.12.4 The Contractor shall review, approve and submit, with reasonable promptness and in such sequence as to cause no delay in the Work or in the work of the State or any separate contractor, all Shop Drawings, Product Data and Samples required by the Contract Documents. 4.12.5 By approving and submitting Shop Drawings, Product Data and Samples, the Contractor represents that he / she has determined and verified all materials, field measurements, and field construction criteria related thereto, or will do so, and that he / she has checked and coordinated the information contained within such submittals with the requirements of the Work and of the Contract Documents. 4.12.6 The Contractor shall not be relieved of responsibility for any deviation from the requirements of the Contract Documents by the Architect's approval of Shop Drawings, Product Data or Samples under Subparagraph 2.2.7 of these General Conditions unless the Contractor has specifically informed the Architect and the State in writing of such deviation at the time of sub- mission and the Architect and the State has given written approval to the specific deviation. The Contractor shall not be relieved from responsibility for errors or omissions in the Shop Drawings, Product Data or Samples by the Architect's approval thereof. 4.12.7 The Contractor shall direct specific attention, in writing or on resubmitted Shop Drawings, Product Data or Samples, to revisions other than those requested by the Architect on previous submittals. 4.12.8 No portion of the Work requiring submission of a Shop Drawing, Product Data or Sample shall be commenced until the submittal has been approved by the Architect as provided in Subparagraph 2.2.7 of these General Conditions. All such portions of the Work shall be in accordance with approved submittals.

  • Technology Research Analyst Job# 1810 General Characteristics

  • Database The LERG is available through Telcordia. ICONN is available through the Qwest web site.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Data Encryption Contractor must encrypt all State data at rest and in transit, in compliance with FIPS Publication 140-2 or applicable law, regulation or rule, whichever is a higher standard. All encryption keys must be unique to State data. Contractor will secure and protect all encryption keys to State data. Encryption keys to State data will only be accessed by Contractor as necessary for performance of this Contract.

  • Background Data The Disclosing Party's Background Data, if any, will be identified in a separate technical document.

  • Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.

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