Method of Safety Data Exchange Sample Clauses

Method of Safety Data Exchange. On signing of this PV Agreement, GW will provide all prospective product SUSARs and spontaneous SADRS (as per sections 1.3, 1.4, 1.6 and 2.2) to Novartis via secure e-mail. Where either party undertakes investigational studies (Phases I, II, III and IV) for Product and becomes the sponsor for a study, or upon the submission of the first Marketing Authorisation Application (MAA) for Product in the Novartis Territory, commencing from the date of the sponsored study approval/ MAA submission, GW and Novartis will provide the prospective safety information to the other party as specified in sections 1 and 2 of this Appendix 3 respectively. Any information originating from Investigator Initiated studies will also be forwarded to GW by Novartis. Each party shall evaluate the Safety Information reported in their respective territories from clinical studies (sponsored either by company or investigator initiated) or from commercial/spontaneous use as per existing company standard operating procedures in their respective territories. Expedited exchange between the parties shall apply only to Safety Information as defined below, unless otherwise requested by a regulatory authority. If necessary, discussion between both parties shall be conducted within the defined timelines regarding case specific issues and a final consensus reached on individual case reports shall be confirmed via email. In the event of a discrepancy in the assessment of the reportability of a SUSAR or SADR, the more conservative approach should be taken and the case shall be reported in the Territories of both parties as needed. Each company reserves the right to follow their own SOPs for reportability assessment and submission to competent authorities. Novartis will be responsible for collecting follow up information to any ICSRs originating in their territory and will make all reasonable attempts to do so. If additional information is outstanding follow-up will be performed for all reports for a minimum of two attempts or until acceptable resolution is reached. GW Pharma will also request follow up information as required through Novartis. Novartis will be responsible for obtaining the follow-up information from the reporting sources as requested by GW Pharma for cases originating in their Territory. GW Pharmacovigilance will then assess the case including a full medical review and further attempts for obtaining follow-up information may be required or the case may be closed as relevant. GW will ...
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs

Related to Method of Safety Data Exchange

  • Method of Communication Except as otherwise provided in this Agreement, all notices and communications hereunder shall be in writing, or by telephone subsequently confirmed in writing. Any notice shall be effective if delivered by hand delivery or sent via telecopy, recognized overnight courier service or certified mail, return receipt requested, and shall be presumed to be received by a party hereto (i) on the date of delivery if delivered by hand or sent by telecopy, (ii) on the next Business Day if sent by recognized overnight courier service and (iii) on the third Business Day following the date sent by certified mail, return receipt requested. A telephonic notice to the Administrative Agent as understood by the Administrative Agent will be deemed to be the controlling and proper notice in the event of a discrepancy with or failure to receive a confirming written notice.

  • Auction Schedule; Method of Submission of Orders (a) The Fund and the Auction Agent shall conduct Auctions for Preferred Shares in accordance with the schedule set forth below. Such schedule may be changed at any time by the Auction Agent with the consent of the Fund, which consent shall not be withheld unreasonably. The Auction Agent shall give notice of any such change to BD. Such notice shall be received prior to the first Auction Date on which any such change shall be effective. Time Event ---- -----

  • Method of Notice All notices shall be given (i) by delivery in person (ii) by a nationally recognized next day courier service, (iii) by first class, registered or certified mail, postage prepaid, (iv) by facsimile, or (v) by electronic mail] to the address of the OETC Contract Administrator or Contractor's Contract Coordinator or such other address as either party may specify in writing.

  • Method of Giving Consent Any consent of a member required by this Agreement may be given by a written consent.

  • Compliance with Applicable Laws, Rules and Regulations The Dealer Manager represents to the Company that (a) it is a member of FINRA in good standing, and (b) it and its employees and representatives who will perform services hereunder have all required licenses and registrations to act under this Agreement. With respect to its participation and the participation by each Participating Dealer in the offer and sale of the Offered Shares (including, without limitation, any resales and transfers of Offered Shares), the Dealer Manager agrees, and, by virtue of entering into the Participating Dealer Agreement, each Participating Dealer shall have agreed, to comply with any applicable requirements of the Securities Act and the Exchange Act, applicable state securities or blue sky laws, and, specifically including, but not in any way limited to, NASD Conduct Rules 2340 and 2420, and FINRA Conduct Rules 2310, 5130 and 5141.

  • Compliance with Rules of Principal Market (i) Exchange Cap. Subject to Section 2(e)(ii) below, the Company shall not issue or sell any shares of Common Stock pursuant to this Agreement, and the Investor shall not purchase or acquire any shares of Common Stock pursuant to this Agreement, to the extent that after giving effect thereto, the aggregate number of shares of Common Stock that would be issued pursuant to this Agreement would exceed the maximum number of shares of Common Stock that the Company may issue pursuant to this Agreement and the transactions contemplated hereby (taking into account all shares of Common Stock issued or issuable pursuant to any transaction or series of transactions that may be aggregated with the transactions contemplated by this Agreement under applicable rules of The NASDAQ Stock Market) without (A) breaching the Company’s obligations under the applicable rules of The NASDAQ Stock Market or (B) obtaining stockholder approval under the applicable rules of The NASDAQ Stock Market (the “Exchange Cap”), unless and until the Company elects to solicit stockholder approval of the transactions contemplated by this Agreement and the stockholders of the Company have in fact approved the transactions contemplated by this Agreement in accordance with the applicable rules and regulations of The NASDAQ Stock Market and the Certificate of Incorporation and Bylaws of the Company. For the avoidance of doubt, the Company may, but shall be under no obligation to, request its stockholders to approve the transactions contemplated by this Agreement; provided, that if stockholder approval is not obtained in accordance with this Section 2(e)(i), the Exchange Cap shall be applicable for all purposes of this Agreement and the transactions contemplated hereby at all times during the term of this Agreement (except as set forth in Section 2(e)(ii) below).

  • Purpose; Incorporation by Reference of Auction Procedures and Settlement Procedures (a) On each Auction Date, the provisions of the Auction Procedures will be followed by the Auction Agent for the purpose of determining the Applicable Rate for the of APS, for the next Dividend Period therefor. Each periodic operation of such procedures is hereinafter referred to as an "Auction."

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!