Demonstration of Presence of SBAs Sample Clauses

Demonstration of Presence of SBAs. Subject to this Clause 5.6.3, sanofi pasteur shall commence a Clinical Study with a Clinical Candidate or Product to demonstrate the presence of SBAs in Adolescents within six (6) months of receipt of a final clinical study report demonstrating, in adults, the presence of SBAs in connection with use of a Clinical Candidate or Product. For the purpose of this Agreement, presence of SBAs will be deemed to have been demonstrated against Neisseria meningitidis serogroup B (“Demonstration of Presence of SBAs”), if a Programme Antigen or a Product (i) elicits a [**] fold increase in SBA Activity, as measured with a standard assay system, as identified in the Development Plan, which utilises human complement as the exogenous complement source, against at least [**] percent ([**]%) of a representative panel of Neisseria meningitidis serogroup B strains, in at least [**] percent ([**]%) of the subjects allocated to receive one test vaccine (i.e. at least one dosage with or without adjuvant) (the “Response Rate”); and (ii) satisfies the safety endpoints of that Clinical Study with the very same formulation. Without prejudice to the generality of the foregoing, following the design of the relevant Clinical Study, the Steering Committee will agree the statistical analysis to be performed on the Clinical Study results, including possible determination of the confidence intervals or other statistical measures for the Response Rate endpoint. If the Steering Committee agree statistical limits around the Response Rate endpoint and Demonstration of Presence of SBAs shall also be deemed to have occurred if the Clinical Study results are within these agreed limits and Clause 5.6.3 (ii) is also satisfied. If either the FDA or the European Agency for the Evaluation of Medicinal Products establishes a functional assay other than SBA Activity (an “Alternative Assay”) as an alternative efficacy endpoint for the grant of a Marketing Authorisation for a Meningitis B Product, the Parties shall adopt such Alternative Assay and Demonstration of Presence of SBAs will be deemed satisfied if there is a successful demonstration of such functional activity using the Alternative Assay.
Sample 1
AutoNDA by SimpleDocs

Related to Demonstration of Presence of SBAs

  • Verification of Coverage Prior to beginning any work under this Agreement, Consultant shall furnish City with certificates of insurance and with original endorsements effecting coverage required herein. The certificates and endorsements for each insurance policy are to be signed by a person authorized by that insurer to bind coverage on its behalf. The City reserves the right to require complete, certified copies of all required insurance policies at any time.

  • EFFECT OF COMPLIANCE Compliance with and fulfillment of this Agreement shall be deemed to resolve all issues raised in the NOV.

  • Certification of Compliance San Diego Municipal Code section 22.4225 requires each Bidder to fill out and file a living wage certification with the Living Wage Program Manager within thirty (30) days of Award of the Contract.

  • Inspection of Agreement A copy of this Agreement shall be available at all reasonable times at the principal corporate trust office of the Warrant Agent for inspection by the holder of any Warrant Certificate. The Warrant Agent may require such holder to submit his Warrant Certificate for inspection by it.

  • MAINTENANCE OF STANDARDS The Employer agrees, subject to the following provisions, that all conditions of employment in his/her individual operation relating to wages, hours of work, overtime differentials and general working conditions shall be maintained at not less than the highest standards in effect at the time of the signing of this Agreement, and the conditions of employment shall be improved whenever specific provisions for improvement are made elsewhere in this Agreement.

  • Compliance with Xxxxx Xxxxx and Related Act requirements. All rulings and interpretations of the Xxxxx- Xxxxx and Related Acts contained in 29 CFR parts 1, 3, and 5 are herein incorporated by reference in this contract.

  • Limitation on Duties Regarding Preservation of Collateral The Lender's duty with respect to the custody, safekeeping and physical preservation of the Collateral in its possession, under Section 9-207 of the Uniform Commercial Code or otherwise, shall be to deal with it in the same manner as the Lender deals with similar property for its own account. Neither the Lender nor any of its directors, officers or employees shall be liable for failure to demand, collect or realize upon all or any part of the Collateral or for any delay in doing so or shall be under any obligation to sell or otherwise dispose of any Collateral upon the request of the Borrower or otherwise.

  • Rectification of Safety Hazard Where, because of the existence of a safety hazard, a site has been stopped for a defined period of time and Employees sent off site by agreement between Site Managers and any combination of Union Official/s, Health and Safety Committee, those people who remain on site to do rectification work will be paid at the rate of double time for all such work.

  • Access to and Maintenance of Auction Records The Auction Agent shall afford to the Company, its agents, independent public accountants and counsel, access at reasonable times during normal business hours to review and make extracts or copies (at the Company's sole cost and expense) of all books, records, documents and other information concerning the conduct and results of Auctions, provided that any such agent, accountant or counsel shall furnish the Auction Agent with a letter from the Company requesting that the Auction Agent afford such person access. The Auction Agent shall maintain records relating to any Auction for a period of two years after such Auction (unless requested by the Company to maintain such records for such longer period not in excess of four years, then for such longer period), and such records, in reasonable detail, shall accurately and fairly reflect the actions taken by the Auction Agent hereunder. The Company agrees to keep confidential any information regarding the customers of any Broker-Dealer received from the Auction Agent in connection with this Agreement or any Auction, and shall not disclose such information or permit the disclosure of such information without the prior written consent of the applicable Broker- Dealer to anyone except such agent, accountant or counsel engaged to audit or review the results of Auctions as permitted by this Section 2.7, provided that the Company reserves the right to disclose any such information if it is advised by its counsel that its failure to do so would (i) be unlawful or (ii) expose it to liability, unless the Broker-Dealer shall have offered indemnification satisfactory to the Company. Any such agent, accountant or counsel, before having access to such information, shall agree to keep such information confidential and not to disclose such information or permit disclosure of such information without the prior written consent of the applicable Broker-Dealer, provided that such agent, accountant or counsel may reserve the right to disclose any such information if it is advised by its counsel that its failure to do so would (i) be unlawful or (ii) expose it to liability, unless the Broker-Dealer shall have offered indemnification satisfactory to such agent, accountant or counsel.

  • Construction of Provisions Although certain provisions of this Agreement contain express language which precludes the Servicer's recovery of, or reimbursement for, expenses incurred hereunder, no inference to the contrary shall be drawn from absence of such, or similar, language in any other provision hereof regarding expenses.

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