Central Laboratory. As discussed with Sponsor, **** has been identified as suitable lab for the present Project. Estimated total pass-through costs have been added within the budget for PEP005-009.

Central Laboratory. SPONSOR will select and contract with a central laboratory for all clinical safety labs required by the protocol and TKL will manage all aspects from the site and laboratory perspective.

Central Laboratory. Lab Handling and Shipping (Includes if needed to be performed during Unscheduled Visit and in case of reaction to Ocrelizumab administration) Centrální laboratoř: Laboratorní manipulace a doprava (zahrnuje, pokud je to nutné provést během neplánované návštěvy a v případě reakce na podání ocrelizumabu) Administration of IV Ocrelizumab, additional hours (If Ocrelizumab is administered over 3.5 hours) Podání Ocrelizumabu i.v., další hodiny (Pokud je Ocrelizumab podáván déle než 3,5 hodiny) Vital Signs (additional to vitals at examination) (Additional vital signs if Ocrelizumab is administered over 3.5 hours) Vitální funkce (dodatečné k životním funkcím při vyšetření) (Další vitální funkce, pokud je Ocrelizumab podáván déle než 3,5 hodiny) Neurological examination, complete (If needed to be performed during Unscheduled Visit) Neurologické vyšetření, kompletní (pokud je nutné provést během neplánované návštěvy)

Central Laboratory. 8. Central Maintenance (Divisional Shops, Maintenance Training, Power, Reconditioning Shop, Maintenance Services) One (1) Representative 1. Central Maintenance (Divisional Shops, Reconditioning Shop, Maintenance Training, Maintenance Services) 2. Power

Central Laboratory. 15.1 Identification of Central Laboratories X 15.2 Pre-Qualification Audit of Central Laboratories X 15.3 Selection of Central Laboratories X 15.4 Payment of Central Laboratories X 15.5 Management of Central Laboratories X 15.6 Organise Project Teleconferences X 15.7 Provide status reports X 15.8 Review of clinical laboratory data X 15.9 Lab Data transfer to study database X

Central Laboratory. XXXXXXXXXX shall be responsible for making all necessary ------------------- arrangement for services from the central clinical laboratory ("CCL") selected by XXXXXXXXXX for tests specified by the Protocol. PPD shall review for completeness and accuracy all billing from the CCL and signify its approval for payment thereon. PPD shall on a monthly basis deliver to XXXXXXXXXX such xxxxxxxx for direct payment by XXXXXXXXXX to the CCL. EXHIBIT C PROPOSAL -------- EXHIBIT D TIMELINES --------- ESTIMATED DURATION OF PPD ACTIVITIES Letter of Intent (LOI) signed, begin identifying investigative sites .....................Completed Final Protocol received at PPD .............................................................Month 0 Investigative sites identified ...........................................................Month 0.5 Begin obtaining IRB approvals ............................................................Month 1.0 Study Drug available .....................................................................Month 1.5 Patient enrollment ......................................................................Months 2-7 Active patient participation ..........................................................Months 2-8.5 Last CRF to PPD data management ...........................................................Month 10 Last data query to PPD data management ....................................................Month 11 Transfer of original investigative files to XXXXXXXXXX ....................................Month 12 Total PPD Commitment: 12 Months EXHIBIT E

Related to Central Laboratory

Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.
Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, 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 reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, 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, the Time of Sale Prospectus 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; 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, the Time of Sale Prospectus 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 and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Research Analyst Independence The Company acknowledges that the Underwriters’ research analysts and research departments are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriters’ research analysts may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of their respective investment banking divisions. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriters’ investment banking divisions. The Company acknowledges that each of the Underwriters is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities of the companies that may be the subject of the transactions contemplated by this Agreement.
Benchmarking 19.1 The Parties shall comply with the provisions of Framework Schedule 12 (Continuous Improvement and Benchmarking) in relation to the benchmarking of any or all of the Goods and/or Services.
Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

Central Laboratory Sample Clauses

Filter & Search

Related Clauses

Parent Clauses

Related to Central Laboratory