Clinical Protocol. (a) NCI will facilitate the solicitation and receipt of XXXx for clinical research, contemplating the use of Collaborator’s Formulary Agents. NCI will require potential Sponsors to complete a “Letter of Intent” (“LOI”). NCI will provide Collaborator with a copy of any LOI submitted which requests use of Collaborator’s Formulary Agents, which contains a summary of the draft clinical protocol including the proposed statistical analysis plan for the Study and, estimated funding from the Collaborator to support the Study.

Clinical Protocol. Clinical protocol proposals for each study within the scope of the CRADA Research Plan will be solicited from selected intramural and extramural clinical investigators. Each clinical protocol should describe in detail the research to be conducted and must DC submitted to the PRC for approval prior to implementation. Each clinical protocol received by NCI will be forwarded to Collaborator for review and comment approximately two weeks before C-3 CONFIDENTIAL it is reviewed by the PRC. Comments from Collaborator received by CTEP before the PRC meeting will be discussed by the PRC, will be given due consideration, and will be incorporated into the protocol, absent good cause. Comments from either Collaborator or the CTEP staff that are agreed upon in the PRC meeting will DC formatted as a consensus review, which is returned to the investigator for necessary and/or suggested changes before the protocol can DC given Final approval and submitted to the FDA. A copy of the final approved protocol will be forwarded to Collaborator at the same time as it is submitted to the FDA. NCI protocol #00-C-0050 (P-92), entitled ‘Phase 3 Randomized Study of Autologous Lvmphoma Derived Idiotype Specific Vaccination Plus Sargramostim (GM-CSF) in Patients with Indolent Follicular Lvmphoma in First Complete Remission’ will be transferred to Collaborator upon FDA approval of Collaborator’s IND application.

Clinical Protocol. (a) IC will facilitate the solicitation and receipt of proposals for clinical research, contemplating the use of Collaborator’s Formulary Agents. IC will require potential Sponsors to complete a “Letter of Intent” (“LOI”). IC will provide Collaborator with a copy of any LOI submitted which requests use of Collaborator’s Formulary Agents, which contains a summary of the draft clinical protocol including the proposed statistical analysis plan for the Study, and estimated funding from the Collaborator to support the Study.

Clinical Protocol. Biodel shall furnish to Aegis a copy of the clinical protocol and the related patient informed consent form for any clinical trial study, which involves an Enhancement Agent or the Aegis Technology; and Aegis shall be entitled to share such documents with the Aegis insurance carriers to the extent required to comply with its contractual obligations to such entities. Aegis agrees that any personally identifiable information or protected health information, which comes into Aegis’ possession under this License Agreement will be protected and acted on in accordance with applicable data protection legislation, such as the Health Insurance Portability and Accountability Act of 1996 as well as all other applicable laws and regulations.

Clinical Protocol. Effective April 29, 2004, NCI protocol #00-C-0050 (P-92), entitled ‘Phase 3 Randomized Study of Autologous Lymphoma Derived Idiotype Specific Vaccination Plus Sargramostim (GM-CSF) in Patients with Indolent Follicular Lymphoma in First Complete Remission’ will be conducted under Collaborator’s IND application # 5427.

Clinical Protocol. First the GH secretory reserve was assessed by three stimulation tests in addition to the ITT, and subsequently spontaneous GH secretion was measured during 24h with blood sampling intervals of 10 minutes. The GH stimulation tests were carried out in random order on separate days (during a two- week period) in the fasting condition. The following tests were performed: the GHRH test (Fer- ring, Hoofddorp, The Netherlands: 1 μg/kg body weight by i.v. bolus injection, blood samples drawn at 0, 20, 30, 45, 60 and 90 min), the l-arginine infusion test (500 mg/kg body weight with a maximum of 30 g, infusion during 30 minutes, blood samples drawn at 0, 30, 45, 60, 90 and 120 min), and the combined GHRH-arginine test as an i.v. bolus injection of GHRH (1 μg/ kg body weight) after which l-arginine (500 mg/kg body weight with a maximum of 30 g) was infused during 30 minutes, blood samples drawn at 0, 30, 45, 60, 90 and 120 min. The peak serum response of GH was used as the primary variable for analysis of stimulation tests. For the 24h sampling study, the patients were admitted to the Clinical Research Center in the morning. An indwelling i.v. cannula was inserted in a forearm vein at least 60 min before sampling began. Blood samples were withdrawn at 10 min. intervals for 24h, starting at 09.00h. A slow infusion of 0.9% NaCl and heparin (1 U/ml) was used to maintain patency of the i.v. catheter. The subjects were not allowed to sleep during the daytime. Meals were served at 09.00, 12.30 and 17.30h. Lights were turned off between 22.00-24.00h. Plasma samples for GH measurements were collected, centrifuged at 4°C for 7 minutes, and stored at –20°C until later analysis. Assays GH concentrations in the samples of the stimulation tests were measured by time resolved immunofluorometric assay (Wallac, Inc, Turku, Finland). Reference values, listed in the tables and main text were obtained with the same assay. Human biosynthetic GH (Pharmacia and Upjohn, Inc, Uppsala, Sweden) was used as standard, calibrated against WHO-IRP 80-505 and the detection limit of this GH assay is 0.01 μg/l with an interassay coefficient of variation of 1.6-8.4%, between 0.1 and 15 μg/l (1 μg/l = 2.6 mU/l). GH concentration in the serum samples of 24h profiles of the patients in this study were measured with the more sensitive automatic immunochemiluminescence assay (Nichols Diagnostics Institute, San Clemente, CA), using 22 kDa rhGH as standard. Cross reactivity with 20kDa GH was 30%. Assay sens...

Related to Clinical Protocol

Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Protocol The attached Protocol shall be an integral part of this Agreement.
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.
FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
Marketing Plan The MCOP shall submit an annual marketing plan to ODM including all planned activities for promoting membership in or increasing awareness of the MCOP. The marketing plan submission shall include an attestation by the MCOP that the plan is accurate and is not intended to mislead, confuse, or defraud the eligible individuals or ODM.

Clinical Protocol Sample Clauses

Filter & Search

Related Clauses

Parent Clauses

Sub-Clauses

Related to Clinical Protocol