Clinical Trial. The coverage described in this provision applies to Members who are eligible to participate in an approved clinical trial, Phase I, II, III and/or IV according to the trial protocol with respect to the treatment of cancer or another life threatening condition. We provide coverage for the clinical trial if the Member’s practitioner is participating in the clinical trial and has concluded that the Member’s participation would be appropriate; or the Member provides medical and scientific information establishing that his or her participation in the clinical trial would be appropriate. We provide coverage of routine patient costs for items and services furnished in connection with participation in the clinical trial. We will not deny a qualified Member participation in an approved clinical trial with respect to the treatment of cancer or another life threatening disease or condition. We will not deny or limit or impose additional conditions on the coverage of routine patient costs for items and services furnished in connection with participation in the clinical trial. We will not discriminate against the Member on the basis of the Member’s participation in the clinical trial.
Clinical Trial. With respect to a Medical Product, any investigation in human subjects intended to discover or verify the clinical pharmacological and/or other pharmacodynamic effects of one or more Investigational Medicinal Products and/or to identify any adverse reactions to one or more Investigational Medicinal Products and/or to study absorption, distribution, metabolism and excretion of one or more Investigational Medicinal Products with the object of ascertaining its/their safety and/or efficacy. Clinical Trial includes post-authorisation studies.
Clinical Trial. EYEFITE shall use Commercially Reasonable Efforts to initiate (i.e., dosing of the first patient) a Phase III Trial of the Licensed Compound no later than the one (1) year anniversary of the date of CANFITE’s compliance with Section 4.1. If EYEFITE fails to initiate a Phase III Trial of the Licensed Compound by such anniversary, and provided that such failure is not due to a delay that is beyond EYEFITE’s reasonable control, including, without limitation, delays caused by Regulatory Authorities or by CANFITE, then EYEFITE may obtain a six (6) month extension of such period for a payment of one (1) million U.S. dollars (US$1,000,000), provided that EYEFITE may not obtain more than four extensions (each one requiring such payment). Failure to initiate a Phase III Trial of the Licensed Compound within the two (2) year anniversary of the date of CANFITE’s compliance with Section 4.1 shall constitute a material breach of this Agreement, unless such failure is due to a delay that is beyond EYEFITE’s reasonable control, including, without limitation, delays caused by Regulatory Authorities or by CANFITE.
Clinical Trial. Based on the findings of this preclinical study, the NCI sponsored a Phase 2 clinical study to evaluate the ability of this new idiotype vaccine to elicit tumor-specific T-cell immunity, as measured by the ability of patient T cells to specifically lyse their own tumor cells in vitro, and to exert antitumor effects as measured by the elimination of t(l4;18)-bearing cells from the peripheral blood of uniformly treated FL patients in first CR (complete remission). Patients in this study were previously untreated and received a uniform chemotherapy regimen, PACE; Prednisone, Adriamycin, Cytoxan, and Etoposide. (modified ProMACE without methotrexate). By design, therefore. they comprised a very homogeneous patient population in a minimal residual disease state. Of 35 patients, 23 (66%) achieved CR by standard clinical criteria. One of the patients was lost to analysis because of early relapse within six months, and two were excluded because a vaccine could not be made. This left a total study group of 20 patients in CR. Six to 15 months after completion of chemotherapy, these 20 patients were treated with a series of five monthly vaccinations with autologous FL Ig protein (0.5 mg) conjugated to KLH, together with local granulocyte-macrophage colony-stimulating factor (GM-CSF, 100 or 500 mcg/m2) subcutaneously (19). Eighteen of 20 patients remain in continuous, first complete remission (median: 42+ months from completion of chemotherapy, range: 284+ to 53+). UPN 9 and 14 relapsed at 15 and 7 months after completion of vaccine therapy, respectively. UPN 9 had never cleared the t(14;18)-bearing cells from the peripheral blood; UPN 14 did not have the MBR rearrangement and thus, molecular CR status could not be established. The rationale for a pivotal, randomized trial, which is the subject of this CRADA is thus based on three independent results from this completed Phase 2 study: (I) tumor-specific CD8+ T-cell responses (cytotoxicity against autologous FL targets and cytokine production) were seen in 17 of 20 (85%) vaccinated patients, (2) 8 of 1 1 (73%) patients sampled after completion of vaccination converted to PCR negative and have maintained both PCR negativity and clinical CR, and (3) with a median follow-up of 36+ months after completion of chemotherapy (range 22+ to 47+ months), 18 of 20 (90%) patients remain in continuous clinical CR. Taken together, these data suggest that idiotype vaccination can elicit a tumor-specific response that is associated wit...
Clinical Trial. Hadasit further acknowledges and agrees that all the results of Clinical Trials including currently performed clinical trials concerning the intellectual property and technology which is the subject matter of this Agreement, including all intellectual property right thereof, data, information, records, notes forms and regulatory files belong exclusively to OraMed.
Clinical Trial. As long as the Company has not made a determination to discontinue the Clinical Trial, without the consent of SMRI, the Company (i) will not substantially reduce the number of patients to be randomized in the Clinical Trial and (ii) will use commercially reasonable efforts to diligently pursue the Clinical Trial; provided, that any delay or cessation of the Clinical Trial due to delayed enrollment, adverse effects or regulatory requirements or similar factors will not constitute a failure to use commercially reasonable efforts to diligently pursue the Clinical Trial. [*] Confidential Treatment is Requested
Clinical Trial. 1.1 Advaxis shall use Commercially Reasonable Efforts and commercially reasonable clinical practices to conduct the Clinical Trial. Advaxis shall include in the Clinical Trial such patient sites located in the Territory chosen by Advaxis in its discretion with the participation and advice of Stendhal. Advaxis shall keep Stendhal informed on a quarterly basis on the progress, developments and results of the Clinical Trial, except as may be prohibited by law, and shall promptly notify Stendhal upon learning of a relevant event that could have a material impact on the Clinical Trial or the Product. Stendhal shall advise Advaxis on and provide direction regarding relevant regulatory authorities and/or ethics committees in the Territory with jurisdiction over the Clinical Trial. The Parties agree that, Stendhal shall use Commercially Reasonable Efforts to obtain, and shall file for, all regulatory approvals from any regulatory authority with jurisdiction over the Product, in the Territory. The Parties further agree that the responsibilities of the Parties with respect to the clinical testing, promotion, marketing, and commercialization of the Product, including any regulatory approval from any regulatory authorities and/or ethics committees with jurisdiction over the sites of the Clinical Trial in the Territory, shall be set forth in greater detail as specified in the Project Plan as defined in §2.1, below. * Confidential material redacted and filed separately with the Commission.
Clinical Trial. XTL shall use Commercially Reasonable Efforts to initiate (i.e., dosing of the first patient) a Phase IIB Trial of the Licensed Compound no later than ***** the date of DOV’s compliance with Section 4.1. If XTL fails to initiate a Phase IIB Trial of the Licensed Compound by such *****, and provided that such failure is not due to a delay that is beyond XTL’s reasonable control, including, without limitation, delays caused by Regulatory Authorities or by DOV, then XTL may obtain a *****, provided that if XTL fails to initiate a Phase IIB Trial of the Licensed Compound by the end of such *****, and provided that such failure is not due to a delay that is beyond XTL’s reasonable control, including, without limitation, delays caused by Regulatory Authorities or by DOV, then XTL may obtain a *****. The ***** described in the previous sentence are *****. Notwithstanding the foregoing, if during the ***** immediately following the Effective Date, XTL enters into a sublicense in accordance with Section 2.1(a) or XTL assigns this Agreement in connection with a change of control in accordance with Section 12.2, then the fee for each of the ***** permitted in accordance with this Section 5.1 shall be ***** U.S. dollars (US$*****). Failure to initiate a Phase IIB Trial of the Licensed Compound within ***** the date of DOV’s compliance with Section 4.1 shall constitute a material breach of this Agreement, unless such failure is due to a delay that is beyond XTL’s reasonable control, including, without limitation, delays caused by Regulatory Authorities or by DOV.
Clinical Trial. “Phase 2 Clinical Trial” shall mean any controlled human clinical trial designed to: (a) evaluate the effectiveness of the intended use of the therapeutic agent for a particular indication or indications; (b) identify short-term side effects and risks that are associated with the therapeutic agent in the dosage range to be prescribed; and (c) satisfy the requirements of 21 CFR § 312.21(b).
Clinical Trial. 13.1. DOLIAGE will be allowed to perform, in collaboration with CI, clinical trials in order to enhance the marketability of the PRODUCTS within the TERRITORY
