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(14;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: 28+ 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: (1) 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 11 (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 with ...
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
13.2. The clinical trials will involve up to 2/4 centers and approximately 100 patients.
13.3. The protocols for the clinical trials will be approved by both Parties and respective Ethical Committees prior to initiation of the study.
13.4. The costs of performing the clinical trial will be born by DOLIAGE. CI will reimburse DOLIAGE as outlined Section 4.1.5 above
13.5. DOLIAGE will have in place confidentiality agreements with all clinicians involved with the clinical trial. DOLIAGE will do its best to prevent any non-agreed dissemination regarding the clinical trial or its results without the prior consent of CI.
13.6. All information developed as part of the clinical trial will be considered as Confidential Information (as defined below under Section 14) and cannot be used for any other purpose by DOLIAGE other than to promote the Products in a way which is beneficial for the Product. In the event the AGREEMENT is terminated then all information collected under this Agreement, including the information gathered as part of the clinical trial will become the property of CI. DOLIAGE also acknowledges that it will not use any of the information obtained under this Agreement, including information obtained as part of the clinical trial, to promote another device which would compete with the PRODUCTS.
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.
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. The term “Phase III Clinical Trial” shall mean a controlled study in humans of the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to file an NDA to obtain Regulatory Approval to market the product, as further defined in 21 C.F.R. § 312.21(c), as amended (or its successor regulation or comparable Laws in countries outside the United States). [**] or [**]. The term “[**]” or “[**]” shall mean the applicable compound identified in Exhibit E.
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. Zila agrees to enter into the GSA with Quintiles. In the event Zila terminates the GSA within twelve (12) months following its execution, for reasons other than cause, or Quintiles terminates the GSA for cause, then PharmaBio shall have the right, but not obligation, to terminate this Agreement. This option must be exercised in writing within thirty (30) days following the termination. If PharmaBio exercises such right, then (i) Zila shall immediately, but in no event less than ten (30) days, pay to PharmaBio a cash payment equal to $500,000 (less any amounts received by PharmaBio as royalty payments through the date of option exercise), and (ii) PharmaBio’s right to royalty payments shall terminate.
