GOAL OF THIS CRADA Sample Clauses

GOAL OF THIS CRADA. The principal goal of this CRADA is to develop recombinant poxviruses as vaccines that can be used for the therapy and/or prevention of specific human carcinomas. A second principal goal is to further the clinical development of PANVACTM (also referred to as “Investigational Agent” or “Test Article”), an existing poxvirus-based vaccine, for purposes of the same. The scope of this CRADA including any in vitro and in vivo testing conducted by Dr. Xxxxxxx Xxxxxx’x laboratory is strictly limited to the development of recombinant poxviruses encoding for tumor-associated antigens, cytokines, and/or immunostimulatory molecules as vaccine immunotherapies for the treatment and prevention of cancer and more specifically, solid cancer tumors of the breast, lung, ovary, liver, gastric system, bladder, kidney and pancreas. For purposes of clarity, the scope of the CRADA research specifically excludes: (1) non-solid tumor cancer indications that comprise hematological cancers, (2) prostate, melanoma and colorectal cancer, and (3) vaccine immunotherapies which make use of canary poxvirus vectors, NYVAC (a high attenuated vaccinia strain of virus), non-viral eukaryotic expression vectors and recombinant yeast vectors. [***] ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(2), (4), (5) and (6) and 230.406 [***] GLOSSARY of TERMS CEA: CEA (carcinoembryonic antigen) is a tumor-associated antigen expressed in many carcinomas and some normal tissue. The LTIB has developed a CEA agonist construct, which is a modified form of the XXX xxxx to make it more immunogenic. The PANVAC construct contains the entire XXX xxxx with the CEA agonist epitope.
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GOAL OF THIS CRADA. The principal goal of this CRADA is to develop recombinant poxviruses as vaccines that can be used for the therapy and/or prevention of human prostate cancer.The scope of this CRADA including any in vitro and in vivo testing conducted by Dr. Xxxxxxx Xxxxxx’x laboratory is strictly limited to the development of recombinant poxviruses encoding for prostate-associated antigens, cytokines, and/or immunostimulatory molecules as vaccine immunotherapies for the treatment and prevention of prostate cancer. [***] [***] [***] ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(2), (4), (5) and (6) and 230.406 [***] [***] [***] [***] GLOSSARY of TERMS Vaccinia: Vaccinia is the poxvirus that has been used in the smallpox eradication program. It is not the smallpox virus, but a virus originally derived from cowpox. Many genes can be inserted into vaccinia and other poxviruses. When this occurs, it is then termed a recombinant virus (e.g., rV- for recombinant vaccinia). Vaccinia is a replication competent virus and has been used as the primary (first) vaccination in diversified prime and boost vaccine regimens in both pre-clinical and clinical studies. Fowlpox: Fowlpox is replication incompetent in mammalian cells. Many genes can be inserted into fowlpox. When this occurs, it is then termed a recombinant fowlpox (rF-). Recombinant fowlpox has been used as multiple booster vaccinations in diversified prime and boost vaccine regimens. Fowlpox appears to be very safe and is a member of the Avipox family. MVA: MVA stands for modified vaccinia Ankara. TRICOM: TRICOM is a triad of T-cell costimulatory molecules consisting of the following human T-cell costimulatory molecule genes: B7.1, ICAM-l and LFA-3. TRICOM was developed at NCI in the LTIB. TRICOM has been shown to activate T cells more than the additive effect of each costimulatory molecule when used individually. A T-cell costimulatory molecule is necessary for the enhanced activation of human T cells, which are believed to be the primary cell type responsible for vaccine-mediated anti-tumor activity. The NCI has demonstrated that the addition of all three of these genes, i.e., TRICOM, into recombinant vaccinia and fowlpox results in enhanced activation of T cells. This has been shown in both murine and human systems in vitro and in murine systems in vivo. It also appears to be the case in clinical trials.
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GOAL OF THIS CRADA. The principal goal of this CRADA is to develop TRC105, a human chimeric monoclonal antibody supplied by Tracon Pharmaceuticals, Inc. (Tracon), as a cancer therapeutic agent. The subject of this CRADA including any preclinical and clinical testing conducted by NCI’s Center for Cancer Research (CCR) is strictly limited to the development of TRC 105 for the treatment of cancer. To the knowledge of Tracon and NCI, the research conducted under this CRADA does not depend on any third party proprietary materials that are not commercially available unless specifically stated otherwise. Health Research Inc. (Health Research) has granted a worldwide license to Tracon for the development and commercialization of TRC105. Health Research is a not-for-profit corporation. Health Research is not a Party to this CRADA. The objectives of this CRADA will be divided into three parts: Part I: […***…] Part II: […***…] ***Confidential Treatment Requested PHS ICT-CRADA Case Ref. No.02661 MODEL ADOPTED June 18, 2009 Page 24 of 43 Confidential TRACON CONFIDENTIAL […***…] Part III: Tracon will generate and supply the CCR with TRC105 in sufficient amounts and adequate purity for testing in mutually agreed upon phase I and phase II human clinical trials that will be conducted at the NIH. INTRODUCTION Tracon Pharmaceuticals, Inc. licenses, develops, and commercializes targeted therapies for cancer. Tracon is conducting a Phase 1 trial to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of TRC105 in patients with advanced cancer.
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GOAL OF THIS CRADA. The principal goal of this CRADA is to evaluate the potential therapeutic benefit of administering GlobeImmune, Inc.’s proprietary whole recombinant heat-killed yeast vaccine (referred to herein as “Tarmogens” ((Targeted Molecular Immunogens)) expressing NCI-supplied tumor antigens for the treatment and/or prevention of cancer in animals and in humans. Activities under this CRADA will involve the cooperation and collaboration of LTIB at NCI and the Division of Cancer Treatment and Diagnosis (DCTD) at NCI. The subject matter of this CRADA including any in vitro and in vivo testing conducted by Dr. Xxxxxxx Xxxxxx is strictly limited to the development of vaccines that utilize NCI’s proprietary tumor associated antigens and GlobeImmune, Inc.’s proprietary Tarmogens. The objectives of this CRADA will be divided into two parts: Part I: [*] [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Part II: [*]
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GOAL OF THIS CRADA. The principal goal of this CRADA is to evaluate the potential therapeutic benefit of administering GlobeImmune, Inc.’s proprietary whole recombinant heat-killed yeast vaccine (referred to herein as “Tarmogens” ((Targeted Molecular Immunogens)) expressing NCI-supplied tumor antigens for the treatment and/or prevention of cancer in animals and in humans. Activities under this CRADA will involve the cooperation and collaboration of LTIB at NCI and the Division of Cancer Treatment and Diagnosis (DCTD) at NCI. The subject matter of this CRADA including any in vitro and in vivo testing conducted by Dr. Xxxxxxx Xxxxxx is strictly limited to the development of vaccines that utilize NCI’s proprietary tumor associated antigens and GlobeImmune, Inc.’s proprietary Tarmogens. The objectives of this CRADA will be divided into two parts: Part I: Preclinical Studies: In vitro studies will be performed to investigate the immunogenicity of Tarmogens expressing NCI’s proprietary tumor-associated antigens (TAAs). These TAAs include Carcinoembryonic Antigen (CEA), Brachyury, [*] point mutated ras, [*]. These recombinant Tarmogens expressing tumor antigens will be produced and supplied to NCI by GlobeImmune, Inc. In vivo studies will be performed by NCI to test the immunogenicity of mutually selected recombinant Tarmogens in preclinical animal models. The data will be shared with GlobeImmune, Inc. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Related to GOAL OF THIS CRADA

  • Performance of this Agreement Buyer shall have duly performed or complied with all of the obligations to be performed or complied with by it under the terms of this Agreement on or prior to the Closing Date.

  • Enforcement of this Agreement The parties agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity.

  • Duration of this Agreement The Term of this Agreement shall be as specified in Schedule A hereto.

  • Amendment of this Award Agreement The Committee may waive any conditions or rights under, amend any terms of, or alter, suspend, discontinue, cancel or terminate this Award Agreement prospectively or retroactively; provided, however, that any such waiver, amendment, alteration, suspension, discontinuance, cancelation or termination that would materially and adversely impair your rights under this Award Agreement shall not to that extent be effective without your consent (it being understood, notwithstanding the foregoing proviso, that this Award Agreement and the Restricted Shares shall be subject to the provisions of Section 7(c) of the Plan).

  • Amendment of this Contract No provision of this Contract may be changed, waived, discharged or terminated orally, but only by an instrument in writing signed by the party against which enforcement of the change, waiver, discharge or termination is sought.

  • Scope of this Agreement This Agreement shall apply both to the option and to the Option Shares acquired upon the exercise of the option.

  • Effect of this Agreement Subject to the Corporation’s right to terminate the Option pursuant to Section 7.4 of the Plan, this Option Agreement shall be assumed by, be binding upon and inure to the benefit of any successor or successors to the Corporation.

  • Effective Period of this Agreement This Agreement shall take effect upon its execution and shall remain in full force and effect for an initial term of two (2) years from the date of its execution (unless terminated as set forth in Section 11), and shall continue in effect from year to year thereafter, subject to annual approval of such continuance by the Board of Trustees of the Trust, including the approval of a majority of the Trustees of the Trust who are not interested persons of the Trust or of Distributor by vote cast in person at a meeting called for the purpose of voting on such approval.

  • Execution of this Agreement This Agreement may be executed in multiple counterparts, each of which will be deemed to be an original copy of this Agreement and all of which, when taken together, will be deemed to constitute one and the same agreement. The exchange of copies of this Agreement and of signature pages by facsimile or other electronic transmission shall constitute effective execution and delivery of this Agreement as to the parties and may be used in lieu of the original Agreement for all purposes.

  • Term of this Agreement The term of this Agreement shall continue in effect, unless earlier terminated by either party hereto as provided hereunder, for a period of two years. Thereafter, unless otherwise terminated as provided herein, this Agreement shall be renewed automatically for successive one-year periods. This Agreement may be terminated without penalty: (i) by provision of sixty (60) days' written notice; (ii) by mutual agreement of the parties; or (iii) for "cause" (as defined herein) upon the provision of thirty (30) days' advance written notice by the party alleging cause.

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