PHASE I/II - CLINICAL EVALUATION OF BIOLOGICAL RESPONSE

独立地，而不是作为联邦政府的代理人，这位大师 协议（MA）保持器应进行生物学的临床试验 反应调节剂（BRM），按照 美国国家癌症研究所（NCI）提交，以回应 根据《并购协议》发布的个别主协议订单（MAO）。 每个MAO 将需要进行至少一项此类临床试验。 在 进行该等协议时，MA保持器须提供所有服务， 合格的人员、材料、设备和设施 由政府根据《澳门特别行政区行政条例》的规定提供。 根据MAO的具体要求，临床方案 应需要研究任何数量的BRM，包括单克隆 抗体和相关构建体、细胞因子、生长/分化 因子，肿瘤疫苗，细胞过继转移，基因转移， 抗转移剂、抗癌基因剂或其组合 这些. 每项方案的目标应包括毒性评估 治疗方案，抗肿瘤作用机制的探索， 观察抗肿瘤反应，并测量特异性 实验室参数适用于该方案。 方案应 由NCI正式批准，并由NCI的临床试验监测 监测服务。 MA保持器应符合所有联邦 实验性药物临床试验的监管要求。

Independently and not as an agent of the Federal Government, this Master Agreement (MA) holder shall conduct clinical trials of biological response modifiers (BRMs) in accordance with protocols approved by the National Cancer Institute (NCI), which are submitted in response to individual Master Agreement Orders (MAOs) issued under the MA. Each MAO will entail the performance of at least one such clinical trial. In conducting such protocols, the MA holder shall furnish all services, qualified personnel, materials, equipment, and facilities not otherwise provided by the Government under the terms of the MAO. Depending upon the specific requirements of the MAO, clinical protocols shall entail study of any of a number of BRMs, including monoclonal antibodies and related constructs, cytokines, growth/differentiation factors, tumor vaccines, adoptive transfer of cells, gene transfer, anti-metastatic agents, anti-oncogene agents, or some combination of these. Objectives of each protocol shall include assessment of toxicity of the treatment regimen, exploration of mechanisms of antitumor action, observation of antitumor responses, and measurement of specific laboratory parameters appropriate for that protocol. Protocols shall be formally approved by the NCI, and monitored by the NCI's Clinical Trials Monitoring Service. The MA holder shall comply with all federal regulatory requirements for clinical trials of experimental agents.