材料转让协议
A Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible 两个组织之间的研究资料. MTA定义了提供者的权利 and the recipient with respect to the use of 这种材料s and any derivatives. 生物 materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such 比如化合物，甚至是某些类型的软件. 十大彩票网投平台 (USA) requires MTAs for any incoming or outgoing materials in order to monitor what materials are coming on campus, and what materials (and to whom) USA is supplying. 美国的 商业化和工业合作办公室 (OCIC) manages the MTA review process and is the signatory for approval of all MTA 请求. 来美国或离开美国的教职员工需要事先获得MTA to transferring any materials from/to other institutions such as plasmids, cell lines, 动物等.
The Forms, Guidelines, and Procedures below provide USA 研究ers with USA-approved MTA forms, outline appropriate routing steps and responsible office, and the time 完成审查和执行请求所需的时间.
所有MTA的查询应通过电子邮件发送至OCIC techtransfer@basilinfracon.com.
When USA faculty are 收到材料s, complete the MTA Pre-Review Questionnaire 和MTA一起发邮件到 techtransfer@basilinfracon.com.
如果您是从学术机构收到的，请使用收件人UBMTA.
If you are receiving from a company, request company’s standard MTA and email to techtransfer@basilinfracon.com
When USA faculty are 发送材料s, complete the MTA Pre-Review Questionnaire 和MTA一起发邮件到 techtransfer@basilinfracon.com.
如果您要发送到学术机构，请使用提供商UBMTA.
如果您要发送给公司，请使用商业实体MTA.
If you are sending any nonbiological 研究 materials, use the 非生物MTA.
材料转让协议文件
Typically, for 来料s, the entity sending out 这种材料 will require 使用自己的MTA表格. 为了向外转移物资，美国有 标准的MTA协议 OCIC网站 为了涵盖这些材料. 无论材料是传入的还是传出的，都是协议 of this type are negotiated by the 商业化和工业合作办公室.
十大彩票网投平台是该条约的签署国 统一生物材料转让协议(UBMTA)主协议, a contracting mechanism published by NIH on behalf of PHS to facilitate the transfer 学术机构之间的生物材料. 因此，这是没有必要的 for USA to negotiate individualized terms for each transfer of a biological material. Instead, an Implementing Letter is executed, which denotes the biological material 以及提供机构和接收机构. 只要有可能, the UBMTA will be utilized to expedite the transfer of applicable biological materials
进料转移协议.e. 收到材料
An incoming MTA protects a 研究er's ability to use and publish 研究, any existing and potential intellectual property and define the use of any accompanying confidential 信息. 对即将到来的MTA的审查确保协议条款不冲突 与研究相关的其他协议授予的权利.
外发材料转让协议.e. 发送材料
MTAs for outgoing material typically prevent 这种材料 provider from losing control 超过材料和它的研究用途. 如果不存在协议，那么接收方 of 这种材料 has no legal restrictions 在 use of 这种材料, or on transferring 这种材料.
通过预审查问卷进行合规性审查
MTAs (incoming/receiving and outgoing/sending) must undergo a compliance review to 确保有适当的合规协议:
- 活的动物 -机构动物护理及使用委员会(IACUC).
- 人体组织和/或数据 - Compliance with 45 CFR 46 (and all other applicable federal regulations), and, if required, have protocol(s) reviewed and approved by the Institutional Review Board (IRB).
- 有害物质 - Biosafety compliance and, if applicable, have protocol(s) reviewed and approved 机构生物安全委员会(IBC).
- 利益冲突(COI) – Review needed where the decision to undertake the 研究 is based on receiving access to 这种材料(s) from a non-governmental or industrial provider must follow 委员会对财务披露的要求.
其他注意事项:
发送/接收活体(脊椎动物)
所有动物订单都经过处理 美国研究合规和保证 (RCA)，并且需要经过批准的IACUC协议. IACUC的审查将决定是否 需要一个MTA. 作为一般规则:
- mta需要用于:
- Sending/receiving animals by incoming and outgoing 教师 (transfer of animals)
- Sending/receiving animals from/to collaborators or other institutions (unless as part (已包含在协议条款中的)
- 在以下情况下，通常不需要mta:
- PI已与供应商签订合同，生成新的动物模型. 请与 the IACUC office before executing the contract as there are some requirements set 在使用小灵通资金提供这些服务时，由法律和法律事务部授权.
RCA will reach out to the PI for any clarifications and if 需要一个MTA and there 不是有一个已经存档了吗. PI也可以按照指示启动这个过程 在 研究合规 & 保证 网页.
从存储库订购材料，例如.g. 美国国立卫生研究院艾滋病试剂计划
Some repositories require registrations and some require MTAs, and some require both. If you are registering to use a repository, or if you are ordering a specific material, and the repository requires an institutional signature, then documentation will need to be submitted to the 商业化和工业合作办公室. 电子邮件 注册文件 techtransfer@basilinfracon.com.
转移出口管制物料
《十大彩票网投平台》. 本规定由国务院实施 工业和安全局 (BIS)在商务部内. 出口管制条例规管下列物品的出口 两用 goods and services (goods and services having both military and civilian uses) that 在 商业管制清单(CCL). These are items that are not inherently military in nature; they are primarily commercial 具有潜在军事用途的物品. 商务部必须发布一份 出口许可证, or provide an exception to or exclusion from license requirements before any 控制项目、软件或CCL上的信息可以出口或再出口. 有民事诉讼 违反《十大彩票网投平台》的刑事处罚.
Upon receipt of a completed MTA Pre-Review Questionnaire, OCIC will conduct a “Restricted Party Screening”, to ensure USA is not engaging with an export restricted party and 通知美国研究合规办公室 & 适当的保证.
| 步骤 | 负责单位或人员 | 时间轴 |
|---|---|---|
| 将填妥的MTA预检讨问卷及MTA电邮至 techtransfer@basilinfracon.com. 包括其他组织的联系人信息 | 发送/接收的科学家 | |
| Initiate MTA Pre-Questionnaire and MTA review, conduct “Restricted Party Screening” search and route to the appropriate 研究 compliance officer, if applicable. | 商业化和工业合作办公室(OCIC) | 2-5个工作日 |
| If applicable, compliance review and approve for Human Subjects, Animals, Conflicts 感兴趣的 | 研究、合规和保证办公室(RCA) |
5-7个工作日 (两个遵从性检查并行进行) |
| 根据需要审查和协商协议的条款和条件. | OCIC和RCA | 标准协议和UBMTA的5-7个工作日. 非标准协议可能需要 最多15-30天的谈判时间. |
| 当另一方同意后，OCIC将审查拟议的MTA. 经批准, USA and the PI signs first, returns the signed agreement to the other party, follow-up 执行协议并关闭日志 | OCIC | 收到提议的协议后5-7天 |