Material Safety Issues Clause Samples
The Material Safety Issues clause establishes requirements and procedures for identifying, reporting, and addressing significant safety concerns related to products, services, or operations. Typically, this clause obligates parties to promptly notify each other if a material safety issue arises, and may require immediate corrective actions, recalls, or suspension of activities until the issue is resolved. Its core practical function is to ensure that safety risks are managed proactively, protecting both parties and end users from harm and minimizing potential liability.
Material Safety Issues. If, during the Development Term, either Party determines that there is a Material Safety Issue, such Party shall promptly notify the other Party and the JSC shall promptly meet to discuss such Material Safety Issue and to seek to approve an appropriate course of action to address such Material Safety Issue (which may include delaying, modifying, suspending or terminating one or more of the Collaboration Activities). During the pendency of such discussion, each Party may suspend or delay any Collaboration Activity allocated to it under the Collaboration Plans to the extent such activity is affected by such Material Safety Issue. If the JSC approves a course of action to address such Material Safety Issue, then the Parties shall thereafter take all reasonable actions necessary to implement such course of action. If the JSC does not approve a course of action to address such Material Safety Issue within twenty one (21) days after becoming aware of such Material Safety Issue, then either Party may refer such matter to the Executive Officers for discussion and attempted resolution. If the Executive Officers approve a course of action to address such Material Safety Issue, then the Parties shall thereafter take all actions necessary to implement such course of action. If the Executive Officers do not approve a course of action to address such Material Safety Issue within twenty one (21) days after the matter is referred to them, then, the matter shall be considered a Deadlocked Matter in accordance with Section 3.2(b); provided, however, that the Party with final decision-making authority may not exercise such authority to require the other Party to commence or continue any Collaboration Activity if the other Party determines, in good faith, that such Collaboration Activity should not be commenced or continued due to such Material Safety Issue and in such instance the Party with final decision-making authority would have the right to authorize a clinical research organization to conduct the particular activity on its own behalf.
Material Safety Issues. If either Party believes that the Signal Finding Study should be terminated because it is necessary to protect the safety, health or welfare of subjects enrolled in the Signal Finding Study due to the existence of a Material Safety Issue (as defined below), then the Parties will promptly meet and discuss in good faith the safety concerns raised by such Party and consider in good faith the input, questions and advice of the other Party. “Material Safety Issue” means a Party’s good faith belief that there is an unacceptable risk for harm in humans based upon the observation of serious adverse effects in humans after the Material has been administered to or taken by humans.
Material Safety Issues. If either Party believes that either of the Studies should be terminated because it is necessary to protect the safety, health or welfare of subjects enrolled in any of the Studies due to the existence of a Material Safety Issue (as defined below), then the Parties will promptly meet and discuss in good faith the safety concerns raised by such Party and consider in good faith the input, questions and advice of the other Party. “Material Safety Issue” means a Party’s good faith belief that there is an unacceptable risk for harm in humans based upon the observation of serious adverse effects in humans after the Material has been administered to or taken by humans.
Material Safety Issues. If, during the Development Program Term, either Party determines that there is a Material Safety Issue, such Party shall promptly notify the other Party, and the JSC shall promptly meet to discuss such Material Safety Issue. In the event of a Material Safety Issue that arises prior to Dynavax’s payment to Vaxart of the Dynavax Election Payment and the assignment by Vaxart to Dynavax of the Vaccine Candidate IND, Vaxart may suspend or delay any Development Program Activity to the extent such activity is affected by such Material Safety Issue, and shall, to the extent required, take all actions as may be required by Applicable Law (e.g., regulatory reporting) and such other actions as Vaxart determines are appropriate to address such Material Safety Issue. In the event of a Material Safety Issue that arises after Dynavax’s payment to Vaxart of the Dynavax Election Payment and the assignment by Vaxart to Dynavax of the Vaccine Candidate IND, Dynavax may require the suspension or delay of any Development Program Activity to the extent such activity is affected by such Material Safety Issue, and shall, to the extent required, take all actions as may be required by Applicable Law and such other actions as Dynavax determines are appropriate to address such Material Safety Issue.