Common use of Material Safety Issues Clause in Contracts

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. 3.8.1. 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 Clinical Development Plan or CMC Development Plan 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, notwithstanding Section 2.1.4(c)(2), Protagonist shall have the matter final decision-making authority to determine the appropriate course of action to address such Material Safety Issue and Protagonist’s decision shall be considered a Deadlocked Matter final and binding on the Parties, subject to the limitations set forth in accordance with Section 3.2(b2.1.4(c)(3); provided, however, that the Party with Protagonist may not exercise its final decision-making authority may not exercise such authority to require the other Party Xxxxxxx to commence or continue any Collaboration Activity if the other Party Xxxxxxx 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 Protagonist would have the right to authorize a clinical research organization to conduct the particular activity on its own behalfbehalf of Protagonist.

Material Safety Issues. If3.7.1.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 Parties 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 a Development Plan to the extent such activity is affected by such Material Safety Issue. If the JSC approves Parties agree upon 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 Parties do not approve agree upon 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, Xxxxxxx shall determine the matter appropriate course of action to address such Material Safety Issue and Xxxxxxx’x decision shall be considered a Deadlocked Matter in accordance with Section 3.2(b)final and binding on the Parties; provided, however, that the Party with final decision-making authority Xxxxxxx may not exercise such authority to require the other Party Protagonist to commence or continue any Collaboration Activity if the other Party Protagonist 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 Xxxxxxx would have the right to authorize a clinical research organization to conduct the particular activity on its own behalfbehalf of Protagonist, at Xxxxxxx’x sole cost.

Material Safety Issues. 3.8.1. 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 a Development Plan 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, Xxxxxxx shall have the matter final decision-making authority to determine the appropriate course of action to address such Material Safety Issue and Xxxxxxx’x decision shall be considered a Deadlocked Matter final and binding on the Parties, subject to the limitations set forth in accordance with Section 3.2(b2.1.4(c)(3); provided, however, that the Party with Xxxxxxx may not exercise its final decision-making authority may not exercise such authority to require the other Party Protagonist to commence or continue any Collaboration Activity if the other Party Protagonist 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 Xxxxxxx would have the right to authorize a clinical research organization to conduct the particular activity on its own behalfbehalf of Protagonist, at Xxxxxxx’x sole cost. [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Material Safety Issues. If, during the Development Research 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 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 Research Plan Activities). During the pendency of such discussion, each Party may suspend or delay any Collaboration Research Plan Activity allocated to it under the Collaboration Plans to the extent such activity is affected by such Material Safety Issue, and, to the extent required, take all actions as may be required by Applicable Law (e.g., regulatory reporting). 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) 30 days after becoming aware of such Material Safety Issue, then either Party may refer such matter to the Executive Officers Senior Executives for discussion and attempted resolution. If the Executive Officers Senior Executives 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 Senior Executives do not approve a course of action to address such Material Safety Issue within twenty one (21) 30 days after the matter is referred to them, then, notwithstanding Section 3.1(f), Cidara shall have 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 determine the other Party appropriate course of action 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 address such Material Safety Issue Issue, and in such instance Cidara’s decision shall be final and binding on 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 behalfParties.