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 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 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 [ * ] 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 [ * ] after the matter is referred to them, then, notwithstanding Section 2.1.4(c)(2), Protagonist shall have the final decision-making authority to determine the appropriate course of action to address such Material Safety Issue and Protagonist’s decision shall be final and binding on the Parties, subject to the limitations set forth in Section 2.1.4(c)(3); provided, however, Protagonist may not exercise its final decision-making authority to require Xxxxxxx to commence or continue any Collaboration Activity if 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 Protagonist would have the right to authorize a clinical research organization to conduct the particular activity on behalf of Protagonist.

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 Clinical Development Plan or CMC Development Plan 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, notwithstanding Section 2.1.4(c)(2), Protagonist shall have the final decision-making authority to determine the appropriate course of action to address such Material Safety Issue and Protagonist’s decision matter shall be final and binding on the Parties, subject to the limitations set forth considered a Deadlocked Matter in accordance with Section 2.1.4(c)(33.2(b); provided, however, Protagonist may not exercise its that the Party with final decision-making authority may not exercise such authority to require Xxxxxxx the other Party to commence or continue any Collaboration Activity if Xxxxxxx 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 Protagonist the Party with final decision-making authority would have the right to authorize a clinical research organization to conduct the particular activity on behalf of Protagonistits own behalf.

Material Safety Issues. 3.7.1. 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 Clinical Development Plan or CMC 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 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 [ * ] 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 [ * ] after the matter is referred to them, then, notwithstanding Section 2.1.4(c)(2), Protagonist Xxxxxxx shall have the final decision-making authority to determine the appropriate course of action to address such Material Safety Issue and Protagonist’s Xxxxxxx’x decision shall be final and binding on the Parties, subject to the limitations set forth in Section 2.1.4(c)(3); provided, however, Protagonist Xxxxxxx may not exercise its final decision-making authority to require Xxxxxxx Protagonist to commence or continue any Collaboration Activity if Xxxxxxx 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 Protagonist Xxxxxxx would have the right to authorize a clinical research organization to conduct the particular activity on behalf of Protagonist, at Xxxxxxx’x sole cost. 3.7.2. If (a) a Material Safety Issue arises after the Restatement Effective Date, (b) such Material Safety Issue is not resolved by the Parties after completing the process set forth in Section 3.7.1, (c) such Material Safety Issue has existed for more than [ * ], (d) Xxxxxxx has not used Diligent Efforts to resolve such Material Safety Issue, and (e) as of such time, the Research Term has expired and there are no ongoing Xxxxxxx Independent Research Activities and (i) such Material Safety Issue applies to each Licensed Compound or Licensed Product that is specifically the subject of any ongoing Clinical Trial or Development activities or (ii) there are no other Licensed Compounds or Licensed Products (other than the Initial Product) that are specifically the subject of then-ongoing or preparation for any Clinical Trial or other Development activities, then Protagonist’s ​ ​ obligations and restrictions under Section 6.7 shall expire on the first date that all conditions set forth in clauses (a) through (d) are satisfied and Section 6.7 shall be of no further force or effect after such date.

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 Clinical Development Plan or CMC Development Plan 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 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 [ * ] 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 [ * ] 30 days after the matter is referred to them, then, notwithstanding Section 2.1.4(c)(23.1(f), Protagonist Cidara shall have the final decision-making authority to determine the appropriate course of action to address such Material Safety Issue Issue, and ProtagonistCidara’s decision shall be final and binding on the Parties, subject to the limitations set forth in Section 2.1.4(c)(3); provided, however, Protagonist may not exercise its final decision-making authority to require Xxxxxxx to commence or continue any Collaboration Activity if 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 Protagonist would have the right to authorize a clinical research organization to conduct the particular activity on behalf of Protagonist.

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 Clinical Development Plan or CMC 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 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 [ * [*] 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 [ * [*] after the matter is referred to them, then, notwithstanding Section 2.1.4(c)(2), Protagonist Xxxxxxx shall have the final decision-making authority to determine the appropriate course of action to address such Material Safety Issue and Protagonist’s Xxxxxxx’x decision shall be final and binding on the Parties, subject to the limitations set forth in Section 2.1.4(c)(3); provided, however, Protagonist Xxxxxxx may not exercise its final decision-making authority to require Xxxxxxx Protagonist to commence or continue any Collaboration Activity if Xxxxxxx 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 Protagonist Xxxxxxx would have the right to authorize a clinical research organization to conduct the particular activity on behalf 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. 3.8.2. If (a) a Material Safety Issue arises after the commencement of a CD Phase 2 Clinical Trial, (b) such Material Safety Issue is not resolved by the Parties after completing the process set forth in Section 3.8.1, (c) such Material Safety Issue has existed for more than [*], (d) Xxxxxxx has not used Diligent Efforts to resolve such Material Safety Issue, and (e) as of such time, the Research Term has expired and (i) such Material Safety Issue applies to each Licensed Compound or Licensed Product that is specifically the subject of then-ongoing or preparation for Phase 1 Activities or Phase 2 Activities or (ii) there are no other Licensed Compounds or Licensed Products (other than the Licensed Product that was the subject of such CD Phase 2 Clinical Trial) that are specifically the subject of then-ongoing or preparation for Phase 1 Activities or Phase 2 Activities, then Protagonist’s obligations and restrictions under Section 6.7 shall expire on the first date that all conditions set forth in clauses (a) through (d) are satisfied and Section 6.7 shall be of no further force or effect after such date. A new Section 3.9 is added to the Agreement as follows: