Publicity Review. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding Licensed Products in the Field and other activities in connection with this Agreement, beyond what may be strictly required by applicable law or regulation, and each Party may make such disclosures from time to time with the approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed. Such disclosures may include achievement of significant events in the Development (including regulatory process and occurrence of Milestone Events) or Commercialization of Licensed Products in the Field hereunder or receipt of payments. When a Party (the “Requesting Party”) elects to make any such public disclosure under this Section 10.4.2, it will give the other Party (the “Cooperating Party”) reasonable notice to review and comment on such statement, it being understood that if the Cooperating Party does not notify the Requesting Party in writing within five (5) business day period or such shorter period if required by applicable law of any reasonable objections, as contemplated in this Section 10.4.2, such disclosure shall be deemed approved, and in any event the Cooperating Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with applicable laws, rules, regulations and regulatory guidance documents, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities (including the FDA), the potential loss of competitive advantage by publishing confidential information regarding the status of development efforts and/or commercialization plans prematurely, and the need to keep investors and others informed regarding the Requesting Party’s business. Accordingly, the Cooperating Party shall not withhold, condition or delay its approval of a proposed disclosure that complies with such principles.
Appears in 2 contracts
Samples: Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.), Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.)
Publicity Review. The Parties acknowledge the importance of supporting each other’s 's efforts to publicly disclose results and significant developments regarding Licensed Products, CK Products in the Field and other activities in connection with this Agreement, beyond what may be strictly is required by applicable law or regulationlaw, and each Party may make such disclosures from time to time with the approval of the other Party, which approval shall not be unreasonably withheld, conditioned withheld or delayed. Such disclosures may include include, without limitation, achievement of Research Performance Milestones, Development Milestones, significant events in the Development (including research, development and regulatory process with respect to such a Development Compound, Licensed Product or CK Product, commercialization activities and occurrence of Milestone Events) or Commercialization of Licensed Products in the Field hereunder or receipt of paymentslike. When a Party (the “"Requesting Party”") elects to make any such public disclosure under this Section 10.4.212.1.2, it will give the other Party (the “"Cooperating Party”") reasonable at least five (5) business days notice to review and comment on such statement, it being understood that if the Cooperating Party does not notify the Requesting Party in writing within such five (5) business day period or such shorter period if required by applicable law of any reasonable objections, as contemplated in this Section 10.4.212.1.2, such disclosure shall be deemed approved, and in any event the Cooperating Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with applicable laws, rules, regulations law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities the FDA (including the FDA), the potential loss of competitive advantage by publishing confidential information regarding the status of development efforts and/or commercialization plans prematurely, and its foreign counterparts) and the need to keep investors and others informed regarding the Requesting Party’s 's business. Accordingly, the Cooperating Party shall not withhold, condition or delay withhold its approval of a proposed disclosure that complies with such principles.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Cytokinetics Inc), Collaboration and License Agreement (Cytokinetics Inc)
Publicity Review. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding Licensed Products in the Field Product and other activities in connection with this AgreementAgreement that may reflect the terms of this Agreement or information that is not otherwise permitted to be disclosed under this Article 11, beyond what may be strictly is required by applicable law or regulationApplicable Law, and each Party may make such disclosures from time to time with the approval of the other Party, which approval shall not be unreasonably withheld, conditioned withheld or delayed. Such disclosures may include include, without limitation, achievement of milestones, significant events in the Development (including development and regulatory process process, commercialization activities and occurrence of Milestone Events) or Commercialization of Licensed Products in the Field hereunder or receipt of paymentslike. When a Party (the “Requesting Party”) elects to make any such public disclosure under this Section 10.4.211.5, it will give the other Party (the “Cooperating Party”) reasonable at [… * …] notice to review and comment on such statement, it being understood that if the Cooperating Party does not notify the Requesting Party in writing within five (5) business day such [… * …] period or such shorter period if required by applicable law of any reasonable objections, as contemplated in this Section 10.4.211.5, such disclosure shall be deemed approved, and in any event the Cooperating Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with applicable laws, rules, regulations and regulatory guidance documentsApplicable Law, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities the FDA (including the FDA), the potential loss of competitive advantage by publishing confidential information regarding the status of development efforts and/or commercialization plans prematurely, and its foreign counterparts) and the need to keep investors and others informed regarding the Requesting Party’s business. Accordingly, the Cooperating Party shall not withhold, condition or delay withhold its approval of a proposed disclosure that complies with such principles.
Appears in 2 contracts
Samples: Development and Commercialization Agreement (Xenoport Inc), Development and Commercialization Agreement (Xenoport Inc)
Publicity Review. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding Licensed Products in the Field Product and other activities in connection with this AgreementAgreement that may reflect the terms of this Agreement or information that is not otherwise permitted to be disclosed under this Article 10, beyond what may be strictly is required by applicable law or regulationlaw, and each Party may make such disclosures from time to time with the approval of the other Party, which approval shall not be unreasonably withheld, conditioned withheld or delayed. Such disclosures may include include, without limitation, achievement of milestones, significant events in the Development (including development and regulatory process process, commercialization activities and occurrence of Milestone Events) or Commercialization of Licensed Products in the Field hereunder or receipt of paymentslike. When a Party (the “Requesting Party”) elects to make any such public disclosure under this Section 10.4.210.5, it will give the other Party (the “Cooperating Party”) reasonable at least five (5) business days’ notice to review and comment on such statement, it being understood that if the Cooperating Party does not notify the Requesting Party in writing within such five (5) business day period or such shorter period if required by applicable law of any reasonable objections, as contemplated in this Section 10.4.210.5, such disclosure shall be deemed approved, and in any event the Cooperating Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with applicable laws, rules, regulations law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities the FDA (including the FDA), the potential loss of competitive advantage by publishing confidential information regarding the status of development efforts and/or commercialization plans prematurely, and its foreign counterparts) and the need to keep investors and others informed regarding the Requesting Party’s 's business. Accordingly, the Cooperating Party shall not withhold, condition or delay withhold its approval of a proposed disclosure that complies with such principles.
Appears in 2 contracts
Samples: License Agreement, License and Collaboration Agreement (Inovio Pharmaceuticals, Inc.)
Publicity Review. The Parties acknowledge the importance of supporting each other’s 's efforts to publicly disclose results and significant developments regarding Licensed Products, CK Products in the Field and other activities in connection with this Agreement, beyond what may be strictly is required by applicable law or regulationlaw, and each Party may make such disclosures from time to time with the approval of the other Party, which approval shall not be unreasonably withheld, conditioned withheld or delayed. Such disclosures may include include, without limitation, achievement of Research Performance Milestones, Development Milestones, significant events in the Development (including research, development and regulatory process with respect to such a Development Compound, Licensed Product or CK Product, commercialization activities and occurrence of Milestone Events) or Commercialization of Licensed Products in the Field hereunder or receipt of paymentslike. When a Party (the “"Requesting Party”") elects to make any such public disclosure under this Section 10.4.212.1.2, it will give the other Party (the “"Cooperating Party”") reasonable at least five (5) business days notice to review and comment on such statement, it being understood that if the Cooperating Party does not notify the Requesting Party in writing within such five (5) business day period or such shorter period if required by applicable law of any reasonable objections, as contemplated in this Section 10.4.212.1.2, such disclosure shall be deemed approved, and in any event the Cooperating Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with applicable laws, rules, regulations law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities the EDA (including the FDA), the potential loss of competitive advantage by publishing confidential information regarding the status of development efforts and/or commercialization plans prematurely, and its foreign counterparts) and the need to keep investors and others informed regarding the Requesting Party’s 's business. Accordingly, the Cooperating Party shall not withhold, condition or delay withhold its approval of a proposed disclosure that complies with such principles.
Appears in 1 contract
Samples: Collaboration and License Agreement (Cytokinetics Inc)
Publicity Review. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding Licensed Products Product within the Field in the Field Territory and other activities in connection with this Agreement, beyond what may be strictly required by applicable law or regulationApplicable Law and the rules of recognized stock exchanges. If, and each Party may make such disclosures from time to time time, a Party wishes to make any such disclosure which is not strictly required by Applicable Law or the rules of recognized stock exchanges it shall provide the other Party with written details of the approval of proposed disclosure and shall only make such disclosure if it has received the other Party, which approval shall ’s prior written consent (not to be unreasonably withheld, conditioned or delayed). Such disclosures may include disclosures relating to achievement of significant events in the Development (including regulatory process and occurrence of Milestone EventsMarketing Approval for Product within the Field in the Territory) or Commercialization of Licensed Products Product within the Field in the Field hereunder or receipt Territory hereunder. Unless otherwise requested by MSB, Grünenthal shall indicate that MSB is the owner and innovator of payments. When a Party (Product and the “Requesting Party”) elects to make any such Product Technology in each public disclosure under regarding Product issued by Grünenthal pursuant to this Section 10.4.2, it will give the other Party (the “Cooperating Party”) reasonable notice to review and comment on such statement, it being understood that if the Cooperating Party does not notify the Requesting Party in writing within five (5) business day period or such shorter period if required by applicable law of any reasonable objections, as contemplated in this Section 10.4.2, such disclosure shall be deemed approved, and in any event the Cooperating Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner10.5.2. The principles to be observed by each Party in such disclosures shall be accuracy, compliance with applicable laws, rules, regulations Applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities (including the FDA), the potential loss of competitive advantage by publishing confidential information regarding the status of development efforts and/or commercialization plans prematurely, and the need to keep investors and others informed regarding the Requesting requesting Party’s business, including as required by the rules of recognized stock exchanges. AccordinglyFor the avoidance of doubt, nothing in this Section 10.5.2 shall prevent a Party from making any disclosure required by Applicable Law or the Cooperating Party shall not withhold, condition or delay its approval rules of a proposed disclosure that complies with such principlesrecognized stock exchanges.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Mesoblast LTD)
Publicity Review. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding Licensed Products in the Field Product and other activities in connection with this AgreementAgreement that may reflect the terms of this Agreement or information that is not otherwise permitted to be disclosed under this Article 11, beyond what may be strictly is required by applicable law or regulationApplicable Law, and each Party may make such disclosures from time to time with the approval of the other Party, which approval shall not be unreasonably withheld, conditioned withheld or delayed. Such disclosures may include include, without limitation, achievement of milestones, significant events in the Development (including development and regulatory process process, commercialization activities and occurrence of Milestone Events) or Commercialization of Licensed Products in the Field hereunder or receipt of paymentslike. When a Party (the “Requesting Party”) elects to make any such public disclosure under this Section 10.4.211.5, it will give the other Party (the “Cooperating Party”) reasonable at least [... * ...] notice to review and comment on such statement, it being understood that if the Cooperating Party does not notify the Requesting Party in writing within five (5) business day such [... * ...] period or such shorter period if required by applicable law of any reasonable objections, as contemplated in this Section 10.4.211.5, such disclosure shall be deemed approved, and in any event the Cooperating Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with applicable laws, rules, regulations and regulatory guidance documentsApplicable Law, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities the FDA (including the FDA), the potential loss of competitive advantage by publishing confidential information regarding the status of development efforts and/or commercialization plans prematurely, and its foreign counterparts) and the need to keep investors and others informed regarding the Requesting Party’s business. Accordingly, the Cooperating Party shall not withhold, condition or delay withhold its approval of a proposed disclosure that complies with such principles.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Xenoport Inc)