Further Publicity. Except for the initial press releases described in Section 14.3.2, whenever a Party (the “Requesting Party”) elects to make any such public disclosure, it shall first notify the other Party (the “Cooperating Party”) of such planned press release or public announcement and provide a draft for review at least three Business Days in advance of issuing such press release or making such public announcement (or, with respect to press releases and public announcements that are required by applicable Law, or by regulation or rule of any public stock exchange, with as much advance notice as possible under the circumstances if it is not possible to provide notice at least three Business Days in advance); provided, however, that a Party may issue such press release or public announcement without such prior review by the other Party if (a) the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing Party; (b) such press release or public announcement does not materially differ from the previously issued press release or other publicly available information; (c) such press release solely relates to the achievement of milestone events under Section 9.3 and Section 9.4 and payments (including amounts) therefore; and (d) such press release or public announcement does not contain the other Party’s name. The Cooperating Party may notify the Requesting Party -85- of any reasonable objections or suggestions that the Cooperating Party may have regarding the proposed press release or public announcement, and the Requesting Party shall reasonably consider any such objections or suggestions that are provided in a timely manner. The principles to be observed in such disclosures shall include accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of the FDA (and its foreign counterparts) and the need to keep investors informed regarding the Requesting Party’s business.
Appears in 1 contract
Samples: Collaboration and License Agreement (Gossamer Bio, Inc.)
Further Publicity. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Products in the Field that may include information that is not otherwise permitted to be disclosed under this ARTICLE 9, and that may be beyond what is required by Law, and each Party may make such disclosures from time to time. Such disclosures may include achievement of milestones, significant events in the Development process with respect to the Products, Commercialization activities with respect to the Products and the like. Except for the initial press releases described in Section 14.3.2, whenever a 9.3.1:
(a) Whenever either Party (the “Requesting Party”) elects to make any such public disclosure, it shall first notify the other Party (the “Cooperating Party”) of such planned press release or public announcement and provide a draft for review at least three no less than [**] Business Days in advance of issuing such press release or making such public announcement (or, with respect to press releases and public announcements that are required by applicable Law, or by regulation or rule of any public stock exchange, with as much advance notice as possible under the circumstances if it is not possible to provide notice at least three no less than [**] Business Days in advance). Each Party shall have the right to review and approve any such planned press release or public announcement proposed by the other Party, including any oral presentation or abstract, that contains Clinical Data or pertains to results of Clinical Studies or other studies with respect to the Licensed Compounds or Products, or that includes Confidential Information of the other Party; provided, however, that (A) the reviewing Party shall attempt to provide such approval as soon as reasonably possible and shall not unreasonably withhold such approval; (B) the reviewing Party shall provide explanations of its disapproval of such press release; and (C) a Party desiring to make such public disclosure may issue such press release or public announcement without such prior review by the other Party if (ai) the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing such Party; , and (bii) such press release or public announcement does not materially differ from the previously issued press release or other publicly available information; (c) such press release solely relates and provided, further, that the other Party shall have the right to the achievement of milestone events under Section 9.3 and Section 9.4 and payments (including amounts) therefore; and (d) such review, but not approve, any press release or public announcement that the proposing Party determines is required by applicable law based on the advice of counsel, which public disclosures are subject to Section 9.3.2(b). The Party reviewing a press release provided under this Section 9.3.2 will review and approve or disapprove such press release within [**] Business Days after its receipt thereof. A press release will be deemed approved if the reviewing Party does not contain provide its disapproval during the other reviewing period. If the reviewing Party disapproves of the press release within the reviewing period, either Party may refer the matter to the JSC for resolution together with the reasons for the withholding of approval. The JSC will make a decision on such matter within [**] Business Days after such referral. If the JSC cannot reach consensus on the matter within such [**] Business Day period, such publication or public disclosure shall be deemed not approved, notwithstanding anything in Section 2.9.3 to the contrary. For clarity, in the event a publication contemplated by this Section 9.3.2 implicates a Third Party’s name. The Cooperating rights under a AbbVie Third Party may notify Agreement or Infinity Third Party Agreement, the Requesting counter party under such agreement shall be considered a reviewing Party -85- of and shall have the right to review and approve any reasonable objections or suggestions that the Cooperating Party may have regarding the proposed planned press release or public announcementannounced proposed by the other Party, subject to the terms and the Requesting Party shall reasonably consider any such objections or suggestions that are provided in a timely manner. conditions set forth herein.
(b) The principles to be observed in such disclosures shall include accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of the FDA (and its foreign counterparts) and the need to keep investors informed regarding the Requesting business of the Party making such public disclosure. Nothing in this Section 9.3 shall restrict a Party from making a disclosure required by Law as reasonably determined by such Party’s businesscounsel, including disclosures required by any laws or regulations relating to the public sale of securities.
Appears in 1 contract
Samples: Collaboration and License Agreement (Infinity Pharmaceuticals, Inc.)
Further Publicity. Except for The Parties acknowledge the initial press releases described importance of supporting each other’s efforts to publicly disclose results and significant developments regarding Licensed Products in Section 14.3.2the Shire Territory and other activities in connection with this Agreement in the Shire Territory that may involve Confidential Information of the other Party generated or obtained in connection with this Agreement pertaining to the Licensed Products, whenever beyond what is required by Law, and each Party may make such public disclosures from time to time with the approval of the [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. -66- other Party. Such disclosures may include, without limitation, achievement of Development milestones, significant events in the Development and regulatory process with respect to Licensed Products, Commercialization activities and the like. When a Party (the “Requesting Initiating Party”) elects to make any such public disclosuredisclosure under this Section 14.6.2, it shall first notify will give the other Party (the “Cooperating Party”) of such planned press release or public announcement and provide a draft for review at least three five (5) Business Days in advance of issuing notice to review and comment on such press release or making such public announcement (orstatement, with respect to press releases and public announcements it being understood that are required by applicable Law, or by regulation or rule of any public stock exchange, with as much advance notice as possible under the circumstances if it is not possible to provide notice at least three Business Days in advance); provided, however, that a Party may issue such press release or public announcement without such prior review by the other Party if (a) the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing Party; (b) such press release or public announcement does not materially differ from the previously issued press release or other publicly available information; (c) such press release solely relates to the achievement of milestone events under Section 9.3 and Section 9.4 and payments (including amounts) therefore; and (d) such press release or public announcement does not contain the other Party’s name. The Cooperating Party may notify the Requesting Party -85- of any reasonable objections or suggestions that the Cooperating Party may have regarding does not notify the proposed press release or public announcementInitiating Party in writing within such five (5) Business Day period of any objections, such disclosure shall be deemed approved, and in any event the Requesting Cooperating Party shall work diligently and reasonably consider to agree on the text of any such objections or suggestions that are provided approved disclosure in a timely an expeditious manner. The principles to be observed in such disclosures shall include accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of the FDA (and its foreign counterparts) and the need to keep investors informed regarding the Requesting Initiating Party’s business.
Appears in 1 contract
Samples: License and Collaboration Agreement (Amicus Therapeutics Inc)
Further Publicity. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Products in the Field and other activities in connection with this Agreement that may include information that is not otherwise permitted to be disclosed under this ARTICLE IX, and that may be beyond what is required by law, and each Party may make such disclosures from time to time. Such disclosures may include achievement of milestones, significant events in the development and regulatory process, commercialization activities and the like. Except for the initial press releases described in Section 14.3.29.4.1, whenever a Party (the “Requesting Party”) elects to make any such public disclosure, it shall first notify the other Party (the “Cooperating Party”) of such planned press release or public announcement and provide a draft for review at least three Business Days in advance of issuing such press release or making such public announcement (or, with respect to press releases and public announcements that are required by applicable Law, or by regulation or rule of any public stock exchangeexchange (including NASDAQ), with as much advance notice as possible under the circumstances if it is not possible to provide notice at least three Business Days in advance); provided, however, that a Party may issue such press release or public announcement without such prior review by the other Party if (ai) the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing Party; , (bii) such press release or public announcement does not materially differ from the previously issued press release or other publicly available information; (c) such press release solely relates to the achievement of milestone events under Section 9.3 and Section 9.4 and payments (including amounts) therefore; , and (diii) such press release or public announcement does not contain the other Party’s name. The Cooperating Party may notify the Requesting Party -85- of any reasonable objections or suggestions that the Cooperating Party may have regarding the proposed press release or public announcement, and the Requesting Party shall reasonably consider any such objections or suggestions that are provided in a timely manner. The principles to be observed in such disclosures shall include accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of the FDA (and its foreign counterparts) and the need to keep investors informed regarding the Requesting Party’s business.
Appears in 1 contract
Samples: Collaboration and License Agreement (Pharmacyclics Inc)
Further Publicity. (a) Each Party hereby consents to the other Party’s release of its announcement attached as Exhibit H after execution and delivery of this Agreement. Except for the release of such announcement attached as Exhibit H after execution and delivery of this Agreement and except as set forth in subsection (b) below, neither Party shall originate any publicity, news release or public announcements, written or oral, whether to the public or press, stockholders or otherwise, relating to this Agreement, including its existence, the subject matter to which it relates, performance under it, or any of its terms, or to any amendment hereto, without the prior written consent of the other Party, save only such announcements or filings that are required by Applicable Laws (including under the rules of any relevant public stock exchange (including NASDAQ) or government agency regulating trading in securities of a Party or its parent Affiliate).
(b) The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose significant results and developments regarding the Licensed Products and other activities in connection with this Agreement that may include information that is not otherwise permitted to be disclosed under this Article XI, and that may be beyond what is required by Applicable Law, but in each case consistent with the need to keep investors reasonably informed regarding such Party’s business in accordance with customary investor relations, and each Party may request to make such disclosures from time to time. Such requested disclosures may include achievement of milestones, significant events in the Development and regulatory process, appropriate Commercialization activities and the like to the extent permitted by Applicable Law. Except for the initial press releases release(s) described in Section 14.3.2subsection (a) above, whenever a Party (the “Requesting Party”) elects to make plans on making any such public disclosure, it shall first notify the other Party (the “Cooperating Party”) of such planned press release or public announcement and provide a draft for review at least three [**] Business Days in advance of issuing such press release or making such public announcement (or, with respect to press releases and public announcements that are required by applicable Applicable Law, or by regulation or rule of any public stock exchangeexchange (including NASDAQ), with as much advance notice as possible under the circumstances if it is not possible to provide notice at least three [**] Business Days in advance); provided. The Requesting Party and Cooperating Party will discuss such proposed public disclosure in good faith. Unless otherwise required by regulation or rule of any public stock exchange (including NASDAQ), howeverthe Requesting Party will not issue such press release or make such public announcement without the prior written consent of the Cooperating Party, not to be unreasonably withheld, conditioned (except, for clarity, as may be reasonably conditioned on the removal of the Cooperating Party’s Confidential Information) or delayed, provided that a Party may issue such press release or make such public announcement without such prior review by the other Party if if: (ai) the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing Requesting Party; , (bii) such press release or public announcement does not materially differ from the previously issued press release or other publicly available information; , (c) such press release solely relates to the achievement of milestone events under Section 9.3 and Section 9.4 and payments (including amounts) therefore; and (diii) such press release or public announcement does not contain the other Cooperating Party’s name. The Cooperating Party may notify name and (iv) the Requesting Party -85- of any reasonable objections or suggestions that notifies the Cooperating Party may have regarding the proposed press release or public announcement, and the Requesting Party shall reasonably consider any such objections or suggestions that are provided in a timely manneradvance of issuance. The principles to be observed in such disclosures shall include accuracy, compliance with applicable Applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of Regulatory Authorities, the FDA (and its foreign counterparts) need to protect competitively sensitive information regarding the Licensed Products, the need to allow time for the filing of desired Development Program Patent Rights before proposed disclosures pertaining to Development Program Inventions, and the need to keep investors reasonably informed regarding the Requesting Party’s business.
Appears in 1 contract
Samples: Collaboration and License Agreement (Achillion Pharmaceuticals Inc)
Further Publicity. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Licensed Products in the Field and other activities in connection with this Agreement that may include information that is not otherwise permitted to be disclosed under this ARTICLE IX, and that may be beyond what is required by law, and each Party may make such disclosures from time to time in accordance with the procedures set forth below. Such disclosures may include achievement of milestones, significant events in the development and regulatory process, commercialization activities and the like. Except for the initial press releases described in Section 14.3.29.4.1, whenever a Party (the “Requesting Party”) elects to make any such public disclosure, it shall first notify the other Party (the “Cooperating Party”) of such planned press release or public announcement and provide a draft for review at least three Business Days [***] [***] in advance of issuing such press release or making such public announcement (or, with respect to press releases and public announcements that are required by applicable Law, or by regulation or rule of any public stock exchangeexchange (including NASDAQ), with as much advance notice as possible under the circumstances if it is not possible to provide notice at least three Business Days [***] [***] in advance); provided, however, that a Party may issue such press release or public announcement without such prior review by the other Party if (ai) the *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing Party; , (bii) such press release or public announcement does not materially differ from the previously issued press release or other publicly available information; (c) such press release solely relates to the achievement of milestone events under Section 9.3 and Section 9.4 and payments (including amounts) therefore; , and (diii) such press release or public announcement does not contain the other Party’s name. The Cooperating Party may notify the Requesting Party -85- of any reasonable objections or suggestions that the Cooperating Party may have regarding the proposed press release or public announcement, and the Requesting Party shall reasonably consider any such objections or suggestions that are provided in a timely manner. The principles to be observed in such disclosures shall include accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of the FDA (and its foreign counterparts) and the need to keep investors informed regarding the Requesting Party’s business.
Appears in 1 contract
Samples: Collaboration and License Agreement (Alector, Inc.)
Further Publicity. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Licensed Products in the Field and other activities in connection with this Agreement that may include information that is not otherwise permitted to be disclosed under this ARTICLE X, and that may be beyond what is required by law, and each Party may make such disclosures from time to time in accordance with the procedures set forth below. Such disclosures may include achievement of milestones, significant events in the development and regulatory process, commercialization activities and the like. Except for the initial press releases described in Section 14.3.210.4.1 or any disclosure made pursuant to the provisions set forth in Sections 10.1, 10.3 or 10.5, neither Party will issue any press release or public announcement relating to the terms and conditions of this Agreement without the prior written approval of the other Party (such approval not to be unreasonably withheld), provided however, (a) whenever a Party (the “Requesting Party”) elects to make any such public disclosure, it shall first notify the other Party (the “Cooperating Party”) of such planned press release or public announcement and provide a draft for review at least three [***] Business Days in advance of issuing such press release or making such public announcement (or, with respect to press releases and public announcements that are required by applicable Law, or by regulation or rule of any public stock exchangeexchange (including NASDAQ), with as much advance notice as possible under the circumstances if it is not possible to provide notice at least three [***] Business Days in advance); provided, however, that a Party may issue such press release or public announcement without such prior review or approval by the other Party if (ai) the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing Party; , (bii) such press release or public announcement does not materially differ from the previously issued press release or other publicly available information; , or (c) such press release solely relates to the achievement of milestone events under Section 9.3 and Section 9.4 and payments (including amounts) therefore; and (diii) such press release or public announcement does not contain the other Party’s name. The Cooperating Party may notify the Requesting Party -85- of any reasonable objections or suggestions that the Cooperating Party may have regarding the proposed press release or public announcement, and the Requesting Party shall reasonably consider any such objections or suggestions that are provided in a timely manner. The principles to be observed in such disclosures shall include accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of the FDA (and its foreign counterparts) and the need to keep investors informed regarding the Requesting Party’s business.
Appears in 1 contract
Samples: Collaboration and License Agreement (Arcellx, Inc.)