Further Publicity; Publications. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Licensed Product in the Field, and each Party may make such disclosures from time to time, subject to this Section 8.2.2 (Further Publicity; Publications). Such disclosures may include achievement of milestones, significant events in the Development process with respect to Licensed Products, Commercialization activities with respect to Licensed Products and the like. Except for the initial press releases described in Section 8.2.1 (Initial Press Releases): (a) Whenever either Party elects to make any such public disclosure, it will first notify the other Party of such planned press release or public announcement and provide a draft for review no less than [***] 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, with as much advance notice as possible under the circumstances if it is not possible to provide notice no less than [***] in advance). Each Party will 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 Licensed Products, or that includes Confidential Information of the other Party; provided, however, that (i) the reviewing Party will attempt to provide such approval as soon as reasonably possible and will not unreasonably withhold such approval; (ii) the reviewing Party will provide explanations of its disapproval of such press release; and (iii) 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 (A) the entire contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by such Party, and (B) such press release or public announcement does not materially differ from a previously issued press release or other publicly available information; and provided, further, that the other Party will have the right to 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 8.2 (Publicity; Publications). The Party reviewing a press release provided under this Section 8.2.2(a) (Further Publicity) will review and approve or disapprove such press release within [***] after its receipt thereof. (b) The principles to be observed in such disclosures will include accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of Regulatory Authorities and the need to keep investors informed regarding the business of the Party making such public disclosure. Nothing in this Section 8.2 (Publicity) will restrict a Party from making a disclosure required by Law as reasonably determined by such Party’s counsel, including disclosures required by any laws or regulations relating to the public sale of securities; provided, however, that such disclosure will include the minimum amount of Confidential Information required by such applicable laws and regulations, and the Parties will use reasonable efforts to seek confidential treatment of Confidential Information to be included in such disclosures. (c) In the event that either Party proposes to publish or present the results of Development or Commercialization carried out on a Licensed Product, such publication or presentation will be subject to the prior review by the other Party for patentability and protection of such other Party’s Confidential Information. Each Party will provide to the other Party the opportunity to review any proposed abstracts, manuscripts or summaries of presentations that cover the results of Development or Commercialization of Licensed Products during the Term. The other Party will respond in writing promptly and in no event later than [***] after receipt of the proposed material with either approval of the proposed material or a specific statement of concern, based upon either the need to seek patent protection or concern regarding competitive disadvantage arising from the proposal. In the event of any such concern, the submitting Party agrees not to submit such publication or to make such presentation that contains such information until the other Party is given a reasonable period of time to seek patent protection for any material in such publication or presentation that it believes is patentable or to resolve any other issues, and the submitting Party will remove from such proposed publication any Confidential Information of the other Party as requested by such other Party. The Parties acknowledge that Pfizer has certain review and approval rights with respect to publications relating to the Development of Licensed Products under Section 14.2 of the Pfizer License Agreement, and the Parties agree that such rights shall apply to any such publications under this Agreement, provided that, PUMA shall be required to obtain any such approvals from Pfizer within the [***] period required by this Section 8.2.2(c) (Further Publicity; Publications).
Appears in 1 contract
Sources: Collaboration and License Agreement (Puma Biotechnology, Inc.)
Further Publicity; Publications. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Licensed Product in the FieldField in a territory, and each Party may make such disclosures from time to time, subject to this Section 8.2.2 (Further Publicity; Publications8.2(b). Such disclosures may include achievement of milestones, significant events in the Development process with respect to Licensed Products, Commercialization activities with respect to Licensed Products and any significant results or events that would materially affect prospects of the likeLicensed Products. Except for the initial press releases described in Section 8.2.1 (Initial Press Releases8.2(a):
(ai) Whenever either any Party elects to make any such public disclosure, it will first notify the other Party Parties of such planned press release or public announcement and provide a draft for review no less than [***] 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 LawLaws, with as much advance notice as possible under the circumstances if it is not possible to provide notice no less than [***] in advance). Each Party will have the right to review and approve any such planned press release or public announcement proposed by the any other Party, including any oral presentation presentation, abstract or abstractmanuscript, that contains clinical data or pertains to results of Clinical Studies or other studies with respect to Licensed Products, or that includes Confidential Information of the such other Party; provided, however, that (iA) the reviewing Party will attempt to review and provide such approval comments as soon as reasonably possible and will not unreasonably withhold such approvalapproval if any Confidential Information of such reviewing Party is removed; (iiB) the reviewing Party will provide explanations of its disapproval of such press releaserelease or public announcement or presentation or publication; and (iiiC) a Party desiring to make such public disclosure may issue such press release or public announcement do so without such prior review by the other Party Parties if (A1) the entire contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by such Party, and (B2) such press release or public announcement does not materially differ from a previously issued press release or other publicly available information; and provided, further, that the other Party Parties will have the right to review, but not approve, any press release or public announcement that the proposing Party determines is required by applicable Law Laws based on the advice of counsel, which public disclosures are subject to Section 8.2 (Publicity; Publications)8.2. The Party reviewing a press release provided under this clause (A) of this Section 8.2.2(a) (Further Publicity8.2(b)(i) will review review, provide an initial round of feedback and approve or disapprove such press release within [***] after its receipt thereof.
(bii) The principles to be observed in such disclosures will include accuracy, compliance with applicable Law Laws and regulatory guidance documents, reasonable sensitivity to potential negative reactions of Regulatory Authorities and the need to keep investors informed regarding the business of the Party making such public disclosure. Nothing in this Section 8.2 (Publicity) will restrict a Party from making a disclosure required by Law Laws as reasonably determined by such Party’s counsel, including disclosures required by any laws or regulations Laws relating to the public sale of securities; provided, however, that such disclosure will include the minimum amount of Confidential Information required by such applicable laws and regulationsLaws, and the Parties will use reasonable efforts to seek confidential treatment of Confidential Information to be included in such disclosures.
(ciii) For any proposed disclosure of scientific findings related to the activities under this Agreement, Company and Licensee will develop a mutually agreed upon publication plan for such findings in advance of such disclosure. In the event that either Party proposes to publish or present the results of Development or Commercialization carried out on a the Licensed Product, such publication or presentation will be subject to the prior review by the other Party for patentability and protection of such other Party’s Confidential Information. In addition, such publishing Party shall agree to follow abide by the standards and guidelines, as amended from time to time, promulgated by the International Committee of Medical Journal Editors (ICMJE) and good publication practice (GPP3) with regard to scientific publications and presentations. Each Party will provide to the other Party the opportunity to review any proposed abstracts, manuscripts or summaries of presentations that cover the results of Development or Commercialization of Licensed Products during the Term. The other Party will respond in writing promptly and in no event later than than; (a) [***] after receipt prior to the intended submission of a manuscript for publication or (b) [***] prior to the proposed material intended submission of an abstract; with either approval of the proposed material or a specific statement of concern, based upon either the need to seek patent protection or concern regarding competitive disadvantage arising from the proposal. In the event of any such concern, the submitting Party agrees not to submit such publication or to make such presentation that contains such information until the other Party is given a reasonable period of time (in any event, not to exceed [***]) to seek patent protection for any material in such publication or presentation that it believes is patentable or to resolve any other issues, and the submitting Party will remove from such proposed publication any Confidential Information of the other Party as requested by such other Party. The Parties acknowledge that Pfizer has certain review and approval rights with respect to publications relating to the Development of Licensed Products under Section 14.2 of the Pfizer License Agreement, and the Parties agree that such rights shall apply to any such publications under this Agreement, provided that, PUMA shall be required to obtain any such approvals from Pfizer within the [***] period required by this Section 8.2.2(c) (Further Publicity; Publications).
Appears in 1 contract
Further Publicity; Publications. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Licensed Product in the Field, and each Party may make such disclosures from time to time, subject to this Section 8.2.2 (Further Publicity; Publications). Such disclosures may include achievement of milestones, significant events in the Development process with respect to Licensed the Products, Commercialization activities with respect to Licensed the Products and the like. Except for the initial press releases described in Section 8.2.1 (Initial Press Releases):
(a) Whenever either Party elects to make any such public disclosure, it will first notify the other Party of such planned press release or public announcement and provide a draft for review 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, with as much advance notice as possible under the circumstances if it is not possible to provide notice no less than [***] Business Days in advance). Each Party will 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 Licensed Productsthe Product, or that includes Confidential Information of the other Party; provided, however, that (iA) the reviewing Party will attempt to provide such approval as soon as reasonably possible and will not unreasonably withhold such approval; (iiB) the reviewing Party will provide explanations of its disapproval of such press release; and (iiiC) 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 entire contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by such Party, and (Bii) such press release or public announcement does not materially differ from a previously issued press release or other publicly available information; and provided, further, that the other Party will have the right to 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 8.2 (Publicity; Publications). The Party reviewing a press release provided under this Section 8.2.2(a) (Further Publicity) will review and approve or disapprove such press release within [***] Business Days after its receipt thereof.
(b) The principles to be observed in such disclosures will include accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of Regulatory Authorities and the need to keep investors informed regarding the business of the Party making such public disclosure. Nothing in this Section 8.2 (Publicity) will restrict a Party from making a disclosure required by Law as reasonably determined by such Party’s counsel, including disclosures required by any laws or regulations relating to the public sale of securities; provided, however, that such disclosure will include the minimum amount of Confidential Information required by such applicable laws and regulations, and the Parties will use reasonable efforts to seek confidential treatment of Confidential Information to be included in such disclosuresdisclosures to the greatest extent possible under such laws and regulations.
(c) In the event that either Party proposes to publish or present the results of Development or Commercialization carried out on a Licensed the Product, such publication or presentation will be subject to the prior review by the other Party for patentability and protection of such other Party’s Confidential Information. Each Party will provide to the other Party the opportunity to review any proposed abstracts, manuscripts or summaries of presentations that cover the results of Development or Commercialization of Licensed Products the Product during the Term. The other Party will respond in writing promptly and in no event later than [***] days after receipt of the proposed material with either approval of the proposed material or a specific statement of concern, based upon either the need to seek patent protection or concern regarding competitive disadvantage arising from the proposal. In the event of any such concern, the submitting Party agrees not to submit such publication or to make such presentation that contains such information until the other Party is given a reasonable period of time to seek patent protection for any material in such publication or presentation that it believes is patentable or to resolve any other issues, and the submitting Party will remove from such proposed publication any Confidential Information of the other Party as requested by such other Party. The Parties acknowledge that Pfizer has certain review and approval rights with respect to publications relating to the Development of Licensed Products under Section 14.2 of the Pfizer License Agreement, and the Parties agree that such rights shall apply to any such publications under this Agreement, provided that, PUMA shall be required to obtain any such approvals from Pfizer within the [***] period required by this Section 8.2.2(c) (Further Publicity; Publications).
Appears in 1 contract
Sources: Collaboration and License Agreement (Aveo Pharmaceuticals Inc)