Press Releases and Publications. (a) The Parties shall jointly agree (such agreement not to be unreasonably withheld by either Party) to the content and timing of all public communications with respect to this Agreement (including without limitation press release(s) pertaining to execution of this Agreement (if any) and other press releases), Q&As, and the content of, and wording for, any listing of the Combined Therapy Clinical Trials required to be listed on a public database or other public registry (such as wxx.xxxxxxxxxxxxxx.xxx). For clarity, if either Party terminates this Agreement pursuant to Section 11.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties; provided that either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity. (b) Olema shall have the exclusive right to publicly disclose, publish or present (i) top-line results from the Combined Therapy Clinical Trials, limited [***], solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either Party under applicable securities laws, and (ii) the conclusions and outcomes of the Combined Therapy Clinical Trials (the “Results”), as set forth in the Final Study Report, at a scientific conference as soon as reasonably practicable following the completion of such Combined Therapy Clinical Trials, subject in the case of (ii) to the following terms and conditions. Olema shall deliver to Novartis a copy of the proposed disclosure, publication or presentation at least [***] before submission to a Third Party. Novartis shall determine whether any of its Confidential Information that is contained in such proposed disclosure, publication or presentation should be modified or deleted, and whether to file a patent application on any Novartis Study Invention disclosed therein. The disclosure, publication or presentation shall be delayed for an additional [***] (i.e., a total [***] from the initial proposal) if Novartis reasonably requests such extension to allow time for the preparation and filing of relevant patent applications directed to a Novartis Study Invention. If Novartis reasonably requests modifications to the disclosure, publication or presentation to prevent the disclosure of Confidential Information of Novartis (other than the Results or Combined Therapy Study Data), Olema shall [***]. In the event of a disagreement as to content, timing and/or venue or forum for any disclosure, publication or presentation of the Results, such dispute (a “Publication Dispute”) shall be referred to the Executive Officers (or their respective designees); provided that, in the absence of agreement after such good faith discussions, and upon expiration of the additional [***]-period, (A) academic collaborators or Study Sites engaged by Olema in connection with the performance of the Combined Therapy Clinical Trials may publish Combined Therapy Study Data obtained by such academic collaborator or Study Site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between Olema and such academic collaborator or Study Site relating to the conduct of Combined Therapy Clinical Trials and (B) Olema may proceed with the disclosure, publication or presentation provided that such disclosure, publication or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the Confidential Information of Novartis (other than the Results or Combined Therapy Study Data). Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication or presentation. The Parties agree that they shall make reasonable efforts to prevent publication of a press release that could jeopardize the future publication of Study Data at a scientific conference or in a scientific journal but in no way will this or any other provision of this Agreement supersede the requirements of any Applicable Law or the rules or regulations of any securities exchange or listing entity on which a Party’s stock is listed (including any such rule or regulation that may require a Party to make public disclosures about interim results of the Combined Therapy Clinical Trials). (c) Olema agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials specific mention, if applicable, of the Novartis Study Drugs and the support and involvement of Novartis. Subject to the limitation set forth in this Section 8.4, Novartis agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials specific mention, if applicable, of Olema Study Drug and the support and involvement of Olema.
Appears in 2 contracts
Samples: Clinical Collaboration and Supply Agreement (Olema Pharmaceuticals, Inc.), Clinical Collaboration and Supply Agreement (Olema Pharmaceuticals, Inc.)
Press Releases and Publications. (a) The Parties shall jointly agree (such agreement not to be unreasonably withheld by either Party) to the content and timing of all public communications with respect to this Agreement (including without limitation press release(s) pertaining to execution of this Agreement (if any) and other Agreement, press releases), Q&As, and the content of, and wording for, any listing of the Combined Therapy Clinical Trials Trial required to be listed on a public database or other public registry (such as wxx.xxxxxxxxxxxxxx.xxxxxx.xxxxxxxxxxxxxx.xxx). For clarity, if either Party terminates this Agreement pursuant to Section 11.412.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties; provided that . Notwithstanding the foregoing in this Section 9.5(a), either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity.
(b) Olema shall have the exclusive right The Recipient and BMS agree to collaborate to publicly disclose, publish or present (i) top-line results from the Combined Therapy Clinical TrialsTrial, limited [***]if possible to avoid jeopardizing the future publication of the Study Data at a scientific conference or in a scientific journal, solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either Party under applicable securities laws, and (ii) the conclusions and outcomes (the “Results”) of the Combined Therapy Clinical Trials (the “Results”), as set forth in the Final Study Report, Trial at a scientific conference as soon as reasonably practicable following the completion of database lock date for such Combined Therapy Clinical TrialsTrial, subject in the case of (ii) to the following terms and conditions. Olema The Party proposing to disclose, publish or present the Results shall deliver to Novartis the other Party a copy of the proposed disclosure, publication or presentation at least [***] before submission to a Third Party. Novartis The reviewing Party shall determine whether any of its Confidential Information that is may be contained in such proposed disclosure, publication or presentation should be modified or deleted, and whether to file a patent application on any Novartis Recipient Study Invention (solely with respect to the Recipient) or BMS Study Invention (solely with respect to BMS) or Combined Therapy Invention disclosed therein. The disclosure, publication or presentation shall be delayed for an additional [***] (i.e., a total of [***] from the initial proposal) if Novartis the reviewing Party reasonably requests such extension to allow time for the preparation and filing of relevant patent applications directed to a Novartis Study Inventionconsistent with the terms of this Agreement. If Novartis the reviewing Party reasonably requests modifications to the disclosure, publication or presentation to prevent the disclosure of Confidential Information of Novartis the reviewing Party (other than the Results or Combined Therapy Study Data), Olema the publishing Party shall [***]edit such publication to prevent the disclosure of such information prior to submission of the disclosure, publication or presentation. In the event of a disagreement as to content, timing and/or venue or forum for any disclosure, publication or presentation of the Results, such dispute (a “Publication Dispute”) shall be referred to the Executive Officers (or their respective designees); provided that, in the absence of agreement after such good faith discussions, and upon expiration of the additional [***]-period] period, (A) academic collaborators or Study Sites clinical trial sites engaged by Olema the Recipient in connection with the performance of the Combined Therapy Clinical Trials Trial may publish Combined Therapy Study Data obtained by such academic collaborator or Study Site clinical trial site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between Olema the Recipient and such academic collaborator or Study Site clinical trial site relating to the conduct of Combined Therapy Clinical Trials Trial and (B) Olema the publishing Party may proceed with the disclosure, publication or presentation provided that such disclosure, publication or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the Confidential Information of Novartis the other Party (other than the Results or Combined Therapy Study Data). Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication or presentation. The Parties agree that they shall make reasonable efforts to prevent publication of a press release that could jeopardize the future publication of Study Data at a scientific conference or in a scientific journal but in no way will this or any other provision of this Agreement supersede the requirements of any Applicable Law or the rules or regulations of any securities exchange or listing entity on which a Party’s stock is listed (including any such rule or regulation that may require a Party to make public disclosures about interim results of the Combined Therapy Clinical TrialsTrial). Notwithstanding the foregoing, nothing herein shall prevent or restrict Ono from making any disclosures of published Study Data disclosed to it by BMS pursuant to Section 9.4 or of the existence of this Agreement, in each case in order for Ono to comply with requirements of Applicable Law, the rules or regulations of any securities exchange or listing entity on which its stock may be traded or pursuant to an order of a court or governmental entity to publicly disclose the existence of the Agreement and the Study Data, provided that if any such disclosure is made by Ono it will only disclose the minimum amount of information necessary to achieve compliance and will provide the Recipient with reasonable advance notice of such disclosure.
(c) Olema The Recipient agrees to include in all permitted press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials Trial specific mention, if applicable, of the Novartis BMS Study Drugs Drug and the support and involvement of NovartisBMS. Subject to the limitation set forth in this Section 8.4, Novartis BMS agrees to include in all permitted press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials Trial specific mention, if applicable, of Olema the Recipient Study Drug and the support and involvement of Olemathe Recipient.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Replimune Group, Inc.)
Press Releases and Publications. (a) The Parties shall jointly agree (such agreement not to be unreasonably withheld by either Party) to the content and timing of all public external communications with respect to this Agreement (including including, without limitation limitation, an initial press release(s) pertaining to execution release, the content of this Agreement (if any) and other which shall be as attached hereto as Exhibit D, subsequent press releases), Q&As, and the content of, and wording for, for of any listing of the any Combined Therapy Clinical Trials Trial required to be listed on a public database or other public registry (such as wxx.xxxxxxxxxxxxxx.xxxxxx.xxxxxxxxxxxxxx.xxx). For clarity, if either Party terminates this Agreement pursuant to Section 11.412.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties; provided that either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity.
(b) Olema shall have the exclusive right Exelixis and BMS agree to collaborate to publicly disclose, publish or present (i1) top-line results from the each Combined Therapy Clinical TrialsTrial, limited [***]if possible to avoid jeopardizing the future publication of the Study Data at a scientific conference or in a scientific journal, solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either any Party under applicable securities laws, and (ii2) the conclusions and outcomes of the Combined Therapy Clinical Trials (the “Results”), as set forth in the Final Study Report, ) of each Combined Therapy Trial at a scientific conference as soon as reasonably practicable following the completion of such Combined Therapy Clinical TrialsTrial, subject in the case of (ii2) to the following terms and conditions. Olema The Party proposing to disclose, publish or present the Results shall deliver to Novartis each other Party a copy of the proposed disclosure, publication or presentation at least [***[ * ] before submission to a Third Party. Novartis Each reviewing Party shall determine whether any of its Confidential Information that is may be contained in such proposed disclosure, publication or presentation should be modified or deleted, and whether to file a patent application on any Novartis Exelixis Study Invention (solely with respect to Exelixis) or BMS Study Invention (solely with respect to BMS) or Combined Therapy Invention disclosed therein. The disclosure, publication or presentation shall be delayed for an additional [***[ * ] (i.e., a total [***of [ * ] from the initial proposal) if Novartis a reviewing Party reasonably requests such extension to allow time for the preparation and filing of relevant patent applications directed to a Novartis Study Inventionapplications. If Novartis a reviewing Party reasonably requests modifications to the disclosure, publication or presentation to prevent the disclosure of Confidential Information a material trade secret or proprietary business Page 49 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of Novartis (other than the Results Securities Exchange Act of 1934, as amended. information, the publishing Party shall edit such publication to prevent the disclosure of such information prior to submission of the disclosure, publication or Combined Therapy Study Data), Olema shall [***]presentation. In the event of a disagreement as to content, timing and/or venue or forum for any disclosure, publication or presentation of the Results, such dispute (a “Publication Dispute”) shall be referred to the Executive Officers (or their respective designees); provided that, in the absence of agreement after such good faith discussions, and upon expiration of the additional [***[ * ]-period, (A) academic collaborators or Study Sites engaged by Olema the Conducting Party in connection with the performance of the Combined Therapy Clinical Trials may publish Combined Therapy Study Data obtained by such academic collaborator or Study Site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between Olema the Conducting Party and such academic collaborator or Study Site relating to the conduct of Combined Therapy Clinical Trials and (B) Olema the publishing Party may proceed with the disclosure, publication or presentation provided that such disclosure, publication or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the Confidential Information of Novartis (other than the Results or Combined Therapy Study Data)data. Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication or presentation. The Parties agree that they shall make reasonable efforts to prevent publication of a press release that could jeopardize the future publication of Study Data at a scientific conference or in a scientific journal but in no way will this or any other provision of this Agreement supersede the requirements of any Applicable Law or the rules or regulations of any securities exchange or listing entity on which a Party’s stock is listed (including including, but not limited to, any such rule or regulation that may require a Party to make public disclosures about interim results of the a Combined Therapy Clinical TrialsTrial).
(c) Olema agrees . Notwithstanding the foregoing, Exelixis hereby authorizes disclosure to include Ono in all press releasesaccordance with Section 9.4 above, presentations and publications BMS hereby authorized disclosure to Ipsen and Takeda in accordance with Section 9.5 above. Notwithstanding the foregoing, nothing herein shall prevent or restrict Ono, Ipsen or Takeda from making any disclosures of published Study Data disclosed to it makes related by BMS pursuant to the Combined Therapy Clinical Trials specific mention, if applicable, Section 9.4 or Exelixis pursuant to Section 9.5 of the Novartis Study Drugs existence of this Agreement, in each case in order for Ono, Ipsen or Takeda to comply with requirements of Applicable Law, the rules or regulations of any securities exchange or listing entity on which its stock may be traded or pursuant to an order of a court or governmental entity to publicly disclose the existence of the Agreement and the support and involvement of Novartis. Subject to the limitation set forth in this Section 8.4, Novartis agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials specific mention, if applicable, of Olema Study Drug and the support and involvement of OlemaData.
Appears in 1 contract
Press Releases and Publications. (a) The Parties shall jointly agree (such agreement not to be unreasonably withheld by either Party) to the content and timing of all public communications with respect to this Agreement (including without limitation press release(s) pertaining to execution of this Agreement (if any) and other Agreement, press releases), Q&As, and the content of, and wording for, any listing of the Combined Therapy Clinical Trials Trial required to be listed on a public database or other public registry (such as wxx.xxxxxxxxxxxxxx.xxxxxx.xxxxxxxxxxxxxx.xxx). For clarity, if either Party terminates this Agreement pursuant to Section 11.412.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties; provided that . Notwithstanding the foregoing in this Section 9.5(a), either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity.
(b) Olema shall have the exclusive right The Recipient and BMS agree to collaborate to publicly disclose, publish or present (i) top-line results from the Combined Therapy Clinical TrialsTrial, limited [***]if possible to avoid jeopardizing the future publication of the Study Data at a scientific conference or in a scientific journal, solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either Party under applicable securities laws, and (ii) the conclusions and outcomes (the “Results”) of the Combined Therapy Clinical Trials (the “Results”), as set forth in the Final Study Report, Trial at a scientific conference as soon as reasonably practicable following the completion of database lock date for such Combined Therapy Clinical TrialsTrial, subject in the case of (ii) to the following terms and conditions. Olema The Party proposing to disclose, publish or present the Results shall deliver to Novartis the other Party a copy of the proposed disclosure, publication or presentation at least [***] [ ]* before submission to a Third Party. Novartis The reviewing Party shall determine whether any of its Confidential Information that is may be contained in such proposed disclosure, publication or presentation should be modified or deleted, and whether to file a patent application on any Novartis Recipient Study Invention (solely with respect to the Recipient) or BMS Study Invention (solely with respect to BMS) or Combined Therapy Invention disclosed therein. The disclosure, publication or presentation shall be delayed for an additional [***] [ ]* (i.e., a total [***] of [ ]* from the initial proposal) if Novartis the reviewing Party reasonably requests such extension to allow time for the preparation and filing of relevant patent applications directed to a Novartis Study Inventionconsistent with the terms of this Agreement. If Novartis the reviewing Party reasonably requests modifications to the disclosure, publication or presentation to prevent the disclosure of Confidential Information of Novartis the reviewing Party (other than the Results or Combined Therapy Study Data), Olema the publishing Party shall [***]edit such publication to prevent the disclosure of such information prior to submission of the disclosure, publication or presentation. In the event of a disagreement as to content, timing and/or venue or forum for any disclosure, publication or presentation of the Results, such dispute (a “Publication Dispute”) shall be referred to the Executive Officers (or their respective designees); provided that, in the absence of agreement after such good faith discussions, and upon expiration of the additional [***[ ]* -period, (A) academic collaborators or Study Sites clinical trial sites engaged by Olema the Recipient in connection with the performance of the Combined Therapy Clinical Trials Trial may publish Combined Therapy Study Data obtained by such academic collaborator or Study Site clinical trial site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between Olema the Recipient and such academic collaborator or Study Site clinical trial site relating to the conduct of Combined Therapy Clinical Trials Trial and (B) Olema the publishing Party may proceed with the disclosure, publication or presentation provided that such disclosure, publication or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the Confidential Information of Novartis the other Party (other than the Results or Combined Therapy Study Data). Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication or presentation. The Parties agree that they shall make reasonable efforts to prevent publication of a press release that could jeopardize the future publication of Study Data at a scientific conference or in a scientific journal but in no way will this or any other provision of this Agreement supersede the requirements of any Applicable Law or the rules or regulations of any securities exchange or listing entity on which a Party’s stock is listed (including any such rule or regulation that may require a Party to make public disclosures about interim results of the Combined Therapy Clinical TrialsTrial). Notwithstanding the foregoing, nothing herein shall prevent or restrict Ono from making any disclosures of published Study Data disclosed to it by BMS pursuant to Section 9.4 or of the existence of this Agreement, in each case in order for Ono to comply with requirements of Applicable Law, the rules or regulations of any securities exchange or listing entity on which its stock may be traded or pursuant to an order of a court or governmental entity to publicly disclose the existence of the Agreement and the Study Data, provided that if any such disclosure is made by Ono it will only disclose the minimum amount of information necessary to achieve compliance and will provide the Recipient with reasonable advance notice of such disclosure.
(c) Olema The Recipient agrees to include in all permitted press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials Trial specific mention, if applicable, of the Novartis BMS Study Drugs Drug and the support and involvement of NovartisBMS. Subject to the limitation set forth in this Section 8.4, Novartis BMS agrees to include in all permitted press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials Trial specific mention, if applicable, of Olema the Recipient Study Drug and the support and involvement of Olemathe Recipient.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Replimune Group, Inc.)
Press Releases and Publications. (a) The Parties shall jointly agree (such agreement not to be unreasonably withheld by either Party) to the content and timing of all public communications with respect to this Agreement (including without limitation except for the initial press release(s) pertaining to execution of announcing this Agreement (if any) and other which are attached hereto as Appendix B), subsequent press releases), Q&As, and the content of, and wording for, any listing of the Combined Therapy Clinical Trials Trial required to be listed on a public database or other public registry (such as wxx.xxxxxxxxxxxxxx.xxxxxx.xxxxxxxxxxxxxx.xxx). For clarity, if either Party terminates this Agreement pursuant to Section 11.412.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties; provided that either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity.
(b) Olema shall have the exclusive right The Recipient and BMS agree to collaborate to publicly disclose, publish or present (i) top-line results from the Combined Therapy Clinical TrialsTrial, limited [***]if possible to avoid jeopardizing the future publication of the Study Data at a scientific conference or in a scientific journal, solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either Party under applicable securities laws, and (ii) the conclusions and outcomes (the “Results”) of the Combined Therapy Clinical Trials (the “Results”), as set forth in the Final Study Report, Trial at a scientific conference as soon as reasonably practicable following the completion of such Combined Therapy Clinical TrialsTrial, subject in the case of (ii) to the following terms and conditions. Olema The Party proposing to disclose, publish or present the Results shall deliver to Novartis the other Party a copy of the proposed disclosure, publication or presentation at least [***] before submission to a Third Party. Novartis The reviewing Party shall determine (i) whether information related to its Study Drug is reported and described in medically and scientifically accurate manner and whether this information should be modified or deleted (ii) whether any of its Confidential Information that is may be contained in such proposed disclosure, publication or presentation should be modified or deleted, deleted and whether (iii)whether to file a patent application on any Novartis Recipient Study Invention (solely with respect to the Recipient) or BMS Study Invention (solely with respect to BMS) or Combined Therapy Invention disclosed therein. The disclosure, publication or presentation shall be delayed for an additional [***] (i.e., a total of [***] from the initial proposal) if Novartis the reviewing Party reasonably requests such extension to allow time for the preparation and filing of relevant patent applications directed to a Novartis Study Inventionapplications. If Novartis the reviewing Party reasonably requests modifications to the disclosure, publication or presentation to prevent the disclosure of Confidential Information of Novartis the reviewing Party (other than the Results or Combined Therapy Study Data) or to correct the medical or scientific accuracy of information associated with its Study Drug (other than the Results or Study Data), Olema the publishing Party shall [***]edit such publication to prevent the disclosure of such information or correct inaccurate medical or scientific information prior to submission of the disclosure, publication or presentation. In the event of a disagreement as to content, timing and/or venue or forum for any disclosure, publication or presentation of the Results, such dispute (a “Publication Dispute”) shall be referred to the Executive Officers (or their respective designees); provided that, in the absence of agreement after such good faith discussions, and upon expiration of the additional [***]-period, (A) academic collaborators or Study Sites clinical trial sites engaged by Olema the Recipient in connection with the performance of the Combined Therapy Clinical Trials Trial may publish Combined Therapy Study Data obtained by such academic collaborator or Study Site clinical trial site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between Olema the Recipient and such academic collaborator or Study Site clinical trial site relating to the conduct of Combined Therapy Clinical Trials Trial and (B) Olema the publishing Party may proceed with the disclosure, publication or presentation provided that such disclosure, publication or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the Confidential Information of Novartis the other Party (other than the Results or Combined Therapy Study Data). Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication or presentation. The Parties agree that they shall make reasonable efforts to prevent publication of a press release that could jeopardize the future publication of Study Data at a scientific conference or in a scientific journal but in no way will this or any other provision of this Agreement supersede the requirements of any Applicable Law or the rules or regulations of any securities exchange or listing entity on which a Party’s stock is listed (including any such rule or regulation that may require a Party to make public disclosures about interim results of the Combined Therapy Clinical TrialsTrial). Notwithstanding the foregoing, nothing herein shall prevent or restrict [**] from making any disclosures of unpublished Study Data disclosed to it by BMS pursuant to Section 9.4 or of the existence of this Agreement, in each case in order for [**] to comply with requirements of Applicable Law, the rules or regulations of any securities exchange or listing entity on which its stock may be traded or pursuant to an order of a court or governmental entity to publicly disclose the existence of the Agreement and the Study Data, provided that if any such disclosure is made by Ono it will only disclose the minimum amount of information necessary to achieve compliance and will provide the Recipient with reasonable advance notice of such disclosure.
(c) Olema The Recipient agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials Trial specific mention, if applicable, of the Novartis BMS Study Drugs Drug and the support and involvement of NovartisBMS. Subject to the limitation set forth in this Section 8.4, Novartis BMS agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials Trial specific mention, if applicable, of Olema the Recipient Study Drug and the support and involvement of Olemathe Recipient.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Aveo Pharmaceuticals, Inc.)
Press Releases and Publications. (a) The Parties shall jointly agree (such agreement not to be unreasonably withheld by either Party) to the content and timing of all public external communications with respect to this Agreement Agreement, including an initial press release by Exelixis, the content of which shall be as [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (including without limitation press release(sI) pertaining to execution of this Agreement not material and (II) would be competitively harmful if any) and other publicly disclosed. 26 attached hereto as Exhibit B, subsequent press releases), media Q&As, and the content of, and wording for, of any listing of the a Combined Therapy Clinical Trials required to be listed Trial on a public database or other public registry (such as wxx.xxxxxxxxxxxxxx.xxxxxxxxxxxxxxxxx.xxx). For clarity, if either Party terminates this Agreement pursuant to Section 11.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties; provided that either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity.
(b) Olema shall have the exclusive right Exelixis and Roche agree to collaborate to publicly disclose, publish publish, or present (with the Conducting Party to lead) (i) top-line results from the each Combined Therapy Clinical TrialsTrial, limited [***]if possible to avoid jeopardizing the future publication of the Study Data at a scientific conference or in a scientific journal, solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either any Party under applicable securities laws, and (ii) the conclusions and outcomes of the Combined Therapy Clinical Trials (the “Results”), as set forth in the Final Study Report, ) of each Combined Therapy Trial at a scientific conference as soon as reasonably practicable following the completion of such Combined Therapy Clinical TrialsTrial, subject in the case of (ii) to the following terms and conditions. Olema The Party proposing to disclose, publish, or present the Results shall deliver to Novartis the other Party a copy of the proposed disclosure, publication publication, or presentation presentation: (a) for abstracts, slide presentations or posters, at least [***[ * ] before prior to submission to a Third Party(in the case of abstracts) or first public presentation (in the case of slide presentations and posters); and (b) at least [ * ] in advance of first submission and each subsequent submission in the case of manuscripts; or (c) within such other timeframe as the Parties may agree. Novartis The reviewing Party shall determine whether any of its Confidential Information that is may be contained in such proposed disclosure, publication publication, or presentation should be modified or deleted, and whether to file a patent application on any Novartis Exelixis Study Invention (solely with respect to Exelixis) or Roche Study Invention (solely with respect to Roche) or Combined Therapy Invention disclosed therein. The disclosure, publication publication, or presentation shall be delayed for an additional [***[ * ] (i.e., if a total [***] from the initial proposal) if Novartis reviewing Party reasonably requests such extension to allow time for the preparation and filing of relevant patent applications directed to a Novartis Study Inventionapplications. If Novartis a reviewing Party reasonably requests modifications to the disclosure, publication publication, or presentation to prevent the disclosure of such Party’s Confidential Information Information, the publishing Party shall remove such information prior to submission of Novartis (other than the Results disclosure, publication, or Combined Therapy Study Data), Olema shall [***]presentation. In the event of a disagreement as to content, timing timing, and/or venue or forum for any disclosure, publication publication, or presentation of the Results, such dispute (a “Publication Dispute”) shall be referred to the Executive Officers (or their respective designees)) for resolution; provided that, in the absence of agreement after such good faith discussions, and upon expiration of the an additional [***[ * ]-period, (A) academic collaborators or Study Sites engaged by Olema the Conducting Party in connection with the performance of the Combined Therapy Clinical Trials may publish Combined Therapy Study Data obtained by such academic collaborator or Study Site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between Olema the Conducting Party and such academic collaborator or Study Site relating to the conduct of Combined Therapy Clinical Trials and (B) Olema the publishing Party may proceed with the disclosure, publication publication, or presentation provided that such disclosure, publication publication, or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the contain any Confidential Information of Novartis (other than the Results or Combined Therapy Study Data)non-publishing Party. Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication publication, or presentation. The Parties agree that they .
(c) Notwithstanding the foregoing, nothing herein shall make reasonable efforts to prevent publication or restrict Chugai, Ipsen, or Takeda from making any disclosures of a press release that could jeopardize the future publication of published Study Data at a scientific conference disclosed to it by Roche pursuant to Section 10.4 or in a scientific journal but in no way will this or any other provision Exelixis pursuant to Section 10.5 of the existence of this Agreement supersede the Agreement, in each case in order for Chugai, Ipsen, or Takeda to comply with requirements of any Applicable Law or Law, the rules or regulations of any securities exchange or listing entity on which its stock may be traded, or pursuant to an order of a Party’s stock is listed (including any such rule court or regulation that may require a Party governmental entity to make public disclosures about interim results publicly disclose the existence of the Combined Therapy Clinical Trials).
(c) Olema agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials specific mention, if applicable, of the Novartis Study Drugs Agreement and the support and involvement of Novartis. Subject to the limitation set forth in this Section 8.4, Novartis agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials specific mention, if applicable, of Olema Study Drug and the support and involvement of OlemaData.
Appears in 1 contract
Press Releases and Publications. (a) The Parties shall jointly agree (such agreement not to be unreasonably withheld by either Party) to the content and timing of all public external communications with respect to this Agreement (including including, without limitation limitation, an initial press release(s) pertaining to execution release, the content of this Agreement (if any) and other which shall be as attached hereto as Exhibit D, subsequent press releases), Q&As, and the content of, and wording for, for of any listing of the any Combined Therapy Clinical Trials Trial required to be listed on a public database or other public registry (such as wxx.xxxxxxxxxxxxxx.xxxxxx.xxxxxxxxxxxxxx.xxx). For clarity, if either Party terminates this Agreement pursuant to Section 11.412.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties; provided that either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity.
(b) Olema shall have the exclusive right Exelixis and BMS agree to collaborate to publicly disclose, publish or present (i1) top-line results from the each Combined Therapy Clinical TrialsTrial, limited [***]if possible to avoid jeopardizing the future publication of the Study Data at a scientific conference or in a scientific journal, solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either any Party under applicable securities laws, and (ii2) the conclusions and outcomes of the Combined Therapy Clinical Trials (the “Results”), as set forth in the Final Study Report, ) of each Combined Therapy Trial at a scientific conference as soon as reasonably practicable following the completion of such Combined Therapy Clinical TrialsTrial, subject in the case of (ii2) to the following terms and conditions. Olema The Party proposing to disclose, publish or present the Results shall deliver to Novartis each other Party a copy of the proposed disclosure, publication or presentation at least [***[ * ] before submission to a Third Party. Novartis Each reviewing Party shall determine whether any of its Confidential Information that is may be contained in such proposed disclosure, publication or presentation should be modified or deleted, and whether to file a patent application on any Novartis Exelixis Study Invention (solely with respect to Exelixis) or BMS Study Invention (solely with respect to BMS) or Combined Therapy Invention disclosed therein. The disclosure, publication or presentation shall be delayed for an additional [***[ * ] (i.e., a total [***of [ * ] from the initial proposal) if Novartis a reviewing Party reasonably requests such extension to allow time for the preparation and filing of relevant patent applications directed to a Novartis Study Inventionapplications. If Novartis a reviewing Party reasonably requests modifications to the disclosure, publication or presentation to prevent the disclosure of Confidential Information a material trade secret or proprietary business [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of Novartis (other than the Results Securities Exchange Act of 1934, as amended. information, the publishing Party shall edit such publication to prevent the disclosure of such information prior to submission of the disclosure, publication or Combined Therapy Study Data), Olema shall [***]presentation. In the event of a disagreement as to content, timing and/or venue or forum for any disclosure, publication or presentation of the Results, such dispute (a “Publication Dispute”) shall be referred to the Executive Officers (or their respective designees); provided that, in the absence of agreement after such good faith discussions, and upon expiration of the additional [***[ * ]-period, (A) academic collaborators or Study Sites engaged by Olema the Conducting Party in connection with the performance of the Combined Therapy Clinical Trials may publish Combined Therapy Study Data obtained by such academic collaborator or Study Site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between Olema the Conducting Party and such academic collaborator or Study Site relating to the conduct of Combined Therapy Clinical Trials and (B) Olema the publishing Party may proceed with the disclosure, publication or presentation provided that such disclosure, publication or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the Confidential Information of Novartis (other than the Results or Combined Therapy Study Data)data. Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication or presentation. The Parties agree that they shall make reasonable efforts to prevent publication of a press release that could jeopardize the future publication of Study Data at a scientific conference or in a scientific journal but in no way will this or any other provision of this Agreement supersede the requirements of any Applicable Law or the rules or regulations of any securities exchange or listing entity on which a Party’s stock is listed (including including, but not limited to, any such rule or regulation that may require a Party to make public disclosures about interim results of the a Combined Therapy Clinical TrialsTrial).
(c) Olema agrees . Notwithstanding the foregoing, Exelixis hereby authorizes disclosure to include Ono in all press releasesaccordance with Section 9.4 above, presentations and publications BMS hereby authorized disclosure to Ipsen and Takeda in accordance with Section 9.5 above. Notwithstanding the foregoing, nothing herein shall prevent or restrict Ono, Ipsen or Takeda from making any disclosures of published Study Data disclosed to it makes related by BMS pursuant to the Combined Therapy Clinical Trials specific mention, if applicable, Section 9.4 or Exelixis pursuant to Section 9.5 of the Novartis Study Drugs existence of this Agreement, in each case in order for Ono, Ipsen or Takeda to comply with requirements of Applicable Law, the rules or regulations of any securities exchange or listing entity on which its stock may be traded or pursuant to an order of a court or governmental entity to publicly disclose the existence of the Agreement and the support and involvement of Novartis. Subject to the limitation set forth in this Section 8.4, Novartis agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials specific mention, if applicable, of Olema Study Drug and the support and involvement of OlemaData.
Appears in 1 contract
Samples: Clinical Trial Collaboration Agreement (Exelixis, Inc.)
Press Releases and Publications. (a) The Parties shall jointly agree (such agreement not to be unreasonably withheld by either Party) to the content and timing of all public communications with respect to this Agreement (including without limitation except for the initial press release(s) pertaining to execution of release announcing this Agreement (if any) and other a draft of which is attached hereto as Appendix C), subsequent press releases), Q&As, and the content of, and wording for, any listing of the Combined Therapy Clinical Trials Trial required to be listed on a public database or other public registry (such as wxx.xxxxxxxxxxxxxx.xxxxxx.xxxxxxxxxxxxxx.xxx). For clarity, if either Party terminates this Agreement pursuant to Section 11.412.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties; provided that either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity.
(b) Olema shall have the exclusive right The Recipient and BMS agree to collaborate reasonably and in good faith to publicly disclose, publish or present (i) top-line results from the Combined Therapy Clinical TrialsTrial, limited [***]if possible to avoid jeopardizing the future publication of the Study Data at a scientific conference or in a scientific journal, solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either Party under applicable securities laws, and (ii) the conclusions and outcomes of the Combined Therapy Clinical Trials Trial (the “Results”), as set forth in the Final Study Report, at a scientific conference as soon as reasonably practicable following the completion of such Combined Therapy Clinical TrialsTrial, subject in the case of (ii) to the following terms and conditions. Olema The Party proposing to disclose, publish or present the Results or any of the Combined Therapy Study Data shall deliver to Novartis the other Party a copy of the proposed disclosure, publication or presentation at least [***] before submission to a Third Party. Novartis The reviewing Party shall determine whether any of its Confidential Information that is contained in such proposed disclosure, publication or presentation should be modified or deleted, and whether to file a patent application on any Novartis Recipient Study Invention (solely with respect to the Recipient) or BMS Study Invention (solely with respect to BMS) or Combined Therapy Invention disclosed therein. The disclosure, publication or presentation shall be delayed for an additional [***] (i.e., a total of [***] from the initial proposal) if Novartis the reviewing Party reasonably requests such extension to allow time for the preparation and filing of relevant patent applications directed to a Novartis Study Inventionapplications. If Novartis the reviewing Party reasonably requests modifications to the disclosure, publication or presentation to prevent the disclosure of Confidential Information of Novartis the reviewing Party (other than the Results or Combined Therapy Study Data), Olema the publishing Party shall [***]edit such publication to prevent the disclosure of such information prior to submission of the disclosure, publication or presentation. In the event of a disagreement as to content, timing and/or venue or forum for any disclosure, publication or presentation of the Results, such dispute (a “Publication Dispute”) shall be referred to the Executive Officers (or their respective designees); provided that, in the absence of agreement after such good faith discussions, and upon expiration of the additional [***]-period, (A) academic collaborators or Study Sites engaged by Olema the Recipient in connection with the performance of the Combined Therapy Clinical Trials Trial may publish Combined Therapy Study Data obtained by such academic collaborator or Study Site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between Olema the Recipient and such academic collaborator or Study Site relating to the conduct of Combined Therapy Clinical Trials Trial and (B) Olema the publishing Party may proceed with the disclosure, publication or presentation provided that such disclosure, publication or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the Confidential Information of Novartis the other Party (other than the Results or Combined Therapy Study Data). Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication or presentation. The Parties agree that they shall make reasonable efforts to prevent publication of a press release that could jeopardize the future publication of Study Data at a scientific conference or in a scientific journal but in no way will this or any other provision of this Agreement supersede the requirements of any Applicable Law or the rules or regulations of any securities exchange or listing entity on which a Party’s stock is listed (including any such rule or regulation that may require a Party to make public disclosures about interim results of the Combined Therapy Clinical TrialsTrial). Notwithstanding the foregoing, nothing herein shall prevent or restrict: (i) [***], or (ii) [***] respectively, to comply with requirements of Applicable Law, the rules or regulations of any securities exchange or listing entity on which its stock may be traded or pursuant to an order of a court or governmental entity to publicly disclose the existence of the Agreement and the Study Data, provided that [***], BMS and Recipient, respectively, will each use reasonable efforts to ensure it will only disclose the minimum amount of information necessary to achieve compliance and to ensure that it will provide the Recipient or BMS, respectively, with reasonable advance notice of such disclosure and the reason for the disclosure requirement.
(c) Olema The Recipient agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials Trial specific mention, if applicable, of the Novartis BMS Study Drugs Drug and the support and involvement of NovartisBMS. Subject to the limitation set forth in this Section 8.4, Novartis BMS agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trials Trial specific mention, if applicable, of Olema the Recipient Study Drug and the support and involvement of Olemathe Recipient.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Mirati Therapeutics, Inc.)