Commercial Considerations. (a) After the Effective Date, nothing in this Agreement shall prevent Roche or its Affiliates from disclosing Confidential Information of Eleven to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of Product in the Territory, (ii) Third Parties acting on behalf of Roche, to the extent reasonably necessary for the development, manufacture or sale of Product in the Territory, or (iii) Third Parties to the extent reasonably necessary to market the Product in the Territory. (b) Either Party may disclose this Agreement to actual or potential licensees, sublicensees, acquirers or investors under terms of confidentiality no less stringent than in this Agreement. (c) The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, if possible, and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure. (d) The Parties acknowledge that either or both Parties may be obligated to make one or more filings (including to file a copy of this Agreement) with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that it will (i) submit in connection with such filing a copy of this Agreement in a form mutually agreed by the Parties in advance or, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “Redacted Agreement”), (ii) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected in the Redacted Agreement, for a period of at least ten (10) years, (iii) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received by it or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request and promptly advise the other Party of any other material communications between it or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (iv) upon the written request of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (v) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only be required to make such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d) to again request the redactions rejected by the applicable governmental authority. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.
Appears in 2 contracts
Samples: License Agreement (Eleven Biotherapeutics, Inc.), License Agreement (Eleven Biotherapeutics, Inc.)
Commercial Considerations. (a) After the Effective Date, nothing Nothing in this Agreement shall prevent Roche a Receiving Party or its Affiliates from disclosing Confidential Information of Eleven the Disclosing Party and the existence and terms of this Agreement to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale commercialization of a Product or Licensed Product in the TerritoryTerritory or to obtain patents in accordance with this Agreement; provided that such Confidential Information will be disclosed only to the extent reasonably necessary to do so, and where permitted, subject to confidential treatment, (ii) Third Parties acting on behalf of Rochethe Receiving Party, to the extent reasonably necessary for the developmentReceiving Party to perform its obligations or exercise its rights under this Agreement, manufacture or sale of Product in the Territory, or (iii) Third Parties requesting Clinical Study data information (in accordance with the Receiving Party’s then-current data sharing policy), (iv) Third Parties to the extent reasonably necessary to market the Product Licensed Products in the Territory.
, (bv) Either Party may disclose its Affiliates, consultants, CROs, licensees or Sublicensees, and its and their directors, officers, employees, agents or advisors (including accountants, attorneys, consultants, bankers, financial advisors and members of advisory boards) who reasonably require Confidential Information, are informed of the confidential nature of such information and are bound by non-use and confidentiality obligations with respect to such Confidential Information, and (vi) any bona fide potential or actual sources of debt or equity financing or parties to a merger, acquisition or similar transaction (including attorneys, accountants, consultants, bankers or financial advisors of the foregoing) who reasonably require such Confidential Information as part of their due diligence investigations and who are informed of the confidential nature of such information and this Agreement and are bound by obligations of non-use and confidentiality with respect to actual or potential licensees, sublicensees, acquirers or investors under terms of confidentiality no less stringent than in this Agreement.
(c) such Confidential Information. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, including the rules and regulations of the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a securities exchange on which its or its Affiliate’s securities are listed (or to which an application for listing has been submitted), to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, if possible, such Confidential Information is disclosed only to the extent reasonably necessary to do so and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure.
(d) . The Parties acknowledge that either or both Parties may be obligated to make one or more filings a filing (including to file a copy of this Agreement) with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that it will (ia) submit in connection with such filing a the redacted copy of this Agreement in a form mutually agreed to by the Parties in advance or, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “Redacted Agreement”), (iib) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected in the Redacted Agreement, for a period of at least ten (10) years, (iiic) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received by it or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request and promptly advise the other Party of any other material communications between it or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (ivd) upon the written request of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (ve) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only be required to make such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d) to again request the redactions rejected by the applicable governmental authority. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Blueprint Medicines Corp), Collaboration and License Agreement (Blueprint Medicines Corp)
Commercial Considerations. (a) After the Effective Date, nothing Nothing in this Agreement shall prevent Roche or its Affiliates from disclosing Confidential Information of Eleven Pieris to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of Product Product(s) in the Territory, (ii) Third Parties acting on behalf of Roche, to the extent reasonably necessary for the development, manufacture or sale of Product Product(s) in the Territory, or (iii) Third Parties to the extent reasonably necessary to market the Product in the Territory, provided that for disclosures according to (ii) or (iii) of this Section, such Third Parties will be subject to the same confidentiality obligations as Roche has hereunder.
(b) Either Party may disclose Nothing in this Agreement shall prevent Pieris or its Affiliates from disclosing (1) Confidential Information of Roche to actual (i) governmental agencies to the extent required or potential licenseesdesirable to secure government approval for the development, sublicenseesmanufacture or sale of Product(s) in the Territory as provided for in Section 19.3.4, acquirers (ii) Third Parties acting on behalf of Pieris, to the extent reasonably necessary for (A) Pieris to perform its activities and obligations under the Research Plan, or investors under (B) the development, manufacture or sale of Product(s) in the Territory as provided for in Section 19.3.4, or (iii) Third Parties to the extent reasonably necessary to market the Product in the Territory as provided for in Section 19.3.4, or (2) to a Third Party the terms of this Agreement as part of confidential due diligence carried out by such Third Party in connection with a potential Change of Control of Pieris; provided that for disclosures according to (1) (ii) and (iii) or (2) of this Section, such Third Parties will be subject to the same confidentiality no less stringent than in this Agreementobligations as Pieris has hereunder.
(c) The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, if possible, Party and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure.
(d) The Parties acknowledge that either or both Parties may be obligated to make one or more filings (including to file a copy of this Agreement) with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that it will (i) submit in connection with such filing a copy of this Agreement in a form mutually agreed by the Parties in advance or, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “Redacted Agreement”), (ii) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected in the Redacted Agreement, for a period of at least ten (10) years, (iii) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received by it or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request and promptly advise the other Party of any other material communications between it or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (iv) upon the written request of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (v) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only be required to make such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d) to again request the redactions rejected by the applicable governmental authority. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.
Appears in 2 contracts
Samples: Research Collaboration and License Agreement (Pieris Pharmaceuticals, Inc.), Research Collaboration and License Agreement (Pieris Pharmaceuticals, Inc.)
Commercial Considerations. (a) After the Effective Date, nothing Nothing in this Agreement shall prevent Roche either Party or its Affiliates from disclosing Confidential Information of Eleven the other Party to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture development or sale of Product in the TerritoryProduct, (ii) Third Parties acting on behalf of Rochesuch Party, to the extent reasonably necessary [*****] for the development, manufacture development or sale of Product in the TerritoryProduct, or (iii) Third Parties to the extent reasonably necessary [*****] to market the Product in the Territory.
Product, (biv) Either Third Parties with which such Party may disclose is considering a potential transaction related to this Agreement who have a [*****] to actual see the Agreement (including each of Almirall’s and such Third Party’s accounting, financial, legal or tax advisors associated with such potential licenseestransaction), sublicensees, acquirers or investors provided that such disclosure shall be limited to the terms such Third Party has requested to review in order to proceed with the potential transaction and that are [*****] for the purposes of proceeding with such potential transaction and is under terms of confidentiality no less stringent than that are consistent with those contained in this Agreement.
, (cv) consultants and advisors subject to terms of confidentiality that are consistent with those contained in this Agreement, or (vi) such Party’s employees, officers, members of its board of directors, and its accounting, legal or tax advisors; provided that, in the case of (i)-(iii), with respect to Almirall, in the Field in the Territory, and with respect to Dermira, outside the Territory. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable LawLaw or GAAP, to defend or prosecute litigation or to comply with governmental regulationsregulations or applicable regulations of a stock exchange, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, if possible, Party and, to the extent practicable[*****], takes reasonable and lawful [*****] actions to minimize [*****] the degree of such disclosure.
(d) The Parties acknowledge that either or both Parties may . No notice shall be obligated to make one or more filings (including to file a copy of required under this Agreement) with the U.S. Securities ARTICLE 12 if and Exchange Commission (or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that it will (i) submit in connection with such filing a copy of this Agreement in a form mutually agreed by the Parties in advance or, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (that the “Redacted Agreement”), (ii) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected specific information contained in the Redacted Agreementproposed disclosure has previously been included in any previous disclosure made by either Party hereunder pursuant to ARTICLE 12, for a period of at least ten (10) years, (iii) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received or is otherwise approved in advance in writing by it or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request and promptly advise the other Party of any other material communications between it or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (iv) upon the written request of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (v) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only be required to make such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d) to again request the redactions rejected by the applicable governmental authority. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.
Appears in 1 contract
Commercial Considerations. (a) After the Effective Date, nothing in this Agreement shall prevent Roche or its Affiliates from disclosing Confidential Information of Eleven to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of Product in the Territory, (ii) Third Parties acting on behalf of Roche, to the extent reasonably necessary for the development, manufacture or sale of Product in the Territory, or (iii) Third Parties to the extent reasonably necessary to market the Product in the Territory.
(b) Either Party may disclose this Agreement to actual or potential licensees, sublicensees, acquirers or investors under terms of confidentiality no less stringent than in this Agreement.
(c) The Receiving A Party may disclose Confidential Information of the Disclosing other Party to the extent that such Confidential Information is required to be disclosed by the Receiving such Party to comply with Applicable Law, to defend including the rules and regulations of the SEC (or prosecute litigation equivalent foreign agency) or a securities exchange on which its or its Affiliate’s securities are listed (or to comply with governmental regulationswhich an application for listing has been submitted); provided that, provided that to the Receiving extent practicable and not prohibited by Applicable Law, the Disclosing Party provides shall provide prior written notice and a draft of such disclosure to the Disclosing Receiving Party, if possibleas soon as practicable in advance of such disclosure to provide the Receiving Party the opportunity to review and comment and shall specify to the Receiving Party when its comments need to be provided in order to be considered. The Receiving Party shall provide any comments as soon as practicable, andand the Disclosing Party shall consider in good faith any timely comments provided by the Receiving Party; provided that the Disclosing Party (i) may or may not accept such comments in its sole discretion, (ii) discloses such Confidential Information only to the extent reasonably necessary to do so, and (iii) to the extent practicable, takes (or causes to be taken) all reasonable and lawful actions to avoid and minimize the degree extent of such disclosure. Notwithstanding anything to the contrary in this Article 12, Arvinas may disclose in accordance with this Section 12.3(a) the achievement of any milestone event under this Agreement (including the nature of any such milestone event) or any milestone and profit share payment pursuant to a press release, SEC filing or other similar disclosure.
(db) The Parties acknowledge that In addition, either or both Parties may be obligated to make one a filing or more filings (including to file disclosure of a copy of this AgreementAgreement or one or more of the Ancillary Agreements (in each case, including any subsequent amendments thereto) with the U.S. Securities and Exchange Commission SEC (or equivalent foreign agency) or a governmental authority. Each Governmental Authority, and each Party will shall be entitled to make such a required filingfiling or disclosure; provided that, provided that it will (i) submit in connection with to the extent not prohibited by Applicable Law, prior to making any such filing or disclosure, such Party shall provide a copy draft of this Agreement or such Ancillary Agreements (in a form mutually agreed by the Parties in advance oreach case, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “Redacted Agreement”), (ii) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreementor amendments thereto, as reflected in the Redacted Agreement, for a period of at least ten (10applicable) years, (iii) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received by it as soon as practicable in advance of such filing or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect disclosure to such confidential treatment request and promptly advise provide the other Party of the opportunity to review and comment and shall specify to the Receiving Party when its comments need to be provided in order to be considered. The Receiving Party shall provide any other material communications between it or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (iv) upon the written request of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment periodcomments as soon as practicable, and (v) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests Disclosing Party shall consider in good faith any changes to timely comments provided by the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Receiving Party’s comments into consideration when deciding whether to agree to such changes (; provided that a the Disclosing Party will only be required to make may or may not accept such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d) to again request the redactions rejected by the applicable governmental authoritycomments in its sole discretion. Each Party will shall be responsible for its own legal and other external costs in connection with any such filing, registration filing or notificationdisclosure pursuant to this Section 12.3(b).
Appears in 1 contract
Commercial Considerations. (a) After the Effective Date, nothing Nothing in this Agreement shall prevent Roche a Receiving Party or its Affiliates from disclosing Confidential Information of Eleven the Disclosing Party and the existence and terms of this Agreement to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale commercialization of a Product in the Territory; provided that such Confidential Information will be disclosed only to the extent reasonably necessary to do so, and where permitted, subject to confidential treatment, (ii) Third Parties acting on behalf of Rochethe Receiving Party, to the extent reasonably necessary for the developmentReceiving Party to perform its obligations or exercise its rights under this Agreement, manufacture or sale of Product in the Territory, or (iii) Third Parties requesting Clinical Study data information (in accordance with the Receiving Party’s then-current data sharing policy), (iv) Third Parties to the extent reasonably necessary to market the Product Products and Shared Products in the Territory.
, (bv) Either Party may disclose this Agreement its Affiliates, consultants, CROs, service providers, licensees or Sublicensees, and its and their directors, officers, employees, agents or advisors (including accountants, attorneys, consultants, bankers, financial advisors and members of advisory boards) who reasonably require Confidential Information, and (vi) any bona fide potential or actual sources of debt or equity financing or parties to actual a merger, acquisition, royalty factoring or potential licenseessimilar transaction (including attorneys, sublicenseesaccountants, acquirers consultants, bankers or investors under terms financial advisors of the foregoing) who reasonably require such Confidential Information as part of their due diligence investigations, in each case (ii)-(vi), who are informed of the confidential nature of such information and are bound by obligations of non-use, non-disclosure and confidentiality no less stringent than in this Agreement.
(c) with respect to such Confidential Information. The Receiving Party may use and disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, including the rules and regulations of the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a securities exchange on which its or its Affiliate’s securities are listed (or to defend or prosecute litigation which an application for listing has been submitted), or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, if possible, such Confidential Information is disclosed only to the extent reasonably necessary to do so and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure.
(d) . The Parties acknowledge that either or both Parties may be obligated to make one or more filings a filing (including to file a copy of this Agreement) with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that it will (ia) submit in connection with such filing a the redacted copy of this Agreement that considers the comments of the other Party in a form mutually agreed by the Parties in advance or, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law good faith (the “Redacted Agreement”), (iib) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected in the Redacted Agreement, for a period of at least ten (10) years, (iii) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received by it or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request and promptly advise the other Party of any other material communications between it or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (iv) upon the written request of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (vc) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only not be required to make such efforts to support such redactions more than once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d) to again request the redactions rejected by the applicable governmental authority. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.
Appears in 1 contract
Samples: Collaboration, Option and License Agreement (Vividion Therapeutics, Inc.)
Commercial Considerations. (a) After Nothing in this Agreement shall prevent Dicerna or its Affiliates from disclosing Confidential Information of Roche to (i) Third Parties acting on behalf of Dicerna, to the Effective Dateextent reasonably necessary and as permitted for the development, nothing manufacture or Co-Promotion of Lead Product in the Territory, (ii) Third Parties requesting Dicerna Phase I Study clinical trial data information (in accordance with Dicerna’s then-current data sharing policy), or (iii) actual and potential partners and investors subject to commercially reasonable confidentiality obligations.
(b) Nothing in this Agreement shall prevent Roche or its Affiliates from disclosing Confidential Information of Eleven Dicerna to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of Product in the Territory, (ii) Third Parties acting on behalf of Roche, to the extent reasonably necessary for the development, manufacture or sale of Product in the Territory, or (iii) Third Parties requesting clinical trial data information (in accordance with the applicable Party’s then-current data sharing policy), (iv) Third Parties to the extent reasonably necessary to market the Product in the Territory.
, or (biv) Either Party may disclose this Agreement actual and potential partners and investors subject to actual or potential licensees, sublicensees, acquirers or investors under terms of commercially reasonable confidentiality no less stringent than in this Agreementobligations.
(c) The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, if possible, Party and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure.
(d) The Parties acknowledge that either or both Parties may be obligated to make one or more filings (including to file a copy of this Agreement) with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that if such filing includes a copy of this Agreement it will (i) submit in connection with such filing a copy of this Agreement in a form mutually agreed by the Parties in advance or, if despite the commercially reasonable efforts of Eleven Dicerna a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “Redacted Agreement”), (ii) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected in the Redacted Agreement, for a period of at least ten (10) years[* * *], (iii) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received by it or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request and promptly advise the other Party of any other material communications between it or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (iv) upon the written request of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (v) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support maintain the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only be required to make such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d19.5(d) to again request the redactions rejected by the applicable governmental authority. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.
Appears in 1 contract
Samples: Collaboration and License Agreement (Dicerna Pharmaceuticals Inc)
Commercial Considerations. Notwithstanding Section 20.1 (Confidential Information), each Party may disclose Confidential Information to the extent such disclosure is reasonably necessary in the following situations:
(a) After in connection with the Effective Date, nothing filing or prosecution of Patents Rights in this Agreement shall prevent Roche or its Affiliates from disclosing Confidential Information of Eleven to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of Product in the Territory, (ii) Third Parties acting on behalf of Roche, to the extent reasonably necessary for the development, manufacture or sale of Product in the Territory, or (iii) Third Parties to the extent reasonably necessary to market the Product in the Territoryaccordance with Section 16.
(b) Either Party may disclose this Agreement regulatory filings and other filings with Regulatory Authorities with respect to actual a Licensed Product in order to obtain or potential licenseesmaintain INDs or applications for Regulatory Approval with respect to a Licensed Product, sublicenseesin each case, acquirers or investors under terms of confidentiality no less stringent than in this Agreement.solely to the extent permitted hereunder;
(c) The Receiving Party may disclose Confidential Information responding to a valid order of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, to defend a court of competent jurisdiction or prosecute litigation or to comply with governmental regulations, other competent authority; provided that the Receiving Party provides prior written notice of such disclosure shall first have given to the Disclosing PartyParty notice and a reasonable opportunity to quash the order or obtain a protective order requiring that the Confidential Information be held in confidence or used only for the purpose for which the order was issued; and provided, further, that if possiblesuch order is not quashed or a protective order is not obtained, and, the Confidential Information disclosed shall be limited to the extent practicable, takes reasonable and lawful actions information that is legally required to minimize the degree of such disclosure.be disclosed;
(d) The Parties acknowledge that either or both Parties may be obligated to make one or more filings (including to file a copy of this Agreement) with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that it will (i) submit in connection with such filing a copy of this Agreement in a form mutually agreed by the Parties in advance or, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “Redacted Agreement”), (ii) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected in the Redacted Agreement, for a period of at least ten (10) years, (iii) to the extent consistent complying with Applicable Law, promptly deliver including regulations promulgated by securities exchanges; provided, further, that the Confidential Information disclosed shall be limited to the information that is legally required to be disclosed;
(e) disclosure to its Affiliates (including its and its Affiliate’s officers, directors, employees and agents) and Third Parties in connection with the performance by the Disclosing Party of its obligations or the exercise of its rights and licenses under this Agreement (including with respect to development, manufacturing and commercialization of Licensed Products and in connection with the exploitation of Joint Inventions); provided that each disclosee, prior to any such disclosure, must be bound by obligations of confidentiality and non-use at least as equivalent in scope as those set forth in this Section 20, except the term of such obligations may be for as long a duration as can reasonably be negotiated, but in any case such term shall have a duration that is commercially reasonable under the circumstances; provided, further, that the Receiving Party remains responsible and primarily liable for the compliance of any such disclosee with such obligations of confidentiality and non-use; [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(f) disclosure of the terms of this Agreement to any bona fide potential or actual investor, investment banker, acquirer, merger partner, Sublicensee, collaborator or other potential or actual financial partner; provided that each disclosee must be bound by obligations of confidentiality and non-use at least as equivalent in scope as those set forth in this Section 20 prior to any such disclosure, except the term of such obligations may be for as long a duration as can reasonably be negotiated, but in any case such term shall have a duration that is commercially reasonable under the circumstances; provided, further, that the Receiving Party remains responsible and primarily liable for the compliance of any such discloses with such obligations of confidentiality and non-use;
(g) disclosure of any scientific and clinical results or scientific and clinical status reports of the Parties under this Agreement (including data from any Clinical Study), in each case, specific to a Licensed Product, to any bona fide potential or actual investor, investment banker, acquirer, merger partner, Sublicensee, collaborator or other potential or actual financial partner; provided that (i) each disclosee must be bound by obligations of confidentiality and non -use at least as equivalent in scope as those set forth in this Section 20 prior to any such disclosure, except the term of such obligations may be for as long a duration as can reasonably be negotiated, but in any case such term shall have a duration that is commercially reasonable under the circumstances, and (ii) such Party submits the contents of such proposed disclosure to the other Party at least [********] prior to such disclosure in order to permit such other Party the opportunity to review and comment on such disclosure (including requiring the removal of any written correspondence received Confidential Information of such other Party, as applicable), but such Party shall not be required to disclose the identity of the disclosee; provided, further, that the Receiving Party remains responsible and primarily liable for the compliance of any such disclosee with such obligations of confidentiality and non-use and
(h) disclosure by it or its representatives from SQZ to MIT to fulfill the U.S. Securities and Exchange Commission obligations under the MIT License. Notwithstanding the foregoing, in the event that a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to clauses (or equivalent foreign agencyb), (c) or a governmental authority with respect (d), it will, except where impracticable, give reasonable advance notice to such confidential treatment request and promptly advise the other Party of any other material communications between it or its representatives with the U.S. Securities such disclosure and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect use reasonable efforts to such secure confidential treatment requestof such information and, (iv) upon the written request in each case, each Party agrees to take all reasonable action to minimize disclosure of Confidential Information of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (v) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only be required to make such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d) to again request the redactions rejected by the applicable governmental authority. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.
Appears in 1 contract
Samples: License and Collaboration Agreement (SQZ Biotechnologies Co)
Commercial Considerations. (a) After the Effective Date, nothing Nothing in this Agreement shall prevent Roche Dermira or its Affiliates from disclosing Confidential Information of Eleven Roche to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture Manufacture or sale of Product in the Territory, (ii) Third Parties acting on behalf of RocheDermira, to the extent reasonably necessary [*****] for the development, manufacture Manufacture or sale of Product in the Territory, or (iii) Third Parties to the extent reasonably necessary [*****] to market the Product in the Territory.
, (biv) Either Party may disclose Third Parties with which Dermira is considering a potential transaction related to this Agreement who have a need to actual see the Agreement (including each of Dermira’s and such Third Party’s accounting, financial, legal or tax advisors associated with such potential licensees, sublicensees, acquirers or investors transaction) provided that such disclosure shall be limited to the terms such Third Party has requested to review in order to proceed with the potential transaction and that are [*****] for the purposes of proceeding with such potential transaction and is under terms of confidentiality no less stringent than that are consistent with those contained in this Agreement.
, (cv) consultants and advisors subject to terms of confidentiality that are consistent with those contained in this Agreement, or (vi) Dermira’s employees, officers, members of its board of directors, and its accounting, legal or tax advisors. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, IFRS or GAAP, to defend or prosecute litigation or to comply with governmental regulationsregulations or applicable regulations of a stock exchange, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, if possible, Party and, to the extent practicable[*****], takes reasonable and lawful [*****] actions to minimize the degree of such disclosure.
(d) The Parties acknowledge . No notice shall be required under Section 17 if and to the extent that either or both Parties may be obligated to make one or more filings (including to file a copy of this Agreement) the specific information contained in the proposed disclosure [*****] Certain portions denoted with an asterisk have been omitted and filed separately with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authorityCommission. Each Party will be entitled to make such a required filing, provided that it will (i) submit in connection with such filing a copy of this Agreement in a form mutually agreed by the Parties in advance or, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “Redacted Agreement”), (ii) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential Confidential treatment of all terms redacted from this Agreement, as reflected in the Redacted Agreement, for a period of at least ten (10) years, (iii) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received by it or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority has been requested with respect to such confidential treatment request and promptly advise the other omitted portions. has previously been included in any previous disclosure made by either Party of any other material communications between it hereunder pursuant to Section 17, or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (iv) upon the written request of is otherwise approved in advance in writing by the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (v) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only be required to make such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d) to again request the redactions rejected by the applicable governmental authority. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.
Appears in 1 contract
Samples: License Agreement (Dermira, Inc.)
Commercial Considerations. (a) After the Effective Date, nothing Nothing in this Agreement shall prevent Roche a Receiving Party or its Affiliates from disclosing Confidential Information of Eleven the Disclosing Party and the existence and terms of this Agreement to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale commercialization of a Product or Licensed Product in the TerritoryTerritory or to obtain patents in accordance with this Agreement; provided that such Confidential Information will be disclosed only to the extent reasonably necessary to do so, and where permitted, subject to confidential treatment, (ii) Third Parties acting on behalf of Rochethe Receiving Party, to the extent reasonably necessary for the developmentReceiving Party to perform its obligations or exercise its rights under this Agreement, manufacture or sale of Product in the Territory, or (iii) Third Parties requesting Clinical Study data information (in accordance with the Receiving Party’s then-current data sharing policy), (iv) Third Parties to the extent reasonably necessary to market the Product Licensed Products in the Territory.
, (bv) Either Party may disclose its Affiliates, consultants, CROs, licensees or Sublicensees, and its and their directors, officers, employees, agents or advisors (including accountants, attorneys, consultants, bankers, financial advisors and members of advisory boards) who reasonably require Confidential Information, are informed of the confidential nature of such information and are bound by non-use and confidentiality obligations with respect to such Confidential Information, and (vi) any bona fide potential or actual sources of debt or equity financing or parties to a merger, acquisition or similar transaction (including attorneys, accountants, consultants, bankers or financial advisors of the foregoing) who reasonably require such Confidential Information as part of their due diligence investigations and who are informed of the confidential nature of such information and this Agreement and are bound by obligations of non-use and confidentiality with respect to actual or potential licensees, sublicensees, acquirers or investors under terms of confidentiality no less stringent than in this Agreement.
(c) such Confidential Information. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, including the rules and regulations of the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a securities exchange on which its or its Affiliate’s securities are listed (or to which an application for listing has been submitted), to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, if possible, such Confidential Information is disclosed only to the extent reasonably necessary to do so and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure.
(d) The Parties acknowledge that either or both Parties may be obligated to make one or more filings (including to file a copy of this Agreement) with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that it will (i) submit in connection with such filing a copy of this Agreement in a form mutually agreed by the Parties in advance or, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “Redacted Agreement”), (ii) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected in the Redacted Agreement, for a period of at least ten (10) years, (iii) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received by it or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request and promptly advise the other Party of any other material communications between it or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (iv) upon the written request of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (v) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts consistent with Applicable Laws to support the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only be required to make such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 17.4(d) to again request the redactions rejected by the applicable governmental authority. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.
Appears in 1 contract
Samples: Collaboration and License Agreement (Blueprint Medicines Corp)