Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances: (a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement; (b) prosecuting or defending litigation as permitted by this Agreement; (c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information; (d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory; (e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory; (f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8; (g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and (h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Information.
Appears in 4 contracts
Samples: License Agreement (Telix Pharmaceuticals LTD), License Agreement (Telix Pharmaceuticals LTD), License Agreement (Telix Pharmaceuticals LTD)
Authorized Disclosure. Notwithstanding the provisions of Section 8.17.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting Patent Rights as permitted by this Agreement;
(b) exercising or enforcing or exercising the Receiving Partysuch party’s rights under this Agreement and in performing the Receiving Party’s its obligations under this Agreement;
(bc) seeking, obtaining and maintaining Marketing Approvals (including complying with the requirements of Regulatory Authorities with respect to filing for, obtaining and maintaining Marketing Approvals);
(d) prosecuting or defending litigation as permitted by this Agreement;
(ce) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided traded (specifically including the recommendations and requests from the Tokyo Stock Exchange (TSE) or the SEC or otherwise submitting information to tax or other governmental authorities);
(f) disclosure in Regulatory Filings or Regulatory Documents that the Receiving Party gives has the Disclosing Party sufficient written notice, right to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationmake under this Agreement;
(dg) in the case of Telix as the Receiving PartyArcus, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Productlicensors to the extent required to comply with the terms and conditions of any agreement between Arcus and such licensors, provided that any such licensors agree to be bound by terms of confidentiality and non-use at least as restrictive as those set forth in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorythis Article 7;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(fh) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees sublicensees) or Subcontractors (in the case or subcontractors, including those of Lilly), Sublicensees) and to the Receiving Party’s and its Affiliates’ Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this AgreementAgreement or any agreement between the Receiving Party and any such persons, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee sublicensee) or Subcontractor (in the case or subcontractor, including those of LxxxxSublicensees), or Representative agrees to be bound by terms of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])7; and
(hi) disclosuredisclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by either Partyobligations of confidentiality and non-use similar to those contained in this Agreement. *** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Each party shall be responsible for any breaches of confidentiality by any of its Affiliates, Sublicensees (or licensees or sublicensees), Subcontractors (or subcontractors, including those of a copy of the Agreement in response Sublicensees), Representatives, advisors and Third Parties (to a request from a taxing authoritywhom it discloses Confidential Information pursuant to Sections 7.3(h), 7.3(i) and 7.6). Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c7.3(d) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 7.3(e), it will, except in the case where it is impractical to do so impracticable, (ia) give reasonable advance notice to the Disclosing Party of such required disclosure, (b) use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts, and (iic) cooperate with any efforts by the Disclosing Party, at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Information. [***]. In addition, notwithstanding the foregoing, to the extent that either party reasonably determines that it is required to make a filing or any other public disclosure with respect to this Agreement or the terms or existence hereof to comply with the requirements, rules, laws or regulations of any applicable stock exchange, Nasdaq, Tokyo Stock Exchange, or any governmental or regulatory authority or body, including without limitation the U.S. Securities and Exchange Commission (the “SEC”) (collectively, the “Securities Disclosure Obligations”), such party shall promptly inform the other party thereof and shall use reasonable efforts to maintain the confidentiality of the terms of this Agreement in any such filing or disclosure. Prior to making any such initial filing of the terms of this Agreement, the parties shall mutually agree on the provisions of this Agreement for which the parties shall seek confidential treatment, it being understood that if one party determines to seek confidential treatment for a provision for which the other party does not, then the parties will use reasonable efforts in connection with such filing to seek the confidential treatment of any such provision. The parties shall cooperate, each at its own expense, in such filing, including without limitation such confidential treatment request. The parties will reasonably cooperate in responding promptly to any comments received from the SEC with respect to such filing in an effort to achieve confidential treatment of such redacted form; provided, however, that a party shall be relieved of such obligation to seek confidential treatment for a provision requested by the other party if such treatment is not achieved after the first round of responses to comments from the SEC. Notwithstanding anything to the contrary in this Agreement, either party may make reference to the existence of this Agreement and describe in general terms the relationship between the parties in connection with any required securities filings without seeking the other party’s prior consent. This paragraph shall apply with respect to the filing of the terms of this Agreement or any public disclosure relating to this Agreement, in each case to comply with Securities Disclosure Obligations, notwithstanding the provisions of this Article 7 or the Confidentiality Agreement.
Appears in 3 contracts
Samples: Option and License Agreement (Arcus Biosciences, Inc.), Option and License Agreement (Arcus Biosciences, Inc.), Option and License Agreement (Arcus Biosciences, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.110.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting Patents as permitted by this Agreement;
(b) enforcing or exercising the Receiving such Party’s rights under this Agreement and performing the Receiving Party’s its obligations under this Agreement;
(bc) prosecuting or defending litigation as permitted by this Agreement;
(cd) complying with applicable court or governmental orders, applicable laws, rules or Applicable Lawsregulations, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving PartyCardiome, disclosure in submissions to or filings with any Regulatory Authority (includingactual and potential Sublicensees, without limitation, in INDs Permitted Subdistributors and BLAs) with respect to any Lilly Product or Companion Diagnostic, other Third Party contractors of Cardiome and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s its Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party Cardiome to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative Person agrees to be bound by terms of confidentiality and non-use substantially as restrictive as comparable in scope to those set forth in this Article 810;
(f) in the case of SteadyMed, the Contract Manufacturers, actual and potential licensees and sublicensees of SteadyMed’s retained or reserved rights hereunder, and actual and potential Third Party contractors of SteadyMed or its Affiliates who have a need to know such information in order for SteadyMed to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Person agrees to be bound by terms of confidentiality and non-use comparable in scope to those set forth in this Article 10; and
(g) disclosure (i) to Third Parties in connection with Patent Prosecution due diligence or the enforcement or defense of any Licensed Patent or Telix Patentsimilar investigations by such Third Parties, (ii) in connection with Regulatory Applications and all other documents or materials submitted disclosure to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential Third Party investors, lenderslenders or other financing sources in confidential financing documents, licenseesprovided, sublicensees and acquirers who are under in each case, that any such Third Party agrees to be bound by reasonable obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authoritynon-use. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c10.2(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 10.2(d), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts. In any event, the Receiving Party agrees to take all reasonable action to avoid disclosure of Confidential InformationInformation hereunder.
Appears in 3 contracts
Samples: Exclusive License and Supply Agreement (Correvio Pharma Corp.), Exclusive License and Supply Agreement (SteadyMed Ltd.), Exclusive License and Supply Agreement (Cardiome Pharma Corp)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Ardelyx may disclose Product Information and each Party may disclose Confidential Information (other than Product Information) to the extent that such disclosure is: (a) required by law, order, or regulation of a government agency or a court of competent jurisdiction, or by the Disclosing rules of a securities exchange, provided that the Party required to make such disclosure shall (i) give the other Party reasonable advance notice of and an opportunity to comment on any such required disclosure, (ii) if requested by the other Party, use Commercially Reasonable Efforts to obtain protective orders or any available limitations on or exemptions from such disclosure requirement where applicable and practicable; (b) made to a patent office for the purposes of filing or enforcing a Patent as expressly permitted by in this Agreement, or if and provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such disclosure protection is reasonably necessary in the following instances:
available; (ac) enforcing made by AstraZeneca or exercising the Receiving Party’s rights its Affiliates, Distributors, Sublicensees or other sublicensees or by Ardelyx (as expressly authorized under this Agreement and performing the Receiving Partyor as necessary to conduct Ardelyx’s obligations under this Agreement;
(b) prosecuting to a Regulatory Health Authority for the purposes of any filing, application or defending litigation request for Regulatory Approval for Licensed Compounds or Licensed Products as permitted in this Agreement; (d) made to investment bankers, financial advisors, actual or potential Third Party partners, investors, licensees, sublicensees or acquirers of all or substantially all of the assets to which this Agreement relates; (e) made by AstraZeneca or its Affiliates, Distributors, Sublicensees, or other sublicensees to Third Parties as may be necessary or useful in connection with the Exploitation of the Licensed Compounds or Licensed Products as contemplated by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements subcontracting or any disclosure requirements of any applicable stock market sublicensing transactions in connection therewith or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure made by Ardelyx to the Receiving Party’s Affiliates, to actual Third Parties as may be necessary or potential Sublicensees (useful in the case connection with its performance of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement; provided that with respect to disclosures as per subsection (d), provided(e), in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxxf), or Representative agrees to be the following sentence, the Party making such disclosures shall ensure that each Third Party recipient is bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality no less restrictive than those contained in this Agreement and shall be liable to the other Party for any breach of such confidentiality obligations by the relevant recipient. In addition (other than but without prejudice to) the above provisions, each Party shall be entitled to disclose, under a binder of confidentiality termcontaining provisions as protective as those of this Article 10, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing any Third Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued purpose of carrying out activities authorized under this Agreement, including without limitation disclosures to Sublicensees or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationsublicensees.
Appears in 3 contracts
Samples: License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.)
Authorized Disclosure. Notwithstanding (a) If, based upon the provisions advice of Section 8.1legal counsel skilled in the subject matter, a Party is required to disclose specific Confidential Information of the other Party to comply with an Applicable Law, regulation, legal process, or order of a government authority or court of competent jurisdiction, the Receiving Party may disclose such Confidential Information only to the entity or person required to receive such disclosure; provided, however, that the Party required to disclose such Confidential Information shall (a) to the extent permitted by such law, regulation, process, order or rules, first have given prompt (but in no event less than five (5) business days) advance notice to such other Party to enable it to seek any available exemptions from or limitations on such disclosure requirement and shall reasonably cooperate in such efforts by the other Party, (b) furnish only the portion of the Confidential Information which is legally required to be disclosed; (c) use all reasonable efforts to secure confidential protection of such Confidential Information, and (d) continue to perform its obligations of confidentiality and non-use set out in this Article 9.
(b) ProNAi (and its Affiliates and Sublicensees) may disclose Confidential Information of Marina to Regulatory Authorities to the extent such disclosure is reasonably necessary in regulatory filings required for the development and/or commercialization of Licensed Products. In addition, each Party may disclose Confidential Information of the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing : filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation patents as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related ; and disclosure to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order Affiliates and Sublicensees and potential Sublicensees or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Partysimilar commercial partners, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a who need to know such information in order for the Receiving development, manufacture and commercialization of Licensed Products, to bankers, lawyers, accountants, agents or other Third Parties in connection with due diligence or similar investigations, and to potential Third Party investors in confidential financing documents or potential acquirers or merger partners in confidence pursuant to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, due diligence; provided that any such AffiliateSublicensee, actual licensee, contractor, employee, consultant, banker, lawyer, accountant, agent or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be Third Party is bound by terms obligations of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) herein. In the case of each disclosure, the Party making such disclosure (i) in connection with Patent Prosecution or the enforcement or defense shall use reasonable efforts to obtain confidential treatment of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the not disclose Confidential Information so disclosed be used only for of the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential InformationParty other than is reasonably necessary.
Appears in 3 contracts
Samples: Exclusive License Agreement (ProNAi Therapeutics Inc), Exclusive License Agreement (ProNAi Therapeutics Inc), Exclusive License Agreement (Marina Biotech, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1Except as expressly provided otherwise in this Agreement, the a Receiving Party or its Affiliates may disclose use and disclose, to Third Parties or the Founding Companies, Confidential Information of the Disclosing Party as expressly permitted by follows: (i) with respect to any such disclosure of Confidential Information, under confidentiality provisions no less restrictive than those in this Agreement, and solely in connection with the performance of its obligations or exercise of rights granted or reserved in this Agreement (including, without limitation, the rights to Develop and Commercialize SPC-3649, and to grant licenses and sublicenses hereunder), provided, that Confidential Information may be disclosed by a Receiving Party to a governmental entity or agency without requiring such entity or agency to enter into a confidentiality agreement with such Receiving Party if such Receiving Party has used reasonable efforts to impose such requirement without success and disclosure to such governmental entity or agency is necessary for the performance of the Receiving Party’s obligations hereunder; (ii) to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement prosecuting patent, copyright and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) trademark applications, complying with applicable court governmental regulations, obtaining Regulatory Approvals, conducting Pre-Clinical Studies or governmental ordersClinical Studies, marketing SPC-3649, or Applicable Lawsas otherwise required by applicable law, regulation, rule or legal process (including Applicable Laws related to securities laws disclosure requirements or the rules of the SEC and any disclosure requirements of any applicable stock market or securities exchange on which the exchange); provided, however, that if a Receiving Party’s Party or any of its Affiliates’ securities are traded, provided Affiliates or Founding Companies is required by law or regulation (including the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any rules of the foregoing submissions or filings in the Territory;
(eSEC and any stock exchange) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that make any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except where impracticable for necessary disclosures, for example, but without limitation, in the case where it is impractical to do so (i) event of medical emergency, give reasonable advance notice to the Disclosing Party of such required disclosure, disclosure requirement and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s will use its reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation required to be disclosed; (iii) in communication with actual or potential investors, merger partners, acquirers, consultants, or professional advisors on a need to know basis, in each case under confidentiality provisions no less restrictive than those of this Agreement; (iv) in communication with actual or potential licensees outside the Field on a need to know basis, in each case under confidentiality provisions no less restrictive than those of this Agreement and such Confidential Information may be redacted to exclude confidential scientific information, the name of the Disclosing Party and other sensitive information reasonably required by the Disclosing Party to be kept confidential; (v) to the extent and only to the extent that such disclosure is required to comply with existing expressly stated contractual obligations owed to such Party’s, its Affiliate’s or Founding Company’s licensor with respect to any intellectual property licensed under this Agreement; or (vi) to the extent mutually agreed to in writing by the Parties. If a Founding Company receives GSK’s Confidential Information as permitted pursuant to this Section 7.2, such Founding Company may only use and disclose GSK’s Confidential Information solely in accordance with this Section 7.2 under confidentiality provisions no less restrictive than those in this Agreement and solely as and to the extent required (x) by law, court order or an existing expressly stated contractual requirement of a licensor to Regulus Patents, or (y) for such Founding Company to perform its rights or obligations in connection with this Agreement.
Appears in 3 contracts
Samples: Exclusive License and Nonexclusive Option Agreement, Exclusive License and Nonexclusive Option Agreement (Regulus Therapeutics Inc.), Exclusive License and Nonexclusive Option Agreement (Isis Pharmaceuticals Inc)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights pursuant to Section 6.1(c);
(b) prosecuting or defending litigation as permitted by this Agreementlitigation;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs and BLAs) connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any performance of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, providedto Affiliates, in permitted (sub)licensees, contractors, IRBs, CROs, academic institutions, consultants, agents, investigators, and employees and contractors engaged by study sites and investigators involved with the Combined Therapy Clinical Trial, each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees whom prior to disclosure must be bound by terms of confidentiality and non-use substantially at least as restrictive protective of Confidential Information as those set forth in this Article 89;
(e) disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with the development and obtaining of regulatory approval of the Combined Therapy, the Recipient Study Drug or the BMS Study Drug;
(f) disclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, IRBs and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the Recipient Study Drug with respect to the Recipient, and the BMS Study Drug with respect to BMS, and, in the event of a Material Safety Issue, to Third Parties that are collaborating with the Recipient or BMS, respectively in the conduct of such other clinical trials of the Recipient Study Drug or the BMS Study Drug, in each case solely to the extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and regulatory requirements; and
(g) subject to a [ ]* advance written notice to BMS, in communications with [ ]* under confidentiality provisions as least as protective of Confidential Information as those of this Agreement; provided that with respect to [ ]* such disclosure (i) in connection with Patent Prosecution or shall be limited to the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy conditions of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than and the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityCombined Therapy Study Data. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing any other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.
Appears in 3 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (Replimune Group, Inc.), Clinical Trial Collaboration and Supply Agreement (Replimune Group, Inc.), Clinical Trial Collaboration and Supply Agreement (Replimune Group, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving A Party may disclose the Confidential Information of CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH THREE ASTERISKS (***), HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing Filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations prosecuting Patents relating to Joint Inventions, Licensed Products as permitted under this Agreement;
(b) prosecuting Regulatory submissions and filings and other interactions with regulatory authorities relating to Licensed Products;
(c) Prosecuting or defending litigation as permitted by under this Agreement;
(cd) complying with Disclosure required by applicable court rules or governmental ordersregulations of any regulatory body including without limitation the U.S. Securities and Exchange Commission or similar regulatory agency in a country other than the United States, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to exchanges (such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;Nasdaq); and
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationDisclosure, in INDs and BLAs) connection with respect to any Lilly Product the performance of this Agreement or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any exercise of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations licenses under this Agreement, providedto Affiliates, in licensees, sublicensees, research collaborators, employees, auditors, consultants, subcontractors, clinical investigators or agents, each case, that any of whom prior to such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to disclosure must be bound by terms similar obligations of confidentiality and non-use substantially as no less restrictive as to those set forth in this Article 8;
11; provided, in each case (gb) disclosure and (d), that the disclosing Party must (i) provide the other Party a reasonable opportunity to review and comment in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patentadvance on such proposed disclosure, (ii) consider in connection with Regulatory Applications and all good faith any comments provided by the other documents or materials submitted to Regulatory Authorities and Party, (iii) limit the disclosure to that actually required, and (iv) seek confidential treatment of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is information required to make be disclosed if the other Party so requests. Further, a disclosure of Party may disclose the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contraryextent such disclosure is required by valid court order or legal process; provided, Lxxxx may freely disclose a copy of however, that such Party gives the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable other Party advance notice to the Disclosing Party of such required disclosure, limits the disclosure to that actually required, and (ii) at cooperates in the Disclosing other Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, attempts to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationthe information required to be disclosed.
Appears in 2 contracts
Samples: Development and License Agreement (Immunomedics Inc), Development and License Agreement (Immunomedics Inc)
Authorized Disclosure. Notwithstanding (a) If, based upon the provisions advice of Section 8.1legal counsel skilled in the subject matter, a Party is required to disclose specific Confidential Information of the other Party to comply with an applicable law, regulation, legal process, or order of a government authority or court of competent jurisdiction, the Receiving Party may disclose such Confidential Information only to the entity or person required to receive such disclosure; provided, however, that the Party required to disclose such Confidential Information shall (a) to the extent permitted by such law, regulation, process, order or rules, first have given prompt (but in no event less than five (5) business days) advance notice to such other Party to enable it to seek any available exemptions from or limitations on such disclosure requirement and shall reasonably cooperate in such efforts by the other Party, (b) furnish only the portion of the Confidential Information which is legally required to be disclosed; (c) use all reasonable efforts to secure confidential protection of such Confidential Information, and (d) continue to perform its obligations of confidentiality and non-use set out in this Article 9.
(b) MirnaRx (and its Affiliates and Sublicensees) may disclose Confidential Information of Marina Bio to Regulatory Authorities to the extent such disclosure is reasonably necessary in regulatory filings required for the development and/or commercialization of Licensed Products. In addition, each Party may disclose Confidential Information of the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing : filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation patents as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related ; and disclosure to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order Affiliates and Sublicensees and potential Sublicensees or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Partysimilar commercial partners, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a who need to know such information in order for the Receiving development, manufacture and commercialization of Licensed Products, to bankers, lawyers, accountants, agents or other Third Parties in connection with due diligence or similar investigations, and to potential Third Party investors in confidential financing documents or potential acquirers or merger partners in confidence pursuant to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, due diligence; provided that any such AffiliateSublicensee, actual licensee, contractor, employee, consultant, banker, lawyer, accountant, [CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] agent or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be Third Party is bound by terms obligations of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) herein. In the case of each disclosure, the Party making such disclosure (i) in connection with Patent Prosecution or the enforcement or defense shall use reasonable efforts to obtain confidential treatment of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the not disclose Confidential Information so disclosed be used only for of the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential InformationParty other than is reasonably necessary.
Appears in 2 contracts
Samples: License Agreement, License Agreement (Marina Biotech, Inc.)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instancesfollows:
(a) enforcing to the extent and to the persons and entities required by an applicable governmental law, rule, regulation or exercising order; provided, however, that the Receiving Party required to disclose Confidential Information will first have given prompt notice to the other Party hereto to enable it to seek any available exemptions from or limitations on such disclosure requirement and will reasonably cooperate in such efforts by the other Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting as necessary to file or defending prosecute patent applications, prosecute or defend litigation as permitted by or otherwise establish rights or enforce obligations under this Agreement, but only to the extent that any such disclosure is necessary;
(c) complying with applicable court as necessary to file or governmental ordersmaintain Regulatory Applications and Regulatory Approvals under this Agreement, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, but only to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to that any such Confidential Informationdisclosure is necessary;
(d) as required by Gilead’s agreements with its licensors for Products; and a Party may disclose the terms of this Agreement to bona fide potential investors, acquirers or Product Licensees who are bound in the case writing by obligations of Telix as the Receiving Party, non-disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any non-use of the foregoing submissions or filings terms of this Agreement at least as stringent as those contained in the Territory;this Section 6; [ * ] = 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 THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliatesextent Gilead is obligated to do so pursuant to applicable U.S. governmental securities laws, to actual or potential Sublicensees rules and regulations by filing a copy of this Agreement with the US Securities and Exchange Commission (in the case of Telix) or licensees or sublicensees (in the case of Lilly“SEC”), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, provided that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure Gilead (i) in connection with Patent Prosecution or requests confidential treatment of at least the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, commercial terms and a copy of the Agreement (provided such material terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything hereof to the contrary, Lxxxx may freely disclose a copy of the Agreement in response extent such confidential treatment is reasonably available to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosureGilead, and (ii) at solicits Aspen’s comments on such request for confidential treatment. Gilead will [ * ] take into account Aspen’s comments on such request to the Disclosing Party’s request extent reasonably practicable and expensepermitted under Applicable Laws. Aspen recognizes that United States laws and SEC policies and regulations to which Gilead is subject may require Gilead to publicly disclose certain terms of this Agreement that neither of the Parties wishes to disclose, shall cooperate with the Disclosing Party’s efforts and that Gilead is entitled hereunder to contest make such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationrequired disclosures.
Appears in 2 contracts
Samples: Manufacture and Distribution Agreement, Manufacture and Distribution Agreement (Gilead Sciences Inc)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights pursuant to Section 6.1(c);
(b) prosecuting or defending litigation as permitted by this Agreementlitigation;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs and BLAs) connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any performance of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, providedto Affiliates, in permitted (sub)licensees, contractors, IRBs, CROs, academic institutions, consultants, agents, investigators, and employees and contractors engaged by study sites and investigators involved with the Combined Therapy Clinical Trial, each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees whom prior to disclosure must be bound by terms of confidentiality and non-use substantially at least as restrictive protective of Confidential Information as those set forth in this Article 89;
(ge) disclosure (i) of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with Patent Prosecution the development of the Combined Therapy, the Recipient Study Drug or the enforcement or defense BMS Study Drug;
(f) disclosure of any Licensed Patent or Telix Patentrelevant safety information contained within the Combined Therapy Study Data to investigators, (ii) in connection with Regulatory Applications IRBs and/or ethics committees and all other documents or materials submitted to Regulatory Authorities and (iii) that are involved in other clinical trials of the existenceRecipient Study Drug with respect to the Recipient, terms and the BMS Study Drug with respect to BMS, and, in the event of a copy Material Safety Issue, to Third Parties that are collaborating with the Recipient or BMS, respectively in the conduct of such other clinical trials of the Agreement (provided Recipient Study Drug or the BMS Study Drug, in each case solely to the extent necessary for the conduct of such terms clinical trials and/or to comply with Applicable Law and copy of the Agreement shall be redacted as requested by Lxxxx) to actual regulatory requirements; and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing any other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (Idera Pharmaceuticals, Inc.), Clinical Trial Collaboration and Supply Agreement (Idera Pharmaceuticals, Inc.)
Authorized Disclosure. Notwithstanding 11.3.1 Nothing in this Agreement shall prohibit disclosure by a Receiver of Confidential Information to its (i) Affiliates, directors, employees, consultants, advisors or clinical investigators, (ii) potential or actual sublicensees, Contractors, assignees, lenders or investors, or (iii) other third parties, if any, but in each case only on a strict need to know basis for purposes of (x) carrying out, or causing to be carried out, any of the provisions of Section 8.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, (y) the exercise or if transfer by such Receiver of any of its rights under this Agreement, and (z) providing for the delegation of any of the obligations of such Receiver under this Agreement; provided, however, that any such person to the extent whom such disclosure is reasonably necessary in made is bound by confidentiality obligations that are no less stringent than the following instances:
(a) enforcing or exercising confidentiality obligations of the Receiving Party’s rights Parties under this Agreement and performing Article 11 (except that the Receiving Party’s duration of such confidentiality obligations under shall be for a period not to exceed [ ]* from the time of disclosure to such person of Confidential Information).
11.3.2 The restrictions set forth in this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related Article 11 shall not prevent either Party from disclosing any Confidential Information to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, government agencies to the extent reasonably possiblenecessary to file for, prosecute or maintain Patent Rights or to seek Regulatory Approval for any Licensed Product. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. The restrictions set forth in this Article 11 shall not prevent disclosure to the extent required by law or pursuant to a judicial or governmental order, provided that the Receiver makes reasonable efforts to minimize the extent of any required disclosure and gives the Discloser sufficient notice to permit the Disclosing Party Discloser to seek a protective order or other confidential or protective treatment similar order with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving PartyReceiver’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationassistance therefor.
Appears in 2 contracts
Samples: License Agreement (Rhythm Holding Company, LLC), License Agreement (Rhythm Holding Company, LLC)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of solely owned by the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights;
(b) prosecuting or defending litigation as permitted by this Agreementlitigation;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs connection with the performance of this Agreement, to Affiliates, permitted sublicensees, contractors, ethics committees and BLAs) with respect to any Licensed Productinstitutional review boards (collectively, “IRBs”), CROs, academic institutions, consultants, agents, investigators, and employees and contractors engaged by study sites and investigators involved with the Combined Therapy Trials, each of whom, subject to Section 2.6(d), prior to disclosure must be bound by similar terms of confidentiality and non-use at least equivalent in correspondence with any Regulatory Authority scope to those set forth in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorythis Article 9;
(e) disclosure that is deemed necessary by either Party to be disclosed to its respective Affiliates, agents, consultants or actual or prospective licensees (or other bona fide collaborators) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any furtherance of the foregoing submissions or filings development, manufacture and/or commercialization of such Party’s Compound, on the condition that such Third Parties agree to be bound by confidentiality CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. and non-use obligations that are substantially consistent with the confidentiality and non-use provisions contained in the Territorythis Agreement;
(f) disclosure to the Receiving Party’s Affiliatesits attorneys, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)accountants, auditors and to the Receiving Party’s Representatives who, in each case, have other advisors on a need to know basis provided such information in order for the Receiving Party individuals or Entities are bound to exercise its rights confidentiality and nondisclosure requirements by professional rules of conduct or fulfill its obligations under this Agreementnondisclosure agreements, provided, in each case, that any such Affiliate, and to actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)prospective acquirers, lenders, financers, or Representative agrees investors as may be necessary to comply with the terms, or in connection with their evaluation, of such potential or actual acquisition, loan, financing, or investment; on the condition that such acquires, lenders, financers, or investors agree to be bound by terms of confidentiality and non-use obligations that are substantially as restrictive as those set forth consistent with the confidentiality and non-use provisions contained in this Article 8Agreement;
(g) disclosure (i) of the Combined Therapy Study Data, Combined Therapy Trial Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with Patent Prosecution the development of the Combined Therapy, the BioXcel Compound or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])Nektar Compound; and
(h) disclosuredisclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, by either PartyIRBs/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the BioXcel Compound with respect to BioXcel, and the Nektar Compound with respect to Nektar, and (in the event of a copy Material Safety Issue) to Third Parties that are collaborating with BioXcel or Nektar, respectively in the conduct of such other clinical trials of the Agreement BioXcel Compound or the Nektar Compound, in response each case solely to a request from a taxing authoritythe extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and regulatory requirements. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.
Appears in 2 contracts
Samples: Clinical Trial Collaboration Agreement, Clinical Trial Collaboration Agreement (BioXcel Therapeutics, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.113.1, the Receiving each Party may disclose Confidential Information of the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instancessituations:
(ai) enforcing filing or exercising prosecuting Galapagos Patents, Gilead Collaboration Patents or Joint Collaboration Patents in accordance with ARTICLE X with the Receiving consent of the other Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement, such consent not to be unreasonably withheld, delayed or conditioned;
(bii) prosecuting regulatory filings and other filings with Governmental Authorities (including Regulatory Authorities), including filings with the SEC or defending litigation FDA, with respect to an Optioned Product as permitted by this Agreementhereunder, provided that any such disclosure in a filing with the SEC is, in the opinion of outside counsel, required;
(ciii) complying with applicable responding to a valid order of a court of competent jurisdiction or governmental ordersother competent authority, or in the opinion of the receiving Party’s legal counsel, making such disclosure as required by Applicable Laws, including Applicable Laws related to securities laws disclosure requirements Law or any disclosure requirements the rules of any applicable a stock market or securities exchange on which the Receiving Party’s securities of the disclosing Party (or any of its Affiliates’ securities parent entity) are traded, listed (or to which an application for listing has been submitted); provided that the Receiving receiving Party gives the Disclosing Party sufficient written noticeshall, to the extent reasonably possiblepracticable under the circumstances, first have given to permit the Disclosing disclosing Party notice and a reasonable opportunity to seek quash the order or obtain a protective order requiring that the Confidential Information be held in confidence or other confidential used only for the purpose for which the order was issued or such disclosure was required by Applicable Law or such rules; and provided further that if such order is not quashed or a protective treatment with respect order is not obtained, the Confidential Information disclosed shall be limited to such Confidential Informationthe information that is legally required to be disclosed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(fiv) disclosure to the Receiving Party’s its Affiliates and its and its Affiliates’ officers, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)directors, employees, agents and advisors, and to the Receiving Party’s Representatives whoany other Third Parties, in each case, have only on a need to need-to-know such information basis and solely in order for connection with the Receiving performance by the disclosing Party to of its obligations or the exercise of its rights or fulfill its obligations under this AgreementAgreement (including with respect to the Development, providedManufacturing and Commercialization of Optioned Products), in each caseprovided that, that prior to any such Affiliatedisclosure, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to each disclosee other than an advisor must be bound by terms obligations of confidentiality and non-use substantially at least equivalent in scope as those set forth in Section 13.1 and Section 13.2 and each advisor must be bound by obligations of confidentiality and non-use that are commercially reasonable;
(v) with prior notice to the other Party as permitted by Applicable Law, disclosure of the material terms of this Agreement or any Ancillary Agreement to any bona fide potential or actual investor, investment banker, acquirer, merger partner or other potential or actual financial partner; provided that each disclosee must be bound by obligations of confidentiality and non-use at least as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution Section 13.1 and Section 13.2 prior to any such disclosure, except that, where the disclosee is an investor, investment banker or the enforcement or defense of any Licensed Patent or Telix Patentfinancial partner, (ii) in connection with Regulatory Applications and all other documents or materials submitted such disclosee shall only need to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested bound by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])commercially reasonable confidential terms; and
(hvi) disclosure of any Collaboration Know-How or status reports (including data from any Clinical Trials) by either Party (i) with the consent of the other Party, such consent not to be unreasonably withheld, delayed or conditioned; provided that each disclosee must be bound by obligations of confidentiality and non-use at least equivalent in scope as those set forth in Section 13.1 and Section 13.2 prior to any such disclosure, except that, where the disclosee is an investor, investment banker or financial partner, such disclosee shall only need to be bound by either Party, of a copy of the Agreement in response commercially reasonable confidential terms or (ii) pursuant to a request from a taxing authoritySection 13.4. Notwithstanding the foregoing, in the event the Receiving that a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(cSections 13.2(a)(i), 13.2(a)(ii) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 13.2(a)(iii), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential InformationInformation hereunder.
Appears in 2 contracts
Samples: Option, License and Collaboration Agreement (Gilead Sciences Inc), Option, License and Collaboration Agreement (Galapagos Nv)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing, prosecuting or maintaining the Patent Rights in accordance with this Agreement;
(b) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court prosecuting or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationdefending litigation;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to complying with applicable court orders or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorygovernmental regulations;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliatesfinancial, legal and other advisors on a need-to-know basis as necessary for such advisors to actual provide financial, legal or potential Sublicensees business advice to the Receiving Party regarding this Agreement or its subject matter, provided that such advisors are bound by non-use and non-disclosure obligations no less restrictive than those set forth in this Agreement, whether by written agreement or by applicable professional ethical obligations;
(f) in the case of TelixTracr, disclosure to Tracr’s Affiliates (including, without limitation, Affiliated Sublicensees), provided that Confidential Information so disclosed shall remain subject to this Article 7;
(g) or licensees or sublicensees (in the case of LillyTracr and Affiliated Sublicensees, disclosure to Third Party Sublicensees and bona fide potential Third Party Sublicensees, on the condition that each such Third Party agrees to be bound by confidentiality and non-use obligations that are no less stringent than the terms of this Agreement;
(h) in the case of Tracr (and Sublicensees), practicing the license granted hereunder or preparing and submitting regulatory filings with respect to Therapeutic Products and/or Diagnostic Products; and [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Receiving Party’s Representatives whoSecurities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(i) in each casethe case of Tracr and Affiliated Sublicensees, have a need disclosure to know Third Parties in connection with due diligence or similar investigations by such information Third Parties and disclosure to potential Third Party investors in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreementconfidential financing documents, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative Third Party agrees to be bound by terms reasonable obligations of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityuse. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Partyother party’s Confidential Information pursuant to Section 8.3(c7.3(c) (but, for clarity, not under or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority7.3(d), it willthe Receiving Party shall, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information at least as diligent as such party would use to protect such party’s own confidential information, but in no event less than reasonable efforts. In any event, the Receiving Party agrees to take all reasonable action to avoid unauthorized disclosure and unauthorized use of Confidential Information.
Appears in 2 contracts
Samples: License Agreement (CRISPR Therapeutics AG), License Agreement (CRISPR Therapeutics AG)
Authorized Disclosure. Notwithstanding the provisions of obligations set forth in Section 8.111.1, the Receiving a Party or its Affiliate may disclose the other Party’s Confidential Information and the terms of the Disclosing Party as expressly permitted by this Agreement, or if and Agreement to the extent extent:
(a) such disclosure is reasonably necessary (i) for the filing or prosecuting of Patent rights as contemplated by this Agreement; (ii) to comply with the requirements of Regulatory Authorities with respect to obtaining and maintaining Regulatory Approval of the Product or submission of information to tax or other Governmental Authorities; or (iii) for prosecuting or defending litigation as contemplated by this Agreement (including enforcing trade secret rights in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this AgreementProduct Know-How);
(b) prosecuting such disclosure is reasonably necessary to its officers, directors, employees, agents, consultants, contractors, licensees, sublicensees, attorneys, accountants, sources of debt or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental ordersequity financing, insurers, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a licensors who need to know such information in order for the Receiving such Party to perform its obligations or exercise its rights or fulfill its obligations under this Agreement or the Material Transfer Agreement, provided, ; provided that in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be disclosees are bound by terms written obligations or legal professional ethical duties and obligations of confidentiality and non-use substantially as restrictive as no less stringent than those set forth in of this Article 8Agreement with a reasonable duration based on customary terms;
(gc) such disclosure (i) is reasonably necessary to any bona fide potential or actual investor, Acquiror, merger partner, or other financial or commercial partner for the sole purpose of evaluating an actual or potential investment, acquisition, or other business relationship; provided that, in connection each case, the disclosees are bound by written obligations of confidentiality and non-use no less stringent than to those of this Agreement with Patent Prosecution or a reasonable duration based on customary terms, and further provided, that in the enforcement or defense case of any Licensed Patent such disclosure of Confidential Information to any actual or Telix Patentpotential competitor of either Party, all competitively sensitive information (iiincluding, for the avoidance of doubt, all financial information) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement herein shall be redacted as requested by Lxxxx) until, subject to Applicable Laws, the execution of a definitive agreement with such actual and or potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as competitor to implement a transaction with the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])receiving Party is imminent; andor
(hd) disclosuresuch disclosure is reasonably necessary to comply with Applicable Laws, including regulations promulgated by either Partyapplicable security exchanges, of a copy of the Agreement in response to a request from a taxing authoritycourt order, administrative subpoena, or other order. Notwithstanding the foregoing, in the event the Receiving if a Party or its Affiliate is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c11.2(a) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 11.2(d), it will, except in the case where it is impractical to do so then such disclosing Party shall (i) give reasonable advance notice use its best efforts to promptly notify the Disclosing other Party of such required disclosure, and (ii) at give the Disclosing other Party an opportunity to seek confidential treatment and, upon the other Party’s request request, such disclosing Party and expense, its Affiliates and their respective Recipients shall cooperate with the Disclosing Party’s use reasonable efforts to contest such requirementobtain, or to obtain assist the other Party in obtaining, a protective order requiring and/or other protection preventing the disclosure, protecting the confidentiality of the Confidential Information, and/or limiting the required disclosure and (iii) if the other Party is unsuccessful in its efforts pursuant to subsection (ii), disclose only that portion of the Confidential Information so disclosed be used only for that such Party is legally required to disclose and under conditions that maximize the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment confidentiality of such Confidential Informationdisclosure wherever available.
Appears in 2 contracts
Samples: Assignment, License, and Collaboration Agreement (Journey Medical Corp), Assignment, License, and Collaboration Agreement (Journey Medical Corp)
Authorized Disclosure. Notwithstanding (a) If, based upon the provisions advice of Section 8.1legal counsel skilled in the subject matter, a Party is required to disclose specific Confidential Information of the other Party to comply with an applicable law, regulation, legal process, or order of a government authority or court of competent jurisdiction, the Receiving Party may disclose such Confidential Information only to the entity or person required to receive such disclosure; provided, however, that the Party required to disclose such Confidential Information shall (a) to the extent permitted by such law, regulation, process, order or rules, first have given prompt (but in no event less than five (5) business days) advance notice to such other Party to enable it to seek any available exemptions from or limitations on such disclosure requirement and shall reasonably cooperate in such efforts by the other Party, (b) furnish only the portion of the Confidential Information which is legally required to be disclosed; (c) use all reasonable efforts to secure confidential protection of such Confidential Information, and (d) continue to perform its obligations of confidentiality and non-use set out in this Article 10.
(b) Each Party may disclose Confidential Information of the Disclosing other Party as expressly permitted by this Agreementto Regulatory Authorities to the extent such disclosure is reasonably necessary in regulatory filings required for the development and/or commercialization of Licensed Products. In addition, or if and each Party may disclose Confidential Information of the other Party (other than Manufacturing Information) to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing : filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation patents as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) ; disclosure to the Receiving Party’s Affiliates, to actual or Sublicensees and potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)Sublicensees, and to the Receiving Party’s Representatives wholicensees or potential licensees of Cara, in each caseand to contractors, have a employees and consultants, who need to know such information in order for the Receiving development, manufacture and commercialization of Licensed Products, to bankers, lawyers, accountants, agents or other Third Parties in connection with due diligence or similar investigations, and to potential Third Party to exercise its rights or fulfill its obligations under this Agreement, provided, investors in each case, confidential financing documents; provided that any such AffiliateSublicensee, actual licensee, contractor, employee, consultant, banker, lawyer, accountant, agent or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be Third Party is bound by terms obligations of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) herein. In the case of each disclosure, the Party making such disclosure (i) in connection with Patent Prosecution or the enforcement or defense shall use reasonable efforts to obtain confidential treatment of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the not disclose Confidential Information so disclosed be used only for of the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential InformationParty other than is reasonably necessary.
Appears in 2 contracts
Samples: License and Api Supply Agreement, License and Api Supply Agreement (Cara Therapeutics, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing, prosecuting or maintaining the Patent Rights in accordance with this Agreement;
(b) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court prosecuting or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationdefending litigation;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to complying with applicable court orders or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorygovernmental regulations;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliatesfinancial, legal and other advisors on a need-to-know basis as necessary for such advisors to actual provide financial, legal or potential Sublicensees business advice to the Receiving Party regarding this Agreement or its subject matter, provided that such advisors are bound by non-use and non-disclosure obligations no less restrictive than those set forth in this Agreement, whether by written agreement or by applicable professional ethical obligations;
(f) in the case of TelixAssignee, disclosure to Assignee’s Affiliates (including, without limitation, Affiliated Licensees), provided that Confidential Information so disclosed shall remain subject to this Article 7;
(g) or licensees or sublicensees (in the case of LillyAssignee and Affiliated Licensees, disclosure to Third Party Licensees and bona fide potential Third Party Licensees, on the condition that each such Third Party agrees to be bound by confidentiality and non-use obligations that are no less stringent than the terms of this Agreement;
(h) in the case of Assignee (and Licensees), preparing and submitting regulatory filings with respect to Products; and
(i) in the Receiving Party’s Representatives whocase of Assignee and Affiliated Licensees, disclosure to Third Parties in each case, have a need connection with due diligence or similar investigations by such Third Parties and disclosure to know such information potential Third Party investors in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreementconfidential financing documents, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative Third Party agrees to be bound by terms reasonable obligations of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityuse. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Partyother party’s Confidential Information pursuant to Section 8.3(c7.3(c) (but, for clarity, not under or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority7.3(d), it willthe Receiving Party shall, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information at least as diligent as such party would use to protect such party’s own confidential information, but in no event less than reasonable efforts. In any event, the Receiving Party agrees to take all reasonable action to avoid unauthorized disclosure and unauthorized use of Confidential Information. [***] = 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 406 of the Securities Act of 1933, as amended.
Appears in 1 contract
Samples: Patent Assignment Agreement (CRISPR Therapeutics AG)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
: (a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
prosecuting Patent Rights pursuant to Section 5.1(c); (b) prosecuting or defending litigation as permitted by this Agreement;
against a Third Party; (c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
stock is listed; (d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs and BLAs) connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any performance of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, providedto Affiliates, in permitted (sub)licensees, contractors, IRBs, contract research organizations, academic institutions, consultants, agents, investigators, and employees and contractors engaged by study sites and investigators involved with or potentially involved with the Combined Therapy Clinical Trial, each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees whom prior to disclosure must be bound by terms of confidentiality and non-use substantially at least as restrictive protective of Confidential Information as those set forth in this Article 8;
7; (ge) disclosure (i) of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with Patent Prosecution the development of the Combined Therapy, the TPT Study Drug or the enforcement EQRx Study Drug; and (f) disclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, IRBs or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications ethics committees and all other documents or materials submitted to Regulatory Authorities and (iii) that are involved in other clinical trials of the existenceTPT Study Drug with respect to TPT, terms and the EQRx Study Drug with respect to EQRx, and, in the event of a copy Material Safety Issue, to Third Parties that are collaborating with TPT or EQRx, respectively in the conduct of such other clinical trials of the Agreement (provided TPT Study Drug or the EQRx Study Drug, in each case solely to the extent necessary for the conduct of such terms clinical trials or to comply with Applicable Law and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityregulatory requirements. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of any of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c7.3 (other than in connection with litigation between the Parties) (but, for clarity, not under or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority)7.3, it will, except in the case where it is impractical to do so (i) will give reasonable advance written notice to the Disclosing such other Party of such required impending disclosure, to the extent legally permissible and (ii) at the Disclosing Party’s request reasonably practicable, and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.
Appears in 1 contract
Samples: Clinical Trial Collaboration Agreement (Turning Point Therapeutics, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent that such disclosure is reasonably necessary in the following instancesis:
(a) enforcing made in response to a valid order of a court or exercising other Governmental Authority or, if in the reasonable opinion of the Receiving Party’s rights under this Agreement and performing , such disclosure is otherwise required by Law, including by reason of filing with securities regulators; provided that the Receiving Party shall, to the extent permitted by Law, first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity, at the Disclosing Party’s obligations under this Agreementexpense, to quash such order or to obtain a protective order or confidential treatment; and provided further that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;
(b) prosecuting made by or defending litigation on behalf of the Receiving Party to Regulatory Authorities as permitted by this Agreementrequired in connection with any filing, application or request for marketing or other Regulatory Approval; provided that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with applicable Law;
(c) complying with applicable court made by or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements on behalf of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written noticeto a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent; provided that reasonable measures shall be taken to assure confidential treatment of such information, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;protection is available; or
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for made by the Receiving Party to its attorneys, auditors, advisors, consultants, contractors, existing or prospective collaboration partners, licensees, sublicensees, existing or prospective investors, prospective acquirers, or other Third Parties as may be necessary or useful in connection with exploitation of Collaboration Products as contemplated by the Collaboration or otherwise in connection with the performance of its obligations or exercise of its rights or fulfill its obligations under as contemplated by this Agreement, provided, in each case, ; provided that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees Persons shall be subject to be bound by terms obligations of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted respect to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of Confidential Information substantially similar scope and magnitude as to the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, and non-use of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationset forth herein.
Appears in 1 contract
Authorized Disclosure. Notwithstanding Except as expressly provided otherwise in the provisions of Section 8.1Transaction Agreements (or the Astellas Agreement), the Receiving each Party may use and disclose Confidential Information of the Disclosing Party other Parties as expressly follows:
(i) under appropriate confidentiality provisions substantially equivalent to those in this Agreement (except that the term of confidentiality may be shorter than the term of confidentiality herein, but in no event less than five (5) years after the termination of the agreement with the disclosee containing such confidentiality provisions): (A) in connection with the performance of its obligations or as reasonably necessary or useful in the exercise of its rights under the Transaction Agreements (or the Astellas Agreement), including the right to grant licenses or sublicenses or extension of the licenses and sublicenses to Affiliates and subcontractors as permitted by this hereunder or in the other Transaction Agreements (or the Astellas Agreement), and (B) to the extent such disclosure is reasonably necessary or if and useful in conducting activities under the 4 Program or Other Programs; (ii) to the extent such disclosure is reasonably necessary in prosecuting or maintaining any patent or other Intellectual Property in accordance with the following instances:
Transaction Agreements (a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Astellas Agreement;
(b) ), prosecuting or defending litigation as permitted by this related to the Transaction Agreements (or the Astellas Agreement;
(c) ), complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment regulations with respect to performance under the Transaction Agreements or the Astellas Agreement (including to comply with the applicable rules of any public stock exchange upon which the stock of such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to Party or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lillyits Affiliate is listed), and to making any regulatory filings, otherwise obtaining marketing approvals or fulfilling post-marketing approval obligations for products that are the Receiving Party’s Representatives who, in each case, have subject a need to know such information in order for Transaction Agreement (or the Receiving Party to exercise its rights or fulfill its obligations under this Astellas Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees otherwise required by applicable Legal Requirements; provided, however, that if a Party is required by applicable Legal Requirements or court order to be bound by terms make any such disclosure of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
another Party’s Confidential Information such Party will, except where impracticable for necessary disclosures (g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoingfor example, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authoritymedical emergency), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing such other Party of such required disclosuredisclosure requirement and, in each of the foregoing, (but not to the extent inappropriate in the case of prosecution and (ii) at the Disclosing Party’s request and expensemaintenance of patents), shall cooperate with the Disclosing Party’s will use its reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other seek confidential treatment of such Confidential InformationInformation required to be disclosed; (iii) in communication with advisors (including financial advisors, lawyers and accountants) or actual or bona fide potential investors or acquirers, or actual or bona fide potential licensees or sublicensees related to products that are the subject of the Transaction Agreements (or the Astellas Agreement), or approved or permitted contractors, service providers, vendors and the like used (or to be used) in connection with activities under any Transaction Agreement or the Astellas Agreement, each on a need to know basis, and in each case under standard confidentiality obligations (subject to the allowances for term of confidentiality provided in subsection (i) above), or (iv) to the extent mutually agreed to by the Parties. In addition to the foregoing, with respect to complying with the disclosure requirements of the SEC or similar regulatory bodies or the rules of an applicable public stock exchange, in connection with any required disclosure of material information related to this Agreement, the Parties shall consult with one another concerning the information to be disclosed where practicable.
Appears in 1 contract
Samples: Master Joint Venture Agreement
Authorized Disclosure. Notwithstanding Except as expressly provided otherwise in the provisions of Section 8.1Transaction Agreements (or the Astellas Agreement), the Receiving each Party may use and disclose Confidential Information of the Disclosing Party other Parties as expressly follows: (i) under appropriate confidentiality provisions substantially equivalent to those in this Agreement (except that the term of confidentiality may be shorter than the term of confidentiality herein, but in no event less than five (5) years after the termination of the agreement with the disclosee containing such confidentiality provisions): (A) in connection with the performance of its obligations or as reasonably necessary or useful in the exercise of its rights under the Transaction Agreements (or the Astellas Agreement), including the right to grant licenses or sublicenses or extension of the licenses and sublicenses to Affiliates and subcontractors as permitted by this hereunder or in the other Transaction Agreements (or the Astellas Agreement), and (B) to the extent such disclosure is reasonably necessary or if and useful in conducting activities under the 4 Program or Other Programs; (ii) to the extent such disclosure is reasonably necessary in prosecuting or maintaining any patent or other Intellectual Property in accordance with the following instances:
Transaction Agreements (a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Astellas Agreement;
(b) ), prosecuting or defending litigation as permitted by this related to the Transaction Agreements (or the Astellas Agreement;
(c) ), complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment regulations with respect to performance under the Transaction Agreements or the Astellas Agreement (including to comply with the applicable rules of any public stock exchange upon which the stock of such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to Party or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lillyits Affiliate is listed), and to making any regulatory filings, otherwise obtaining marketing approvals or fulfilling post-marketing approval obligations for products that are the Receiving Party’s Representatives who, in each case, have subject a need to know such information in order for Transaction Agreement (or the Receiving Party to exercise its rights or fulfill its obligations under this Astellas Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees otherwise required by applicable Legal Requirements; provided, however, that if a Party is required by applicable Legal Requirements or court order to be bound by terms make any such disclosure of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
another Party’s Confidential Information such Party will, except where impracticable for necessary disclosures (g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoingfor example, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authoritymedical emergency), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing such other Party of such required disclosuredisclosure requirement and, in each of the foregoing, (but not to the extent inappropriate in the case of prosecution and (ii) at the Disclosing Party’s request and expensemaintenance of patents), shall cooperate with the Disclosing Party’s will use its reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other seek confidential treatment of such Confidential InformationInformation required to be disclosed; (iii) in communication with advisors (including financial advisors, lawyers and accountants) or actual or bona fide potential investors or acquirers, or actual or bona fide potential licensees or sublicensees related to products that are the subject of the Transaction Agreements (or the Astellas Agreement), or approved or permitted contractors, service providers, vendors and the like used (or to be used) in connection with activities under any Transaction Agreement or the Astellas Agreement, each on a need to know basis, and in each case under standard confidentiality obligations (subject to the allowances for term of confidentiality provided in subsection (i) above), or (iv) to the extent mutually agreed to by the Parties. In addition to the foregoing, with respect to complying with the disclosure requirements of the SEC or similar regulatory bodies or the rules of an applicable public stock exchange, in connection with any required disclosure of material information related to this Agreement, the Parties shall consult with one another concerning the information to be disclosed where practicable.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information of belonging to the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) for complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to regulations promulgated by securities laws disclosure requirements or exchanges and any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are tradedcourt orders, provided the that such Receiving Party gives promptly notifies the Disclosing Party sufficient written notice, in writing prior to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that making any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality disclosure and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate cooperates with the Disclosing Party’s efforts to contest seek confidential treatment or to otherwise limit disclosure. Each Receiving Party may disclose the Disclosing Party’s Confidential Information to its Affiliates, employees, agents, advisors, and independent contractors engaged by such requirementReceiving Party, in each case (a) only to obtain a protective order requiring that the extent such Persons need to know the Confidential Information so disclosed solely in connection with the performance of this Agreement, and (b) provided that each Person receiving Confidential Information must be used only bound by obligations of confidentiality and non-use at least as stringent, and equivalent in scope, to those set forth in this Article 4 prior to any such disclosure and such Receiving Party shall be liable to the Disclosing Party for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment any breach of such obligations by the Person to whom the Confidential InformationInformation was disclosed. Each Receiving Party may also disclose Confidential Information of the Disclosing Party, including the material terms of this Agreement, or provide a copy of any such agreement or a summary of such Party’s findings during any due diligence investigation, in connection with any actual or potential collaboration, investment, acquisition or licensing transaction to any bona fide potential or actual collaborator, investor, investment banker, acquirer, provider of debt or royalty financing, licensee or any potential or actual financial partner without consent of the other Party, and provided that in connection with such disclosure, each Person to whom such Confidential Information is disclosed must be bound by obligations of confidentiality and non-use at least as stringent, and equivalent in scope, to those set forth in this Article 4 prior to any such disclosure and the Receiving Party making such disclosure to such recipient shall be liable to the Disclosing Party for any breach of such obligations by such recipient. In any event, each Party agrees to take all reasonable action to avoid unauthorized use or disclosure of Confidential Information of another Party hereunder. In the event of any conflict between the terms of this Article 4, and the Confidentiality Agreement, the terms of Confidentiality Agreement shall prevail.
Appears in 1 contract
Samples: Purchase and Sale Agreement (Emergent BioSolutions Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the A Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement (including as reasonably necessary for the Receiving Party’s performance of its obligations under this Agreement), or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(cb) complying with applicable court or governmental orders, applicable laws, rules or Applicable Lawsregulations, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ Affiliate’s securities are traded, provided ;
(c) enforcing the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential InformationParty’s rights under this Agreement;
(d) in the case of Telix filing or prosecuting Patent Rights as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorypermitted by this Agreement;
(e) in the case of Lxxxx as the Receiving PartyCompany, disclosure in regulatory submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in F1 Products within the Territory regarding any Lilly Product or Companion Diagnostic or any scope of the foregoing submissions or filings in the TerritoryExclusive ACT License;
(f) in the case of BioAtla, disclosure in regulatory submissions with respect to BioAtla CAB Non-ACT Products within the scope of the Exclusive Non-ACT License;
(g) disclosure to the Receiving Party’s Affiliates, to the Company’s actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)rights with respect to F1 Products, to BioAtla’s actual or potential licensees or sublicensees of rights with respect to BioAtla CAB Non-ACT Products, and to the Receiving Party’s and its Affiliates’ Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)sublicensee, or Representative agrees to be bound by terms of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])4; and
(h) disclosuredisclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by either Party, reasonable obligations of a copy of the Agreement in response to a request from a taxing authorityconfidentiality and non-use. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c4.3(a) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 4.3(b), it will, except in the case where it is impractical to do so impracticable, (i) give reasonable advance notice to the Disclosing Party of such required disclosure, (ii) use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts, and (iiiii) cooperate with any efforts by the Disclosing Party, at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Information.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1obligations set forth in Article 12.1, the Receiving a Party may disclose the other Party’s Confidential Information and the terms of this Agreement or the Disclosing Party as expressly permitted by this Agreement, or if and Exclusive Trademark License to the extent extent:
(a) such disclosure is reasonably necessary in (i) for the following instances:
filing or prosecuting Patent rights as contemplated by this Agreement; (aii) enforcing for the filing or exercising prosecuting of trademark rights as contemplated by the Receiving Party’s rights under Exclusive Trademark License; (iii) to comply with the requirements of Regulatory Authorities or Applicable Laws with respect to obtaining and maintaining Regulatory Approval of the Products; or (iv) for the prosecuting or defending litigation as contemplated by this Agreement and performing or the Receiving Party’s obligations under this AgreementExclusive Trademark License;
(b) prosecuting such disclosure is reasonably necessary to its Affiliates, employees, agents, consultants, contractors, and actual and potential licensees or defending litigation sublicensees (but, in the case of Licensee, subject to Article 12.3) on a need-to-know basis for the purpose of performing its obligations or exercising its rights under this Agreement or the Exclusive Trademark License, including, with respect to Licensor, for the purpose of Development, manufacture, Commercialization or other exploitation of the Products outside the Territory or the Development of any indication outside the Field in the Territory (as permitted long as such indication, once approved, will be automatically included in the Field and the rights or benefits granted to Licensee under this License will be accordingly extended to such indication) during the Term and worldwide after termination of this Agreement; provided that in each case, the disclosees are bound by written obligations of confidentiality and non-use consistent with those contained in this Agreement;
(c) complying with applicable court such disclosure is reasonably necessary to any bona fide potential or governmental ordersactual investor, acquiror, merger partner, or other financial or commercial partner for the sole purpose of evaluating or carrying out an actual or potential investment, acquisition or other business relationship; provided that in connection with such disclosure, such Party shall inform each disclosee of the confidential nature of such Confidential Information and obligate each disclosee in writing to treat such Confidential Information as confidential; or
(d) such disclosure is reasonably necessary to comply with Applicable Laws, including Applicable Laws related to securities laws disclosure requirements regulations promulgated by applicable security exchanges, court order, administrative subpoena or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityorder. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(cArticle 12.2(a) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 12.2(d), it will, except in such Party shall promptly notify the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use reasonable efforts to contest such requirementobtain, or to obtain assist the other Party in obtaining, a protective order requiring that preventing or limiting the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationrequired disclosure.
Appears in 1 contract
Samples: License, Collaboration and Supply Agreement (Capstar Special Purpose Acquisition Corp.)
Authorized Disclosure. Notwithstanding the provisions of (a) In addition to disclosures allowed under Section 8.112.2, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and its Affiliates solely to the extent such disclosure is reasonably necessary in the following instances:
: (ai) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under prosecuting Patent Rights as permitted by this Agreement;
; (bii) in connection with Regulatory Filings for Products; (iii) prosecuting or defending litigation as permitted by this Agreement;
; (civ) complying with applicable Applicable Law, court orders or governmental orders, or Applicable Lawsregulations, including Applicable Laws related rules of self-regulatory organizations and SEC filing and disclosure requirements; (v) Company’s disclosure of Confidential Information under this Agreement (including Novartis’ Confidential Information) to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which Existing Third Party Licensor to the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving limited extent required by an Existing Third Party gives the Disclosing Party sufficient written notice, License; (vi) to the extent such disclosure is reasonably possible, necessary and with prior notice if possible under the circumstances: (A) to permit comply with the Disclosing Party terms of agreements with Third Parties related to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix Collaboration Product that exist as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings Effective Date; (B) to comply with the terms of agreements with Third Parties related to a Collaboration Product that are entered into after the Effective Date, provided that such agreements are entered into in compliance with the Territory;
(e) in terms of this Agreement and, further provided that the case provisions of Lxxxx as the Receiving Party, such agreements requiring disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving other Party’s Affiliates, to actual or potential Sublicensees Confidential Information have been reviewed and approved by such other Party (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees approval not to be bound by terms unreasonably withheld); or (vii) to potential or actual investors or acquirers as may be necessary in connection with their evaluation of a potential or actual investment or acquisition; provided that such persons shall be subject to obligations of confidentiality and non-use substantially at least as restrictive protective as those set forth in this Article 8;
12; and (gviii) disclosure (i) to the extent otherwise necessary or appropriate in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications its rights and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under performing its obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); andhereunder.
(hb) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in In the event the Receiving Recipient Party is required to make a disclosure disclose Confidential Information of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (butParty by law, for clarityapplicable court order or governmental regulation or in connection with bona fide legal process, such disclosure shall not under Section 8.3(h) where, notwithstanding anything to be a breach of this Agreement; provided that the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so Recipient Party (i) give reasonable advance notice to informs the Disclosing Party as soon as reasonably practicable of such the required disclosure, ; (ii) limits the disclosure to that which is legally required to be disclosed; and (iiiii) at the Disclosing Party’s request and expense, shall cooperate assists in an attempt to object to or limit the required disclosure.
(c) Either Party may disclose the existence and terms of this Agreement in confidence to its attorneys and advisors, and to potential acquirers (and their respective professional attorneys and advisors), in connection with a potential merger, acquisition or reorganization and to existing and potential investors or lenders of such Party, as part of their due diligence investigations, or to existing and potential licensees or sublicensees or to permitted assignees, in each case under an agreement to keep the Disclosing Party’s efforts terms of confidentiality and non-use substantially no less rigorous than the terms contained in this Agreement and to contest use such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only information solely for the purposes for which the order was issued or the law or regulation required, and/or purpose permitted pursuant to obtain other confidential treatment of such Confidential Informationthis Section 12.3(c).
Appears in 1 contract
Samples: Collaboration and License Agreement (Aduro Biotech, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1Except as expressly provided otherwise in this Agreement, the a Receiving Party or its Affiliates may use and disclose to Third Parties Confidential Information of the Disclosing Party as expressly permitted by this Agreement, follows: (i) solely in connection with the performance of its obligations or if and to the extent such disclosure is reasonably necessary exercise of rights granted or reserved in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) confidentiality provisions no less restrictive than those in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any a Receiving Party may disclose Confidential Information to a governmental entity or agency without requiring such Affiliate, actual entity or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees agency to be bound by terms of enter into a confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, agreement; (ii) in connection to the extent reasonably necessary to file or prosecute patent, copyright and trademark applications (subject to Section 12.4 (Press Release; Publications; Disclosure of Agreement) below), complying with Regulatory Applications and all other documents applicable governmental regulations, obtaining Approvals, conducting Pre-Clinical Studies or materials submitted to Regulatory Authorities and Clinical Studies, marketing a Product, or as otherwise required by Applicable Law, regulation, rule or legal process (iii) including the rules of the existence, terms SEC and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]any stock exchange); and
(h) disclosureprovided, however, that if a Receiving Party or any of its Affiliates is required by either Party, law or regulation to make any such disclosure of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) impracticable for necessary disclosures, give reasonable advance notice to the Disclosing Party of such required disclosure, disclosure requirement and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s will use its reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation required to be disclosed; (iii) in communication with actual or potential lenders, investors, merger partners, acquirers, consultants, or professional advisors on a need-to-know basis, in each case under confidentiality provisions no less restrictive than those of this Agreement; (iv) to the extent such disclosure is required to comply with existing expressly stated contractual obligations owed to such Party’s or its Affiliates’ licensor with respect to any intellectual property licensed to the other Party under this Agreement; or (v) as mutually agreed to in writing by the Parties. Notwithstanding the foregoing, if either Party concludes based on the reasonable opinion of counsel that a copy of this Agreement must be filed with the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States, such Party will, within a reasonable time prior to any such filing (and to the extent possible at least [***] prior to any such filing), provide the other Party with a copy of this Agreement showing any provisions hereof as to which such Party proposes to request confidential treatment, and the Parties shall coordinate with each other and will use good faith efforts to mutually agree on the redaction of certain provisions of this Agreement (together with all exhibits and schedules) before filing such copy of this Agreement, provided that notwithstanding the foregoing, the filing Party shall retain final decision-making authority over the redactions to be made in its filed copy of this Agreement.
Appears in 1 contract
Samples: Research, Development, and License Agreement (Ionis Pharmaceuticals Inc)
Authorized Disclosure. Notwithstanding (a) If, based upon the provisions advice of Section 8.1legal counsel skilled in the subject matter, a Party is required to disclose specific Confidential Information of the other Party to comply with an applicable law, regulation, legal process, or order of a government authority or court of competent jurisdiction, the Receiving Party may disclose such Confidential Information only to the entity or person required to receive such disclosure; provided, however, that the Party required to disclose such Confidential Information shall (a) to the extent permitted by such law, regulation, process, order or rules, first have given prompt (but in no event less than five (5) business days) advance notice to such other Party to enable it to seek any available exemptions from or limitations on such disclosure requirement and shall reasonably cooperate in such efforts by the other Party, (b) furnish only the portion of the Confidential Information which is legally required to be disclosed; (c) use all reasonable efforts to secure confidential protection of such Confidential Information, and (d) continue to perform its obligations of confidentiality and non-use set out in this Article 11.
(b) Each Party may disclose Confidential Information of the Disclosing other Party as expressly permitted by this Agreementto Regulatory Authorities to the extent such disclosure is reasonably necessary in regulatory filings required for the development and/or commercialization of Licensed Products. In addition, or if and each Party may disclose Confidential Information of the other Party (other than Manufacturing Information) to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing : filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation patents as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) ; disclosure to the Receiving Party’s Affiliates, to actual or Sublicensees and potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)Sublicensees, and to the Receiving Party’s Representatives wholicensees or potential licensees of Cara, in each caseand to contractors, have a employees and consultants, who need to know such information in order for the Receiving development, manufacture and commercialization of Licensed Products, to bankers, lawyers, accountants, agents or other Third Parties in connection with due diligence or similar investigations, and to potential Third Party to exercise its rights or fulfill its obligations under this Agreement, provided, investors in each case, confidential financing documents; provided that any such AffiliateSublicensee, actual licensee, contractor, employee, consultant, banker, lawyer, accountant, agent or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be Third Party is bound by terms obligations of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) herein. In the case of each disclosure, the Party making such disclosure (i) in connection with Patent Prosecution or the enforcement or defense shall use reasonable efforts to obtain confidential treatment of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the not disclose Confidential Information so disclosed be used only for of the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential InformationParty other than is reasonably necessary.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1limitations in this Article 7, the Receiving either Party may disclose the Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable laws or regulations or valid court or governmental orders, provided that the Party making such disclosure provides the other Party with reasonable prior written notice of such request or Applicable Lawsdemand for disclosure and makes a reasonable effort to obtain, including Applicable Laws related or to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which assist the Receiving Party’s or any of its Affiliates’ securities are tradedother Party in obtaining, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order preventing or other confidential or protective treatment with respect to such Confidential Information;
(d) in limiting the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order and/or requiring that the Confidential Information so disclosed terms and conditions of this Agreement be used only for the purposes for which the order was issued or the law or regulation required, or for which the order was issued;
(b) to regulatory authorities in order to seek or obtain approval to conduct clinical trials, or to gain regulatory approval, of Oragenics Products or any products being developed by Intrexon or its other licensees and/or channel partners or collaborators, provided that the Party making such disclosure (i) provides the other Party with reasonable opportunity to obtain review any such disclosure in advance and to suggest redactions or other means of limiting the disclosure of such other Party’s Confidential Information and (ii) does not unreasonably reject any such suggestions;
(c) disclosure to investors and potential investors, acquirers, or merger candidates who agree to maintain the confidentiality of such information, provided that such disclosure is used solely for the purpose of evaluating such investment, acquisition, or merger (as the case may be); Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
(d) disclosure on a need-to-know basis to Affiliates, licensees, sublicensees, employees, consultants or agents (such Confidential Informationas CROs and clinical investigators) who agree to be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 7; and
(e) disclosure of the terms of this Agreement by Intrexon to collaborators and other channel partners or collaborators who agree to be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 7.
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (Oragenics Inc)
Authorized Disclosure. Notwithstanding the provisions of Section 8.116.1, the Receiving each Party may disclose the other Party’s Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instancesto:
(a) enforcing 16.2.1 file or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation prosecute patent applications as permitted contemplated by this Agreement;
(c) complying with applicable court 16.2.2 prosecute or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationdefend litigation;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs 16.2.3 allow its Affiliates and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) and actual or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives whopotential Subcontractors, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill perform its obligations under this Agreement, provided, in each case, ; provided that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound disclosure is covered by terms of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8herein;
16.2.4 subject to the remainder of this Section 16.2, share with its advisors (g) including financial advisors, attorneys and accountants), actual or potential acquisition partners, financing sources or investors and underwriters on a need to know basis; provided that such disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, is covered by terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement to those set forth herein (other than the confidentiality term, which may be as short as [**]include professional ethical obligations); andor
16.2.5 comply with Applicable Law (h) disclosureincluding to obtain and maintain Marketing Approvals for a Licensed Product); provided that with respect to Sections 16.2.1, by either Party16.2.2 or 16.2.5, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to will notify the Disclosing Party of the Receiving Party’s intent to make any disclosure pursuant thereto sufficiently prior to making such required disclosure, and (ii) at disclosure so as to allow the Disclosing PartyParty adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information to be disclosed. Notwithstanding anything to the contrary contained herein, in no event may Kymera disclose Sanofi’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for to any Third Party (including any of Kymera’s investors, collaborators or licensees) engaged in the purposes for which research, development, manufacture or commercialization of pharmaceutical products, other than to actual or potential Subcontractors. Notwithstanding anything to the order was issued contrary contained herein, in no event may Sanofi disclose Kymera’s Confidential Information to any Third Party (including any of Sanofi’s investors, collaborators or licensees) engaged in the law research, development, manufacture or regulation requiredcommercialization of pharmaceutical products, and/or other than to obtain other confidential treatment of such Confidential Informationactual or potential Subcontractors or Sublicensees.
Appears in 1 contract
Samples: Collaboration and License Agreement (Kymera Therapeutics, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, Agreement or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing, prosecuting, or exercising maintaining the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under Licensed Patents as permitted by this Agreement;
(b) regulatory filings for the Licensed Products that such Party has a license or right to develop or commercialize hereunder in a given country or within the Territory;
(c) prosecuting or defending litigation as permitted by this Agreement;
(cd) complying with applicable court orders or governmental orders, or Applicable Lawsregulations, including Applicable Laws related to regulations promulgated by securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are tradedexchanges, provided the Receiving that any Party gives the Disclosing making such disclosure shall promptly notify such other Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective of such order or regulation upon the receipt thereof, and provide reasonable assistance to such other Party in seeking confidential or protective treatment with respect to of such Confidential Information;
(de) in the case of Telix as the Receiving Partydisclosure to its and its Affiliates’ employees, disclosure in submissions consultants, contractors, and agents, to or filings with any Regulatory Authority (including, without limitationits licensees and sublicensees, in INDs and BLAs) each case on a need-to-know basis in connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product development or any commercialization of the foregoing submissions or filings Licensed Products in accordance with the Territory;
(e) in the case terms of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationthis Agreement, in INDs each case under written obligations of confidentiality and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;non-use at least as stringent as those herein; and
(f) disclosure to actual and bona fide potential investors, acquirors, licensees, and other financial or commercial partners solely for the Receiving Party’s Affiliates, to purpose of evaluating or carrying out an actual or potential Sublicensees (in the case of Telix) investment, acquisition, or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives whocollaboration, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its case under written obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
stringent (g) disclosure (i) in connection except with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted respect to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality termduration, which may be shorter as short long as [**]); and
not less than three (h3) disclosureyears) as those herein, by either provided that if this Agreement is being disclosed the disclosing Party redacts the financial terms and other provisions of this Agreement that are not reasonably required to be disclosed in connection with such potential investment, acquisition, or collaboration, which redaction shall be prepared in consultation with the other Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c7.2(c) (but, for clarity, not under or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority7.2(d), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure and (ii) at use the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s same diligent efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation as such Party would use to protect its own confidential information, but in no event less than reasonable efforts. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential Information hereunder. Any information disclosed pursuant to Section 7.2(c) or Section 7.2(d) shall remain Confidential Information and subject to the restrictions set forth in this Agreement, including the foregoing provisions of this Article 7.
Appears in 1 contract
Samples: Exclusive License Agreement (Autonomix Medical, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1Except as expressly provided otherwise in this Agreement, the a Receiving Party may use and disclose Confidential Information of the Disclosing Party as expressly permitted follows: [*] = Certain confidential information contained in this document, marked by this Agreementbrackets, or if has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the extent such disclosure is reasonably necessary in the following instances:Securities Exchange Act of 1934, as amended.
(a) enforcing under appropriate confidentiality provisions at least as protective of such Confidential Information as those in this Agreement, as reasonably necessary for performance of its obligations or exercising the Receiving Party’s exercise of rights under granted in this Agreement (including the rights to make, have made, use, offer for sale, import, sell, and performing the Receiving Party’s obligations under otherwise exploit any IL-1 Antibody or IL-1 Products) including in filing or prosecuting patent applications in accordance with Section 4.2, prosecuting or defending litigation, complying with applicable Law (subject to clause (b) below), seeking and obtaining Regulatory Approval, conducting non-clinical activities or clinical trials, preparing and submitting BLAs to Regulatory Authorities, and marketing IL-1 Products, in each case in accordance with this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, is required by Law; provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and if a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required by Law to make a any such disclosure of the a Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) legally permitted and practicable, give reasonable advance notice to the Disclosing Party of such required disclosuredisclosure requirement, and (ii) at afford the Disclosing Party an opportunity to secure, and, if requested by the Disclosing Party’s request and expense, shall reasonably cooperate with the Disclosing Party’s efforts to contest such requirementParty to, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation required to be disclosed, and disclose only that portion of the Confidential Information that the Receiving Party is legally required to disclose as advised by the Receiving Party’s legal counsel;
(c) in communication with actual or potential investors, lenders, acquirers, merger partners, consultants, professional advisors, collaborators, donors, or funding sources as reasonably necessary, and with its licensors as necessary to satisfy its reporting obligations with respect to any IL-1 Antibody or IL-1 Product, in each case under appropriate confidentiality provisions substantially equivalent to those of this Agreement; or
(d) to the extent mutually agreed to in writing by the Parties.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions Pfizer and Monogram each agree that any disclosure (i) by Pfizer or any of Section 8.1, the Receiving Party may disclose its Affiliates of Monogram Confidential Information of the Disclosing Party as expressly permitted by this AgreementInformation, or (ii) by Monogram or any of its Affiliates of Pfizer Confidential Information, in each case to any of their respective officers, employees or agents shall be made only if and to the extent such disclosure is reasonably necessary to carry out its rights and obligations under this Agreement and shall be limited to the maximum extent possible consistent with such rights and obligations. Monogram and Pfizer each represent that all of their directors, officers, employees and agents who shall have access to Pfizer Technology, Monogram Technology, Pfizer Confidential Information or Monogram Confidential Information are bound by an agreement to maintain such information in confidence. Notwithstanding the following instances:
foregoing, (x) Pfizer may disclose any Monogram Confidential Information to (I) Governmental Authorities (a) enforcing to the extent reasonably necessary to obtain or exercising maintain INDs or Regulatory Approvals for the Receiving PartyPfizer Product, (b) to the extent reasonably necessary to respond to inquiries, requests or investigations, and (c) to the extent reasonably necessary to obtain Regulatory Approval and pricing and reimbursement of the sale of the Commercial Assay in any Ex-US Country, including any Reimbursement Approval, (II) Pfizer Agents or other business consultants, attorneys, accountants or professional service providers, except for [*] = 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 THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. medical, scientific or technical consultants in the area of HIV or antiretroviral resistance testing, and (III) to the extent necessary in order to enforce Pfizer’s rights under this Agreement and performing or the Receiving PartyNote Agreement, (y) Monogram may disclose any Pfizer Confidential Information (I) to Governmental Authorities in order to respond to inquiries, requests or investigations, (II) to attorneys, accountants or professional service providers (III) to outside consultants, suppliers or subcontractors in connection with the Assay, (IV) to the extent necessary in order to enforce Monogram’s obligations rights under this Agreement;
; and (bz) prosecuting Pfizer and Monogram may disclose any Monogram Confidential Information and Pfizer Confidential Information, respectively, when required to be disclosed under Law or defending litigation in connection with a legal proceeding; provided that, in each case enumerated in clauses (x), (y), and (z) of this Section 10.2, the disclosing Party shall obtain the same confidentiality obligations from such Third Parties as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment it obtains with respect to such Confidential Information;
(d) in the case its own proprietary information of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs similar kind and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationvalue.
Appears in 1 contract
Samples: Collaboration Agreement (Monogram Biosciences, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1Except as expressly provided otherwise in this Agreement, the Receiving each Party may use and disclose Confidential Information of the Disclosing other Party solely as expressly permitted by follows:
(a) under appropriate confidentiality provisions substantially equivalent to those in this Agreement:
(i) in connection with the performance of its obligations or as reasonably necessary or useful in the exercise of its rights under this Agreement, including the right to grant licenses or if sublicenses as permitted hereunder;
(ii) in the case of Arrys as the receiving Party, to actual or potential (sub)licensees, acquirers or assignees, collaborators, investment bankers, investors or lenders, in each case, on a need to know basis;
(iii) in the case of AskAt as the receiving Party, to actual or potential acquirers or assignees, collaborators, investment bankers, investors or lenders, in each case, on a need to know basis; and
(iv) in the case of AskAt as the receiving Party, to actual or potential licensees (including an actual or potential licensee who is a Arrys Sublicensee coming into a direct license as provided for in this Agreement) solely as is reasonably necessary for each such disclosee to conduct technical or legal due diligence in connection with the proposed transaction with AskAt; provided that in no event shall such disclosure include any Confidential Information of Arrys other than the scope of Licensed Technology, Licensed Compounds, Licensed Products, in the Field and in the Territory,
(b) to the extent such disclosure is to a Governmental Authority as reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement prosecuting Patent, copyright and performing the Receiving Party’s obligations trademark applications, prosecuting or defending litigation, complying with applicable governmental regulations with respect to performance under this Agreement;
(b) prosecuting , obtaining Regulatory Approval or defending litigation as permitted fulfilling post-approval regulatory obligations for the Licensed Compounds or Licensed Products, or otherwise required by this AgreementApplicable Law; provided, however, that if a Party is required by Applicable Law to make any such disclosure of the other Party’s Confidential Information it shall, except where impracticable for necessary disclosures, give reasonable advance notice to the other Party of such disclosure requirement and, in each of the foregoing, shall use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed and shall only disclosed that Confidential Information that is required to be disclosed;
(c) complying with applicable court to advisors (including lawyers and accountants) on a need to know basis, in each case under appropriate confidentiality provisions or governmental orders, or Applicable Laws, including Applicable Laws related professional standards of confidentiality substantially equivalent to securities laws disclosure requirements or any disclosure requirements those of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;this Agreement; or
(d) in to the case of Telix as extent mutually agreed to by the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in Parties. In the Territory regarding any Licensed Product or any event that a receiving Party discloses Confidential Information of the other Party pursuant to the foregoing submissions provisions of this Section 9.2, the receiving Party shall be primarily liable to the other Party for any act or filings in omission of a disclosee to whom the Territory;
(e) in receiving Party provides the case disclosing Party’s Confidential Information to the same extent as if such act or omission of Lxxxx as the Receiving Party, disclosure in submissions to a disclose were an act or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any omission of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, the Parties shall agree upon a joint press release to announce this Agreement in a form to be mutually agreed by the event Parties; thereafter, each Party may each disclose to Third Parties the Receiving information contained in such press release without the need for further approval by the other. Notwithstanding the foregoing, if a Party is required by Applicable Law to make a disclosure of the Disclosing Party’s Confidential Information pursuant terms of this Agreement in a filing with or other submission to Section 8.3(cthe SEC or foreign equivalent, any stock exchange or market, including publicly disclosing or filing this Agreement as a “material agreement” in accordance with Applicable Laws or applicable stock exchange regulations, and (A) such Party has provided copies of the disclosure to the other Party as far in advance of such filing or other disclosure as is reasonably practicable under the circumstances, (butB) such Party has promptly notified the other Party in writing of such requirement and any respective timing constraints, for clarityand (C) such Party has given the other Party a reasonable time under the circumstances from the date of notice by such Party of the required disclosure to comment upon, not under Section 8.3(h) whererequest confidential treatment or approve such disclosure, notwithstanding then such Party shall have the right to make such public disclosure at the time and in the manner reasonably determined by its counsel to be required by Applicable Law. Notwithstanding anything to the contrarycontrary herein, Lxxxx it is hereby understood and agreed that if a Party seeking to make a disclosure to the SEC as set forth in this Section 9.2, and the other Party provides comments within the respective time periods or constraints specified herein or within the respective notice, the Party seeking to make such disclosure or its counsel, as the case may freely disclose a copy be, shall in good faith (1) consider incorporating such comments and (2) use reasonable efforts to incorporate such comments, limit disclosure or obtain confidential treatment to the extent reasonably requested by the other Party. Each Party shall have the right to issue additional press releases or to make public disclosures with the prior written agreement of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing other Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Information.
Appears in 1 contract
Authorized Disclosure. Notwithstanding Except as expressly provided otherwise in this Agreement, a Receiving Party may use and disclose Confidential Information of the provisions Disclosing Party as follows: (a) in connection with the performance of Section 8.1its obligations or exercise of rights granted or reserved in this Agreement (including the rights to Develop and Commercialize the Covered Products); or (b) to the extent such disclosure is reasonably necessary in filing or prosecuting patent, copyright, and trademark applications, prosecuting or defending litigation, complying with applicable governmental regulations, obtaining regulatory approval, conducting Clinical Trial Investigations, or otherwise Execution Copy required by Law, provided, however, that if a Receiving Party is required in litigation or by Law or regulation to make any such disclosure of a Disclosing Party’s Confidential Information it shall give reasonable advance notice to the Disclosing Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, shall use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed; or (c) to the extent mutually agreed to in writing by the Parties. In addition, a Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written noticeAffiliates and Permitted Transferees, to Third Party appraisers in connection with the extent reasonably possibleappraisal of Company IP for the purpose of contributing such IP into the charter capital of NovaMedica, to permit the Disclosing or in connection with due diligence investigations by or on behalf of a Third Party to seek in connection with a protective order potential license, collaboration, investment, merger, or other confidential acquisition with or protective treatment with respect to by such Confidential Information;
(d) Third Party, and, in the case of Telix as the Receiving Company, to Third Parties in connection with due diligence investigations by or on behalf of a Third Party in connection with a potential license, collaboration, investment or other financing, merger, or acquisition with or by such Third Party; provided, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationhowever, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any each of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each casecases, that any such Affiliate, actual Third Party or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative Affiliate reasonably needs to have access to such Confidential Information and agrees to be bound by reasonable terms of confidentiality and non-use substantially at least as restrictive stringent as those set forth in this Article 8;
(g) , to limit such disclosure (i) in connection with Patent Prosecution to only personnel having a need to know such information, and to return or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted certify to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything as to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment destruction of such Confidential InformationInformation promptly after completing the due diligence investigation, negotiation, or transaction, as the case may be.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Each Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent that such disclosure is reasonably necessary in the following instancesis:
(a) required by law, order, or regulation of a government agency or a court of competent jurisdiction, or by the rules of a securities exchange, provided that the Party required to make such disclosure shall (i) give the other Party reasonable advance notice of and an opportunity to comment on any such required disclosure, (ii) if requested by the other Party, use Commercially Reasonable Efforts to obtain protective orders or any available limitations on or exemptions from such disclosure requirement where applicable and practicable;
(b) made to a patent office for the purposes of filing or enforcing a Patent as permitted in this Agreement, provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available;
(c) made by a Party or exercising its Affiliates, Distributors, Sublicensees or other sublicensees to the Receiving Party’s rights under this Agreement and performing Regulatory Health Authority for the Receiving Party’s obligations under purposes of any filing, application or request for Regulatory Approval for Licensed Compounds or Licensed Products as permitted in this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case made to advisors, actual or potential Third Party partners, investors, licensees, sublicensees or acquirers of Telix as the Receiving Party, disclosure in submissions to all or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any substantially all of the foregoing submissions or filings in the Territoryassets to which this Agreement relates;
(e) made by FOSUN or its Affiliates, Distributors, Sublicensees, or other sublicensees to Third Parties as may be necessary or useful in connection with the case Exploitation of Lxxxx the Licensed Compounds or Licensed Products as the Receiving Partycontemplated by this Agreement, disclosure including subcontracting or sublicensing transactions in submissions to connection therewith; or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) provided that with respect to any Lilly Product disclosures as per subsection (d) and (e) or Companion Diagnosticthe following sentence, the Party making such disclosures shall ensure that each Third Party recipient is bound by obligations of confidentiality no less restrictive than those contained in this Agreement and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure shall be liable to the Receiving Party’s Affiliatesother Party for any breach of such confidentiality obligations by the relevant recipient. In addition (but without prejudice to) the above provisions, each Party shall be entitled to actual or potential Sublicensees (in the case disclose, under a binder of Telix) or licensees or sublicensees (in the case confidentiality containing provisions as protective as those of Lilly)this Article VII, and Confidential Information to the Receiving Party’s Representatives who, in each case, have a need to know such information in order any Third Party for the Receiving Party to exercise its rights or fulfill its obligations purpose of carrying out activities authorized under this Agreement, provided, in each case, that any such Affiliate, actual including without limitation disclosures to Sublicensees or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationsublicensees.
Appears in 1 contract
Samples: License Agreement (Ardelyx, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing disclosure to Affiliates, to potential or exercising the Receiving Party’s rights under this Agreement actual licensees or sublicensees, and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting to employees, contractors, consultants, agents or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements other representatives of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, its Affiliates who have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, Agreement provided, in each case, that any such Affiliate, potential or actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)sublicensee, or Representative employee, contractor, consultant, agent or other representative agrees to be bound or are bound by confidentiality obligations comparable in scope to those set forth in this Article 6;
(b) disclosure to such Receiving Party’s attorneys, independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the Receiving Party, on the condition that such attorneys, independent accountants and financial advisors are bound by confidentiality and non-use obligations consistent with the confidentiality provisions of this Agreement as they apply to the Receiving Party;
(c) disclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties provided, in each case, that any such Third Party agrees to be bound by terms obligations of confidentiality and non-use substantially at least as restrictive stringent as those set forth out in this Article 86;
(gd) as approved by the Disclosing Party in writing for disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) publication by each of the existence, terms and a copy of the Agreement Parties;
(provided such terms and copy of the Agreement shall be redacted e) prosecuting or defending Claims as requested permitted by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])Agreement; and
(hf) disclosurecomplying with applicable court orders, by either Applicable Laws, rules or regulations, or the listing rules of any exchange on which the Receiving Party’s securities are traded, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, provided that: in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information of the Disclosing Party pursuant to this Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority6.3(f), it will, except in the case where it is impractical to do so (i) prohibited or impracticable, give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at disclosure so that the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts Party is afforded a reasonable opportunity to contest oppose such requirement, to obtain a requirement or otherwise seek an appropriate protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationorder.
Appears in 1 contract
Samples: Non Exclusive License Agreement (TScan Therapeutics, Inc.)
Authorized Disclosure. Notwithstanding the provisions obligations of Section 8.112.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as to the extent expressly permitted by this Agreement, Agreement or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) 12.3.1. filing or prosecuting patent applications as permitted by this Agreement;
12.3.2. exercising and enforcing or exercising the Receiving Party’s rights under this Agreement and in performing the Receiving Party’s its obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) 12.3.3. complying with applicable a valid order of any court or other governmental ordersauthority of competent jurisdiction, applicable laws, rules or regulations, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to comply with a valid request from a taxing authority)order of any court or other governmental authority of competent jurisdiction or with applicable laws, rules or regulations, it will, except in the case where it is impractical to do so impracticable, (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts, and (iii) cooperate with any lawful efforts by the Disclosing Party, at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to limit such disclosure to the greatest extent legally permissible, and/or to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain secure other confidential treatment of the Confidential Information required to be disclosed;
12.3.4. disclosure in regulatory filings or regulatory correspondence with respect to Product or Finished Product that the Receiving Party has the right to make under this Agreement;
12.3.5. in the case of PhaseBio as the Receiving Party, disclosure to actual or potential licensees, sublicensees and collaborators with respect to PB2452, provided that any such Confidential Informationactual or potential licensee, sublicensee or collaborator agrees to be bound by terms of confidentiality and non-use at least as stringent as those set forth in this Article 12; and
12.3.6. disclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by reasonable obligations of confidentiality and non-use.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information belonging to the Disclosing Party without the prior written approval of the Disclosing Party as expressly permitted by this Agreement, or if and only to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under Prosecuting Patent Rights as permitted by this Agreement;
(b) prosecuting or defending litigation preparing and submitting Regulatory Submissions and obtaining and maintaining Regulatory Approvals as permitted by this Agreement;
(c) complying with applicable court prosecuting or governmental orders, or Applicable Lawsdefending litigation, including Applicable Laws related responding to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving a subpoena in a Third Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationlitigation;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to complying with Applicable Law or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product court or any of the foregoing submissions or filings in the Territory;administrative orders; or
(e) in the case communications with existing or bona fide prospective acquirers, merger partners, collaboration partners, lenders or investors, and consultants and advisors of Lxxxx as the Receiving Party, disclosure Party in submissions to connection with transactions or filings bona fide prospective transactions with any Regulatory Authority (including, without limitationthe foregoing, in INDs each case on a “need-to-know” basis and BLAs) with respect to any Lilly Product under confidentiality provisions at least as restrictive or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any protective of the foregoing submissions Parties as those set forth in this Agreement or filings otherwise customary for such type and scope of disclosure any such disclosure is limited to the maximum extent practicable for the particular context in the Territorywhich it is being disclosed;
(f) to allow the Receiving Party to exercise its rights and perform its obligations hereunder, provided that such disclosure is covered by terms of confidentiality and non-use at least as restrictive as those set forth herein;
(g) to comply with Applicable Law (whether generally or in pursuit of an application for listing of securities) including the SEC or equivalent foreign agency or regulatory body, or otherwise required by judicial or administrative process, provided that in each such event, as promptly as reasonably practicable and to the extent not prohibited by Applicable Law or judicial or administrative process, such Party will notify the other Party of such required disclosure and provide a draft of the disclosure to the Receiving other Party reasonably in advance of such filing or disclosure for the other Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)review and comment. The non- disclosing Party will provide any comments as soon as practicable, and the disclosing Party will consider in good faith any timely comments provided by the non-disclosing Party; provided that the disclosing Party may or may not accept such comments in its sole discretion. Confidential Information that is disclosed in order to the Receiving Party’s Representatives whocomply with Applicable Law or by judicial or administrative process pursuant to this Section, in each case, have will remain otherwise subject to the confidentiality and non-use provisions of this Article 8 with respect to the Party disclosing such Confidential Information, and such Party will take all steps reasonably necessary, including seeking of confidential treatment or a need protective order for a period of at least [*] (to know the extent permitted by Applicable Law or Governmental Authority), to ensure the continued confidential treatment of such information Confidential Information, and each Party will be responsible for its own legal and other external costs in connection with any such filing or disclosure pursuant to this Section 8.3(g);
(h) where Takeda is the Receiving Party, to its Affiliates for Takeda’s or its Affiliates’ internal research and development of Products under this Agreement; and
(i) to its Affiliates, sublicensees or prospective sublicensees, contractors, subcontractors or prospective contractors or subcontractors, consultants, agents, insurers, lenders and financial and other advisors on a “need-to-know” basis in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees whom prior to disclosure must be bound by terms obligations of confidentiality and non-restrictions on use substantially of such Confidential Information that are at least as restrictive or protective of the Parties as those set forth in this Agreement or otherwise customary for such type and scope of disclosure any such disclosure is limited to the maximum extent practicable for the particular context in which it is being disclosed; provided, however, that, the Receiving Party will remain responsible for any failure by any Person who receives Confidential Information pursuant to Section 8.3(e) or this Section 8.3(i) to treat such Confidential Information as required under this Article 8;
(g) . If and whenever any Confidential Information is disclosed in accordance with this Section 8.3, such disclosure (i) will not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in connection with Patent Prosecution or the enforcement or defense a public disclosure of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement information (other than the confidentiality term, which may be as short as [**]by breach of this Agreement); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in In the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to clauses (a) through (d) of this Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority)8.3, it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing other Party of such required disclosure and use not less than the same efforts to secure confidential treatment of such information as it would to protect its own confidential information from disclosure, and (ii) at permit the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s Party to use its reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Information prior to such disclosure (whether through protective orders or otherwise), cooperate with the Disclosing Party in the exercise of its right to protect the confidentiality of the Confidential Information, and disclose only that Confidential Information which is required to be disclosed.
Appears in 1 contract
Samples: Asset Transfer and License Agreement (Day One Biopharmaceuticals Holding Co LLC)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving The receiving Party may disclose Confidential Information of the Disclosing disclosing Party as expressly permitted by this Agreement, or if and to a Third Party only to the extent that such disclosure is reasonably necessary in the following instancesis:
(a) enforcing required by law, order, or exercising regulation of a government agency or a court of competent jurisdiction, or by the Receiving rules of a securities exchange, provided that the receiving Party required to make such disclosure shall, after providing reasonable advanced notice to the disclosing Party before the disclosure, (i) give the disclosing Party an opportunity to comment on any such required disclosure, (ii) if requested by the disclosing Party’s rights under this Agreement , [***] obtain protective orders or any available limitations on or exemptions from such disclosure requirement where applicable and performing the Receiving Party’s obligations under this Agreementpracticable;
(b) prosecuting made to a patent office for the purposes of filing or defending litigation enforcing a Patent as permitted by in this Agreement;
(c) complying with applicable court made by a Party or governmental ordersits Affiliates, or Applicable Laws, including Applicable Laws related Sublicensees to securities laws disclosure requirements or any disclosure requirements the Regulatory Health Authority for the purposes of any applicable stock market filing, application or securities exchange on which request for Regulatory Approval for the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential InformationProduct as permitted in this Agreement;
(d) in the case of Telix as the Receiving Partymade to advisors, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Third Party partners, investors, licensees, Sublicensees (in or acquirers of all or substantially all of the case of Telix) or licensees or sublicensees (in the case of Lilly)assets to which this Agreement relates; provided, and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, providedhowever, in each case, that any such Affiliatepotential or actual partner, actual investor, licensee, sublicensee or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative acquirer agrees to be bound by terms of confidentiality and non-use substantially obligations with respect to such Confidential Information at least as restrictive protective of the disclosing Party and such Confidential Information as those set forth in the terms of this Article 8VII;
(ge) disclosure (i) made by EOC or its Affiliates, or Sublicensees to Third Parties as may be necessary or useful in connection with Patent Prosecution the Exploitation of Product as contemplated by this Agreement, including subcontracting or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) sublicensing transactions in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of therewith; provided that the existence, terms and a copy of the Agreement (provided Party making such terms and copy of the Agreement disclosures shall be redacted as requested ensure that each Third Party recipient is bound by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality no less restrictive than those contained in this Agreement (other than the confidentiality term, which may and shall be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything liable to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing other Party for any breach of such required disclosure, and (ii) at confidentiality obligations by the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationrelevant recipient.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of (a) In addition to disclosures allowed under Section 8.112.1 and under Section 12.3(c), the Receiving each Party may disclose Confidential Information belonging to the other Party or its Affiliates solely to the extent such disclosure is necessary in the following instances: (i) filing or prosecuting Patent Rights as permitted by this Agreement, to the extent approved by the Disclosing Party; (ii) in connection with Regulatory Filings for FS Product Line or External Products; (iii) prosecuting or defending litigation arising from this Agreement; (iv) complying with Applicable Law, court orders or governmental regulations, including rules of self-regulatory organizations and SEC filing and disclosure requirements; and (v) to potential or actual investors or acquirers as may be necessary in connection with their evaluation of a potential or actual investment or acquisition; provided, that such investors or acquirers shall be subject to reasonable obligations of confidentiality and non-use no less rigorous than the terms contained in this Agreement.
(b) In the event the Recipient Party is required to disclose Confidential Information of the Disclosing Party as expressly permitted by law, applicable court order or governmental regulation or in connection with bona fide legal process, such disclosure shall not be a breach of this Agreement, or if and to ; provided that the extent such disclosure is reasonably necessary in the following instances:
Recipient Party (ai) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives informs the Disclosing Party sufficient written notice, to the extent as soon as reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any practicable of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, required disclosure; (ii) in connection with Regulatory Applications and all other documents or materials submitted limits the disclosure to Regulatory Authorities that which is legally required to be disclosed; and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate assists in an attempt to object to or limit the required disclosure.
(c) Either Party may disclose the existence and terms of this Agreement in confidence to its attorneys and advisors, and to potential and actual acquirers (and their respective professional attorneys and advisors), in connection with the Disclosing a potential or actual merger, acquisition or reorganization and to existing and potential investors or lenders of such Party’s efforts , as part of their due diligence investigations, or to contest existing and potential licensees or sublicensees or to permitted assignees, in each case under reasonable terms of confidentiality and non-use and to use such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only information solely for the purposes for which purpose permitted pursuant to this Section 12.3(c), provided that if such disclosure includes the order was issued or Exhibits to this Agreement, the law or regulation required, and/or to obtain other confidential treatment terms of such Confidential Informationconfidentiality and non-use shall be no less rigorous than the terms contained in this Agreement.
Appears in 1 contract
Samples: License and Distribution Agreement (Acutus Medical, Inc.)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving prosecuting Patent Rights claiming an Invention owned by such Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreementlitigation;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs and BLAs) connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any performance of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, providedto Affiliates, in each casepermitted sublicensees, that any such Affiliatecontractors, actual or potential Sublicensee ethics committees and institutional review boards (in the case of Telix) or licensee or sublicensee (in the case of Lxxxxcollectively, “IRBs”), or Representative agrees CROs, academic institutions, consultants, agents, investigators, and employees and contractors engaged by Study sites and investigators involved with the Combined [ * ] = 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 the Securities Exchange Act of 1934, as amended. Therapy Trials, each of whom prior to disclosure must be bound by similar terms of confidentiality and non-use substantially as restrictive as at least equivalent in scope to those set forth in this Article 89;
(ge) disclosure (i) of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with Patent Prosecution the development of the Combined Therapy, the Exelixis Compound or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])BMS Compound; and
(hf) disclosuredisclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, by either Partyinstitutional review boards and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the Exelixis Compound with respect to Exelixis, and the BMS Compound with respect to BMS, and (in the event of a copy Material Safety Issue) to Third Parties that are collaborating with Exelixis or BMS, respectively in the conduct of such other clinical trials of the Agreement Exelixis Compound or the BMS Compound(s), in response each case solely to a request from a taxing authoritythe extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and regulatory requirements. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing any other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.
Appears in 1 contract
Samples: Clinical Trial Collaboration Agreement (Exelixis, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Party Either party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instancessituations:
(a) enforcing prosecuting or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementdefending litigation;
(b) prosecuting complying with applicable laws and regulations, including regulations promulgated by a global stock market or defending litigation as permitted by this Agreementsecurities exchanges;
(c) complying with applicable a valid order of a court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order competent jurisdiction or other confidential or protective treatment with respect to such Confidential InformationGovernmental Entity;
(d) in the case of Telix as the Receiving Partyfor regulatory, disclosure in submissions to tax or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorycustoms purposes;
(e) in the case for audit purposes, provided that each recipient of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs Confidential Information must be bound by customary obligations of confidentiality and BLAs) with respect non-use prior to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territorysuch disclosure;
(f) disclosure to the Receiving Party’s Affiliatesits Affiliates and Representatives on a need-to-know basis, to actual or potential Sublicensees (in the case provided that each of Telix) or licensees or sublicensees (in the case such recipients of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to Confidential Information must be bound by terms customary obligations of confidentiality and non-use substantially as restrictive as those set forth in this Article 8prior to any such disclosure;
(g) disclosure (i) in connection with Patent Prosecution or upon the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) prior written consent of the existence, terms and a copy of the Agreement Disclosing Party; or
(provided such terms and copy of the Agreement shall be redacted as requested by Lxxxxh) disclosure to actual and potential licensees, acquirors, investors and other sources of funding, including underwriters, debt financing or co-investors, lendersand their respective accountants, financial advisors and other professional representatives (“Financial Advisors”), provided, that (in the case of potential licensees, sublicensees acquirors, investors and acquirers who are under other sources of funding) such disclosure shall be made only to the extent customarily required to consummate such investment or financing transaction and that each recipient of Confidential Information must be bound by customary obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])non-use prior to any such disclosure; and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoingprovided that, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c8.2(a), (b), (c) or (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityd), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance written notice to the Disclosing Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information. In any event, the Buyer shall not file or assist any Third Party in filing any patent application based upon or using the Confidential InformationInformation of the Seller provided hereunder. Notwithstanding any other provision hereunder, the Receiving Party shall be liable to the Disclosing Party for any breach by its Affiliate and Representatives in the case of any disclosure made by a Receiving Party under Section 8.2(f) and any of its Financial Advisors in the case of any disclosure made by a Receiving Party under Section 8.2(h), if any such Person violates the terms of its confidentiality obligation or any of the terms set forth in this Agreement as if such Person was a party hereto. Notwithstanding the foregoing, neither party hereto shall be restricted from disclosing the Purchase Price and the amount and nature of the Royalty in such party’s periodic reports and financial statements or disclosing the terms of the transactions contemplated by this Agreement in accordance with Section 5.1. The Buyer hereby acknowledges that the Seller may from time to time provide the Buyer with information that may constitute material non-public information with respect to itself and the Licensee. Seller makes no representation or warranty and assumes no duty to inform Buyer whether any information delivered to Buyer pursuant to this Agreement constitutes material non-public information. The Buyer hereby agrees that it shall not, and shall cause its Representatives and Affiliates to not, trade any securities of the Seller or the Licensee while in possession of any information received by it from the Seller pursuant to this Agreement in violation of securities laws. [*].
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.110.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation Patents as permitted by this Agreement;
(cb) complying disclosure required in connection with any judicial, regulatory or administrative process relating to or arising from this Agreement (including any enforcement hereof) or to comply with applicable court orders;
(c) disclosure to Affiliates, employees, contractors, consultants or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements agents of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, who have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, ; provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)Sublicensee, employee, contractor, consultant or Representative agent agrees to be bound by terms of confidentiality and non-use substantially as restrictive as comparable in scope to those set forth in this Article 810;
(d) such disclosure is made to such Party’s attorneys, independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the Receiving Party, on the condition Page 38 of 89 that such attorneys, independent accountants and financial advisors are bound by confidentiality and non-use obligations consistent with the confidentiality provisions of this Agreement as they apply to the Receiving Party (provided, however, that in the case of financial advisers, including investment bankers, the term of confidentiality may be shortened to [***] years from the date of disclosure and in the case of attorneys, no written agreement shall be required);
(e) disclosure to existing investors, acquirors or collaborators or potential bona fide investors, acquirors, licensees, Sublicensees or collaborators in connection with due diligence or similar investigations by such Third Parties; provided, in each case, that any such existing or potential investor, acquiror, licensees, Sublicensees or collaborator agrees to be bound by confidentiality and non-use obligations consistent with those contained in this Agreement as they apply to the Receiving Party (but of duration customary in confidentiality agreements entered into for similar purpose);
(f) disclosure to Regulatory Authorities as required by Applicable Laws in relation to Regulatory Approvals and regulatory procedures, proceedings and other filings;
(g) disclosure to: (i) in connection with Patent Prosecution Governmental Authorities to the extent useful or the enforcement necessary to make regulatory filings and obtain or defense of maintain Regulatory Approvals (including fulfilling post-approval regulatory obligations) for any Licensed Patent or Telix Patent, Product; (ii) in connection with Regulatory Applications and all other documents Governmental Authorities, technical committees or materials submitted similar public health or scientific bodies for purposes of securing product use recommendations, tenders, direct procurement contracts or responding to Regulatory Authorities and relevant requests for information; (iii) of the existence, terms comply with Applicable Laws with respect to performance under this Agreement; and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxxiv) to actual and potential investorsGovernmental Authorities in order to respond to inquiries, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in requests or investigations relating to Licensed Products or this Agreement (other than the confidentiality term, which may be as short as [**])Agreement; and
(h) disclosure, to the extent mutually agreed to by either Party, of a copy of the Agreement Parties in response to a request from a taxing authoritywriting. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c10.3(a) (but, for clarity, not under or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority10.3(b), it will, except in the case where it is impractical to do so (i) impracticable for necessary disclosures, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure requirement and (ii) at the Disclosing Party’s request will use its reasonable efforts to secure and expense, shall cooperate with the Disclosing other Party’s efforts to contest such requirement, as necessary, to seek and obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential InformationInformation required to be disclosed to the extent legally permissible and will limit the disclosure of that Confidential Information required to be disclosure to (i) to advisors (including lawyers and accountants) or Governmental Authorities on a need to know basis, in each case under appropriate confidentiality provisions or professional standards of confidentiality substantially equivalent to those of this Agreement, or (ii) to the extent agreed to by the Parties.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.114.1 above, a Party shall be entitled to disclose the Receiving Party may disclose Confidential Information of the Disclosing another Party as expressly permitted by this Agreement, or if and hereto to the extent that such disclosure is reasonably necessary in the following instancesis:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement made in response to a valid request from order of a taxing authority)court of competent jurisdiction; provided, it willhowever, except in that such Party will first (to the case where it is impractical to do so (iextent practicably possible and permitted by such order) give reasonable advance have given notice to the Disclosing such other Party of and given such required disclosureother Party a reasonable opportunity to quash such order, and (ii) at the Disclosing such Party’s request sole cost and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, and to obtain a protective order order, at such Party’s sole cost and expense, requiring that the Confidential Information so disclosed and documents that are the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued issued; and provided further that if a disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order will be limited to that information which is legally required to be disclosed in response to such court or governmental order;
(ii) otherwise required by Applicable Law or the law or regulation requiredrules of a stock exchange; provided, and/or however, that the receiving Party will provide the disclosing Party with notice of such disclosure in advance thereof to obtain other the extent practicably possible, and to the extent permitted seeks confidential treatment of the information disclosed and reasonably cooperates with any efforts of disclosing Party to seek confidential treatment of the information disclosed and discloses only that portion of the Confidential Information required; STRICTLY CONFIDENTIAL
(iii) made by such Confidential InformationParty to a Regulatory Authority as necessary for the development or commercialization of a medicinal product, including the Product, in a country, as required in connection with any filing, application or request for Regulatory Approval or as required by applicable securities laws and regulations, subject to the limitations in Section 14.3(ii);
(iv) made by such Party, in connection with the performance of this Agreement and on a need to know basis only in connection therewith, to Affiliates, directors, officers, employees, consultants, representatives or agents, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Agreement; or
(v) made by such Party in the course of submitting financial accounts to relevant authorities as per local statutory requirements or to existing or potential acquirers; existing or potential collaborators; investment bankers; existing or potential investors, merger candidates, venture capital or private equity firms or other financial institutions or investors for purposes of obtaining financing; or, bona fide strategic potential partners; each of whom prior to disclosure must be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Agreement.
Appears in 1 contract
Samples: Exclusive Commercialization Agreement (RedHill Biopharma Ltd.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.16.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting Patents as permitted by this Agreement;
(b) enforcing or exercising the Receiving such Party’s rights under this Agreement (including registering the licenses granted hereunder with applicable authorities) and in performing the Receiving Party’s its obligations under this Agreement;.
(bc) prosecuting or defending litigation as permitted by this Agreement;
(cd) complying with applicable court or governmental orders, applicable laws, rules or Applicable Lawsregulations, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case disclosure to Affiliates, actual and potential licensees and sub-licensees, employees, consultants or agents of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, Party who have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)sub-licensee, employee, consultant or Representative agent agrees to be bound by terms of confidentiality and non-use substantially as restrictive as comparable in scope to those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])6; and
(hf) disclosuredisclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors or acquirers in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by either Party, reasonable obligations of a copy of the Agreement in response to a request from a taxing authorityconfidentiality and non-use. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c6.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 6.3(d), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts. In any event, the Receiving Party agrees to take all reasonable action to avoid disclosure of Confidential InformationInformation hereunder.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the A Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement (including as reasonably necessary for the Receiving Party’s performance of its obligations under this Agreement), or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation Litigation as permitted by this Agreement;
(cb) complying with requests of government agencies, applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements rules or any disclosure requirements regulations, or the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ Affiliate’s securities are traded, provided ;
(c) enforcing the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential InformationParty’s rights under this Agreement;
(d) in the case of Telix filing or prosecuting Patent Rights as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorypermitted by this Agreement;
(e) in the case of Lxxxx as the Receiving PartyCompany, disclosure in regulatory submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in Products within the Territory regarding any Lilly Product or Companion Diagnostic or any scope of the foregoing submissions or filings in the TerritoryExclusive License;
(f) in the case of BioAtla, disclosure in regulatory submissions with respect to Products within the scope of the Exclusive Non-CAST License;
(g) disclosure to the Receiving Party’s Affiliates, to the Company’s actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (of rights with respect to Products in the case Field, to BioAtla’s actual or potential licensees or sublicensees of Lilly)rights with respect to Products outside the Field, and to the Receiving Party’s Representatives and its Affiliates’ representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)sublicensee, or Representative representative agrees to be bound by terms of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])Article; and
(h) disclosuredisclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by either Party, reasonable obligations of a copy of the Agreement in response to a request from a taxing authorityconfidentiality and non-use. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to this Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority)5.3, it will, except in the case where it is impractical to do so impracticable, (i) give reasonable advance notice to the Disclosing Party of such required disclosure, (ii) use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own Confidential Information, but in no event less than reasonable efforts, and (iiiii) cooperate with any efforts by the Disclosing Party, at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Information.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.110.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting Patents as permitted by this Agreement;
(b) enforcing or exercising the Receiving such Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(bc) prosecuting or defending litigation as permitted by this Agreement;
(cd) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or and potential licensees and Sublicensees (in the case of TelixLicensee) or licensees or sublicensees and (sub)licensees (in the case of LillyC4T), and to employees, consultants or agents of the Receiving Party’s Representatives who, in each case, Party who have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee licensee or Sublicensees (in the case of TelixLicensee) or licensee or sublicensee and (sub)licensees (in the case of LxxxxC4T), employee, consultant or Representative agent agrees to be bound by terms of confidentiality and non-use substantially as restrictive as comparable in scope to those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])10; and
(hf) disclosuredisclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential or actual Third Party investors, ACTIVE/119414966.70 acquirers or collaborators in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by either Party, reasonable obligations of a copy of the Agreement in response to a request from a taxing authorityconfidentiality and non-use. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(cSections 10.3(c) or (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityd), it will, except in the case where it is impractical to do so (i) impracticable or legally impermissible, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure and (ii) at the Disclosing use such Party’s request and expense, shall cooperate with the Disclosing Party’s commercially reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information at least as diligently as such Party would use to protect its own confidential information. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential InformationInformation hereunder and to only disclose that portion of Confidential Information that is necessary to comply with the requirements provided in Section 10.3(c) or (d).
Appears in 1 contract
Samples: License and Collaboration Agreement (C4 Therapeutics, Inc.)
Authorized Disclosure. Notwithstanding (a) If, based upon the provisions advice of Section 8.1legal counsel skilled in the subject matter, a Party is required to disclose specific Confidential Information of the other Party to comply with an applicable law, regulation, legal process, or order of a government authority or court of competent jurisdiction, the Receiving Party may disclose such Confidential Information only to the entity or person required to receive such disclosure; provided, however, that the Party required to disclose such Confidential Information shall (a) to the extent permitted by such law, regulation, process, order or rules, first have given prompt (but in no event less than five (5) business days) advance notice to such other Party to enable it to seek any available exemptions from or limitations on such disclosure requirement and shall reasonably cooperate in such efforts by the other Party, (b) furnish only the portion of the Confidential Information which is legally required to be disclosed; (c) use all reasonable efforts to secure confidential protection of such Confidential Information, and (d) continue to perform its obligations of confidentiality and non-use set out in this Article 9.
(b) Each Party may disclose Confidential Information of the Disclosing other Party as expressly permitted by this Agreementto Regulatory Authorities to the extent such disclosure is reasonably necessary in regulatory filings required for the development and/or commercialization of Licensed Products. In addition, or if and each Party may disclose Confidential Information of the other Party (other than Restricted Manufacturing Information) to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing : filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation patents as permitted by this Agreement;
(c) complying with applicable court ; disclosure to The Rockefeller University or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, Amgen Inc. to the extent reasonably possible, necessary to permit fulfill obligations under the Disclosing Party to seek a protective order Rockefeller License or other confidential or protective treatment with respect to such Confidential Information;
the Amgen Agreement (d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationapplicable), in INDs accordance with this Agreement and BLAs) with respect to any Licensed Product, the Rockefeller License or Amgen Agreement; and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or Sublicensees and potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)Sublicensees, and to the Receiving Party’s Representatives wholicensees or potential licensees of Amylin, in each caseand to contractors, have a employees and consultants, who need to know such information in order for the Receiving development, manufacture and commercialization of Licensed Products, to bankers, lawyers, accountants, agents or other Third Parties in connection with due diligence or similar investigations, and to potential Third Party to exercise its rights or fulfill its obligations under this Agreement, provided, investors in each case, confidential financing documents; provided that any such AffiliateSublicensee, actual licensee, contractor, employee, consultant, banker, lawyer, accountant, agent or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be Third Party is bound by terms obligations of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) herein. In the case of each disclosure, the Party making such disclosure (i) in connection with Patent Prosecution or the enforcement or defense shall use reasonable efforts to obtain confidential treatment of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the not disclose Confidential Information so disclosed be used only for of the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential InformationParty other than is reasonably necessary.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting Patents as permitted by this Agreement;
(b) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(bc) prosecuting or defending litigation as permitted by this Agreement;
(cd) complying with applicable court orders or governmental orders, regulations or Applicable Laws, including Applicable Laws related to rules of a securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territoryexchange;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationAratana, in INDs regulatory filings and BLAs) submissions with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority Products in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the TerritoryAratana Field;
(f) in the case of Advaxis, in regulatory filings and submissions with respect to Advaxis Products in the Advaxis Field;
(g) disclosure to the Receiving Party’s Affiliates, provided that Confidential Information so disclosed shall remain subject to actual or potential Sublicensees this Article 8;
(h) in the case of TelixAratana, disclosure to Sublicensees and bona fide potential Sublicensees, on the condition that each such Third Party agrees to be bound by confidentiality and non-use obligations that are no less stringent than the terms of this Agreement;
(i) or licensees or sublicensees (in the case of Lilly)Advaxis, disclosure to licensees and bona fide potential licensees of Advaxis Products in the Advaxis Field, on the condition that each such Third Party agrees to be bound by confidentiality and non-use obligations that are no less stringent than the terms of this Agreement; and
(j) disclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to the Receiving Party’s Representatives who, potential Third Party investors in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreementconfidential financing documents, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative Third Party agrees to be bound by terms reasonable obligations of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityuse. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Partyother party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority8.3(d), it willshall, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information at least as diligent as such party would use to protect its own confidential information, but in no event less than reasonable efforts. In any event, the Receiving Party agrees to take all reasonable action to avoid unauthorized disclosure and unauthorized use of Confidential Information.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of obligations set forth in Section 8.112.1, the Receiving a Party or its Affiliate may disclose the other Party’s Confidential Information and the terms of the Disclosing Party as expressly permitted by this Agreement, or if and Agreement to the extent extent:
(a) such disclosure is reasonably necessary in (i) for the following instances:
(a) enforcing filing or exercising the Receiving Party’s prosecuting of Patent rights under this Agreement and performing the Receiving Party’s obligations under as contemplated by this Agreement;
; (bii) to comply with the requirements of Regulatory Authorities with respect to obtaining and maintaining Regulatory Approval of Product; or (iii) for prosecuting or defending litigation as permitted contemplated by this Agreement; THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
(b) such disclosure is reasonably necessary to its officers, directors, employees, agents, consultants, contractors, licensees, sublicensees, attorneys, accountants, lenders, insurers or licensors on a need-to-know basis for the sole purpose of performing its obligations or exercising its rights under this Agreement; provided that in each case, the disclosees are bound by obligations of confidentiality and non-use no less stringent than those contained in this Agreement;
(c) complying with applicable court such disclosure is reasonably necessary to any bona fide potential or governmental ordersactual investor, acquiror, merger partner, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements other financial or any disclosure requirements commercial partner for the sole purpose of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to evaluating an actual or potential Sublicensees (in the case of Telix) investment, acquisition or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, other business relationship; provided that in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be disclosees are bound by terms written obligations of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;having a minimum term of *****; or
(gd) such disclosure (i) in connection is reasonably necessary to comply with Patent Prosecution Laws, including regulations promulgated by applicable security exchanges, court order, administrative subpoena or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityorder. Notwithstanding the foregoing, in the event the Receiving if a Party or its Affiliate is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c12.2(a) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 12.2(d), it will, except in such Party will promptly notify the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing other Party of such required disclosuredisclosure and, and (ii) at upon the Disclosing other Party’s request request, such Party and expense, shall cooperate with the Disclosing Party’s its Affiliates will use reasonable efforts to contest such requirementobtain, or to obtain assist the other Party in obtaining, a protective order requiring that preventing or limiting the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationrequired disclosure.
Appears in 1 contract
Samples: Research Collaboration, Option and License Agreement (Exicure, Inc.)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights with respect to any Inventions;
(b) prosecuting or defending litigation as permitted by brought in connection with any Third Party Claim or under the terms of this Agreement;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs connection with the performance of this Agreement, to Affiliates, permitted sublicensees, contractors, ethics committees and BLAs) with respect to any Licensed ProductIRBs, CROs, academic institutions, consultants, agents, investigators, and in correspondence employees and contractors engaged by Study Sites and investigators involved with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs Combined Therapy Study and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, who have a need to know such information in order for connection with the Receiving Party proper performance the Combined Therapy Study, each of whom prior to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to disclosure must be bound in writing by similar terms of confidentiality and non-use substantially as restrictive as at least equivalent in scope to those set forth in this Article 89, where such period of confidentiality shall last for time period stated in Section 9.1(a);
(e) disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patents to Regulatory Authorities in connection with the development of the Combined Therapy, the Checkmate Compound or the BMS Compound;
(f) disclosure of Combined Therapy Study Data in accordance with Section 8.5 and Section 8.6 (as applicable); and
(g) disclosure of relevant Safety Information contained within the Combined Therapy Study Data to investigators, institutional review boards and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the Checkmate Compound with respect to Checkmate, and the BMS Compound with respect to BMS, and (iin the event of a Material Safety Issue) to Third Parties that are collaborating with Checkmate or BMS, respectively in connection with Patent Prosecution the conduct of such other clinical trials of the Checkmate Compound or the enforcement or defense BMS Compound, in each case solely to the extent necessary for the proper conduct of any Licensed Patent or Telix Patent, (ii) in connection such clinical trials and/or to comply with Regulatory Applications Applicable Law and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityregulatory requirements. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment. If a Party intends to make a disclosure of the other Party’s Confidential Information pursuant to Section 9.3(a), it shall give advance notice to such other Party of such intended disclosure, and the Parties shall cooperate with respect to the timing and secure the other Party’s permission to make such disclosure taking into account the non-disclosing Party’s plans for Patent filings on Inventions in accordance with Section 6.1.
Appears in 1 contract
Samples: Master Clinical Trial Collaboration Agreement (Checkmate Pharmaceuticals, Inc.)
Authorized Disclosure. Notwithstanding the provisions foregoing, each of Section 8.1, the Receiving Party RIB-X and WAKUNAGA may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to a Third Party to the extent such disclosure is reasonably necessary in to exercise the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions granted to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations retained by it under this Agreement, provided, or to conduct clinical trials as permitted hereunder with respect to Products or in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)prosecuting patent applications, or Representative agrees to be bound prosecuting or defending litigation, or Portions of this Exhibit, indicated by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as xxxx “[***]); and
(h) disclosure,” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, by either Partyas amended. to the extent required to comply with applicable governmental regulations, the requirements of a copy of the Agreement in response to tax authority, Regulatory Authority or other governmental entity; provided, that if a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required by law to make a any such disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (butInformation, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx extent it may freely disclose a copy of the Agreement in response to a valid request from a taxing authority)legally do so, it will, except in the case where it is impractical to do so (i) will give reasonable (under the circumstances) advance notice to the Disclosing Party of such required disclosure, and (ii) at disclosure so as to permit the Disclosing Party’s request and expenseParty to secure, shall cooperate with the Disclosing Party’s efforts to contest such requirementif it so desires, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Information prior to its disclosure (whether through protective orders or otherwise). If the Disclosing Party has not filed a patent application with respect to such Confidential Information, it may require the Receiving Party to delay the proposed disclosure (to the extent the Disclosing Party may legally do so), for up to ninety (90) days, to allow for the filing of such an application; provided, that if a disclosure is required by law or order and such a delay is not possible, the Parties shall cooperate to restrict or delay disclosure to the extent possible in order to allow for the filing of such an application or the securing of other protection for such Confidential Information. Further, WAKUNAGA retains a right to disclose to Xxxxxx any part of Confidential Information including contents of this Agreement, but within and to the extent of necessity to obtain Xxxxxx’x consent as set forth in Section 2.5 hereof or as otherwise required by [***], subject to Xxxxxx’x agreement to maintain such information as confidential, and provided that RIB-X shall be given prior notice of the nature and content of any such disclosure to Xxxxxx.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.16.1.1 (Confidential Information), the Receiving Party and its Recipients may disclose Confidential Information belonging to the Disclosing Party to the extent that such disclosure is reasonably necessary to:
(a) Subject to the proviso of Section 6.1.5(b), comply with Applicable Laws (including the rules, regulations or requirements of the U.S. Securities and Exchange Commission or a national securities exchange or another similar regulatory body) or any judicial or administrative process or court or governmental order (including in connection with the prosecution or defense of litigation), if in the reasonable opinion of the Receiving Party’s counsel, such disclosure is so required; provided, that Confidential Information disclosed shall be limited to that information which the Receiving Party is advised by legal counsel is legally required under the relevant Applicable Law, rule, regulation, requirement, judicial or administrative process or court or governmental order;
(b) Make filings and submissions to, or correspond or communicate with, any Governmental Authority reasonably necessary for the filing, prosecuting, defending or enforcing Patent Rights, for obtaining or maintaining approval to conduct Clinical Trials, or for Developing, Manufacturing or Commercializing, or conducting Medical Affairs activities in respect of, the Licensed Compound or the Licensed Products, in each case, as contemplated by and in accordance with this Agreement; provided that such disclosure is only to the extent reasonably necessary for the foregoing; or
(c) Disclose pharmacovigilance information originating from a Party, its Affiliates, or the other Party to Governmental Authorities, investigators, ethical committees and internal review boards, and any other Third Parties that have a need to know such information according to each Party’s risk management and Adverse Event reporting policies and requirements. In the event that the Receiving Party or its Recipients, as applicable, deem it reasonably necessary to disclose Confidential Information belonging to the Disclosing Party pursuant to this Section 6.1.2 (Authorized Disclosure), the Receiving Party shall, to the extent possible, provide the Disclosing Party with reasonable advance notice of such disclosure and take reasonable measures to ensure confidential treatment of such information. In addition, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and belonging to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek any Third Party who is performing diligence in connection with a protective order or other confidential or protective treatment transaction with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority Party (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or including potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lillyand licensees), and to the Receiving Party’s Representatives who, in each case, have a any Third Party (including licensees) who need to know for the purposes of compliance with an existing agreement; provided that, each such information in order for Third Party has signed a written confidentiality agreement with the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as is no less restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Informationterms hereof.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights pursuant to Section 6.1(c);
(b) prosecuting or defending litigation as permitted by this Agreementlitigation;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs and BLAs) connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any performance of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, providedto Affiliates, in permitted (sub)licensees, contractors, IRBs, CROs, academic institutions, consultants, agents, investigators, and employees and contractors engaged by study sites and investigators involved with the Combined Therapy Clinical Trial, each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees whom prior to disclosure must be bound by terms of confidentiality and non-use substantially at least as restrictive protective of Confidential Information as those set forth in this Article 89;
(e) disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with the development of the Combined Therapy, the Recipient Study Drug or the BMS Study Drug;
(f) disclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, IRBs and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the Recipient Study Drug with respect to the Recipient, and the BMS Study Drug with respect to BMS, and, in the event of a Material Safety Issue, to Third Parties that are collaborating with the Recipient or BMS, respectively in the conduct of such other clinical trials of the Recipient Study Drug or the BMS Study Drug, in each case solely to the extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and regulatory requirements; and
(g) disclosure (i) in connection with Patent Prosecution or to actual and/or bona fide potential licensees and/or collaborators of the enforcement or defense terms of any Licensed Patent or Telix Patent, this Agreement and (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) actual and/or bona fide potential acquirers, merger partners, and/or investors, of the existenceCombined Therapy Study Data and the terms of this Agreement, terms in each case, under confidentiality and a copy non-use obligations at least as protective of the Agreement (provided such terms and copy Confidential Information as those of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityAgreement. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing any other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Aveo Pharmaceuticals, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.111.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this AgreementInformation, or if and without violating its obligations under Article 11, to the extent such the disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted required by this Agreement;
(c) complying with applicable a valid order of a court or other governmental orders, or Applicable Lawsbody having jurisdiction, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are tradedSecurities and Exchange Commission; provided, provided however, that the Receiving Party gives the Disclosing Party sufficient reasonable prior written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosuredisclosure and makes a reasonable effort to assist the Disclosing Party in obtaining, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order preventing or limiting the disclosure and/or requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation requiredrequires, and/or or for which the order was issued, and thereafter discloses only the minimum Confidential Information required to be disclosed in order to comply, whether or not a protective order or other similar order is obtained by the Disclosing Party. The Receiving Party will limit access to the Confidential Information of the Disclosing Party to only those of the Receiving Party’s employees or authorized representatives having a need to know in connection with such Party’s performance of its obligations under this Agreement and who are bound by obligations of confidentiality, non-disclosure and non-use consistent with and at least as stringent as those set forth herein. Notwithstanding the foregoing, CELLSCRIPT shall be permitted to disclose Argos Product information to Third Party developmental and analytical service providers who are permitted subcontractors hereunder and who have a need to know such information in connection with performance of its obligations hereunder, provided such providers shall be subject to and bound by obligations of confidentiality, non-disclosure and non-use consistent with and at least as stringent as those set forth herein. No provision of this Agreement shall be construed so as to preclude the use or disclosure of Confidential Information as may be reasonably necessary for Argos to secure any regulatory or governmental approvals or licenses with respect to Argos’ Arcelis® autologous vaccines, or of either Party to obtain other confidential treatment of such Confidential Informationpatents related to its Inventions and Intellectual Property, or to limit either Party’s ownership of, or ability to use its Technology, Inventions or Intellectual Property.
Appears in 1 contract
Samples: Master Process Development and Supply Agreement (Argos Therapeutics Inc)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) for complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to regulations promulgated by securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are tradedexchanges, provided that the Receiving Party gives required to disclose such information promptly notifies the Disclosing Party sufficient written notice, prior to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that making any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality disclosure and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate cooperates with the Disclosing Party’s efforts to contest such requirementseek confidential treatment or to otherwise limit disclosure. Each Receiving Party may disclose the other Party’s Confidential Information to its Representatives (and, in the case of Abingworth, to obtain a protective order requiring that the Abingworth Investors, solely with respect to the terms and conditions of this Agreement), in each case (a) only to the extent such Persons need to know the Confidential Information so disclosed solely in connection with the performance of this Agreement, and (b) provided that each Person receiving Confidential Information must be used bound by obligations of confidentiality and non-use at least as stringent as an equivalent in scope to those set forth in this Article 9 prior to any such disclosure and the Party making such disclosure to such Person will be liable to the other Party for any breach of such obligations by such disclosee (provided that a Party’s Representative or an Abingworth Investor will only for be bound by the purposes for which obligations set forth in this Article 9 to the order was issued extent that such Representative or the law or regulation required, and/or to obtain other confidential treatment of Abingworth Investor actually receives such Confidential Information). Each Party may also disclose the material terms of this Agreement and updates regarding the Development and Commercialization progress of the Product, or a summary of such Party’s findings during its due diligence investigation of the Product (if applicable) to any bona fide potential or actual investor, investment banker, acquirer, provider of debt or royalty financing, or other potential or actual financial partner without the consent of the other Party, and provided that in connection with such disclosure, each disclosee must be bound by obligations of confidentiality and non-use at least as stringent as an equivalent in scope to those set forth in this Article 9 prior to any such disclosure and the Party making such disclosure to such disclosee will be liable to the other Party for any breach of such obligations by such disclosee. Notwithstanding anything in the foregoing to the contrary, Exhibit D constitutes CymaBay’s Confidential Information, and CymaBay may disclose Exhibit D to Third Parties as determined by CymaBay in its sole discretion. In any event, each Party agrees to take all reasonable action to avoid unauthorized use or disclosure of Confidential Information of the other Party hereunder.
Appears in 1 contract
Samples: Development Financing Agreement (CymaBay Therapeutics, Inc.)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose particular Confidential Information of the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights pursuant to Section 6.1(c);
(b) prosecuting or defending litigation as permitted by this Agreementlitigation;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs and BLAs) connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any performance of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in to [***] each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees whom prior to disclosure must be bound by terms of confidentiality and non-use substantially at least as restrictive protective of Confidential Information as those set forth in this Article 89;
(e) disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with the development of the Combined Therapy, the Recipient Study Drug or the BMS Study Drug;
(f) disclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, IRBs and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the Recipient Study Drug with respect to the Recipient, and the BMS Study Drug with respect to BMS, and, in the event of a Material Safety Issue, to Third Parties that are collaborating with the Recipient or BMS, respectively in the conduct of such other clinical trials of the Recipient Study Drug or the BMS Study Drug, in each case solely to the extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and regulatory requirements; and
(g) disclosure (i) in connection with of Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Prosecution or Rights, and the enforcement or defense terms of any Licensed Patent or Telix Patentthis Agreement, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [***]); and
(h) disclosure, and provided that such recipients must be bound by either Party, terms of a copy confidentiality and non-use at least as protective of the Agreement Confidential Information as those set forth in response to a request from a taxing authoritythis Article 9. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing any other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment. 9.4 Disclosure to [***]; Disclosure to [***]. [***].
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Mirati Therapeutics, Inc.)
Authorized Disclosure. (a) Notwithstanding anything to the provisions of Section 8.1contrary contained in this Supply Agreement, the a Receiving Party may disclose Confidential Information of the Disclosing Party to the extent required, as expressly permitted advised by counsel, (i) in response to a valid order of a court or other governmental body or as required by or to comply with Applicable Laws, (ii) with respect to Amgen or its Affiliates, filing or prosecuting Patent Rights for Amgen Products, or (iii) prosecuting or defending litigation against Third Parties; provided however, that the Receiving Party shall advise the Disclosing Party in advance of such disclosure to the extent practicable and permissible by such order or Applicable Laws, shall reasonably cooperate with the Disclosing Party, if requested, in seeking an appropriate protective order or other remedy, and shall otherwise continue to perform its obligations of confidentiality set forth in this Supply Agreement.
(b) Notwithstanding anything to the contrary contained in this Supply Agreement, Amgen or if its Affiliates may disclose Confidential Information of Nektar to the extent such disclosure is reasonably necessary, as advised by counsel, under the following circumstances:
(i) regulatory filings for the Product, Licensed Product, or Amgen Products; or
(ii) conducting pre-clinical or clinical trials of Amgen Products. In the event Amgen or one of its Affiliates intends to disclose Confidential Information of Nektar pursuant to this Section 10.2(b), Amgen will, except where impracticable, give reasonable advance notice to Nektar of such disclosure and use reasonable efforts to secure confidential treatment of such Confidential Information.
(c) Notwithstanding anything to the contrary contained in this Supply Agreement, Amgen or its Affiliates may disclose Confidential Information of Nektar to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [***]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it willAmgen shall, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing Party of such required disclosure, disclosures to Nektar and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Information.
(d) Notwithstanding anything to the contrary contained in this Supply Agreement, Confidential Information of Nektar received by Amgen hereunder may be disclosed by Amgen to [***].
Appears in 1 contract
Samples: Supply, Dedicated Suite and Manufacturing Guarantee Agreement (Nektar Therapeutics)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information of belonging to the Disclosing Party as expressly permitted by this AgreementParty, or if and provided that any such disclosure shall be made only to the extent such disclosure is reasonably necessary necessary, and that, other than in the instances of clauses (c) and (d) below (and with respect to (c) and (d) below, only to the extent required as set forth in an opinion of counsel), such disclosure of Confidential Information by Vyera shall not include CytoDyn trade secrets, or non-public Regulatory Approval, Regulatory Documentation, and Regulatory Materials, or CytoDyn Know-How absent the advance express written approval from CytoDyn, and in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under prosecuting Patents as permitted by this Agreement; however, CytoDyn may not disclose any Vyera Confidential Information as it relates to a Licensed Product;
(b) prosecuting or defending litigation as permitted by this Agreementpreparing and submitting Regulatory Materials and obtaining and maintaining Regulatory Approvals for Licensed Products;
(c) complying with applicable court prosecuting or governmental orders, or Applicable Lawsdefending litigation, including Applicable Laws related responding to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving a subpoena in a Third Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationlitigation;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to complying with Applicable Law or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product court or any of the foregoing submissions or filings in the Territoryadministrative orders;
(e) in the case communications with existing or bona fide prospective acquirers, merger partners, lenders or investors, and consultants and advisors of Lxxxx as the Receiving Party, disclosure Party in submissions to connection with transactions or filings bona fide prospective transactions with any Regulatory Authority (including, without limitationthe foregoing, in INDs each case on a “need-to-know” basis and BLAsunder appropriate confidentiality provisions substantially similar to those of this Agreement (provided that the term of such confidentiality obligations in such other agreement may only extend for five (5) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;years); and
(f) disclosure to the Receiving Party’s its Affiliates, (with respect to actual CytoDyn only) sublicensees or potential Sublicensees (in the case of Telix) prospective sublicensees, subcontractors or licensees or sublicensees (in the case of Lilly)prospective subcontractors, consultants, agents and to the Receiving Party’s Representatives who, in each case, have advisors on a need to know such information “need-to-know” basis in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees whom prior to disclosure must be bound by terms obligations of confidentiality and non-restrictions on use of such Confidential Information that are substantially as restrictive as similar to those set forth in this Article 8;10 (provided that the term of such confidentiality obligations in such other agreement may only extend for five (5) years); provided, however, that, the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to Section 10.3(e) or this Section 10.3(f) to treat such Confidential Information as required under this Article 10.
(g) If and whenever any Confidential Information is disclosed in accordance with this Section 10.3, such disclosure (i) shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in connection with Patent Prosecution or the enforcement or defense a public disclosure of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement information (other than the confidentiality term, which may be as short as [**]by breach of this Agreement); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to clauses (a) through (e) of this Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority)10.3, it will, except in the case where it is impractical to do so (i) impracticable or prohibited by Applicable Law, give reasonable advance notice to the Disclosing other Party of such required disclosure and use not less than the same efforts to secure confidential treatment of such information as it would to protect its own confidential information from disclosure, and (ii) at . Each Receiving Party shall notify the Disclosing Party promptly on discovery of any unauthorized use or disclosure of the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for by the purposes for which the order was issued Receiving Party or the law any of its Affiliates, agents or regulation required, and/or to obtain other confidential treatment of such Confidential Informationrepresentatives.
Appears in 1 contract
Samples: Commercialization and License Agreement (CytoDyn Inc.)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights with respect to any Inventions;
(b) prosecuting or defending litigation as permitted by this Agreementbrought in connection with any Third Party Claim, subject to the terms of Article 6;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any stock is listed; [*] = 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 its Affiliates’ securities are tradedthe Securities Exchange Act of 1934, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;as amended.
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs connection with the performance of this Agreement, to Affiliates, permitted sublicensees, contractors, ethics committees and BLAs) with respect to any Licensed ProductIRBs, CROs, academic institutions, consultants, agents, investigators, and in correspondence employees and contractors engaged by Study Sites and investigators involved with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs Combined Therapy Study and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, who have a need to know such information in order for connection with the Receiving Party proper performance of the Combined Therapy Study, each of whom prior to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to disclosure must be bound in writing by terms of confidentiality and non-use substantially as restrictive as those set forth consistent with industry standards;
(e) disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patents to Regulatory Authorities in this Article 8connection with the development of the Combined Therapy, the Compugen Compound or the BMS Compound;
(f) disclosure of Safety Information in accordance with Section 8.5(c)(iv) or Section 8.6(c)(iv) to ensure patient safety;
(g) disclosure of Combined Therapy Study Data in accordance with Section 8.5(c) and Section 8.6(c);
(ih) disclosure of relevant Safety Information contained within the Combined Therapy Study Data to investigators, institutional review boards and/or ethics committees and Regulatory Authorities that are involved in connection other clinical trials of the Compugen Compound with Patent Prosecution respect to Compugen, and the BMS Compound with respect to BMS, and (in the event of a Material Safety Issue) to Third Parties that are collaborating with Compugen or BMS, respectively, in the conduct of such other clinical trials of the Compugen Compound or the enforcement or defense BMS Compound, in each case solely to the extent necessary for the proper conduct of any Licensed Patent or Telix Patent, (ii) in connection such clinical trials and/or to comply with Regulatory Applications Applicable Law and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])regulatory requirements; and
(hi) disclosure(i) to actual and/or bona fide potential licensees and/or collaborators, by either Party, of a copy disclosure of the terms of this Agreement solely for the purpose of evaluating or carrying out an actual or potential collaboration, and (ii) to actual and/or bona fide potential investors, acquirers and/or merger partners, disclosure of the Combined Therapy Study Data and the terms of this Agreement, in response to each case ((i) and (ii)), under confidentiality and non-use obligations at least as protective of Confidential Information as those of this Agreement; except the term of such obligations may be for as long a request from duration as can reasonably be negotiated, but in any case such term shall have a taxing authorityduration that is commercially reasonable under the circumstances. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it willshall, except in to the case where it is impractical extent permitted pursuant to do so (i) Applicable Law, give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment. If a Party intends to make a disclosure of the other Party’s Confidential Information pursuant to Section 9.3(a), it shall give advance notice to such other Party of such intended disclosure, and the Parties shall cooperate with respect to the timing and secure the other Party’s permission to make such disclosure taking into account the non-disclosing Party’s plans for Patent filings on Inventions in accordance with Section 6.1.
Appears in 1 contract
Samples: Master Clinical Trial Collaboration Agreement (Compugen LTD)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1limitations in this Article 7, the Receiving either Party may disclose the Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable laws or regulations or valid court or governmental orders, provided that the Party making such disclosure provides the other Party with reasonable prior written notice of such request or Applicable Lawsdemand for disclosure and makes a reasonable effort to obtain, including Applicable Laws related or to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which assist the Receiving Party’s or any of its Affiliates’ securities are tradedother Party in obtaining, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order preventing or other confidential or protective treatment with respect to such Confidential Information;
(d) in limiting the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order and/or requiring that the Confidential Information so disclosed terms and conditions of this Agreement be used only for the purposes for which the order was issued or the law or regulation required, or for which the order was issued;
(b) to regulatory authorities in order to seek or obtain approval to conduct regulatory trials, or to gain regulatory approval, of Collaboration Products or any products being developed by Intrexon or its other licensees and/or channel partners or collaborators, provided that the Party making such disclosure (i) provides the other Party with reasonable opportunity to obtain review any such disclosure in advance and to suggest redactions or other means of limiting the disclosure of such other Party’s Confidential Information and (ii) does not unreasonably reject any such suggestions;
(c) disclosure to investors and potential investors, acquirers, or merger candidates who agree to maintain the confidentiality of such information, provided that such disclosure is used solely for the purpose of evaluating such investment, acquisition, or merger (as the case may be); Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
(d) disclosure on a need-to-know basis to Affiliates, licensees, sublicensees, employees, consultants or agents (such Confidential Informationas CROs) who agree to be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 7; and
(e) disclosure of the terms of this Agreement by Intrexon to collaborators and other channel partners or collaborators who agree to be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 7.
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (Intrexon Corp)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the A Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by or the terms of this Agreement:
(a) To such Receiving Party’s Affiliates and, or as applicable, sublicensees; provided that such Affiliates and/or sublicensees are bound by legally enforceable obligations to maintain the confidentiality of the Disclosing Party’s Confidential Information in a manner consistent with the confidentiality provisions of this Agreement;
(b) To employees, directors, agents, contractors, consultants and advisers of the Receiving Party and its Affiliates and sublicensees, its legal counsel, and legal counsel representing any of the foregoing, including, without limitation, the individuals and entities listed in Exhibit B, in each case to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this Agreement; provided that each such individual and entity is bound by legally enforceable obligations to maintain the confidentiality of the Disclosing Party’s Confidential Information in a manner consistent with the confidentiality provisions of this Agreement; and further provided that each Party shall remain responsible for any failure by its Affiliates and sublicensees, and its Affiliates’ and sublicensees’ respective employees, directors, agents, consultants, advisors, and contractors, to treat such Confidential Information as required under this Article XVII (as if such Affiliates, licensees, sublicensees employees, directors, agents, consultants, advisors and contractors were Parties directly bound to the requirements of this Article XVII);
(c) To the extent such disclosure is reasonably necessary in the following instancessituations:
(ai) enforcing filing or exercising prosecuting of Patent Rights as contemplated by this Agreement or conducting or defending litigation;
(ii) submitting regulatory filings and other filings with governmental authorities (including Regulatory Authorities);
(iii) complying with Applicable Laws, including regulations promulgated by securities exchanges, it being expressly understood that Cell Medica shall have the Receiving right to disclose the existence and terms of this Agreement, the Co-Development Agreement and status of activities conducted hereunder and thereunder in connection with its IPO, as required by applicable Law and/or any securities exchange rules on which it lists its shares in such IPO, or in connection with subsequent public filings as required under Applicable Laws or such securities exchange rules;
(d) to a Party’s rights under Affiliates, directors, employees, agents, independent contractors, licensors, attorneys, independent accountants or financial advisors on a need-to-know basis for the sole purpose of performance of this Agreement or the Co-Development Agreement or providing advice with respect to this Agreement or the Co-Development Agreement, provided that in each such case on the condition that such disclosee is bound by confidentiality and performing the Receiving Party’s non-use obligations under substantially consistent with those contained in this Agreement;
(be) prosecuting to actual or defending litigation as permitted by this Agreement;
bona fide potential investors, acquirors, sublicensees and other financial or commercial partners solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, license or collaboration (c) complying with applicable court and any attorney, accountant or governmental ordersother advisor, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s Party or any of its Affiliates’ securities are traded, advising on such matter); provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, that in each case, have a need to know such information in order for case on the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, condition that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be persons are bound by terms of confidentiality and non-use obligations substantially as restrictive as consistent with those set forth contained in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix PatentAgreement, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided save that such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]for a term of no less than five (5) years following the disclosure of such Confidential Information to such persons; and further provided that in each such case where such Confidential Information is also entitled to attorney-client privilege, the attorney work product privilege, or any other similar privilege, protection, or immunity (“Privileged and Confidential Information”), the Receiving Party shall ensure that each such actual or bona fide potential investor, acquiror, sublicensee and other financial or commercial partner (or attorney, accountant or other advisor) has a common legal interest with the Disclosing Party and the Receiving Party at the time of disclosure and that such Privileged and Confidential Information is disclosed solely pursuant to a written common interest agreement sufficient to protect the privileged status of such Privileged and Confidential Information; and
(hf) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party where such disclosure is required by judicial or administrative process, provided that in such event such Party shall promptly notify the other Party in writing of such required disclosure and provide the other Party an opportunity to make a challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article XVII, and the Disclosing Party’s Party disclosing Confidential Information pursuant to Section 8.3(c) (butlaw or court order shall take all steps reasonably necessary, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose including seeking of confidential treatment or a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirementprotective order, to obtain a protective order requiring that ensure the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other continued confidential treatment of such Confidential Information.
Appears in 1 contract
Samples: Exclusive License and Option Agreement (Athenex, Inc.)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights pursuant to Section 6.1(c);
(b) prosecuting or defending litigation as permitted by this Agreementlitigation;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs and BLAs) connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any performance of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, providedto Affiliates, in permitted (sub)licensees, contractors, IRBs, CROs, academic institutions, consultants, agents, investigators, and employees and contractors engaged by study sites and investigators involved with the Combined Therapy Study, each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees whom prior to disclosure must be bound by terms of confidentiality and non-use substantially as restrictive as similar to those set forth in this Article 89;
(e) disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with the development and registration of the Combined Therapy, the Recipient FDC or the BMS Study Drug as permitted by this Agreement;
(f) disclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, IRBs and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the Recipient FDC with respect to the Recipient, and the BMS Study Drug with respect to BMS, and, in the event of a Material Safety Issue, to Third Parties that are collaborating with the Recipient or BMS, respectively in the conduct of such other clinical trials of the Recipient FDC or the BMS Study Drug, in each case solely to the extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and regulatory requirements; and
(g) disclosure (i) of the terms and conditions of this Agreement and the Combined Therapy Study Data to actual and/or bona fide potential investors, other financing sources, financial advisors, merger partners and acquirers in connection with Patent Prosecution due diligence or the enforcement similar investigations by or defense on behalf of such Third Parties, or in confidential financing documents, provided, in each case, that any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted such Third Party agrees to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested bound by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under written obligations of confidentiality that are of and non-use substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authoritythose contained herein. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing any other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Intensity Therapeutics, Inc.)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights with respect to any Inventions;
(b) prosecuting or defending litigation as permitted by brought in connection with any Third Party Claim or under the terms of this Agreement;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs connection with the performance of this Agreement, to Affiliates, permitted sublicensees, contractors, ethics committees and BLAs) with respect to any Licensed ProductIRBs, CROs, academic institutions, consultants, agents, investigators, and in correspondence employees and contractors engaged by Study Sites and investigators involved with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs Combined Therapy Study and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, who have a need to know such information in order for connection with the Receiving Party proper performance the Combined Therapy Study, each of whom prior to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to disclosure must be bound in writing by similar terms of confidentiality and non-use substantially as restrictive as at least equivalent in scope to those set forth in this Article 8, where such period of confidentiality shall last for time period stated in Section 8.1;
(e) disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patents to Regulatory Authorities in connection with the development of the Combined Therapy, the Company Compounds (in the case of the Company) or the BMS Compound (in the case of BMS);
(f) disclosure of Combined Therapy Study Data in accordance with Section 7.4 or Section 7.5 (as applicable); and
(g) disclosure of relevant Safety Information contained within the Combined Therapy Study Data to investigators, institutional review boards and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of either or both of the Company Compounds with respect to the Company, and the BMS Compound with respect to BMS, and (iin the event of a Material Safety Issue) to Third Parties that are collaborating with the Company or BMS, respectively in connection with Patent Prosecution the conduct of such other clinical trials of the Company Compounds or the enforcement or defense BMS Compound, in each case solely to the extent necessary for the proper conduct of any Licensed Patent or Telix Patent, (ii) in connection such clinical trials and/or to comply with Regulatory Applications Applicable Law and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityregulatory requirements. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(b), or Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment. If a Party intends to make a disclosure of the other Party’s Confidential Information pursuant to Section 9.1(a), it shall give advance notice to such other Party of such intended disclosure, and the Parties shall cooperate with respect to the timing and secure the other Party’s permission to make such disclosure taking into account the non-disclosing Party’s plans for Patent filings on Inventions in accordance with Section 5.1.
Appears in 1 contract
Samples: Master Clinical Trial Collaboration Agreement (BioAtla, Inc.)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patent Rights pursuant to Section 6.1(c);
(b) prosecuting or defending litigation as permitted by this Agreementlitigation;
(c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationstock is listed;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs and BLAs) connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any performance of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, providedto Affiliates, in permitted (sub)licensees, contractors, IRBs, CROs, academic institutions, consultants, agents, investigators, and employees and contractors engaged by study sites and investigators involved with the Combined Therapy Clinical Trial, each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees whom prior to disclosure must be bound by terms of confidentiality and non-use substantially at least as restrictive protective of Confidential Information as those set forth in this Article 89;
(e) disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with the development and obtaining of regulatory approval of the Combined Therapy, the Recipient Study Drug or the BMS Study Drug;
(f) disclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, IRBs and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the Recipient Study Drug with respect to the Recipient, and the BMS Study Drug with respect to BMS, and, in the event of a Material Safety Issue, to Third Parties that are collaborating with the Recipient or BMS, respectively in the conduct of such other clinical trials of the Recipient Study Drug or the BMS Study Drug, in each case solely to the extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and regulatory requirements; and
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted subject to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [***] advance written notice to BMS, in communications with [***]), under confidentiality provisions as least as protective of Confidential Information as those of this Agreement; and
(h) disclosure, by either Party, provided that with respect to [***] such disclosure shall be limited to the terms and conditions of a copy of this Agreement and the Agreement in response to a request from a taxing authorityCombined Therapy Study Data. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing any other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Replimune Group, Inc.)
Authorized Disclosure. Notwithstanding the provisions foregoing, each of Section 8.1, the Receiving Party RIB-X and WAKUNAGA may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to a Third Party to the extent such disclosure is reasonably necessary in to exercise the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions granted to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations retained by it under this Agreement, provided, or to conduct clinical trials as permitted hereunder with respect to Products or in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)prosecuting patent applications, or Representative agrees to be bound prosecuting or defending litigation, or Portions of this Exhibit, indicated by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as xxxx “[***]); and
(h) disclosure,” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, by either Partyas amended. to the extent required to comply with applicable governmental regulations, the requirements of a copy of the Agreement in response to tax authority, Regulatory Authority or other governmental entity; provided, that if a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required by law to make a any such disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (butInformation, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx extent it may freely disclose a copy of the Agreement in response to a valid request from a taxing authority)legally do so, it will, except in the case where it is impractical to do so (i) will give reasonable (under the circumstances) advance notice to the Disclosing Party of such required disclosure, and (ii) at disclosure so as to permit the Disclosing Party’s request and expenseParty to secure, shall cooperate with the Disclosing Party’s efforts to contest such requirementif it so desires, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Information prior to its disclosure (whether through protective orders or otherwise). If the Disclosing Party has not filed a patent application with respect to such Confidential Information, it may require the Receiving Party to delay the proposed disclosure (to the extent the Disclosing Party may legally do so), for up to ninety (90) days, to allow for the filing of such an application; provided, that if a disclosure is required by law or order and such a delay is not possible, the Parties shall cooperate to restrict or delay disclosure to the extent possible in order to allow for the filing of such an application or the securing of other protection for such Confidential Information. Further, WAKUNAGA retains a right to disclose to Xxxxxx any part of Confidential Information including contents of this Agreement, but within and to the extent of necessity to obtain Xxxxxx’x consent as set forth in Section 2.5 hereof or as otherwise required by the Termination Agreement, subject to Xxxxxx’x agreement to maintain such information as confidential, and provided that RIB-X shall be given prior notice of the nature and content of any such disclosure to Xxxxxx.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the A Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement (including as reasonably necessary for the Receiving Party’s performance of its obligations under this Agreement), or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(cb) complying with applicable court or governmental orders, applicable laws, rules or Applicable Lawsregulations, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ Affiliate’s securities are traded, provided ;
(c) enforcing the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential InformationParty’s rights under this Agreement;
(d) in the case of Telix filing or prosecuting Patent Rights as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorypermitted by this Agreement;
(e) in the case of Lxxxx as the Receiving PartyCompany, disclosure in regulatory submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in Products within the Territory regarding any Lilly Product or Companion Diagnostic or any scope of the foregoing submissions or filings in the TerritoryExclusive ACT License;
(f) in the case of BioAtla, disclosure in regulatory submissions with respect to BioAtla CAB Non-ACT Products within the scope of the Exclusive Non-ACT License;
(g) disclosure to the Receiving Party’s Affiliates, to the Company’s actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)rights with respect to Products, to BioAtla’s actual or potential licensees or sublicensees of rights with respect to BioAtla CAB Non-ACT Products, and to the Receiving Party’s and its Affiliates’ Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)sublicensee, or Representative agrees to be bound by terms of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])6; and
(h) disclosuredisclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by either Party, reasonable obligations of a copy of the Agreement in response to a request from a taxing authorityconfidentiality and non-use. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c6.3(a) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 6.3(b), it will, except in the case where it is impractical to do so impracticable, (i) give reasonable advance notice to the Disclosing Party of such required disclosure, (ii) use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts, and (iiiii) cooperate with any efforts by the Disclosing Party, at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Information.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information of belonging to the Disclosing Party as expressly permitted by this Agreement, or if and to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:
(a) enforcing preparing, filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting Patents;
(b) preparing, filing or prosecuting or defending litigation as permitted by this AgreementRegulatory Materials;
(c) prosecuting or defending litigation; [*] = 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 406 of the Securities Act of 1933, as amended.
(d) subject to Section 11.4, complying with applicable court or governmental ordersApplicable Law (including, or Applicable Lawswithout limitation, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the rules and regulations of any applicable stock market or national securities exchange on which exchange, regulations of the State Administration of Foreign Exchange of the People’s Republic of China, and the State Intellectual Property Office of the People’s Republic of China) and with judicial process, if in the reasonable opinion of the Receiving Party’s or any of its Affiliates’ securities are tradedcounsel, such disclosure is necessary for such compliance, provided that the Receiving Party gives shall promptly notify the other Party of such required disclosure so that the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to can seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Partyappropriate remedies and, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate reasonably assist the Disclosing Party in seeking such protective order or other reasonable remedies; and
(e) disclosure (i) in connection with the performance of this Agreement and solely on a “need to know basis”, to Affiliates; potential or actual collaborators (including potential Sublicensees); or employees, contractors, or agents; or (ii) solely on a “need to know basis” to potential or actual investment bankers, consultants, advisors, investors, partners, collaborators, lenders, or acquirers; each of whom in the case of clause (i) or (ii) prior to disclosure must be bound by written obligations of confidentiality and non-use no less restrictive than the obligations set forth in this Article 11; provided, however, that the Receiving Party shall remain responsible for any failure by any Person to which it discloses or provides access to Confidential Information of the Disclosing Party pursuant to this Article 11 to treat such Confidential Information as required under this Article 11. Notwithstanding anything in this Agreement to the contrary, ZAI may, in its sole discretion, disclose [*] in connection with the performance of this Agreement in non-confidential corporate presentations. If and whenever any Confidential Information is disclosed in accordance with this Section 11.2, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (otherwise than by breach of this Agreement). Where reasonably possible and subject to Section 11.4, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s efforts intent to contest make such requirement, disclosure pursuant to obtain a protective order requiring that paragraphs (a) through (d) of this Section 11.2 sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of its Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or subject to obtain other confidential treatment of such Confidential Informationdisclosure.
Appears in 1 contract
Samples: License Agreement (Zai Lab LTD)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instancessituations:
(a) enforcing regulatory filings and other filings with Governmental Authorities, including filings with the Securities and Exchange Commission or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementother relevant exchange on which such Party is listed;
(b) prosecuting or defending litigation as permitted by this Agreement;litigation; [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Partydisclosure to its employees, disclosure in submissions to or filings with any Regulatory Authority (includingagents, without limitation, in INDs and BLAs) with respect to any Licensed Productconsultants, and any bona fide Third Party potential (sub)-licensees (including potential Third Party partners) only on a need-to-know basis and solely as necessary in correspondence connection with any Regulatory Authority in the Territory regarding any Licensed Product performance of or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under otherwise contemplated by this Agreement, provided, provided that in each case, that any case the recipient of such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees Confidential Information must agree to be bound by terms similar obligations of confidentiality and non-use substantially as restrictive as at least equivalent in scope to those set forth in this Article 8;12 prior to any such disclosure; and
(ge) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existencematerial terms of this Agreement to any bona fide potential investor, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investorsinvestment banker, lendersacquiror, merger partner, licensees, sublicensees and acquirers who are under obligations of confidentiality or other potential or actual financial or commercial partner; provided that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) connection with such disclosure, by either Party, of a copy the disclosing Party shall use all reasonable efforts to inform each recipient of the Agreement in response confidential nature of such Confidential Information and cause each recipient of such Confidential Information to a request from a taxing authoritytreat such Confidential Information as confidential. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to clause (a) through (c) of this Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority)12.2, it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use diligent efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential InformationInformation hereunder. Each Party will be responsible for any acts or omissions of any Third Party to which such Party discloses Confidential Information in accordance with this Section 12.2.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Amag Pharmaceuticals Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.110.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation Patents as permitted by this Agreement;
(cb) complying disclosure required in connection with any judicial, regulatory or administrative process relating to or arising from this Agreement (including any enforcement hereof) or to comply with applicable court orders;
(c) disclosure to Affiliates, employees, contractors, consultants or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements agents of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, who have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, ; provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)Sublicensee, employee, contractor, consultant or Representative agent agrees to be bound by terms of confidentiality and non-use substantially as restrictive as comparable in scope to those set forth in this Article 810;
(d) such disclosure is made to such Party’s attorneys, independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the Receiving Party, on the condition that such attorneys, independent accountants and financial advisors are bound by confidentiality and non-use obligations consistent with the confidentiality provisions of this Agreement as they apply to the Receiving Party (provided, however, that in the case of financial advisers, including investment bankers, the term of confidentiality may be shortened to [***] years from the date of disclosure and in the case of attorneys, no written agreement shall be required);
(e) disclosure to existing investors, acquirors or collaborators or potential bona fide investors, acquirors, licensees, Sublicensees or collaborators in connection with due diligence or similar investigations by such Third Parties; provided, in each case, that any such existing or potential investor, acquiror, licensees, Sublicensees or collaborator agrees to be bound by confidentiality and non-use obligations consistent with those contained in this Agreement as they apply to the Receiving Party (but of duration customary in confidentiality agreements entered into for similar purpose);
(f) disclosure to Regulatory Authorities as required by Applicable Laws in relation to Regulatory Approvals and regulatory procedures, proceedings and other filings;
(g) disclosure to: (i) in connection with Patent Prosecution Governmental Authorities to the extent useful or the enforcement necessary to make regulatory filings and obtain or defense of maintain Regulatory Approvals (including fulfilling post-approval regulatory obligations) for any Licensed Patent or Telix Patent, Product; (ii) in connection with Regulatory Applications and all other documents Governmental Authorities, technical committees or materials submitted similar public health or scientific bodies for purposes of securing product use recommendations, tenders, direct procurement contracts or responding to Regulatory Authorities and relevant requests for information; (iii) of the existence, terms comply with Applicable Laws with respect to performance under this Agreement; and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxxiv) to actual and potential investorsGovernmental Authorities in order to respond to inquiries, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in requests or investigations relating to Licensed Products or this Agreement (other than the confidentiality term, which may be as short as [**])Agreement; and
(h) disclosure, to the extent mutually agreed to by either Party, of a copy of the Agreement Parties in response to a request from a taxing authoritywriting. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c10.3(a) (but, for clarity, not under or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority10.3(b), it will, except in the case where it is impractical to do so (i) impracticable for necessary disclosures, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure requirement and (ii) at the Disclosing Party’s request will use its reasonable efforts to secure and expense, shall cooperate with the Disclosing other Party’s efforts to contest such requirement, as necessary, to seek and obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential InformationInformation required to be disclosed to the extent legally permissible and will limit the disclosure of that Confidential Information required to be disclosure to (i) to advisors (including lawyers and accountants) or Governmental Authorities on a need to know basis, in each case under appropriate confidentiality provisions or professional standards of confidentiality substantially equivalent to those of this Agreement, or (ii) to the extent agreed to by the Parties.
Appears in 1 contract
Authorized Disclosure. Notwithstanding (a) Ifa Party is required to disclose specific Confidential Information of the provisions other Party to comply with an applicable law, regulation, legal process, or order of Section 8.1a government authority or court of competent jurisdiction, the Receiving Party may disclose such Confidential Information only to the entity or person required to receive such disclosure; provided, however, that the Party required to disclose such Confidential Information shall (a) to the extent permitted by such law, regulation, process, order or rules, first have given prompt (but in no event less ) advance notice to such other Party to enable it to seek any available exemptions from or limitations on such disclosure requirement and shall reasonably cooperate in such efforts by the other Party at the other Party’s expense, (b) furnish only the portion of the Confidential Information which is legally required to be disclosed; (c) use all reasonable efforts to secure confidential protection of such Confidential Information, and (d) continue to perform its obligations of confidentiality and non-use set out in this Article 11.
(b) Each Party may disclose Confidential Information of the Disclosing other Party as expressly permitted by this Agreementto Regulatory Authorities to the extent such disclosure is reasonably necessary in regulatory filings required for the development and/or commercialization of Licensed Products. In addition, or if and each Party may disclose Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing : filing or exercising prosecuting patents as permitted by this Agreement; disclosure to Affiliates, Other Licensees or Sublicensees or potential Other Licensees or Sublicensees; disclosure to contractors, employees and consultants, who need to know such information for the Receiving Party’s rights under this Agreement development, manufacture and performing commercialization of Licensed Products; disclosure to bankers, lawyers, accountants, agents or other Third Parties in connection with due diligence or similar investigations or in furtherance of the Receiving Party’s obligations under this Agreement;
; and to potential Third Party investors or lenders (b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(dand their respective advisors) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, confidential financing documents; provided that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be Third Party is bound by terms obligations of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) herein. In the case of each disclosure, the Party making such disclosure (i) in connection with Patent Prosecution or the enforcement or defense shall use reasonable efforts to obtain confidential treatment of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the not disclose Confidential Information so disclosed be used only for of the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential InformationParty other than is reasonably necessary.
Appears in 1 contract
Samples: License Agreement (Lipocine Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.110.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation Patents as permitted by this Agreement;
(cb) complying disclosure required in connection with any judicial, regulatory or administrative process relating to or arising from this Agreement (including any enforcement hereof) or to comply with applicable court orders;
(c) disclosure to Affiliates, employees, contractors, consultants or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements agents of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, who have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, ; provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)Sublicensee, employee, contractor, consultant or Representative agent agrees to be bound by terms of confidentiality and non-use substantially as restrictive as comparable in scope to those set forth in this Article 810;
(d) such disclosure is made to such Party’s attorneys, independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the Receiving Party, on the condition that such attorneys, independent accountants and financial advisors are bound by confidentiality and non-use obligations consistent with the confidentiality provisions of this Agreement as they apply to the Receiving Party (provided, however, that in the case of financial advisers, including investment bankers, the term of confidentiality may be shortened to [***] years from the date of disclosure and in the case of attorneys, no written agreement shall be required);
(e) disclosure to existing investors, acquirors or collaborators or potential bona fide investors, acquirors, licensees, Sublicensees or collaborators in connection with due diligence or similar investigations by such Third Parties; provided, in each case, that any such existing or potential investor, acquiror, licensees, Sublicensees or collaborator agrees to be bound by confidentiality and non-use obligations consistent with those contained in this Agreement as they apply to the Receiving Party (but of duration customary in confidentiality agreements entered into for similar purpose);
(f) disclosure to Regulatory Authorities as required by Applicable Laws in relation to Regulatory Approvals and regulatory procedures, proceedings and other filings;
(g) disclosure to: (i) in connection with Patent Prosecution Governmental Authorities to the extent useful or the enforcement necessary to make regulatory filings and obtain or defense of maintain Regulatory Approvals (including fulfilling post-approval regulatory obligations) for any Licensed Patent or Telix Patent, Product; (ii) in connection with Regulatory Applications and all other documents Governmental Authorities, technical committees or materials submitted similar public health or scientific bodies for purposes of securing product use recommendations, tenders, direct procurement contracts or responding to Regulatory Authorities and relevant requests for information; (iii) of the existence, terms comply with Applicable Laws with respect to performance under this Agreement; and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxxiv) to actual and potential investorsGovernmental Authorities in order to respond to inquiries, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in requests or investigations relating to Licensed Products or this Agreement (other than the confidentiality term, which may be as short as [**])Agreement; and
(h) disclosure, to the extent mutually agreed to by either Party, of a copy of the Agreement Parties in response to a request from a taxing authoritywriting. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c10.3(a) (but, for clarity, not under or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority10.3(b), it will, except in the case where it is impractical to do so (i) impracticable for necessary disclosures, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure requirement and (ii) at the Disclosing Party’s request will use its reasonable efforts to secure and expense, shall cooperate with the Disclosing other Party’s efforts to contest such requirement, as necessary, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation requiredseek and obtain, and/or to obtain other confidential treatment of such Confidential InformationInformation required to be disclosed to the extent legally permissible and will limit the disclosure of that Confidential Information required to be disclosure to (i) to advisors (including lawyers and accountants) or Governmental Authorities on a need to know basis, in each case under appropriate confidentiality provisions or professional standards of confidentiality substantially equivalent to those of this Agreement, or (ii) to the extent agreed to by the Parties.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.15.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting Patents as permitted by this Agreement;
(b) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(bc) prosecuting or defending litigation as permitted by this Agreement;
(cd) complying with applicable court or governmental orders, applicable laws, rules or Applicable Lawsregulations, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(de) in the case of Telix Flame as the Receiving PartyParty during the Term or after expiration (but not earlier termination) of this Agreement, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Compound or Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Compound or Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) Flame as the Receiving Party during the Term or licensees or sublicensees (in the case after expiration, but not earlier termination, of Lillythis Agreement), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)Sublicensee, or Representative agrees to be bound by terms of confidentiality and non-non use substantially at least as restrictive as those set forth in this Article 8;Section 5; and
(g) disclosure (i) to Third Parties in connection with Patent Prosecution due diligence or the enforcement or defense of similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, provided, in each case, that any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted such Third Party agrees to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested bound by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under reasonable obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authoritynon-use. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c5.3(c) or Section 5.3(d), each party (butexcept in the case of Xxxxx, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx where Xxxxx may freely disclose a copy of the Agreement agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (***) without complying with (i) or (ii) below) will (i) give reasonable advance notice to the Disclosing Party of such required disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other confidential treatment of such Confidential Information.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the The Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and only to the extent such disclosure is reasonably necessary in the following instances, or to the extent permissible under the other applicable provisions of this Agreement or the Investment Agreement:
(a) filing, prosecuting, maintaining, enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under defending Patent Rights as permitted by this Agreement;
(b) prosecuting or defending litigation as reasonably required in generating Regulatory Documentation and filing for and obtaining Regulatory Licenses as permitted by this Agreement;
(c) complying with applicable court prosecuting or governmental orders, or Applicable Lawsdefending litigation, including Applicable Laws related responding to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving a subpoena in a Third Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationlitigation;
(d) subject to Section 10.4, complying with applicable Law (including regulations promulgated by securities exchanges) or court or administrative orders, including as a result of any actions taken by a Party not in violation of this Agreement or the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the TerritoryInvestment Agreement;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings complying with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product obligation under this Agreement or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;Investment Agreement; or
(f) disclosure to its Affiliates and existing or prospective (sub)licensees, subcontractors, consultants, agents and advisors to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order extent reasonably necessary for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement or the Investment Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to whom before disclosure must be bound by terms of under a written agreement containing confidentiality and non-use substantially as restrictive as provisions that are consistent with those set forth in this Article 8;
(g) Agreement, provided that the Receiving Party shall remain responsible for any violation of such confidentiality provisions by any Person who receives Confidential Information pursuant to this Section 10.3.1(f). If and whenever any Confidential Information is disclosed in accordance with this Section 10.3, such disclosure (i) shall not cause any such information to cease to be Confidential Information for purposes of this Agreement, except to the extent that such disclosure results in connection with Patent Prosecution or the enforcement or defense a public disclosure of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement information (other than the confidentiality term, which may be as short as [**]by breach of this Agreement); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving a Party is required intends to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(c10.3.1(c) (but, for clarity, not under or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority10.3.1(d), it will, except in where impracticable or not legally permitted, give [...***...] advance notice (or, if [...***...] notice is not possible under the case where it is impractical to do so (i) give circumstances, reasonable advance notice notice) to the Disclosing other Party of such required disclosure, disclosure and (ii) at use not less than the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s same efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Informationinformation as it would to protect its own confidential information from disclosure (but no less than reasonable efforts).
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instancessituations:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementprosecuting FibroGen China Patents in accordance with Article 9;
(b) prosecuting regulatory filings and other filings with Governmental Authorities (including Regulatory Authorities), including filings with the U.S. SEC or defending litigation as permitted by this AgreementCFDA, with respect to a Product;
(c) complying with applicable court prosecuting or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationdefending litigation;
(d) in the case of Telix as the Receiving Partycomplying with applicable laws and regulations, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territoryincluding regulations promulgated by securities exchanges;
(e) disclosure to its Affiliates, employees, agents, and independent contractors, and any licensees or Sublicensees or distributors (including JVCo), in each case only on a need-to-know basis and solely in connection with the performance of this Agreement (and in the case of Lxxxx as FibroGen China, the Receiving PartyAstellas Agreements or other agreements with licensees of Products), disclosure provided that each disclosee must be bound by obligations of confidentiality and non-use at least equivalent in submissions scope to or filings with any Regulatory Authority (including, without limitation, those set forth in INDs and BLAs) with respect this Article 12 prior to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territorysuch disclosure;
(f) disclosure of the material terms of this Agreement to the Receiving Party’s Affiliatesany bona fide potential or actual investor, to investment banker, acquirer, merger partner, or other potential or actual or potential Sublicensees (financial partner, and in the case of TelixFibroGen China, to any licensee of Products; provided that in connection with such disclosure, the disclosing Party shall inform each disclosee of the confidential nature of such Confidential Information and cause each disclosee to treat such Confidential Information as confidential; and
(g) disclosure of any Collaboration Inventions or licensees status reports (including data from any Clinical Trials) to any bona fide potential or sublicensees (actual investor, investment banker, acquirer, merger partner, or other potential or actual financial partner, and in the case of Lilly)FibroGen China, and to the Receiving Party’s Representatives who, in any licensee of Products; provided that each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to disclosee must be bound by terms obligations of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of 12 prior to any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(cSections 12.2(a), 12.2(b), 12.2(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 12.2(d), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts use Commercially Reasonable Efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential InformationInformation hereunder.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Fibrogen Inc)
Authorized Disclosure. Notwithstanding the provisions of Section 8.17.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting Patent Rights as permitted by this Agreement;
(b) exercising or enforcing or exercising the Receiving Partysuch party’s rights under this Agreement and in performing the Receiving Party’s its obligations under this Agreement;
(bc) seeking, obtaining and maintaining Marketing Approvals (including complying with the requirements of Regulatory Authorities with respect to filing for, obtaining and maintaining Marketing Approvals);
(d) prosecuting or defending litigation as permitted by this Agreement;
(ce) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided traded (specifically including the recommendations and requests from the Tokyo Stock Exchange (TSE) or the SEC or otherwise submitting information to tax or other governmental authorities);
(f) disclosure in Regulatory Filings or Regulatory Documents that the Receiving Party gives has the Disclosing Party sufficient written notice, right to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationmake under this Agreement;
(dg) in the case of Telix as the Receiving PartyArcus, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Productlicensors to the extent required to comply with the terms and conditions of any agreement between Arcus and such licensors, provided that any such licensors agree to be bound by terms of confidentiality and non-use at least as restrictive as those set forth in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorythis Article 7;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(fh) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees sublicensees) or Subcontractors (in the case or subcontractors, including those of Lilly), Sublicensees) and to the Receiving Party’s and its Affiliates’ Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this AgreementAgreement or any agreement between the Receiving Party and any such persons, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee sublicensee) or Subcontractor (in the case or subcontractor, including those of LxxxxSublicensees), or Representative agrees to be bound by terms of confidentiality and non-use substantially at least as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])7; and
(hi) disclosuredisclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by either Partyobligations of confidentiality and non-use similar to those contained in this Agreement. *** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CONFIDENTIAL TREATMENT REQUESTED Each party shall be responsible for any breaches of confidentiality by any of its Affiliates, Sublicensees (or licensees or sublicensees), Subcontractors (or subcontractors, including those of a copy of the Agreement in response Sublicensees), Representatives, advisors and Third Parties (to a request from a taxing authoritywhom it discloses Confidential Information pursuant to Sections 7.3(h), 7.3(i) and 7.6). Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c7.3(d) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 7.3(e), it will, except in the case where it is impractical to do so impracticable, (ia) give reasonable advance notice to the Disclosing Party of such required disclosure, (b) use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts, and (iic) cooperate with any efforts by the Disclosing Party, at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Information. [***]. In addition, notwithstanding the foregoing, to the extent that either party reasonably determines that it is required to make a filing or any other public disclosure with respect to this Agreement or the terms or existence hereof to comply with the requirements, rules, laws or regulations of any applicable stock exchange, Nasdaq, Tokyo Stock Exchange, or any governmental or regulatory authority or body, including without limitation the U.S. Securities and Exchange Commission (the “SEC”) (collectively, the “Securities Disclosure Obligations”), such party shall promptly inform the other party thereof and shall use reasonable efforts to maintain the confidentiality of the terms of this Agreement in any such filing or disclosure. Prior to making any such initial filing of the terms of this Agreement, the parties shall mutually agree on the provisions of this Agreement for which the parties shall seek confidential treatment, it being understood that if one party determines to seek confidential treatment for a provision for which the other party does not, then the parties will use reasonable efforts in connection with such filing to seek the confidential treatment of any such provision. The parties shall cooperate, each at its own expense, in such filing, including without limitation such confidential treatment request. The parties will reasonably cooperate in responding promptly to any comments received from the SEC with respect to such filing in an effort to achieve confidential treatment of such redacted form; provided, however, that a party shall be relieved of such obligation to seek confidential treatment for a provision requested by the other party if such treatment is not achieved after the first round of responses to comments from the SEC. Notwithstanding anything to the contrary in this Agreement, either party may make reference to the existence of this Agreement and describe in general terms the relationship between the parties in connection with any required securities filings without seeking the other party’s prior consent. This paragraph shall apply with respect to the filing of the terms of this Agreement or any public disclosure relating to this Agreement, in each case to comply with Securities Disclosure Obligations, notwithstanding the provisions of this Article 7 or the Confidentiality Agreement.
Appears in 1 contract
Samples: Option and License Agreement
Authorized Disclosure. Notwithstanding the provisions of Section 8.16.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting Patents as permitted by this Agreement;
(b) enforcing or exercising the Receiving such Party’s rights under this Agreement (including registering the licenses granted hereunder with applicable authorities) and in performing the Receiving Party’s its obligations under this Agreement;.
(bc) prosecuting or defending litigation as permitted by this Agreement;
(cd) complying with applicable court or governmental orders, applicable laws, rules or Applicable Lawsregulations, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements the listing rules of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case disclosure to Affiliates, actual and potential licensees and sublicensees, employees, consultants or agents of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, Party who have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)sublicensee, employee, consultant or Representative agent agrees to be bound by terms of confidentiality and non-use substantially as restrictive as comparable in scope to those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])ARTICLE 6; and
(hf) disclosuredisclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors or acquirers in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by either Party, reasonable obligations of a copy of the Agreement in response to a request from a taxing authorityconfidentiality and non-use. Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c6.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 6.3(d), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts. In any event, the Receiving Party agrees to take all reasonable action to avoid disclosure of Confidential InformationInformation hereunder.
Appears in 1 contract
Samples: License Agreement (Tonix Pharmaceuticals Holding Corp.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Party Either party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instancessituations:
(a) enforcing prosecuting or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreementdefending litigation;
(b) prosecuting complying with applicable laws and regulations, including regulations promulgated by a global stock market or defending litigation as permitted by this Agreementsecurities exchanges;
(c) complying with applicable a valid order of a court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order competent jurisdiction or other confidential or protective treatment with respect to such Confidential InformationGovernmental Entity;
(d) in the case of Telix as the Receiving Partyfor regulatory, disclosure in submissions to tax or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territorycustoms purposes;
(e) in the case for audit purposes, provided that each recipient of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs Confidential Information must be bound by customary obligations of confidentiality and BLAs) with respect non-use prior to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territorysuch disclosure;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), its Affiliates and to the Receiving Party’s Representatives who, in each case, have on a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreementbasis, provided, in provided that each case, that any such Affiliate, actual or potential Sublicensee (in the case recipient of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to Confidential Information must be bound by terms customary obligations of confidentiality and non-use substantially as restrictive as those set forth in this Article 8prior to any such disclosure;
(g) disclosure (i) in connection with Patent Prosecution or upon the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) prior written consent of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**])Disclosing Party; andor
(h) disclosure to potential licensees, investors and other sources of funding, including debt financing or co-investors, and their respective accountants, financial advisors and other professional representatives, provided, that such disclosure shall be made only to the extent customarily required to consummate such investment or financing transaction and that each recipient of Confidential Information must be bound by customary obligations of confidentiality and non-use prior to any such disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, ; provided that in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.3(c8.2(a), (b), (c) or (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityd)), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance written notice to the Disclosing Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts use [ * ] to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information. For clarity, any use or [ * ] = 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 THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. disclosure of Confidential InformationInformation disclosed under the Confidentiality Agreement that is authorized under this Article 8 shall not be restricted by, or be deemed a violation of, the Confidentiality Agreement. In any event, the Buyer shall not file or assist any Third Party in filing any patent application based upon or using the Confidential Information of Seller provided hereunder. Notwithstanding anything set forth in this Agreement, including Section 8.2, patent and patent-related material and documentation may be only disclosed to or accessed by Buyer’s counsel, without further disclosure to Buyer or its Representatives.
Appears in 1 contract
Samples: Royalty Purchase Agreement
Authorized Disclosure. Notwithstanding the provisions of Section 8.1Except as otherwise provided in this Agreement, the a Receiving Party may use and disclose Confidential Information of the Disclosing Party as expressly permitted by follows:
(a) Confidential Information may be shared with a Party’s and its Affiliates’ employees and agents (including, without limitation, consultants, attorneys, accountants and financial advisors) under appropriate confidentiality provisions not less restrictive than those contained in this Agreement, in connection with the performance of its obligations or if exercise of rights granted or reserved in 23 [*] = 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 the Securities Exchange Act of 1934, as amended. this Agreement; (b) to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) [*], complying with applicable court governmental regulations, obtaining Regulatory Approval, complying with government subpoenas, marketing Licensed Products or governmental orders, or otherwise required by Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, Law; provided, in each casehowever, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and if a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required by subpoena or Applicable Law to make a any such disclosure of the a Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing Party of such required disclosuredisclosure requirement and, and (ii) at except to the Disclosing Party’s request and expenseextent inappropriate in the case of [*], shall cooperate with the Disclosing Party’s use its reasonable efforts to contest such requirement, the extent practicable to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Information.Information required to be disclosed; (c) to existing or prospective advisors or investors, in each case under appropriate confidentiality provisions not less restrictive than those contained in this Agreement; (d) as reasonably required under the circumstances, to a Third Party in connection with: (i) a merger, consolidation or similar transaction by such Party, or (ii) the sale of all or substantially all of the assets of such Party or to which this Agreement relates, in each case under appropriate confidentiality provisions not less restrictive than those contained in this Agreement; (e) to the extent necessary, Confidential Information may be shared with [*] under appropriate confidentiality provisions not less restrictive than those contained in this Agreement; or (f) to the extent mutually agreed in writing by the Parties. In each of the above authorized disclosures, except to the extent such disclosure is required by Applicable Law, the Receiving Party shall remain responsible for any failure by any Person who receives the Confidential Information pursuant to this Section 9.2 to treat such Confidential Information as required under this Article 9. ARTICLE 10
Appears in 1 contract
Samples: License Agreement
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instancessituations:
(a) enforcing filing or exercising prosecuting Collaboration Patents or other Partner Patents relating to any invention used in the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this AgreementCollaboration (subject to any applicable Third Party Licenses) in accordance with Article 9;
(b) prosecuting regulatory filings and other filings with Governmental Authorities (including Regulatory Authorities), including filings with the SEC or defending litigation as permitted by this AgreementFDA, with respect to a Product;
(c) complying with applicable court prosecuting or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationdefending litigation;
(d) in the case of Telix as the Receiving Partycomplying with Applicable Laws, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territoryincluding regulations promulgated by securities exchanges;
(e) in the case of Lxxxx as the Receiving Partydisclosure to its Affiliates, disclosure in submissions to or filings with any Regulatory Authority (includingemployees, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnosticagents, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)independent contractors, and to the Receiving Party’s Representatives whoany Sublicensees, in each case, have case only on a need to need-to-know such information basis and solely in order for connection with the Receiving Party to exercise its rights or fulfill its obligations under performance of this Agreement, provided, in provided that each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to disclosee must be bound by terms obligations of confidentiality and non-use substantially at least as restrictive equivalent in scope as those set forth in this Article 812 prior to any such disclosure;
(f) disclosure of the material terms of this Agreement to any bona fide potential or actual investor, investment banker, acquirer, merger partner, or other potential or actual financial partner, with the prior written consent of the other Party not to be unreasonably withheld, and provided that in connection with such disclosure, each disclosee must be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 12 prior to any such disclosure; and [ * ] = 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 THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
(g) disclosure of any Collaboration results or status reports (including data from any Clinical Trials) to any bona fide potential or actual investor, investment banker, acquirer, merger partner, or other potential or actual financial partner, with the prior written consent of the other Party not to be unreasonably withheld and provided that (i) each disclosee must be bound by obligations of confidentiality and non-use at least as equivalent in connection with Patent Prosecution or the enforcement or defense of scope as those set forth in this Article 12 prior to any Licensed Patent or Telix Patentsuch disclosure, and (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) the case of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) Medivation’s disclosure, by either Party, Medivation submits the contents of a copy of the Agreement in response such proposed disclosure to a request from a taxing authorityPartner at least ten (10) days prior to such disclosure. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(cSections 12.2(a), 12.2(b), 12.2(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 12.2(d), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential InformationInformation hereunder.
Appears in 1 contract
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instancessituations:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;prosecuting Collaboration Patents in accordance with Article 9; [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(b) prosecuting subject to Section 12.3, regulatory filings and other filings with Governmental Authorities (including Regulatory Authorities), including filings with the SEC or defending litigation FDA, as permitted by this Agreementnecessary for the Development or Commercialization of a Product, as required in connection with any filing, application or request for Approval, provided however, that reasonable measures will be taken to assure confidential treatment of such information;
(c) complying with applicable court prosecuting or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Informationdefending litigation;
(d) in the case of Telix as the Receiving Partycomplying with Applicable Law, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territoryincluding regulations promulgated by securities exchanges;
(e) disclosure to its Affiliates, employees, agents, and independent contractors, and any Sublicensees of Collaboration Technology only on a need-to-know basis and solely in connection with the case performance of Lxxxx this Agreement, provided that each disclosee must be bound by obligations of confidentiality and non-use at least as the Receiving Party, disclosure equivalent in submissions to or filings with any Regulatory Authority (including, without limitation, scope as and no less restrictive than those set forth in INDs and BLAs) with respect this Article 12 prior to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territorysuch disclosure;
(f) disclosure of the material terms of this Agreement to the Receiving Party’s Affiliatesany bona fide potential or actual investor, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly)investment banker, and to the Receiving Party’s Representatives whoacquirer, in each casemerger partner, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreementcollaborator, providedsublicensee, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx)distributor, or Representative agrees other potential or actual financial partner; provided that in connection with such disclosure, the disclosing Party shall use all reasonable efforts to inform each disclosee of the confidential nature of such Confidential Information and cause each disclosee to treat such Confidential Information as confidential;
(g) disclosure of any Collaboration results or status reports (including data from any Clinical Trials) to any bona fide potential or actual investor, investment banker, acquirer, merger partner, collaborator, sublicensee, or other potential or actual financial partner; provided that (i) each disclosee must be bound by terms obligations of confidentiality and non-use substantially at least as equivalent in scope as and no less restrictive as than those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of 12 prior to any Licensed Patent or Telix Patentsuch disclosure, and (ii) in connection with Regulatory Applications and all the disclosing Party submits the contents of such proposed disclosure to the other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as Party at least [**])*] prior to such disclosure, but the disclosing Party shall not be required to disclose the identity of the disclosee; and
(h) disclosure, by either Party, of a copy of the Agreement in response disclosure pursuant to a request from a taxing authoritySection 12.5. Notwithstanding the foregoing, in the event the Receiving a Party is required to make a disclosure of the Disclosing other Party’s Confidential Information pursuant to Section 8.3(cSections 12.2(a), 12.2(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityor 12.2(d), it will, except in the case where it is impractical to do so (i) impracticable, give reasonable advance notice to the Disclosing other Party of such required disclosure, disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s use reasonable efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such information. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential InformationInformation hereunder. Notwithstanding the foregoing, either Party may disclose without any limitation such Party’s U.S. federal income tax treatment and the U.S. federal income tax structure of the transactions relating to such Party that are based on or derived from this Agreement, as well as [***] materials [***] relating to such tax treatment or tax structure, except to the extent that nondisclosure of such matters is reasonably necessary in order to comply with applicable securities laws.
Appears in 1 contract
Samples: Collaboration and License Agreement (Alder Biopharmaceuticals Inc)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1, the Receiving Each receiving Party may disclose Confidential Information of belonging to the Disclosing disclosing Party as expressly permitted by this Agreement, Agreement or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing, prosecuting, or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation maintaining Patents as permitted by this Agreement;
(b) regulatory filings for Products (for Pediatrix, only in the Pediatrix Territory) that such Party has a license or right to Develop hereunder in a given country or jurisdiction;
(c) prosecuting or defending litigation arising under this Agreement;
(d) complying with applicable court orders or governmental orders, or Applicable Laws, including Applicable Laws related regulations; and
(e) disclosure to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its and its Affiliates’ securities are tradedemployees, provided the Receiving Party gives the Disclosing Party sufficient written noticecontractors and agents, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
ARS Collaborators (d) in the case of Telix as the Receiving Party, disclosure in submissions ARS) and to or filings with any Regulatory Authority Sublicensees (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationPediatrix), in INDs each case on a need- to-know basis in connection with the Development and BLAs) with respect to any Lilly Product or Companion Diagnosticmanufacture of Compositions, and Development, manufacture and Commercialization of Products in correspondence accordance with any Regulatory Authority the terms of this Agreement, in the Territory regarding any Lilly Product or Companion Diagnostic or any each case under written obligations of the foregoing submissions or filings in the Territory;confidentiality and non- use at least as stringent as those herein; and
(f) disclosure to potential and actual investors, acquirers, licensees and other financial or commercial partners solely for the Receiving Party’s Affiliates, to purpose of evaluating or carrying out an actual or potential Sublicensees (investment, acquisition or collaboration in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving such receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights case under written or fulfill its professional obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially at least as restrictive stringent as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityherein. Notwithstanding the foregoing, in the event the Receiving a receiving Party is required to make a disclosure of the Disclosing disclosing Party’s Confidential Information pursuant to Section 8.3(c13.3(c) or (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authorityd), and before making any such disclosure, it willshall, except in the case where it is impractical to do so (i) impracticable or prohibited, give reasonable prompt advance written notice to the Disclosing disclosing Party of such required requirement and its intended disclosure, and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing disclosing Party’s efforts to contest limit or avoid such requirement, disclosure and/or to obtain seek a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation requiredorder, and/or to obtain other confidential treatment of such Confidential InformationInformation or other available remedy. In any event, the Parties agree to take all reasonable action to avoid disclosure of a disclosing Party’s Confidential Information hereunder. Any information disclosed pursuant to Section 13.3(c) or (d) shall remain Confidential Information and subject to the restrictions set forth in this Agreement, including the foregoing provisions of this Article 13.
Appears in 1 contract
Samples: Collaboration and Distribution Agreement (Silverback Therapeutics, Inc.)
Authorized Disclosure. Notwithstanding the provisions of Section 8.1Except as expressly provided otherwise in this Agreement, the a Receiving Party may use and disclose Confidential Information of the Disclosing Party as expressly permitted by follows: (i) to its employees, consultants, Affiliates, subcontractors or other Third Parties, under written confidentiality obligations at least as restrictive as those in this Agreement, in connection with the performance of its obligations or if exercise of rights granted or reserved pursuant to this Agreement (including, without limitation, the rights to conduct the Research Programs, Early Development Programs and Targacept Post-Exercise Activities, Develop Product Candidates, Refused Candidates or Returned Licensed Products, commercialize Products and to grant licenses and sublicenses hereunder); (ii) to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing filing or exercising the Receiving Party’s rights under this Agreement prosecuting patent, copyright and performing the Receiving Party’s obligations under this Agreement;
(b) trademark applications, prosecuting or defending litigation as permitted by this Agreement;
(c) litigation, complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements rules and regulations of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority regulatory authorities (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product stock exchange rule or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lillylisting requirements), and to the Receiving Party’s Representatives whoobtaining Regulatory Approvals, in each caseconducting preclinical activities or clinical trials, have a need to know such information in order for the Receiving Party to exercise its rights marketing Products, or fulfill its obligations under this Agreement, otherwise required by law; provided, in each casehowever, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality and non-use substantially as restrictive as those set forth in this Article 8;
(g) disclosure (i) in connection with Patent Prosecution or the enforcement or defense of any Licensed Patent or Telix Patent, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and if a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoing, in the event the Receiving Party is required by law or regulation to make a any disclosure of the a Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (but, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except where impracticable (by way of example only, in the case where it is impractical to do so (i) event of medical emergency), give reasonable advance notice to the Disclosing Party of such disclosure requirement and an opportunity to comment on any such required disclosure, and (ii) at take into account such comments in good faith and, except to the Disclosing Party’s request and expenseextent inappropriate in the case of patent applications, shall cooperate in reasonable respects with the Disclosing Party’s efforts to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential Information required to be disclosed; (iii) in communication with actual or potential investors, consultants, professional advisors, bankers, acquirors, acquirees or merger partners on a need to know basis, in each case under appropriate confidentiality provisions substantially equivalent to those of this Agreement; or (iv) to the extent mutually agreed in writing by the Parties. Without limiting the generality of the foregoing, each Party shall take such action, and shall cause its Affiliates and Sublicensees to take such action, to preserve the confidentiality of the other Party’s Confidential Information as such Party would customarily take to preserve the confidentiality of its own Confidential Information and shall, in any event, use at least reasonable care to preserve the confidentiality the other Party’s Confidential Information.
Appears in 1 contract
Samples: Product Development and Commercialization Agreement (Targacept Inc)
Authorized Disclosure. Notwithstanding Subject to the provisions terms and conditions of Section 8.1, the this Agreement: (a)either Receiving Party may disclose such Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and (i) to the extent such disclosure is reasonably necessary in the following instances:
(a) enforcing or exercising the Receiving Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court or governmental orders, or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange on which the Receiving Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
(d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), Affiliates and to the Receiving Party’s Representatives whoand its Affiliates’ directors, in each caseofficers (including managing members or partners), limited partners, directors, employees, accountants, attorneys, financial advisors or consultants (together, “Representatives”) who (A) have a need to know such information in order the Confidential Information for the Receiving Party to exercise its rights Permitted Purpose, (B) are apprised of the confidential nature of the Confidential Information and (C) are under written or fulfill its professional obligations under this Agreementof confidentiality, provided, in each case, that any such Affiliate, actual or potential Sublicensee (in the case of Telix) or licensee or sublicensee (in the case of Lxxxx), or Representative agrees to be bound by terms of confidentiality non-disclosure and non-use substantially in respect of Confidential Information to Receiving Party at least as restrictive stringent as those set forth in this Article 8;
contained herein or (gii) disclosure (i) as required by law, regulation, subpoena or court order or otherwise in connection with Patent Prosecution a judicial, administrative or the enforcement or defense of any Licensed Patent or Telix Patentgovernmental proceeding, (ii) in connection with Regulatory Applications and all other documents or materials submitted to Regulatory Authorities and (iii) of the existence, terms and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authority. Notwithstanding the foregoingthat, in the event that the Receiving Party is required or requested to make a disclosure of such disclosure, the Disclosing Party’s Confidential Information pursuant to Section 8.3(c) (butReceiving Party shall, for clarity, not under Section 8.3(h) where, notwithstanding anything to the contraryextent legally permissible, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority), it will, except in the case where it is impractical to do so (i) give reasonable advance notice to notify the Disclosing Party in advance of such required disclosure, and the disclosure so as to allow the Disclosing Party an opportunity to seek (ii) at the Disclosing Party’s request and sole expense, shall cooperate with the Disclosing Party’s efforts to contest such requirement, to obtain ) a protective order requiring or other appropriate remedy; in the case of disclosures of information pertaining to the Purchaser Agent and/or the Purchasers, provided, further, that such notice and opportunity shall not be required in respect of (A) disclosures required pursuant to the Securities Act, the Exchange Act, or the listing rules of the Nasdaq Capital Market, the Nasdaq Global Select Market, the Nasdaq Global Market or the New York Stock Exchange (or any nationally recognized securities exchange that is a successor to any of the foregoing) on which the Company’s common stock is listed or (B) disclosures to any regulatory or self-regulatory authority as required by Applicable Law in connection with an examination, audit, inspection, inquiry, request or general supervisory oversight, and (b) the Purchaser and Purchaser Agent may disclose such Confidential Information (i) so long as such Persons are subject to customary confidentiality obligations, in connection with a Purchaser’s own financing or securitization transactions and upon the occurrence of a default, event of default or similar occurrence with respect to such financing or securitization transaction, (ii) to prospective transferees (other than those identified in the immediately preceding clause (i)) or purchasers of any interest in the Revenue Interests (provided that the Confidential Information Purchasers and Purchaser Agent shall obtain such prospective transferee’s or purchaser’s agreement to the terms of this provision or to similar confidentiality terms), (iii) as Purchaser Agent reasonably considers appropriate in exercising remedies under the Transaction Documents or (iv) to any actual or potential investors, co-investors, members, and partners or their Affiliates so disclosed be used only for the purposes for which the order was issued or the law or regulation requiredlong as such Persons are subject to confidentiality, and/or to obtain other confidential treatment non-use and non-disclosure obligations in respect of such Confidential InformationInformation at least as restrictive as those contained herein. The Receiving Party shall be responsible for any breaches of this Section by its Representatives.
Appears in 1 contract
Samples: Revenue Interest Purchase Agreement (ImmunityBio, Inc.)
Authorized Disclosure. Notwithstanding the provisions any other provision of Section 8.1this Agreement, the Receiving each Party may disclose Confidential Information of belonging to the Disclosing other Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
: (a) enforcing filing or exercising the Receiving prosecuting Patent Rights claiming an Invention owned by such Party’s rights under this Agreement and performing the Receiving Party’s obligations under this Agreement;
; (b) prosecuting or defending litigation as permitted by this Agreement;
litigation; (c) complying with applicable court Applicable Law or governmental orders, the rules or Applicable Laws, including Applicable Laws related to securities laws disclosure requirements or any disclosure requirements regulations of any applicable stock market or securities exchange on which the Receiving such Party’s or any of its Affiliates’ securities are traded, provided the Receiving Party gives the Disclosing Party sufficient written notice, to the extent reasonably possible, to permit the Disclosing Party to seek a protective order or other confidential or protective treatment with respect to such Confidential Information;
stock is listed; (d) in the case of Telix as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitationdisclosure, in INDs and BLAs) connection with respect to any Licensed Product, and in correspondence with any Regulatory Authority in the Territory regarding any Licensed Product or any performance of the foregoing submissions or filings in the Territory;
(e) in the case of Lxxxx as the Receiving Party, disclosure in submissions to or filings with any Regulatory Authority (including, without limitation, in INDs and BLAs) with respect to any Lilly Product or Companion Diagnostic, and in correspondence with any Regulatory Authority in the Territory regarding any Lilly Product or Companion Diagnostic or any of the foregoing submissions or filings in the Territory;
(f) disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees (in the case of Telix) or licensees or sublicensees (in the case of Lilly), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, providedto Affiliates, in each casepermitted sublicensees, that any such Affiliatecontractors, actual or potential Sublicensee ethics committees and institutional review boards (in the case of Telix) or licensee or sublicensee (in the case of Lxxxxcollectively, “IRBs”), or Representative agrees CROs, academic institutions, consultants, agents, investigators, and employees and contractors engaged by Study sites and investigators involved with the Combined Page 47 [ * ] = 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 the Securities Exchange Act of 1934, as amended. Therapy Trials, each of whom prior to disclosure must be bound by similar terms of confidentiality and non-use substantially as restrictive as at least equivalent in scope to those set forth in this Article 8;
9; (ge) disclosure (i) of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with Patent Prosecution the development of the Combined Therapy, the Exelixis Compound or the enforcement or defense BMS Compound; and (f) disclosure of any Licensed Patent or Telix Patentrelevant safety information contained within the Combined Therapy Study Data to investigators, (ii) in connection with Regulatory Applications institutional review boards and/or ethics committees and all other documents or materials submitted to Regulatory Authorities that are involved in other clinical trials of the Exelixis Compound with respect to Exelixis, and the BMS Compound with respect to BMS, and (iiiin the event of a Material Safety Issue) to Third Parties that are collaborating with Exelixis or BMS, respectively in the conduct of such other clinical trials of the existenceExelixis Compound or the BMS Compound(s), terms in each case solely to the extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and a copy of the Agreement (provided such terms and copy of the Agreement shall be redacted as requested by Lxxxx) to actual and potential investors, lenders, licensees, sublicensees and acquirers who are under obligations of confidentiality that are of substantially similar scope and magnitude as the obligations of confidentiality in this Agreement (other than the confidentiality term, which may be as short as [**]); and
(h) disclosure, by either Party, of a copy of the Agreement in response to a request from a taxing authorityregulatory requirements. Notwithstanding the foregoing, in the event the Receiving if a Party is required or otherwise intends to make a disclosure of the Disclosing any other Party’s Confidential Information pursuant to Section 8.3(c9.3(b) (but, for clarity, not under and/or Section 8.3(h) where, notwithstanding anything to the contrary, Lxxxx may freely disclose a copy of the Agreement in response to a valid request from a taxing authority9.3(c), it will, except in the case where it is impractical to do so (i) shall give reasonable advance notice to the Disclosing such other Party of such required disclosure, impending disclosure and (ii) at the Disclosing Party’s request and expense, shall cooperate with the Disclosing Party’s efforts endeavor in good faith to contest such requirement, to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued or the law or regulation required, and/or to obtain other secure confidential treatment of such Confidential InformationInformation and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.
Appears in 1 contract