Common use of Xxxxx-Xxxxxx Certifications Clause in Contracts

Xxxxx-Xxxxxx Certifications. If either Party (i) reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or abridged NDA that refers to or relies on regulatory documentation for a Product that was submitted by Rhythm to any Regulatory Authority, (ii) receives any notice of certification regarding any Patent Rights included in Camurus Patent Rights (i.e., Patent Rights Controlled by Camurus) or Rhythm Patent Rights (i.e., Patent Rights Controlled by Rhythm) pursuant to the Xxxxx-Xxxxxx Act claiming that any such Patent Rights are invalid or unenforceable or claiming that the any such Patent Rights will not be infringed by the manufacture, use, marketing or sale of a product for which an ANDA is filed, or (iii) receives any equivalent or similar certification or notice in any other jurisdiction, it shall notify the other Party in writing, identifying the alleged applicant or potential applicant and furnishing the information upon which such determination is based, and provide the other Party a copy of any such notice of certification within five (5) days of receipt and the Parties’ rights and obligations with respect to any legal action as a result of such certification shall be as set forth above in Sections 7.9 or 7.10. 8.1 Except to the extent expressly authorized by this Agreement including in Sections 8.3 and 8.4 or otherwise agreed in writing, each Recipient and its Affiliates and its Sublicensees and licensees in possession of Confidential Information of the Disclosing Party shall maintain such Confidential Information as confidential and use it only for the purposes of this Agreement in accordance with this Section 8. This obligation shall continue during the term of this Agreement and for a period equal to ten (10) years after the date of expiration or termination of this Agreement; provided, however, that this obligation shall continue to apply after such ten (10) year period to any Know-How, development data, other data, regulatory filings and other information disclosed, provided, licensed, transferred or otherwise made available by either Party to the other Party under this Agreement, until such time as such Know-How, development data, other data, regulatory filings and other information becomes exempt pursuant to subparagraphs (i) through (v) below. Each Party shall guard such Confidential Information using the same degree of care as it normally uses to guard its own confidential, proprietary information of like importance, but in any event no less than reasonable care. Notwithstanding the foregoing, the Recipient of the categories of Confidential Information identified in Sections 1.16 (i)-(iv) inclusive shall be relieved of the confidentiality and limited use obligations of this Agreement to the extent that the Recipient establishes by written evidence that: (i) the Confidential Information was previously known to the Recipient from sources other than the Disclosing Party at the time of disclosure and other than under an obligation of confidentiality and non-use; (ii) the Confidential Information was generally available to the public or otherwise part of the public domain at the time of its disclosure; or (iii) the Confidential Information became generally available to the public or otherwise part of the public domain after its disclosure to the Recipient Party other than through any act or omission of the Recipient Party in breach of this Agreement; or (iv) the Confidential Information is acquired in good faith in the future by the Recipient Party from a Third Party who has a lawful right to disclose such information and who is not under an obligation of confidence to the Disclosing Party with respect to such information; or (v) the Confidential Information is subsequently developed by or on behalf of the Recipient Party without use of the Disclosing Party’s Confidential Information. 8.2 For clarity, specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Recipient Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Recipient Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Recipient Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Recipient Party unless the combination is in the public domain or in the possession of the Recipient Party. 8.3 Notwithstanding the above obligations of confidentiality and non-use a Recipient may disclose Confidential Information: (i) to a Regulatory Authority as reasonably necessary to obtain and maintain Regulatory Approval in a particular jurisdiction to the extent consistent with the licenses granted under terms of this Agreement, provided that reasonable effort will be taken to ensure confidential treatment of such information. (ii) disclose Confidential Information: (a) to the extent such disclosure is reasonably necessary to comply with the order of a court; or (b) to the extent such disclosure is required to comply with a legal requirement, including to the extent such disclosure is required in publicly filed financial statements or other public statements or filings under rules governing a stock exchange or pursuant to applicable securities laws or regulations (e.g., the rules of the United States Securities and Exchange Commission, NASDAQ, NYSE, or any other stock exchange on which securities issued by either Party may be listed); provided, to the extent possible bearing in mind such legal requirements and subject to the next subsequent sentence of this Section 8.3.(ii), such Party shall provide the other Party with a copy of the proposed text of such statements or disclosure five (5) business days in advance of the date on which the disclosure is to be made to enable the other Party to review and provide comments, unless a shorter review time is agreed. If compliance with a legal requirement requires filing of this Agreement, the filing Party shall to the extent possible seek confidential treatment of portions of this Agreement from the relevant competent authority to the extent that such confidential treatment is available pursuant to applicable law and shall provide the other Party with a copy of the proposed filings at least five (5) business days prior to filing for the other Party to review any such proposed filing and provide comments. Each Party agrees that it will obtain its own legal advice with regard to its compliance with legal requirements and will not rely on any statements made by the other Party relating to such legal requirements; and (iii) by filing or prosecuting Patent Rights, the filing or prosecution of which is contemplated by this Agreement, without violating Section 8.1; it being understood that publication of such filings occurs in some jurisdictions within eighteen (18) months of filing, and that such publication shall not violate the above secrecy provision. (iv) to such Recipient’s employees, Affiliates, contractors (including clinical researchers and CMO’s), licensees, sublicensees, agents, consultants and potential business partners, as such Recipient reasonably determines is necessary to receive the benefit of the licenses and rights granted or available to it under this Agreement or to fulfill its obligations pursuant to this Agreement; provided, however, any such persons must be obligated to substantially the same extent as set forth in Section 8.1 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement and breach by such persons of their confidentiality obligations shall be deemed a breach by the Recipient of its confidentiality obligations hereunder. For the avoidance of doubt, it is understood and agreed that Camurus may not disclose any Confidential Information relating to the Product to any licensee of the FC Technology without the prior written consent of Rhythm except when exercising its rights under Sections 2.4 and 3.7. (a) to its actual or potential investment bankers; (b) to existing and potential investors in connection with an offering or placement of securities for purposes of obtaining financing for its business and to actual and prospective lenders for the purpose of obtaining financing for its business and to potential licensees or sublicensees of the FC Technology or any other rights licensed to the Recipient pursuant to this Agreement; and (c) to a bona fide potential acquirer or merger partner for the purposes of evaluating entering into a merger or acquisition, provided, however, any such persons must be obligated to substantially the same extent as set forth in Section 8.1 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement; and (vi) disclose Confidential Information to its legal advisers for the purpose of seeking advice. 8.4 Nothing in this Section 8 restricts either Party from using or disclosing any of its own Confidential Information for any purpose whatsoever; provided that, to the extent Know-How is exclusively licensed by one Party to the other, the licensor may not continue to use and disclose such Know-How in a manner not consistent with the exclusivity of the license granted. 8.5 Other than the press release pertaining to this transaction that the Parties have agreed upon and attached as Exhibit 8.5 to this Agreement and save as permitted in Section 8.3: (i) neither Party, as a Recipient, shall make any public announcement or statement to the public containing Confidential Information of the Disclosing Party without the prior written consent of the Disclosing Party. No such public announcements or statements shall be made without the prior review and consent of the appropriate individual designated for the purpose by the other Party; and (ii) save as may otherwise be provided herein neither Party shall mention or otherwise use the name or Trademark of the other Party or its Affiliates in any publication, press release, promotional material or other form of publicity without the prior written consent of the appropriate individual designated for the purpose by the other Party. 8.6 With respect to public disclosure required to be made pursuant to regulatory requirements or stock exchange rules applicable to a Party, each such Party will use reasonable efforts to submit to the other Party a draft of any public announcement (“Proposed Disclosure”) directly related to the Product at least three (3) business days prior to the date on which such Party plans to make such announcement, and in any event will submit such draft to the other Party at least twenty-four (24) hours prior to the release of such Proposed Disclosure. If a Party is unable to comply with the foregoing twenty-four (24)-hour notice requirement because of a legal obligation or stock or securities exchange requirement to make more rapid disclosure, such Party will not be in breach of this Agreement but will in that case give telephone and email notice to a senior executive of the other Party and provide a draft of the Proposed Disclosure with as much notice as possible prior to the release of such announcement. A Party that receives a draft of any Proposed Disclosure that the other Party is planning to make may not make any disclosure or public announcement of the substance or content of such Proposed Disclosure until such time as such other Party has released such Proposed Disclosure to the public. Any draft of any Proposed Disclosure provided by one Party to the other pursuant to this Section 8.6 shall be deemed and treated as Confidential Information of the Party that is proposing to make such Proposed Disclosure. 8.7 Notwithstanding the foregoing Camurus shall be entitled to include the name of Rhythm within a list of collaborators.

Xxxxx-Xxxxxx Certifications. If either Party (i) reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or abridged NDA that refers to or relies on regulatory documentation for a Product that was submitted by Rhythm Ra Pharma to any Regulatory Authority, (ii) receives any notice of certification regarding any Patent Rights included in Camurus Patent Rights (i.e., or Ra Pharma Patent Rights Controlled by Camurus) or Rhythm Patent Rights (i.e., Patent Rights Controlled by Rhythm) pursuant to the Xxxxx-Xxxxxx Act claiming that any such Patent Rights are invalid or unenforceable or claiming that the any such Patent Rights will not be infringed by the manufacture, use, marketing or sale of a product for which an ANDA is filed, or (iii) receives any equivalent or similar certification or notice in any other jurisdiction, it shall notify the other Party in writing, identifying the alleged applicant or potential applicant and furnishing the information upon which such determination is based, and Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. provide the other Party a copy of any such notice of certification within five [***] (5[***]) days of receipt and the Parties’ rights and obligations with respect to any legal action as a result of such certification shall be as set forth above in Sections 7.9 or 7.10. 8.1 Except to the extent expressly authorized by this Agreement including in Sections 8.3 and 8.4 or otherwise agreed in writing, each Recipient and its Affiliates and its Sublicensees and licensees in possession of Confidential Information of the Disclosing Party shall maintain such Confidential Information as confidential and use it only for the purposes of this Agreement in accordance with this Section 8. This obligation shall continue during the term of this Agreement and for a period equal to ten the longer of: (10a) [***] ([***]) years after the date of expiration or termination of this Agreement; provided, however, that this obligation shall continue to or (b) for so long as the exceptions set out below in the next subsequent paragraph do not apply after such ten (10) year period to any Know-How, development data, other data, regulatory filings and other information disclosed, provided, licensed, transferred or otherwise made available by either Party to the other Party under this Agreement, until such time as such Know-How, development data, other data, regulatory filings and other information becomes exempt pursuant to subparagraphs (i) through (v) belowrelevant Confidential Information. Each Party shall guard such Confidential Information using the same degree of care as it normally uses to guard its own confidential, proprietary information of like importance, but in any event no less than reasonable care. Notwithstanding the foregoing, the Recipient of the categories of Confidential Information identified in Sections 1.16 (i)-(iv) Section 1.12 inclusive shall be relieved of the confidentiality and limited use obligations of this Agreement to the extent that the Recipient establishes by written evidence that: (i) the Confidential Information was previously known to the Recipient from sources other than the Disclosing Party at the time of disclosure and other than under an obligation of confidentiality and non-use; (ii) the Confidential Information was generally available to the public or otherwise part of the public domain at the time of its disclosure; or (iii) the Confidential Information became generally available to the public or otherwise part of the public domain after its disclosure to the Recipient Party other than through any act or omission of the Recipient Party in breach of this Agreement; or (iv) the Confidential Information is acquired in good faith in the future by the Recipient Party from a Third Party who has a lawful right to disclose such information and who is not under an obligation of confidence to the Disclosing Party with respect to such information; or (v) the Confidential Information is subsequently developed by or on behalf of the Recipient Party without use of the Disclosing Party’s Confidential Information. 8.2 For clarity, specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Recipient Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Recipient PartyRecipient. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Recipient Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Recipient Party unless the combination is in the public domain or in the possession of the Recipient PartyRecipient. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. 8.3 Notwithstanding the above obligations of confidentiality and non-use a Recipient may disclose Confidential Informationmay: (i) disclose Confidential Information to a Regulatory Authority as reasonably necessary to obtain and maintain Regulatory Approval in a particular jurisdiction to the extent consistent with the licenses granted under terms of this Agreement, provided that reasonable effort will be taken to ensure confidential treatment of such information.; and (ii) disclose Confidential Information: (a) to the extent such disclosure is reasonably necessary to comply with the order of a court; or (b) to the extent such disclosure is required to comply with a legal requirement, including to the extent such disclosure is required in publicly filed financial statements or other public statements or filings under rules governing a stock exchange or pursuant to applicable securities laws or regulations (e.g., the rules of the United States Securities and Exchange Commission, NASDAQ, NYSE, or any other stock exchange on which securities issued by either Party may be listed); provided, to the extent possible bearing in mind such legal requirements and subject to the next subsequent sentence of this Section 8.3.(ii8.3(ii), such Party shall provide the other Party with a copy of the proposed text of such statements or disclosure five [***] (5[***]) business days in advance of the date on which the disclosure is to be made to enable the other Party to review and provide comments, unless a shorter review time is agreed. If compliance with a legal requirement requires filing of this Agreement, the filing Party shall to the extent possible seek confidential treatment of portions of this Agreement from the relevant competent authority to the extent that such confidential treatment is available pursuant to applicable law and shall provide the other Party with a copy of the proposed filings at least five [***] (5[***]) business days prior to filing for the other Party to review any such proposed filing and provide commentsfiling. Each Party agrees that it will obtain its own legal advice with regard to its compliance with legal requirements and will not rely on any statements made by the other Party relating to such legal requirements; and (iii) disclose Confidential Information by filing or prosecuting Patent Rights, the filing or prosecution of which is contemplated by this Agreement, without violating Section 8.1the above secrecy provision; it being understood that publication of such filings occurs in some jurisdictions within eighteen (18) months of filing, and that such publication shall not violate the above secrecy provision.; and (iv) disclose Confidential Information to such Recipient’s employees, Affiliates, contractors (including clinical researchers and CMO’s), licensees, sublicensees, agents, consultants and potential business partners, as such Recipient reasonably determines is necessary to receive the benefit of the licenses and rights granted or available to it under this Agreement or to fulfill fulfil its obligations pursuant to this Agreement; provided, however, any such persons must be obligated to substantially the same extent as set forth in Section 8.1 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement and breach by such persons of their confidentiality obligations shall be deemed a breach by the Recipient of its confidentiality obligations hereunder. For the avoidance of doubt, it is understood and agreed that Camurus may not ; and (v) disclose any Confidential Information relating to the Product to any licensee of the FC Technology without the prior written consent of Rhythm except when exercising its rights under Sections 2.4 and 3.7. Information: (a) to its actual or potential investment bankers; (b) to existing and potential investors in connection with an offering or placement of securities for purposes of obtaining financing for its business and to actual and prospective lenders for the purpose of obtaining financing for its business and to Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. potential licensees or sublicensees of to the FC Technology or any other rights licensed to the Recipient pursuant to this AgreementTechnology; and (c) to a bona fide potential acquirer or merger partner for the purposes of evaluating entering into a merger or acquisition, provided, however, any such persons must be obligated to substantially the same extent as set forth in Section 8.1 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement; and (vi) disclose Confidential Information to its legal advisers for the purpose of seeking advice. 8.4 Nothing in this Section 8 restricts either Party from using or disclosing any of its own Confidential Information for any purpose whatsoever; provided that, to the extent Know-How is exclusively licensed by one Party to the other, the licensor may not continue to use and disclose such Know-How in a manner not consistent with the exclusivity of the license granted. 8.5 Other than the press release pertaining to this transaction that the Parties have agreed upon and attached as Exhibit 8.5 to this Agreement and save as permitted in Section 8.38.2: (i) neither Party, as a Recipient, Party shall make any public announcement or statement to the public containing Confidential Information of the Disclosing Party without the prior written consent of the Disclosing Partyother. No such public announcements or statements shall be made without the prior review and consent of the appropriate individual designated for the purpose by the other Party; and (ii) save as may otherwise be provided herein neither Party shall mention or otherwise use the name or Trademark of the other Party or its Affiliates in any publication, press release, promotional material or other form of publicity without the prior written consent of the appropriate individual designated for the purpose by the other Party. 8.6 With respect to public disclosure required to be made pursuant to regulatory requirements or stock exchange rules applicable to a Party, each such Party will use reasonable efforts to submit to the other Party a draft of any public announcement (“Proposed Disclosure”) directly related to the Product for review and comment at least three [***] (3[***]) business days prior to the date on which such Party plans to make such announcement, and in any event will submit such draft to the other Party at least twenty-four (24) hours [***] prior to the release of such Proposed Disclosure, and will review and consider in good faith any comments provided in response by the other Party. If a Party is unable to comply with the foregoing twenty-four (24)-hour [***] notice requirement because of a legal obligation or stock or securities exchange requirement to make more rapid disclosure, such Party will not be in breach of this Agreement but will in that case give telephone and email notice to a senior executive of the other Party and provide a draft of the Proposed Disclosure with as much notice as possible prior to the release of such announcement. A Party that receives a draft of any Proposed Disclosure that the other Party is planning to make may not make any disclosure or public announcement of the substance or content of such Proposed Disclosure until such time as such other Party has released such Proposed Disclosure to the public. Any draft of any Proposed Disclosure provided by one Party to the other pursuant to this Section 8.6 shall be deemed and treated as Confidential Information of the Party that is proposing to make such Proposed Disclosure. 8.7 Notwithstanding the foregoing foregoing, Camurus shall be entitled to include the name of Rhythm Ra Pharma within a list of collaborators. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.