“Confidential Information” means any and all proprietary Know-How, information and data, including scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data, whether communicated in writing or orally or by any other method, which is provided by or on behalf of one Party to the other Party and/or its Affiliate in connection with this Agreement.
4. Confidentiality and Publication
4.1 Non-Disclosure and Non-Use Obligation. All Confidential Information disclosed by one Party to the other Party or its Affiliate hereunder shall be maintained in confidence by the receiving Party and shall not be disclosed to any Third Party or used for any purpose except as set forth herein, without the prior written consent of the disclosing Party, except to the extent that such Confidential Information:
(a) is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s business records;
(b) is in the public domain by use and/or publication before its receipt from the disclosing Party, or thereafter enters the public domain through no fault of the receiving Party;
(c) is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or
(d) is independently developed by the receiving Party without access to or reference to Confidential Information received from the disclosing Party, as documented by the receiving Party’s business records contemporaneous with such development.
Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the receiving Party.
4.2 Permitted Disclosures
Notwithstanding Section 4.1, a receiving Party shall be permitted to disclose Confidential Information of the disclosing Party, if such Confidential Information:
(a) is disclosed to governmental or other regulatory agencies in order to obtain patents or to gain or maintain approval to conduct clinical trials or to market Product under this Agreement, in each case, in accordance with this Agreement, but such disclosure may be only to the extent reasonably necessary to obtain patents or authorizations, and provided that reasonable steps are taken to ensure confidential treatment of such Confidential Information (if available);
(b) is disclosed by the receiving Party (or its Affiliates) to Related Parties, agent(s), consultant(s), and/or other Third Parties for any and all purposes the receiving Party or its Affiliates deem necessary or advisable in the course of conducting activities in accordance with this Agreement (including the exercise of licenses granted to the receiving Party hereunder, and/or, in the case of Merck (or its Affiliates), engaging in transactions with potential Third Party collaborators, service providers and/or other transferees of rights and/or obligations hereunder) on the condition that such Third Parties agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement; provided, that, with respect to Confidential Information received by NewLink from Public Health Canada, the foregoing shall at all times be subject to terms of confidentiality and non-use provisions of the NewLink Canada License;
(c) is deemed necessary by counsel to the receiving Party to be disclosed 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 agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement;
(d) is deemed necessary by the receiving Party to be disclosed in connection with a potential or actual financing, merger or acquisition of the receiving Party (or its Affiliate), in which case such Party shall have the further right to disclose Confidential Information to Third Parties involved in such financing, merger or acquisition, provided that such Third Parties agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement; or
(e) is required by the terms of the NewLink Canada License to be disclosed to Public Health Canada to satisfy NewLink’s or Merck’s, as applicable, obligations to report any required information, on the condition that, Public Health Canada be bound by terms of confidentiality and non-use provisions with respect to such information, as specified in the NewLink Canada License.
In addition, if a Party is required by judicial or administrative process or Applicable Law to disclose Confidential Information of the other Party that is subject to the non-disclosure provisions of Section 4.1, such Party shall promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process or as required by Applicable Law shall remain otherwise subject to the confidentiality and non-use provisions of Section 4.1, and the Party disclosing Confidential Information pursuant to law or court order or as required by Applicable Law shall take all steps reasonably necessary, including without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.
4.3 Know-How; Joint Know-How. [Redacted.]
4.4 Ownership of Confidential Information. For the purposes of this Article 4, where pursuant to the terms of this Agreement one Party owns Confidential Information that has been generated by the other Party, then such Confidential Information shall be treated as if it had been generated by such owning Party and disclosed by such owning Party to such other Party.
4.5 Terms of Agreement. Neither Party nor its Affiliates shall disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Party, except as follows: A Party and its Affiliates may disclose the terms or conditions of this Agreement (but not any other Confidential Information, which may be disclosed only as described elsewhere in this Article 4), (a) on a need-to-know basis to its legal and financial advisors to the extent such disclosure is reasonably necessary; provided that such advisors are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or are bound by written agreements providing for confidentiality and non-use obligations, in each case, that are no less stringent than those confidentiality and non-use provisions contained in this Agreement; (b) to a Third Party in connection with a potential or actual (i) merger, consolidation or similar transaction by such Party or its Affiliates, (ii) sale of all or substantially all of the assets of such Party or its Affiliates (or, with respect to Merck, sale of all or substantially all of the assets of Merck to which this Agreement relates) or (iii) financing; provided that, in each case, the disclosing Party shall ensure that such Third Party is bound by confidentiality and non-use obligations with respect to Confidential Information of the other Party no less restrictive than those contained in this Agreement and such disclosing Party shall be fully liable to the other Party for breach of the confidentiality and non-use obligations under this Agreement by such Third Parties; (c) to the United States Securities and Exchange Commission or any other securities exchange or governmental authority, including as required to make an initial or subsequent public offering; or (d) as otherwise required by Applicable Law; provided that in the case of (c) and (d) the disclosing Party shall (x) submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable (and in no event less than [*] prior to the anticipated date of disclosure, unless such shorter period is reasonably necessary to comply with Applicable Law) so as to provide a reasonable opportunity to comment on any such required disclosure, (y) if requested by such other Party, seek, or cooperate with such Party’s efforts to obtain, confidential treatment or a protective order with respect to any such disclosure to the extent available at such other Party’s expense, and (z) use good faith efforts to incorporate the comments of such other Party in any such disclosure or request for confidential treatment or protective order, and if disclosure of the terms of this Agreement is required by Applicable Law or the rules of any securities exchange or market on which a Party’s securities are listed or traded, the Parties shall agree on a redacted version of this Agreement to be so disclosed; provided, however, that in the event the Parties cannot agree on such a redacted version of the Agreement, the disclosing Party shall have the right to disclose such terms of this Agreement as such Party’s counsel determines is necessary to comply with Applicable Law or the rules of any securities exchange or market on which such Party’s securities are listed or traded.