Master Alliance Provisions Guide (MAPGuide)

ViiV – MPP, HIV Prevention Medicine (Cabotegravir LA for PrEP), License Agreement

  • Protecting & sharing information | Confidentiality

Definitions

Confidential Information” means all information that would reasonably be regarded as, or is designated as, of a confidential or commercially sensitive nature by the person to which the information relates including any matter relating to, or arising in connection with, this Agreement or the business or affairs of any of the parties, ViiV, and/or any of their Affiliates.

13. Confidentiality
13.1 Each Party shall hold Confidential Information disclosed to it under or in connection with this Agreement in strict confidence and shall not use such Confidential Information for any other purpose than the performance of this Agreement.

13.2 The Party that releases, exchanges, or discloses Confidential Information (the “Disclosing Party”) shall use reasonable efforts to mark such Confidential Information as “Confidential”. In the event that Confidential Information is disclosed and not so marked, the receiving Party agrees to treat such information as confidential to the extent that a reasonable person would consider such information to be confidential given the content and circumstances of the disclosure.

13.3 A receiving Party shall not disclose any Confidential Information received from the Disclosing Party and/or any of its Affiliates under or in connection with this Agreement, or otherwise developed by any Party in the performance of activities in furtherance of this Agreement, except to such of its, and its Affiliates’ officers, employees, agents, representatives, advisors, consultants and Sublicensees to whom disclosure is necessary to exercise the Party’s rights or perform the Party’s obligations under this Agreement, and who are bound by confidentiality and non-use obligations (i) no less onerous than those contained in this Clause 13 and (ii) enforceable by the Disclosing Party.

13.4 The obligations in Clauses 13.1, 13.2 and 13.3 shall not apply to the following as established by reasonable, written proof:

(A) information which at the time of disclosure is in the public domain;

(B) information which, after its disclosure, becomes part of the public domain by publication or otherwise, except by breach of this Agreement;

(C) information that a Party can demonstrate was lawfully possessed by it prior to disclosure under or in connection with this Agreement;

(D) information that a Party receives from a Third Party which is not legally prohibited from disclosing such information;

(E) information a Party is required by law to disclose, provided that the other Party is promptly notified of any such requirement; or

(F) information which is independently developed by the receiving Party or its Affiliates who had no knowledge of the Disclosing Party’s Confidential Information.

13.5 If a receiving Party becomes obligated by law to disclose Confidential Information received under or in connection with this Agreement, or any portion thereof, to any Third Party, governmental authority or court, that Party shall immediately notify the Disclosing Party thereof of each such requirement and identify the Confidential Information to be disclosed so that the Disclosing Party may seek an appropriate protective order or other remedy with respect to narrowing the scope of such requirement and, to the extent necessary, waive the receiving Party’s compliance with the confidentiality obligations of this Agreement.

13.6 The Parties acknowledge that disclosure of any Confidential Information in breach of this Agreement could give rise to irreparable injury to the non-breaching Party or its Affiliates and that such injury will not be adequately compensated by damages. Accordingly, the non-breaching Party and its Affiliates shall be entitled to the remedies of specific performance and injunctive relief or other equitable relief for any threatened or actual breach of this Clause 13. Such relief shall be in addition to all other remedies available to the non-breaching Party at law or in equity.

13.7 All Confidential Information shall remain the property of the Disclosing Party. In the event that a court or other legal or administrative tribunal of competent jurisdiction, directly or through an appointed master, trustee or receiver, assumes partial or complete control over the assets of a Party , based on the insolvency or bankruptcy of such Party (or based on any other analogous or similar status of that Party under foreign laws), the bankrupt or insolvent Party shall promptly notify the court or other tribunal:

(A) that Confidential Information remains the property of the Disclosing Party; and

(B) of the confidentiality obligations under this Agreement.

In addition, the bankrupt or insolvent Party shall, to the extent permitted by law, take all steps necessary or desirable to maintain the confidentiality of such Confidential Information and to ensure that the court, other tribunal or appointee maintains such information in confidence in accordance with the terms of this Agreement.

13.8 For the avoidance of doubt, ViiV shall treat any information relating to a Sublicensee disclosed to it by the MPPF under Clauses 6 as Confidential Information provided that ViiV shall be entitled to disclose information about the quantities of Licensed Products sold or supplied by Sublicensees on an aggregate basis provided such disclosure does not reveal any Confidential Information of any Sublicensee.

13.9 The obligations under this Clause 13 shall remain in full force and effect for the duration of this Agreement plus five (5) years.

14. Publicity and external communications

14.1 Each Party shall seek the other Party’s written approval of any initial press release or public announcement concerning the grant, scope or terms of this Agreement (“Initial Announcement”) prior to such press release, or any other publication regarding this Agreement, being made. Following the Initial Announcement, neither Party shall be required to seek the other Party’s consent to respond to reactive statements to the Initial Announcement, provided such statements are accurate and not misleading.

14.2 The MPPF shall not refer to ViiV and/or its Affiliates, or ViiV’s and/or its Affiliate(s)’ Trade Marks in any external communications without prior approval from ViiV, except where such reference is to the ViiV company name and is limited to a factual statement that ViiV is the licensor of the Patent Rights under this Agreement. For the avoidance of doubt, the MPPF shall in no circumstances refer to any brand name of ViiV and/or its Affiliates in any communication without ViiV’s prior written approval.

14.3 Subject to Clauses 13, 14.1 and 14.2, neither Party shall be required to obtain the other Party’s prior consent for any external communication relating to this Agreement.

14.4 The MPPF shall provide ViiV the opportunity to review and comment on the methodology behind any external communication regarding the MPPF’s analysis of the economic and public health impact of this Agreement at least five (5) Business Days prior to publication of any such communication. For the avoidance of doubt, the MPPF shall not be required to provide ViiV the opportunity to review any subsequent communications made by MPPF regarding its analysis of the economic and public health impact of this Agreement that are based on methodology already reviewed by ViiV, however the MPPF will use reasonable endeavours to provide copies of any such communications to ViiV at least five (5) Business Days prior to publication, where practicable.

14.5 Each Party shall ensure that any of its external communication relating to this Agreement is accurate and not misleading.

14.6 Each Party acknowledges that it is solely responsible and liable for its external communications relating to this Agreement, including compliance with any Applicable Law.

14.7 The MPPF shall promptly submit to ViiV for review any Materials submitted to the MPPF by a Sublicensee under Clause 12.4 of the Sublicence. ViiV shall within fifteen (15) Business Days of receipt of the Materials provide its comments to the MPPF and MPPF shall share such comments with such Sublicensee. The MPPF shall ensure that the Licensee takes into consideration any reasonable comment of ViiV on the Materials.

14.8 The MPPF shall promptly inform ViiV any Sublicensee’s proposal under Clause 12.5 of the Sublicence to engage with any guideline bodies or external experts in relation to the development of Licenced Product, and shall at ViiV’s request, (a) meet with ViiV to discuss such engagement and (b) ensure that the Sublicensee complies with any reasonable request of ViiV regarding the engagement.

Schedule 2 – Form of Sublicense

11. CONFIDENTIALITY

11.1 Each Party shall hold Confidential Information disclosed to it under or in connection with this Agreement in strict confidence, and shall not use such Confidential Information for any other purpose than the performance of this Agreement.

11.2 The Party that releases, exchanges, or discloses Confidential Information (the “Disclosing Party”) shall use reasonable efforts to mark such Confidential Information as “Confidential.” In the event that Confidential Information is disclosed and not so marked, the receiving Party agrees to treat such information as confidential to the extent that a reasonable person would consider such information to be confidential given the content and circumstances of the disclosure.

11.3 Neither Party shall disclose any Confidential Information received from the other Party under or in connection with this Agreement, or otherwise developed by any Party in the performance of activities in furtherance of this Agreement, except to such of its, and its Affiliates’ officers, employees, agents, representatives, advisors and consultants (and in the case of the Licensor to ViiV and/or any of its Affiliates) to whom disclosure is necessary to exercise the Party’s rights or perform the Party’s obligations under this Agreement (and in the case of the Licensor, under the terms of the Head Licence), and who are bound by confidentiality and non-use obligations (i) no less onerous than those contained in this Clause 11 and (ii) enforceable by the Disclosing Party.

11.4 The obligations in Clauses 11.1, 11.2 and 11.3 shall not apply to the following as established by reasonable, written proof:

11.4.1 information which at the time of disclosure is in the public domain;

11.4.2 information which, after its disclosure, becomes part of the public domain by publication or otherwise, except by breach of this Agreement;

11.4.3 information that a Party can demonstrate was lawfully possessed by it prior to disclosure under or in connection with this Agreement;

11.4.4 information that a Party receives from a Third Party which is not legally prohibited from disclosing such information;

11.4.5 information a Party is required by law to disclose, provided that the other Party is promptly notified of any such requirement; or

11.4.6 information which is independently developed by the receiving Party or its Affiliates who had no knowledge of the Disclosing Party’s Confidential Information.

11.5 If a receiving Party becomes obligated by law to disclose Confidential Information received under or in connection with this Agreement, or any portion thereof, to any Third Party, governmental authority or court, that Party shall immediately notify the Disclosing Party of each such requirement and identify the Confidential Information to be disclosed so that such Disclosing Party (or ViiV or its Affiliates where the Confidential Information relates to or belongs to ViiV or its Affiliates) may seek an appropriate protective order or other remedy with respect to narrowing the scope of such requirement and, to the extent necessary, waive the receiving Party’s compliance with the confidentiality obligations of this Agreement.

11.6 The Parties acknowledge that disclosure of any Confidential Information in breach of this Agreement could give rise to irreparable injury to the non-breaching Party and that such injury will not be adequately compensated by damages. Accordingly, the non-breaching Party, and ViiV and its Affiliates where the non-breaching Party is the Licensor, shall be entitled to the remedies of specific performance and injunctive relief or other equitable relief for any threatened or actual breach of this Clause 11. Such relief shall be in addition to all other remedies available to the non-breaching Party at law or in equity.

11.7 All Confidential Information shall remain the property of the Disclosing Party. In the event that a court or other legal or administrative tribunal of competent jurisdiction, directly or through an appointed master, trustee or receiver, assumes partial or complete control over the assets of a Party to this Agreement, based on the insolvency or bankruptcy of such Party (or based on any other analogous or similar status of that Party under foreign laws), the bankrupt or insolvent Party shall promptly notify the court or other tribunal (a) that Confidential Information remains the property of the Disclosing Party and (b) of the confidentiality obligations under this Agreement. In addition, the bankrupt or insolvent Party shall, to the extent permitted by law, take all steps necessary or desirable to maintain the confidentiality of such Confidential Information and to ensure that the court, other tribunal or appointee maintains such information in confidence in accordance with the terms of this Agreement.

11.8 Nothing in this Agreement shall be construed as preventing or in any way inhibiting the Licensee from complying with statutory and regulatory requirements relating to, or arising out of, its rights under this Agreement.

11.9 The obligations under this Clause 11 shall remain in full force and effect for the duration of this Agreement plus five (5) years.

12. PUBLICITY AND EXTERNAL COMMUNICATIONS

12.1 Each Party shall ensure that any external communication in relation to this Agreement is accurate and not misleading.

12.2 Each Party acknowledges that it is solely responsible and liable for its communications relating to this Agreement, including compliance with any Applicable Law.

12.3 Each Party shall seek the other Party’s written approval of any initial press release or public announcement concerning the entry into this Agreement (“Initial Sublicence Announcement”) prior to such press release, or any other publication regarding this Agreement, being made. Following the Initial Sublicence Announcement, neither Party shall be required to seek the other Party’s consent to respond to reactive statements to the Initial Announcement, provided such statements are accurate and not misleading.

12.4 The Licensee shall provide the Licensor the opportunity to review and comment on any written or oral publication, manuscript, abstract or the like which (i) includes data or other information generated under or in connection with this Agreement or (ii) otherwise relates to Licensed Product (“Materials”), at least twenty (20) Business Days prior to publication of any such Materials. The Licensee shall take into account any reasonable comments of the Licensor (and/or of ViiV, as communicated to the Licensor) on such Materials.

12.5 Prior to the Licensee engaging with any guideline bodies or external experts in relation to the development of Licensed Product, the Licensee shall (a) inform the Licensor in writing of its intention to do so, (b) meet with the Licensor to discuss such engagement and (c) comply with any reasonable request of the Licensor (or of ViiV, as communicated to the Licensor) regarding the engagement.

12.6 Subject to Clauses 12.1-12.5, neither Party shall be required to obtain the prior consent of the other Party for any external communication relating to this Agreement.