Master Alliance Provisions Guide (MAPGuide)

DNDi – BioDelivery Sciences International, Visceral Leishmaniasis Research Collaboration Agreement

  • Protecting & sharing information | Confidentiality



2.6 Material Transfer. To the extent any material is transferred by one Party to another under this Agreement the Party receiving such material will use the material solely for the purposes of performing its responsibilities assigned to it under the R&D Plan and applicable Project Plan(s) in compliance with all applicable Laws. Neither Party will use the other Party’s material for any other purposes. Neither Party will sell, transfer, disclose or otherwise provide access to the other Party’s material without the prior written consent of the other Party; provided that each Party may allow access to the other Party’s material to such first Party’s employees, consultants, agents and subcontractors for purposes of performing the R&D Plan in accordance with the applicable Project Plan(s), and provided further that such employees, agents and subcontractors are apprised of the proprietary nature of such material and are bound by written agreement to protect the confidentiality of such material and any results obtained from working with such material and to assign to the subcontracting Party any IPR made in the course of working with such material. Upon completion of all activities under the R&D Plan or the earlier expiration or termination of this Agreement, each Party will return any remaining quantities of the other Party’s material to such other Party, or otherwise dispose of such material as directed by such other Party and certify in writing to the other Party such destruction has taken place.

2.7 Data and Reports

(a) Data. Each Party will keep complete and accurate notes, accounts and records of the data, results, materials, or other information arising out of or resulting from the research performed by such Party under this Agreement (collectively, “Program Data”). The Program Data will be deemed the Confidential Information of both Parties under this Agreement, and both Parties shall have unfettered rights to access and reference to the Program Data in support of their clinical and regulatory activities.


7.1 Treatment of Confidential Information. Any and all information disclosed or submitted in writing or in other tangible form under this Agreement or the R&D Plan to one Party by the other Party during the Term will hereinafter be referred to as the “Confidential Information” of the disclosing Party. In addition, all confidential information disclosed under the Confidentiality Agreement between the Parties, dated March 12, 2008, between DNDi and BDSI (the “Confidentiality Agreement”) shall be deemed Confidential Information under this Agreement, and the Confidentiality Agreement is hereby terminated and shall be of no further force and effect. Each Party will receive and maintain the other Party’s Confidential Information in strict confidence and in accordance with all applicable laws, rules and regulations. Each party also agrees not to use the Confidential Information disclosed to it by the other Party for its own, independent use or in any way, directly or indirectly, harmful or competitive with the other Party. Each Party acknowledges that the confidentiality provisions of this Agreement shall be deemed to be an agreement to keep each Party’s Confidential Information in confidence as contemplated by Regulation FD promulgated by the United States Securities and Exchange Commission. In addition, DNDi acknowledges and agrees that some BDSI Confidential Information maybe considered “material non–public information” for purposes of the United States’ securities laws and that DNDi and its officers, directors, employees and agents will abide by all such laws relating to the handling of and acting upon such Confidential Information. Except as provided under this Section 7.1, neither Party will disclose any Confidential Information of the other Party to any Third Party. Neither Party will use the Confidential Information of the other Party for any purpose other than as required to perform that Party’s obligations, or exercise that Party’s rights hereunder. Each Party may disclose the other Party’s Confidential Information to the receiving Party’s Affiliates, employees, consultants or agents requiring access thereto for the purposes of this Agreement, provided, however, that prior to making any such disclosures, each such Affiliate, employee, consultant or agent will be bound by written agreement to maintain Confidential Information in confidence and not to use such information for any purpose other than in accordance with the terms and conditions of this Agreement. Each Party agrees to take all reasonable steps necessary to ensure that the other Party’s Confidential Information will be maintained in confidence, including (without limitation) such steps as it takes to prevent the disclosure of its own proprietary and confidential information of like character. Each Party agrees that this Agreement will be binding upon its Affiliates, and upon the employees, consultants and agents involved under this Agreement and in conjunction with the R&D Plan of such Party and its Affiliates. Each Party will take all steps necessary to ensure that its Affiliates, employees, consultants and agents will comply with the terms and conditions of this Agreement. The foregoing obligations of confidentiality and non–use will survive, and remain in effect for a period of five (5) years from, the termination or expiration of this Agreement.

7.2 Exclusions from Nondisclosure Obligation. The nondisclosure and nonuse obligations in Section 7.1 will not apply to any specific portion of Confidential Information to the extent that the receiving Party can establish by competent written proof that:

(a) it is or was in the public domain at the time of its disclosure; or

(b) after disclosure, it becomes part of the public domain by publication or otherwise, except by breach of its obligations under section 7.1 by the receiving Party; or

(c) it was in such receiving Party’s possession at the time of its disclosure; or

(d) it is received by such receiving Party on a non–confidential basis from a Third Party who has the lawful right to disclose such information; or

(e) it is independently discovered or developed by the receiving Party or its Affiliate without the aid, application, or use of Confidential Information of the other Party.

7.3 Permitted Disclosures. Each Party may disclose Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following situations:

(a) filing or prosecuting Patents forming part of the Collaboration IP;

(b) regulatory filings with any Governmental Authority or stock exchange;

(c) prosecuting or defending litigation; or

(d) complying with applicable Laws or the valid and enforceable order of a court of competent jurisdiction. In each case, in section 7.3, the Party obligated or making such disclosure will (i) give at least a sixty (60) day advance written notice to the other Party, (ii) make a reasonable effort to obtain confidential treatment of the Confidential Information so disclosed, and (iii) disclose the Confidential information only to the extent reasonably necessary or required.

7.4 Return of Confidential Information. Promptly after the termination or expiration of this Agreement for any reason, each Party will return to the other Party, or destroy as directed by such other Party, all tangible manifestations of such other Party’s Confidential Information, and delete all electronic manifestations of such other Party’s Confidential Information, at that time in the possession of the receiving Party and certify to the other Party that all information has been returned, destroyed or deleted.



11.15 Publicity. DNDi and BDSI shall consult with each other before issuing any press release or public statement with respect to this Agreement or the provisions contemplated herein and neither shall issue any such press release or make any such public statement without the prior consent of the other, which consent shall not be unreasonably withheld; provided, however, (a) that a Party may, without the prior consent of the other Party, issue such press release or make such public statement as may, upon the advice of counsel, be required by law or the rules and regulations of any stock exchange, or (b) if it has made reasonable attempts and has used reasonable efforts to consult with the other Party prior thereto, such consent shall be deemed to have been given if the recipient of the press release or public statement fails to respond to the other Party within two business days after the recipient’s receipt of such press release or public statement. Notwithstanding the foregoing, each Party agrees to use its best efforts to review and comment on the other Party’s suggested press release or public statement within two business days and agrees to continue such review in serial fashion until agreement as been reached on the final form of all press releases or public statements. No such consent of the other Party shall be required to release information which has previously been made public.