Master Alliance Provisions Guide (MAPGuide)

BMGF – Arsanis, S. Aureus Antibody Strategic Relationship Letter Agreement

  • Protecting & sharing information | Information sharing
  • Protecting & sharing information | Publication of Results

3. Global Access Commitments

(j) Publication; Access to Data and Information. The Company (in addition to the publication requirements of any applicable grants from the Foundation):

(i) will publish the results and information developed in connection with each Program within a reasonable period of time after such information or results are obtained, subject to reasonable delays or limitations on content of such publications that are necessary to protect intellectual property and trade secrets or other proprietary knowhow covering the Platform Technology itself and subject to third party confidentiality obligations;

(ii) will promptly provide to the Foundation from time to time, upon the Foundation’s reasonable request and subject to customary confidentiality restrictions, access to data and information regarding the Company’s S. aureus antibody development programs (including raw data and regarding antibodies being developed for use in developed countries and for any indication, subject to the Foundation agreeing to appropriate confidentiality obligations) and each Program, and the reasonably contemplated use of the Platform Technology for such programs; and

(iii) will promptly provide to the Foundation from time to time, upon the Foundation’s request, rights to share such non-public data and information regarding each Program, and the reasonably contemplated use of the Platform Technology for such Programs, subject to the reasonable need to protect confidential information (including, in the event that the Foundation proposes to share any such data or information with any Direct Competitor, such disclosure to a Direct Competitor shall be permitted only to the extent that the Foundation or a Foundation-supported Entity is collaborating with such competitor, and limited to the disclosure of data or information directly relating to the development, production or commercialization of a Product, as applicable to such collaboration) and to avoid untimely public disclosures that may bar access to patent protection or public disclosures that may undermine trade secret protection or may impact the market competitiveness of a Company product.

All publications must be made in accordance with “open access” terms and conditions consistent with the Foundation’s Open Access Policy available at: http://www.gatesfoundation.org/How- We-Work/General-Information/Open-Access-Policy, which may be modified from time to time.

If any publication or presentation contains Adimab Confidential Information, the Company may submit such publication or presentation for prior review and approval by Adimab for patentability and protection of Adimab Confidential Information as provided in Section 6.8 (and subject to Section 6.2) of the Adimab Agreement. The Company may not proceed with such publications or presentations containing Adimab Confidential Information unless approved of in advance in writing by Adimab in accordance with Section 6.8 of the Adimab Agreement. The Company will use reasonable efforts to obtain such approval. The Company will provide to Adimab the opportunity to review, in accordance with Section 6.8 of the Adimab Agreement, any proposed abstracts, manuscripts or summaries of public presentations that contain Adimab Confidential Information.

6. Required Reporting; Audit Rights

(a) In addition to reports required to be delivered to the Foundation under the Investment Documents, the Company will furnish, or cause to be furnished, to the Foundation the following reports and certifications:

(i) within [**] days after the end of each of the Company’s fiscal years during which the Foundation owns any securities in the Company, a certificate from the Company signed by an officer of the Company and substantially in the form attached to this Letter Agreement as Appendix 3, certifying that the requirements of the Foundation Investment set forth in this Letter Agreement were met during the immediately preceding fiscal year, describing the use of the proceeds of the Foundation Investment and evaluating the Company’s progress toward achieving the Global Access Commitments;

(ii) within [**] days after the end of the Company’s fiscal year during which the Foundation ceases to own any securities in the Company, a certificate from the Company signed by an officer of the Company and substantially in the form attached to this Letter Agreement as Appendix 4, certifying that the requirements of the Foundation Investment set forth in this Letter Agreement were met during the term of the Foundation Investment, describing the use of the proceeds of the Foundation Investment and evaluating the Company’s progress toward achieving the Global Access Commitments;

(iii) any other information respecting the operations, activities and financial condition of the Company as the Foundation may from time to time reasonably request to discharge any expenditure responsibility, within the meaning of Sections 4945(d)(4) and 4945(h) of the Code, of the Foundation with respect to the Foundation Investment, and to otherwise monitor the charitable benefits intended to be served by the Foundation Investment. The Foundation will reimburse the Company for any reasonable third-party expenses incurred by the Company in order to prepare any information the Company is required to prepare solely as a result of this Section 6(a)(iii); and

(iv) full and complete financial reports of the type ordinarily required by commercial investors under similar circumstances to the extent required pursuant to Treasury Regulation 53.4945-5(b)(4).

(b) At the Foundation’s reasonable request, the Company will provide the Foundation with a summary of scientific data and progress to date on all Programs and any Platform Technology related to the foregoing, and the considerations made by the Company with respect to accessibility, affordability and cost-effectiveness of the applicable Products for people and payors in Developing Countries, in addition to the information that may be required under any grant agreements or other funding agreements.

(c) Without limiting the foregoing, at the Foundation’s request, the Company will permit the Foundation or its representatives to inspect (at a reasonable time and location) the scientific records of the Company relating to each Program with due regard to the reasonable need to protect trade secrets covering the Platform Technology.

(d) The Company will maintain books and records adequate to provide information ordinarily required by commercial investors under similar circumstances, including accounting records and copies of any reports submitted to the Foundation related to each Program. The Company will retain such books, records, and reports for [**] years after the Foundation ceases to hold Company securities and will make such books, records, and reports available to the Foundation at reasonable times to enable the Foundation to monitor and evaluate how the Foundation’s funds have been used.

(e) The Company will permit employees or agents of the Foundation at any reasonable time and upon reasonable prior notice, during normal business hours, to examine or audit the Company’s books and accounts of record and to make copies and memoranda of the same, in each case at the Foundation’s expense to audit the Company’s compliance with the use of the Foundation Investment and the Global Access Commitments. If the Company maintains any records (including computer generated records and computer software programs for the generation of such records) in the possession of a third party, the Company, upon request of the Foundation, will notify such party to permit the Foundation free access to such records at all reasonable times and to provide the Foundation with copies of any records it may reasonably request in connection with such audit, request or inquiry, all at the Foundation’s expense.