Provision Language
3. Global Access Commitments
As a condition to the Foundation making the Foundation Investment and to ensure satisfaction of the Charitable Purpose and Global Access, the Company agrees to the following (collectively “Global Access Commitments”): […]
(k) Publication; Access to Data and Information. The Company will (in addition to the publication requirements of any grant agreement with the Foundation):
[…]
(ii) promptly provide to the Foundation from time to time, upon the Foundation’s request and in a format that is acceptable to the Foundation, access to data and information regarding the Projects (including information necessary and sufficient to support the utilization of the Company’s Platform Technology by partners who are collaborating on the Projects as set forth in the applicable statement of work (taking into account the need to protect the intellectual property of such Platform Technology)), the reasonably contemplated use of the Platform Technology and Funded Developments for such Projects (taking into account the need to protect the intellectual property of such Platform Technology), and the considerations made by the Company with respect to accessibility, affordability and cost effectiveness.
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 90 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 G, 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 90 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 H, 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) promptly after receipt or submission by the Company, copies of all filings, submissions, reports, communications, inspection reports, Form 483, Warning Letters, Medical Device Reports (MDRs), notices of recall or withdrawal, and all other written communications, received from or provided to any regulatory authority, including but not limited to FDA and health authorities in Germany, relating to safety concerns in relation to any Product;
(iv) 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)(iv); and
(v) 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 Projects 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 written request, the Company will permit the Foundation or its Representatives to inspect(at a reasonable time during regular office hours and in a way that does not unnecessarily interfere with the Company’s activities) the scientific records of the Company relating to each Project with due regard to the reasonable need to protect trade secrets covering the Platform Technology and provided that the relevant persons performing the inspection are subject to reasonable confidentiality undertakings. Any such inspection must be notified at least ten (10) Business Days in advance. In such notice, the Foundation shall specify in reasonable detail the scientific records it would like to inspect. The Foundation or its Representative will not be allowed to take any copies of any records disclosed within the framework of the inspection without theCompany’s consent, which consent will not be unreasonably withheld.
(d) The Company shall maintain books and records adequate to provide such information as is necessary to comply with Treasury Regulations section 53.4945-5(b)(4), as amended from time to time, including accounting records and copies of any reports submitted to the Foundation related to each Project, and shall provide the Foundation upon request access to such books and records to the extent required in Treasury Regulation 53.4945-5(b)(4). The Company will retain such books, records, and reports for [***] years after the Foundation ceases to hold any Company securities and will make such books, records, and reports available to the Foundation upon request at reasonable times to enable the Foundation to monitor and evaluate how the Foundation’s funds have been used.
(e) The Company will permit an international accounting firm reasonably acceptable to the Company 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 of the same to the extent reasonably required for such audit, 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 accounting firm access to such records at all reasonable times and to provide the accounting firm with copies of any records it may reasonably request in connection with such audit, request or inquiry, all at the Foundation’s expense. The Foundation may exercise its audit right under this Section 6(e) no more than once in any calendar year and no more than once for the same books and records; provided that in the event the Company has previously been found to have been in breach the Foundation shall have the right to request an audit once per calendar quarter. In addition, any access shall be subject to reasonable confidentiality undertakings to be assumed by the accounting firm towards the Company.