Md. Code Regs. 24.05.03.08

Current through Register Vol. 51, No. 24, December 2, 2024

Section 24.05.03.08 - Audits and Inquiries

A. Audits.

(1) The Department may require at any reasonable time before or after the issuance of a certificate that any information provided to the Department by an applicant be audited at the applicant's expense by an independent auditor selected by the applicant and reasonably satisfactory to the Department.

(2) The Department may require at any reasonable time an audit of any information submitted to the Department:

(a) By any company that applies for certification by the Department as a qualified Maryland biotechnology company; or

(b) By any company that has been certified by the Department as a qualified Maryland biotechnology company within the immediate past 4 calendar years.

(3) An audit under §A(2) of this regulation shall include, but is not limited to, the company's ownership, location, finances, capital structure, operations, facilities, equipment, contracts, research, development, and products.

(4) An audit under §A(2) of this regulation shall be conducted at the company's expense by an independent auditor selected by the company and reasonably satisfactory to the Department

(5) The Department may initiate an audit by delivering to the applicant or company a written request, for the performance of an audit stating the scope of the audit to be undertaken and the matters to be examined in the course of the audit.

(6) Within 10 business days after an applicant or company receives a request from the Department for the performance of an audit under §A(1) or (2) of this regulation, the applicant or company shall submit to the Department a written response naming the independent auditor selected by the applicant or company.

(7) If the Department approves the auditor, it shall give written notice to the applicant or company that the Department approves the auditor and shall provide instructions to the auditor for the scope and conduct of the audit. If the Department disapproves of the selected auditor, the Department shall give written notice to the applicant or company of the disapproval and of the reasons for it. The applicant or company shall, within 5 business days, select an alternative auditor and submit to the Department a written response naming the alternate independent auditor selected by the applicant or company.

(8) The auditor shall proceed to conduct the audit with due diligence and dispatch, and in accordance with the Department's instructions. Within 90 days of the Department's notice accepting the selection of an auditor, the auditor shall submit to the Department, and to the applicant or company a full report of its audit procedures, tests, matters examined, and findings.

B. Inquiries; Duty of Applicants and Companies to Respond.

(1) The Department may make written inquiry, including a request for the production, inspection, or copying of documents specified in the inquiry, of any applicant for or holder of a certificate to obtain information bearing on the eligibility or continuing eligibility of the applicant or holder. This inquiry may include, but may not be limited to, whether a qualified investor has sold, transferred, or otherwise disposed of the ownership interest in a QMBC based on which the certificate was issued.

(2) The Department may make written inquiry, including a request for the production, inspection, or copying of documents specified in the inquiry, of any company that makes an application to the Department for certification as a qualified Maryland biotechnology company, or that the Department has already determined to be a qualified Maryland biotechnology company, as to the facts and circumstances that affect the company's eligibility or continued eligibility for certification as a qualified Maryland biotechnology company. This inquiry may include, but may not be limited to the company's:

(a) Ownership;

(b) Location;

(c) Finances;

(d) Capital structure;

(e) Facilities;

(f) Equipment;

(g) Contracts,

(h) Biotechnology research activities;

(i) Biotechnology development activities;

(j) Biotechnology production and manufacturing activities;

(k) Intellectual property; and

(l) Whether the company has or continues to have its headquarters and base of operations in the State.

(3) An applicant or company to which a written inquiry from the Department is directed under §B(1) or (2) of this regulation shall submit a full and complete written response, with copies of all requested documents, within 45 days of the date of the inquiry. The response shall be verified as true and correct by oath or affirmation made under penalty of perjury by an individual or by an individual officer, partner, or member of the applicant or company.

Md. Code Regs. 24.05.03.08

Regulations .08 adopted effective September 17, 2012 (39:18 Md. R. 1197)