Md. Code Regs. 24.05.03.13

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

Section 24.05.03.13 - Procedures for Certification of Qualified Maryland Biotechnology Companies

A. To be certified by the Department as a qualified Maryland biotechnology company, a biotechnology company shall file with the Department a verified application for certification as a qualified Maryland biotechnology company made under oath or affirmation subject to penalty of perjury. An application may be filed at any time.

B. Application.

(1) The application shall be in a form approved from time to time by Department.

(2) The biotechnology company's application shall be complete and shall provide the information and documents required by this chapter and the application form, and in the instructions to the application form.

C. Information and Documents to be Provided. The biotechnology company shall provide the information and documents required, requested, described, or listed in the application form and in the instructions to the application form, including but not limited to:

(1) The full legal name of the company;

(2) The street address of the principal place of business of the company, the mailing addresses of the officers, principals, or managing members of the company, and the company's web page URL, email address, and telephone number;

(3) The mailing address, email address, and telephone number of an individual with authority to act on behalf of the company;

(4) The company's federal employer identification number;

(5) The company's Maryland State Department of Assessments and Taxation entity identification number;

(6) The company's Maryland Unemployment Insurance account number assigned by the Department of Labor, Licensing and Regulation;

(7) The company's most recent annual, quarterly, and monthly financial statements prepared in accordance with generally accepted accounting principles showing:

(a) Contributed owners' equity of at least $100,000; or

(b) Noncurrent debt consisting of non-demand, non-callable loans, with terms of not less than 3 years, aggregating at least $100,000;

(c) Noncurrent debt in the form of notes or other instruments with terms of not less than 3 years, convertible to equity securities of the QMBC, aggregating at least $100,000;

(d) A capital structure including a combination of any of contributed owners' equity, noncurrent debt consisting of non-demand, non-callable loans, with terms of not less than 3 years, or noncurrent debt in the form of notes or other instruments with terms of not less than 3 years, convertible to equity securities of the QMBC, the total of all types of capital aggregating at least $100,000; or

(e) Evidence of an award of non-dilutive grants (including SBIRs, STTRs or other grants) of $100,000 or more;

(8) If the company will rely to any extent on noncurrent debt or noncurrent convertible debt to establish that its capital structure meets the requirements set forth in §C of this regulation, a statement of an independent certified public accountant certifying that under generally accepted accounting principles the company's debt so relied upon is correctly classified as noncurrent liabilities and has terms of not less than 3 years;

(9) If the applicant is a corporation or a limited liability company:

(a) Its full legal name and the street and mailing addresses of its principal place of business;

(b) A certified copy of its articles of incorporation, articles of organization, or other organic organizational document, with all amendments through the date of the application;

(c) A certificate of good standing from the Maryland State Department of Assessments and Taxation dated not more than 90 days before the date on which the application is filed;

(d) If the applicant is a foreign entity, a certificate, translated if necessary into standard English, of the appropriate official of the jurisdiction under the laws of which it is organized attesting that it is duly organized, existing, and in good standing under the laws of that jurisdiction, dated within 90 days of the date on which the application is filed;

(e) The names and business addresses of all of its officers and directors or managing members; and

(f) The names and addresses of each of its shareholders or members who own or hold, directly or indirectly, shares or ownership interests of any class representing 5 percent or more of the aggregate equity capital of the applicant;

(10) If the applicant is a partnership, limited partnership, limited liability partnership, or similar entity:

(a) A copy of its partnership agreement, and all amendments to it, certified as to completeness and accuracy by a general partner;

(b) If applicable, a certified copy of its certificate of limited partnership or other similar publicly filed organizational document and all amendments or supplements to it;

(c) The names and business addresses of its general partners or managing members;

(d) If applicable, a certificate of good standing from the Maryland State Department of Assessments and Taxation dated not more than 90 days before the date on which the application is filed; and

(e) If the applicant is a foreign limited partnership, limited liability partnership, or similar entity, a certificate, translated if necessary into standard English, from the appropriate official of the jurisdiction under the laws of which it is organized, attesting that it is duly organized, existing, and in good standing under the laws of that jurisdiction, dated not more than 90 days before the date on which the application is filed;

(11) Copies of any shareholder agreement, subscription agreement, investor agreement, operating agreement, voting trust agreement, private placement memorandum, Regulation D disclosure document, or other instrument concerning or affecting the offer, issuance, or ownership of equity interests in the company which has been or will be delivered to investors or to which investors in the company are or will be parties;

(12) The company's business plan, which shall contain:

(a) A description of the company in sufficient detail to establish that the company is actually and actively engaged in activities constituting biotechnology as defined in Regulation 14C of this chapter and that it meets the criteria for a qualified Maryland biotechnology company stated in this chapter;

(b) A factual narrative describing the company from its inception through the date of the application in sufficient detail to establish that it is organized, is actively engaged in the conduct of a biotechnology business in the State, and in fact operates as a biotechnology company in the State as of the date of the filing of the application, and that it will continue to do so in the future; and

(c) Statements or descriptions of the company's

(i) Strategy;

(ii) Product descriptions and highlights;

(iii) Management;

(iv) Board of directors or equivalent management;

(v) Financing plans including potential exit strategies;

(vi) Intellectual property assets;

(vii) Plans for the predictable progression of its innovative product as research;

(viii) Development, and production milestones;

(ix) Contingency provisions for experimental or clinical failure;

(x) Commercialization plans;

(xi) Contracts for the performance of biotechnology activities on behalf of the company by third persons; and

(xii) Full-time and part-time employees employed in the State and outside of the State and the numbers of such employees;

(13) Copies of any private placement memorandum, prospectus, or similar disclosure and information documents, and any filings with securities regulatory agencies, prepared or made by the qualified Maryland biotechnology company as issuer in connection with the investment;

(14) A description of the uses and purposes to which the investment will be applied by the qualified Maryland biotechnology company;

(15) A signed statement of the applicant made under penalty of perjury that the contents of the application are true to the best of the knowledge, information, and belief of the applicant and of its officer or other duly authorized representative making the statement on behalf of the applicant, and attesting that the applicant is:

(a) In good standing and authorized to do business in the State;

(b) Current in the payment of all tax obligations to the State or to any unit or subdivision of the State; and

(c) Not in default under the terms of any contract with, indebtedness to, or grant from the State, or any unit or subdivision of the State;

(16) Affirmative evidence by certification in a form prescribed and approved by the Department and made under oath or affirmation subject to penalty of perjury by an officer or other person duly authorized to make statements on behalf of the biotechnology company attesting that the biotechnology company is:

(a) In good standing and authorized to do business in the State;

(b) Current in the payment of all tax obligations to the State or to any unit or subdivision of the State; and

(c) Not in default under the terms of any contract with, indebtedness to, or grant from the State, or any unit or subdivision of the State; and

(17) A statement by an officer or duly authorized representative of the qualified Maryland biotechnology company describing the qualified Maryland biotechnology company's intended use or application of the investment.

D. Other Documents and Information. The following documents are not required at the time of submission of the QMBC application but may be requested by the Department to substantiate or expand upon information provided in the QMBC application:

(1) Descriptions of the biotechnology intellectual property owned by or assigned to the company or in which the company has rights under license or other agreements listed as invention disclosures or patents by title with dates of application and expiration;

(2) Copies of patents, intellectual property license and use agreements, and new product clinical testing studies, reports, and related governmental approval proceedings to which the company is a party may be requested by the Department on an as needed basis;

(3) A description of the sites, buildings, and facilities owned, leased, used, or occupied by the company in the State and outside of the State, including:

(a) The street address of each site, building, or facility;

(b) A tax parcel map for each site, building, or facility identifying the location of each site, building, or facility;

(c) A copy of the most recent real property tax assessment and property tax bill for each parcel of real property that the company occupies as owner of the property;

(d) A copy of any lease with respect to each site, building, or facility that the company occupies under a lease of the real property;

(e) Copies of contracts for the performance of biotechnology activities on behalf of the company by third parties;

(f) The number of full-time and part-time employees of the applicant employed in the State as well as those outside of the State shall be stated in the business plan;

(g) A statement of the number of employees at each site, building, or facility and the titles, job descriptions, and duties of each employee; and

(h) A detailed description of the company's biotechnology research, development, or production activities and the company's business, financial, and administrative operations carried on at each site, building, or facility;

(4) A full physical description of the company's headquarters site, building, or facility;

(5) A full physical description, including installed machinery and equipment for biotechnology activities, of the sites, buildings, and facilities constituting the company's base of operations; and

(6) A description of the company's plans or intentions to purchase, lease, or otherwise acquire sites, buildings, or facilities at any time and in any location with 36 months of the date on which the application is filed.

E. Issuance or Denial of Certificate.

(1) Based on the information set forth in the company's application, the Department may issue:

(a) A certificate that a company is a qualified Maryland biotechnology company; or

(b) A written determination that a company is not a qualified Maryland biotechnology company.

(2) The issuance of a certificate that a company is a qualified Maryland biotechnology company is subject to the Department's determination that:

(a) The information in the application and other documents submitted by the company is accurate;

(b) The company maintains its headquarters and base of biotechnology operations in the State as required by the Act and this chapter; and

(c) The company is eligible for certification as a qualified Maryland biotechnology company under the Act and this chapter.

(3) The Department's decision to issue or not to issue a certificate that a company is a qualified Maryland biotechnology company is final and not subject to further administrative review. The Department may revoke a certificate upon a determination by the Department that the company has become ineligible for certification.

Md. Code Regs. 24.05.03.13

Regulations .13 adopted effective September 17, 2012 (39:18 Md. R. 1197)