Mass. Gen. Laws ch. 75, sec. 43 — MA Code / Part I / Title XII / Chapter 75 / Section 43
Biologic laboratories; advisory board; insurance; agreements with private parties; yearly reports; accounts
Status: in_force

Section 43. (a) There is hereby established the University of Massachusetts biologic laboratories. The purpose of said laboratories shall be the research, development and production of childhood vaccines and biologic products designed to reduce or prevent morbidity and mortality in the commonwealth, including but not limited to those products which may be of little or no interest to commercial manufacturers and are therefore otherwise substantially unavailable to the citizens of the commonwealth. The biologic laboratories shall operate pursuant to this chapter and in accordance with regulations promulgated thereunder. (b) There shall be an advisory board to advise the president and the board of trustees of the university with respect to the operation of the biologic laboratories. The advisory board shall meet at least twice per year, and at such other times as are necessary to effectuate its purpose. The advisory board shall consist of the following members: the commissioner of public health or his designee, the director of the childhood immunization program of the department of public health, the deans of the medical school and the school of public health of the university or their designees, and at least three but not more than five additional members appointed by the president of the university, including a consumer and a practicing pediatrician or other physician specializing in family medicine. Each advisory board member appointed by the president of the university shall serve for a term of five years, provided, however, that in making initial appointments, the president shall appoint one or two members for a term of three years and one or two members for a term of four years. Appointed members of the advisory board shall be eligible for reappointment and may be removed by the president of the university during their terms for cause. (c) The university shall obtain liability insurance sufficient to indemnify the commonwealth, the university and the biologic laboratories, and their officers and employees, for any liability arising from the out-of-state sale, distribution and use of laboratory products, and to indemnify the commonwealth for any liability arising under chapter two hundred and fifty-eight as a result of any activities of the laboratories. (d) The board of trustees may authorize the biologic laboratories to enter into agreements with private parties with respect to the research, development and production of vaccines and other biologic products; provided, however, that the board, in consultation with the advisory board, shall develop and follow written criteria for affording a preference to private companies that agree to conduct such research, development or production, or a substantial portion thereof, in the commonwealth. (e) Any trade secret or other proprietary information of the biologic laboratories shall be exempt from the definition of public records in clause twenty-sixth of section seven of chapter four. (f) The director of the biologic laboratories shall submit to the clerks of the senate and the house of representatives a detailed report of the activities of the laboratories within ninety days after the end of each fiscal year. Said report shall include for the prior fiscal year a description of the patents and licenses received, agreements entered into, the status of existing agreements, royalties and other benefits received as a result of the work of the biologic laboratories, expenditures, current assets and liabilities of the laboratories, one-year and five-year financial plans and identification of current and projected revenues and expenses, anticipated capital expenditures and start-up expenses. Said report shall include an accounting statement detailing the receipts and expenditures, including obligations whether paid or unpaid, of appropriated funds for the prior fiscal year and shall include projections of the amount of appropriated funds required for the next three years. Pursuant to section twelve of chapter eleven, the department of the state auditor shall conduct an audit of the biologic laboratories, in accordance with generally accepted government auditing standards, as often as the state auditor determines is necessary. (g) The university shall maintain on its books a separate account for the biologic laboratories. All revenues generated by the activities of the biologic laboratories shall be deposited in a separate special trust established pursuant to section eleven; provided, however, that expenditures made from said trust fund shall be exclusively for the purposes of the biologic laboratories established in subsection (a). (h) The advisory board shall be consulted prior to the appointment of a chief executive officer of the biologic laboratories. The chief executive officer shall present budgets, staffing plans, operating plans and production plans to the advisory board for its review and comment.

Section 43. (a) There is hereby established the University of Massachusetts biologic laboratories. The purpose of said laboratories shall be the research, development and production of childhood vaccines and biologic products designed to reduce or prevent morbidity and mortality in the commonwealth, including but not limited to those products which may be of little or no interest to commercial manufacturers and are therefore otherwise substantially unavailable to the citizens of the commonwealth. The biologic laboratories shall operate pursuant to this chapter and in accordance with regulations promulgated thereunder.

(b) There shall be an advisory board to advise the president and the board of trustees of the university with respect to the operation of the biologic laboratories. The advisory board shall meet at least twice per year, and at such other times as are necessary to effectuate its purpose. The advisory board shall consist of the following members: the commissioner of public health or his designee, the director of the childhood immunization program of the department of public health, the deans of the medical school and the school of public health of the university or their designees, and at least three but not more than five additional members appointed by the president of the university, including a consumer and a practicing pediatrician or other physician specializing in family medicine. Each advisory board member appointed by the president of the university shall serve for a term of five years, provided, however, that in making initial appointments, the president shall appoint one or two members for a term of three years and one or two members for a term of four years. Appointed members of the advisory board shall be eligible for reappointment and may be removed by the president of the university during their terms for cause.

(c) The university shall obtain liability insurance sufficient to indemnify the commonwealth, the university and the biologic laboratories, and their officers and employees, for any liability arising from the out-of-state sale, distribution and use of laboratory products, and to indemnify the commonwealth for any liability arising under chapter two hundred and fifty-eight as a result of any activities of the laboratories.

(d) The board of trustees may authorize the biologic laboratories to enter into agreements with private parties with respect to the research, development and production of vaccines and other biologic products; provided, however, that the board, in consultation with the advisory board, shall develop and follow written criteria for affording a preference to private companies that agree to conduct such research, development or production, or a substantial portion thereof, in the commonwealth.

(e) Any trade secret or other proprietary information of the biologic laboratories shall be exempt from the definition of public records in clause twenty-sixth of section seven of chapter four.

(f) The director of the biologic laboratories shall submit to the clerks of the senate and the house of representatives a detailed report of the activities of the laboratories within ninety days after the end of each fiscal year. Said report shall include for the prior fiscal year a description of the patents and licenses received, agreements entered into, the status of existing agreements, royalties and other benefits received as a result of the work of the biologic laboratories, expenditures, current assets and liabilities of the laboratories, one-year and five-year financial plans and identification of current and projected revenues and expenses, anticipated capital expenditures and start-up expenses.

Said report shall include an accounting statement detailing the receipts and expenditures, including obligations whether paid or unpaid, of appropriated funds for the prior fiscal year and shall include projections of the amount of appropriated funds required for the next three years.

Pursuant to section twelve of chapter eleven, the department of the state auditor shall conduct an audit of the biologic laboratories, in accordance with generally accepted government auditing standards, as often as the state auditor determines is necessary.

(g) The university shall maintain on its books a separate account for the biologic laboratories. All revenues generated by the activities of the biologic laboratories shall be deposited in a separate special trust established pursuant to section eleven; provided, however, that expenditures made from said trust fund shall be exclusively for the purposes of the biologic laboratories established in subsection (a).

(h) The advisory board shall be consulted prior to the appointment of a chief executive officer of the biologic laboratories. The chief executive officer shall present budgets, staffing plans, operating plans and production plans to the advisory board for its review and comment.