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U. S. DI PARTMENT OF ENERGY

(A) A copy of its articles of incorporation;

(B) A statement of the institution's purpose and aims; and

(C) A statement indicating the source of the institution's funds.

(ii) A copy of the institution's established patent policy, together with the date and manner of its adoption;

(iii) The name, title, address, and telephone number of the officer responsible for administration of patent and invention matters and a description of staffing in this area, including all offices which contribute to the institution's patent management capabilities;

(iv) A description of the institution's procedures for identifying and reporting inventions and a description of the procedures for evaluation of such inventions for inclusion in the institution's promotional program;

(v) A copy of the agreement signed by employees engaged in research and development, indicating their obligation in regard to inventions conceived or first actually reduced to practice in the course of their assigned duties;

(vi) A copy of the invention report form or outlines utilized for preparation of invention reports;

(vii) A statement of whether the institution has an agreement with any patent management organizations or consultants and a copy of any such agreements;

(viii) A description of the plans and intentions of the institution to bring to the marketplace inventions to which it retains title, including a description of the efforts typically undertaken by the institution to license its inventions.

(ix) A description of the institution's past patent application and patent licensing activities, including the following:

(A) Number of inventions reported to the institution during each of the past 5 years; (B) Number of patent applications filed during each of the past 5 years;

(C) Number of patents obtained during each of the past 5 years;

(D) Number of exclusive licenses issued during each of the past 5 years;

(E) Number of nonexclusive licenses, other than those to sponsoring Government agencies, issued during each of the past 5 years;

(F) Gross royalty income during each of the past 5 years; and

(G) A general description of royalties charged, including minimum and maximum royalty rates.

(x) A list of subsidiary or affiliate institutions which would be covered by an agreement signed by the institution;

(xi) If the institution is a subsidiary or affiliate organization, the name of the other related organization and a description of the relationship:

(xii) The amount of support from each Federal Agency for research and development activities currently being administered by the institution, giving Government agency and breakdown;

(xiii) A statement of the institution's policies with respect to the sharing of royalties with employees; and

(xiv) A description of the uses made of any net income generated by the institution's patent management program.

PROCUREMENT REGULATIONS

9-9.109-6

(3) Before an institution's technology transfer program and capabilities are approved, the institution shall have a technology transfer program which, as a minimum shall include the five criteria listed below. In addition to these criteria, consideration will be given to whether or not other Government agencies have approved an institutional patent agreement with the requesting institution. The six criteria are:

(i) An established patent policy which is consistent with the four policy objectives in §9-9.109-6(a) and is administered on a continuous basis by an officer or organization responsible to the institution;

(ii) Agreements with employees requiring them to assign to the institution or its designee or the Government any invention conceived or first actually reduced to practice by them in the course of or under Government contracts and awards, or assurance that such agreements are obtained prior to the assignment of personnel to Government-supported research and development projects;

(iii) Procedures for insuring that inventions are promptly identified and timely disclosed to the officer or organization administering the patent policy of the institution; (iv) Procedures for insuring that inventions disclosed to the institution are evaluated for inclusion in the institution's promotional program; and

(v) An active and effective promotional program for the licensing and marketing of

inventions.

(vi) The institution has a policy of preferring, in appropriate circumstances, nonexclusive over exclusive licensing and domestic over foreign manufacture.

(4) In connection with requests for advance waivers, an approved technology transfer program and capabilities shall be considered in lieu of commercial, manufacturing, and marketing capabilities which normally reside in industry. Such approval shall not be considered sufficient in and of itself as justifying the granting of an advance waiver to an institution. Approval of the grant of an advance waiver must be viewed in light of the considerations of §9-9.109-6(b) above and the four objectives set forth in §9-9.109-6(a) above.

(5) In requests for identified waivers, however, the fact that an institution with an approved technology transfer program and capabilities has identified an invention and has expressed a desire to commercialize it through a request for a waiver therefor shall normally constitute a presumption that the institution has met the criteria of §9-9.109-6(c) unless it is indicated that under one or more of the criteria the presumption is inapplicable.

(6) If, in addition to a DOE-approved technology transfer program, an educational institution has a written procedure whereby the institution reviews for patentable subject matter papers concerning scientific or technical developments, the following paragraph (g) may be substituted for paragraph (g) of the Patent Rights (short form) clause of §9-9.107-6 or other Patent Rights clause in the contract.

(g) In order that information concerning scientific or technical developments conceived or first actually reduced to practice in the course of or under the contract is not prematurely published so as to adversely affect patent interest of DOE, the Contractor agrees to screen for patent review each paper prior to its intended publication date. If a Subject Invention is identified by the Contractor in a paper submitted for review, the paper will be submitted to Patent Counsel prior to publication. Publication may be delayed by Patent Counsel for such time as is necessary to file a patent application thereon, up to a maximum of 100 days from the date the paper was submitted to Patent Counsel, or for a period longer than 100 days as mutually agreed.

(i) Terms and conditions of waivers.

Each waiver shall contain, as a minimum, provisions covering each of the following:

2.-9.109-6

U. S. DEPARTMENT OF ENERGY

(1) Advance waivers shall apply only to inventions reported in accordance with paragraph(e)(2)(1) of the clause of 89-9.107-5(a) and with which is included an election as to whether the contractor will retain the rights waived in the invention, and specifying those countries in which rights will be retained.

(2) Subject to the rights granted in paragraphs (c)(1), (2) and (3) of the Patent Rights clause of 89-9.107-5(a), the contractor or inventor shall agree to convey to the Government, upon request, the entire domestic right, title, and interest in any subject invention when the contractor or inventor, as appropriate:

(i) Does not elect, in accordance with (1)(1) of this section to retain such rights; or (ii) Fails to have a United States patent application filed on the invention in accordance with paragraph (1)(5) of this section, or decides not to continue prosecution of such application;

(iii) At any time, no longer desires to retain title.

(3) Subject to the rights granted in paragraph (c)(1), (2) and (3) of the Patent Rights clause of 89-9.107-5(a), the contractor or inventor shall agree to convey to the Government, upon request, the entire right, title and interest in any subject invention in any foreign country, if the contractor or inventor, as appropriate:

(i) Does not elect, in accordance with paragraph (i)(1) of this section, to retain such rights in the country; or

(ii) Fails to have a patent application filed in the country on the invention in accordance with paragraph (i)(6) of this section, or decides not to continue prosecution or to pay any maintenance fees covering the invention. To avoid forfeitures of the patent application or patent, the contractor or inventor shall notify the Patent Counsel not less than 60 days before the expiration period for any action required by the Foreign Patent Office.

(4) Conveyances requested pursuant to paragraph (i)(2) or (3) of this section shall be made by delivering to the Patent Counsel duly executed instruments and such other papers as are deemed necessary to vest in the Government the entire right, title, and interest in the invention to enable the Government to apply for and prosecute patent applications covering the invention in this or the foreign country, respectively, or otherwise establish its ownership of the invention.

(5)(i) With respect to each invention in which the contractor has an advance waiver and elects to retain domestic rights pursuant to paragraph (i)(1) of this section, the contractor shall have a domestic patent application filed within 6 months after submission of the invention disclosure pursuant to paragraph (e)(2)(i) of the clause of §9-9.107-5(a) or such longer period as may be approved by the Patent Counsel for good cause shown in writing by the contractor or inventor. For identified inventions waived to the contractor or inventor, the contractor or inventor shall have a domestic patent application filed within 6 months after the waiver has become effective. With respect to such inventions, the contractor or inventor shall promptly notify the Patent Counsel of any decision not to file an application.

(ii) For each subject invention on which a patent application is filed by the contractor or inventor, the contractor or inventor shall:

(A) Within 2 months after the filing or within 2 months after submission of the invention disclosure if the patent application previously has been filed, deliver to Patent Counsel a copy of the application as filed including the filing date and serial number;

(B) Include the following statement in the second paragraph of the specification of the application and any patents issued on a subject invention, "The Government has rights in this invention pursuant to Contract No. by the U.S. Department of Energy;"

(or Grant No.

awarded

PROCUREMENT REGULATIONS

9-9.109-6

(C) Within 6 months after filing the application or within 6 months after submitting the invention disclosure if the application has been filed previously, deliver to the Patent Counsel a duly executed and approved instrument fully confirmatory of all rights to which the Government is entitled, and provide DOE an irrevocable power to inspect and make copies of the patent application filed. If, however, a waiver request is pending, delivery of the confirmation instrument may be delayed until a determination of the waiver request is made;

(D) Provide the Patent Counsel with a copy of the patent within 2 months after

a patent is issued on the application; and

(E) Not less than 30 days before the expiration of the response period for any action required by the Patent and Trademark Office, notify the Patent Counsel of any decision not to continue prosecution of the application and deliver to the Patent Counsel executed instruments granting the Government a power of attorney.

(iii) For each invention in which the contractor initially elects pursuant to (i)(1) of this section not to retain the rights waived, the contractor shall inform the Patent Counsel promptly in writing of the date and identity of any on sale, public use, or public disclosure of the invention which may constitute a statutory bar under 35 U.S.C. 102, which was authorized by or known to the contractor, or any contemplated action of this nature.

(6)(i) With respect to each invention in which the contractor elects pursuant to (i)(1) of this section to retain the rights waived in a foreign country, or in which the contractor or inventor has obtained a waiver of foreign rights on an identified invention, the contractor or inventor shall have a patent application filed on the invention in that country, in accordance with applicable statutes and regulations, and within one of the following periods:

(A) Eight months from the date of a corresponding United States application filed by the contractor or inventor, or if such an application is not filed, 6 months from the date the invention is submitted in a disclosure pursuant to paragraph (e)(2)(i) of the clause of §9– 9.107-5(a);

(B) Six months from the date a license is granted by the Commissioner of Patents and Trademarks to file foreign applications where such filing has been prohibited by security reasons; or

(C) Such longer period as may be approved by the Patent Counsel.

(ii) The contractor or inventor shall notify the Patent Counsel promptly of each foreign application filed and, upon written request, shall furnish an English version of the application without additional compensation.

(7) The contractor or inventor shall, three years after a waiver is effective as to an invention, and at three-year intervals thereafter, and when specifically requested by the Patent Counsel, furnish Patent Counsel a report setting forth:

and

(i) The commercial use that is being made, or is intended to be made, of said invention,

(ii) The steps taken to bring the invention to the point of practical application or to make the invention available for licensing.

(8) The Government shall retain at least an irrevocable, nonexclusive, paid-up license to make, use, and sell the invention throughout the world by or on behalf of the Government (including any Government agency) and States and domestic municipal governments, unless the Head of the Agency or designee determines that it would not be in the public interest to acquire the license for the States and domestic municipal governments.

(9) The Head of the Agency or designee has the right to require the granting of a nonexclusive, exclusive, or partially exclusive license to a responsible applicant or applicants, upon terms reasonable under the circumstances:

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U.S. DEPARTMENT OF ENERGY

tions;

(i) To the extent that the invention is required for public use by Governmental regula

(ii) As may be necessary to fulfill health, safety or energy needs; or

(iii) Such other purposes as may be stipulated in the applicable agreement.

(10) The Head of the Agency or designee has the right to terminate such waiver in whole or in part unless the recipient of such waiver demonstrates to the satisfaction of the Head of the Agency or designee that effective steps have been taken, or within a reasonable time thereafter are expected to be taken, necessary to accomplish substantial utilization of the invention.

(11) The Head of the Agency or designee has the right, commencing four years after a waiver is effective as to an invention, to require the granting of a nonexclusive or partially exclusive license to a responsible applicant or applicants, upon terms reasonable under the circumstances, and in appropriate circumstances to terminate the waiver in whole or in part, following a hearing upon notice thereof to the public, upon a petition by an interested person justifying such hearing;

(i) If the Head of the Agency or designee determines upon review of such material as is relevant, and after the recipient of the waiver or other interested person has had the opportunity to provide such relevant and material information as the Head of the Agency or designee may require, that such waiver has tended substantially to lessen competition or to result in undue market concentration in any section of the United States in any line of commerce to which the technology relates; or

(ii) The recipient of the waiver demonstrates to the satisfaction of the Head of the Agency or designee at such hearing that effective steps have been taken, or within a reasonable time thereafter are expected to be taken, necessary to accomplish substantial utilization of the invention.

(j) Termination.

(1) Any waiver may be terminated at the discretion of the Head of the Agency or designee, in whole or in part, if the request for waiver is found to contain false material statements or nondisclosure of material facts, and such were specifically relied upon in reaching the waiver determination.

(2) Any waiver, as applied to particular inventions, may be terminated at the discretion of the Head of the Agency or designee, in whole or in part, if the requirements set forth in paragraph (i) of this section (terms and conditions of the waivers) have not been fulfilled and such failure is determined by the Head of the Agency or designee to be material and detrimental to the interests of the United States and the general public.

(3) Prior to terminating a waiver under paragraph (j)(1) or (j)(2) of this section, the recipient of the waiver will be given written notice of the intention to terminate the waiver, the extent of such proposed termination and the reason therefor, and a period of 30 days, or such longer period as the Head of the Agency or designee shall determine for good cause shown in writing, to show cause why the waiver should not be so terminated.

(4) All terminations of waivers shall be subject to the rights granted in paragraph (c)(1) of the clause of §9-9.107–5(f), and termination shall normally be partial in nature, requiring the waiver recipient to grant nonexclusive or partially nonexclusive licenses to responsible applicants upon terms reasonable under the circumstances.

(k) Effective date.

Waivers shall be effective on the following dates: