(4) The purpose and nature of the invention, including the anticipated use thereof;

(5) The extent to which the contractor has made or will make substantial investment of financial resources or technology developed at the contractor's private expense which will directly benefit the commercialization of the invention;

(6) The extent to which the field of technology of the invention has been developed at the contractor's expense;

(7) The extent to which Government intends to further develop the invention to the point of commercial utilization;

(8) The extent to which the invention is concerned with the public health, public safety, or public welfare;

(9) The likely effect of the waiver on competition and market concentration;

(10) In the case of a nonprofit educational institution, the extent to which such institution has a technology transfer capability and program, approved by the Secretary or his designee as being consistent with the applicable policies of this section; and

(11) The small business status of the contractor.

(d) Procedures. (1) All waiver determinations shall be initiated by a written request. Such requests may be submitted by existing or potential contractors in the case of requests for an advance waiver and by contractors or employee-inventors in the case of requests for waiver for identified inventions. A request for an advance waiver may also be made for an identified invention which has already been conceived and which reasonably may be first actually reduced to practice in the course of or under an OWRT contract. Such waiver requests must include a copy of the patent or patent application covering the identified invention.

(2) A request for an advance waiver shall be submitted to the contracting officer or to contractors for their subcontractors at any time prior to execution of the contract or within thirty (30) days thereafter, but should normally be submitted as part of the contract proposal. Advance waivers may

also be requested where the purpose or scope of work of an existing contract is to be substantially altered. When advance waivers are granted, the rights set forth in paragraphs (b), (c), and (d) of the clause of § 14R9.107-5(a) should be modified, to conform to the waiver granted.

(3) A request for waiver (other than advance waivers for an identified invention shall be submitted to the contracting officer at the time the invention is reported to OWRT, or not later than six (6) months after conception or first actual reduction to practice, whichever occurs first, or such longer period as may be authorized by the contracting officer for good cause shown in writing by the contractor or inventor.

(4) All requests for waiver received by OWRT or its contractors will be forwarded promptly to the Solicitor, together with any reference or supporting documents provided by the staff of the activity. If the request for waiver appears to contain insufficient information, the Solicitor may seek additional information from the requestor to supplement the request, and may also seek additional information from other sources. The Solicitor will thoroughly analyze the request in view of each of the objectives and considerations set forth in this section and shall also consider the overall rights obtained by the Government in the patent, copyright, and data clauses of the contract. Where it appears that a lesser part of the rights of the United States than requested would be more appropriate in view of the policies set forth in this section, the Solicitor should attempt to negotiate a compromise acceptable to both the requestor and OWRT.

(5) The Solicitor will prepare and recommend a Statement of Considerations setting forth the rationale for either accepting or rejecting the waiver request. While the Statement need not make specific findings as to each and every consideration of paragraph (b) or (c) of this section, it will cover those that raise significant issues and those that are decisive, and it will explain the basis for the recommended determination. There may be occasions when the application of the

various considerations in paragraphs (b) or (c) of this section to a particular case could cause conflicting results, and in those instances the differences will be reconciled giving due regard to the overall policies set forth in this section.

(6) The Statement shall serve as a recommended basis for the waiver determination. The Solicitor will also obtain comments from the appropriate OWRT program division to assist the Secretary or his designee in the waiver determination.

(7) In making waiver determinations, the Secretary or his designee shall objectively review all requests for waiver in views of the objectives and considerations set forth in this section. If this determination and the rationale therefor is not accurately reflected in the recommended Statement of Consideration, a new Statement shall be prepared.

(8) Where the request for advance waiver has not been approved prior to the effective date of the contract and the terms and conditions of the waiver has thus not been made a part of the contract, the contracting officer shall promptly notify the requestor by letter of the determination of the Secretary or his designee, and the basis therefor. If the advance waiver is approved, the letter shall state the scope, terms, and conditions of such waiver. Where the terms and conditions of an approved advance waiver have not been made a part of the contract, the letter shall inform the requestor that the advance waiver shall be effective (i) as of the effective date of the contract for an advance waiver of inventions identified, i.e., conceived prior to the effective date of the contract, or (ii) as of the date the invention is reported with an election by the contractor to retain rights therein, i.e., for an invention conceived or first actually reduced to practice after the effective date of the contract; provided a copy of the letter is signed and promptly returned to the contracting officer by the requestor acknowledging the acceptance of the scope, terms, and conditions of the advance waiver. After the acceptance by the contractor of an advance waiver, the contracting officer shall cause a unilateral no-cost modifi

cation to be made to the contract incorporating the terms and conditions of the waiver in lieu of previous patent provisions. Whenever a requested determination has been denied, the requestor may, within thirty (30) days, request reconsideration. Such a request shall include any additional facts and rationale not previously submitted which support the request. Requests for reconsideration shall be submitted and processed in accordance with the procedures set forth in paragraph (d) of this section.

(e) Content of waiver requests. (1) All requests for waiver shall include the following information:

(i) The requestor's identification, business address, and, if represented by counsel, the counsel's name and address.

(ii) An identification of the pertinent contract or proposed contract and a copy of the contract statement of work or a nonproprietary statement which fully describes the proposed work to be performed.

(iii) The nature and extent of waiver requested.

(iv) A full and detailed statement of facts, to the extent known by or available to the requestor, directed to each of the considerations set forth in paragraph (b) or (c) of this section, as applicable, and a statement applying such facts and considerations to the policies set forth in paragraph (a) of this section. It is important that this submission be tailored to the unique aspects of each request for waiver, and be as complete as feasible; and

(v) The signature of the requestor or his authorized representative with the following statement:

The facts set forth in this request for waiver are within the knowledge of the requestor and are submitted with the intention that the Secretary or his designee rely on them in reaching the waiver determination.

(2) Requests for waiver for identified inventions shall, in addition to paragraph (e)(1)(i) through (v) of this section include:

(i) The full names of all inventors;

(ii) A statement of whether a patent application has been filed on the invention, together with a copy of such

application if filed, or, if not filed, a complete description of the invention;

(iii) If a patent application has not been filed, any information which may indicate a potential statutory bar to the patenting of the invention under 35 U.S.C. 102, or a statement that no bar or potential bar is known to exist; and

(iv) Where the requestor is the inventor, written authorization from the applicable contractor or subcontractor permitting the inventor to request a waiver.

(3) Subject to Department of the Interior regulations, requirements, and restrictions on the treatment of proprietary and classified information, all material submitted in requests for waiver or in support thereof will be made available to the public after a determination on the waiver request has been made, regardless of whether a waiver is granted. Accordingly, requests for waiver should not contain information or data that the requestor is not willing to have made public. If proprietary or classified information is needed to make the waiver determination, such information shall not be submitted unless specifically requested by the Solicitor.

(f) Record waiver determinations. The Solicitor shall maintain and periodically update a publicly available record of waiver determinations.

(g) Waiver situations and types of waivers. (1) The various factual situations which are appropriate for waivers cannot be categorized precisely inasmuch as the appropriateness of a waiver will depend upon the manner in which the considerations set forth in paragraph (b) or paragraph (c) of this section relates to the facts and circumstances surrounding the particulating contracting situation or the particular invention in order to best achieve the objectives set forth in paragraph (a) of this section. However, some examples of factors bearing on where waivers might be appropriate are the following:

(i) Cost sharing contracts;

(ii) Situations in which OWRT is providing increased funding to a specific on-going privately sponsored research, development, or demonstration project;

(iii) Situations involving the private use of Government facilities and the contractor is funding all or a part of such costs; and

(iv) Situations in which the equities of the contractor are so substantial in relation to that of the Government that the waiver is necessary to obtain the participation of the contractor.

(2) As stated in paragraph (a) of this section, waivers may be granted as to all or any part of the rights of the United States to an invention except for certain rights set forth in paragraph (i) of this section. Accordingly, the waiver of all patent rights that are inherent to an invention, rather than part of the rights, will not necessarily be appropriate. The scope of the waiver will depend upon the relationship of the contractual situation or identified invention to the considerations set forth in paragraph (b) or (c) of this section in order to best achieve the objectives set forth in paragraph (a) of this section. For example, waivers may be restricted to a particular field of use in which the contractor has substantial equities or a commercial position, or restricted to those uses that are not the primary object of the contract effort. Waivers may also be limited to particular geographical locations, may be made effective only for a specified duration of time, or may require the contractor to license others at reduced royalties in consideration of the Government's contribution to the research, development, or demonstration effort.

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(3) In advance waivers of identified inventions, the invention will deemed to be a Subject Invention and the waiver will be considered as being effective as of the effective date of the contract. This will be true regardless of whether the identified invention had been first reduced to practice under the contract. A purpose of such waivers is to clarify and definitize the rights of the parties to such inventions when the facts surrounding the first actual reduction to practice prior to or during the contract are or will be difficult to establish.

(h) Waivers to educational institutions. (1) Except to the extent that a nonprofit educational institution may be engaged as a contractor operating a

Government-owned facility or undertaking other special contracts, the following considerations apply to the granting of advance and identified waivers to educational institutions having an approved technology transfer program and capability. To obtain approval of its technology transfer program, educational institutions shall forward their requests to OWRT as provided in paragraph (h)(2) of this section.

(2) A nonprofit educational institution desiring to obtain approval of its technology transfer program and capability shall provide OWRT at the time of contracting with the following information:

(i) General information concerning the institution, including:

(A) A copy of its Articles of Incorporation;

(B) A statement of the institution's purposes 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 outline 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

to the marketplace inventions which it retains title including a description of the efforts typically undertaken by the institution to license its inventions together with copies of earnest offers or proposals to the institution from identified prospective licensee(s) to commit funds, facilities, proprietary background technology and know-how, and the services of personnel, to bring to the marketplace an invention or inventions to which the institution retains title;

(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 ten (10) years;

(B) Number of patent applications filed during each of the past ten (10) years;

(C) Number of patents obtained during each of the past ten (10) years;

(D) Number of exclusive licenses issued during each of the past ten (10) years;

(E) Number of nonexclusive licenses, other than those to sponsor Government agencies, issued during each of the past ten (10) years;

(F) Gross royalty income during each of the past ten (10) years;

(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 Government support 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.

(3) Before an institution's technology transfer program and capabilities

are approved for the contracting, the institution shall have a technology transfer program which, as a minimum shall include the five (5) criteria listed below:

(i) An established patent policy which is consistent with the four policy objectives in § 14R-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 institutions are evaluated for inclusion in the institution's promotional program for the licensing and marketing of inventions.

(4) In considering approval of technology transfer programs and capabilities in connection with requests for waivers, such approval 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 a waiver to an institution. Approval of the grant of a waiver must be viewed in light of the considerations of § 14R-9.106(b) or (c) above, as applicable, and the four objectives set forth in § 14R-9.109-6(a) above.

(i) Terms and conditions of waivers. Each waiver shall contain, as a minimum, provisions covering each of the following:

(1) Advance waivers shall apply only to inventions reported in accordance with paragraph (e)(2)(i) of the clause of 14R-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 specify

ing those countries in which rights will be retained.

(2) Subject to the rights granted in paragraphs (c)(1), (2), and (3) of the clause of § 14R-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 (i)(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 (i)(5) of this section, or decides not to continue prosecution of such application; or

(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 clause of § 14R-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 forfeiture of the patent application or patent, the contractor or inventor shall notify the contracting officer or 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 Solicitor 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.