FINAL_Amendment_2_NIAID-DAIDS-NIHAI2015029.pdf

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 1

Amendment No. 2

NIAID-DAIDS-NIHAI2015029

“Comprehensive Resources for HIV Microbicides and Biomedical Prevention”

Solicitation Number: NIAID-DAIDS-NIHAI2015029

Amendment Number: Two (2)

Amendment Issue Date: September 1, 2015

Proposal Due Date/Time: Thursday, September 24, 2015 at 3:00 PM, Local Time

(Unchanged)

Issued By: John R. Manouelian

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY cornorj@mail.nih.gov Robert Corno, Contract Specialist Phone: 240.669.5151

SECONDARY

manouelj@mail.nih.gov John R. Manouelian, Contracting Officer Phone: 240.669.5152

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of Amendment 2 is to: (1) provide responses to questions from potential offerors, regarding the solicitation; (2) revise Attachment 1: Packaging and Delivery of the Proposal for Research and Development and Research and Development Support-for Use with eCPS, Section III. DISCS, paragraph A. Delivery Instructions for “If Hand Delivery or Express Service”, to remove the “MSC 9821” code and replace “Bethesda, MD 20892-mailto:cornorj@mail.nih.gov mailto:manouelj@mail.nih.gov

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 2

9821” with “Rockville, MD 20852”; and (3 notify potential offerors that NIAID is pursuing a Declaration of Exceptional Circumstances (DEC), to include two deviated clauses in any resultant contract awards.

The solicitation is amended to provide the following responses to questions from potential offerors:

Question 1

Regarding the electronic submission of the proposals through the NIAID electronic Contract Proposal Submission (eCPS) website at: https://ecps.nih.gov/ - for multiple TA proposal applications, will we need to submit each application separately in the electronic application portal?

Response to Question 1 Correct. For multiple Task Area proposals, an Offeror will need to submit each Task Area proposal separately in the Electronic Contract Proposal Submission (eCPS) website.

Question 2 Please specify the naming convention desired to delineate Technical and Business volumes for each Task Area.

Response to Question 2 As specified in the solicitation, under Attachment 1, Packaging and Delivery of Proposal, Section III, DISCS, paragraph B.5. File Naming Convention, it is required that the filenames for both your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number, and the type of the proposal (i.e., Technical, Business, or Excel Workbook). In addition to these instructions, please include the Task Area for each separate Technical Proposal, Business Proposal, and Excel Workbook, to which you are responding.

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Task Area X_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_ Task Area X_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_ Task Area X_Business.xlsx

Question 3 Regarding Task Area A: Preclinical Gap-Filling Services:

a) Can we propose to perform non-GLP in vitro/ex vivo assays or methods while performing GLP small and large animal safety models?

b) Do the above satisfy the criteria to meet all applicable regulatory requirements?

Response to Question 3

a) As described in the RFP, the scope of work for Task Area A includes both non-GLP and GLP activities. It is up to the Offeror to propose a strategy that addresses all stated requirements.

https://ecps.nih.gov/

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 3

b) The Offeror must demonstrate in their proposal that they have met the appropriate regulatory requirements.

Question 4 Regarding Sample Task Order A-1:

a) We would plan to design the study and then contract out the work. We have identified 3 potential subcontractors. Is it sufficient to say that “One of the following 3 companies will be contracted to perform the study outlined below” and then describe the study, and address the qualifications of all 3 companies? Would it be better to pick a subcontractor (from a choice of 3 possibilities) for the purposes of the Sample Task Order? If so, do we need a letter of collaboration from the intended subcontractor? If so, may we also include the other two companies as potential contractors in the section addressing the general requirements of the Base Contract Statement of Work? If so, do we need 3 letters of collaboration?

b) Attachment 9 (Additional Technical Proposal Instructions) page 4-5, section C.1-C.8 requests documentation of previous experience with a number of types of studies.

Specifically, numbers C.4-C.8 seem outside the range of specific requirements presented in the Base Contract Statement of Work (attachment 3, pages 7-8). Must we document experience with ALL of these types of studies to be responsive?

c) How does the application grading criterion suffer if reference is not made to address all of #s C.4-C.8?

Response to Question 4

a) The Offeror should provide sufficient detail in their proposal that demonstrates that they and any selected subcontractor(s) can fulfill the requirements as outlined in the RFP. The Offeror shall include a commitment letter from any and all subcontractors that they intend to use for said Task Area. Please refer to Section L – Instructions, Conditions, and Notices to Offerors, paragraph 2.c.12 for information regarding the commitment letter.

b) Attachment 9, Additional Technical Proposal Instructions, pages 4-5, section C.4-C.8 are examples of studies that fall under Task Area A requirement (see Attachment 3, Statement of Work for Base Contract, page 7, paragraph 2.d). The Offeror should document previous experience with any of the types of activities that are listed. The Government recognizes that no single Offeror is likely to have experience with all of these types of studies.

c) We are unable to quantify the exact point total that will be deducted if all aspects of this Task Area are not addressed. This determination will be made by the Special Emphasis Panel during the technical peer review of proposals. Offerors are expected to address all aspects of the Task Area to which they are responding.

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 4

Question 5 Regarding the Base Contract Statement of Work for Task Area A:

a) Task Area A includes the following (attachment 3, page 8, section e.2.): “Synthesis of labeled API and formulations for preclinical and clinical pharmacology and pharmacodistribution studies. Labeling may include attachment or inclusion of any entity or modification that facilitates detection of the product in vitro or in vivo, such as radiolabeling or fluorescent-tagging. Must we include a plan for both radiolabeling AND fluorescent tagging of APIs and formulations?

b) Does the application grading criterion suffer if both are not addressed?

c) Must these services be performed under GLP?

d) Task Area A includes the following (attachment 3, page 8, section e.3.): “All analytical services required for performance of in vitro, ex vivo, and in vivo safety and efficacy studies. Analytical services may include biophysical characterization, homogeneity testing and polymorphism of APIs and formulations, activity in relevant matrices derived from in vitro and ex vivo culture conditions, and/or in vivo-derived body fluids.” Must we provide a detailed plan for ALL of the services mentioned after the words “may include”?

e) How will the application grading suffer if all are not addressed?

f) Must these services be performed under GLP?

Response to Question 5

a) The Offeror should demonstrate in their proposal that they can meet the requirement if a labeled API or formulation is required for a study. Radiolabeling and fluorescent-tagging are given as examples.

b) We are unable to quantify the exact point total that will be deducted if all aspects of this Task Area are not addressed. This determination will be made by the Special Emphasis Panel during the technical peer review of the proposals. Offerors are expected to address all aspects of the Task Area to which they are responding.

c) As described in the Statement of Work, the scope of work for Task Area A covers protocols for both GLP and non-GLP studies. The answer depends on whether the labeled API or formulation is used in a GLP study.

d) Offerors should demonstrate in their proposal(s) that they have sufficient expertise to perform these types of analytical services.

e) We are unable to quantify the exact point total that will be deducted if all aspects of this Task Area are not addressed. This determination will be made by the Special Emphasis

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 5

f) As described in the scope of work, the scope of work for Task Area A covers protocols for both GLP and non-GLP studies. The answer depends on whether the analytical services support a GLP study.

Question 6 Regarding Task Area B: HIV Animal Models Supporting Product Development:

a) The Samples task Order B (Evaluation of a long-acting injectable formulation in nonhuman primates) references only the evaluation of the pharmacokinetic (PK) profile and potential efficacy of a long-acting injectable formulation in a repeat, low-dose (RLD) vaginal or rectal SIV/SHIV transmission model in nonhuman primates (NHP). However, Base Contract Statement of Work for Task Area B (attachment 3; page 9 of solicitation) indicates that one or more HIV animal models(s) may be presented for the evaluation of products- specifically nonhuman primate and/or humanized mouse model. Can a response be submitted only addressing the nonhuman primate model?

b) Does the application grading criterion suffer if reference is not made to address the humanized mouse model as well?

c) Can we propose pharmacokinetic/pharmacodynamic (PK/PD) studies in macaques under task B?

Responses to Question 6

a) No. As stated in the additional Technical Proposal Instructions, a humanized mouse animal model should be proposed in addition to proposing a nonhuman primate model (see Attachment 9, page 6).

b) We are unable to quantify the exact point total that will be deducted if all aspects of this Task Area are not addressed. This determination will be made by the Special Emphasis

c) Yes an Offeror can propose pharmacokinetic/pharmacodynamic (PK/PD) studies in macaques under task B.

Question 7 Regarding Task Area C: Bioanalytical Support Services:

a) The bioanalytical lab performs services that comply with GCP. Will this adequately meet the requirements for conducting studies that comply with GLP?

b) Attachment 9 (Additional Technical Proposal Instructions) page 4-5, section C.1-C.8 requests documentation of previous experience with a number of types of studies.

Specifically, numbers C.4-C.8 seem outside the range of specific requirements presented in the Base Contract Statement of Work (attachment 3, pages 7-8).

c) Must we document experience with ALL of these types of studies to be responsive?

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 6

d) How does the application grading criterion suffer if reference is not made to address all of #s C.4-C.8?

Responses to Question 7

a) The Offeror should demonstrate in their proposal that the analytical lab proposed meets GLP requirements.

b) Attachment 9, Additional Technical Proposal Instructions, pages 4-5 only relates to Task Area A. Therefore this question does not apply to Task Area C.

c) We are unable to quantify the exact point total that will be deducted if all aspects of this Task Area are not addressed. This determination will be made by the Special Emphasis

Question 8 Regarding Task Area D: Product Manufacturing:

Can analytical and supporting services to support GMP manufacturing be outsourced to a facility that complies with GLP?

Responses to Question 8 The Offeror and any proposed subcontractors must meet the requirements of the RFP – including the guidelines that govern cGMP/GLP.

Question 9 Is a small business subcontracting plan is required for each proposed subcontractor?

Responses to Question 9 Pursuant to Section L, item 2.c.6.d.9., as part of the prime’s subcontracting plan, the prime contractor’s plan must contain assurances that the offeror will include in all subcontracts the contract clause "Utilization of Small Business Concerns", and assure that all subcontractors, other than small businesses, in excess of $650,000 adopt a plan similar to the plan agreed upon by the offeror.

Question 10 Are letters of support/collaboration required from identified subcontractors in the technical proposal for the business proposal?

Responses to Question 10 Yes, a letter of commitment is required from all proposed Subcontractors. Section L, Instructions, Conditions, and Notices to Offerors, paragraph 2, Instructions to Offerors, paragraph c, Business Proposal Instructions, paragraph 12., Subcontractors, states what must be included in this letter.

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 7

Question 11 If an offeror is submitting a response to more than one Task area, as per Amendment #1, we must propose separate technical and business proposals and those must be delivered both electronically and via disk mailing, correct?

Responses to Question 11 Correct, as per Amendment #1, an offeror must propose and submit separate technical and business proposals for each proposed Task Area, and those must be delivered both electronically and via mailed disk. Please also refer to Attachment 1, Packaging and Delivery of the Proposal for Research and Development and Research and Development Support—for Use with eCPS.

Question 12 If the offeror is responding to more than one task area, is the 200 page limitation for the Technical Proposal per each Task Area response?

Response to Question 12 Yes, if an offeror is responding to more than one Task Area, the 200 page limitation applies to each individual Technical Proposal.

Question 13 If offeror is responding to more than one task area, may we include resumes for shared personnel across one or more task area responses only once and refer to the original resume?

Response to Question 13 You must treat each response as a stand-alone response. If you are responding to more than one Task Area, you must ensure that each Technical and Business proposal is complete in and of itself, since proposals under more than one Task Area will be reviewed independently of one another.

Question 14 The submission is due prior to 3:00PM local time (EST). Does the delivery of the Express Delivery Disk submission portion need to be postmarked by 3:00PM local time (EST) or does it need to be received by 3:00PM local time (EST)?

Response to Question 14 The delivery of the Express Delivery Disk submission portion needs to be received at this office by 3:00 p.m. local time (EST) on September 24, 2015. Please also refer to Attachment 1, Packaging and Delivery of Proposal for Research and Development and Research and Development Support—for Use with eCPS, Section III, DISCS, paragraph A.3.

Question 15 Can the disk be hand delivered in person on the due date?

Response to Question 15 Yes, the disk can be delivered in person, provided it is received at this office by 3:00 p.m. local time (EST) on September 24, 2015. Please also refer to Attachment 1, Packaging and Delivery of

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 8

Proposal for Research and Development and Research and Development Support—for Use with eCPS, Section III, DISCS, paragraph A.

Question 16 For hand delivery of disk submission, please confirm that the address and point of contact the same as for mailed submissions.

Response to Question 16 If hand delivering your disk submission, you should use the address provided under “If Hand Delivery or Express Service”, which is cited under Attachment 1, Packaging and Delivery of Proposal for Research and Development and Research and Development Support—for Use with eCPS, SECTION III – DISCS, paragraph A. Delivery Instructions. However, please note that the address for “If Hand Delivery or Express Service” has been slightly revised, by virtue of this amendment (please refer to the revised address, which is provided at the beginning of this amendment).

Question 17 Are there additional solicitation electronic application directions that you can supply?

Responses to Question 17 Please refer to Attachment 1, Packaging and Delivery of Proposal for Research and Development and Research and Development Support—for Use with eCPS, Section II, Online Submission of Electronic Proposals, for the electronic application directions.

Question 18 Page 71, paragraph 3 (Additional Personnel), states “List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis… For all proposed personnel who are not currently members of the offeror's staff, a letter of commitment or other evidence of availability is required.” Does this requirement for letters of commitment only apply to full-time staff or does it also apply to any staff contributing any level of effort who is not a member of the offeror’s staff?

Responses to Question 18 According to page 71, paragraph 3, of the RFP, the commitment letter or other evidence of availability is required for all proposed staff who are not currently members of the offeror’s staff.

Question 19 Does this letter of commitment requirement only apply to staff listed as Key Personnel?

Responses to Question 19 See response to Question 18.

The solicitation is also amended to revise ATTACHMENT 1: PACKAGING AND DELIVERY

OF THE PROPOSAL FOR RESEARCH AND DEVELOPMENT AND RESEARCH AND

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 9

DEVELOPMENT SUPPORT-FOR USE WITH ECPS, SECTION III – DISCS, paragraph A.

Delivery Instructions for “If Hand Delivery or Express Service”, is to remove the “MSC 9821” code and replace “Bethesda, MD 20892-9821” with Rockville, MD 20852”, and shall read as follows:

A. Delivery Instructions:

If Hand Delivery or Express Service If using U.S. Postal Service

Robert Corno Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 5601 Fishers Lane, Room 3D10 Rockville, MD 20852

Robert Corno Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, MD 20892-9821

The solicitation is amended to provide the following notification to potential offerors that NIAID is pursuing a Declaration of Exceptional Circumstances (DEC), to include two deviated clauses in any resultant contract awards.

NIAID is pursuing a Declaration of Exceptional Circumstances (DEC), in order to include the following two deviated clauses in any resultant contract awards:

352.227-11 Patent Rights – Exceptional Circumstances (SEPT 2014)

This clause applies to all Contractor and subcontractor (at all tiers) Subject Inventions.

(a) Definitions. As used in this clause—

Agency means the Agency of the U.S. Department of Health and Human Services that is entering into this contract.

Class 1 Subject Invention means a Subject Invention described and defined in the DEC that will be assigned to a third party assignee, or assigned as directed by the Agency.

Class 2 Subject Invention means a Subject Invention described and defined in the DEC.

Class 3 Subject Invention means a Subject Invention that does not fall into Class 1 or Class 2 as defined in this clause.

DEC means the Determination of Exceptional Circumstances signed by [insert approving official] ____ on ____ [insert date] ____ and titled “[insert description].”

Invention means any invention or discovery, which is or may be patentable or otherwise protectable under Title 35 of United States Code, or any novel variety of plant that is or may be protectable under the Plant Variety Protection Act (7 U.S.C. 2321, et. seq.)

http://api.fdsys.gov/link?collection=uscode&title=7&year=mostrecent&section=2321&type=usc&link-type=html

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Made means: When used in relation to any invention other than a plant variety, the conception or first actual reduction to practice of such invention; or when used in relation to a plant variety, that the Contractor has at least tentatively determined that the variety has been reproduced with recognized characteristics.

Material means any proprietary material, method, product, composition, compound, or device, whether patented or unpatented, which is provided to the Contractor under this contract.

Nonprofit organization means a university or other institution of higher education or an organization of the type described in section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501(c)) and exempt from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute.

Practical application means to manufacture, in the case of a composition or product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or Government regulations, available to the public on reasonable terms.

Small business firm means a small business concern as defined at section 2 of 85 (15 U.S.C. 632) and implementing regulations of the Administrator of the Small Business Administration. For the purpose of this clause, the size standards for small business concerns involved in Government procurement and subcontracting at 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively, will be used.

Subject Invention means any invention of the Contractor made in the performance of work under this contract.

Third party assignee means any entity or organization that may, as described in the DEC, be assigned Class 1 inventions.

(b) Allocation of principal rights. (1) Retention of pre-existing rights. Third party assignees shall retain all preexisting rights to Material in which the Third party assignee has a proprietary interest.

(2) Allocation of Subject Invention rights. (i) Disposition of Class 1 Subject Inventions. (A) Assignment to the Third party assignee or as directed by the Agency. The Contractor shall assign to the Third party assignee designated by the Agency the entire right, title, and interest throughout the world to each Subject Invention, or otherwise dispose of or transfer those rights as directed by the Agency, except to the extent that rights are retained by the Contractor under paragraph (b)(3) of this clause. Any such assignment or other disposition or transfer of rights will be subject to a nonexclusive, nontransferable, irrevocable, paid-up license to the U.S.

Government to practice or have practiced the Subject Invention for or on behalf of the U.S.

throughout the world. Any assignment shall additionally be subject to the “March-in rights” of 35 U.S.C. 203. If the Contractor is a U.S. nonprofit organization it may retain a royalty free, http://api.fdsys.gov/link?collection=uscode&title=26&year=mostrecent&section=501&type=usc&link-type=html http://api.fdsys.gov/link?collection=uscode&title=26&year=mostrecent&section=501&type=usc&link-type=html http://api.fdsys.gov/link?collection=uscode&title=26&year=mostrecent&section=501&type=usc&link-type=html http://api.fdsys.gov/link?collection=uscode&title=26&year=mostrecent&section=501&type=usc&link-type=html http://api.fdsys.gov/link?collection=uscode&title=15&year=mostrecent&section=632&type=usc&link-type=html https://www.federalregister.gov/select-citation/2014/08/19/13-CFR-121.3 https://www.federalregister.gov/select-citation/2014/08/19/13-CFR-121.3 http://api.fdsys.gov/link?collection=uscode&title=35&year=mostrecent&section=203&type=usc&link-type=html

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nonexclusive, nontransferable license to practice the invention for all nonprofit research including for educational purposes, and to permit other U.S. nonprofit organizations to do so.

(B) [Reserved]

(ii) Disposition of Class 2 and 3 Subject Inventions. Class 2 Subject Inventions shall be governed by FAR clause 52.227-11, Patent Rights-Ownership (December 2007) (incorporated herein by reference). However, the Contractor shall grant a license in the Class 2 Subject Inventions to the provider of the Material or other party designated by the Agency as set forth in Alternate I.

(iii) Class 3 Subject Inventions shall be governed by FAR clause 52.227-11, Patent Rights- Ownership by the Contractor (December 2007) (previously incorporated herein by reference).

(3) Greater Rights Determinations. The Contractor, or an employee-inventor after consultation by the Agency with the Contractor, may request greater rights than are provided in paragraph (b)(1) of this clause in accordance with the procedures of FAR paragraph 27.304-1(c). In addition to the considerations set forth in paragraph 27.304-1(c), the Agency may consider whether granting the requested greater rights will interfere with rights of the Government or any Third party assignee or otherwise impede the ability of the Government or the Third party assignee to, for example, develop and commercialize new compounds, dosage forms, therapies, preventative measures, technologies, or other approaches with potential for the diagnosis, prognosis, prevention, and treatment of human diseases.

A request for a determination of whether the Contractor or the employee-inventor is entitled to retain such greater rights must be submitted to the Agency Contracting Officer at the time of the first disclosure of the invention pursuant to paragraph (c)(1) of this clause, or not later than 8 months thereafter, unless a longer period is authorized in writing by the Contracting Officer for good cause shown in writing by the Contractor. Each determination of greater rights under this contract shall be subject to paragraph (c) of the FAR clause at 52.227-13 (incorporated herein by reference), and to any reservations and conditions deemed to be appropriate by the Agency such as the requirement to assign or exclusively license the rights to Subject Inventions to the Third party assignee.

A determination by the Agency denying a request by the Contractor for greater rights in a Subject Invention may be appealed within 30 days of the date the Contractor is notified of the determination to an Agency official at a level above the individual who made the determination.

If greater rights are granted, the Contractor must file a patent application on the invention. Upon request, the Contractor shall provide the filing date, serial number and title, a copy of the patent application (including an English-language version if filed in a language other than English), and patent number and issue date for any Subject Invention in any country for which the Contractor has retained title. Upon request, the Contractor shall furnish the Government an irrevocable power to inspect and make copies of the patent application file.

(c) Invention disclosure by Contractor. The Contractor shall disclose in writing each Subject Invention to the Agency Contracting Officer and to the Director, Division of Extramural Inventions and Technology Resources (DEITR), if directed by the Contracting Officer, as

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provided in paragraph (j) of this clause within 2 months after the inventor discloses it in writing to Contractor personnel responsible for patent matters. The disclosure to the Agency Contracting Officer shall be in the form of a written report and shall identify the contract under which the invention was Made and all inventors. It shall be sufficiently complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological, or electrical characteristics of the invention. The disclosure shall also identify any publication, on sale (offer for sale), or public use of the invention and whether a manuscript describing the invention has been submitted for publication, and if so, whether it has been accepted for publication at the time of disclosure.

In addition, after disclosure to the Agency, the Contractor will promptly notify the Contracting Officer and DEITR of the acceptance of any manuscript describing the invention for publication or of any on sale or public use planned by the Contractor. If the Contractor assigns a Subject Invention to the Third party assignee, then the Contractor and its employee inventors shall assist the Third party assignee in securing patent protection. All costs of securing the patent, including the cost of the Contractor's assistance, are at the Third party's expense. Any assistance provided by the Contractor and its employee inventors to the Third party assignee or other costs incurred in securing patent protection shall be solely at the Third party's expense and not billable to the contract.

(d) Contractor action to protect the Third party assignee's and the Government's interest. (1) The Contractor agrees to execute or to have executed and promptly deliver to the Agency all instruments necessary to: Establish or confirm the rights the Government has throughout the world in Subject Inventions pursuant to paragraph (b) of this clause; convey title to a Third party assignee in accordance with paragraph (b) of this clause; and enable the Third party assignee to obtain patent protection throughout the world in that Subject Invention.

(2) The Contractor agrees to require, by written agreement, its employees, other than clerical and nontechnical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the Contractor, each Subject Invention “Made” under contract in order that the Contractor can comply with the disclosure provisions of paragraph (c) of this clause, and to execute all papers necessary to file patent applications on Subject Inventions and to establish the Government's rights or a Third party assignee's rights in the Subject Inventions. This disclosure format should require, as a minimum, the information required by subparagraph (c)(1) of this clause. The Contractor shall instruct such employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars.

(3) If the Contractor is granted greater rights, the Contractor agrees to include, within the specification of any United States non-provisional patent application it files, and any patent issuing thereon, covering a Subject Invention the following statement: “This invention was made with Government support under (identify the Contract) awarded by (identify the specific Agency). The Government has certain rights in the invention.”

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(4) The Contractor agrees to provide a final invention statement and certification prior to the closeout of the contract listing all Subject Inventions or stating that there were none.

(e) Subcontracts. (1) The Contractor will include this clause in all subcontracts, regardless of tier, for experimental, developmental, or research work. At all tiers, the clause must be modified to identify the parties as follows: References to the Government are not changed, and the subcontractor has all rights and obligations of the Contractor in the clause. The Contractor will not, as part of the consideration for awarding the contract, obtain rights in the subcontractor's Subject Inventions.

(2) In subcontracts, at any tier, the Agency, the subcontractor, and the Contractor agree that the mutual obligations of the parties created by this clause constitute a contract between the subcontractor and the Agency with respect to the matters covered by the clause; provided, however, that nothing in this paragraph is intended to confer any jurisdiction under the Contract Disputes Act in connection with proceedings under paragraph (c)(1)(ii) of FAR clause 52.227- 13.

(f) Reporting on utilization of Subject Inventions in the event greater rights are granted to the Contractor. The Contractor agrees to submit, on request, periodic reports no more frequently than annually on the utilization of a Subject Invention or on efforts at obtaining such utilization that are being made by the Contractor or its licensees or assignees when a request under subparagraph b.3. has been granted by the Agency. Such reports shall include information regarding the status of development, date of first commercial sale or use, gross royalties received by the Contractor, and such other data and information as the Agency may reasonably specify.

The Contractor also agrees to provide additional reports as may be requested by the Agency in connection with any march-in proceeding undertaken by the Agency in accordance with paragraph (h) of this clause. As required by 35 U.S.C. 202(c)(5), the Agency agrees it will not disclose such information to persons outside the Government without permission of the Contractor.

(g) Preference for United States industry in the event greater rights are granted to the Contractor.

Notwithstanding any other provision of this clause, the Contractor agrees that neither it nor any assignee will grant to any person the exclusive right to use or sell any Subject Invention in the United States unless such person agrees that any product embodying the Subject Invention or produced through the use of the Subject Invention will be manufactured substantially in the United States. However, in individual cases, the requirement for such an agreement may be waived by the Agency upon a showing by the Contractor or its assignee that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.

(h) March-in rights in the event greater rights are granted to the Contractor. The Contractor acknowledges that, with respect to any Subject Invention in which it has acquired ownership through the exercise of the rights specified in paragraph (b)(3) of this clause, the Agency has the right to require licensing pursuant to 35 U.S.C. 203 and 210(c), and in accordance with the http://api.fdsys.gov/link?collection=uscode&title=35&year=mostrecent&section=202&type=usc&link-type=html http://api.fdsys.gov/link?collection=uscode&title=35&year=mostrecent&section=203&type=usc&link-type=html

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procedures in 37 CFR 401.6 and any supplemental regulations of Agency in effect on the date of contract award.

(i) Special provisions for contracts with nonprofit organizations in the event greater rights are granted to the Contractor. If the Contractor is a nonprofit organization, it shall:

(1) Not assign rights to a Subject Invention in the United States without the written approval of the Agency, except where an assignment is made to an organization that has as one of its primary functions the management of inventions, provided that the assignee shall be subject to the same provisions as the Contractor;

(2) Share royalties collected on a Subject Invention with the inventor, including Federal employee co-inventors (but through their Agency if the Agency deems it appropriate) when the Subject Invention is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR 401.10;

(3) Use the balance of any royalties or income earned by the Contractor with respect to Subject Inventions, after payment of expenses (including payments to inventors) incidental to the administration of Subject Inventions for the support of scientific research or education;

(4) Make efforts that are reasonable under the circumstances to attract licensees of Subject Inventions that are small business concerns, and give a preference to a small business concern when licensing a Subject Invention if the Contractor determines that the small business concern has a plan or proposal for marketing the invention which, if executed, is equally as likely to bring the invention to practical application as any plans or proposals from applicants that are not small business concerns; provided, that the Contractor is also satisfied that the small business concern has the capability and resources to carry out its plan or proposal. The decision whether to give a preference in any specific case will be at the discretion of the Contractor; and

(5) Allow the Secretary of Commerce to review the Contractor's licensing program and decisions regarding small business applicants, and negotiate changes to its licensing policies, procedures, or practices with the Secretary of Commerce when the Secretary's review discloses that the Contractor could take reasonable steps to more effectively implement the requirements of paragraph (i)(4) of this clause.

(j) Communications. All invention disclosures and requests for greater rights shall be sent to the Agency Contracting Officer, as directed by the Contracting Officer. Additionally, a copy of all disclosures, confirmatory licenses to the Government, face page of the patent applications, waivers and other routine communications under this funding agreement at all tiers must be sent to:

Director, Division of Extramural Inventions & Technology Resources (DEITR) Office of Policy for Extramural Research Administration (OPERA) Office of Extramural Research (OER) National Institutes of Health (NIH) 6705 Rockledge Drive, Suite 310, MSC 7980 Bethesda, Maryland 20892-7980 https://www.federalregister.gov/select-citation/2014/08/19/37-CFR-401.6 http://api.fdsys.gov/link?collection=uscode&title=35&year=mostrecent&section=202&type=usc&link-type=html https://www.federalregister.gov/select-citation/2014/08/19/37-CFR-401.10

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 15

Telephone: (301) 435-1986 Fax (301) 480-0272 NIH Invention Reporting Web site: http://www.iEdison.gov.

(End of clause)

352.227-14 Rights in Data – Exceptional Circumstances (SEPT 2014)

(a) Definitions. As used in this clause—[Definitions may be added or modified in paragraph (a) as applicable.]Show citation box

Computer database or database means a collection of recorded information in a form capable of, and for the purpose of, being stored in, processed, and operated on by a computer. The term does not include computer software.

Computer software—(i) Means (A) Computer programs that comprise a series of instructions, rules, routines, or statements, regardless of the media in which recorded, that allow or cause a computer to perform a specific operation or series of operations; and

(B) Recorded information comprising source code listings, design details, algorithms, processes, flow charts, formulas, and related material that would enable the computer program to be produced, created, or compiled.

(ii) Does not include computer databases or computer software documentation.

Computer software documentation means owner's manuals, user's manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

Data means recorded information, regardless of form or the media on which it may be recorded.

The term includes technical data and computer software. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management information.

Form, fit, and function data means data relating to items, components, or processes that are sufficient to enable physical and functional interchangeability, and data identifying source, size, configuration, mating and attachment characteristics, functional characteristics, and performance requirements. For computer software it means data identifying source, functional characteristics, and performance requirements but specifically excludes the source code, algorithms, processes, formulas, and flow charts of the software.

Limited rights means the rights of the Government in limited rights data as set forth in the Limited Rights Notice in Alternate II paragraph (g)(3) if included in this clause. “Limited rights data” means data, other than computer software, that embody trade secrets or are commercial or financial and confidential or privileged, to the extent that such data pertain to items, components, or processes developed at private expense, including minor modifications.

http://www.iedison.gov/

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 16

Restricted computer software means computer software developed at private expense and that is a trade secret, is commercial or financial and confidential or privileged, or is copyrighted computer software, including minor modifications of the computer software.

Restricted rights, as used in this clause, means the rights of the Government in restricted computer software, as set forth in a Restricted Rights Notice of Alternate III paragraph (g)(4) if included in this clause, or as otherwise may be provided in a collateral agreement incorporated in and made part of this contract, including minor modifications of such computer software.

Technical data means recorded information (regardless of the form or method of the recording) of a scientific or technical nature (including computer databases and computer software documentation). This term does not include computer software or financial, administrative, cost or pricing, or management data or other information incidental to contract administration. The term includes recorded information of a scientific or technical nature that is included in computer databases (See 41 U.S.C. 403(8)).

Unlimited rights means the rights of the Government to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so.

(b) Allocation of rights. (1) Except as provided in paragraph (c) of this clause, the Government shall have unlimited rights in—

(i) Data first produced in the performance of this contract;

(ii) Form, fit, and function data delivered under this contract;

(iii) Data delivered under this contract (except for restricted computer software) that constitute manuals or instructional and training material for installation, operation, or routine maintenance and repair of items, components, or processes delivered or furnished for use under this contract;

and

(iv) All other data delivered under this contract unless provided otherwise for limited rights data or restricted computer software in accordance with paragraph (g) of this clause.

(2) The Contractor shall have the right to—

(i) Assert copyright in data first produced in the performance of this contract to the extent provided in paragraph (c)(1) of this clause;

(ii) Use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, unless provided otherwise in paragraph (d) of this clause;

(iii) Substantiate the use of, add, or correct limited rights, restricted rights, or copyright notices and to take other appropriate action, in accordance with paragraphs (e) and (f) of this clause; and http://api.fdsys.gov/link?collection=uscode&title=41&year=mostrecent&section=403&type=usc&link-type=html

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 17

(iv) Protect from unauthorized disclosure and use those data that are limited rights data or restricted computer software to the extent provided in paragraph (g) of this clause.

(c) Copyright. (1) Data first produced in the performance of this contract. (i) Unless provided otherwise in paragraph (d) of this clause, the Contractor may, without prior approval of the Contracting Officer, assert copyright in scientific and technical articles based on or containing data first produced in the performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. The prior, express written permission of the Contracting Officer is required to assert copyright in all other data first produced in the performance of this contract.

(ii) When authorized to assert copyright to the data, the Contractor shall affix the applicable copyright notices of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number).

(iii) For data other than computer software, the Contractor grants to the Government and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly by or on behalf of the Government. For computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public) by or on behalf of the Government.

(2) Data not first produced in the performance of this contract. The Contractor shall not, without the prior written permission of the Contracting Officer, incorporate in data delivered under this contract any data not first produced in the performance of this contract unless the Contractor—

(i) Identifies the data; and

(ii) Grants to the Government, or acquires on its behalf, a license of the same scope as set forth in paragraph (c)(1) of this clause or, if such data are restricted computer software, the Government shall acquire a copyright license as set forth in paragraph (g)(4) of this clause (if included in this contract) or as otherwise provided in a collateral agreement incorporated in or made part of this contract.

(3) Removal of copyright notices. The Government will not remove any authorized copyright notices placed on data pursuant to this paragraph (c), and will include such notices on all reproductions of the data.

(d) Release, publication, and use of data. The Contractor shall have the right to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, except—

(1) As prohibited by Federal law or regulation (e.g., export control or national security laws or regulations);

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AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015029 18

(2) As expressly set forth in this contract; or

(3) If the Contractor receives or is given access to data necessary for the performance of this contract that contain restrictive markings, the Contractor shall treat the data in accordance with such markings unless specifically authorized otherwise in writing by the Contracting Officer or in the following paragraphs.

(4) In addition to any other provisions, set forth in this contract, the Contractor shall ensure that information concerning possible inventions made under this contract is not prematurely published thereby adversely affecting the ability to obtain patent protection on such inventions.

Accordingly, the Contractor will provide the Contracting Officer a copy of any publication or other public disclosure relating to the work performed under this contract at least 30 days in advance of the disclosure. Upon the Contracting Officer's request the Contractor agrees to delay the public disclosure of such data or publication of a specified paper for a reasonable time specified by the Contracting Officer, not to exceed 6 months, to allow for the filing of domestic and international patent applications in accordance with Clause 352.227-11, Patent Rights— Exceptional Circumstances (abbreviated month and year of Final Rule publication).

(5) Data on Material(s). The Contractor agrees that in accordance with paragraph (d)(2), proprietary data on Material(s) provided to the Contractor under or through this contract shall be used only for the purpose for which they were provided, including screening, evaluation or optimization and for no other purpose.

(6) Confidentiality. (i) The Contractor shall take all reasonable precautions to maintain Confidential Information as confidential, but no less than the steps Contractor takes to secure its own confidential information.

(ii) Contractor shall maintain Confidential Information as confidential unless specifically authorized otherwise in writing by the Contracting Officer. Confidential Information includes/does not include [Government may define confidential information here.]

(e) Unauthorized marking of data. (1) Notwithstanding any other provisions of this contract concerning inspection or acceptance, if any data delivered under this contract are marked with the notices specified in paragraph (g)(3) or (4) of this clause (if those alternate paragraphs are included in this clause), and use of the notices is not authorized by this clause, or if the data bears any other restrictive or limiting markings not authorized by this contract, the Contracting Officer may cancel or ignore the markings. However, pursuant to 41 U.S.C. 253d, the following procedures shall apply prior to canceling or ignoring the markings.

(i) The Contracting Officer will make written inquiry to the Contractor affording the Contractor 60 days from receipt of the inquiry to…