FDA-RFQ-1120913.doc

FDA-RFQ-1120913

PART 1: DESCRIPTION

All questions shall be submitted to Juana Quinteros via email at Juana.Quinteros@fda.hhs.gov. Questions are due no later than August 20, 2013, 2:00PM Eastern Time.

All quotes and revisions shall be submitted to Juana Quinteros via email at

Juana.Quinteros@fda.hhs.gov.

Quotes and all revisions are due no later than September 6, 2013, 4:30 PM Eastern Time.

Offerors shall ensure the RFQ number is visible in the subject line of the email.

Faxed quotes shall not be accepted.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 13 and included in this notice. This announcement constitutes the only full and open competition solicitation. The resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-69.

PART 2: SUPPLIES OR SERVICES AND PRICES/COSTS

2.1 The government anticipates a Firm Fixed price contract for an Evaluation of Drug Product Formulation and in-vitro performance characteristics related to abuse-deterrence for solid oral dosage forms of opioids.

2.2 Pricing:

Materials and Equipment

PART 3: DESCRIPTION/SPECIFICATIONS

Background Opioid analgesics, which are commonly prescribed for pain in both cancer and non-cancer patients, carry a high risk of abuse and misuse and have accounted for increase in visits to the emergency departments and deaths related to drug overdose. Drug overdose rates have been rising steadily in the Unites States since 1970 with more than 15,500 deaths reported in 2009. One of several Agency efforts to reduce the abuse and misuse of opioid prescription drugs is encouraging development of abuse-deterrent formulations of opioids. Abuse-deterrent formulations are intended to prevent manipulation of the drug product for extraction of the active with the purpose to employ alternate routes of administration, such as snorting, injection, and smoking.

In the recent past, the Agency has approved several new formulations of opioids that are designed to deter abuse. According to FDA commissioner, Margaret Hamburg, if the FDA concludes that the newly approved opioid formulations significantly deter abuse, the agency will have the legal authority to require generic versions of those products to also have abuse-deterrent properties.

The science of abuse deterrence through formulation modification is relatively new, therefore, requiring research in this area. Specifically, understanding the influence of role of excipients in the formulation, coupled with the manufacturing process, in conjunction with in vitro methods used to determine the consequences of product tampering would greatly assist in the development of risk models to assist in the Agency’s evaluation of abuse-deterrent products. Information generated from this research will assist in the assessment of innovator product claiming to have tamper resistant properties. It will also enable the development of needed equivalence standards to evaluate generic versions claiming abuse-deterrent properties.

Objectives The project will investigate the effect of physicochemical properties of the active and excipients and composition of the drug product, along with the drug product manufacturing technology on the manipulation of the drug product for extraction of the active ingredient for putative abuse. This investigation will employ various mechanical and chemical manipulation techniques, commonly used by abusers, to assist in extraction of the active from the drug product, coupled with in-vitro characterization techniques to develop objective standards for abuse-deterrent properties.

Technical Requirements:

Task 1 Formulation development A variety of “abuse-deterrent” formulations will be prepared using different drug-excipient ratios and manufacturing process using model drugs.

Task 2: Formulation Testing

These formulations will be tested and compared to both marketed abuse-deterrent formulations as well as traditional formulations for physico-chemical properties related to product tampering such as hardness, and dissolution. These products will also be compared via a battery of in vitro physical manipulation and chemical extraction tests to determine the influence of formulation design features on potential tampering.

Task 3: Developing risk assessment model and standards.

The results of these studies comparing different formulation designs will be used to develop a graded risk assessment model and standards to evaluate abuse-deterrent formulations.

Reports and Deliverables:

Quarterly Progress Report

30 days following the close of every third month from the contract award date.

Reports (i.e., quarterly progress reports, annual reports and final report), containing the description of experiments and data analysis, will be provided to the FDA in both paper and electronic format. In addition, all of the raw data from the experiments will be provided to the FDA in both paper and electronic format, along with these reports.

No information furnished to or generated by the contractor in the performance of this contract will be released to the public until it has been reviewed by the Government Contracting Officer’s Technical Representative for accuracy of factual data and interpretation. The Government will have sixty (60) calendar days after receipt of the manuscript or other written draft of the material to be released, to review, comment, and return to the contractor. The contractor and the Government will mutually agree on the authorship of any scientific paper(s) resulting from this contract.

Receipts for appropriate expenditures should be submitted and will be reimbursed at each three month reporting period.

PART 4: INSPECTION AND ACCEPTANCE

The OCOMM COR will perform inspection and acceptance of deliverables to be provided.

For the purpose of this PART, (Determined at time of Award) is the authorized representative of the Contracting Officer.

PART 5: DELIVERY OR PERFORMANCE

5.1

PERIOD OF PERFORMANCE

Base Year-

September 15, 2013-September 14, 2014

Option Year One- September 15, 2014-September 14, 2015

5.2

PLACE OF PERFORMANCE

Contractor’s Facility or an offsite appropriate facility will be the place of performance. Any in person meetings will occur at 7500 Standish Place, Rockville, MD 20855.

PART 6: CONTRACT ADMINISTRATION

Contracting Officers Representative (COR)

6.1 The following COR will represent the Government for the purpose of this contract: (Determined at time of Award )

6.1.1The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

6.1.2 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

Contracting Officer and Specialist 6.1.3 The contact information for the Contracting Officer:

James Chestnut James.Chesnut@fda.hhs.gov 301-827-3366

6.1.4 The contact information for the Contract Specialist:

Juana Quinteros

Juana.Quinteros@fda.hhs.gov

301-827-6764

PART 7: SPECIAL CONTRACT REQUIREMENTS

INVOICING INSTRUCTIONS

FDA TWO-WAY-Matching Invoice Clause

A.

The contractor shall submit all invoices to all addressees in the manner specified below:

(I) One original and one copy to the approving official:

U.S. Food And Drug Administration

Office Of Acquisitions And Grants Services

ATTN: Juana Quinteros/CS 5630 Fishers Lane

Room 2122, HFA-500

Rockville, Maryland 20857

E-mail: Juana.Quinteros@FDA.HHS.GOV *** Acceptable methods of delivery include: mail, hand delivery, and e-mail

(II) One copy to the contracting officer representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

U.S. Food And Drug Administration

Office Of Program Operations

ATTN: [INSERT NAME], COR

White Oak Campus

10903 New Hampshire Avenue

Room XXXX

Silver Spring, Maryland 20993

E-mail: xxxx.xxxx@FDA.HHS.GOV

*** Acceptable methods of delivery include: mail, hand delivery, or e-mail

B.

Invoices submitted under this contract must comply with the requirements set forth in far clauses 52.232-25 (prompt payment) and 52.232-33 (payment by electronic funds transfer – central contractor registration) and/or other applicable far clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) name and address of the contractor;

(ii) invoice date and invoice number;

(iii) purchase order/award number;

(iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(v) shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) terms of any discount for prompt payment offered;

(vii) name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) name, title, and phone number of person to notify in event of defective invoice;

(ix) taxpayer identification number (TIN);

(x) electronic funds transfer (EFT) banking information, including routing transit numberof the financial institutionreceivin payment and the number of the account into which funds are to be deposited;

(xi) name and telephone number of the FDA contracting officer technical representative (cotr) or other program center/office point of contact, as referenced on the purchase order;

(xii) any other information or documentation required by the purchase order/award.

(xiii) contractor is ■ is not □ required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) List Of All Invoices Submitted To Date Under The Subject Award, Including The Following:

(1) Invoice Number, Amount, & Date Submitted

(2) Corresonding Payment Amount & Date Received

(B) Total Amount Of All Payments Received To Date Under The Subject Contract Or Order

(C) And, For Definitized Contracts Or Orders Only, Total Estimated Amounts Yet To Be Invoiced For The Current, Active Period Of Performance

C.

An electronic invoice is acceptable if submitted in adobe acrobat (pdf) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D.

Questions regarding invoice payments should be directed to the FDA payment office at:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments

PART 8: CLAUSES

8.1 FAR Clauses:

8.1.1 FAR Clause 52.252-2: Clauses Incorporated by Reference (FEB 1998):

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquisition.gov/far/index.html.

· FAR 52.212-4: Contract Terms and Conditions—Commercial Items (FEB 2012).

· FAR 52.216-24: Limitation of Government Liability (APR 1984).

· FAR 52.217-5: Evaluation of Options (JUL 1990).

· FAR 52.217-8: Option to Extend Services (NOV 1999).

· FAR 52.217-9: Option to Extend the Term of the Contract (MAR 2000).

· FAR 52.233-2: Service of Protest (SEP 2006).

· FAR 52.246-4: Inspection of Services-Fixed Price Clause

FULL TEXT:

8.1.2 FAR 52.212-5: Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (AUG 2013):

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)).

____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

_X__ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-5).

___ (6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note).

___ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

___ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

___ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__X_ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (11) [Reserved]

___ (12) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (13) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

_X__ (14) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (15 U.S.C. 637(d)(2) and (3)).

___ (15) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (iv) Alternate III (July 2010) of 52.219-9.

___ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

___ (18) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (19) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

___ (ii) Alternate I (June 2003) of 52.219-23.

___ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (21) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_x__ (23) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

_x__ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

___ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Mar 2012) (E.O. 13126).

_x__ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_x__ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_x__ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

_x__ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

__x_ (32) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

_x__ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

___ (34) 52.222-54, Employment Eligibility Verification (Jul 2012). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (37) (i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).

___ (ii) Alternate I (Dec 2007) of 52.223-16.

_X__ (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).

___ (39) 52.225-1, Buy American Act--Supplies (Feb 2009) (41 U.S.C. 10a-10d).

___ (40) (i) 52.225-3, Buy American Act--Free Trade Agreements--Israeli Trade Act (Nov 2012) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

___ (ii) Alternate I (Mar 2012) of 52.225-3.

___ (iii) Alternate II (Mar 2012) of 52.225-3.

___ (iv) Alternate III (Nov 2012) of 52.225-3.

___ (41) 52.225-5, Trade Agreements (Nov 2012) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X__ (42) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (43) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2303 Note).

___ (44) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (45) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (46) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

_X__ (47) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

___ (48) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (49) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (50) 52.232-36, Payment by Third Party (Jul 2013) (31 U.S.C. 3332).

___ (51) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (52) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

_X__ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

_X__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__X_ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act -- Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C.206 and 41 U.S.C. 351, et seq.).

___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act -- Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

___ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

___ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

___ (7) 52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O. 13495).

___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Mar 2009) (Pub. L. 110-247).

___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

(vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(viii) 52.222-41, Service Contract Act of 1965, (Nov 2007), (41 U.S.C. 351, et seq.)

(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (Nov 2007) (41 U.S.C. 351, et seq.)

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (Feb 2009) (41 U.S.C. 351, et seq.)

(xii) 52.222-54, Employment Eligibility Verification (Jul 2012).

(xiii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xiv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xv) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations

8.2 HHSAR Clauses Incorporated by Reference

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: http://farsite.hill.af.mil/VFHHSARA.HTM.

HHSAR Clause Description

Date

352.202-1

Definitions

(Jan 2006)

352.203-70

Anti-lobbying

352.215-70

Late proposals and revisions

352.223-70

Safety and health

352.224-70

Privacy Act

352.228-7

Insurance--Liability to third persons

(Dec 1991)

352.233-71

Litigation and claims

352.242-73

Withholding of contract payments

(Jan 2006)

352.242-71

Tobacco-free Facilities

352.242-74

Final decisions on audit findings

(Apr 1984)

352.270-1

Accessibility of meetings, conferences, (Jan 2001) and seminars to persons with disabilities

PART 9: INSTRUCTIONS TO OFFERORS

9.1 This contract incorporates one or more provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html:

52.212-1 Instructions to Offerors – (JUL 2013) Commercial Items

52.212-3 Offeror Representations and Certifications-Commercial Items

(AUG 2013)

An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via https://www.acquisition.gov.

9.2 Technical Capability The cover letter shall include; FOB point; a POC (name and telephone number); a statement from the offeror verifying that they are SAM Registered; business size; and payment terms.

Factor 1: Scientific and Technical Approach

Scientific and technical appropriateness, adequacy and feasibility of the proposal to perform tasks specified in the Scope of Work.

Factor 2: Personnel

a) Adequacy and appropriateness of the documented experience, education, training and availability of the Team investigators and other personnel proposed to accomplish the tasks specified in the Scope of Work. Specifically, at minimum, the principal investigator should have a graduate degree in the area of respiratory drug delivery, pharmacokinetics and pharmacodynamics of orally inhaled drug products, or equivalent training and experience in this area.

b) Adequacy and appropriateness of the demonstrated ability of the key personnel to manage complex and diverse pharmaceutical product research, development projects, pharmacokinetic studies for orally inhaled drug products.

Factor 3: Equipment and Facilities

Documented availability of adequate equipment and facilities for conducting all phases of the proposed research as specified in the Scope of Work, including analytical instruments for measurements of APSD and pharmacokinetic measurements.

Factor 4: Past Performance/Experience The offeror shall submit references for the same or similar experience directly relevant to the type of work needed that demonstrates satisfactory performance.

Such experience includes projects performed in the past two years similar in scope to this requirement.

9.3 Price The offeror shall submit a complete pricing matrix for a firm fixed-price as indicated in PART 2, 2.2.

PART 10: EVALUATION FACTORS

Award will be made to the party whose quote offers the best value to the Government. The Government shall award using a tradeoff process. The Government will evaluate information based on the following evaluation criteria to meet or exceed the requirements:

Evaluation factors will include; 1) Scientific and Technical Approach (50 percent); 2) Personnel (30 percent); 3) Equipment and Facilities (20 percent); 4) Past Performance; and price.

Scientific and Technical Approach, Personnel and Equipment and Facilities when combined with past performance are significantly more important than price. When all factors are equal, price becomes the determining factor.

The offeror’s ability to demonstrate the following factors as noted in PART 9.

10.1 Scientific and Technical Approach The contractor shall demonstrate they can provide all of the items listed under the Technical Requirements section in Part 3.

10.1.1 The offeror meets the requirement to provide a Firm Fixed price contract for an Evaluation of Drug Product Formulation and in-vitro performance characteristics related to abuse-deterrence for solid oral dosage forms of opioids for a period of 24 months.

10.2 Personnel The contractor shall demonstrate that they can provide the required Labor categories and meets the Personnel requirement in section 9.2.

10.3 Equipment and Facilities

The contractor shall demonstrate that they can provide adequate equipment and facilities and meets the Equipment and Facilities requirement in section 9.2.

10.4 Past Performance/ Experience

The offeror meets and has demonstrated the past performance/experience requirement in section 9.2.

10.5 Price

The price proposal shall represent the Offeror’s response to the requirements of the solicitation. The Government will evaluate the total price of all contract line items.

The Offeror’s ability to submit a complete pricing matrix for a firm fixed-price as indicated in PART 2, 2.2.

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