AMENDMENT 0001 RFQ-BARDA-08-17.doc

RFQ-BARDA-08-17

Amendment 0001

PRIVATE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

N/A

PRIVATE

2. AMENDMENT/MODIFICATION NO.PRIVATE

3. EFFECTIVE DATE

04/11/2008

4. REQUISITION/PURCHASE REQ. NO

N/A

5. PROJECT NO. (If applicable)

N/A

PRIVATE

6. ISSUED BY

U.S. DEPT OF HEALTH & HUMAN SERVICES

ASPR/BARDA

330 INDEPENDENCE AVE SW, ROOM G640

WASHINGTON, D.C. 20201

N/A

PRIVATE

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State, and Zip Code)

FORMCHECKBOX

9A. AMENDMENT OF SOLICITATION NO.

RFQ-BARDA-08-17

9B. DATED (SEE ITEM 11) 04/01/2008

FORMCHECKBOX

10A. MODIFICATION OF CONTRACT/ORDER NO.

CODE:

FACILITY CODE:

10B. DATED (SEE ITEM 11)

PRIVATE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FORMCHECKBOX

The above numbered solicitation is amended as set forth in item 14. The hour and date specified for receipt of Offers FORMCHECKBOX is extended FORMCHECKBOX is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning ONE (1) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers, FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

PRIVATE

12. ACCOUNTING AND APPROPRIATION DATA (If Required)

N/A

PRIVATE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO., AS DESCRIBED IN ITEM 14

PRIVATE

FORMCHECKBOX

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify Authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

FORMCHECKBOX

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43,103 (b).

FORMCHECKBOX

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

FORMCHECKBOX

D. OTHER (Specify type of modification and authority)

PRIVATE

E. IMPORTANT: Contractor

FORMCHECKBOX

PRIVATE

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.

The purpose of this amendment is to extend the quotation due date, update Exhibit A, and update paragraphs 3.2, 4.18, and 6.3 of the solicitation. The solicitation referenced in block 9A hereof is amended as set forth in the continuation sheets for block 14 hereto attached.

PRIVATE

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

PRIVATE

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

PRIVATE

15B. CONTRACTOR/OFFEROR

15C. DATE

SIGNED

16B. UNITED STATES OF AMERICA

16C. DATE

SIGNED

(Signature of person authorized to sign)

(Signature of Contracting Officer)

NSN 7540-01-152-8070

STANDARD FORM 30 (REV. 10-83)

Previous Edition Unusable

Prescribed by GSA FAR (48 CFR) 53.243

CONTINUATION OF BLOCK 14 OF SF 30

1. The due date for quotations set forth in Block 8 of SF 1449 is changed as follows:

FROM:

April 16, 2008. 04:30PM EDT.

TO:

April 25, 2008. 04:30PM EDT.

2. The text of paragraph 3.2 of the solicitation is changed as follows:

3.2. Insert a check mark in paragraph (b) of FAR 52.212-5 to items (1), (16)-(24), (28), (31), and (36).

TO:

3.2. Insert a check mark in paragraph (b) of FAR 52.212-5 to items (1), (7), (8)(iii), (10), (16)-(24), (28), (31), and (36).

3. The text of paragraph 4.18 of the solicitation is changed as follows:

FROM:

4.18. Fair Opportunity Ordering. Subject to FAR § 16.505, Ordering, the following procedures will be used to issue orders hereunder.

4.18.1 SEQ CHAPTER \h \r 1All work under this contract will be ordered through the issuance of written "Task Order(s)" on an Optional Form 347 signed by the contracting officer. The contracting officer is the only individual authorized to award a Task Order under this contract. The contractor shall only commence work upon receipt of a written Task Order award executed by the contracting officer.

4.18.2 For orders exceeding the micro-purchase threshold, see FAR § 2.101, at the time of the order placement, and subject to the exceptions to the fair opportunity process, see FAR § 16.505(b)(2), the Government will place an order with the contract-holder that provides the greatest overall benefit to the Government upon consideration of factors pertinent to an individual order.

4.18.3 Fair opportunity to be considered for each order will be accomplished by one, or a combination of, the following order placement procedures.

4.18.3.1. In accordance with FAR 16.505(b)(1), the contracting officer will provide each awardee a fair opportunity to be considered for each order exceeding $3,000 issued under multiple task order contracts by issuing a Task Order Request (TOR) to each contract-holder. The contracting officer may issue a TOR to fewer than all contract-holders upon a determination that one of the exceptions to the fair opportunity process described in FAR 16.505(b)(2) applies. A TOR will be issued either verbally by the contracting officer, or in a written format that has been executed by the contracting officer. A review pursuant to this subparagraph will be deemed adequate for fair opportunity consideration.

(a) A TOR may provide a Statement of Work, order-specific factors to be used in the selection decision, reporting requirements, deliverables and delivery schedule, and any special instructions or terms applicable to the order.

(b) Selection factors for award will be specific for each individual order.

(c) A TOR will request a written proposal and/or an oral presentation to be prepared and submitted by the contract-holder to the contracting officer. The contracting officer will use the TOR proposal as one basis, or the sole basis, for the order placement decision. The TOR will set forth the specific requirements for the proposal. Information that may be requested includes, but is not limited to, an approach to perform the work, technical and managerial resources, schedule for performance identifying major milestones, conflict-of-interest certification, and a price itemized by price elements.

(d) Unless otherwise specified in a TOR, a contract-holder shall prepare and deliver a proposal within seven (7) calendar days of receipt of the TOR to the contracting officer for consideration.

4.18.4 Orders placed hereunder will be executed on an OF 347 and will, at a minimum, contain the following information:

(a) Date of order.

(b) Contract number and order number.

(c) Description of services, contract item number(s) and description, quantity, and price.

(d) Delivery or performance schedule.

(e) Place of delivery or performance (including consignee).

(f) Any packaging, packing, and shipping instructions.

(g) Accounting and appropriation data.

(h) Delegation of a Task Order Project Officer, if applicable.

4.18.5 The name, address, telephone number, facsimile number and e-mail address of the agency task and delivery order ombudsman will be included at contract award

TO:

4.18. Fair Opportunity Ordering. Subject to FAR § 16.505, Ordering, the following procedures will be used to issue orders hereunder.

4.18.1 SEQ CHAPTER \h \r 1All work under this contract will be ordered through the issuance of written "Task Order(s)" on an Optional Form 347 executed by the contracting officer. The contracting officer is the only individual authorized to issue a Task Order under this contract. The contractor shall only commence work upon receipt of a properly awarded written Task Order executed by the contracting officer.

4.18.2 For orders exceeding the micro-purchase threshold, see FAR § 2.101, at the time of the order placement, and subject to the exceptions to the fair opportunity process, see FAR § 16.505(b)(2), the Government will place an order with the contract-holder that provides the greatest overall benefit to the Government upon consideration of factors pertinent to an individual order.

4.18.3 Fair opportunity to be considered for each order will be accomplished by one, or a combination of, the following order placement procedures.

4.18.3.1. If the contracting officer has adequate information available at the time of order placement to ensure that each awardee is provided a fair opportunity to be considered for placement of that order in accordance with Article 4.18.2, then the contracting officer may, without contacting any of the contract-holders before selecting an order awardee, unilaterally issue an order to a contract-holder. The type of information that the contracting officer may review includes, but is not limited to, contract-holders’ pricelists and items; past performance on earlier orders under this contract, including quality, timeliness and price; potential impact on other orders placed with the contractor; and/or other available information pertinent to the contract-holder’s capability to perform the order. A review pursuant to this subparagraph will be deemed adequate for fair opportunity consideration.

4.18.3.2. If the contracting officer, at his discretion, determines that additional information should be obtained from a contract holder(s) prior to an order placement, then the contracting officer may issue a Task Order Request (TOR) to the extent needed to establish an adequate basis for fair opportunity consideration of placement of that order in accordance with Article 4.18.2. The contracting officer may issue a TOR to fewer than all contract-holders. A TOR will be issued either verbally by the contracting officer, or in a written format that either has been executed by the contracting officer or sent via electronic mail directly from the contracting officer. A review pursuant to this subparagraph will be deemed adequate for fair opportunity consideration.

(a) A TOR may provide a Statement of Work, order-specific factors to be used in the selection decision, reporting requirements, deliverables and delivery schedule, and any special instructions or terms applicable to the order.

(b) Selection factors for award will be specific for each individual order.

(c) A TOR will request a written proposal and/or an oral presentation to be prepared and submitted by the contract-holder to the contracting officer. The contracting officer will use the TOR proposal as one basis, or the sole basis, for the order placement decision. The TOR will set forth the specific requirements for the proposal. Information that may be requested includes, but is not limited to, an approach to perform the work, technical and managerial resources, schedule for performance identifying major milestones, conflict-of-interest certification, and a price itemized by price elements.

(d) Unless otherwise specified in a TOR, a contract-holder shall prepare and deliver a proposal within seven (7) calendar days of receipt of the TOR to the contracting officer for consideration.

4.18.4 Orders placed hereunder will be executed on an OF 347 and will, at a minimum, contain the following information:

(b) Date of order.

(b) Contract number and order number.

(c) Description of services, contract item number(s) and description, quantity, and price.

(d) Delivery or performance schedule.

(e) Place of delivery or performance (including consignee).

(f) Any packaging, packing, and shipping instructions.

(g) Accounting and appropriation data.

(h) Delegation of a Task Order Project Officer, if applicable.

4.18.5 [Reserved] [The name, address, telephone number, facsimile number and e-mail address of the agency task and delivery order ombudsman will be included at contract award]

4. The text of paragraph 6.3 of the solicitation is changed as follows:

6.3. Paragraph (b)(6) of FAR 52.212-1 is hereby tailored by inserting at the end of the sentence, “In accordance with the terms and conditions of this solicitation, and Exhibit A, Supplies or Services and Prices/Costs, all proposals shall provide a pricing table including items, units of measure, time for delivery after receipt of order, and prices for all supplies and services that may be necessary to perform any order issued hereunder within the Scope of Work, see Solicitation, Article 5.0, Attachment 1. All items shall be defined and/or described (e.g., a labor category definition in terms of function and requirements; service definition in terms of tasks performed). Items and prices shall be proposed for the base ordering period and each of the three optional ordering periods, for a total of four ordering periods. The Government intends to establish all items and all prices at the time of contract award that may be necessary to perform any order issued under the contract; therefore, it is imperative that quoters submit all pricing information with their initial quotation. Failure to submit adequate pricing information may result in rejection of your quotation.”

6.3. Paragraph (b)(6) of FAR 52.212-1 is hereby tailored by inserting at the end of the sentence, “In accordance with the terms and conditions of this solicitation, and Exhibit A, Supplies or Services and Prices/Costs, all proposals shall provide a pricing table including items, units of measure, time for delivery after receipt of order, and prices for all supplies and services that may be necessary to perform any order issued hereunder within the Scope of Work, see Solicitation, Article 5.0, Attachment 1. All items shall be defined and/or described (e.g., a labor category definition in terms of function and requirements; service definition in terms of tasks performed). Items and prices shall be proposed for the base ordering period and each of the three optional ordering periods, for a total of four ordering periods. The Government intends to establish all items and all prices at the time of contract award that may be necessary to perform any order issued under the contract; therefore, it is imperative that quoters submit all pricing information with their initial quotations. Failure to submit adequate pricing information may result in rejection of your quotation. Additionally, the Government provides a list of items in Exhibit A that are anticipated to be needed in performance of orders within the Scope of Work; this list is not inclusive of all items that may be needed or quoted. Quoters shall provide pricing, at a minimum, for the Base Period and each Option Period for the items set forth in Exhibit A by the Government, and may additionally include any other items deemed necessary.”

5. Exhibit A, Supplies or Services and Prices/Costs, to the solicitation is changed as follows:

Exhibit A

Supplies or Services and Prices/Costs

ARTICLE A.1.0

Brief description of supplies or services

This is an indefinite-delivery, indefinite-quantity (IDIQ) contract for services and related supplies to conduct pre-clinical animal safety and toxicology studies. During the ordering period of the contract, contracting officers assigned to the office in Block 16 of the SF 1449 may order services or supplies at the ceiling prices herein, or may request the contractor to propose a price that will not exceed the ceiling prices.

A.1.1. The Government will issue all orders under the contract on a firm-fixed price basis or a time and materials/labor hour basis with a not-to-exceed price.

A.1.2. The contract-holder shall only incorporate the items and prices set forth herein to develop its performance approach and price proposal in response to a Task Order Request, see Solicitation, Article 4.0.

A.1.3. While it is the Government’s intent to establish all items and all prices at the time of contract award that may be necessary to perform any order issued within the Scope of Work, see Solicitation, Article 5.0, Attachment 1, the Government recognizes that in extraordinary circumstances, an order may require specialized item(s) that were not foreseen during contract negotiations and thus are not listed in the Contract Price List, see Article A.2.0, infra. Costs/Prices for any such specialized items shall be separately identified in an order proposal, shall be based upon documented prices/costs and such documentation shall be provided with the proposal, will be evaluated pursuant to the policies and methods in FAR Subpart 15.4, and will be subject to negotiation. The Government may reject a proposal containing such items at its discretion, if the Government deems such rejection to be in its best interests.

ARTICLE A.2.0

Contract Price List

CLIN

Item

Unit Time for Delivery Ceiling Price [For example, Base Period:

Labor Category

A001 Scientist I

Hr n/a

$100.00 A002 Technician III

$ 80.00 Option Period I:

Supply Item

A101 Towel

$ 1.00

Fixed Rate for Service

A102 Assay I test 3 days ARO

$500.00]

Exhibit A

Supplies or Services and Prices/Costs

ARTICLE A.1.0

Brief description of supplies or services

This is an indefinite-delivery, indefinite-quantity (IDIQ) contract for services and related supplies to conduct pre-clinical animal safety and toxicology studies. During the ordering period of the contract, contracting officers assigned to the office in Block 16 of the SF 1449 may order services or supplies at the ceiling prices herein, or may request the contractor to propose a price that will not exceed the ceiling prices.

A.1.1. The Government will issue all orders under the contract on a firm-fixed price basis or a time and materials/labor hour basis with a not-to-exceed price.

A.1.2. The contract-holder shall only incorporate the items and prices set forth herein to develop its performance approach and price proposal in response to a Task Order Request, see Solicitation, Article 4.0.

A.1.3. While it is the Government’s intent to establish all items and all prices at the time of contract award that may be necessary to perform any order issued within the Scope of Work, see Solicitation, Article 5.0, Attachment 1, the Government recognizes that in extraordinary circumstances, an order may require specialized item(s) that were not foreseen during contract negotiations and thus are not listed in the Contract Price List, see infra Article A.2.0. Costs/Prices for any such specialized items shall be separately identified in an order proposal, shall be based upon documented prices/costs and such documentation shall be provided with the proposal, will be evaluated pursuant to the policies and methods in FAR Subpart 15.4, and will be subject to negotiation. The Government may reject a proposal containing such items at its discretion, if the Government deems such rejection to be in its best interests.

ARTICLE A.2.0

Contract Price List

CLIN

Item

Unit Time for Delivery Ceiling Price A001 General Health observations (Base Period) A101 General Health observations (Option Period 1) A201 General Health observations (Option Period 2) A301 General Health observations (Option Period 3) A002 Viability

A102

A202

A302

A003 Physical exams

A103

A203

A303

A004 Body weights

A104

A204

A304

A005 Inoculation site scoring

A105

A205

A305

A006 Body temperature

A106

A206

A306

A007 Urinalysis

A107 A207

A307 A008 Hematology1 A108

A208

A308

1Hematology Panel

A009 Clinical Chemistry2 A109

A209

A309

2Clinical Chemistry Panel

A010 Necropsy3 A110

A210

A310

3Necropsy Panel

X

X

X

X

X

X

A011 Histopathology3 A111

A211

A311

3 Histopathology Panel

X

X

X

X

X

X

Additional Items:

[For example, Base Period:

Labor Category

A001 Scientist I

$100.00 A002 Technician III

$ 80.00 Option Period I:

Supply Item

A101 Towel

Ea

$ 1.00

Fixed Rate for Service

A102 Assay I test 3 days ARO

$500.00]

[END OF AMENDMENT 0001]