This is a Request for Proposal (RFP), to manufacture and preform stability testing on 4 lots of WR 279, 396 and Paromomycin Alone cream using the Batch Production Record and testing procedures provided by the Government.

Award Notice Posted

Solicitation number
W81XWH13R0040
Agency
Awarded
to Eurofins Advantar Laboratories, LLC
Set-aside
No set-aside

Opportunity facts

Contract number
W81XWH13P0425 Federal contract award
NAICS code
325412 Pharmaceutical Preparation Manufacturing
PSC
Not on record
Place of performance
US Army Medical Research Acquisition Activity Attn: Mcmr-AAA, 820 Chandler Street Frederick MD 21702 US
More information

Notice details come from SAM.gov. Updated .

Notice text

3 versions

Update #3 · Latest ·

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii)This solicitation document, W81XWH13R0040, is issued as a Request for Proposal (RFP), to manufacture and perform stability testing on 4 lots of WR 279,396 and Paromomycin Alone cream (2 lots each) using the Batch Production Record and testing procedures provided by the Government.

(iii) This solicitation document incorporates provisions and clauses that are in effect through Federal Acquisition Circular 05-66, Effective 28 February 2013.

(iv) There is no set-aside for this RFP. NAICS code:325412 Size STD 700
(v) This requirment is to provide all labor, equipement (unless other wise noted as Government Furnished Equipment (GFE)), materials, supplies, transportation, supervision, training and other items and/or services necessary to acquire 4 lots (optional 3 additional lots) of WR 279,396 and Paromomycin Alone cream along with stability testing and reports, as follows:
CLIN 0001 Manufacturing Start Up; the contractor shall supply an Approved Quality Plan; Approved Batch Production Record and an Approved Technology Transfer Report
CLIN 0002 The contractor shall supply 4 lots of (2) Combo Equivalance (2) Paromomycin Equivalance Cream
CLIN 0003 Optional Stability Testing lot 1; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0004 Optional Stability Testing lot 2; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0005 Optional Stability Testing lot 3; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0006 Optional Stability Testing lot 4; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0007 Optional Lots of Combo or Paro Cream; the contractor shall supply additional lots (Lots 5 through 7) of either Combo Equivalance Cream or Paromomycin Equivalance Cream.
CLIN 0008 Optional Stability Testing lot 5; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0009 Optional Stability Testing lot 6; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0010 Optional Stability Testing lot 7; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0011 Optional Process Validation; The contractor shall supply process validation protocal and reports, the lots are to be determined.
(vi) The requirment shall be Firm Fixed Price.
(vii) This is a multi year contract the Period of Preformance is 01 Aug 2013 through 31 July 2018.
(viii) Provision at FAR 52.252-1 Solicitation Provisions Incorporated by Reference (available at http://farsite.hill.af.mil) applies to this acquisition.

(ix) Provision at FAR 52.252-2 Clauses Incorporated by Reference (available at http://farsite.hill.af.mil) applies to this acquisition.

(x) Provision at FAR 52.212-1, Instruction to Offerors - Commercial Items, applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation is the most advantageous to the Government, price and other factors considered (considering price and ability to meet the description of work)

(xi) Provision at FAR 52.212-2, Evaluation Commercial Items, applies to this acquisition. The Government will evaluate offers in response to this request in accordance with FAR Part 13.106 procedures (lowest price technically acceptable) and award a purchase order/contract to the responsible offeror whose offer conforming to this request, will be most advantageous to the Government considering price and the ability to meet all of the solicitation requirements.

(xii) Provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition (offfers are to include a completed copy). The contractor shall be registered in the Online Representations and Certifications Application ORCA at http://orca.bpn.gov/.

(xiii) Clause at FAR 52.212-4 Contract Terms and Conditions Commercial Items, applies to this acquisition. Addendum to FAR 52.212-4:

Update #2 ·

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii)This solicitation document, W81XWH13R0040, is issued as a Request for Proposal (RFP), to manufacture and perform stability testing on 4 lots of WR 279,396 and Paromomycin Alone cream (2 lots each) using the Batch Production Record and testing procedures provided by the Government.

(iii) This solicitation document incorporates provisions and clauses that are in effect through Federal Acquisition Circular 05-66, Effective 28 February 2013.

(iv) There is no set-aside for this RFP. NAICS code:325412 Size STD 700
(v) This requirment is to provide all labor, equipement (unless other wise noted as Government Furnished Equipment (GFE)), materials, supplies, transportation, supervision, training and other items and/or services necessary to acquire 4 lots (optional 3 additional lots) of WR 279,396 and Paromomycin Alone cream along with stability testing and reports, as follows:
CLIN 0001 Manufacturing Start Up; the contractor shall supply an Approved Quality Plan; Approved Batch Production Record and an Approved Technology Transfer Report
CLIN 0002 The contractor shall supply 4 lots of (2) Combo Equivalance (2) Paromomycin Equivalance Cream
CLIN 0003 Optional Stability Testing lot 1; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0004 Optional Stability Testing lot 2; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0005 Optional Stability Testing lot 3; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0006 Optional Stability Testing lot 4; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0007 Optional Lots of Combo or Paro Cream; the contractor shall supply additional lots (Lots 5 through 7) of either Combo Equivalance Cream or Paromomycin Equivalance Cream.
CLIN 0008 Optional Stability Testing lot 5; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0009 Optional Stability Testing lot 6; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0010 Optional Stability Testing lot 7; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0011 Optional Process Validation; The contractor shall supply process validation protocal and reports, the lots are to be determined.
(vi) The requirment shall be Firm Fixed Price.
(vii) This is a multi year contract the Period of Preformance is 01 Aug 2013 through 31 July 2018.
(viii) Provision at FAR 52.252-1 Solicitation Provisions Incorporated by Reference (available at http://farsite.hill.af.mil) applies to this acquisition.

(ix) Provision at FAR 52.252-2 Clauses Incorporated by Reference (available at http://farsite.hill.af.mil) applies to this acquisition.

(x) Provision at FAR 52.212-1, Instruction to Offerors - Commercial Items, applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation is the most advantageous to the Government, price and other factors considered (considering price and ability to meet the description of work)

(xi) Provision at FAR 52.212-2, Evaluation Commercial Items, applies to this acquisition. The Government will evaluate offers in response to this request in accordance with FAR Part 13.106 procedures (lowest price technically acceptable) and award a purchase order/contract to the responsible offeror whose offer conforming to this request, will be most advantageous to the Government considering price and the ability to meet all of the solicitation requirements.

(xii) Provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition (offfers are to include a completed copy). The contractor shall be registered in the Online Representations and Certifications Application ORCA at http://orca.bpn.gov/.

(xiii) Clause at FAR 52.212-4 Contract Terms and Conditions Commercial Items, applies to this acquisition. Addendum to FAR 52.212-4:

Update #1 ·

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii)This solicitation document, W81XWH13R0040, is issued as a Request for Proposal (RFP), to manufacture and perform stability testing on 4 lots of WR 279,396 and Paromomycin Alone cream (2 lots each) using the Batch Production Record and testing procedures provided by the Government.

(iii) This solicitation document incorporates provisions and clauses that are in effect through Federal Acquisition Circular 05-66, Effective 28 February 2013.

(iv) There is no set-aside for this RFP. NAICS code:325412 Size STD 700
(v) This requirment is to provide all labor, equipement (unless other wise noted as Government Furnished Equipment (GFE)), materials, supplies, transportation, supervision, training and other items and/or services necessary to acquire 4 lots (optional 3 additional lots) of WR 279,396 and Paromomycin Alone cream along with stability testing and reports, as follows:
CLIN 0001 Manufacturing Start Up; the contractor shall supply an Approved Quality Plan; Approved Batch Production Record and an Approved Technology Transfer Report
CLIN 0002 The contractor shall supply 4 lots of (2) Combo Equivalance (2) Paromomycin Equivalance Cream
CLIN 0003 Optional Stability Testing lot 1; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0004 Optional Stability Testing lot 2; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0005 Optional Stability Testing lot 3; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0006 Optional Stability Testing lot 4; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0007 Optional Lots of Combo or Paro Cream; the contractor shall supply additional lots (Lots 5 through 7) of either Combo Equivalance Cream or Paromomycin Equivalance Cream.
CLIN 0008 Optional Stability Testing lot 5; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0009 Optional Stability Testing lot 6; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0010 Optional Stability Testing lot 7; The contractor shall supply stability testing reports for the given paramaters.
CLIN 0011 Optional Process Validation; The contractor shall supply process validation protocal and reports, the lots are to be determined.
(vi) The requirment shall be Firm Fixed Price.
(vii) This is a multi year contract the Period of Preformance is 01 Aug 2013 through 31 July 2018.
(viii) Provision at FAR 52.252-1 Solicitation Provisions Incorporated by Reference (available at http://farsite.hill.af.mil) applies to this acquisition.

(ix) Provision at FAR 52.252-2 Clauses Incorporated by Reference (available at http://farsite.hill.af.mil) applies to this acquisition.

(x) Provision at FAR 52.212-1, Instruction to Offerors - Commercial Items, applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation is the most advantageous to the Government, price and other factors considered (considering price and ability to meet the description of work)

(xi) Provision at FAR 52.212-2, Evaluation Commercial Items, applies to this acquisition. The Government will evaluate offers in response to this request in accordance with FAR Part 13.106 procedures (lowest price technically acceptable) and award a purchase order/contract to the responsible offeror whose offer conforming to this request, will be most advantageous to the Government considering price and the ability to meet all of the solicitation requirements.

(xii) Provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition (offfers are to include a completed copy). The contractor shall be registered in the Online Representations and Certifications Application ORCA at http://orca.bpn.gov/.

(xiii) Clause at FAR 52.212-4 Contract Terms and Conditions Commercial Items, applies to this acquisition. Addendum to FAR 52.212-4:

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