RealTime Thermocycler

Trade Agreement: NAFTA/AIT/Canada FTAs with Peru/Colombia/Panama Tendering Procedures: Generally only one firm has been invited to bid Attachment: None Non-Competitive Procurement Strategy: Interchangeable Parts Comprehensive Land Claim Agreement: No Vendor Name and Address: Life Technologies Inc. 5250 Main Way Burlington Ontario Canada L7L5Z1 Nature of Requirements: Marlene Hall Supply Specialist Telephone: 204 984-6423 E-mail: marlene.hall@pwgsc-tpsgc.gc.ca

File No.: 6D063-132299/A

TITLE: Real Time Thermocycler

Public Works and Government Services Canada (PWGSC), on behalf of Public Health Agency Canada (PHAC), intends to negotiate with Life Technologies Inc. for the provision of a Real Time Thermocycler System.

DEFINITION OF REQUIREMENT The Public Health Agency of Canada has a requirement for the supply and delivery of one (1) ABI 7500 Fast Real-Time PCR System.

The National Laboratory for HIV Reference Services (NLHRS) represents Canada's premier reference laboratory for HIV and HTLV testing in support of testing programs conducted by provincial ministries of health and the Canadian Blood Services. Our role is to strengthen the country's capacity to diagnose, detect and characterize HIV infection, which threatens the public health system and blood supply. Our reference diagnostic testing program and Reference Material, Proficiency testing and External Quality Control program supports national and international stakeholders. As well, our Surveillance program is at the leading edge of new and novel HIV and Hepatitis C testing due to its reference diagnostic and technical capacity and we have the ability to rapidly 'alert' public health and blood screening agencies of potential new threats. We have extensive experience in molecular and serological testing, from a variety of sample types, for HIV-1 and HIV-2 as well as other human retroviruses (Human T-cell Leukemia Virus (HTLV-I, HTLV-II), SIV and endogenous retroviruses (ERVs)). Our laboratory is also actively involved in the development and optimization of new and innovative technologies.

The NLHRS also possesses an invaluable expertise in HIV serological and molecular testing of challenging samples (whole blood, cell pellets, plasma, formalin fixed and frozen tissue and dried blood spots (DBS), etc.) for Canadian provinces and the Canadian Blood Services. This requires us to deliver time sensitive results in a timely manner in order to avoid devastating consequences for patients across Canada. The molecular assays that the NLHRS currently performs to detect the presence of HIV DNA are end-point nested polymerase chain reactions (PCR). The NLHRS has been working towards transferring these tests to RealTime PCR. Brand new primers and probes have been evaluated and validated on the ABI 7500 Fast instrument.

The NLHRS currently has 4 functioning thermocyclers to perform the end-point PCR assays. To successfully complete the transfer of these assays to the 7500 Fast, the NLHRS requires an additional ABI 7500 Fast instrument to maintain current workflow and meet the increased testing demand. Without this additional instrument the NLHRS would not be able to meet its turn-around-time due to delays in testing. It would be problematic to our stakeholders; the delay in testing would increase the time it takes to provide test results to the labs who submit results, this in turn would increase the time it takes for patients to receive their test results. For positive patients this could result in transmission of the virus to others if the patient is unaware of their infection status. In negative patients it could result in continued precautionary medication when it is unnecessary.

No other instrument would be acceptable as it would not fall within our current workflow or be able to be used interchangeably with the current NLHRS instrument.

SECURITY REQUIREMENT There is a security requirement associated with this requirement.

Any interested supplier must demonstrate by way of a statement of capabilities that its product meets the following mandatory requirements:

PERFORMANCE/ CRITERIA/OBJECTIVES/SPECIFICATIONS

1. The Real Time PCR system must be compatible with the current chemistry and workflow. 2. The Real Time PCR system must be in 96-microtiter well plate format.

3. The Real Time PCR system must be able to perform high-speed thermal cycling to deliver high quality results in less than 30 minutes while maintaining thermal uniformity.

4. Excellent precision; can differentiate between 5000 and 1000 template copies.

5. The Real Time PCR system must support a variety of application to follow current workflow including: - Gene expression - Absolute quantitation - SNP genotyping - High resolution melt analysis - Present/Absent analysis

6. The Real Time PCR system must be calibrated for current chemistry: FAM?/SYBR® Green I, VIC®/JOE?, NED?/ TAMRA?/ Cy3?, ROX?/Texas Red®, and Cy5?. 7. The Real Time PCR system must have multiplexing capabilities.

8. The Real Time PCR system must come with a laptop.

9. The Real Time PCR system must fit on a bench top.

JUSTIFICATION FOR PRE-IDENTIFIED SUPPLIER Life Technologies Inc. is the only known supplier that can provide an ABI 7500 Fast PCR System that meets all of the mandatory performance specifications.

TRADE AGREEMENTS The following limited tendering reasons pertain to this requirement:

Government Contract Regulations, Part 1, Section 6(d) only one person is capable of performing the contract.

Government on Internal Trade (AIT), Article 506-12(a) to ensure compatibility with existing products, to recognize exclusive rights, such as exclusive licences, copywright and patent rights, or to maintain specialized products that must be maintained by the manufacturer or its prepresentative;

North American Free Trade Agreement (NAFTA), 1016.2(d) for additonal deliveries by the original supplier that are intended either as replacement parts or continuing services for existing suppliers, services or installations, or as the extension of existing suppliers, services or installations, where a change of supplier would compel the entity to procure equipment or services not meeting requirements of interchangeability with already existing equipment or services, including software to the extent that the initial procurement of the software was covered by this Chapter;

DELIVERY DATE The equipment must be delivered on or before March 31, 2014, FOB destination.

PRE-IDENTIFIED SUPPLIER Life Technologies Inc. 5250 Mainway Burlington, Ontario L7K 5Z1 Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, may submit a statement of capabilities in writing to the contact person identified in this Notice on or before the closing date of this Notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any procurement.

Documents may be submitted in either official language of Canada.