: Cytotoxicity and Genotoxicity Testing in Human Hepatic (HepaRG) Cells Treated with Diverse Chemical Toxicants

HEALTH CANADA ADVANCE CONTRACT AWARD NOTICE

TITLE:  Cytotoxicity and Genotoxicity Testing in Human Hepatic (HepaRG) Cells Treated with Diverse Chemical Toxicants

SOLICITATION NUMBER:   1000162249

1.  The purpose and explanation of an ACAN

An Advance Contract Award Notice (ACAN) allows Health Canada contracting authorities to post a notice on the Government Electronic Tendering System (GETS), for no less than fifteen (15) calendar days, indicating to the supplier community that a good, service or construction contract will be awarded 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.

2.  Rights of suppliers

Suppliers who believe that they are fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities clearly demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If there is a reasonable level of evidence regarding capability, the requirements will be opened to electronic or traditional bidding processes.

3.  Proposed Contractor

Integrated Laboratory Systems Inc. (ILS)
PO Box 13501
Research Triangle Park,  NC  27709
U.S.A.

4.  Definition of Requirements or Expected Results

Health Canada is seeking to award a contract to Integrated Laboratory Systems (ILS) to perform cytotoxicity and genotoxicity testing following chemical exposures of human cells to diverse genotoxic and non-genotoxic agents.  The scientific data will be used to assist Health Canada in the development of non-animal based lab methods for the practical application of genomics tools for hazard identification and human health risk assessment of environmental chemicals. Dr. Carole Yauk, a research scientist at Health Canada, was recently awarded a five-year Genomics Research and Development Initiative (GRDI) grant through a competitive, externally reviewed process.  Dr. Carol Swartz, the In Vitro Toxicology Program Manager at ILS, and Dr. Leslie Recio, the Chief Scientist at ILS, co-authored with Dr. Carole Yauk, the proposal that won the five-year GRDI grant.   ILS has worked with Health Canada for the past two years through a contract that was initially awarded through a competitive contracting process. ILS has already optimized the methodology that is required for the next phase of the research.  

5.  Minimum requirements

Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements: 

a.	The supplier’s principal investigator must have a PhD in biomedical sciences (toxicology, biochemistry, molecular biology, etc.) and at least ten years of direct experience managing in vitro genetic toxicology experiments.

b.	The project team must have significant expertise in mechanistic-based toxicology research in the area of mutagenesis, toxicogenomics and regulatory-based genotoxicity assessment.
  
c.	The contractor must have at least ten years of experience conducting chemical exposures in human TK6 cells.

d.	The contractor must have extensive experience using rat liver S9 metabolic activation with human TK6 cells (i.e., optimization of concentration and type of induction based on the chemical of interest).

e.	The contractor must have at least one year of experience conducting chemical exposures in human HepaRG cells.

f.	The contractor must have demonstrated proficiency conducting cytotoxicity and genotoxicity testing using high-content flow cytometry-based assays to measure cell viability, apoptosis/ necrosis, cell cycle arrest and micronucleus frequency with the In Vitro MicroFlow test kit in both human TK6 cells and human HepaRG cells.

g.	The contractor must be familiar with the TGx-28.65 genotoxicity classifier, a 65-gene signature developed using 28 genotoxic and non-genotoxic chemicals in human TK6 cells in culture.

h.	The contractor’s facility and procedures must be consistent with industry standards for Quality Control (QC) and Quality Assurance (QA), including Standard Operating Protocols (SOPs) for the required testing that meet national or international guidelines (e.g., OECD test guideline 487), established data acceptance criteria, established data management and processing procedures, and established procedures for data analysis, data interpretation, and preparation of final reports.
i.	The contractor must have managed and executed at least 5 projects of similar nature, size and complexity in the last 5 years. 
j.	The project team must include a minimum of 2 members, including a project manager/mechanistic-based toxicologist, specializing in mutagenesis and toxicogenomics, and a laboratory technician. 

6.  Reason for non-competitive award

Section 6 of the Government Contracts Regulations contains four exceptions that permit the contracting authority to set aside the requirement to solicit bids.  For the proposed procurement, the following exception applies:

(d)	Only One Person or Firm is capable of performing the contract.

In light of the fact that the work of the proposed contract will build on work performed by ILS under a previous contract that was competitively awarded, and the fact that senior scientists at ILS helped to draft the proposal that won the funding for this latest work, it is believed that ILS has unique technical expertise and advantage that makes it highly unlikely any other supplier could do the work, especially for the funding available.

7.  Applicable trade agreements and justification for limited tendering or the Procurement Strategy for Aboriginal Business

This requirement is subject to the various trade agreements, including the North American Free Trade Agreement (NAFTA); the Agreement on Internal Trade (AIT); and the World Trade Organization - Agreement on Government Procurement (WTO-GPA).  However, this requirement also meets the conditions for limiting the tendering procedures in accordance with:

I.	AIT, Article 506.12 (b).
II.	NAFTA, Article 1016.2 (b)
III.	WTO-AGP, Article XV
	
which allow for contracts to be directed to a particular firm when the products or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists.
	
This requirement is not subject to the Procurement Strategy for Aboriginal Business.

8.  Ownership of Intellectual Property

Health Canada will retain ownership of the copyright on the deliverables of this contract by virtue of Section 6.4.1 of the Treasury Board Secretariat Policy on Title to Intellectual Property Arising Under Crown Procurement Contracts, which states that the Crown may retain ownership of intellectual property when the main purpose of the contract is to generate knowledge and information for public dissemination.

9.  Period of the proposed contract

The contract period shall be from the award of the contract until May 31, 2015.  Health Canada reserves the right to exercise four option periods.

10.  Estimated value of the proposed contract

The initial contract is worth $50,000.00 CAD.  However, the contract will include four option years at a maximum of $50,000.00 CAD per year, for a maximum total potential contract value of $250,000.00 CAD. 

11. Closing date and time 

The closing date and time for accepting Statements of Capabilities is 2 p.m. EDT on the 24th
of July 2014.

12.  Contact Person

All inquiries with regard to this Notice must be addressed by e-mail to:

Robert Merrick
Senior Contracting Officer
Materiel and Assets Management Division
Health Canada
E-mail:   Robert.Merrick@hc-sc.gc.ca