Standing Offer Agreement for the provision of scientific expert advice or review and recommendation on non-clinical and Toxicology data.

NOTICE OF PROPOSED PROCUREMENT (NPP)

Solicitation #: 1000201293 Closing Date: June 19,2018 Time: 2 PM, EDT

This requirement is for the department of Health Canada.

TITLE:

Standing Offer Agreement for the provision of scientific expert advice or review and recommendation on

non-clinical and Toxicology data.

BACKGROUND:

The Therapeutic Products Directorate (TPD) at Health Canada (HC) requires the services of

external scientific experts to provide scientific advice and/or review non-clinical data,

concerns/issues on multiple different ongoing files for new or supplemental new drug

submissions.

The assessment will guide TPD in determining the final disposition of these submissions and any

further evaluation of the product.

SCOPE:

The consultant will be required to perform a critical review and provide expert scientific opinion, in the

form of feedback or a written report, on issues including, but not limited to, the following:

• non-clinical data (e.g., pharmacology, non-clinical pharmacokinetics, toxicology, genotoxicity);

• responses to clarifaxes from sponsors that may require special toxicology or non-clinical

expertise;

• appropriate safety levels of excipient ingredients identified in drug substances for ongoing drug

submissions;

• qualifying data and studies for impurities identified during chemistry review of drug submissions;

• effect of shelf-life extensions on levels of impurities in drug substances for ongoing drug

submissions;

Notice of Proposed Procurement (NPP)

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ESTIMATED VALUE: $2,500,000.00 including option years.

OWNERSHIP OF INTELLECTUAL PROPERTY: The Crown will own Intellectual Property.

SECURITY REQUIREMENT:

The Contractor/Offeror personnel requiring access to PROTECTED information, assets or

sensitive work site(s) must EACH hold a valid RELIABILITY STATUS, granted or approved

by Health Canada or CISD/PWGSC.

Subcontracts which contain security requirements are NOT to be awarded without the prior

written permission of Health Canada.

The Contractor/Offeror must comply with the provisions of the:

(a) Security Requirements Check List and security guide (if applicable), attached at

Appendix “B”;

(b) Industrial Security Manual (Latest Edition).

It is a condition that, prior to performance of any obligation under any Call-up resulting from this

RFSO, the Contractor and sub-contractors and their employees assigned to the performance of

such contract will be security cleared by the federal government at the reliability level.

If the successful bidder does not have the required reliability level prior to performance of any

obligation under any contract resulting from this RFSO, Health Canada will sponsor the security

screening for the Contractor and sub-contractors and their employees assigned to the performance

of such contract until it is obtained. However, no Call-up against any Standing Offer can be

permitted for that resource until the required security clearance is obtained.

Notice of Proposed Procurement (NPP)

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MANDATORY REQUIREMENTS:

Attention Bidders: Each of the below Mandatory Criteria MUST be included in the technical

Proposal. Write beside each of the criteria the relevant page number(s) from your proposal

which addresses the requirement identified in the criteria.

Bidders MUST meet ALL the mandatory requirements described below. This will be evaluated as

Yes” or “No”. Proposals not receiving “Yes” for any mandatory requirement will not

be considered further.

Mandatory Criteria Page # YES NO

M1. Bidders MUST provide demonstrated evidence, by providing a detailed

curriculum vitae for each proposed resource, of a minimum total of three(3) years of

experience within the last five(5) years (final date of inclusion is May 7, 2018) of

working experience critically assessing toxicological data. This experience could be

gained from a consulting firm, pharmaceutical or biotechnology company, regulatory

agency or academic institution.

The potential consultant should also highlight their area of expertise (e.g. reproductive

toxicology, genotoxicity, teratology, general toxicology, etc).

M2. The resource(s) proposed by the Bidder MUST have a minimum of a D.V.M or

M.D. or Master’s degree from a recognized university, in toxicology or a related

discipline. Copy of degree required for each resource. Please note that a ‘world

equivalency’/credential is required for any non-Canadian degrees.

M3. All proposed resources MUST have completed the exercise entitled “

‘Toxicological evaluation of proposed impurity limits for styrene, Impurity X and

Impurity Y in sodium polystyrene sulfonate drug product’ (See Appendix A).

M4. Certifications at Appendix A

Bidders MUST sign and submit ALL Certifications at Appendix "A" with the technical

proposal.

Notice of Proposed Procurement (NPP)

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SELECTION METHODOLOGY:

Compliant Combined Rating of Technical Merit and Price:

It is understood by the parties submitting proposals that, to qualify, bidders must meet all mandatory

requirements as well as the minimum score identified for the point-rated criteria (70%). The contract

will be awarded based on a determination of best value taking into account both the technical merit of the

proposals and the price evaluations. To arrive at an overall score achieved by a firm, a weighting has

been established whereby technical merit will be valued at 80% of the bid and price at 20%.

Enquiries regarding this Request for Proposals are to be submitted in writing to:

Name: Randy Brown

Email address: randy.brown2@canada.ca