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) Page 2 of 4 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) Page 3 of 4 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) Page 4 of 4 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