Generation of Transgenic Mouse with Human Chimeric Transferrin Receptor
This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement con... This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. NINDS-20-005984 includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2020-05 (effective March 30, 2020) simplified procedures for commercial items. This acquisition will be conducted under the procedures for acquiring commercial items authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.501. This requirement is assigned North American Industry Classification System (NAICS) code 112990 with a size standard of $1.0 million dollars. Only one award will be made because of this solicitation. This will be awarded as a firm fixed price type contract. BACKGROUND The Brain MRI Molecular Contrast Unit (BMCCU) in NINDS is developing a novel class of brain MRI contrast agents which will provide for improved contrast of specific brain pathologies. As part of this endeavor, the ability to translate into humans is paramount. There are distinct amino acid level differences between the mouse and human transferrin receptor, which will be utilized as the targeting domain for delivery into the brain. We require the production of a novel transgenic mouse model possessing human protein sequence embedded in the endogenous mouse transferrin receptor to allow for binding and uptake while not interfering with the native function of the receptor in mouse biology. The salient characteristics that apply to this acquisition are as follows: The Government requires a novel human-mouse chimeric transferrin receptor transgenic mouse model as follows: i) The mouse endogenous transferrin receptor apical domain (amino acids 199-381) will be replaced with the human transferrin receptor apical domain (amino acids 196-378). ii) The mouse will be designed such that the endogenous intron/exons will be utilized and not a cDNA cassette to preserve intronic signaling which may not be fully elucidated and lead to potential transcription/translation error. iii) The mouse will be engineered using CRISPR/Cas9 methodology using genomic sequence for development of the targeting construct. iv) The final construct will be introduced into ES cells to establish validated knockin cells for introduction into mice. The ES cell clones will be karyotyped to ensure correct insertion within the locus. v) Delivery of a targeting vector analysis to ensure integrity. vi) Delivery of an ES cell genotyping report to ensure proper targeting prior to introduction in mice. vii) Heterozygous mice will be generated from the ES cell clones for delivery. viii) Provide exclusivity of the transgenic line regarding intellectual property. Vendor will not retain or provide produced transgenic line as a product to other consumers. ix) Guarantee of minimum 3-4 heterozygous transgenic mice Quantity: A minimum of three to four heterozygous knockin chimeric mice will be delivered, healthy, and capable of breeding to establish a sustained animal colony. PAYMENT Payment shall be made upon the delivery and acceptance of all required items in accord with the Prompt Payment Act. DELIVERY / INSTALLATION The Contractor shall deliver the item(s) within 34-40 weeks of purchase order award to the following location. Delivery shall be to: 10 Center Drive Building 10, 5C Bethesda, MD 20892 CONTRACT CLAUSES/PROVISIONS The following Federal Acquisition Regulation and Health & Human Services Acquisition Regulation Provisions/Clauses apply to this acquisition: FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This solicitation incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/. Clause No. Title FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2018) FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (OCT 2018) FAR 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (OCT 2018) FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (JAN 2019). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition: FAR Clause 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment FAR Clause 52.209-9 Updates of Publicly Available Information Regarding Responsibility FAR Clause 52.219-28 Post Award Small Business Program Representation FAR Clause 52.222-3 Convict Labor FAR Clause 52.222-19 Child Labor-Cooperation with Authorities and Remedies FAR Clause 52.222-21 Prohibition of Segregated Facilities FAR Clause 52.222-26 Equal Opportunity FAR Clause 52.222-36 Affirmative Action for Workers with Disabilities FAR Clause 52.222-40 Notification of Employee Rights Concerning Payment of Union Dues or Fees FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving FAR Clause 52.225-3 Buy American Act -Free Trade Agreements - Israeli Trade Act FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases Far Clause 52.232-33 Payment by Electronic Funds Transfer-System for Award Management FAR Clause 52.204-25_Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment FAR Clause 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Please complete and resubmit with offer) FAR 52.227-14 – Rights in Data-General EVALUATION The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Refer to Technical Factors under Attachment 2. Technical Factors and Past Performance when combined, are significantly more important than cost or price. RESPONSES AND PRICE PROPOSAL Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); and product description. In addition, your quote must include the following: Federal Tax Identification Number (TIN); Data Universal Numbering System (DUNS) Number; and Business Size (e.g., small or large). Please submit an executed copy of FAR Clause 52.204-25_Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment FAR Clause 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (attached). Contracting Office Address: 301 North Stonestreet Avenue Bethesda, MD 20892 United States Primary Point of Contact.: Michelle Cecilia Contract Specialist michellececilia.cecilia@nih.gov Phone: 301-827-7199 Secondary Point of Contact: Valerie Whipple, Contracting Officer valerie.whipple@nih.gov Phone: 301-827-5218 SUBMISSION INFORMATION All responses must be received by 2:00 P.M., Eastern Standard Time, on May 14, 2020, and reference number NINDS-20-005984. Responses must be submitted electronically via electronic mail at michellececilia.cecilia@nih.gov and valerie.whipple@nih.gov . Fax responses will not be accepted. ? ATTACHMENT 2: TECHNICAL FACTORS The Government will award a contract or purchase order resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors (Generation of targeting vector and ES cell line and Guarantee of live animal delivery with appropriate geneotype) together shall be considered more important than cost/price and past performance combined. The technical evaluation factors are detailed below: Factor 1: The product meets all the salient characteristics listed above. Pass/Fail x) The mouse endogenous transferrin receptor apical domain (amino acids 199-381) will be replaced with the human transferrin receptor apical domain (amino acids 196-378). xi) The mouse will be designed such that the endogenous intron/exons will be utilized and not a cDNA cassette to preserve intronic signaling which may not be fully elucidated and lead to potential transcription/translation error. xii) The mouse will be engineered using CRISPR/Cas9 methodology using genomic sequence for development of the targeting construct. xiii) The final construct will be introduced into ES cells to establish validated knockin cells for introduction into mice. The ES cell clones will be karyotyped to ensure correct insertion within the locus. xiv) Delivery of a targeting vector analysis to ensure integrity. xv) Delivery of an ES cell genotyping report to ensure proper targeting prior to introduction in mice. xvi) Heterozygous mice will be generated from the ES cell clones for delivery. xvii) Provide exclusivity of the transgenic line regarding intellectual property. Vendor will not retain or provide produced transgenic line as a product to other consumers. xviii) Guarantee of minimum 3-4 heterozygous transgenic mice Factor 2: Demonstrates generation of targeting vector and ES cell line (20%) The contractor shall detail in its technical proposal how it shall meet each of the project requirements. This shall include detailed specifications of the offered transgenic mouse and its capabilities to provide satisfactory results. Technical approach shall be evaluated for the ways in which the proposed equipment meets or exceeds the equipment specification requirements. Factor 3: Demonstrates guarantee of live animal delivery with appropriate genotype (80%) The contractor shall detail in its technical proposal the terms and conditions for delivery of the outlined transgenic animal and ensure that additional technical attempts will be made with the ES cells should the initial animal fail to meet quality standards and checks. Factor 4: Past Performance (Not Scored) The offeror shall provide a list of two (2) past performance references completed during the past three (3) years, similar in size and scope to the requirements outlined in the Statement of Work. Offerors shall include the following information for each contract identified: • Name of Contracting Organization • Contract Number • Contract Type • Total Contract Value • Description of Requirement and Specific Responsibilities of the Offeror as they relate to this SOW • Contract Period of Performance 5. Factor 4: Cost/Price (Not Scored) Offeror(s) cost/price proposal will be evaluated for reasonableness. For a price to be considered reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404. The Offeror shall submit firm fixed prices for all items listed in the SOW/PD (including option period(s) or optional lines, if applicable). Technical proposals will be evaluated using a summary adjectival rating in accordance with the following scale: Excellent The proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and objectives. The risk of unsuccessful performance is very low as the proposal provides a clear understanding of the requirements and demonstrates the offerors ability to meet the requirement. Risk Level: Very Low Good The proposal demonstrates an approach which is expected to meet all requirements and objectives. This approach includes advantageous characteristics of substance, and few relatively minor disadvantages, which collectively can be expected to result in satisfactory performance. The risk of unsuccessful performance is low as the proposal contains alternative solutions which are considered feasible and practical. These solutions are further considered to reflect low risk in that they are clear and precise, supported, and demonstrate an understanding of the requirements. Risk Level: Low Acceptable The proposal demonstrates an approach which is capable of meeting all requirements and objectives. The approach includes both advantageous and disadvantageous characteristics of substance, where the advantages are not outweighed by the disadvantages. Collectively, the advantages and disadvantages are likely to result in acceptable performance. The risk of unsuccessful performance is moderate, as the proposal solutions are generally feasible and practical. These solutions may also be considered to reflect moderate risk in that they may be somewhat clear and precise, partially supported, and/or demonstrate a general understanding of the requirements. Risk Level: Neutral Marginal The proposal demonstrates an approach which may not be capable of meeting all requirements and objectives. The approach has disadvantages of substance and advantages, which if they exist, are outweighed by the disadvantages. Collectively, the advantages and disadvantages present a low or questionable likelihood of resulting in satisfactory performance. The risk of unsuccessful performance is high as the proposal contains solutions which may not be feasible and practical. These solutions may also be considered to reflect high risk in that they lack clarity and precision, are generally unsupported, and/or do not demonstrate a complete understanding of the requirements. Risk Level: High Unacceptable The proposal demonstrates an approach which, based on a very high risk, will very likely not be capable of meeting all requirements and objectives. This approach has several disadvantages of substance, and advantages which, if they exist, are outweighed by disadvantages. Collectively, the advantages and disadvantages are unlikely to result in satisfactory performance. The risk of unsuccessful performance is very high as the proposal contains solutions which are not feasible and practical. The solutions may also be considered to reflect very high risk in that they lack any clarity or precision. Risk Level: Very High
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