(General Competitive Bidding Notice) Contracted Services for Synthesis of Drug Substance dstERAP (Clinical Trial Drug GMP Grade)

(General Competitive Bidding Notice) Contracted Services for Synthesis of Drug Substance dstERAP (Clinical Trial Drug GMP Grade) (General Competitive Bidding Notice) Contracted Services for Synthesis of Drug Substance dstERAP (Clinical Trial Drug GMP Grade) October 20, 2026 We will conduct a general competitive bidding as follows. Bidding Explanation Documents (5127KB) Inquiry Form / Contact Person Contracting Officer: President, National Institute of Biomedical Innovation, Health and Nutrition Yusuke Nakamura Details 1. Contract Name, etc. Contract Name: Contracted Services for Synthesis of Drug Substance dstERAP (Clinical Trial Drug GMP Grade) Specifications: As per bidding explanation document. Contract Period: From: Date of contract conclusion To: January 29, Reiwa 9 Delivery Location: 7-6-8 Saito Asagi, Ibaraki City, Osaka Prefecture, National Institute of Biomedical Innovation, Health and Nutrition Bidding Method: Bids shall be for the total amount. When determining the successful bid, the successful bid price will be the bid amount plus 10% of that amount (if there is a fraction of less than one yen, that fraction shall be rounded down). Therefore, bidders shall state in their bid the amount equivalent to 100/110 of the estimated contract amount, regardless of whether they are a taxable or exempt business operator for consumption tax. 2. Eligibility Requirements Not a person falling under the provisions of Article 4 and Article 5 of the Contract Administration Manual. Must be rated in grade A to D in "Sales of Goods" of the Reiwa 7, 8, and 9 Ministry of Health, Labour and Welfare General Competitive Bidding Qualifications (All-Ministry Unified Qualifications). Must have a system capable of reliably delivering the contracted services/goods. Must not have provided false information in the qualification application or supporting documents. Must not have a significantly deteriorated financial condition or creditworthiness. Must possess qualifications determined by the Contracting Officer based on the provisions of Article 3 of the Contract Administration Manual. For public interest corporations, there must be no issues regarding the "Thorough Review of Government-Related Public Interest Corporations" (December 25, Reiwa 21 Cabinet Decision). Must not be a person whose management is substantially controlled by a gangster or equivalent. Must be a corporate entity. Furthermore, must have no overdue taxes for corporate tax, consumption tax, and local consumption tax. Must comply with the "Act on the Protection of Personal Information" (Act No. 57 of Reiwa 15) and have the ability to properly manage personal information. Must be enrolled in social insurance (employees' pension insurance, health insurance (managed by the Japan Health Insurance Association), seaman's insurance, national pension, workers' accident compensation insurance, and employment insurance) and have no arrears in insurance premiums for the applicable systems. 3. Bidding Form Submission Location, etc. 1) Bidding Form Submission Location, Bidding Explanation Document Distribution Location, and Contact Information: 7-6-8 Saito Asagi, Ibaraki City, Osaka Prefecture, 567-0085 National Institute of Biomedical Innovation, Health and Nutrition, General Affairs Department, Accounting Division, Contract Section Phone: 072-641-9824 2) Bidding Explanation Document Distribution Method: Distribution will be available from the date of this announcement on the Procurement Information page of our institute's website, or at the distribution location specified in 3.1) above. 3) Bid Submission Deadline: Friday, November 6, Reiwa 8, 17:00 (same for mail) 4) Bid Opening Date and Time and Location: Monday, November 9, Reiwa 8, 11:00 Second Conference Room, National Institute of Biomedical Innovation, Health and Nutrition 4. Other Language and Currency Used in Contract Procedures: Japanese language and Japanese currency only. Bid Bond and Contract Deposit: Fully waived. Invalid Bids: Bids submitted by persons who do not meet the eligibility requirements specified in this announcement, bids by bidders who have failed to fulfill their obligations, and other bids that violate the bidding conditions shall be deemed invalid. Requirement for Contract Creation: Required. Method of Determining the Successful Bidder: The successful bidder will be the bidder who submits a bid that can perform the contracted services as determined by the Contracting Officer, and who submits the lowest valid bid within the limit of the estimated price established in accordance with Article 41 of the Accounting Regulations and Article 16, Paragraph 1 of the Contract Administration Manual. Details are in the bidding explanation document. Bidding Explanation Documents Subject: Contracted Services for Synthesis of Drug Substance dstERAP (Clinical Trial Drug GMP Grade) Reiwa 8 October National Institute of Biomedical Innovation, Health and Nutrition ① Bidding Explanation Document・・・・・・・・・・・・・・・・1 copy ② Specifications・・・・・・・・・・・・・・・・・・・・・・・・1 copy ③ Draft Contract・・・・・・・・・・・・・・・・・・・・・・・・1 copy ①-③: Please be familiar with the contents when responding. ④ Inquiry Form・・・・・・・・・・・・・・・・・・・・・・・・1 copy ⑤ Contact Person・・・・・・・・・・・・・・・・・・・・・・・・1 copy ④-⑤: Submit by email by the deadline (October 27, Reiwa 8). Please submit the inquiry form regardless of whether there are any inquiries. ⑥ Competitive Bidding Qualification Confirmation Documents・・・・・・・・・・・・・・・・1 copy ⑦ Pledge・・・・・・・・・・・・・・・・・・・・・・・・・・・・2 copies ⑧ Statement of Insurance Premium Payment・・・・・・・・・・・・・・・・1 copy ⑥-⑧: Submit by the deadline (November 5, Reiwa 8). ⑨ Bid Form・・・・・・・・・・・・・・・・・・・・・・・・・・・・1 copy ⑨: The first bid must be made by the representative with the authority to contract. Please strictly adhere to the submission deadline (November 6, Reiwa 8). ⑩ Bid Form and Other Instructions・・・・・・・・・・・・・・・・1 copy ⑪ Bid Withdrawal Form・・・・・・・・・・・・・・・・・・・・・・・・1 copy ⑪: If not responding, submit by November 6, Reiwa 8. ⑫ Power of Attorney・・・・・・・・・・・・・・・・・・・・・・・・1 copy ⑬ Annual Power of Attorney・・・・・・・・・・・・・・・・・・・・・・・・1 copy ⑫-⑬: Be familiar with the contents and bring them to the bid opening venue on the bid opening day (November 9, Reiwa 8) if applicable. Bidding Explanation Document Regarding the bidding notice (dated October 20, Reiwa 8) for "Contracted Services for Synthesis of Drug Substance dstERAP (Clinical Trial Drug GMP Grade)", the bidding and other procedures shall be conducted in accordance with the National Institute of Biomedical Innovation, Health and Nutrition Accounting Regulations (Reiwa 17 Regulations No. 7) (hereinafter referred to as "Accounting Regulations") and the National Institute of Biomedical Innovation, Health and Nutrition Contract Administration Manual (Reiwa 17 Manual No. 8) (hereinafter referred to as "Contract Administration Manual"), as well as this bidding explanation document. 1. Contracting Officer: President, National Institute of Biomedical Innovation, Health and Nutrition, Yusuke Nakamura 2. Consigned Work Details: (1) Contract Name: Contracted Services for Synthesis of Drug Substance dstERAP (Clinical Trial Drug GMP Grade) (2) Specifications: Details are as per the attached "Specifications". (3) Contract Period: From: Date of contract conclusion To: January 29, Reiwa 9 (4) Delivery Location: 7-6-8 Saito Asagi, Ibaraki City, Osaka Prefecture, National Institute of Biomedical Innovation, Health and Nutrition (5) Bidding Method: Bids shall be for the total amount. When determining the successful bid, the successful bid price will be the bid amount plus 10% of that amount (if there is a fraction of less than one yen, that fraction shall be rounded down). Bidders shall state in their bid the amount equivalent to 100/110 of the estimated contract amount, regardless of whether they are a taxable or exempt business operator for consumption tax. (6) Bid Bond and Contract Deposit: Fully waived. 3. Eligibility Requirements: (1) Not a person falling under the provisions of Article 4 and Article 5 of the Contract Administration Manual. (2) Must be rated in grade A to D in "Sales of Goods" of the Reiwa 7, 8, and 9 Ministry of Health, Labour and Welfare General Competitive Bidding Qualifications (All-Ministry Unified Qualifications). (3) Must have a system capable of reliably performing and delivering the contracted services/goods. (4) Must not have provided false information in the qualification application or supporting documents. (5) Must not have a significantly deteriorated financial condition or creditworthiness. (6) Must possess qualifications determined by the Contracting Officer based on the provisions of Article 3 of the Contract Administration Manual. (7) For public interest corporations, there must be no issues regarding the "Thorough Review of Government-Related Public Interest Corporations" (December 25, Reiwa 21 Cabinet Decision). (8) Must not be a person whose management is substantially controlled by a gangster or equivalent. (9) Must be a corporate entity. Furthermore, must have no overdue taxes for corporate tax, consumption tax, and local consumption tax. (10) Must comply with the "Act on the Protection of Personal Information" (Act No. 57 of Reiwa 15) and have the ability to properly manage personal information. (11) For those to whom the following systems apply, there must be no arrears in insurance premiums for the two years immediately preceding the bid submission deadline (for ⑤ and ⑥, two insurance years): ① Employees' Pension Insurance ② Health Insurance (managed by the Japan Health Insurance Association) ③ Seaman's Insurance ④ National Pension ⑤ Workers' Accident Compensation Insurance ⑥ Employment Insurance Note) For insurance premiums in ⑤ and ⑥, if the deadline for annual renewal procedures has not yet arrived for the current year, the premiums for the previous year and the year before that shall apply. If the deadline for annual renewal procedures has passed, the premiums for the current year and the previous year shall apply. Arrears are not permitted (only those whose payment deadline has passed are included for installment payments). 4. Documents to be Submitted, etc.: (1) Inquiry Form / Contact Person: Submit by email by 17:00 on Tuesday, October 27, Reiwa 8. Please submit the inquiry form regardless of whether there are any inquiries. Email Address: keiyaku＠nibn.go.jp (2) Competitive Bidding Qualification Confirmation Documents, etc.: Those wishing to participate in this general competitive bidding must submit the documents proving eligibility as per Section 3 of this bidding explanation document (*) by 17:00 on Thursday, November 5, Reiwa 8, to the location specified in 5(1). Furthermore, if requested by the Contracting Officer or their representative for explanations regarding the documents, you must comply. (*) The following documents are included: ① Copy of Qualification Examination Result Notification (All-Ministry Unified Qualifications) ② Company Profile ③ For public interest corporations, documents proving Section 3(7). ④ Pledge (Pledge under Section 3(3) and Pledge under Section 3(8)) ⑤ Statement of Insurance Premium Payment (Statement under Section 3(11)) (3) Bid Submission Deadline is Friday, November 6, Reiwa 8, 17:00 (same for mail). See Section 5 below for details. (4) Bid Withdrawal Form: If not responding, submit by the day before bid opening (November 6, Reiwa 8). (5) Power of Attorney / Annual Power of Attorney: If applicable, bring to the bid opening venue on the bid opening day (November 9, Reiwa 8). 5. Bidding Form Submission Location, etc.: (1) Bidding Form Submission Location, Contract Terms Display Location, and Contact Information: 7-6-8 Saito Asagi, Ibaraki City, Osaka Prefecture, 567-0085 National Institute of Biomedical Innovation, Health and Nutrition, General Affairs Department, Accounting Division, Contract Section Phone: 072-641-9824 (2) Bidding Form Submission Method: ① The bid form must be prepared using the attached bid form format. If submitted directly, it must be placed in an envelope, sealed, and the name (or company name/trade name for corporations) and "Bid Form for Bid Opening on November 9, Reiwa 8, Contracted Services for Synthesis of Drug Substance dstERAP (Clinical Trial Drug GMP Grade)" must be written on the envelope. ② If submitting by mail (registered mail only), use a double envelope. Write "Bid Form for Bid Opening on November 9, Reiwa 8, Contracted Services for Synthesis of Drug Substance dstERAP (Clinical Trial Drug GMP Grade)" on the outer envelope. Write the name, etc., on the inner envelope as in the case of direct submission. Send to the address in 5(1) above by the bid form submission deadline. Bids by telegram, facsimile, telephone, or other methods are not permitted. ③ Bidders cannot exchange, amend, or cancel their submitted bid forms. ④ The date on the bid form should be the submission date. (3) Invalid Bids: Bids falling under any of the following categories shall be deemed invalid: ① Those who do not have the eligibility requirements specified in this bidding explanation document. ② Those who have violated the bidding conditions. ③ Those who have failed to fulfill the obligations required of bidders. ④ Bid forms with corrected amounts. ⑤ Bid forms lacking signatures or seals. ⑥ In the case of a re-bid, bids exceeding the lowest amount of the previous bid. (4) Bid Postponement, etc.: In cases where bidders collude or exhibit disruptive behavior, and it is recognized that fair competitive bidding cannot be conducted, the bidding may be postponed or canceled. (5) Bidding by Proxy: ① If a proxy is bidding, the bidder's name, company name, or trade name, indication of proxy status, and the proxy's name must be written on the bid form and sealed. A power of attorney must be submitted by the bid opening time. ② A bidder or their proxy cannot act as a proxy for another bidder in this consigned work. 6. Bid Opening and Post-Successful Bid Procedures: (1) Bid Opening Date and Time and Location: Monday, November 9, Reiwa 8, 11:00 Second Conference Room, National Institute of Biomedical Innovation, Health and Nutrition (2) Bid Opening: ① Bid opening shall be conducted with the bidder or their proxy in attendance. However, if the bidder or their proxy is not present, staff unrelated to the bidding procedures will be in attendance. ② Bidders or their proxies cannot enter the bid opening venue after the bid opening time. ③ When entering the bid opening venue, bidders or their proxies must present or submit documents proving their eligibility, identification, or power of attorney upon request by the bidding staff. ④ Bidders or their proxies cannot leave the bid opening venue except in cases recognized as unavoidable by the Contracting Officer. ⑤ If, after bid opening, no bid reaches the estimated price limit among the bids submitted by the bidders or their proxies, a second round of bidding will be conducted. (3) Method of Determining the Successful Bidder: ① Bidders who have submitted bid forms that meet the conditions specified in the announcement and bidding explanation document. ② Those whose bids are within the limit of the estimated price established in accordance with Article 41 of the Accounting Regulations and Article 16, Paragraph 1 of the Contract Administration Manual. ③ The bidder with the lowest bid price among the eligible bidders. ④ Those recognized by the Contracting Officer as capable of reliably carrying out the contracted services and sincerely adhering to the contract terms. (4) In Case of Multiple Bidders Meeting the Successful Bid Conditions: If there are multiple bidders who meet the successful bid conditions specified in the preceding paragraph, a lottery will be held among them to determine the successful bidder. If a bidder cannot draw the lottery, a staff member unrelated to the bidding procedures will draw the lottery on their behalf to determine the successful bidder. (5) Contract Creation: ① Upon determining the successful bidder, the contract shall be concluded without delay.