Formal Invitation to tender for the Provision of Von Willebrand Factor (2 lots)

AI-generated analysis of the documents. Check the official notice and any amendments for current submission details.

1. At a glance

2. Scope of Work

The contract involves the provision of Von Willebrand Factor (VWF) for the treatment of Von Willebrand Disease at St James's Hospital. This includes supplying both recombinant and plasma-derived VWF products. The anticipated annual volumes for the two lots are as follows:

• Lot 1: Recombinant Von Willebrand Factor

• Annual indicative volume: 500,000 international units (IU)

• Lot 2: Plasma-derived Von Willebrand Factor

• Annual indicative volume: 4,000,000 IU

The contractor will be responsible for:

• Supplying VWF products that are licensed in Ireland by the Health Products Regulatory Authority (HPRA) or a major European regulatory authority.
• Ensuring that products have a shelf life of at least 12 months upon delivery.
• Adhering to specified storage conditions, including maintaining room temperature for at least 6 months.
• Providing a minimum of two validated viral inactivation procedures, such as solvent detergent and heat treatment.
• Managing the logistics of delivery to St James's Hospital, ensuring timely availability of products for patient treatment.
• Reporting on product stability and efficacy as required by the contracting authority.

The contract will be managed through a Service Level Agreement (SLA) that outlines key performance indicators (KPIs) and service expectations.

3. Background & buyer context

This procurement is initiated by St James's Hospital to ensure a reliable supply of Von Willebrand Factor products for treating patients with Von Willebrand Disease. The contract aligns with the Health Service Executive (HSE) and HSE-funded agencies' strategic objectives to enhance patient care and treatment options. The current provider is not specified, but the need for a new tender arises from the desire to secure competitive pricing and reliable supply chains in the context of evolving clinical requirements.

4. Eligibility & selection criteria

Bidders must meet the following eligibility and selection criteria:

• Turnover requirement:

• Lot 1: Minimum average annual turnover of €680,000 over the past three years.

• Lot 2: Minimum average annual turnover of €2,400,000 over the past three years.

• Insurance:

• Employers Liability: €13 million

• Public Liability: €6.5 million

• Product Liability: €6.5 million

• Certifications: Not specified for this tender.

• Past experience: Not specified for this tender.

• Personnel: Not specified for this tender.

• Geographic / facility constraints: Not specified for this tender.

5. Award criteria & scoring

Bids will be evaluated based on the following criteria:

The evaluation will follow the Most Economically Advantageous Tender (MEAT) principle. There are no specified minimum scoring thresholds per criterion or overall.

6. Submission requirements

Bidders must submit the following documentation:

• Method statement / response document (using the provided template, with a maximum of 20 pages).
• CVs for key personnel (maximum of 2 pages each).
• Pricing schedule (using the compulsory pricing schedule template).
• Case studies demonstrating relevant experience (minimum of 2, with values between €500,000 and €2,000,000).
• Declarations including ESPD, Bona Fides, Tax clearance, and Conflict of Interest.
• Mandatory site visit: Not specified.
• Submission portal: All documents must be submitted electronically via eTenders in a single ZIP folder.

7. Key dates & process

8. Contract terms that matter

The contract will have a duration of 36 months, with two optional extensions of 12 months each, subject to satisfactory performance reviews. Key terms include:

• Payment terms: Not specified.
• Key SLAs/KPIs: Compliance with delivery schedules and product specifications.
• Liquidated damages: Not specified.
• Termination clauses: Not specified.
• IP ownership: Not specified.
• Sub-contracting rules: Elements of the contract may be sub-contracted, but the primary tenderer must be clearly identified.

9. Risks, red flags & unusuals

Potential risks and concerns include:

• The turnover requirements for Lot 2 are significantly higher than those for Lot 1, which may limit competition.
• The contract is contingent on the successful delivery of products that meet stringent regulatory standards, which may pose challenges for new entrants.
• The lack of specified past experience requirements may lead to variability in the quality of submissions.

10. SME fit assessment

Small and medium-sized enterprises (SMEs) that can credibly bid for this tender typically have:

• Experience in supplying medical products, particularly in the area of blood products or similar pharmaceuticals.
• The necessary insurance coverage as specified.
• The capacity to meet the turnover requirements, either independently or through a consortium.
• The ability to prepare a comprehensive bid, which may take several days to compile, including gathering documentation and case studies.

Consortium arrangements are permitted, allowing SMEs to partner with larger firms to meet the requirements.

11. Where to dig deeper

• Source RFT filename: 001 Invitation to tender for the treatment of Von Willebrand Factor 18.docx
• eTenders CFT ID: Not specified.
• Contact email: [email protected]
• Important attachments:
• Document 002 — Economic, Financial and Capacity Response Document
• Document 003 — Compulsory Pricing Schedule
• Document 004 — CA’s Terms and Conditions