CONTRACT NOTICE – OFFICIAL JOURNAL

Section I: Contracting Authority

I.1)

Name, Address and Contact Point(s)

I.2)

Type of contracting Authority and Main Activity or Activities

Other (Please specify) Private Company Limited by Guarantee

General public services Defence Public order and safety Environment Economic and financial affairs Health Housing and community amenities Social protection Recreation, culture and religion Education Other (Please specify) Cell Therapies

Section II: Object of the Contract

II.1)

Description

II.1.1)

Title attributed to the contract by the contracting authority

II.1.2(a))

Type of works contract

II.1.2(b))

Type of supplies contract

II.1.2(c))

Type of service contract

II.1.2)

Main site or location of works, place of delivery or performance

UK.

II.1.3)

This notice involves

A public contract
The setting up of a Dynamic Purchasing System
The establishment of a framework agreement

II.1.4)

Information on framework agreement (if applicable)

Framework agreement with a single operators
Framework agreement with several operators

Number of participants to the framework agreement envisaged

Duration of the framework agreement

Justification for a framework agreement the duration of which exceeds four years

Estimated total value of purchases for the entire duration of the framework agreement

Frequency and value of the contracts to be awarded

II.1.5)

Short description of the contract or purchase(s)

The Cell Therapy Catapult has recognised the need to engage with established Manufacturing Partners to leverage existing expertise across the Cell Therapy industry in its pursuit of the rapid development, delivery and commercialisation of cell therapies.

The Cell Therapy Catapult has internal activities for analytical, process development and manufacturing proving with its facilities on the 12th Floor of Guy's Hospital. It is desired to partner with centres of excellence for clinical manufacturing activities.

The Cell Therapy Catapult is engaged in numerous projects with an array of diverse products, and therefore wishes to engage in a framework agreement with several suppliers covering a wide range of skills and capabilities in order that these can be leveraged when required.

In order to fulfil its mission, the Cell Therapy Catapult needs to have access to sufficient manufacturing outsource providers to be able to confidently deliver on current and future projects across the entirety of the cell therapy industry. These projects could be internal Cell Therapy Catapult projects or those for which the Cell Therapy Catapult is acting on behalf of a client or partner. For this reason the Cell Therapy Catapult is looking to engage with outsource providers who may be able to offer one or more desired services in the following lots:

Lot 1: Immune cell therapy manufacture (including gene modified immune cell therapy).

Lot 2: Pluripotent derived cell therapy manufacture (iPS or hES).

Lot 3: MSC and other multi-potent cell therapy manufacture.

Lot 4: Other somatic cell therapy manufacture.

Lot 5: 3D culture based cell therapy manufacture.

To enable the manufacture in the specific lots the organisation should have experience, expertise and technology that includes the following activities where relevant to the particular lot:

— MHRA MIA(IMP) license for cell therapy applications (or equivalent local license outside of the UK);

— HTA license for donor material procurement testing (or equivalent local license outside of the UK);

— Hosting of GMP audits;

— Tech transfer support for incoming processes, including ability to absorb Catapult staff into the facility to aid tech transfer;

— Preparation of batch documentation;

— Manufacturing technologies and capability to enable processes may include but should not be limited to:

- Non-enclosed processing (using MBSCs within grade B background or isolators within grade C or grade D background);

- Enclosed processing (using closed systems in a grade C or grade D background);

- Adherent cell culture in T-flasks, cell factories and on microcarriers in bioreactors;

- Suspension culture of cells in static mode and in bioreactors;

- 3D culture of cells on surfaces;

- Cell separation;

- Cell activation;

- Differentiation;

- Volume reduction and washing of cells;

- Aseptic vial/bag filling;

- Product labelling;

- Cryopreservation;

— QC analytical testing of final products, in-process controls and raw materials;

— QA batch review;

— QP release of clinical material;

— Regular project meetings to report progress.

II.1.6)

Common Procurement Vocabulary (CPV)

II.1.7)

Contract covered by the Government Procurement Agreement (GPA)

II.1.8)

Division into lots

one lot only

one or more lots

all lots

II.1.9)

Will variants be accepted

II.2)

Quantity or Scope of the Contract

II.2.1)

Total quantity or scope

II.2.2)

Options

Provisional timetable for recourse to these options

Number of possible renewals

In the case of renewable supplies or service contracts, estimated time frame for subsequent contracts

II.3)

Duration of the contract or limit for completion

Section III: Legal, Economic, Financial and Technical Information

III.1)

Conditions Relating to the Contract

III.1.1)

Deposits and guarantees required

Tenderers may be requested to sign a Parent Company Guarantee, depending on the evaluation of Financial Information.

III.1.2)

Main Terms of financing and payment and/or reference to the relevant provisions

III.1.3)

Legal form to be taken by the grouping of suppliers, contractors or service providers to whom the contract is to be awarded

III.1.4)

Other particular conditions to which the performance of the contract is subject

Any conditions will be detailed in the tender documents.

III.2)

Conditions for Participation

III.2.1)

Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers

Please see the PQQ.

III.2.2)

Economic and financial capacity

III.2.3)

Technical capacity

III.2.4)

Reserved contracts

The contract is restricted to sheltered workshops
The execution of the contract is restricted to the framework of sheltered employment programmes

III.3)

Conditions Specific to Service Contracts

III.3.1)

Is provision of the service reserved to a specific profession?

III.3.2)

Will legal entities be required to state the names and professional qualifications of the personnel responsible for the execution of the service?

Section IV: Procedure

IV.1)

Type of Procedure

Open		Restricted
Accelerated restricted		Negotiated
Accelerated negotiated		Competitive dialogue

Justification for the choice of accelerated procedure

IV.1.1)

Have candidates already been selected?

IV.1.2)

Limitations on the number of operators who will be invited to tender or to participate

Objective criteria for choosing the limited number of candidates

Please see the PQQ.

IV.1.3)

Reduction of the number of operators during the negotiation or dialogue

Recourse to staged procedure to gradually reduce the number of solutions to be discussed or tenders to be negotiated

IV.2)

Award Criteria

IV.2.2)

An electronic auction will be used

IV.3 Administrative Information

IV.3.1)

Reference number attributed to the notice by the contracting authority

CON-0038

IV.3.2)

Previous publication(s) concerning the same contract

Prior Information Notice
Notice on a Buyer Profile

Other previous publications

IV.3.3)

Conditions for obtaining specifications and additional documents

IV.3.4)

Time-limit for receipt of tenders or requests to participate

IV.3.5)

Date of dispatch of invitations to tender or to participate to selected candidates

IV.3.6)

Language or languages in which tenders or requests to participate can be drawn up

IV.3.7)

Minimum time frame during which the tenderer must maintain the tender 

IV.3.8)

Conditions for opening tenders

Section VI: Other Information

VI.1)

Indicate whether this procurement is a recurrent one and the Estimated timing for further notices to be published

VI.2)

Does the contract relate to a Project/Programme financed by Community Funds?

VI.3)

Additional Information

To express interest and request a copy of the PQQ please email ojeu@ct.catapult.org.uk

The deadline for completed PQQs is 23.6.2014 at 10:00 hours.

Prior to the deadline, Candidates will be able to attend a briefing session on the procurement process.

VI.4)

Procedures for appeal

VI.4.1)

Body responsible for appeal procedures

Body responsible for mediation procedures

VI.4.2)

Lodging of appeals
Precise information on deadline(s) for lodging appeals:

VI.4.3)

Service from which information about the lodging of appeals may be obtained

VI.5)

Dispatch date of this Notice

ANNEX B

Information About Lots

1)

Short Description

2)

Common Procurement Vocabulary (CPV)

3)

Quantity or scope

4)

Indication about different contract dates

5)

Additional Information about lots

ANNEX B

Information About Lots

1)

Short Description

2)

Common Procurement Vocabulary (CPV)

3)

Quantity or scope

4)

Indication about different contract dates

5)

Additional Information about lots

ANNEX B

Information About Lots

1)

Short Description

2)

Common Procurement Vocabulary (CPV)

3)

Quantity or scope

4)

Indication about different contract dates

5)

Additional Information about lots

ANNEX B

Information About Lots

1)

Short Description

2)

Common Procurement Vocabulary (CPV)

3)

Quantity or scope

4)

Indication about different contract dates

5)

Additional Information about lots

ANNEX B

Information About Lots

1)

Short Description

2)

Common Procurement Vocabulary (CPV)

3)

Quantity or scope

4)

Indication about different contract dates

5)

Additional Information about lots