Common use of Allocation criteria Clause in Contracts

Allocation criteria. 1. The frequency with which available amounts of medical countermeasures are allocated between participating Contracting Parties ("the generally applicable allocation criteria") shall be submitted to the SPPSC for approval, in accordance with Article 7. The Contracting Parties shall receive the total quantity of the medical countermeasures that they have reserved or ordered, but the rate of delivery shall depend on the production capacity of the contractor and on the generally applicable allocation criteria. 2. A Contracting Party may, on well-founded and substantiated grounds, such as problems encountered in delivery or due to urgent needs, request derogation from the generally applicable allocation criteria laid down in paragraph 1, for a specified time period. Derogation shall only be permitted following approval by the SPPSC by common accord. The Chair shall inform the SPPSC of any approved derogations from the generally applicable allocation criteria, including the time periods for which such derogations are approved. 3. Paragraph 2 shall not prevent two or more Contracting Parties agreeing, on a bilateral basis, on a temporary derogation from the generally applicable allocation criteria agreed pursuant to paragraph 1 for a framework contract they have entered into, for the amounts to which they are entitled under those criteria. Those Contracting Parties shall inform the SPPSC of any such agreement, including the duration of the temporary derogation agreed. The terms of a temporary derogation from the generally applicable allocation criteria shall be agreed between the contractor and the agreeing Contracting Parties. Where the medical countermeasures concerned are medicinal products, contractors shall ensure that the medicinal products are authorised to be placed on the market in the Member States of the Contracting Parties, in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20016 or Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 7.

Allocation criteria. 1. The frequency with which available amounts of medical countermeasures are allocated between participating Contracting Parties ("the generally applicable allocation criteria") shall be submitted to the SPPSC for approval, in accordance with Article 7. The Contracting Parties shall receive the total quantity of the medical countermeasures that they have reserved or ordered, but the rate of delivery shall depend on the production capacity of the contractor and on the generally applicable allocation criteria. 2. A Contracting Party may, on well-founded and substantiated grounds, such as problems encountered in delivery or due to urgent needs, request derogation from the generally applicable allocation criteria laid down in paragraph 1, for a specified time period. Derogation shall only be permitted following approval by the SPPSC by common accord. The Chair shall inform the SPPSC of any approved derogations from the generally applicable allocation criteria, including the time periods for which such derogations are approved. 3. Paragraph 2 shall not prevent two or more Contracting Parties agreeing, on a bilateral basis, on a temporary derogation from the generally applicable allocation criteria agreed pursuant to paragraph 1 for a framework contract they have entered into, for the amounts to which they are entitled under those criteria. Those Contracting Parties shall inform the SPPSC of any such agreement, including the duration of the temporary derogation agreed. The terms of a temporary derogation from the generally applicable allocation criteria shall be agreed between the contractor and the agreeing Contracting Parties. Where the medical countermeasures concerned are medicinal products, contractors shall ensure that the medicinal products are authorised to be placed on the market in the Member States of the Contracting Parties, in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20016 or Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 77.‌ 6 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 7 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).