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Title: |
Equipment Purchase Agreement |
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Entities: |
BioProgress plc; Bioprogress Technology International, Inc.; FMC Corp. |
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Date: |
2004 |
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Size: |
Preview shows 21KB of 56KB total |
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Price: |
$43 |
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ID: |
#284206 |
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Equipment Purchase Agreement
This Agreement is made as of February 3, 2004 by and between FMC Corporation, FMC BioPolymer, 1735 Market Street, Philadelphia, PA 19103 USA (FMC) and BioProgress PLC, Hostmoor Avenue, March, Cambridgeshire, PE15 0AX, United Kingdom (BioProgress).
WHEREAS, FMC BioProgress and BioProgress Technology International Inc (BioProgress T.I. Inc) have entered into an alliance whereby FMC has received an exclusive license of BioProgress T.I. Incs NRobe System intellectual property as more specifically described in the Master License Agreement executed as of this same date between the parties and capitalized terms not defined in this Agreement shall bear the meanings set out in the Master Licence Agreement;
WHEREAS, BioProgress shall manufacture, or have manufactured, Equipment for the production of the NRobe dosage form as more specifically described in Annex A (the NRobe Equipment or the Equipment);
WHEREAS, FMC desires to enter into a long-term commitment to purchase NRobe Equipment exclusively from BioProgress and BioProgress is willing to supply FMC with NRobe Equipment.
WHEREAS, FMC, BioProgress T.I. Inc and BioProgress have entered into a Framework Agreement executed on this same date that establishes general terms and conditions governing their relationship;
NOW, THEREFORE, BioProgress agrees to sell and FMC agrees to purchase the NRobe Equipment subject to the following terms and conditions:
Article One - The NRobe Dosage Form Machine; Specifications
1.1 The NRobe Equipment to be delivered to FMC shall meet the broad specifications set forth in Annex A. The parties acknowledge that although a lab scale model of the Equipment has been produced, the specifications for the Equipment that will eventually be purchased under this Agreement and commercialized by FMC have not been finalized but will be developed by mutual agreement according to the process set forth in Annex B. Accordingly, FMC acknowledges that it will be jointly responsible for the final agreed Specifications (the Specifications) and that it has undertaken its own due
diligence with respect to whether Equipment made fully in accordance with the Specifications is fit for any particular purpose. The warranty given by BioProgress pursuant hereto shall, accordingly, be limited to compliance with the Specifications and freedom from defects in materials or workmanship.
1.2 FMC acknowledges that BioProgress intends to have a third party specialty manufacturer (the Contract Manufacturer) produce the Equipment under its supervision. Any such arrangements are the responsibility of BioProgress, provided however that: (i) FMC will have the right to consult and visit any Contract Manufacturer involved in fabrication of any element of the Equipment; (ii) any such Contract Manufacturer will be fully apprised of FMCs exclusive rights to the NRobe System intellectual property, shall expressly disclaim and waive any claim to such intellectual property currently existing and\or developed by BioProgress, BioProgress T.I. Inc or FMC in the future, and shall assign such intellectual property to BioProgress T.I. Inc (for licensing to FMC pursuant to the Master License Agreement); (iii) to the extent that any improvements in such intellectual property are developed by such Contract Manufacturer, BioProgress shall procure that the Contract Manufacturer shall grant to BioProgress T.I. Inc a fully paid royalty free irrevocable licence to use such improvements (for licensing to FMC); where such improvements are not severable from the NRobe System intellectual property, such licence shall be exclusive in the field of the NRobe System; (iv) any contract with any such third party Contract Manufacturer shall contain provisions consistent with the preceding items (i), (ii) and (iii); and (v) FMC shall have the right to approve any Contract Manufacturer selected by BioProgress hereunder (provided, however, that approval is hereby granted to the appointment of Harro Hfliger Verpackungsmaschinen GmbH) (HH) as the initial Contract Manufacturer subject to the agreement of appropriate terms). So soon as is practicable following the date of signature hereof, and, in any event within ten ( 10) days, FMC and BioProgress will jointly commence negotiating in good faith the terms of a supply agreement with HH which contains such provisions and is otherwise to the extent possible consistent with the terms of this Agreement; provided that it is expressly agreed that if the terms finally agreed with HH as to liability (which shall include, without limitation, the terms of the obligation to insure which will be reviewed in the light of industry practice), delivery, and pricing factors are not consistent with those in this Agreement, the Parties will amend the terms of this Agreement so that they reflect the terms finally agreed with HH in such supply agreement. For purposes of this Agreement it is understood and agreed that BioProgress may delegate its design, production, shipment, and installation roles to a Contract Manufacturer.
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1.3 Any Contract Manufacturer to be utilized by BioProgress (other than HH which FMC acknowledges complies with the criteria) must meet the following criteria:
| i) | the Contract Manufacturer must have a demonstrable and successful record of manufacturing equipment for producing solid dosage forms; |
| ii) | the Contract Manufacturer must be in compliance with all applicable cGMP standards and other regulations applicable to production of pharmaceutical (or vitamin, as applicable) dosage forms; |
| iii) | the Contract Manufacturer must have demonstrable technical capabilities that will assure it can meet its specific design, production, and\or installation role. |
1.4 FMC reserves the right to, on reasonable notice, change the Specifications of the Equipment to meet specific customer needs subject to the Change Control Procedure set out in Article 1.5. If the Specifications change requires a design change, the design review procedures set forth in Article Two shall also be triggered.
1.5 If FMC requires a change in the Specifications of the Equipment, FMC shall notify BioProgress in writing specifying in as much detail as practicable the nature of the such change or improvement. Upon receipt of such notification, the following procedures shall come into effect:
| (i) | BioProgress shall liaise with the Contract Manufacturer to consider the impact upon the design or production of the Equipment of the change or improvement proposed, the requirement for any additional development work tooling and/or equipment, the effect upon existing production schedules, the manner of defraying the additional development or capital costs (which shall be for the account of FMC) and the potential effect upon the price of the Equipment concerned and shall, as soon as practicable, and in any event within thirty (30) days, prepare and deliver to FMC a report specifying in reasonable detail the additional costs likely to be incurred and/or any investment required and giving a preliminary estimate on the effects on the price of the Equipment (including, if so requested, amortization of additional investment costs over any quantity of the Equipment for which FMC is prepared to place firm and binding orders), its estimate of the effect of such change or improvement on production of existing orders and, if applicable,why it considers that its ability to provide Equipment pursuant to this Agreement may be adversely affected. |
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| (ii) | BioProgress shall discuss any proposed change or improvement with FMC which may withdraw its proposal or make such changes as it deems expedient to its proposal in the light of BioProgresss comments and BioProgress shall then prepare a firm estimate of the effect on the price of the Equipment. |
| (iii) | Within fourteen (14) days of receipt of such firm estimate, FMC shall either: |
| (a) | accept the proposal in which case the parties shall sign a memorandum recording the change to the Specifications the resulting change to the price of the Equipment and any additional development or tooling costs payable; or |
| (b) | withdraw its request. |
| (iv) | No change to the Specifications shall be implemented without the agreement of both parties recorded in accordance with sub-clause 1.5(iii)(a) above. |
| 1.6 | BioProgress or the Contract Manufacturer may also propose improvements in the Equipment which shall be dealt with in accordance with clause 1.5 above. |
| 1.7 | The parties recognize that modifications to the Specifications may be required by law or regulation, particularly those relating to the safety of the Equipment or any products produced thereby. Such modifications shall be addressed in accordance with clause 1.5 above. |
Article Two - Design Reviews
2.1 Consistent with the Design Cooperation Protocol set forth in Annex B, BioProgress shall periodically review the final design of the NRobe Equipment with FMC as such designs are being developed so that FMC may verify BioProgress progress and compliance with the Specifications. Prior to the release of the final design BioProgress and FMC shall conduct a final design review. It is understood that all designs, layout and detail drawings, etc., necessary for FMCs verification and review will be made available at these times. Upon request, BioProgress engineers and managers will be available to FMC for consultation regarding the design. If BioProgress delegates any design work to a Contract Manufacturer, FMC will have the same design review rights stated above with respect to the work of the Contract Manufacturer.
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2.2 During the period BioProgress is manufacturing or having manufactured the Equipment, FMC shall have the right to visit the manufacturing plant (by prior written notice during normal working hours) as may be necessary to allow FMC to review progress and verify that the Equipment is being manufactured according to the Specifications provided that FMC shall use all reasonable efforts not to disrupt production at the Contract Manufacturers plant and shall undertake to comply with such security and safety requirements as BioProgress or the relevant Contract Manufacturer shall reasonably require. BioProgress will provide periodic reports to FMC describing the progress being made by BioProgress in the major production steps as outlined in the production schedule set forth in Annex C.
Article Three - Acceptance\Performance Testing
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