Document:

Equipment Purchase Agreement, dated February 3, 2004, between FMC Corp

 Exhibit 4.15 
  
 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. Inc’s NRobeTM 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 NRobeTM dosage form as more specifically described in Annex A (the “NRobeTM Equipment” or the “Equipment”); 
  
 WHEREAS, FMC desires to enter into a long-term commitment to purchase NRobeTM Equipment exclusively from BioProgress and BioProgress is willing to supply FMC with NRobeTM 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 NRobeTM Equipment subject to the following terms and conditions: 
  
 Article One - The NRobeTM Dosage Form Machine; Specifications 
  
 1.1 The NRobeTM 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 FMC’s exclusive rights to the NRobeTM 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 NRobeTM System intellectual property, such licence shall be exclusive in the field of the NRobeTM 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 Höfliger 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
BioProgress’s 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 NRobeTM 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 FMC’s 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 Manufacturer’s 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 
  
 3.1 Prior to shipment of any Equipment hereunder BioProgress shall conduct a preshipment
trial pursuant to the procedure set forth in Annex D. The purpose of this trial shall be primarily to determine that the Equipment is compliant with the Specifications. With each machine delivered hereunder, BioProgress shall deliver a written
certificate certifying that the specific machine has passed this preshipment trial and fully meets the Specifications. FMC shall have the option to observe any such preshipment trial. It is understood that all defects in materials and workmanship
which may be identified as a result of this trial will be corrected by BioProgress or the Contract Manufacturer prior to shipment of the Equipment unless specifically directed to the contrary by FMC. 
  
 3.2 Unless otherwise specifically agreed, the Contract Manufacturer who has produced a
specific unit of Equipment shall assist with the installation of such Equipment. For the avoidance of doubt, BioProgress shall include the cost of such installation in its invoices for the Equipment but shall show the same as a separate item over
and above the price of the unit of Equipment. FMC shall be responsible, at its own cost or the cost of its customer, for ensuring that all footings and preparatory works required for the Equipment and made known to FMC by BioProgress are
satisfactorily completed prior to the commencement of such installation and that all power and other services are laid on in accordance with the requirements to be included in the Specifications. FMC shall be responsible for the cost of all
consumables used as part of any commissioning and testing process. 
  
 3.3 Upon
completion of installation of each NRobeTM
Equipment machine, BioProgess shall notify FMC’s representative that the subject Equipment is installed and ready for site acceptance testing. FMC or its designee shall promptly commence the site acceptance test procedure set out in Annex D.

  

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 3.4 FMC shall certify to BioProgress (in writing, upon request) its acceptance of each NRobeTM Equipment machine installed once the NRobeTM Equipment machinehas demonstrated during the site acceptance procedure its
performance to be in accordance with the Specifications. 
  
 3.5 In the event that
FMC reasonably believes that the acceptance procedure identifies areas of nonconformance with the Specifications, FMC shall itemize those areas in which the NRobeTM Equipment has failed to perform acceptably in accordance with the Specifications. BioProgress shall acknowledge said
list and, save in the case of any bona fide dispute, in which case the provisions of Clause 3.6 shall apply, shall inform FMC, in writing, as to how and when the nonconformance shall be corrected. BioProgress agrees that such corrections shall be
carried out with all reasonable despatch . FMC shall have the right to withhold payment of any outstanding funds due on such specific machine until such time as it has fully complied with Specifications. Upon completion of the corrections by
BioProgress, BioProgress shall notify FMC of same and the acceptance procedures shall again be commenced in their entirety, should FMC elect to do so. Where FMC does not elect to repeat the acceptance procedures or to refer any dispute as to
compliance pursuant to Clause 3.6 within fourteen (14) days of such notification, the specific machine shall be deemed accepted and any sums withheld in respect thereof shall become due and payable. 
  
 3.6 In the event that the parties are unable to agree whether or not the Equipment has
performed acceptably in accordance with the Specifications under the acceptance procedure or whether any Equipment has any defect in workmanship or materials, the matter may be referred at the instance of either party to such person as may be
appointed by agreement between the parties or, in default of agreement, nominated on the application of either party by the President for the time being of the Institute of Mechanical Engineers in London (the “Expert”). Such person shall
act as an expert and not as an arbitrator and shall be entitled to appoint such technical expert or experts as he considers necessary to assist him in determining the matter referred to him. The decision of the Expert (which shall be given by him in
writing stating his reasons) shall, in the absence of manifest error, be final and binding on the parties. Each party shall provide the Expert with such information as he may reasonably require for the purposes of his determination. If either party
claims any such information to be confidential to it, then provided that in the opinion of the Expert, that party has properly claimed the same as confidential, the Expert shall not disclose the same to the other party or to any third party. The
costs of the Expert (including the costs of any technical expert appointed by him) shall be borne in such proportions as the Expert may determine to be fair and reasonable in all the circumstances or, if no such determination is made by the Expert,
by the parties in equal proportions. 
  

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 Article Four - Term 
  
 4.1 The term of this Agreement shall commence on the date it has been executed by both parties and save as otherwise provided for by the
Change of Control procedures set forth in the Framework Agreement or where terminated earlier in accordance with Clauses 4.2 below, continue until the expiry or earlier termination of the Master Licence Agreement. 
  
 4.2 i). If as a result of a breach by a Contract Manufacturer of their agreement with
BioProgress, such agreement is terminated during the Initial Period, BioProgress shall, in accordance with Clause 1.2 appoint a replacement Contract Manufacturer. For the avoidance of doubt, other than as a consequence of a Change of Control or
termination of the Master Licence, FMC shall not be entitled to terminate this Agreement in the Initial Period. 
  
 ii). If, during any full calendar year after such Initial Period greater than twenty per cent (20%) of the Equipment ordered for an agreed delivery date
within such year (a) fails to be delivered within 5 weeks following such agreed delivery date, or (b) fails to be accepted pursuant to Article 3, or (c) is in breach of the clause 11.2 below and BioProgress cannot replace, repair or make good such
defects or defaults in accordance with clause 11.3 below, FMC may terminate this Agreement on sixty (60) days written notice. Following termination of this Agreement pursuant to this sub-clause (ii), FMC shall pay to BioProgress a sum of seven and a
half percent (7.5%) of the total cost (including costs of delivery, installation and commissioning) to FMC or its Affiliates of any Equipment purchased by it from the date of termination of this Agreement until 31 December 2023, payable within
thirty (30) days of the date of initial delivery to FMC or its Affiliates of each such Equipment. 
  
 iii). For the purposes of this Article 4, “Initial Period” means the period from the date of this Agreement to the earlier to happen of (a) the
sixth anniversary of this Agreement and (b) the expiration of the first three year period set out in Clause 2.9 of the Master License Agreement. 
  
 Article Five - Equipment Orders 
  
 5.1 FMC undertakes that, during the term of this Agreement, it will purchase NRobeTM Equipment only from BioProgress. FMC shall provide to BioProgress 
  

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 no later than September 15 in each year a non-binding written rolling forecast of anticipated orders for the next three
(3) calendar years broken down to show orders anticipated for delivery in each calendar quarter. The first such written forecast shall be due on September 15, 2004. 
  
 5.2 Orders during the first year of this Agreement’s term shall be provided consistent with Annex C. Following that period FMC shall
give binding orders to BioProgress on a quarterly basis, with orders for delivery in each calendar quarter to be provided in writing no later than one hundred and eighty (180) days prior to the start of the respective calendar quarter. Orders shall
state the desired delivery period. Such orders shall be binding on BioProgress when accepted, provided that orders will be deemed accepted unless BioProgress refuses to accept the same in writing within fourteen (14) days of receipt thereof. If
BioProgress is unable to supply the quantity of Equipment specified in the delivery period specified, BioProgress may offer FMC an alternative delivery date. If such alternative delivery date is acceptable to FMC, FMC shall confirm the same in
writing and there shall be a binding contract for the purchase of the Equipment on the terms of the order amended as to the delivery date. FMC shall not be in breach of any obligation to purchase minimum quantities of Equipment in accordance with
Article 2.9 of the Master License Agreement if and to the extent that such failure is solely by reason of the refusal by BioProgress to accept bona fide orders for delivery in any quarter which are not materially in excess of the quantities forecast
for such quarter unless FMC shall have refused to accept extended delivery dates offered for such by BioProgress which are still within the relevant delivery period laid down in Article 2.9 of the Master License Agreement. 
  
 5.3 It is acknowledged that the business structure whereby FMC makes the Equipment available
for use or ownership by customers shall be solely determined by FMC but FMC shall not thereby increase or purport to increase the liability of BioProgress to FMC or any third party beyond that set out in this Agreement. Without limiting the
generality of the foregoing any warranty offered by FMC to any customer in excess of that pursuant to Article 11 hereof shall be at the sole expense of FMC. 
  
 5.4 FMC shall specify with each order placed the location where each item of NRobeTM Equipment is to be installed to permit any necessary customization to comply with local conditions and regulatory
requirements 
  
 Article Six - Purchase Price 
  
 6.1 BioProgress shall be responsible for the delivery of all Equipment purchased hereunder on
an Ex Works basis (Incoterms 2000) at the premises of 
  

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 the Contract Manufacturer (suitably packed for safe transit) and for installation and commissioning such Equipment at the
site where the Equipment is to be installed and shall invoice each such element of the price separately. However, FMC shall be responsible for the costs of shipment of the Equipment from the premises of the Contract Manufacturer to the site where
the Equipment is to be installed and for insuring the Equipment from the time of delivery Ex Works. 
  
 6.2 The price to be paid by FMC to BioProgress shall be 
  
 a) a fixed price of USD ** in respect of the initial laboratory scale and one tenth scale machine (laboratory scale USD **, one tenth scale USD ** ) and USD ** in respect of the first full scale machine ordered hereunder ( inclusive of
installation and commissioning but not shipment in accordance with Article 6.1) provided that FMC does not require any significant change to the initial broad specifications set out in Annex A in its form as at the date of signature of this
Agreement. It is agreed and acknowledged that otherwise any production or development costs above the fixed price for such machines shall be borne by BioProgress. 
  
 b) thereafter, determined pursuant to the formula set forth in Annex E, provided however, that it is intended broadly that the price shall
provide a reasonable net return to BioProgress in its sale to FMC Equipment It is agreed that a reasonable net return for this purpose shall be no less than ** percent ( ** ) of the total cost to BioProgress of the Equipment, including its Ex Works
delivery, installation and commissioning. 
  
 6.3 Unless otherwise mutually agreed
in writing, payment for each order shall be in the following stage payments: 
  
 a) In the case of the first one tenth scale machine and the first full scale machine ordered hereunder, the stage payment shall be as set out in Annex C 
  
 b) In the case of the second to the fifth full scale machines ordered inclusive 
  
 ** percent ( ** ) deposit with order to be paid within fifteen (15) days of the order.

  
 ** percent ( ** ) upon receipt of the preshipment test certificate, to be paid
within fifteen (15) days of such receipt. 
  
 ** percent ( ** ) upon installation
and acceptance of the subject machine to be paid within fifteen (15) days of acceptance. 
  

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 c) Thereafter 
  
 One third deposit with order to be paid within fifteen (15) days of the order 
  
 One third upon receipt of the preshipment test certificate, to be paid within 15 days of such receipt 
  
 One third upon installation and acceptance of the subject machine to be paid within fifteen (15) days of acceptance 
  
 PROVIDED that in each case, where FMC shall not have arranged for shipment to take place
and/or installation of the Equipment to commence within ten (10) weeks of the date on which BioProgress has informed FMC that the Equipment is ready for delivery, then the balance of the price (less any element thereof identified as in respect of
installation and commissioning) shall immediately become due and payable and, in addition, FMC shall be liable to pay to BioProgress, by way of supplement to the price for each piece of Equipment, $ ** per week ( or the actual, reasonable cost of
storage incurred, if higher) for each additional week beyond such ten (10) week period up to a maximum of $ ** . 
  
 Unless otherwise mutually agreed, payments hereunder shall be made in Euros by wire transfer 
  
 6.4 If FMC should fail to pay any amounts specified under this Agreement by the due date thereof, the amount owed shall bear interest from
the due date until paid at four percent (4%) over the prime interest rate of the European Central Bank from the due date until paid, as reported on the due date in the Financial Times. Except where there is a bona fide dispute, BioProgress shall
further be entitled to suspend delivery of Equipment until the outstanding amount, together with any interest due thereon, has been received in full from FMC. Where any amount is subject to bona fide dispute, FMC shall be entitled to withhold the
sums in dispute only pending resolution of the dispute but, in the event that it is found or agreed that such sums were properly payable, interest shall be due thereon (or upon such amount as was properly payable) from the original due date until
the date of payment. All sums shall otherwise be payable in full without deduction or set off 
  
 6.5 BioProgress acknowledges the prior receipt of US$** from FMC in 2002 and agrees that the sum shall be applied as payment ($ ** ) for the laboratory scale machine already produced by BioProgress and as deposit
payment ($ ** ) for the one-tenth scale machine being produced by BioProgress (total purchase price $ ** ), as further detailed in Annex C. 
  

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 Article Seven - Spare Parts and Service 
  
 7.1 FMC may at its sole discretion choose to enter into a contract directly with any Contract
Manufacturer utilized by BioProgress, to provide spare parts for the NRobeTM Equipment and\or to provide technical support and service for the NRobeTM Equipment after it is installed including repair service, provided however, that if repairs are for a failure of the Equipment covered by the warranty set forth in Article 11, then,
whether or not FMC has entered into such a contract, FMC shall offer BioProgress or its Contract Manufacturer the first opportunity to carry out such repairs and the cost of such repairs shall be borne by BioProgress. FMC shall not be entitled to
procure spare parts proprietary to BioProgress or covered by NRobeTM intellectual property rights from any person other than BioProgress or the Contract Manufacturer of the subject Equipment without the express prior written consent of BioProgress. The warranty provided under Article 11
of this Agreement shall not apply to the extent that, in the reasonable opinion of BioProgress, any defect in the Equipment is due to technical support or service provided, or spare parts supplied, by an unauthorized third party. 
  
 7.2 BioProgress shall not receive any compensation from FMC for any spare parts or service
provided by a party other than BioProgress but FMC acknowledges that BioProgress shall be entitled to charge its Contract Manufacturer a royalty on spare parts and technical support provided by such Contract Manufacturer. 
  
 Article Eight - Excuses for Non-Performance 
  
 8.1 Neither party shall be held liable or responsible to the other party for failure or delay
in fulfilling any obligation of this Agreement or of any orders placed or any acknowledgement sent in accordance with this Agreement, if such delay or failure is caused by actions or events which are beyond the reasonable control of the affected
party, the effect of which is to prevent or interfere with that party’s performance hereunder, including, without limitation, (i) any Act of God or public enemy, fire, explosion, accident, embargo or any other circumstances of like or different
character commonly referred to as force majeure; or (ii) interruption of or delay in transportation or shortage or failure of supply of materials or equipment, breakdowns, labor strife from whatever cause arising; or (iii) compliance by either party
hereto with any order, action, directive or request of any governmental official, department, agency or authority. 
  
 8.2 If either party hereto is rendered unable, wholly or in part, by any of the conditions described in Article 8.1 above to carry out any of its duties or obligations
under this Agreement, other than accrued obligations to make cash payments, such party shall forthwith give written notice thereof to the other party, such notice to briefly describe the cause of such inability; and in the event 
  

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 that the party giving such notice is unable to perform, shall, to the extent caused by those reasons, be excused and such
duties and obligations and the corresponding duties and obligations of the other party shall be adjusted accordingly. The party giving the notice pursuant to the foregoing provision shall be obligated to use all reasonable diligence to remove the
cause. 
  
 Article Nine - Assignment 
  
 This Agreement may not be assigned to a third party by either party without
the prior written consent of the other party, provided however, that FMC may freely assign the N RobeTM Agreements, or delegate performance under any of the NRobeTM Agreements to: any FMC subsidiary for so long, only, as such subsidiary remains a Subsidiary of FMC in which case FMC shall, nonetheless, remain liable
to BioProgress for any acts or omissions of such Subsidiary in relation to the NRobeTM Agreements so assigned or delegated, and for the purposes of this Agreement “Subsidiary” shall mean a corporation or other entity, a majority of the Voting Shares of which is at the time owned,
directly or indirectly, by a party to this Agreement or by one or more other Subsidiaries, or by a party to this Agreement and one or more other Subsidiaries, and “Voting Shares” shall mean stock of the class or classes having general
voting power under ordinary circumstances to elect at least a majority of the board of directors, managers or trustees of a corporation or other entity (irrespective of whether or not at the time stock or other securities of any other class or
classes shall have or might have voting power by reason of the happening of any contingency). 
  
 Article Ten - Waiver 
  
 Either party’s waiver of any breach, or failure to enforce any of the terms and conditions of this Agreement, at any time, shall not in any way affect, limit or waive such party’s right thereafter to enforce and compel strict
compliance with every term and condition of this Agreement. 
  
 Article Eleven - Warranty 
  
 11.1 BioProgress shall perform its
services with care, skill and diligence, using that degree of skill and care ordinarily exercised and consistent with generally accepted practices. BioProgress shall be responsible for the professional quality, technical accuracy, completeness, and
coordination of all reports, designs, drawings, plans, information, specifications, and other items and services to the extent furnished by BioProgress under this Agreement but shall be responsible for the production of joint development work only
as set out in Article 1.1. 
  

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 11.2 BioProgress warrants that all goods, articles, material and work will conform with the Specifications, and that
Equipment supplied hereunder shall at the time of delivery and for the period of one (1) year or 2000 hours of operation thereafter (whichever is less) (the “Warranty Period”) be free from defects in materials or workmanship. 

 
 11.3 BioProgress shall replace, repair or make good without cost to FMC any defects or
faults arising within the Warranty Period, resulting from imperfect or defective work or materials furnished by BioProgress provided that such defects or faults are reported to BioProgress in writing within thirty ( 30 ) days of the date of
discovery of such defect and BioProgress (and, where appropriate, the Contract Manufacturer) are provided access to inspect the Equipment concerned. Acceptance or use of goods by FMC shall not constitute a waiver of any claim under this warranty.
After the expiration of the Warranty Period BioProgress will cooperate reasonably and in good faith with FMC, but at FMC’s sole cost, in addressing claims by customers related to alleged defects or failure to meet Specifications. 
  
 11.4 The warranties set out above shall not apply to: 
  

	 	(a)	any defect caused other than by faulty materials or workmanship or caused by an accident, misuse, negligence, lack of reasonable maintenance, incorrect fitting, storage or
alteration; 

  

	 	(b)	any part or accessory which is not supplied by BioProgress or an approved Contract Manufacturer; 

  

	 	(c)	any high wear or consumable parts or materials replaced as part of normal maintenance. The parties agree to develop a list of such high wear or consumable parts as part of the
Design Review Process and to add such list to this Agreement as Annex F 

  
 11.5 Upon receipt of a claim report from FMC during the Warranty Period, BioProgress shall promptly, and without undue delay, notify FMC’s representative of its plans to effect repair of the Equipment. 
  
 11.6 In respect of any claim by an unaffiliated third party (“Third Party Claim”)
relating to Equipment supplied by BioProgress to FMC, BioProgress shall indemnify, defend and hold FMC harmless from and against any and all claims, demands, losses, liabilities, damages, costs and expenses (including the cost of settlement,
reasonable legal and accounting fees and any other expenses for investigating or defending any actions or threatened actions) directly arising out of or directly resulting from any such Third Party Claim involving death or 
  

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 bodily injury actually or allegedly arising out of or resulting from the use of the Equipment, where such use of the
Equipment was in accordance with its intended use. The Parties agree that the provisions of Clause 8.5 of the Master License Agreement shall be incorporated herein. 
  
 11.7 SAVE AS PROVIDED IN CLAUSE 11.6, BIOPROGRESS SHALL ON NO ACCOUNT BE LIABLE TO FMC FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL,
EXEMPLARY OR PUNITIVE DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT OR FOR LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. 
  
 11.8 During the term of this Agreement and for one (1) year thereafter, BioProgress shall
maintain product liability insurance in respect of Equipment delivered hereunder with minimum limits of the sterling equivalent of $1,000,000 (One Million Dollars) per occurrence and $20,000,000 (Twenty Million Dollars) in the aggregate with an
insurance company registered in the United Kingdom and being a member of the British Insurers Association. BioProgress shall provide FMC with a copy of the certificate of such insurance and evidence of the payment of premiums therefore promptly upon
request. 
  
 Article Twelve - Patent Infringement Warranty

  
 Save where and to the extent that the Equipment has been
modified at the request and in accordance with the instructions of FMC, BioProgress warrants that none of the Equipment, the use thereof or any of the applications, processes or designs employed in the manufacture thereof infringes the valid claims
of any letter patent, patent application, copyright, trade secret or any other property right of any third party. 
  
 Article Thirteen - Risk and Title 
  
 13.1 Unless otherwise mutually agreed in writing, all Equipment shall be sold to FMC on Ex Works (Incoterms 2000) basis, with risk in each item of Equipment therefore passing to FMC on delivery of the Equipment to the
carrier designated by FMC. While BioProgress shall carry out the installation and commissioning of the Equipment, risk shall remain with FMC, and BioProgress shall not be responsible for any loss of or damage to the Equipment unless and to the
extent caused by any negligent act or omission of BioProgress, its Contract Manufacturer or their servants or agents. 
  

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 13.2 In the event that there is a partial or total loss of the Equipment to be supplied (including a total write off for
insurance purposes) prior to risk passing, BioProgress shall (unless FMC shall have elected to exercise the right to cancel the contract by reason of delay) use all reasonable endeavours to replace the lost or damaged items without delay at its own
expense and shall apply to proceeds of any insurance for such purposes. Where FMC shall have elected to cancel the order, BioProgress shall procure that the proceeds of any applicable insurance shall be paid to FMC to the extent of any and all sums
previously paid to BioProgress by FMC in respect of the order concerned. 
  
 13.3
Notwithstanding delivery, title to the Equipment shall not pass to FMC until FMC has certified acceptance pursuant to Article 3.4. 
  
 Article Fourteen - Late Delivery 
  
 The Parties recognize that the initial items of NRobeTM Equipment up to and including the fifth full sized machine to be delivered hereunder will be the subject of continuing development work and
that, while BioProgress will seek to deliver such Equipment so far as is practicable in accordance with any agreed delivery schedule, such delivery schedule cannot be guaranteed and FMC shall have no claim against BioProgress by reason of any
failure to adhere thereto. 
  
 With effect from the sixth full
scale machine to be delivered hereunder, where any item of Equipment is not made available for delivery within five (5) weeks following the agreed delivery date, then BioProgress will allow FMC a rebate of ** percent ( ** ) of the purchase price of
such item of Equipment (less VAT and any installation or commissioning element) for each additional week or part of a week following the end of such five (5) week period during which such item of Equipment remains not available for delivery up to a
maximum rebate of ** percent ( ** ) of such purchase price. 
  
 Article Fifteen-Accounting Records 
  
 For such
time as the price of Equipment hereunder is on a cost plus basis only (and not, for the avoidance of doubt, during any period where machines are sold on the basis of a fixed price whether or not adjusted in accordance with Annex E(iii)) BioProgress
will keep and will procure that its Contract Manufacturer will keep records showing cost of production of Equipment sold to FMC under this Agreement, such records to be in sufficient detail to enable the production costs to be accurately determined
in accordance with the Contract Manufacturer’s standard accounting practices. BioProgress will permit and will 
  

 15 

 procure that the Contract Manufacturer will permit their respective books and records to be examined once a year for the
preceding year during regular office hours to the extent necessary to verify the cost of production as used to determine the price of Equipment supplied herunder as a cost plus basis, such examination to be made at the expense of FMC by an
independent auditor appointed by FMC who shall report to FMC only the amount of the cost of production of Equipment sold on a cost plus basis during the period under examination. Any such examination must be made within sixty (60) days following the
end of any calendar year. If any examination reveals that FMC has been charged more than the cost of production of the Equipment supplied plus 15% for the period being examined, the auditor shall promptly notify both BioProgress and FMC of the
perceived discrepancy together with the auditor’s detailing of the asserted discrepancy. At the request of either party, any such discrepancy perceived in the auditor’s report shall be the subject of a prompt meeting between BioProgress
and FMC in accordance with the Framework Agreement at which meeting the parties shall discuss the purported discrepancy and attempt to resolve any dispute concerning it. If any examination reveals that FMC overpaid sums due to BioProgress under this
Agreement as to costs being examined by more than the greater of (i) $ ** and (ii) ** percent ( ** ) of the cost amount that was the basis for such original payment, then BioProgress shall pay the cost of the auditor’s examination of the books
and records. If BioProgress and FMC shall be unable to resolve the dispute, then at the request of either party it shall be deemed a dispute subject to the provisions of Article Seven of the Framework Agreement. FMC agrees to hold strictly
confidential all information concerning costs of production and all information learned in the course of any audit hereunder, except when it is necessary for FMC to enforce its rights under this Agreement. If FMC chooses not to audit during the
required time period for any year, or if it audits and does not object to any report within sixty (60) days of the date the report is delivered, the report shall be deemed final, binding and conclusive and not subject to any further review or
adjustment for any reason whatsoever. 
  
 Article Sixteen -
Notices 
  
 All notices required or permitted to be given
under this Agreement shall be in writing and shall be sent by courier, registered or certified mail and also by telecopier and shall be deemed to have been given upon mailing and telecopier transmission. Any such notices shall be addressed to the
receiving party at such party’s address set forth above, or at such other address as may from time to time be furnished by similar notice by either party. 
  

 16 

 Article Seventeen - General Terms 
  
 17.1 The validity, interpretation and performance of this Agreement shall be governed and construed in accordance with the laws of the
Commonwealth of Pennsylvania, U.S.A., without regard to conflict of law principles. 
  
 17.2 This document is executed in the English language and constitutes the full understanding of the parties, and a complete and exclusive statement of the terms of their agreement. This Agreement, together with the Framework Agreement, the
Film Supply Agreement and the Master License Agreement supersedes any and all prior and/or existing agreements and courses of dealings between the parties and all such prior and/or existing agreements and courses of dealings are hereby terminated by
mutual consent of the parties. 
  
 17.3 The Agreement may be amended by agreement
of the parties, provided however, that no terms, conditions, understanding or agreement purporting to modify or vary the terms of this Agreement shall be binding unless hereafter made in writing and signed by the duly authorized representatives of
each party and no modification shall be effected by the acknowledgement or acceptance of purchase order or shipping instruction forms containing terms and conditions at variance with or in addition to those set forth herein. 
  
 17.4 The unenforceability or invalidity of any provisions of this Agreement shall not affect
the enforceability or validity of the balance of this Agreement. 
  
 17.5 Each
party hereto is an independent contractor and it not an agent, employee, or legal representative of the other and persons engaged by each of them shall not be employees, legal representatives or agents of the other party. Other than as specifically
set forth in this Agreement, neither party is authorized to do business in the other party’s name or to obligate the other party in any way. 
  
 17.6 The terms of the generally applicable Framework Agreement entered into between FMC and BioProgress shall apply to performance and activities under this Agreement.

  
 17.7 Save where otherwise expressly agreed, the price quoted for any Equipment
shall be exclusive of any tax, duty or other governmental charges arising as a result of the export, importation, sale, or use of the NRobeTM Equipment. 
  
 IN WITNESS WHEREOF, the parties have executed this Agreement as of the date and year written above. 
  

 17 

							
	 FMC CORPORATION
	 	 BIOPROGRESS PLC

				
	 By:
	 	 /s/ Theodore H. Butz

	 	 By:
	 	 /s/ Graham Hind

				
	 Name:
	 	 Theodore H. Butz

	 	 Name:
	 	 Graham Hind

				
	 Date:
	 	 February 3, 2004

	 	 Date:
	 	 February 3, 2004

  

 18 

 Annex A 
 Baseline Equipment Specifications 
  
 There are two stages to establishing machine specifications 1) initial machine and dose form design specifications for the 1/10th machine and 2) the subsequent design requirements needed to meet customer requirements for full production scale machines. 
  

During the design of the 1/10th
machine, FMC would provide design input for the 1/10th machine User Requirement Specification (URS) that would
include but not limited to the following three areas. 
  

	 	•	Productivity: 

  

	 	•	Modular design (separate film, fill, compaction, plc stations) 

  

	 	•	High output: 5,000 dose/hour for 1/10th machine

  

	 	•	Consistent output per hour 

  

	 	•	Rapid changeover (film, fill, etc) 

  

	 	•	Easy clean (polished stainless steel, dust removal, sealed bearings, sealed plc, etc.) 

  

	 	•	Smallest dimensions possible ( i.e. size of unit) 

  

	 	•	Minimal change parts 

  

	 	•	All product contact parts traceable, fit for purpose and certified as required by F.D.A e.g. where possible/practible contact parts in 316L stainless steel 

	 	•	Operation: 

  

	 	•	Easy to use software system for programming temperatures, pressures, weights, etc. 

  

	 	•	Touch screen plc 

  

	 	•	Secure User levels, password protected 

  

	 	•	Batch programmable operation 

  

	 	•	Fault diagnostics 

  

	 	•	Independent of human intervention except for loading of input materials 

  

	 	•	Recipe Driven Option 

  

	 	•	Varying Extent of Automation i.e modular design so that customers can add on increasingly complex process automation 

  

	 	•	All pneumatic and electrical drawings supplied 

  

	 	•	Control: 

  

	 	•	Alarms indicating warning and action limits, which can be set as required by operator 

  

	 	•	Programmable settings where appropriate (with suitable ranges and limits) for; fill weight, tamping force, film temperature, vacuum?, etc. 

  

 19 

	 	•	High sensitivity and reliability, with feedback control of all critical parameters at a level appropriate for control parameter 

  

	 	•	Safety interlocks and emergency shutoff 

  

	 	•	All critical process parameters measured using instrumentation calibrated to appropriate standards. Calibration certificates available 

  

	 	•	Detailed documentation database, export capable, compliance to FDA documentation regs, GMP compliant. Software validated and in accordance with requirements of CFR 21 Part 11

  

	 	•	User requirements for the final dosage form performance criteria would include but not be limited to 

  

	 	•	Must be capable to enrobing pharmaceutical formulations in the form of powders, pellets and granules 

  

	 	•	Feed mechanism for film is flexible i.e machine capable of running with films which support themselves during forming and advance through the machine supplied as rolls

  

	 	•	Machine design does not negatively impact dosage form performance e.g. due to process temp have a retardation of disintegration/dissolution 

  

	 	•	Fill mechanism adaptable depending on whether powders, pellets or granules within limits of the dosator function are being filled to specific weight limits within + or – 5% of
individual weight requirements 

  

	 	•	Force limits can be varied within specified range to appropriate accuracy. 

  

	 	•	Seal integrity assured by control of process variables. 

  

	 	•	Disintegration and dissolution performance comparable to industry standards 

  

	 	•	Capable of running different film formulations at similar speeds without need to redesign machine to accommodate minor changes for example adequate control of roller temperature via
chilled water supply or heating method to enable different temp of operation for different films 

  

	 	•	General Notes 

  

	 	•	These are initial specifications that we believe are needed to design the machine and dosage form. As the 1/10th design process evolves, FMC requires the flexibility to change the machine design in order to clarify the specifications so they will be representative of a
final machine. This would be done during the design cooperation protocol process 

  

	 	•	FMC would then sign off on the 1/10th size
specifications. This would be the starting point for the URS for the full-scale machine. 

  

 20 

 Final Equipment Specifications 
  
 A full scale machine URS will be completed by the team and will be consistent with the above as well as reflect the
experience of the parties, market expectations and design refinement and would include 
  

	 	•	A specified dose form per hour 

  

	 	•	Weighting checking 

  

	 	•	Software 

  

	 	•	Clean in Place options 

  

	 	•	Fill mechanism adaptable to powder, pellets and granules 

  
 General Notes 
  

	 	•	Full scale production machine specifications will be finalized upon after the production of the first five machines to allow for debugging the machines in a commercial
environment  

  

	 	•	Changes made after this point would then be made as per section 1.5 in the equipment supply contract 

  

 21 

 Annex B 
  
 Design Cooperation Protocol 
  

	 	•	During the design period, technical meetings will be regularly held with FMC, Contract Manufacturer and BioProgress to assess progress in design and manufacture of equipment. Such
meetings shall, among other things, discuss design of equipment from a customer perspective and reach decisions around design and manufacturing path forward to be done to work toward the required specifications 

  

	 	•	Design project plan shall be completed by the design cooperation team within 30 days of signing the contract for the 1/10th scale machine so timelines and milestones can be established 

  

	 	•	Milestones should be established to evaluate three stages of the 1/10th machine and full size machine for 

  

	 	•	dose form design 

  

	 	•	cGMP design 

  

	 	•	beta site design 

  

	 	•	Milestone achievement is documented through appropriate testing 

  

	 	•	FMC will provide a URS for the full-scale machine and then milestones and project plans will be created. 

  

	 	•	Meetings will be held to update team on machine design and production progress via reporting against the milestones and project plans created 

  

	 	•	Annually this team should present an overview to the Liaison team as defined by the Framework agreement 

  

 22 

 Annex C 
  
 Delivery Schedule 
  
 Estimated delivery of first operational 1/10th scale machine will be June 2004.
Final specs will be agreed by September 2004 and machine adjustment will be made by no later than November 2004. (To be agreed as soon as practicable following signature) 
  
 Lead times will then be established by FMC and BioProgress to build subsequent 1/10th scale machines and lead times to deliver and install the machines 
  
 Learnings from the design of 1/10th
machine will then be applied to the full-scale machine and the estimated delivery of full-scale machines will work from milestones and timelines set in Annex B. Initial estimates are the full-scale machine design and operating machine can be
completed seven months after the completion of the 1/10th machine. 
  
 The full- scale machine specifications will then be finalized when customers evaluate the
first five machines. 
  
 Lead times will then be established by FMC and
BioProgress to build subsequent full-scale machines and lead times to deliver and install the machines 
  
 Equipment Delivery 
  
 Initial lab scale
machine – Purchase completed upon signing agreements; initially located at Farmasierra. 
  
 Initial 1/10th scale machine to be delivered as stated above. Initial deposit of $
** to be made at time of signing agreements with final payment to be made upon the successful testing of the machine. 
  
 One full-scale machine will be ordered and **% deposit paid by 31 December 2004; **% will be paid on the agreement of the specification; **% on the successful factory
testing; and the final **% on the successful site test. Should Farmasierra order a full scale machine, BioProgress will credit $ ** USD (US $ ** ) toward the price of the machine and the balance due will be the cost to build the machine less the $
** USD (US $ ** ) 
  

 23 

 Annex D 
  
 Factory Acceptance Test Procedures – to be performed at Contract Manufacturer 
  

	 	•	Machine defined by the URS to test the machine operates with the guidelines 

  

	 	•	Produces a does form of suitable characteristics, including but not limited to 

  

	 	•	Weight uniformity 

  

	 	•	Good seal integrity 

  

	 	•	Dosage form per hour 

  
 Site Acceptance Test – to be performed at customer site 
  

	 	•	Testing to reflect the URS as it falls within pharmaceutical tests for 

  

	 	•	Installation Qualification 

  

	 	•	Operational Qualification 

  

	 	•	Includes calibration, software testing and training of operators & engineers 

  

	 	•	Productivity Qualification 

  

	 	•	If needed 

  

 24 

 Annex E 
  
 NRobeTM Equipment Price Formula 
  
 i) The price of the first one tenth scale machine and the first full scale machine to be delivered hereunder shall be fixed as set out in Article 6.2. 
  
 ii) the price for the second to fifth full size machines delivered hereunder shall be: 
  
 a) the actual cost of production of such machines to BioProgress plus

  
 b) the cost to BioProgress of installing and commissioning
the machine 
  
 (each calculated in accordance with the standard
accounting conventions operated by the Contract Manufacturer at the relevant time) plus 
  
 c) ** % of the sum of a+b., 
  
 Provided, however, that the cost of production shall exclude any design and development costs, which shall be borne by BioProgress. 
  
 iii) With respect to machines from the sixth full-sized machine delivered hereunder onwards, the parties shall annually negotiate in good faith a fixed machine price
reflecting a) the price of the machine Ex Works and b)the commissioning and installation element consistent with the principle of actual cost plus a fair return as set forth in Article 6.2 (b), with reference to the following factors: 
  
 a) With effect from the first and each subsequent anniversary of the date upon which the
fixed price was first agreed, BioProgress shall be entitled to increase each of the two elements of the price on which the fair return is calculated by the rise in the cost to BioProgress of labour and materials included in each such element
calculated in accordance with the tables published by the German Institute of Machine Manufacturers up to a maximum of the percentage increase in the German retail prices index over the period concerned. The fair margin percentage shall then be
calculated on the new cost basis to set the fixed price for the following year. 
  
 b) Productivity savings and economies of scale (based on projected sales to FMC) shall be shared between the parties. Half of FMC’s share of projected productivity gains shall be reflected in the fixed price for the subject year; the
remainder of FMC’s share of such productivity gains, if and to the extent actually achieved, shall be rebated to FMC at the end of the year, along with FMC’s share of any further productivity gains achieved as a result of the actual

  

 25 

 number of machines being produced for FMC being higher than the number projected for the year. For this purpose
FMC’s share of productivity gains shall be one-third of the total productivity gains actually achieved related to production of NRobeTM machines. 
  
 For the avoidance of doubt, the annual fixed price agreed pursuant to the above framework shall be 
  
 a) based on compliance with regulatory requirements as laid down by the EU. Any additional costs required in order to adapt machines to comply with local regulatory
requirements, electrical current differences or otherwise for machines to be installed outside the EU shall be payable by FMC 
  
 b) subject to any changes agreed pursuant to Article 1(5) and 
  
 c) exclusive of any optional items identified as available at extra cost in the Specifications 
  

 26Film Supply Agreement, dated February 3, 2004, between FMC Corporation

 Exhibit 4.16 
  
 FILM SUPPLY AGREEMENT 
  
 THIS AGREEMENT is made as of February 3, 2004 by and between FMC Corporation, FMC BioPolymer, 1735 Market Street, Philadelphia, Pennsylvania 19103, U.S.A.
(“FMC”), and BioProgress PLC, Hostmoor Avenue, March, Cambridgeshire, PE15 0AX, United Kingdom (“BioProgress”). 
  
 WHEREAS, FMC BioProgress Technology International Inc (“BioProgress T.I.)and BioProgress have entered into an alliance whereby FMC has received an
exclusive license of BioProgress T.I’s NRobeTM
System for solid dosage forms, as more specifically set forth in the Framework Agreement executed between the parties and BioProgress T.I.on February 3 2004. 
  
 WHEREAS, BioProgress intends to manufacture pharmaceutical quality film for use in producing pharmaceutical dosage forms, as more specifically described
in Annex A (the “Film”) and is in the process of establishing a facility for such purpose; 
  
 WHEREAS, as part of its utilization of the NRobeTM System technology FMC desires to enter into a contract to purchase Film from BioProgress and BioProgress is willing to supply FMC with Film.

  
 NOW, THEREFORE, BioProgress agrees to sell and FMC agrees to
purchase the Film subject to the following terms and conditions: 
  
 1. THE
FILM 
  
 The Film shall meet the specifications set forth in
Annex A (the “Specifications”), and shall be produced in a certified cGMP facility. Compliance with the Specifications shall be determined in accordance with the analytical methods set forth in Annex B. Upon reasonable notice to
BioProgress FMC may change the specifications of the Film to reflect the refinement of the NRobeTM System as it is commercialized provided that, where such change, in the reasonable opinion of BioProgress, is likely to cause technical difficulties for the equipment producing the Film,
BioProgress shall, within fourteen (14) days of receipt of notice of change from FMC, give notice of such technical difficulties. The parties will work together in good faith to establish a solution to such difficulties but BioProgress shall not be
obliged to implement the change until a solution acceptable to both parties is agreed. 

 2. TERM 
  
 2.1 Unless sooner terminated as hereinafter provided, the term of this Agreement shall commence on the date it has been executed by both parties (“Commencement
Date”)and continue until December 31, 2006 provided, however, that BioProgress shall not be obliged to supply Film hereunder until it gives notice to FMC that it has established a certified cGMP facility and that such facility is able to
commence production of Film in accordance with the Specifications (“Start of Production” or “SOP”). BioProgress shall use all reasonable endeavours to reach SOP as soon as practicable following the Commencement Date but if it
shall not have certified SOP by the second anniversary of the Commencement Date, either party shall be entitled to terminate this Agreement by not less than three (3) months notice in writing. 
  
 2.2 This Agreement shall not be automatically renewed or otherwise extended. Any renewal or
extension of this Agreement shall require a separate written document. 
  
 3.
QUANTITY 
  
 With effect from SOP, BioProgress agrees to
supply FMC and FMC agrees to purchase from BioProgress, not less than fifty percent (50%) of FMC’s requirements for HPMC film used for NRobeTM System applications in each calendar year (or pro rata for the period following SOP in the year in which SOP occurs or up to termination in the year in
which termination occurs), provided however, should FMC require more than fifty thousand (50,000) square meters of Film in any year, the parties shall consult to discuss FMC’s specific needs and the availability of such excess amount and
BioProgress shall use its reasonable efforts to supply such amount subject to capacity constraints and prior commitments to other customers. 
  
 4. FORECASTS AND ORDERS 
  
 4.1 No later than October 1, 2004, FMC shall give BioProgress a non-binding written forecast of its purchases of Film for the calendar year 2005 and
BioProgress shall confirm in writing whether or not it is able to supply the forecasted quantities. No later than October 1, 2005 FMC shall give BioProgress a non-binding written forecast of its purchases of Film for the calendar year 2006 and
BioProgress shall confirm in writing whether or not it is able to supply the forecasted quantities. At least sixty (60) days prior to the beginning of each calendar quarter, FMC shall give BioProgress an updated forecast covering specific deliveries
of Film for such quarter. With effect from SOP, FMC shall provide to BioProgress no later than the 4th of each month
a purchase order for deliveries of Film for that month together with estimates of the quantity of Film to be delivered in the following two months. FMC shall endeavour to minimize variations between firm orders placed and the firm estimates
previously made for the month concerned. 
  

 2 

 4.2 Orders shall be binding upon BioProgress only when accepted and approved in writing by an authorized
representative of BioProgress. BioProgress will have the right to accept or reject any order, or to accept part of any order and to reject the balance or to accept the order subject to an extended delivery period. FMC shall not be liable for any
failure to order fifty percent (50%) of its requirements for a year from BioProgress where such failure was by reason of the failure of BioProgress to accept orders for delivery in the year concerned. BioProgress shall not be liable to FMC for any
failure to supply FMC with fifty percent (50%) of its requirements for Film in a year where such failure is as a result of FMC’s refusal to accept shipments in whole or in part which conform to specificiations. 
  
 5. PRICE 
  
 5.1 The price of Film during the term of this Agreement shall be BioProgress’ cost of production plus ** ( **%) (which
cost of production shall be calculated in accordance with BioProgress’s standard accounting practice based on the most recently completed fiscal year, and calculated on an annual basis, all of which shall be subject to Article 18 below.)

  
 6. THE FACILITY 
  
 The parties acknowledge the vital importance of cGMP compliance at the
facility at which the Film is produced. BioProgress shall maintain such compliance at all times during production of Film, as further set forth in Article 11.2 below. FMC and/or its customers shall have the right to audit the facility for compliance
on ten (10) days written notice. 
  
 7. TERMS OF DELIVERY 
  
 7.1 The terms of delivery shall be Ex Works BioProgress’ plant unless otherwise
mutually agreed in writing. All deliveries shall be accompanied by a certificate containing the lot numbers, certificates of analysis and the analytical approval dates for the shipment. 
  
 7.2 BioProgress will use all reasonable efforts to deliver each shipment by the delivery date agreed at the time the Order is accepted.
However, if any shipment is not delivered by the end of two (2) weeks following the due delivery date, BioProgress shall pay to FMC a rebate of ** percent ( **%) of the price of the relevant shipment of Film for each further week (or part of a week)
beyond such two week period by which the 
  

 3 

 shipment is delayed up to a maximum rebate of ** percent ( **%) of the price of the shipment. Such rebate shall be
payable as a credit against future orders for Film.BioProgress shall, as soon as practicable, notify FMC if it believes that a shipment is likely to be delayed. 
  

8. CONTAINERS - WEIGHTS 
  
 8.1 All shipments of Film shall be packed in packaging agreed between the parties. BioProgress weights on all shipments shall govern except in the case of
demonstrated error (at the first point upon arrival where FMC is able to check such weights), in which case an adjustment shall be made, in the case of any shipment under specified weight, by a credit against the next following invoice or, where a
shipment is over weight either, at the option of FMC, by reducing the quantity of the next order to be delivered or adding the sum underpaid to the next following invoice. BioProgress shall mark the packaging in accordance with the reasonable
instructions of FMC, including any instructions relating to hazardous goods, such as international danger symbols, material name, declaration of hazard and emergency instructions. All information held by or available to BioProgress as to potential
hazards in the transport handling or use of Film shall be promptly communicated to FMC. 
  
 8.2 Should any difference arise in regard to weights or quantities, FMC shall, if so requested by BioProgress, hold the shipment of Film delivered intact for a reasonable period to permit inspection and reweighing by
BioProgress. Any quantity agreed to be over or under weight following such inspection shall be dealt with in accordance with Article 8.1 above. Payment shall not prejudice FMC’s rights of rejection. 
  
 9. TERMS OF PAYMENT 
  
 9.1 Unless otherwise mutually agreed in writing, payment shall be made in Euros, by wire transfer, and payable thirty (30) days from the
date of the bill of lading. Late payments shall bear interest from the due date until the date paid at four percent (4%) over the prime interest rate of the European Central Bank as reported on the due date in the Financial Times. Except where there
is a genuine dispute as to whether the sum unpaid is due, BioProgress shall further be entitled to suspend deliveries of the Film until the outstanding amount, together with any interest due thereon, has been received in full from FMC. 

 
 9.2 Save as otherwise expressly provided herein, all payments shall be made without
deduction or set off. Any credits due FMC upon the expiration or termination of this Agreement shall be paid to FMC by wire transfer or as otherwise agreed. 
  

 4 

 10. EXCUSES FOR NON-PERFORMANCE 
  
 10.1 Neither party shall be held liable or responsible to the other party for failure or delay in fulfilling any obligation
of this Agreement or of any orders placed or any acknowledgment sent in accordance with this Agreement, if such delay or failure is caused by actions or events which are beyond the reasonable control of the affected party, the effect of which is to
prevent or interfere with that party’s performance hereunder, including, without limitation, (i) any Act of God or public enemy, fire, explosion, accident, embargo or any other circumstances of like or different character commonly referred to
as force majeure; or (ii) interruption of or delay in transportation or shortage or failure of supply of materials or equipment, breakdowns, labor strife from whatever cause arising; or (iii) compliance by either party hereto with any order, action,
directive or request of any governmental official, department, agency or authority. 
  
 10.2 If either party hereto is rendered unable, wholly or in part, by any of the conditions described in Article 10.1 above to carry out any of its duties or obligations under this Agreement, other than accrued
obligations to make cash payments, such party shall forthwith give written notice thereof to the other party, such notice to briefly describe the cause of such inability; and in the event that the party giving such notice is unable to perform such
duties or obligations for any above-described reason such failure to perform shall, to the extent caused by those reasons, be excused and such duties and obligations and the corresponding duties and obligations of the other party shall be adjusted
accordingly. The party giving the notice pursuant to the foregoing provision shall be obligated to use all reasonable diligence to remove the cause. 
  
 10.3 If, as a result of such conditions, BioProgress is unable to fully supply FMC’s requirements hereunder, BioProgress shall allocate all available
Film from its plant on an equitable basis among FMC, BioProgress and BioProgress’ other customers, taking into consideration the respective quantities of Film purchased by FMC during the twelve (12) month period prior to the allocation.

  
 11. WARRANTY 
  
 11.1 BioProgress’ hereby warrants that the Film shall be manufactured
in accordance with current Good Manufacturing Practices (as set out in Article 11.2 below) and shall meet the Specifications at the time of delivery to the carrier. BioProgress makes no other warranty, express or implied, covering the film.

  
 11.2 BioProgress warrant that the Film supplied hereunder
conforms to current Good Manufacturing Practices shall mean that the Film complies with all applicable provisions of the U.S. Federal Food, Drug and Cosmetic Act and implementing regulations and their non-U.S. counterparts. “cGMP” means
those current practices, as amended from time to time, related to the manufacture of pharmaceutical active ingredients and their precursors laid down in guidelines and regulations such as the GMP rules of the World Health Organization, the United
States Code of Federal Regulations 
  

 5 

 (Title 21, Parts 210-211), the Guide to Inspection of Bulk Pharmaceutical Chemicals (U.S. Department of Health and Human
Services, Revised September 1991), the Pharmaceutical Inspection Convention, and the European Community Guide to Good Manufacturing Practice in the production of pharmaceutical products. 
  
 12. DAMAGES - CLAIMS 
  
 12.1 In respect of Third Pary Claims relating to Film manufactured by or on behalf of BioProgress, BioProgress shall indemnify, defend and hold FMC and
its subsidiaries harmless from and against one hundred percent (100%) of the amount of any and all Product Liability provided that the Film is used for its intended purpose. In respect of Third Party Claims relating to Film manufactured by or on
behalf of FMC by parties other than BioProgress or its contractors, FMC shall indemnify, defend and hold BioProgress and its subsidiaries (as defined below) harmless from and against one hundred percent (100%) of the amount of any and all Product
Liability. “Product Liability” shall mean any losses directly arising out of or directly resulting from any Third Party Claim for death or bodily injury actually or allegedly arising out of or resulting from the use and/or sale of the
Film.The Parties agree that the provisions of Clause 8.5 of the Master License Agreement between them shall be incorporated herein. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE
DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT OR FOR LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. 
  
 12.2 FMC shall inspect each shipment of Film within thirty (30) days of receipt, and in any event before use. FMC shall have
the right within such thirty (30) day period to reject any Film that fails to meet the warranted specifications and return such Film to BioProgress at BioProgress’ cost. Failure of FMC to make claim in writing against BioProgress within thirty
(30) days after such arrival shall constitute an irrevocable acceptance of the shipment, except as to those shipments in which BioProgress fails to provide a correct certificate of analysis as prescribed hereunder. In this latter case, FMC shall
have thirty (30) days after receipt of a correct certificate of analysis in which to reject the Film or file a claim. 
  
 12.3 In the event that the parties are unable to agree whether or not Film delivered is in accordance with the Specification or has met the test criteria,
the matter may be referred at the instance of either party to such person as may be appointed by agreement between the parties or, in default of agreement, nominated on the application of either party by the President for the time being of the
Proprietary Association of Great Britain in London (the “Expert”). Such person shall act as an expert and not as an arbitrator and shall be entitled to appoint such technical expert or experts as he considers 
  

 6 

 necessary to assist him in determining the matter referred to him. The decision of the Expert (which shall be given by
him in writing stating his reasons) shall, in the absence of manifest error, be final and binding on the parties. Each party shall provide the Expert with such information as he may reasonably require for the purposes of his determination. If either
party claims any such information to be confidential to it, then provided that in the opinion of the Expert, that party has properly claimed the same as confidential, the Expert shall not disclose the same to the other party or to any third party.
The costs of the Expert (including the costs of any technical expert appointed by him) shall be borne in such proportions as the Expert may determine to be fair and reasonable in all the circumstances or, if no such determination is made by the
Expert, by the parties in equal proportions. 
  
 13. TERMINATION

  
 Either party shall be entitled to terminate this
Agreement on six (6) months written notice in the event that the other a) commits any material breach of this Agreement which is not remedied within thirty (30) days of written notice of the breach being given, or b) enters into any arrangements
with its creditors or goes into liquidation whether voluntary or compulsory. 
  
 14. PATENTS AND TRADEMARKS 
  
 14.1 FMC hereby
grants to BioProgress a non-exclusive royalty free sub license (if and to the extent required for BioProgress to carry out its obligations hereunder) to make film for use in the NRobeTM System only for FMC under the Master Licence Agreement. The sublicense granted
hereunder shall be for the purposes of Bioprogress carrying out its obligations hereunder only and shall be coterminous with this Agreement. 
  
 14.2 In the event that a party is charged with infringement of any patent held by a third person by virtue of its performance in accordance with this
Agreement, the party shall have the right, at its sole option, to suspend the performance of such allegedly infringing activity, without liability or obligation to the other party, until such challenge is resolved to its satisfaction. However, if
any such suspension by either party continues for any consecutive period of six (6) months, the other party shall have the right to terminate this Agreement upon at least thirty (30) days prior written notice. 
  
 15. TOXICOLOGICAL DISCLOSURES 
  
 Each party hereto undertakes to inform the other immediately of any
injurious effects or side effects whatsoever of the Film of which it obtains any knowledge at any time during the term of this Agreement. 
  

 7 

 16. TAXES - DUTIES AND CHARGES 
  
 Any tax, duty or other Governmental charges arising as a result of the importation, sale, or use of the Film, other than tax
on the income of BioProgress, shall be paid by FMC. 
  
 17. ASSIGNMENT

  
 This Agreement may not be assigned to a third party by
either party without the prior written consent of the other party, provided however, that FMC may freely assign this Agreement, or delegate performance under it to any FMC subsidiary for so long, only, as such subsidiary remains a Subsidiary of FMC
in which case FMC shall, nonetheless, remain liable to BioProgress for any acts or omissions of such Subsidiary in relation to the Agreement so assigned or delegated, and for the purposes of theis Agreement, “Subsidiary” shall mean a
corporation or other entity, a majority of the Voting Shares of which is at the time owned, directly or indirectly, by a party to this Agreement or by one or more other Subsidiaries, or by a party to this Agreement and one or more other
Subsidiaries, and Voting Shares shall mean stock of the class or classes having general voting power under ordinary circumstances to elect at least a majority of the board of directors, managers or trustees of a corporation or other entity
(irrespective of whether or not at the time stock of any other class or classes shall have or might have voting power by reason of the happening of any contingency). 
  
 18 ACCOUNTING RECORDS 
  
 BioProgress will keep records showing cost of production of Film sold to FMC under this Agreement, such records to be in sufficient detail to enable the
production costs to be accurately determined in accordance with BioProgress’s standard accounting practices. BioProgress will permit its books and records to be examined once a year for the preceding year during its regular office hours to the
extent necessary to verify thecost of production as used to determine the price of Film supplied herunder, such examination to be made at the expense of FMC by an independent auditor appointed by FMC who shall report to FMC only the amount of the
cost of production of Film for the period under examination. Any such examination must be made within sixty (60) days following the end of any calendar year. If any examination reveals that FMC has been charged more than the cost of production of
the Film supplied plus * percent (*%) for the period being examined, the auditor shall promptly notify both BioProgress and FMC of the perceived discrepancy together with the auditor’s detailing of the asserted 
  

 8 

 discrepancy. At the request of either party, any such discrepancy perceived in the auditor’s report shall be the
subject of a prompt meeting between BioProgress and FMC in accordance with the Framework Agreement at which meeting the parties shall discuss the purported discrepancy and attempt to resolve any dispute concerning it. If any examination reveals that
FMC overpaid sums due to BioProgress under this Agreement as to the period being examined by more than (i) $* and (ii) * percent (*%) of the amount that was payable for such period, then BioProgress shall pay the cost of the auditor’s
examination of the books and records. If BioProgress and FMC shall be unable to resolve the dispute, then at the request of either party it shall be deemed a dispute subject to the provisions of Article Eight of the Framework Agreement. FMC agrees
to hold strictly confidential all information concerning costs of production and all information learned in the course of any audit hereunder, except when it is necessary for FMC to enforce its rights under this Agreement. If FMC chooses not to
audit during the required time period for any year, or if it audits and does not object to any report within sixty (60) days of the date the report is delivered, the report shall be deemed final, binding and conclusive and not subject to any further
review or adjustment for any reason whatsoever. 
  
 19. WAIVER 

 
 Either party’s waiver of any breach, or failure to enforce any of
the terms and conditions of this Agreement, at any time, shall not in any way affect, limit or waive such party’s right thereafter to enforce and compel strict compliance with every term and condition of the Agreement. 
  
 20. CONTINUING OBLIGATIONS 
  
 Termination or expiration of this Agreement shall not relieve either party
from full performance of any obligations incurred prior thereto. 
  
 21
DISPUTES 
  
 Save as provided in Article 12.3, any dispute
arising in connection with this Agreement shall be addressed under the terms of Article 7 of the Framework Agreement. 
  

 9 

 22 GENERAL PROVISIONS 
  
 22.1 Governing Law. This Agreement shall be governed by and construed according to the laws of the Commonwealth of Pennsylvania. 
  
 22.2 Taxes. Unless otherwise agreed in writing all taxes in connection
with or related to the execution of this Agreement shall be borne by BioProgress and FMC, respectively, each for their respective activities under this Agreement. 
  
 22.3 Amendments. Alterations and modifications of and amendments to this Agreement shall only be valid if made in
writing and executed by the authorized representatives of both parties. 
  
 22.4 Partial Invalidity. In the event that any of the provisions of this Agreement or the Agreements are invalid because they are inconsistent with the applicable law, this shall in no manner affect the validity of any other
provisions hereof. The parties hereto shall be obliged to replace any such invalid provisions by new provisions having similar economic effects to the extent legally possible. 
  
 22.5 Expenses. Each party shall pay its own expenses incurred with drafting, negotiating and concluding this
Agreement and any related due diligence or other preparation. 
  
 22.6 Notices. Notice to either party under this Agreement shall be provided as follows: 
  
 If to FMC: 
  
 Division Manager, FMC BioPolymer 
 FMC
Corporation 
 1735 Market Street 
 Philadelphia, PA 19103 USA 
  
 If to BioProgress:

  
 Chief Executive Officer 
 Hostmoor Avenue, 
 March Cambridgeshire

 PE15 0AX, United Kingdom 
  
 22.7 Waiver. The failure of either party to this Agreement or the Agreements to insist upon the strict performance of any or all of the terms and
conditions hereof or to exercise any right or privilege herein conferred, shall not be construed as a waiver of any such term, condition, right or privilege. 
  

 10 

 22.8 No Partnership or Agency Created. Nothing in this Agreement shall be deemed to create or
constitute a partnership or other legal entity between FMC and BioProgress, nor do they create any legal agency between the parties. 
  
 22.9 Two Originals. This Agreement is executed in the English language in two (2) execution copies, both being regarded as originals. 

 
 AGREED TO: 
  

							
	 /s/ Theodore H. Butz
	 	 /s/ Graham Hind

	
	 	

	 FMC Corporation
	 	 BioProgress PLC

				
	 Date:
	 	 February 3, 2004

	 	 Date:
	 	 February 3, 2004

  

 11 

 ANNEX A 
  
 Film specification 
  

					
	 Property

	  	 Nominal value

	  	 Range

	 **
	  	**	  	**

  
 Film composition 
  

			
	 Ingredient

	 	 %

	 **
	 	 **

  
 Film dimensions 
  
 ** 
  

 12 

 ANNEX B 
  
 Methods Of Analysis 
  
 To be agreed between the parties in accordance with practice within the Industry no later than Febraury 29 2004 
  

 13

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