EXHIBIT 10.10
THIS AGREEMENT is made 15th September 1993
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BETWEEN
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COURTAULDS CHEMICALS (HOLDINGS) LIMITED whose registered office is at 50 Xxxxxx
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Street, London. WIA 2BB ("COURTAULDS"): and
GLYCYX PHARMACEUTICALS LIMITED whose registered office is at Cedar House. 41
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Cedar Avenue. Xxxxxxxx XX 1 2. Bermuda ("GLYCYX").
WHEREAS., the parties have reached agreement on the following terms for the
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supply of the product described in Schedule 1 (the "PRODUCT") by Courtaulds to
Glycyx.
NOW IT IS AGREED as follows:
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1. Definitions
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In this Agreement:
(1) "COMMENCEMENT DATE" means 1st January 1994.
(2) "CALENDAR YEAR" means calendar years beginning on 1st January,
and ending on 31st December each year.
(3) "SPECIFICATION" means the specification for the Product set out
in Schedule 1. as amended from time to time in writing by mutual
agreement of the parties.
(4) "TONNE" means a tonne of 1.000 kilogramms.
(5) "MONTH" means a calendar month.
(6) "AFFILIATE" means any corporation or other entity which controls,
is controlled by, or is under common control with, a party to
this Agreement. A corporation or other entity shall be regarded
as in control of another corporation or entity if it owns or
directly or indirectly controls more than fifty percent (50%) of
the voting stock or other ownership interest of the other
corporation or entity, or if it possesses, directly or
indirectly, the power to direct or cause the direction of the
management and policies of the corporation or other entity.
(7) "CERTIFICATE OF ANALYSIS" means the certificate of analysis to be
provided by Courtaulds with each shipment of Product, setting
forth:
(a) the results of the quality test procedures with respect
to such shipment;
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WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS
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(b) the manufacturing date: and
(c) a statement that the batch of Products has been released
for shipment in accordance with the following criteria:
(1) all manufacturing materials used in the manufacture
of such Products have complied with the Specification
and (2) all manufacture and quality control operations
by Courtaulds with respect to such Product have been
carried out according to current Good Manufacturing
Practices. in-process control. manufacturing and testing
procedures. and standard operating procedures in the
form agreed upon by the parties.
2. Sale and Purchase
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(1) With effect from the Commencement Date Courtaulds shall sell and
deliver the Product to Glycyx and Glycyx shall purchase the
Product from Courtaulds on the terms and conditions of this
Agreement.
(2) Courtaulds undertakes to supply such quantities of the Product
meeting the Specification as Glycyx may order from Courtaulds
from time to time, subject always to minimum quantities as
follows:
(a) Within one month after Glycyx receives the first order from
their marketing partner. following the first country being
approved for the sale of distribution of the Product as a
drug, Glycyx will place an order on Courtaulds (the "INITIAL
ORDER") for [*] of the Product, and delivery of [*] of the
Product shall be made by Courtaulds within 20 weeks of
receipt of the Initial Order and the balance of [*] of
Product will be delivered by Courtaulds within 14 weeks
after the [*] has been delivered to Glycyx;
(b) Between 6 and 14 months after the Initial Order, Glycyx will
place a further order for [*] of the Product and delivery
shall be made by Courtaulds within 20 weeks of the further
order (the "SECOND ORDER"); and
(c) Between 20 and 28 months after the Initial Order. Glycyx
will place an order for [*] of the Product, and Courtaulds
shall deliver [*] of the Product within 12 weeks of
receiving the order and the balance 10 weeks later (the
"THIRD ORDER").
(3) Subject to Clause 2(2), Courtaulds shall supply to Glycyx the
quantities of the Product specified in Glycyx' order
confirmations as aforesaid, and shall make deliveries to Glycyx
in the installments and at such times and places as Glycyx shall
require from time to time.
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THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
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(4) Courtaulds hereby agrees that, during the term of this Agreement.
Courtaulds and its Affiliates will only supply Product to Glycyx
or its bona fide designees which designees will be notified to
Courtaulds in writing by Glycyx.
3. Delivery
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(1) The Product shall be supplied on an ex-works basis to Glycyx or
on a delivered basis to Glycyx or Glycyx's designee in accordance
with Glycyx's instructions.
(2) Title to and risk in the Product shall pass to Glycyx either upon
collection by Glycyx of the Product from Courtaulds' Buckhaven
plant or upon delivery to (Glycyx or their designee at
destinations to be nominated by Glycyx.
(3) Deliveries of the Product will initially be in 50 kg net weight
Mauser drums (which will be double polythene lined and
non-returnable). Courtaulds shall test each lot of Product before
delivery to Glycyx and provide a Certificate of Analysis for each
lot of Product delivered.
4. Price and Payment
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(1) The price to be paid by Glycyx for the minimum orders of Product
supplied pursuant to Clause 2(2) hereunder shall be as follows:
(a) for Product supplied pursuant to the Initial Order [*] the
price shall be [*]:
(b) for Product supplied pursuant to the Second Order of [*] the
price shall be [*]; and
(c) for Product supplied pursuant to the Third Order of [*] the
price shall be [*];
Provided that Courtaulds is able to buy the required quantities of raw
materials (namely beta alanine and p Nitro benzoylchloride) at the
appropriate time such raw materials are required to make the Product
and at a price for such raw materials respectively of [*] delivered to
Courtaulds' plant at Buckhaven, [*]. If both Glycyx and Courtaulds are
unable to purchase the raw materials at the prices referred to above.
Courtaulds will forthwith notify Glycyx and the parties will meet and
negotiate in good faith within 30 days a revised price per kilogramme
for the
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THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
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Product. If the parties fail to agree on a revised price within 30
days or if Glycyx is unable to End an acceptable supplier of such raw
materials at a mutually acceptable price. this Agreement shall
terminate forthwith. If requested by Glycyx, Courtaulds shall deliver
the Product to a consignment address and charge Glycyx at cost for
Carriage and insurance.
(2) At the beginning of October each Calendar year Glycyx and
Courtaulds will negotiate in good faith and agree on prices for
any quantities ordered over the quantities referred to in Clause
2(2) above.
(3) Glycyx shall make payment to Courtaulds in British Pounds
Sterling within 30 days after the later of (i) the date of
dispatch of Product to Glycyx or (ii) Glycyx's receipt of the
invoice with respect to shipment of such Product.
5. Terms of Supply.
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(1) Courtaulds warrants to Glycyx that all Product supplied hereunder
will at the time of dispatch to Glycyx or its designees (i)
comply with the Specification. (ii) be Manufactured, packaged,
stored and supplied in accordance with Good Manufacturing
Practices and the Drug Master File with respect to Product and
(iii) not be adulterated or misbranded within the meaning of the
United States Federal Food, Drug and Cosmetic Act or any other
similar law or regulation within the United Kingdom. Courtaulds
shall comply with the requirements of all laws regulations and
codes of practice relating to the manufacture of the Product that
are in force in the United Kingdom (including UK DHSS and ISO
9002 standards) and the United States of America (being the
standards of the FDA).
(2) Should Glycyx have requirements for compliance with other laws or
regulations they shall notify Courtaulds of these and the direct
cost of complying with such further laws or regulations shall be
reimbursed to Courtaulds by Glycyx.
(3) Courtaulds shall maintain for a least 6 years for each batch of
Product made and produce for inspection by Glycyx all
documentation regarding the manufacture of the Product, reference
samples (solvents excluded) and quality control records, as
Glycyx may from time to time require and shall provide Glycyx
upon request with copies of the same.
(4) Glycyx or their authorized representatives may carry out quality
assurance inspections of Courtaulds' production facilities for
the Product at reasonable times during the course of this
Agreement and may take reasonable samples for quality assurance
purposes only. Courtaulds shall promptly provide Glycyx with all
relevant information reasonably
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required for the investigation of any complaints regarding the
quality of Produce. Courtaulds shall promptly inform Glycyx of
the outcome of any inspections by regulatory authorities
(including, without limitation. the National Drug Inspectorate)
of Courtaulds' manufacturing site for Product.
(5) Courtaulds shall not make any change to the manufacturing process
for Product which would necessitate an amendment to the Drug
Master File for Product, without the prior written consent of
Glycyx.
(6) The Product to be supplied to Glycyx by Courtaulds shall be
manufactured at Courtaulds' premises at Buckhaven or such other
place as Glycyx and Courtaulds may agree.
6. Liability and Indemnity
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(1) Neither party shall be liable (in contract, tort or otherwise)
and irrespective of any negligence of such party for any indirect
or consequential losses (including but not limited to loss of
goodwill, business or anticipated savings), loss of profits or
use or third party claims, suffered by the other party in
connection with this Agreement or the Product save to the extent
that such claims relate to death or personal injury resulting
from the negligence of the first party in which case there shall
be no limit to such party's liability.
(2) Notwithstanding Clause 6(l) above Glycyx shall have the
responsibility to make any claim that any supply of the Product
does not meet the Specification within 45 days from the date of
delivery of such Product or within 25 days after Glycyx becomes
aware that the Product does not meet the Specification; provided
that in the latter event such claims must be brought within six
months from the date of delivery of such Product. Glycyx will, in
the event it receives Product which does not meet the
Specification, require Courtaulds to redeliver a Product which
does comply at Courtaulds' risk and expense. Where Glcyx claims
that a Product does not comply with the Specification, it shall
give full details of such claim and give Courtaulds reasonable
access to investigate the matter before the remainder of the
Product of the same consignment is used or returned to
Courtaulds. If Glycyx does not so notify Courtaulds within the
time limits set out above Glycyx shall be treated as having
waived all claims connected with the matter which should have
been so notified and, other than as provided in Clauses 6(l) and
6(3), Courtaulds shall have no further liability in respect of
Product which does not comply with the Specification.
(3) In the event that Glycyx recalls any of its products due to the
failure of Courtaulds or any of its employees to supply the
Product in accordance with the Specification in any material
respect, Courtaulds shall
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compensate Glycyx for the reasonable costs of physical recovery
and destruction of the Product and any products incorporating the
Product directly incurred by Glycyx as a result of such recall.
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(4) For the avoidance of doubt Glycyx hereby acknowledges that
Courtaulds has neither been a party to nor is competent to judge
the result of any clinical trials of the Product.
7. Duration and Termination
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(1) Either party may terminate this Agreement by at least 12 months'
prior written notice given at any time but not to expire prior to
the fifth anniversary of the Commencement Date.
(2) Either party may terminate this Agreement forthwith by written
notice to the other upon any material breach by the other which
is not remedied within 30 days of notification in writing to the
offending party, or if the other goes into liquidation or if a
receiver or administrator is appointed over or an encumbrancer
takes possession of any part of its assets, or it makes any
composition with its creditors or is deemed unable to pay its
debts, or suffers any analogous act under foreign law.
(3) Courtaulds may in addition terminate this Agreement forthwith by
written notice to Glycyx if the Product license is withdrawn by a
competent health authority in either the United Kingdom or the
United States of America and may require Glycyx to pay
Courtaulds' cost for any reasonable quantities of raw materials,
work in progress (including the payment of waste) or finished
goods in connection with the Product. Within 30 days of such
termination, Courtaulds shall furnish Glycyx with a statement of
all such materials. Glycyx shall pay such amount within 30 days
of such statement date.
(4) Termination shall be without prejudice to Clause 6 and to any
liabilities accrued at the date of termination.
8. Force Majeure
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(1) If any party is delayed in or prevented from carrying out any of
its obligations under this Agreement for any reason beyond such
party's reasonable control, that party shall be excused
performance of such obligation for as long as and to the extent
that the prevention or delay lasts; provided that the party
affected gives the other as much advance notice of such
circumstances as is practicable, and in any event shall have
notified the other in writing within seven days of discovery of
such
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THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
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circumstances, identifying the same and indicating the
anticipated period and quantities of the Product affected.
(2) A party affected by such circumstances shall use all reasonable
endeavours to minimize the extent and duration of their effect on
this Agreement.
(3) Notwithstanding Clause 8(l), if either party invokes force
majeure for a continuous period of 90 days or more, or 90 days or
more in any period of 180 days, the other party may forthwith
terminate this Agreement by notice to the other.
9. Confidentiality
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(1) Glycyx shall keep secret and shall not divulge to any third party
any information given by Courtaulds in connection with this
Agreement and/or the Product or which otherwise becomes known to
Glycyx concerning Courtaulds' Drug Master File for the Product,
the manufacturing process for the Product, or Courtaulds and its
products through its performance of this Agreement or use the
same other than for the purpose of executing this Agreement.
Courtaulds shall keep secret and shall not divulge to any third
party any information given by or on behalf of Glycyx in
connection with this Agreement and/or the Product or use the same
other than for the purpose of executing this Agreement. The
foregoing obligations shall not apply to information which is:
(i) in the public domain or subsequently enters the public
domain other than by breach of this Agreement;
(ii) can be shown by the receiving party by documentary
evidence to have been in its possession or control prior
to disclosure by the disclosing party;
(iii) received from a third party lawfully entitled to disclose
the same; or
(iv) is required by law, regulation or court order to be
disclosed; provided that the receiving party has taken
such steps as are reasonably available under the law (but
not the institution of legal action) to protect such
information and notifies the disclosing party prior to
disclosure and provided further that such disclosure shall
only be made to the extent actually required by such law,
regulation or court order.
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10. Assignment
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Courtaulds may assign any of its rights or duties hereunder with the
prior consent of Glycyx which may not be unreasonably withheld save
that such consent may be reasonably withheld by Glycyx if Courtaulds
wishes to assign its rights and duties hereunder to a company which at
the time of the proposed assignment (i) is selling Balsalazide Sodium
in a finished form; or (ii) is manufacturing, formulating, or
marketing a product which competes or will compete with Balsalazide
Sodium. Glycyx may assign its rights and duties hereunder with the
prior written consent of Courtaulds which consent shall not be
unreasonably withheld.
11. Miscellaneous
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(1) Save as otherwise provided herein, any order, notice, claim or
demand hereunder shall be given in writing and shall be deemed
duly served seven days after it has been sent property addressed
by registered air mail to the address of the party set out below,
and if sent by facsimile deemed sufficiently served on the date
and at the time when it is sent to the following fax number or
such other number(s) as may be notified by the party in question
from time to time):
(a) in the case of notices to Glycyx to:
Glycyx Pharmaceuticals Ltd.
0000 X. Xxxxxxxx Xxxx, Xxxxx 000
Xxxx Xxxx, Xxxxxxxxxx 00000 XXX
Fax No.: 0000 000 000 0000
FAO: President
(b) in the case of notices to Courtaulds to:
00 Xxxxxx Xxxxxx
Xxxxxx X0X 0XX
Fax No.: 000-000-0000
FAO: The Company Secretary
(2) The parties acknowledge that for reasons of administrative
convenience. supplies of the Product may be requested and orders
confirmed on forms which embody the parties' respective standard
conditions of trade, but such conditions shall not apply to the
supply of the Products hereunder.
(3) This Agreement supersedes and cancels all previous agreements or
arrangements between Glycyx and Courtaulds relating to the supply
of Products by Glycyx. and any such previous agreement or
arrangement is hereby terminated without compensation, but
without prejudice to any
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right resulting from any prior breach of such agreement or any
rights or indemnity which may have accrued to either party under
any such previous agreement or arrangement.
(4) No amendment to this Agreement shall be effective unless it is
made in writing and signed by a duly authorized representative on
behalf of each party.
(5) No failure by either party to enforce any provision of this
Agreement shall constitute a waiver of that party's rights or
thereafter prevent it from insisting on strict compliance
therewith.
(6) This Agreement shall be governed by the law of England and the
parties submit to the non-exclusive jurisdiction of the English
courts.
(7) It is expressly agreed that Glycyx and Courtaulds shall be
independent contractors and that the relationship between the two
parties shall not constitute a partnership, joint venture or
agency. Neither Glycyx or Courtaulds shall have the authority to
make any statements, representations or commitments of any kind
or to take any action which shall be binding on the other,
without the prior written authorization of the other party to do
so.
(8) In case any one or more of the provisions of this Agreement shall
for any reason be held to be invalid, illegal or unenforceable in
any respect, such invalidity, illegality or unenforceability
shall not affect any other provisions hereof, but this Agreement
shall be construed as if such provisions had never been contained
herein.
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IN WITNESS whereof the parties hereto have executed this Agreement the day and
year first before written.
SIGNED by )
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for and on behalf of )
COURTAULDS CHEMICALS ) /s/ Xxxxxxx X. XxXxxxxxx
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(HOLDINGS) LIMITED )
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SIGNED by )
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for and on behalf of )
GLYCYX PHARMACEUTICALS ) /s/ Xxxxx Xxxxxxxx
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LIMITED )
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(Page 1 of 4)
SCHEDULE I
BALSALAZIDE SODIUM
Written by: Date:
Approved by: Date:
Xxx.Xx. 07.JUL.93 supersedes: 27 MAY 1993
Page 1 of 4
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SPECIFICATIONS
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TEST METHODS
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