Exhibit 10.1
DATED 31 AUGUST 2001
CIMA LABS INC (1)
AND
ASTRAZENECA UK LIMITED (2)
SUPPLY AGREEMENT
IN RELATION TO [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Exhibit 10.1
INDEX
1. INTERPRETATIONS AND DEFINITIONS
2. DURATION
3. SALE AND PURCHASE
4. FORECASTING AND ORDERING
5. DELIVERY AND TITLE
6. PRICE
7. PAYMENT
8. WARRANTIES & QUALITY OF THE PRODUCT
9. ASTRAZENECA'S IVRS
10. REGULATORY REQUIREMENTS
11. FORCE MAJEURE
12. HARDSHIP
13. TERMINATION
14. COMPETITION
15. MOST FAVOURED CUSTOMER
16. CONFIDENTIALITY
17. PROVISION OF TECHNOLOGY & IMPROVEMENTS
18. ANNOUNCEMENTS/PUBLICITY
19. NOTICES
20. AGENCY, PARTNERSHIP OR JOINT VENTURE EXCLUDED
21. NON-ASSIGNMENT
22. ENTIRE AGREEMENT
23. REMEDIES AND WAIVERS
24. SEVERABILITY/INVALIDITY
25. VARIATIONS AND/OR AMENDMENTS
26. LAW AND JURISDICTION
27. COUNTERPARTS
SCHEDULE 1 : PRODUCT SPECIFICATION
SCHEDULE 2 : PACKING SPECIFICATION
SCHEDULE 3 : STOCK REPORTING FORMAT
SCHEDULE 4 PRICE MATRIX
SCHEDULE 5 SUPPLY PARAMETERS
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Exhibit 10.1
SCHEDULE 6 SELF SUPPLY TERMS
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Exhibit 10.1
THIS AGREEMENT is dated 31st August 2001 and is made BETWEEN:
(1) CIMA LABS INC., a Delaware corporation, whose principal office is at
00000 Xxxxxx Xxxx Xxxx, Xxxx Xxxxxxx, Xxxxxxxxx, 00000,XXX ("CIMA");
and
(2) ASTRAZENECA UK LIMITED (No. 03674842) a company incorporated in England
and Wales whose registered office is at 00 Xxxxxxxx Xxxx, Xxxxxx X0X
0XX ("AstraZeneca").
WHEREAS:
(A) CIMA owns rights to certain oral drug delivery technology marketed
under the trade xxxx DuraSolv(TM) and related know-how.
(B) AstraZeneca has an exclusive licence to use and sell products
containing the drug [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***].
(C) CIMA and AstraZeneca have entered into a Development and Licence Option
Agreement (the "Option Agreement") pursuant to which CIMA has granted
AstraZeneca an exclusive licence dated 28 May 1999 (the "Licence
Agreement") to use the DuraSolv(TM) technology in formulations with API
(together, the "Product").
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Exhibit 10.1
(D) In accordance with the general obligations of Clause 3.5 of the Option
Agreement, CIMA wishes to manufacture, supply and AstraZeneca wishes to
purchase Product and Placebo on the terms and conditions set out below
(the "Agreement").
NOW IT IS HEREBY AGREED as follows:
1 INTERPRETATIONS AND DEFINITIONS
1.1 HEADINGS AND DEFINITIONS
In this Agreement, including its Schedules, the headings are included
for ease of reference only and shall not affect its interpretation and,
unless the context expressly requires otherwise:
1.1.1 "Affiliate" means, with respect to each party, any
corporation or other business entity that (a)
directly or indirectly controls, is owned by or is
under common ownership with a party to this Agreement
to the extent of at least fifty percent (50%) of the
equity (or such lesser percentage which is the
maximum allowed to be owned by a foreign organisation
in a particular jurisdiction) having the power to
vote or direct the affairs or such entity, or (b)
directly or indirectly Controls, is Controlled by or
is under common Control with such party;
1.1.2 "Associated Company" means any company which is
either the parent undertaking or a subsidiary
undertaking of the party in question or a subsidiary
undertaking of such party's parent undertaking and an
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Exhibit 10.1
undertaking in which the party in question has a
participating interest (as defined in section 260
Companies Act 1985) and which is not a subsidiary
undertaking of the party in question. "Parent
undertaking" and "subsidiary undertaking" shall have
the meanings attributed thereto in section 258
Companies Xxx 0000;
1.1.3 "Business Day" means a day (other than a Saturday,
Sunday or Bank Holiday) on which banks are open for
the transaction of normal business in the City of
London;
1.1.4 "Calendar Quarter" means each successive period of
three calendar months commencing in each Calendar
Year on 1st January, 1st April, 1st July and 1st
October and referred to as Q1, Q2, Q3 and Q4
respectively;
1.1.5 "Calendar Year" means each successive period of
twelve calendar months commencing on 1st January;
1.1.6 "Certificate of Analysis" means the certificate of
analysis to accompany all Product delivered to
AstraZeneca in the agreed format;
1.1.7 "Commercial Phase" means from [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to
the date of termination of this Agreement;
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Exhibit 10.1
1.1.8 "manufacture of Product" means storage, checking and
testing of both incoming materials and outgoing
Product, processing and blister packing of tablets
with overprinted lidding into pre-formed strips of
multiples of 6 or 2 tablets per strip which are then
bulk packed in an agreed container ready for
shipment. It is agreed between the parties that this
definition complies with the description 'bulk
unlabelled and unpacked blisters' in Exhibit I of the
Development and Licence Agreement as far as pricing
is concerned .In such description it is acknowledged
that unlabelled allows for provision of certain
variable Product information and packing instructions
and that if AstraZeneca wishes CIMA to provide
Product in non standard packaging (cassettes) prior
to bulk packing, additional costs shall be incurred;
1.1.9 "Manufacturing Quarter" means the calendar quarter in
which product or placebo is manufactured but which is
cleared for delivery within the 15 days following
that calendar quarter;
1.1.10 "Placebo" means formulations made using CIMA's
DuraSolv(TM) Technology but without the inclusion of
API. Manufacture of Placebos shall mean the same as
manufacture of Product but in addition Placebos are
to be supplied packed in cartons prior to being
packed into an agreed container ready for shipment.
It is agreed between the parties that this definition
complies with the description for 'Finished Packaged
Product' in Exhibit 1 of the Development and Licence
Agreement in relation to
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Exhibit 10.1
pricing;
1.1.11 "Quality Assurance Agreements" mean the quality
assurance agreement signed by the parties and dated
23rd April 1999 and the US quality assurance
agreement signed by the parties dated April 11, 2000;
1.1.12 "Product" means any pharmaceutical dosage form which
is formulated using the DuraSolv(TM) Technology and
which contains [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] as its active
ingredient, whether taste masked (in any flavour ) or
untreated;
1.1.13 "Product Specification" means the specification for
the Product as specified in Schedule 1 and as amended
from time to time by agreement in writing between the
parties;
1.1.14 "Pre-printed Foil" means forming and lidding foil
purchased by CIMA for exclusive use in the
manufacture of particular market variants of Product;
1.1.15 "Packing Specification" means the specification for
Placebo and Product ready for delivery to
AstraZeneca;
1.2 DEFINITIONS
Unless expressly stated otherwise in clause 1.1 above,
capitalised terms shall
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Exhibit 10.1
bear the meaning ascribed to them in the Licence Agreement.
1.3 COMPANY
References to a "company" shall be construed so as to include
any company, corporation or other body corporate wherever and
however incorporated or established.
1.4 CONTROL
For the purposes of this Agreement a person is to be taken as
having "Control" of a company if:
1.4.1 the directors of the company or of another company
which has control of it (or any of them) are
accustomed to act in accordance with his directions
or instructions; or
1.4.2 either alone or with any one or more associates he is
entitled to exercise, or directly influence the
exercise of, one third or more of the voting power at
any general meeting of the company or of another
company which has control of it; or
1.4.3 he is otherwise able to secure by any voting or other
powers conferred by the articles of association or
other document regulating that or any other company
that the affairs of the company are conducted in
accordance with his wishes,
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Exhibit 10.1
and where two or more persons together satisfy any of the above conditions, they
are to be taken as having control of the company.
1.5 PERSONS
The word "person" and words importing persons shall be
construed so as to include individuals, firms, bodies
corporate, joint ventures, governments, states or agencies of
state (whether or not having separate legal personality).
1.6 SUCCESSORS AND ASSIGNEES
A reference to any party to this Agreement shall include a
reference to its legal successors and permitted assignees.
1.7 GENDER
References to any of the masculine, feminine or neuter genders
shall include the other genders and references to the singular
number shall include the plural and vice versa if the context
so requires.
1.8 REFERENCES
Unless the context expressly requires otherwise, references to
recitals, clauses, paragraphs, parties and Schedules are to
the recitals, clauses and paragraphs of and the parties and
Schedules to this Agreement. To the extent that there is
conflict between or ambiguity relating to, on the one hand,
any or all of the Schedules and, on the other, the remainder
of this Agreement, the wording of the Schedules shall prevail.
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Exhibit 10.1
1.9 SCHEDULES
The Schedules and any attachments form part of this Agreement
and shall have the same force and effect as if expressly set
out in the body of this Agreement and any reference to this
Agreement shall include the Schedules and any attachments.
1.10 LEGAL TERMS
References to any English term for any action, remedy, method
of judicial proceeding, legal document, legal status, court,
official or any legal concept or thing shall in respect of any
jurisdiction other than England be deemed to include what most
nearly approximates in that jurisdiction to the English legal
term.
1.11 DATES AND TIMES
Reference to a date or time is a reference to that date or
time in London, England, unless expressly stated otherwise.
1.12 WRITING
References to writing shall include any mode of reproducing
words in a legible and non-transitory form.
2 TERM AND TERMINATION
2.1 TERM
This Agreement will be coterminous with the Licence Agreement
and as such will be effective as of the date hereof and will
expire on a country by country basis,
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Exhibit 10.1
upon the later date of (a) ten (10) years after the date of
first commercial sale of the Product in the relevant country,
or (b) the expiration of the last Patent covering the Product
filed in that country. The parties will meet in good faith
jointly to consider ways to extend this Agreement to the
extent permitted by applicable law or regulation at least
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
before this Agreement is due to terminate pursuant to this
clause 2.1 and the parties may so extend the term in a writing
signed by both parties.
2.2 TERMINATION
2.2.1 AstraZeneca may terminate this Agreement in its
entirety or with respect to use of the rights
licensed in any country or countries under the
Licence Agreement, with or without cause, upon
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] written notice to CIMA. Such
termination will not relieve AstraZeneca or any
obligation to make payments to CIMA for royalties
accrued prior to the effective date of such
termination. AstraZeneca may sell, transfer or
otherwise dispose of for payment any of the Product
that is not sold prior to the effective date of such
termination, so long as such sale, transfer or
disposal occurs within three months of the effective
date of termination of this Agreement.
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Exhibit 10.1
2.2.2 Either party may terminate this Agreement prior to
its expiration by giving written notice to the other
party, if the other party materially fails or
neglects to perform its obligations under this
Agreement and the same is not cured or being cured to
the non-breaching party's reasonable satisfaction
within forty five (45) days after the non-breaching
party gives written notice specifying the nature and
extent of such material breach; provided, however,
that CIMA may not assert a material payment default
by AstraZeneca on invoiced amounts disputed in good
faith by AstraZeneca if AstraZeneca provides a
written description of the disputed amounts to CIMA.
Cure of a material payment default by AstraZeneca
will be made by remitting to CIMA the amount of the
overdue payment with accrued interest thereon,
calculated using a major US commercial bank rate
selected by CIMA, during the forty-five day period.
2.2.3 This Agreement shall terminate at the same time as
the termination (for whatever reason) of the Licence
Agreement and any notice to terminate served under
the terms of the Licence Agreement shall be deemed
also to be a notice to terminate this Agreement.
2.2.4 Either party may terminate this Agreement immediately
and without notice in the event that an application
is made by the other party for the appointment of a
receiver, trustee or custodian for any of the other
party's assets; a petition under any section or
chapter of the federal Bankruptcy Code or any similar
law or regulation of the United States or Puerto Rico
or the United Kingdom is filed by or against the
other party is not
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Exhibit 10.1
dismissed within sixty (60) days; the other party
makes an assignment for the benefit of its creditors;
the other party becomes insolvent or fails generally
to pay its debts when they come due; or if Control of
the other party passes to any persons who do not on
the Effective Date Control that party provided,
however, that such change in Control would result in
an unreasonable competitive situation for the party
claiming a right to terminate.
2.2.5 If AstraZeneca terminates this Agreement other than
under Sections 2.2.1 or 2.2.2, or if CIMA terminates
this Agreement under Section 2.2.2, then AstraZeneca
will pay to CIMA the amounts set out in clause 9.2(d)
of the Licence Agreement.
2.2.6 CIMA may terminate this Agreement upon
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] notice in the event that AstraZeneca
or its Affiliates commercialise under any agreement
with a third party a formulation of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
This restriction on AstraZeneca and its Affiliates is
subject to the right of AstraZeneca to self-supply
the Product under Section 3.2 of this Agreement.
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Exhibit 10.1
2.3 ADDITIONAL REMEDIES
Termination of this Agreement for any reason will be without
prejudice to, and will not affect the right of, either party
to recover any and all damages to which it may be entitled, or
to exercise any other remedies that it may otherwise have.
2.4 SURVIVAL
Clauses 10, 12, 13, 17, 18, 19, 20, 21, 22, 23, 24 and 26
shall survive the termination of this Agreement howsoever the
same occurs.
3 SALE AND PURCHASE
3.1 Except under the conditions of clause 3.2 of this Agreement,
CIMA shall manufacture and supply all quantities of the
Product and Placebo required by AstraZeneca and within the
forecast limitations set forth in clause 5 of this Agreement
and AstraZeneca shall purchase all quantities of the Product
and Placebo during the Validation Phase and the Commercial
Phase from CIMA upon the terms of this Agreement and in
accordance with the provisions of the Quality Assurance
Agreement (as amended from time to time). In the event that
there is a conflict between the terms of this Agreement and
the terms of Quality Assurance Agreements, the terms of this
Agreement shall prevail.
3.2 As described more particularly in Schedule 6 of this
Agreement, CIMA shall grant AstraZeneca a self supply option
for Product. The payments to be made by AstraZeneca to CIMA
under the terms of Schedule 6 shall be the only payments made
in relation to the self supply option and shall cover all
future strengths and
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Exhibit 10.1
dosage forms of the Product.
3.3 Supply of quantities of Product substantially greater than
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
tablets per calendar year may require investment on the part
of CIMA. Such quantities should be forecast in writing by
AstraZeneca no later than [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] prior to the date on
which AstraZeneca requires delivery of such quantity to
commence.
4 OBLIGATIONS IN RELATION TO MANUFACTURING AND SUPPLY STANDARDS
4.1 CIMA undertakes to obtain and maintain all permits,
registrations and licences necessary for its equipment,
facilities and resources to be used to manufacture Placebo and
Product that meets the agreed Specification in accordance with
the terms of the Quality Assurance Agreement using purchased
excipients and Pre-printed Foil.
4.2 CIMA shall hold agreed Safety Stock as described in Clause 7
and 8.
4.3 CIMA shall provide AstraZeneca with a Certificate of Analysis
and agreed campaign documentation no later than
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
(except in relation to Product
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Exhibit 10.1
under investigation by CIMA) after completion of blister
packing to initiate collection of Product by AstraZeneca. In
addition, fully signed manufacturing campaign validation
reports shall be provided by CIMA before the expiry of the
period stipulated in the relevant validation protocol.
4.4 CIMA may employ a third party to test Product in whole or in
part, provided that such third party is approved by
AstraZeneca and that such party agrees to be bound by the
terms of the Quality Assurance Agreement. CIMA shall bear the
full liability for such third party costs.
4.5 If revised manufacturing standards or revised Product
specifications are required which result in an increased cost
of production to CIMA, and which relate specifically to the
Product:
4.5.1 as a result of requests by external regulatory
bodies, the Parties shall discuss and agree on an
implementation plan to achieve such revisions within
thirty days of the revisions being known to both
Parties. AstraZeneca shall either bear the cost of
goods increases agreed or exercise its right to
self-supply described in clause 3.2 above;
4.5.2 as a result of a request by AstraZeneca, the Parties
shall discuss and agree an implementation plan to
achieve such revisions for which AstraZeneca shall
bear the cost in full on terms to be agreed;
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Exhibit 10.1
4.5.3 it is understood by the Parties that this clause 4
does not apply to failures by CIMA to meet the
existing standards and specifications.
4.6 AstraZeneca shall provide forecasts and orders in accordance
with the terms of this Agreement and shall provide design and
text for variable Product information to CIMA no later than
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in
advance of scheduled use by CIMA.
4.7 AstraZeneca shall provide API to CIMA for use solely in the
manufacture of Product in accordance with Clause 7.
4.8 AstraZeneca shall collect Product from CIMA's manufacturing
facility promptly after the provision by CIMA of agreed
documentation as described in Clause 4.3 and AstraZeneca shall
inspect the Product on arrival at AstraZeneca's user
facilities in accordance with its obligations under the
Quality Assurance Agreement.
4.9 Each party shall inform the other party without delay of
receipt of notice of any impending or threatened litigation or
governmental investigation or impending audit of any kind that
is or could be related to the manufacture of Product.
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Exhibit 10.1
5 FORECASTING AND ORDERING
5.1 During the Commercial Phase the following shall apply:
5.1.1 Prior to 30th October in each Calendar Year,
AstraZeneca shall provide CIMA with a forecast ("THE
ANNUAL FORECAST") of AstraZeneca's annual
requirements for the Product and Placebo for each
Calendar Quarter of the subsequent Calendar Year
which will be expressed in terms of formulation
batches, each formulation batch being not less than
equal to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] (a "BATCH").
5.1.2 In each Calendar Year after 2002, AstraZeneca shall
be obliged to purchase not less than [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of
the Annual Forecast for Product and CIMA shall be
obliged to supply up to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] of the Annual
Forecast for Product prorated equally throughout the
year.
5.1.3 For the avoidance of doubt, CIMA shall not be obliged
at any time to supply more than [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES
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Exhibit 10.1
AND EXCHANGE COMMISSION.***] of the Annual Forecast
in 5.1.2 or more than [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] tablets
(product plus placebo combined), whichever is the
smaller, in any given Calendar Year unless the
Parties agree otherwise.
5.1.4 In the event that AstraZeneca does forecast to
require more than such maximum quantity, CIMA shall
immediately notify AstraZeneca of its receipt of such
a forecast and CIMA is obliged to inform AstraZeneca
in writing within thirty (30) days of receipt of such
forecast what quantity (if any) above the maximum
forecast quantity CIMA is able to supply.
5.1.5 In order to assist CIMA's production planning,
AstraZeneca shall, at the end of each Calendar
Quarter provide to CIMA a non-binding update of
AstraZeneca's requirements for Product and Placebo
for the next fifteen calendar months, with the first
six (6) month-by-month and the remainder by quarter.
5.1.6 AstraZeneca shall place binding orders for the
Product and Placebo required in each Manufacturing
Quarter with CIMA not less than thirty (30) days
before the start of that Manufacturing Quarter.
Quantities of individual market variants of Product
required to be delivered in each calendar month of
that Calendar Quarter shall be provided by
AstraZeneca in the form of call-off/manufacturing
orders to be placed no
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Exhibit 10.1
later than one month prior to the start of the month
of delivery.
6 DELIVERY AND TITLE
6.1 Unless otherwise agreed all quantities of the Product and
Placebo supplied pursuant to this Agreement shall be delivered
EXW, CIMA to load Product and Placebos on to collecting
vehicle at CIMA's risk, from CIMA's facility at Eden Prairie,
MN, USA (Incoterms 2000).
6.2 Risk in respect of all Product and Placebo supplied to
AstraZeneca pursuant to this Agreement shall pass accordingly.
Title to all Product and Placebo supplied to AstraZeneca shall
at all times remain with AstraZeneca.
6.3 API shall be delivered by AstraZeneca at AstraZeneca's expense
to CIMA's facility at 00000 Xxxxxx Xxxx Xxxx, Xxxx Xxxxxxx, XX
00000 XXX and AstraZeneca shall retain title to all deliveries
of API at all times. Risk shall pass with ownership and both
parties undertake to maintain adequate insurance cover.
7 API TO BE SUPPLIED TO CIMA
7.1 All deliveries of API shall meet agreed API and package
specifications and be accompanied by a Certificate of Analysis
and with at least [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] of its agreed shelf life
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Exhibit 10.1
remaining.
7.2 CIMA shall store API in conditions approved by AstraZeneca and
shall rotate stock held to eliminate shelf life losses.
7.3 CIMA shall test and handle API consistent with information
provided by AstraZeneca and in compliance with local laws and
regulations.
7.4 All API deliveries must meet CIMA approved packaging,
documentation and labelling; including certificate of
analysis; gross/tare/net weight and manufacturing lot number.
The quantities and timing of deliveries shall be as follows:
7.4.1 During the Commercial Phase the Parties shall ensure
that a safety stock of API is maintained (the "API
Safety Stock") equivalent to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of
the Annual Forecast of Product (provided by
AstraZeneca on 30th October each Calendar Year)
multiplied by the agreed conversion ratio of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]. CIMA shall provide AstraZeneca at
the time of the monthly Stock Report described in
Clause 9 with the date that AstraZeneca needs to
deliver stock replenishment material in quantities
not less than [***CONFIDENTIAL TREATMENT
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Exhibit 10.1
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]. Such
forecast delivery date shall not be less than 1 month
after the month that the stock report is issued to
AstraZeneca.
7.4.2 It is recognised by the parties that if AstraZeneca's
actual requirements vary substantially within the
allowed limits of Clause 5.1.2 and 5.1.4, that
adjustments may be needed to the API Safety Stock
level described in Clause 7.4.1 above. In such an
event, CIMA shall notify AstraZeneca at the time of
the monthly Stock Report that a new API Safety Stock
level is required and recommend new deliveries of API
that are required.
7.5 During the Commercial Phase CIMA shall consume API at the rate
of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Batch .API consumed in excess of this rate shall be replaced
by AstraZeneca but at the expense of CIMA based on an API
price of USD [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]. CIMA shall provide a breakdown in writing of
any amounts due and shall make payment due in a Calendar Year
within 30 days after the end of that Calendar Year as part of
the reconciliation described in Clause 11.
8 PRE-PRINTED FOILS AT CIMA
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Exhibit 10.1
8.1 Some markets for the Product require Pre-printed Lidding Foil
("Pre-printed Lidding Foil"). AstraZeneca shall supply to CIMA
its design and text for the Pre-printed Lidding Foil for such
markets at least three (3) months in advance of CIMA's
manufacture of the Product for such markets. The cost for the
Pre-printed Lidding Foil has not been included in the costing
on Schedule 4. CIMA agrees to provide and AstraZeneca agrees
to pay [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] per tablet for all Product manufactured using
the Pre-printed Lidding Foil. This additional cost will be
billed to AstraZeneca in addition to the costs on Schedule 4.
9 STOCK REPORTING
9.1 CIMA shall provide a stock report at the end of each calendar
month in the format as attached in Schedule 3 relating to API
stock holding and performance against agreed conversion ratios
as described in Clause 7.6 (the "Stock Report").
9.2 In addition CIMA at the time of the report
(a) will recommend adjustments to API Safety Stock levels and
request stock replenishment quantities of API from AstraZeneca
as described in Clauses 7.4.2; and
(b) will recommend adjustments to Pre-printed Foil Safety
Stock levels
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Exhibit 10.1
both for confirmation by AstraZeneca within [5] working days.
10 PRICE
10.1 All sums payable by AstraZeneca under this Agreement are
exclusive of Value Added Tax which, if payable, shall be borne
and paid by AstraZeneca upon the provision by CIMA of an
appropriate VAT invoice.
10.2 The price to be paid by AstraZeneca for Product and Placebos
during the Commercial Phase will conform to the pricing in
Schedule 4.
10.3 Subject to the exceptional circumstances set out in Clause 4.5
of this Agreement, the prices in Schedule 4 shall remain fixed
through [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]. On [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] and thereafter, the prices in
Schedule 4 shall be adjusted [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***].
25
Exhibit 10.1
11 ORDER AND INVOICE PRICING AND RECONCILIATION
11.1 During the Commercial Phase, Product and Placebo shall be
ordered and invoiced as follows:
11.1.1 In addition to the prices specified in Schedule 4 the
following surcharges shall apply,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]
cassette surcharge Pre-printed Lidding Foil surcharge
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]
cassette surcharge Pre-printed Lidding Foil surcharge
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]
26
Exhibit 10.1
11.1.2 Within thirty days of the end of the first calendar
year CIMA shall debit or credit AstraZeneca with an
amount equal to the difference between the amount so
invoiced and the sum due with respect to the
aggregate of:
(a) Prices for Product as described in Schedule 4
that take account of cumulative batches and variants
actually ordered; and
(b) sums due in respect of performance against API
conversion ratio according to clause 7.5.
11.1.3 For each Calendar Year thereafter Placebos and the
cassette surcharge will continue to be used in orders
and invoices as described in Clause 11.1.2 but
Product will be ordered and invoiced at prices
according to Schedule 4 and where the cumulative
number of Batches of Product shall be taken as the
sum of the Batches of Product in the previous year
plus those Batches of Product forecast in
AstraZeneca's Annual Forecast for the year in
question and the number of variants forecast to be
ordered shall be taken as 5-12.
11.1.4 Within thirty days of the end of the calendar year
CIMA will debit or credit AstraZeneca with an amount
as described in clause 11.1.2.
12 PAYMENT
27
Exhibit 10.1
AstraZeneca shall pay all invoices in full in US Dollars by wire
transfer to CIMA's registered office at Eden Prairie, Minnesota no
later than 30 days following receipt of invoice (by fax or otherwise)
subject to CIMA complying with its obligations under clause 4.3 of this
Agreement.
13 WARRANTIES, QUALITY OF THE PRODUCT AND LIABILITY
13.1 CIMA hereby warrants and undertakes to AstraZeneca that:
13.1.1 the performance by CIMA of its obligations to
AstraZeneca hereunder will not breach any covenant or
obligation of CIMA to any third party, or infringe
any rights of any third party; CIMA is not aware of
any matter or impediment which would prevent CIMA
from performing or would restrict or hinder CIMA in
the performance of its obligations hereunder;
13.1.2 Product to be supplied to AstraZeneca pursuant to
this Agreement (and all associated packaging and
documentation) shall be manufactured, analysed and
supplied in accordance with the provisions of Clause
4 which are summarised in Schedule 5 as supply
parameters (the "Supply Parameters").
13.2 CIMA will inform AstraZeneca promptly in writing of any event
which in the reasonable judgement of CIMA may adversely affect
the suitability of the Product for AstraZeneca's use.
28
Exhibit 10.1
13.3 AstraZeneca shall notify CIMA of any non-compliance with the
Supply Parameters within forty-five (45) days of AstraZeneca's
receipt of Product. If and to the extent that AstraZeneca has
failed to examine the Product in accordance with this clause
13.3 (or it has failed to so notify CIMA in accordance with
this clause 13.3) the relevant consignment of the Product
shall be deemed to have been accepted by AstraZeneca in
satisfactory condition in respect of all damage, shortage or
defects which would have been discovered upon such
examination.
13.4 CIMA and AstraZeneca agree to make best endeavours to resolve
all claims made in accordance with Clause 13.3. If a dispute
arises between the parties in relation to such claims which
cannot be resolved by the parties within ninety(90) days of a
claim being notified by AstraZeneca pursuant to clause 13.3,
either party shall be entitled to require that the matter in
dispute be referred to an independent expert nominated by
agreement of the parties or, failing agreement, appointed by
[the President of the International Chamber of Commerce,
Paris] at the instigation of either party. Such referral shall
be solely for the purpose of establishing whether or not there
is any shortage, damage or defect (as the case may be) in
relation to the Supply Parameters. Save in the case of fraud
or manifest error the decision of such independent expert
shall be binding upon the parties. In the event that the
independent expert decides there was no shortage, damage or
defect, the costs of the independent expert shall be borne by
AstraZeneca. In all other circumstances, the costs of the
independent expert shall be borne by CIMA.
29
Exhibit 10.1
13.5 If AstraZeneca brings a claim against CIMA in respect of a
defect in any Product supplied or in any associated packaging
or documentation, CIMA's liability in respect of such claim
shall at AstraZeneca's option be limited to either:-
13.5.1 replacing the defective item at CIMA's expense; or at
AstraZeneca's sole discretion;
13.5.2 refunding to AstraZeneca the cost paid to CIMA by
AstraZeneca for such defective item.
13.6 In the event of AstraZeneca bringing a claim against CIMA in
respect of a non-disclosed change (as described in the Quality
Assurance Agreement) CIMA shall be required to bear the cost
of any resulting validation of the change and the cost of
obtaining any necessary regulatory approvals or alternatively
(at AstraZeneca's option) reverting to the original form of
manufacture and bearing the cost of any recall of Product
necessitated by such non-disclosed change.
13.7 In the event of direct loss or damage to AstraZeneca's
employees, agents or contractors; to AstraZeneca's property or
to the environment associated with production using the
Product (and excluding circumstances which have been caused
directly by API or the negligence of AstraZeneca or its
employees, agents or contractors) CIMA shall bear the full
cost of any such loss or damage PROVIDED THAT CIMA shall bear
no liability for special, indirect or consequential loss.
30
Exhibit 10.1
13.8 In the event of direct loss or damage to CIMA's employees,
agents or contractors; to CIMA's property or to the
environment arising out of its due performance of its
obligations under this Agreement (and excluding circumstances
which have been caused directly by the negligence of CIMA or
its employees, agents or contractors) AstraZeneca shall bear
the full cost of any such loss or damage PROVIDED THAT
AstraZeneca shall bear no liability for special, indirect or
consequential loss.
13.9 CIMA UNDERTAKES NO OTHER WARRANTIES OF ANY KIND, EXPRESS OR
IMPLIED, AND EXPRESSLY DISCLAIMS ANY WARRANTY OF
MECHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND ANY AND
ALL LIABILITY FOR SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES.
14 VENDOR PERFORMANCE
CIMA shall comply with the Vendor Rating Scheme an indicative version
of which is set out in Schedule 5 and shall use its best endeavours to
maintain Division 1 status throughout the term of this Agreement.
15 FORCE MAJEURE
15.1 Subject to clause 15.3, each party shall be released from its
obligations under this Agreement to the extent that its
performance hereunder is delayed, hindered or prevented by
circumstances which are not within its reasonable control,
31
Exhibit 10.1
including, without limitation, acts or restraints of
governments or public authorities; war, revolution, riot or
civil commotion; strikes, lock-outs or other industrial
action; blockage or embargo; failure of supplies of power,
fuel, transport, equipment or other goods or services; and
explosion, fire, flood or natural disaster (a "Force Majeure
Event").
15.2 The party affected by such circumstances shall, as soon as it
becomes aware of them, give full written particulars of them
to the other party, and shall use best endeavours to resume
full performance of its obligations under this Agreement
without delay, and pending such resumption shall use best
endeavours to facilitate any efforts that the other party may
make to procure an alternative method by which its obligations
under this Agreement may be performed. Furthermore, if, as a
result of a Force Majeure Event CIMA is unable to supply the
quantity of Product ordered by AstraZeneca or the quantity
which AstraZeneca would have ordered but for such
circumstances then:-
15.2.1 AstraZeneca shall be obliged to purchase such Product
as it has actually ordered but at the price which
would have applied under schedule 4 had CIMA been
able to supply and had AstraZeneca purchased the
quantities actually required by AstraZeneca; and
15.2.2 if such circumstances continue or are forecast to
continue for more than [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], CIMA shall
use all reasonable endeavours to offer to
32
Exhibit 10.1
AstraZeneca alternative capacity for Product (at
prices and on terms to be agreed) which can be
operable within a further [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] to the
standards required by the Quality Assurance
Agreement; and
15.2.3 CIMA shall allocate all available capacity of Product
produced by CIMA proportionally as between CIMA,
AstraZeneca and other customers of CIMA and CIMA
shall be deemed to have supplied the Product ordered
or forecast for the purposes of calculating the price
of the Product.
15.3 Neither party shall be entitled to relief under this clause 15
for any delay or failure in performing any of its payment
obligations under this Agreement.
15.4 If a Force Majeure Event other than the supply of API prevails
for a continuous period in excess of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], the party entitled to
notification of such circumstances in accordance with clause
15.2 may, without prejudice to any other rights or remedies
which may be available to it, terminate this Agreement with
immediate effect by giving written notice of termination to
the other party.
15.5 If AstraZeneca is notified of a Force Majeure Event, the
obligation upon AstraZeneca to purchase the Product from CIMA
in accordance with this
33
Exhibit 10.1
Agreement shall be suspended for the duration of the force
majeure event.
16 HARDSHIP
16.1 For so long as any circumstances prevail which prevent or
impede AstraZeneca from using or selling the Product and which
AstraZeneca cannot control by taking all measures which can
reasonably be expected then AstraZeneca shall not be obliged
to place any further orders for the Product notwithstanding
any other provision of this Agreement but shall be obliged to
purchase such quantities of Product as it has actually
ordered. If such circumstances prevail for a period of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] or
more, AstraZeneca shall be entitled to terminate this
Agreement forthwith on written notice to CIMA PROVIDED THAT,
on or prior to such termination, AstraZeneca shall:
(i) purchase all Product actually ordered prior to the date of
termination at the price specified in Schedule 4 and
(ii) pay CIMA for the purchase value of Pre-printed Foil
Safety Stock it holds or has ordered solely for use in the
manufacture of Product; and
(iii) compensate CIMA for all reasonable costs and expenses
incurred by CIMA (including the costs of excipients and
packaging materials specific to AstraZeneca purchased or
manufactured by CIMA solely for use in the
34
Exhibit 10.1
manufacture of Product) in order to comply with its
obligations to supply Product pursuant to this Agreement such
costs and expenses not to exceed the cost of manufacturing six
(6) months' Safety Stock based on the latest forecast.
17 CONFIDENTIALITY
17.1 Subject to clause 18, any know-how or other information
proprietary to either party to this Agreement which is
disclosed by that party ("the Discloser") or on its behalf to
the other party ("Recipient") in connection with this
Agreement ("Confidential Information") shall remain the
property of the Discloser and shall not, without the prior
written consent of the Discloser, be disclosed to any third
party or used by the Recipient except for the performance of
the Recipient's obligations under this Agreement.
17.2 The obligations of non-use and confidentiality contained in
this clause 17 shall not apply to any information which the
Recipient can reasonably demonstrate;
17.2.1 was already in the possession of the Recipient and at
the Recipient's free use and disposal or in the
public domain (through no fault of the Recipient)
prior to its disclosure by the Discloser hereunder;
or
17.2.2 is purchased or otherwise legally acquired by the
Recipient at any time from a third party having good
title thereto and the right to disclose the same; or
35
Exhibit 10.1
17.2.3 comes into the public domain, otherwise than through
the fault of the Recipient; or
17.2.4 is independently generated by the Recipient without
any recourse or reference to the information
disclosed by the Discloser.
All documents supplied by either party to the other which
contain Confidential Information within the scope of this
clause 17 shall be promptly returned by the Recipient to the
Discloser upon the expiry or termination of this Agreement.
The obligations of each party under this clause shall survive
the expiry or termination of this Agreement provided that the
Recipient shall have the right to retain in its legal
department a single copy for archival purposes to ensure
compliance with the above obligations.
17.3 In addition to the Confidential Information identified in
clause 17, each party shall treat as Confidential Information
all information which it receives or obtains relating to:
17.3.1 the contents of or negotiations relating to this
Agreement; and
17.3.2 the business and customers of the other party.
17.4 Each of the parties may disclose Confidential Information to
its directors and employees and professional advisers who need
to know the Confidential Information, provided that each party
shall procure that prior to such disclosure
36
Exhibit 10.1
each of those directors, employees and professional advisers
to whom Confidential Information is to be disclosed is made
aware of the confidentiality obligations herein contained and
undertakes to adhere to such terms of this Agreement as if he
were a party to it.
17.5 Each party is entitled to disclose Confidential Information to
Associated Companies, provided that each party shall procure
that prior to such disclosure each of those Associated
Companies to which Confidential Information is to be disclosed
is made aware of the confidentiality obligations herein
contained and undertakes to adhere to such terms of this
Agreement as if it were a party to it.
17.6 Nothing in this clause 17 shall preclude disclosure of any
Confidential Information required by any governmental or
regulatory authority or court entitled by law to disclosure of
the same including, for the avoidance of doubt, any
information required for disclosure under the Securities Act
of 1933 (as amended) or the Securities Exchange Act of 1934
(as amended) or in accordance with the regulations of any
recognised stock exchange, or which is required by law,
provided that the party concerned promptly notifies the other
party when such requirement to disclose has arisen.
18 ANNOUNCEMENTS/PUBLICITY
18.1 Save as expressly permitted in clause 18.2 neither party shall
make any announcement about the transaction contemplated by
this Agreement without the
37
Exhibit 10.1
prior written consent of the other party.
18.2 If any announcement concerning the transaction contemplated by
this Agreement or any ancillary matter is required of a party
by law or any securities exchange or regulatory or
governmental body to which either party is subject, the
announcement shall be made only after informing the other
party as to the terms of and timetable for publication of any
such announcement (if such consultation is reasonably
practicable).
19 NOTICES
19.1 All notices and other communications given or made in relation
to this Agreement;
19.1.1 shall be in English and in writing;
19.1.2 shall be delivered by hand or courier or sent by
facsimile;
19.1.3 shall be delivered or sent to the party concerned at
the relevant address or facsimile number, shown in
clause 19.2 subject to such amendments as may be
notified from time to time in accordance with this
clause by the relevant party to the other party by no
less than three (3) Business Days' notice; and
38
Exhibit 10.1
19.1.4 shall be deemed to have been duly given or made if
addressed in the aforesaid manner:
19.1.4.1 if delivered by hand or courier, upon
delivery; and
19.1.4.2 if sent by facsimile, when a complete and
legible copy of the communication, has been
received at the appropriate address,
provided that if any notice or other communication
would otherwise become effective on a non-Business
Day or after 5.00 p.m. on a Business Day, it shall
instead be deemed to be given or made at 10.00 a.m.
on the next Business Day.
19.2 The initial details for the purposes of clause 19.1 are: For
AstraZeneca
Xxxxxxxx Xxxxx, Xxxxxxxx Xxxx
Xxxxxxxxxxxx, Xxxxxxxx
XX00 0XX, Xxxxxxx
Facsimile: 01625 514061
For the attention of: Supply Manager
For CIMA
00000 Xxxxxx Xxxx Xxxx
Eden Prairie
39
Exhibit 10.1
MN 00000
X.X.X.
Facsimile: 001 612 947 8770
For the attention of: President and Chief Executive Officer
20 AGENCY, PARTNERSHIP OR JOINT VENTURE EXCLUDED
20.1 Nothing in this Agreement shall be construed so as to
constitute either party to be the agent of the other.
20.2 Nothing in this Agreement and no action taken by the parties
pursuant to this Agreement shall constitute a partnership or
joint venture of any kind between the parties.
21 NON-ASSIGNMENT
21.1 Save as hereinafter provided this Agreement shall not be
assigned nor any of the obligations hereunder transferred (nor
the performance of any obligation hereunder sub-contracted) by
either party except with the prior written consent of the
other, provided that no consent shall be required in the cases
of an assignment or transfer to an Associated Company of that
party provided that any such assignment shall be made on terms
that, should any such assignee cease to be an Associated
Company of the assignor then the Agreement and any obligations
which have been transferred to the assignee shall be
transferred
40
Exhibit 10.1
back to the assignor.
22 ENTIRE AGREEMENT
22.1 Each party acknowledges that in entering into this Agreement
it places no reliance on any representation or warranty
relating to the subject matter of this Agreement, save for the
representations and warranties expressly set out herein.
22.2 Subject to any terms implied by law, this Agreement, the
Licence Agreement and the Quality Assurance Agreements
together represent the entire agreement between the parties in
relation to the subject matter of this Agreement and supersede
any previous agreement or arrangement, between the parties in
relation to that subject matter whether written or oral or
which might be inferred from the conduct of the parties.
23 REMEDIES AND WAIVERS
23.1 No delay or omission on the part of either party in exercising
any right, power or remedy provided by law or under this
Agreement shall:-
23.1.1 impair such right, power or remedy; or
23.1.2 operate as a waiver thereof.
41
Exhibit 10.1
23.2 The single or partial exercise of any right, power or remedy
provided by law or under this Agreement shall not preclude any
other or further exercise thereof or the exercise of any other
right, power or remedy.
23.3 The rights, powers and remedies provided in this Agreement are
cumulative and not exclusive of any rights, powers and
remedies provided by law.
24 SEVERABILITY/INVALIDITY
24.1 Should any provision of this Agreement be held to be illegal,
invalid or unenforceable in any respect by any judicial or
other competent authority under the law of any jurisdiction:
24.1.1 such provision shall, so far as it is illegal,
invalid or unenforceable in any jurisdiction, be
given no effect by the parties and shall be deemed
not to be included in this Agreement in that
jurisdiction;
24.1.2 the other provisions of this Agreement shall be
binding on the parties in that jurisdiction as if
such provision were not included herein;
24.1.3 the legality, validity and enforceability of the
provision in any other jurisdiction shall not be
affected or impaired; and
24.1.4 the parties agree to negotiate in good faith to amend
such provision to the extent possible for
incorporation herein in such reasonable manner as
42
EXHIBIT 10.1
most closely achieves the intention of the parties
and without rendering such provision invalid or
unenforceable.
25 VARIATIONS AND/OR AMENDMENTS
25.1 This Agreement may only be varied or amended by agreement in
writing signed by or on behalf of the parties.
26 LAW AND JURISDICTION
26.1 This Agreement shall be governed by, interpreted and enforced
in accordance with the laws of the State of Delaware, without
regard to its choice of law provisions.
26.2 The parties will use all reasonable efforts to resolve in an
amicable fashion any dispute, claim or controversy that may
arise relating to the terms or performance of this Agreement.
If the parties are unable to resolve such dispute within
thirty (30) days after initial notice, either party may, by
notice to the other, have such dispute referred to a senior
officer of each company. Such officers shall attempt to
resolve the dispute by good faith negotiation within thirty
(30) days after receipt of such notice. If the designated
officers are not able to resolve such dispute within ninety
(90) days after receipt of such notice, the parties will
submit the dispute to arbitration by a single arbitrator in
Minneapolis, Minnesota, in accordance with the Commercial
Arbitration Rules of the American Arbitration Association then
in effect. The arbitrator must be a retired judge of a state
or federal court of the United States or a licensed lawyer
with at least ten (10) years
43
EXHIBIT 10.1
of intellectual property law experience from a law firm with
at least ten (10) attorneys and at least an AV rating by
Martindale Xxxxxxx. A list of ten (10) potential arbitrators
shall be obtained from the AAA. Each party to the dispute will
rank the potential arbitrators from one to ten with one being
the most desirable. The arbitrator who receives the least
points shall be the arbitrator for such dispute. If there is a
tie, a random drawing will be held and the first arbitrator
chosen will be the arbitrator for the dispute. Judgment upon
the arbitration award will be final, binding and conclusive
and may be entered in any court having jurisdiction. The
parties hereto further agree that the arbitrator is not
authorised to award any punitive damages in connection with
any controversy or claim settled by arbitration hereunder.
27 COUNTERPARTS
27.1 This Agreement may be executed in more than one counterpart,
each of which when executed and delivered shall be deemed to
constitute an original. This Agreement shall become effective
when one or more counterparts have been signed by both parties
and such a counterpart (so signed) has been delivered to each
of the parties.
IN WITNESS whereof this Agreement has been entered into the day and year first
above written.
SIGNED for and on behalf of
CIMA LABS INC
/s/ Xxxx X. Xxxxxxx
Name Xxxx X. Xxxxxxx
44
EXHIBIT 10.1
Title President & CEO
Date August 23, 2001
SIGNED for and on behalf of
ASTRAZENECA UK LIMITED
/s/ C.R.W. Xxxxx
C R W Xxxxx
Authorised Signatory
Date 31 August 2001
45
EXHIBIT 10.1
SCHEDULE 1
PRODUCT SPECIFICATION
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION; 4 pages omitted. ***]
EXHIBIT 10.1
SCHEDULE 2
PACKING SPECIFICATION FOR UK AND US
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION; 2 pages omitted. ***]
EXHIBIT 10.1
SCHEDULE 3
STOCK REPORTING FORMAT
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION; 3 pages omitted. ***]
EXHIBIT 10.1
SCHEDULE 4
PRICE MATRIX [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] MG TABLETS
CIMA TABLET PRICES
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION; 4 pages omitted. ***]
EXHIBIT 10.1
SCHEDULE 6
SELF SUPPLY TERMS
1. CIMA will grant to AstraZeneca an option to manufacture or have
manufactured up to one hundred percent (100%) of its requirements of
the Product for distribution, marketing and sale by AstraZeneca, its
Affiliates and sublicensees ("Self-Supply") commencing at any time
after the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] after
commercial launch of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] formulation of Product, except as provided in Section 2
below. AstraZeneca may exercise such option by so notifying CIMA in
writing at least three (3) months before AstraZeneca requires the
Technology Transfer to begin that AstraZeneca intends to Self-Supply.
If AstraZeneca exercises its option to Self-Supply, AstraZeneca shall
pay an Option fee (the "Self-Supply Option Fee") equal to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. For the avoidance of
doubt, no further payments will be due from AstraZeneca to CIMA in
respect of this option to Self-Supply any other (future or existing)
dosage forms of the Product..
2. If CIMA is unable to supply AstraZeneca with AstraZeneca's requirements
of the Product, for any reason other than force majeure of a duration
less than 60 days, (or AstraZeneca's inability to supply API as
specified in Clause 7 of the Agreement) AstraZeneca may elect to
manufacture the Product or have it manufactured by its Affiliates and
sublicensees. In such situation, if AstraZeneca has already elected to
Self-Supply at the time CIMA becomes unable to supply the balance of
AstraZeneca's requirements, AstraZeneca will receive a refund of any
portion of the
EXHIBIT 10.1
Self-Supply Option Fee that AstraZeneca has paid to CIMA. However,
AstraZeneca shall in such circumstances continue to be obligated to pay
to CIMA the per tablet fee referred to in Section 3 below.
If CIMA subsequently becomes able to again supply AstraZeneca with
AstraZeneca's requirements of the Product and AstraZeneca elects to
purchase any portion of its requirements of the Product from CIMA or
elects to have CIMA reserve manufacturing capacity for manufacture of
any portion of AstraZeneca's requirements of the Product, AstraZeneca
shall repay to CIMA that portion of the Self-Supply Option fee refunded
to AstraZeneca under this Section 2.
3. If AstraZeneca elects to Self-Supply or to manufacture under Section 2
of this Schedule, in addition to the technology transfer fee,
AstraZeneca shall pay to CIMA either (i) [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] per tablet manufactured by AstraZeneca, if at
the time AstraZeneca elects to self-supply CIMA is supplying finished
packaged Product to AstraZeneca, or (ii) [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] per tablet manufactured by AstraZeneca, if at
the time AstraZeneca elects to Self-Supply CIMA is supplying bulk,
unpackaged blisters to AstraZeneca.
4. If AstraZeneca elects to Self-Supply or to manufacture, under Section 2
of this Schedule, AstraZeneca will have no right to make changes of any
kind to the Product or the manufacturing process without CIMA's written
consent, may not use of permit its Affiliates or sublicencees to use
the technology for any purpose other
2
EXHIBIT 10.1
than to manufacture the Product, and may not permit its Affiliates or
sublicensees to further transfer the technology. If AstraZeneca ceases
to utilise the manufacturing technology to manufacture the Product, the
manufacturing licence will automatically terminate and revert to CIMA.
5. If AstraZeneca elects to Self-Supply or to manufacture under Section 2
of this Schedule, CIMA will provide to AstraZeneca, its Affiliates
and/or sublicensees, at AstraZeneca's sole expense, technical support
and assistance to ensure the smooth and satisfactory establishment of
the DuraSolv Technology at the new manufacturing site.
3
