EXHIBIT 10.30
SUPPLY AGREEMENT - TRILOSTANE
STERLING SNIFF
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SIGNATORIES TO THE SUPPLY AGREEMENT:
------------------------------------
This Supply Agreement (the "Agreement"), by and between:
Stegram Pharmaceuticals Ltd., with principal executive offices located at 00
Xxxxxxxxxx Xxxxx, Xxxxxxxxxxxxx, Xxxxxx XX00 0XX, XX ("Stegram")
Bioenvision, Inc., with principal executive offices located at 000 Xxxx Xxxxxx,
00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, XXX ("Bioenvision")
Dechra Ltd., with principal executive offices located at Jamage Industrial
Estate, Talke Pits, Xxxxx xx Xxxxx, Xxxxxxxxxxxxx, XX0 0XX, XX ("Dechra")
AND
Sterling S.N.I.F.F. Italia SpA, with principal executive offices located at via
della Carboneria 30/32, Xxx. Xxxxxxx, 00000, XXXXXXXX - XXXXXXX, Xxxxx
("Sterling"),
is made and effective as of l2th day of August 2005 (the "Commencement Date").
WHEREAS:
(1) Stegram is the proprietor of patents and technical information
relating to the development and uses of a dehydrogenase inhibitor and
receptor blocker and related compounds, including trilostane,
hereinafter referred to as "the Product".
(2) Bioenvision obtained certain rights to practice the inventions of
such patents and technical information from Stegram, pursuant to that
certain Co-Development Agreement, dated 17th July 1998 (as amended,
the "Co-Development Agreement").
(3) Dechra obtained certain rights to the Product for use in the
veterinary market from Stegram, pursuant to that certain
Manufacturing and Distribution Agreement between Stegram and Arnolds
Veterinary Products, a trading division of Dechra, dated 10 December
2001 and pursuant to that certain Joinder, dated 26 February 2004, by
and between Stegram, Bioenvision and Arnolds.
(4) Sterling has manufactured the Product (as defined in Section 1 below)
at the direction and desire of Stegram and desires to continue to
manufacture Product at the direction and desire of Stegram,
Bioenvision and Dechra.
(5) Stegram, Bioenvision and Dechra desire for Sterling to continue to
manufacture Product on their respective behalf pursuant to the terms
of this Agreement.
(6) Bioenvision, Dechra and Sterling acknowledge that title to Industrial
Property Rights pertaining to the Product, which include proprietary
information on synthesis, process, analytical, technical, commercial
information, know-how and data relating to the
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manufacture and commercial exploitation of the Product, is and
remains at all times the exclusive property of Stegram, excepting
such information as is transferred under the terms of the
abovementioned Agreements or is transferred by subsequent Agreements
which shall be at the sole discretion of Stegram.
(7) This Agreement is a non-exclusive Agreement with Sterling.
1. DEFINITIONS AND INTERPRETATION
1.1 In this Agreement, unless the context requires otherwise:
"Agreement" shall be this Supply Agreement and its associated Schedules.
"Buffer Stock" means a quantity of Product maintained on Sterling's
inventory and at Sterling's expense as a contingency to meet supply
requirements in the event of a manufactured batch failing to comply with
the Specification, or in the event of other unforeseen and/or emergency
requirements.
"Bulk Product" means Product in a form as manufactured by Sterling to
the Specification set out in Schedule 2 and prior to its formulation
into medicinal Finished Product.
"Certificate of Analysis" means a document certifying the results of
analysis performed on the Product following manufacture in order to
determine compliance with the Specification (set out in Schedule 2) for
the Product. Analytical results shall be reported on the Certificate of
Analysis in a manner which is acceptable to the relevant regulatory
authorities. The Certificate of Analysis shall also show the Product
batch number to which the analysis refers, the dispatched quantity of
Product produced as the batch, and the date of manufacture of the batch.
"Commencement date" shall be the date of this Agreement.
"Designee" means a Party acting on behalf of or in lieu of another Party
or the subsidiary or trading division of a Party acting on behalf of or
in lieu of the Party to this Agreement.
"Drug Master File" means a description of the Product, its manufacture,
its Specification and other information relevant to its production by
Sterling including such information about Sterling and Sterling's
production operation as is relevant to satisfy regulatory authorities as
to the fitness of the Product as manufactured by Sterling for use of the
Product in human and veterinary medicine. A European Drug Master File
will comprise an "Open Part" and a "Closed Part" or other designations
with the same meanings. "Open Part" means that Information contained
within a regulatory submission which is in principle accessible by the
public. "Closed Part" means that Information contained within a
regulatory submission which is not available for public disclosure or
use and shall include but not be limited to a description of the
manufacturing process, Product specification and methods of analysis,
raw materials and intermediates and their specifications and methods of
analysis, a description of possible impurities, stability test data and
packaging and labelling. The Information contained in the Open Part and
the Closed Part of a European Drug Master
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File or any other Drug Master File the format of which includes a Closed
Part or confidential section, shall be authorised by Stegram.
Bioenvision and Dechra shall be responsible for ensuring that such
Information is included in the Closed Part and that the Closed Part and
Open Part are clearly marked in the Drug Master File. A United States
Drug Master File is confidential in its entirety and in this regard is
therefore equivalent to the Closed Part of a European Drug Master File.
"Europe" means the countries of the European Union, Switzerland and
Norway.
"Finished Product" means Product formulated into a dosage form for use
as a human or veterinary medicine.
"(current) Good Manufacturing Practice" means the batchwise
manufacturing of the Product shall be conducted under conditions of
current Good Manufacturing Practice as required by but not limited to
the pharmaceutical industry regulatory authorities in Europe, the United
States of America and Japan.
"Industrial Property Rights" means all know-how, copyright, trademarks,
patents, designs, information and documentation, including but not
limited to the Specification, drawings and Information relating to
manufacture and analysis, assembly and use of the Product.
"Information" means any scientific, statistical, commercial or technical
information, know-how or data which may be disclosed or communicated by
any Party to Sterling directly or indirectly, verbally, or by any other
means.
"Nominee" means a Person nominated by Stegram to conduct certain aspects
of Stegram's business on behalf and with consent of Stegram as expressly
set forth in this Agreement.
Stegram, at its sole discretion, appoints as Nominees Xxxxxxx Xxxxxxx
Xxxxxxx, trading as Xxxxxxx Business Developments, with offices located
at 0 Xxxxxxxxxx, Xxxxxxxxxxx, Xxxxxxx, Xxxxxxxxxxxxxx XX00 0XX, XX
("PBD") and Xxxxx Analytical Limited, with offices located at Vallum
Farm, Military Road, East Wallhouses, Xxxxxxxxx xxxx Xxxx XX00 0XX, XX
("Xxxxx") and Micron Technologies Limited, with offices located at
Xxxxxxxxx Xxxxxxxxx, Xxxxxxxxx, Xxxxxxxx, Xxxx XX0 0XX, XX ("Micron").
Notwithstanding any other provision of this Agreement to the contrary,
Stegram shall remain fully responsible for each and every obligation
performed on its behalf pursuant to this Agreement by its Nominee as if
each such obligation had been performed directly by Stegram.
"Parties" means collectively Stegram, Bioenvision and Dechra and "Party"
means one of these.
"Person" means any individual, firm, unincorporated association, body
corporate or any other entity.
"Price" means the price payable for the Product as set out in Schedule
3.
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"Product" means the product described in Schedule 1 and all
modifications developments and improvements relating thereto.
"Purchase Terms" means the purchase terms set out in Schedule 4.
"Qualified Person" means a person who fulfils the minimum conditions of
scientific and technical qualifications referred to in Article 23 of EEC
(European Economic Community) Directive 75/319/EEC and Article 31 of EEC
Directive 81/851/EEC or qualifications as may be ordered by subsequent
EEC Directives from time to time.
"Quality Audit" means an inspection undertaken by any Party hereto or
their respective Designee(s) or Nominee(s) by prior arrangement at any
reasonable time at Sterling's premises for the purposes of confirmation
of regulatory compliance and quality assurance. Sterling undertakes to
make available to any such Party or its respective Designee or Nominee,
personnel, documentation, factory facilities, laboratories and other
sources of information, relating to production, quality assurance and
quality control of the Product.
"Re-Processed Product" means Product which has not complied with the
required standard of quality including but not limited to the
Specification, and is purified in order to meet the required standard of
quality by Sterling's application of a chemical or other necessary
operation typified by but not limited to recrystallisation.
"Schedule" means Schedules which constitute part of this Agreement and
are designated as:
Schedule 1 - Product
Schedule 2 - Specification
Schedule 3 - Price and Quantity of Product
Schedule 4 - Purchase Terms
Schedule 5 - Record of additions, deletions, or
amendments to Supply Agreement and
Schedules (with file references to
written consents) and procedural
agreements made with the Parties or
their respective Designees or Nominees
"Specification" means the specification of the Product set out in
Schedule 2 or any other specification determined by Stegram.
"Stage 1" means (17a)-1 7-hydroxy-2-(hydroxymethylene)androst-4-en-3-one
"Stage 2" means (17a)-androsta-2,4-dieno(2,3,d)isoxazol-17-ol
"Stage 3" means (4a
,5a,17a)-4,5-epoxyandrost-2-eno-(2,3,d)-isoxazol-17-ol (designated by
Chemical Abstracts Service Registry Number 20051-76-7)
"Term" means the period of eight (8) years commencing on the date of
this Agreement.
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"Validation Batch" means a batch of Product, data from which is used to
demonstrate the efficacy of the manufacturing process, the
reproducibility of Product quality, Product stability, and other
parameters which may be required by regulatory authorities in order to
grant approval of the manufacturing process and Product quality.
"Writing" and "Written" mean transmission of information by means of
black or blue ink applied by hand or machine to paper by the sender and
signed and dated by the sender. The definition expressly excludes
information sent by facsimile or electronic mail (e-mail) by means of
the internet unless otherwise authorised by the Parties.
"Year" means the period of twelve (12) months from the date of this
Agreement and each subsequent consecutive period of twelve (12) months
during the period of this Agreement.
1.2
Reference to a clause, paragraph or Schedule is to a clause, paragraph or
Schedule of or to this Agreement unless the context requires otherwise.
1.3
Reference to any gender includes the other gender and words denoting the
singular include the plural and vice versa unless the context requires
otherwise.
1.4
Reference to a statutory provision includes a reference to that statutory
provision as from time to time amended extended or re-enacted and any
regulations made under it.
1.5
The headings in this agreement are for ease of reference only and shall not
affect its construction or interpretation.
2. CONTACTS
2.1
Contact names, addresses, communications numbers and e-mail addresses of the
Parties, their authorized Nominees and Designees under the terms of this
Agreement, and Sterling, are listed below. Also below are certain general
obligations of the Parties pursuant to this Agreement, subject to the terms and
conditions set forth in this Agreement in their entirety.
Under the terms of this Agreement the Parties or their authorized Nominees and
Designees under the terms of this Agreement, Sterling, and AS-Tec, shall perform
individual duties including but not necessarily limited to those described in
this Agreement:
AS-Tec Chemicals Limited, Beech House, Xxxxxx Knowledge Park, Xxxxxxxx Xxxx,
Xxxxxxx XX0 0XX, XX (hereinafter referred to as "AS-Tec").
AS-Tec is the UK sales agent and representative of Sterling in the UK.
Contact Xxxxx Xxxxxx
Telephone x00-0000-000000
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Fax x00-0000-000000
e-mail xxxxx@xx-xxx-xxxxxxxxx.xx.xx
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Bioenvision
Bioenvision, either directly or through one or more of its subsidiaries, markets
Finished Product for use in human medicine and shall provide regular quantity
requirement forecasts for the Product to Stegram and orders for the product to
Sterling and payment in UK pounds sterling direct to Sterling for the provision
of Product under the terms of this Agreement.
Contact Xxxx Xxxxxxxx
Telephone x00-000-000-0000
Fax x00-0 00-000-0000
e-mail xxxxxxxxxxxx@xxxxxxxxxxx.xxx
Dechra Ltd.
Dechra, either directly or through one or more of its trading divisions, markets
Finished Product for use in veterinary medicine and shall provide regular
quantity requirement forecasts for the Product to Stegram and orders for the
Product to Sterling and payment in UK pounds sterling direct to Sterling for the
provision of Product under the terms of this Agreement.
Arnolds Veterinary Products, Xxxxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxxxxx, Xxxxxxxxxx
XX0 0XX, XX (hereinafter referred to as "Arnolds"). Arnolds is a trading
division and Designee of Dechra Ltd.
Contact Xx Xxxx
Telephone x00-0 000-000000
Fax x00-0000-000000
e-mail xx.xxxx@xxxxxx.xxx
Dales Pharmaceuticals, Snaygill Industrial Estate, Xxxxxxxx Xxxx, Xxxxxxx, XX00
0XX, XX (hereinafter referred to as "Dales"). Dales is a company engaged in the
production of pharmaceutical dosage forms in which capacity Dales acts as a
manufacturing contractor.
Dales is a trading division and Designee of Dechra Ltd.
Dales Xxxx Xxxxxx
Telephone x00-0000-000000
Fax x00-0000-000000
e-mail x.xxxxxx@xxxxxxxxxxx.xxx
Xxxxx Analytical Limited, Vallum Farm, Military Road, East Wallhouses, Xxxxxxxxx
xxxx Xxxx XX00 0XX, XX (hereinafter referred to as "Xxxxx"). Xxxxx is a company
engaged in the business of chemical analysis and quality control and has been
appointed by Stegram to conduct independent quality control of the Product on
behalf of Stegram. Xxxxx is a Nominee of Stegram.
Xxxxx Xx Xxxx Xxxxxxxxxxx
Telephone x00-0000-000000
Fax x00-0000-000000
e-mail x.xxxxxxxxxxx@xxxxx-xxxxxxxxxx.xx.xx
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Micron Technologies Limited, Xxxxxxxxx Xxxxxxxxx, Xxxxxxxxx, Xxxxxxxx, Xxxx XX0
0XX, XX (hereinafter referred to as "Micron").
On behalf of Stegram and in its capacity as Nominee of Stegram, Micron
Technologies shall micronise bulk Product to a particle size and particle size
distribution specification as determined by Stegram, conduct appropriate
analysis to ensure compliance with the particle size and particle size
distribution specification as determined by Stegram and arrange shipment as
required by one of the Parties or a Nominee during the term of this Agreement.
Micron Xxxxx Xxxxxxx
Telephone x00-0000-000000
Fax x00-0000-000000
e-mail xxxxxxxx@xxxxxxxxxx.xxx
Xxxxxxx Xxxxxxx Xxxxxxx trading as Xxxxxxx Business Developments, 0 Xxxxxxxxxx,
Xxxxxxxxxxx, Xxxxxxx, Xxxxxxxxxxxxxx XX00 0XX, XX (hereinafter referred to as
"PBD"). Xxxxxxx Xxxxxxx Xxxxxxx is a Nominee of Stegram.
Contact Xx Xxxxxxx Xxxxxxx
Telephone x00-0000-000000
Fax x00-0000-000000
e-mail xxxxxxxx@xxxxxxxxxxxxxx.xxx
Stegram
Stegram is the proprietor of a business engaged in but not limited to the sale
of the Product. Title to industrial Property Rights pertaining to the Product,
which include proprietary information on synthesis, process, analytical,
technical, commercial information, know-how and data relating to the manufacture
and commercial exploitation of the Product, is and remains at all times the
exclusive property of Stegram, excepting such information as is transferred
under the terms of the abovementioned Agreements (section "Whereas") or is
transferred by subsequent Agreements which shall be at the sole discretion of
Stegram.
Contact Xx Xxxxxx Xxxxxxxx
Telephone x00-0000-000000
Fax x00-0000-000000
e-mail xxxxxxxxx@xxxxxxx.xxx.xx
Sterling
Sterling shall provide the services set forth in this Agreement, including,
without limitation, the following: manufacture of Product in bulk form at the
address set forth in the section `Signatories to the Supply Agreement', solely
for the Parties, under conditions of current Good Manufacturing Practice to a
Specification provided by Stegram, validate analytical methodologies provided by
Stegram, conduct analyses on the Product and its intermediates as required by
Stegram for the purposes of quality control, conduct storage stability testing
of the Product, provide samples of Product and its intermediates, and store
Product all pursuant to applicable current Good Manufacturing Practice and other
applicable regulatory requirements. Sterling shall also arrange shipment of
Product and shall invoice direct Dechra or Bioenvision or Stegram, as the case
may be.
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Under the terms of the Agreement Sterling may conduct manufacturing process
development and analytical methodology development on the Product only in
collaboration with and by written consent of Stegram.
Contact Xx Xxxx Xxxxxxx
Telephone x00-000-0000000
Fax x00-000-0000000
e-mail Xxxxxxxx@xxxxxxxxxxxxx.xx
Each Party and/or Nominee shall have the opportunity to change or modify the
contact information set forth above upon prior written notification to each of
the Parties hereto.
2.2
The Parties and Sterling wish to ensure continuity of supply and orders for the
Product and have agreed to enter into this Agreement on the terms set out below.
3. This clause deleted.
4. SALE OF THE PRODUCT
4.1
During the continuance of this Agreement Sterling shall sell such quantities of
the Product to Stegram and Bioenvision and Dechra as may be ordered by Stegram
or Bioenvision or Dechra, respectively, at any time or from time to time.
4.2
Sterling shall not sell any of the Product to any Person other than the Parties
or their respective Designees or successors without each Party's prior written
consent and this obligation shall continue beyond termination of this Agreement.
4.3
Under the terms of this Agreement, from time to time, Stegram or Bioenvision or
Dechra shall purchase Product from Sterling. In the routine operation of its
business and under the terms of this Agreement, Sterling shall invoice directly
Stegram or Bioenvision or Dechra, as the case may be, for Product delivered to a
destination as directed by each such Party. Title to the Product shall be taken
by Stegram or Bioenvision or Dechra, as the case may be, upon delivery of the
Product, with payment due, in each case, within sixty (60) days of the date of
the related invoice. The invoice will not be dated or shipment arranged until
Sterling is notified that the Product is of acceptable quality.
When this Agreement is fully executed Stegram shall immediately provide Sterling
with the authorised HPLC methodology. Invoicing and shipping of the Product
shall be arranged on the basis of Sterling's HPLC results, when Sterling has
demonstrated familiarity with the HPLC methodology.
Interest shall be payable by the purchasing Party to Sterling, on payments made
more than three (3) days late at the rate of seven percent (7%) unless such late
payment is caused by fault of the banks. In the event that such fault is invoked
as being the cause of late payment by the purchasing Party, the purchasing Party
shall provide evidence to Sterling SNIFF.
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5. TERMS OF BUSINESS
5.1
All sales of the Product by Sterling shall be in accordance with the terms of
this Agreement including, but not limited to, the Purchase Terms set out in
Schedule 4.
5.2
The Product shall be sold by Sterling at the Price as set out in Schedule 3.
5.3
During the term of this Agreement, each Party shall deliver separately to
Sterling Purchase Order(s) for the Product. Such Purchase Orders shall be in
writing, and shall be confirmed by Sterling in writing not more than five (5)
working days after Stegram or Bioenvision or Dechra, as the case may be,
delivers such Purchase Order.
5.4
On delivery of the Product by Sterling to Stegram, Bioenvision or Dechra or
their respective Designees or Nominees, the recipient of such Product shall be
responsible for the safe-keeping and safe-handling of the Product.
5.5
This clause deleted.
5.6
Sterling shall keep full records of the total quantity of the Product produced,
stocked and delivered by Sterling together with information relating to any
authorisations or other licences granted in respect of the Product and Sterling
shall permit authorised officers or Nominees or Designees of each Party hereto,
at all reasonable times, to have access to the premises where such records and
information are kept for the purpose of inspecting the same. Between the 1st and
31st of January of each year in which the Agreement is in effect, Sterling shall
provide the Parties with a record of Product produced, stocked and delivered in
the previous calendar year.
5.7
The Parties or their respective Designees or Nominees shall be allowed
reasonable access for the purposes of inspection of Sterling's manufacturing
facilities relating to the Product, by prior appointment. Access shall include
access to machinery, equipment, information, documents, records and personnel.
5.8
The Parties shall deliver purchase orders for Product to Sterling at least
ninety (90) days in advance of requirements and each calendar quarter shall
provide a 12-month rolling forecast. Each order quantity will be in multiples of
31kg.
5.8.1
When an order is placed, it will not be subject to cancellation or deferral by
Stegram or
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Bioenvision or Dechra for reasons associated with forecasting error, budgetary
considerations or related reasons.
5.9
Force majeure and other constraints; Neither the Parties nor Sterling shall be
deemed to be in breach of this Agreement due to a failure to perform any
obligation hereunder where such failure results from any cause beyond its
reasonable control including but without prejudice to the generality of the
foregoing, an act of God, or a strike, lockout, labour dispute, riot, civil
unrest, insurrection, war or other military action, fire, xxxxx, xxxxxxx,
accident, mechanical failure, statutory intervention, or government regulation.
In the event that Sterling invokes force majeure, Sterling shall at once inform
the Parties and produce tangible evidence which may include, but shall not be
limited to written material and/or photographs.
5.10
The rights and obligations contained in this Agreement will be automatically
taken over by any legal successors of any of the contractual Parties with prior
written agreement of the Parties, which agreement shall not be unreasonably
withheld or delayed.
5.11
When the terms of the Agreement require a Party or Sterling to communicate with
each other, each of the Parties and Sterling authorise such communications to
occur through the designated Nominee of the Party or Sterling receiving such
communication.
6. SPECIFICATION AND QUALITY OF THE PRODUCT
6.1
All Product sold by Sterling pursuant to this Agreement shall conform in all
respects to the Specification as set out in Schedule 2, shall be of satisfactory
quality and shall comply with all applicable laws and regulations and with rules
and regulations applying to the conduct of current Good Manufacturing Practice
applicable to the manufacture of human and veterinary medicines and medicinal
materials as are in force at any time during the term of this Agreement.
Compliance of Product with the Specification shall be determined by Xxxxx. In
the event that Sterling disputes analytical results determined by Xxxxx
pertaining to compliance of Product with the Specification, resolution of the
dispute shall be sought by means of good faith discussion between Sterling and
Xxxxx. If the dispute is not resolved by this means, Sterling and Xxxxx shall,
at the earliest time convenient to both of them, arrange a cooperative
laboratory investigation at Xxxxx'x premises in order to resolve the dispute.
This investigation shall be conducted by appropriately qualified employees of
Xxxxx and of Sterling in a manner which is acceptable to both Sterling and
Xxxxx.
Any Party hereto which orders Product from Sterling during the term of this
Agreement shall be entitled to reject and return at Sterling's expense any
quantity of the Product which is not in accordance with the Specification as
determined by Xxxxx, or in the event of a dispute between Sterling and Xxxxx, as
determined by analytical results upon which Sterling and Xxxxx are agreed
following a co-operative laboratory investigation, and/or are not otherwise
supplied in accordance with the terms of this Agreement.
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6.2
Sterling is responsible for ensuring that all necessary documentary records
relating to the manufacture, testing and distribution of the Product are
maintained in accordance with all applicable legal and regulatory requirements
and with rules and regulations applying to the conduct of current Good
Manufacturing Practice applicable to the manufacture of human and veterinary
medicines and medicinal materials as are in force at any time during the term of
this Agreement and for a period of at least eight (8) years.
In order to ensure that the Product in the form physically delivered to Stegram
or Bioenvision or Dechra or their respective Designees or Nominees, complies
with all applicable legal and regulatory requirements and with rules and
regulations applying to the conduct of current Good Manufacturing Practice
applicable to the manufacture of human and veterinary medicines and medicinal
materials as are in force at any time during the term of this Agreement, the
Parties are responsible for ensuring that Sterling is quality-audited by a
Qualified Person for purposes of satisfying their internal or regulatory
requirements during the term of this Agreement.
6.3
The Specification may be changed during the term of this Agreement by Stegram
for regulatory, commercial or other reasons and after clearance by the relevant
regulatory authorities and agreement to such changes shall not be unreasonably
withheld by Sterling. Authorisation of change of Specification shall be given in
writing by Stegram to Sterling. A change in specification for the Product
purchased from Sterling shall not be made without the prior written consent of
Bioenvision and Dechra and such consent shall not be unreasonably withheld or
delayed.
6.4
The testosterone used to manufacture the Product may only be that manufactured
by Schering Aktiengesellschaft, D-13342 Berlin, Germany or its subsidiaries. The
Specification or source of testosterone raw material may be changed only by
written authorisation from Stegram.
6.5
Sterling warrants and represents:
6.5.1
that it has full capacity and authority and all necessary licences and consents
to enter into and perform this Agreement; and
6.5.2
that it shall perform its obligations under this Agreement in strict compliance
with all applicable laws, enactments, orders, regulations and other similar
instruments in force from time to time.
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7. MANUFACTURE AND DELIVERY OF THE PRODUCT
7.1
Sterling shall produce the Product in batches of multiples of 31kg unless varied
by written consent by one or more of the Parties, subject to the following
provisos:
- that Stegram or Stegram's Nominee shall be informed in writing of
the intended batch size by the ordering Party no later than the time
of placing an order for the Product;
- that the ordering Party shall obtain a guarantee from Sterling that
the Product shall be accepted and paid for by the ordering Party
only if the Product complies with the prevailing specification
issued by Stegram; and
- that the ordering Party shall maintain compliance with the
requirements of relevant regulatory authorities by ordering, at the
ordering Party's expense from Sterling, the production of a
requisite number of validation batches at the appropriate scale
which comply with the prevailing Product specification as issued by
Stegram. Analytical data from these validation batches shall be used
by the ordering Party, at the ordering Party's expense, to obtain
approval by the relevant regulatory authority for the batch size
required.
Raw materials and Product in manufacture, storage and shipment shall be the
responsibility of Sterling and remain insured by Sterling until delivery to
Micron's premises or delivery to any other location as specified by Stegram,
Bioenvision or Dechra as applicable. Sterling shall notify the ordering Party
and Stegram or Stegram's Nominee of the batch number of a new batch as soon as
possible, to facilitate administrative matters such as arrangements for analysis
by Xxxxx and micronisation.
7.2
Sterling shall maintain a minimum of 31kg (one batch) of the Product as Buffer
Stock at Sterling's warehouse.
7.3
Delivery of the Product with carriage, insurance and all taxes and duties paid
shall take place at Micron's premises at Xxxxxxxxx Xxxxxxxxx, Xxxxxxxxx,
Xxxxxxxx, Xxxx XX0 0XX, XX or such other premises as one of the Parties shall
notify Sterling from time to time.
7.4
Sterling shall ensure that the Product is dispatched to Micron on dates
specified by a Party hereto in prioritized order of receipt by Sterling.
Further, delivery of Product to Micron or such other premises as a Party shall
notify Sterling from time to time shall take place during normal working hours
during a working day.
7.5
Stegram or its Nominee shall within two (2) working days of the arrival of each
delivery of the Product at Micron's premises (or other destination designated by
a Party) inspect the packaging for physical damage and tampering and also
usually within fourteen (14) working days inspect the Product for visually
apparent gross contamination. Occurrence of damage to or tampering
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with packaging and/or contamination of product shall be immediately reported to
Stegram or Stegram's Nominee and Sterling.
7.6
If Stegram rejects and any Party returns any delivery of the Product that is
found to be not in accordance with the Specification after implementation of the
procedures described in clause 6.1 and Schedule 4, Sterling shall provide a
similar quantity of replacement Product that complies with the Specification,
from Buffer Stock, within seven (7) working days of notification of the
rejection by Stegram, and re-process returned Product within sixty (60) days of
receipt. Re-Processed Product conforming to the Specification will be held as
part of Sterling Buffer Stock. The Re-Processed Product shall be supplied to the
original purchasing Party to fulfil a subsequent order when the Party requires
further Product.
Following the production of Re-Processed Product, Sterling shall immediately
send a report on Sterling's letterhead (in a form suitable for submission to the
relevant regulatory authority) to Stegram describing the method of re-processing
and a Certificate of Analysis for the Re-Processed Product. Sterling shall also
send samples of the Re-Processed Product to Xxxxx following procedure as set out
in Schedule 4, clauses S4.11 and S4.12.
7.7
Prior to acceptance of Product, Stegram or Stegram's Nominee shall determine the
compliance of the Product with Specification.
Stegram appoints Xxxxx, Stegram's Nominee under this Agreement, as the ultimate
arbiter of compliance of Product with Specification and requisite quality. In
the event that Sterling disputes analytical results obtained by Xxxxx on batches
of Product manufactured by Sterling, the dispute shall be resolved according to
the procedure described in clause 6.1.
If Stegram or Stegram's Nominee deem such Product not to comply with
Specification, commercial use of such Product by Dechra or Bioenvision or their
Designees shall be at the risk of Dechra or Bioenvision.
7.8
Risk in and responsibility for the Product shall pass from Sterling once the
Product is satisfactorily unloaded and stacked at Micron's premises or such
other premises as has been notified to Sterling by a Party in accordance with
clause 7.3.
7.9
Sterling shall manufacture the Product according to Stegram's chemical
manufacturing process and this process shall not be changed, amended or varied
unless authorised by Stegram in writing. Any change, amendment or variation
which is agreed by Stegram shall be confirmed in writing by Sterling to Stegram.
7.10
From each batch of Product manufactured by Sterling, Sterling shall set aside 40
grams of each intermediate made at Xxxxx 0, Xxxxx 2 and Stage 3 of the chemical
manufacturing process. The 40 grams of each Stage of each batch of Product shall
be dispatched to Xxxxx immediately on
Page 15 of 22
completion of each batch. The cost of shipment shall be billed to Stegram on a
calendar quarterly basis.
8. PRODUCT RECALL
In the event of Finished Product recall Sterling shall reimburse each relevant
Party for all costs and expenses incurred by each such Party in the case of
Sterling being directly or indirectly responsible for the cause of Finished
Product recall.
9. INDEMNITY
9.1
Sterling shall indemnify and keep indemnified each of the Parties against any
and all claims, demands, costs, expenses if there will be any conditions set out
in clause 8.
9.2
Sterling shall compensate each of the Parties for financial losses incurred by
each such Party resulting from failure by Sterling to comply with any of its
obligations under the terms of this Agreement.
A Party shall compensate Sterling for financial losses incurred resulting from
failure by the Party to comply with any of its obligations under the terms of
this Agreement.
10. INDUSTRIAL PROPERTY RIGHTS
10.1
Sterling undertakes immediately to notify Stegram in writing of any enquiry,
whether oral, written or delivered in any medium of communication, received by
Sterling concerning purchase or sale of the Product or for any information
concerning manufacture or analysis or use or any other aspect pertaining to the
Product. Furthermore Sterling undertakes immediately to inform Stegram in
writing of the identity of the enquirer.
Page 16 of 22
10.2
Sterling acknowledges that title to the Industrial Property Rights relating to
the Product is and remains at all times the exclusive property of Stegram and
further acknowledges that Sterling has no right to use, disclose, copy or
otherwise dispose of the same except in accordance with any express authority
under this Agreement and further that any such authority shall immediately cease
on termination of this agreement whatever the cause of termination. Sterling
shall produce a Drug Master File relating to the Product comprising an Open Part
and a Closed Part (as appropriate) as required by the Parties and defined by
Stegram, within a reasonable and agreed period of time as required by the
Parties and provide the Parties with all necessary assistance in order to ensure
that the Drug Master File may be lodged with the relevant authorities by the
Parties with Stegram as the relevant owner. On termination of this Agreement,
Sterling shall return to Stegram all documents relating in any way to the
Industrial Property Rights or the design or manufacture of the Product and any
and all copies of them, except that Sterling may retain one copy of such
Information for record keeping purposes required by law, regulation, rule, act
or order of any governmental authority or agency (but only to the extent so
required).
10.2.1
Sterling further agrees and accepts that if Sterling should cease the production
of the Product for any proper reason or commit a breach of this Agreement (other
than a breach which Sterling has an opportunity to cure and does cure to the
Parties' satisfaction within thirty (30) days), then Sterling shall return all
Information in its possession to Stegram within thirty (30) days of request.
10.2.2
All submissions for regulatory approval for the Product and/or the Finished
Product will be made by the applicable Party or its Designee or Nominee.
Sterling agrees to support regulatory submissions by provision of any
information as may be requested by the applicable Party hereto, which is in the
possession of Sterling.
10.3
This clause deleted.
10.4
Sterling shall immediately bring to the attention of Stegram any improper or
wrongful use of any Industrial Property Rights related to the Product which
comes to its notice and shall use every effort to safeguard the Industrial
Property Rights and interests of Stegram and shall assist Stegram in taking all
steps necessary to defend the Industrial Property Rights including, at the
specific request of Stegram, the prosecution of any actions which Stegram may
deem necessary to commence for the protection of any of its rights.
11. CONFIDENTIALITY
11.1
In consideration of the disclosure of Information by any Party and Sterling to
each other, the Parties and Sterling undertake to keep confidential all
Information of each other which shall not be disclosed to any third party nor
used for purposes other than compliance with the obligations
Page 17 of 22
of this Agreement without express written consent by the Party or Sterling to
such disclosure or use.
11.2
The Parties and Sterling agree only to disclose Information to such employees,
agents, representatives, Designees or Nominees, in each case, as need to have
access to the Information in the course of proper and legitimate pursuit of the
business conducted directly or indirectly pursuant to this Agreement and to bind
any such employees, agents, representatives, Designees or Nominees to retain
such Information in strict confidence.
11.3
The obligations of confidence and non-use herein and those implied by law shall
not apply to any part of the Information which was available to the public
before the date of this Agreement or to Information which becomes publicly
available at or after the Commencement Date through no breach of this Agreement
by Sterling or a Party hereto.
11.4
Upon the request of a disclosing Party or Sterling to the other (the recipient),
the recipient shall return forthwith all written or other documentary
Information furnished by the disclosing Party, together with all other items in
recipient's possession which, in whole or in part, embody Information.
11.5
This Agreement shall not be construed as granting Sterling any licence or other
right in respect of the Information whether or not such Information is the
subject of patents or patent applications.
12. DURATION AND TERMINATION
12.1
This Agreement shall commence on the date of the Agreement and subject to the
provisions of this clause 12, shall be fixed for eight (8) years subject to
extension by mutual written agreement of the Parties and Sterling. Further,
Schedule 4 to this Agreement shall be reviewed by the Parties and Sterling on
each anniversary of the commencement date. An extraordinary review may be
requested as considered necessary or appropriate by the Parties hereto or
Sterling, due to changes in conditions of the markets for raw materials or
Product.
12.2
Without prejudice to the foregoing, Stegram or Sterling may terminate this
Agreement immediately by written notice to the other if and to the extent any of
the following events occur:
12.2.1
Stegram or Sterling has committed a material breach (save for any breach caused
by the Person seeking to rely on this clause) of this agreement which, in the
case of a breach capable of remedy, has not been remedied within thirty (30)
days of the receipt by such other Person of a notice specifying the breach and
requiring its remedy.
Page 18 of 22
12.2.2
An administrative order is made or a petition for such an order is presented in
respect of Stegram or Sterling.
12.2.3
A receiver (which expression shall include an administrative receiver) is
appointed in respect of Stegram or Sterling or any of the assets of Stegram or
Sterling.
12.2.4
Any voluntary arrangement is proposed under section 1 of the Insolvency Xxx 0000
in respect of Stegram or Sterling.
12.2.5
Stegram or Sterling ceases to carry on business (the winding-up of Stegram or
Sterling but not its moving, fusion, incorporation or sale to other Persons).
12.2.6
Any of the Parties experiences catastrophic loss of business due to withdrawal
of the Product for regulatory or commercial reasons.
12.2.7
The Parties and Sterling are unable to reach agreement with regard to Price of
the Product. The pricing structure for the Product has been agreed by the
Parties and Sterling for the period ending 31st December 2007. For the avoidance
of irreconcilable dispute concerning the price of the Product, the Parties and
Sterling agree to negotiate a pricing formula within the period up to and
including the occasion of the next price negotiations in calendar quarter 4 of
2007. This pricing formula would become effective from 1st January 2008 and
remain effective until 3lst December 2009 or another date agreed by the Parties
and Sterling. On establishment of a pricing formula agreed from time to time by
the Parties and Sterling for the duration of this Agreement, clause 12.2.7 shall
be deleted.
12.2.8
Sterling fails to supply Product which complies with the Specification or
quality requirements as judged by Stegram or relevant regulatory authorities, or
is unable or unwilling to manufacture Product in the size of batch required by
Stegram, Stegram having given Sterling a reasonable period of notice to effect
the necessary changes, or consistently fails to deliver Product by the agreed
date, and Sterling does not effect reparation of such failure following
notification by Stegram.
12.2.9
Sterling fails to achieve regulatory approval due to failure to submit correct
information and data in accordance with due dates set by regulatory authorities.
13. ENTIRE AGREEMENT
13.1
This Agreement constitutes the entire Agreement between the Parties and Sterling
in connection
Page 19 of 22
with its subject matter. The terms, provisions or conditions
contained in the conditions of sale or business of Sterling or in any quotation
invoice or other similar document of Sterling shall not apply to this Agreement
and shall be excluded. No change, alteration or deviation from the Agreement may
be made without the prior written authorization of each of the Parties hereto
which are affected by such change, alteration or deviation.
13.2
No Party or Sterling has relied on any representation or promise except as
expressly set out in this Agreement.
13.3
This clause deleted
13.4
Each Party unconditionally waives any rights it may have to seek to rescind this
Agreement on the basis of any statement made by the other (whether made
carelessly or not) whether or not such statement is set out or referred to in
this agreement unless such statement was made fraudulently.
13.5
This Agreement supersedes any prior agreements, understandings and agreements
between, and any oral or written representations made by, Sterling and the
Parties to it relating to its subject matter.
14. ASSIGNMENT
Sterling shall not without the prior written consent of the Parties, assign,
transfer, change or deal in any similar manner with this Agreement or its rights
or any part of them under this agreement, or purport to do any of the same, nor
subcontract any or all of its obligations under this Agreement. The Parties
shall have the right to assign their rights and/or delegate their obligations
under this Agreement upon the prior written consent of the other Parties hereto,
which consent shall not be unreasonably withheld or delayed. For purposes of
this Clause 14 consummation of a merger, acquisition or other business
combination pursuant to which all or substantially all of the assets of the
Parties shall not constitute an assignment subject to the provisions of this
Clause 14.
15. NO PARTNERSHIP
Each of the Parties and Sterling is an independent contractor and nothing in
this agreement shall create or be deemed to create a partnership between the
Parties and Sterling or the relationship of principal or agent. Accordingly no
Party or Sterling shall have any right or authority to act on behalf of the
other nor to bind the other by contract or otherwise.
Page 20 of 22
16. COSTS AND EXPENSES
Except as otherwise stated in this Agreement, each Party and Sterling shall pay
its own costs and expenses in relation to the negotiation, preparation,
execution and implementation of this Agreement.
17. INVALIDITY
The invalidity, illegality or unenforceability of any provision of this
Agreement shall not affect the other provisions.
18. EXECUTION
This Agreement may be executed in any number of counterparts, and by the Parties
and/or Sterling on separate counterparts, each of which, when so executed, shall
be an original, but all counterparts shall together constitute one and the same
instrument.
19. AMENDMENT AND WAIVER
19.1
No variation of this Agreement shall be effective unless it is made in writing,
refers specifically to this Agreement, and is signed by the Parties, and also by
Sterling, in the case of variation which specifically affects Sterling.
19.2
No waiver of any term, provision or condition of this Agreement shall be
effective except to the extent made in writing and signed by the waiving Party.
19.3
No omission or delay on the part of any Party in exercising any right, power or
privilege under this Agreement shall operate as a waiver by it or of any right
to exercise it in future or of any other of its rights under this Agreement.
20. THIRD PARTY RIGHTS
A Person who is not a signatory to this Agreement shall have no right under the
Contracts (Rights of Third Parties) Xxx 0000 to enforce any term of this
Agreement. This clause does not affect any right or remedy of any Person which
exists or is available otherwise than pursuant to that Act.
21. LAW AND JURISDICTION
21.1
This Agreement shall be governed by and construed in all respects in accordance
with English Law.
21.2
The Parties and Sterling submit to the exclusive jurisdiction of the English
courts and agree that
Page 21 of 22
in respect of proceedings in England and any other jurisdiction, process may be
served on either of them in the manner specified for notices in clause 22.
21.3
Without prejudice to Stegram's right to serve any process directly on Sterling,
Sterling appoints AS-Tec as its agents to accept service of any process issued
out of the courts of England and Wales to be served on it in relation to this
agreement or anything arising out of it.
21.4
The rights set out in this clause 21 are in addition to any other manner of
service permitted by law.
22. NOTICES
22.1
Any notice or other communication to be given under this Agreement must be in
writing and may be delivered or sent by prepaid first class letter post to the
Party or Sterling to be served at that Party's or Sterling's address set forth
in the preamble to this Agreement. Service of notice by facsimile and / or
electronic mail (email) by way of the internet is not acceptable under the terms
of the Agreement.
22.2
Any notice or document shall be deemed served at the time of delivery.
23. This clause deleted
As witness the hands of the Parties to this Agreement:
Stegram
/s/ X. X. XXXXXX............................. (signed)
X. X. Xxxxxx.................................. (print name)
Director...................................... (company position)
9-9-2005...................................... (date)
Bionvision
/s/ X. X. XXXX............................... (signed)
X. X. Xxxx.................................... (print name)
CEO (company position)
21-9-05....................................... (date)
Dechra
/s/ E. TORR.................................. (signed)
E. Torr....................................... (print name)
Director...................................... (company position)
21/09/05...................................... (date)
Page 22 of 22
Sterling
/s/ GIANLUIGI FEZLIN......................... (signed)
Gianluigi Fezlin.............................. (print name)
President..................................... (company position)
24/08/2005.................................... (date)
