Exhibit 10.31
SUPPLY AGREEMENT - TRILOSTANE
STEROID SpA
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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
Steroid SpA, Xxxxx Xxxxxx 000, 00000, Xxxxxxx Monzese MI, Italy ("Steroid"),
is made and effective as of 12th 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) Steroid 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 Steroid to continue to
manufacture Product on their respective behalf pursuant to the terms
of this Agreement.
(6) Bioenvision, Dechra and Steroid 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 manufacture and
commercial exploitation of the Product, is and remains at all
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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 Steroid.
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 Steroid's
inventory and at Steroid'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 contractor 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 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
Steroid including such information about Steroid and Steroid's
production operation as is relevant to satisfy regulatory authorities as
to the fitness of the Product as manufactured by Steroid 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 File or any other Drug Master
File the format of which includes a Closed Part or
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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 that 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 Steroid directly or indirectly, verbally, or by any other
means, which has been confirmed in writing.
"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 Steroid's premises for the purposes of confirmation
of regulatory compliance and quality assurance. Steroid 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.
"Reworked 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 Steroid's application of a chemical 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)-17-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 5 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 12 (twelve) months from the date of this
Agreement and each subsequent consecutive period of 12 (twelve) 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 Steroid, 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, and Steroid, shall perform
individual duties including but not necessarily limited to those described in
this Agreement:
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
Steroid and payment in UK pounds sterling direct to Steroid for the provision of
Product under the terms of this Agreement.
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Contact Xxxx Xxxxxxxx
Telephone x00-000-000-0000
Fax x00-000-000-0000
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 Steroid and payment in UK pounds sterling direct to Steroid 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 x00-0000-00 1632
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 may also from time to time place orders with
Steroid for the Product on behalf of any of the Parties. 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
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.
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Xxxxxx Xxxxx Xxxxxxx
Telephone x00-0000-000000
Fax x00-0000-000000
e-mail xxxxxxx@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
Steroid
Steroid 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. Steroid shall also arrange shipment of
Product and shall invoice direct Dechra or Bioenvision or Stegram or Dales, as
the case may be. Under the terms of the Agreement Steroid may conduct
manufacturing process development and analytical methodology development on the
Product only in collaboration with and by written consent of Stegram.
Contact Xx Xxxxxx Xxxxx
Telephone x00-00-0000000
Fax x00-00-00000000
e-mail xxxxxxx_xxxxx@xxxxxxx.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.
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2.2
The Parties and Steroid 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 Steroid 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
Steroid 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 or Dales shall purchase Product from Steroid. In the routine operation of
its business and under the terms of this Agreement, Steroid shall invoice
directly Stegram or Bioenvision or Dechra or Dales, 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, or Dales 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 Steroid is notified that the Product is of
acceptable quality.
5. TERMS OF BUSINESS
5.1
All sales of the Product by Steroid 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 Steroid at the Price as set out in Schedule 3.
5.3
During the term of this Agreement, each Party or Dales shall deliver separately
to Steroid Purchase Order(s) for the Product. Such Purchase Orders shall be in
writing, and shall be confirmed by Steroid in writing not more than five (5)
working days after Stegram or Bioenvision or Dechra, or Dales, as the case may
be, delivers such Purchase Order.
5.4
On delivery of the Product by Steroid to Stegram, Bioenvision or Dechra or their
respective Designees or Nominees, the recipient of such Product shall be
responsible for the safekeeping and safe-handling of the Product.
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5.5
This clause deleted.
5.6
Steroid shall keep full records of the total quantity of the Product produced,
stocked and delivered by Steroid together with information relating to any
authorisations or other licences granted in respect of the Product and Steroid
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, Steroid 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 Steroid's manufacturing
facilities relating to the Product, by prior appointment. Access shall include
access to machinery, equipment, information, documents, records and personnel
limited to those with relevance to the Product.
5.8
The Parties shall deliver purchase orders for Product to Steroid at least 90
(ninety) days in advance of requirements and each calendar quarter shall provide
a 12-month rolling forecast. Each order quantity will be in multiples of the
standard batch size of 31kg.
5.8.1
When an order is placed, it will not be subject to cancellation or deferral by
Stegram or Bioenvision or Dechra or Dales for reasons associated with
forecasting error, budgetary considerations or related reasons.
5.9
Force majeure and other constraints; Neither the Parties nor Steroid 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.
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 and Steroid
with prior written agreement of the contractual Parties and Steroid, which
agreement shall not be unreasonably withheld or delayed.
5.11
When the terms of the Agreement require a Party or Steroid to communicate with
each other each of the Parties and Steroid authorise such communications to
occur through the designated Nominee of the Party or Steroid receiving such
communication.
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6. SPECIFICATION AND QUALITY OF THE PRODUCT
6.1
All Product sold by Steroid 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, and any
Party hereto which orders Product from Steroid during the term of this Agreement
shall, pursuant to clause 8 of this Agreement, be entitled to claim from Steroid
any expense incurred due to any quantity of the Product which is not in
accordance with the Specification as determined by Xxxxx and/or is not otherwise
supplied in accordance with the terms of this Agreement.
6.2
Steroid 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 5 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 Steroid 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 Steroid. Authorisation of change of Specification shall be given in
writing by Stegram to Steroid. A change in specification for the Product
purchased from Steroid 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 Xxxxxxxx Xxxxxxxxxxxxxxxxxx, X-00000 Xxxxxx, Xxxxxxx or its subsidiaries. The
specification or source of testosterone raw material may be changed only by
written authorisation from Stegram.
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6.5
Steroid 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.
7. MANUFACTURE AND DELIVERY OF THE PRODUCT
7.1
Steroid shall produce the Product in batches of 31kg unless varied by written
consent by one or more of the Parties and Steroid, 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 Steroid 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.
- That the ordering Party shall maintain compliance with the
requirements of relevant regulatory authorities by ordering at the
ordering Party's expense from Steroid, 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 Steroid and remain insured by Steroid until delivery to
Micron's premises or delivery to any other location as specified by Stegram,
Bioenvision or Dechra as applicable. Steroid 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
Steroid shall maintain a minimum of 31kg (one batch) of the Product as Buffer
Stock at Steroid'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 Steroid from time to time.
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7.4
Steroid shall ensure that the Product is dispatched to Micron on dates specified
by a Party hereto in prioritized order of receipt by Steroid. Further, delivery
of Product to Micron or such other premises as a Party shall notify Steroid from
time to time shall take place during normal working hours during a working day.
7.5
Stegram or its Nominee shall within 2 (two) 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 14 working days inspect the Product for visually apparent gross
contamination. Occurrence of damage to or tampering with packaging and / or
contamination of product shall be immediately reported to Stegram or Stegram's
Nominee, and Steroid.
7.6
In the event of a dispute concerning quality of the Product and consequent
implementation of the requirements of clause 8, and following concurrence of all
Parties involved in the dispute, 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 procedure described in Schedule 4,
Steroid shall provide a similar quantity of replacement Product that complies
with the Specification, from Buffer Stock, within 7 (seven) working days of
notification of the rejection by Stegram, and rework returned Product within 30
(thirty) days of receipt. Reworked Product conforming to the Specification will
be held as part of Steroid Buffer Stock until Stegram agrees to purchase such
Reworked Product. The purchase of Reworked Product shall be at Stegram's
discretion.
Following the production of Reworked Product, Steroid shall immediately send a
report on Steroid's letterhead (in a form suitable for submission to the
relevant regulatory authority) to Stegram describing the method of rework and a
Certificate of Analysis for the Reworked Product. Steroid shall also send
samples of the Reworked Product to Xxxxx following procedure as set out in
Schedule 4, clauses S4.11 and S4.12.
7.7
Prior to each shipment 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.
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 Steroid once the
Product is satisfactorily unloaded and stacked at Micron's premises or such
other premises as has been notified to Steroid by a Party in accordance with
clause 7.3.
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7.9
Steroid 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 Steroid to Stegram.
7.10
From each batch of Product manufactured by Steroid, Steroid shall set aside 100
grams of each intermediate made at Xxxxx 0, Xxxxx 2 and Stage 3 of the chemical
manufacturing process. The 100 grams of each Stage of each batch of Product
shall be dispatched to Xxxxx immediately on completion of each batch. The cost
of shipment shall be sterling (pound)200.00 delivered for each Stage and this
cost shall be billed to Stegram.
8. PRODUCT RECALL
In the event of Finished Product recall arising from a verified defect in the
Product manufactured by Steroid, Steroid shall reimburse each relevant Party for
all costs and expenses incurred by each such Party in the case of Steroid being
directly responsible for the cause of Finished Product recall.
In the event of a dispute concerning Product quality, a resolution of the
dispute shall be sought by means of good faith discussion between Steroid and
Xxxxx. If the dispute is not resolved by this means, Steroid and Xxxxx shall, at
the earliest time convenient to both of them, arrange a co-operative 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 Steroid in a manner which is acceptable to both Steroid and Xxxxx.
9. INDEMNITY
9.1
Steroid shall indemnify and keep indemnified each of the Parties against any and
all claims, demands, costs and expenses if there will be any conditions set out
in clause 8.
9.2
Steroid shall compensate each of the Parties for financial losses incurred by
each such Party resulting from failure by Steroid to comply with any of its
obligations under the terms of this Agreement.
10. INDUSTRIAL PROPERTY RIGHTS
10.1
Steroid undertakes immediately to notify Stegram in writing of any enquiry,
whether oral, written or delivered in any medium of communication, received by
Steroid 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, Steroid undertakes immediately to inform Stegram in
writing of the identity of the enquirer.
Page 14 of 20
10.2
Steroid 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 Steroid 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. Steroid
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,
Steroid 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.
10.2.1
Steroid further agrees and accepts that if Steroid should cease the production
of the Product for any proper reason or commit a breach of this Agreement (other
than a breach which Steroid has an opportunity to cure and does cure to the
Parties' satisfaction within thirty (30) days), then Steroid would return all
Information in its possession to Stegram within 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. Steroid
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
Steroid.
10.3
This clause deleted.
10.4
Steroid 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. Any expenses
incurred by Steroid when supporting Stegram in these actions shall be reimbursed
to Steroid. In the event that Steroid takes such actions, Steroid shall
regularly and frequently estimate costs likely to be incurred and immediately
inform Stegram of these estimated costs. The regularity and frequency of such
estimated costs shall be agreed in advance between Stegram and Steroid.
11. CONFIDENTIALITY
11.1
In consideration of the disclosure of Information by any Party and Steroid to
each other, the Parties and Steroid 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 15 of 20
of this Agreement without express written consent by the Party or Steroid to
such disclosure or use.
11.2
The Parties and Steroid 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 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 Steroid or a Party hereto.
11.4
Upon the request of a disclosing Party or Steroid 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 Steroid 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 5 years subject to extension by
mutual written agreement of the Parties and Steroid. Further, Schedule 3 and
Schedule 4 to this Agreement shall be reviewed by the Parties and Steroid on
each anniversary of the commencement date. An extraordinary review may be
requested as considered necessary or appropriate by the Parties hereto or
Steroid, due to changes in conditions of the markets for raw materials or
Product.
12.2
Without prejudice to the foregoing, Stegram or Steroid 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 Steroid 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 30 days of the
receipt by such other Person of a notice specifying the breach and requiring its
remedy.
Page 16 of 20
12.2.2
An administrative order is made or a petition for such an order is presented in
respect of Stegram or Steroid.
12.2.3
A receiver (which expression shall include an administrative receiver) is
appointed in respect of Stegram or Steroid or any of the assets of Stegram or
Steroid.
12.2.4
Any voluntary arrangement is proposed under section 1 of the Insolvency Xxx 0000
in respect of Stegram or Steroid.
12.2.5
Stegram or Steroid ceases to carry on business (the winding-up of Stegram or
Steroid 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 Steroid are unable to reach agreement with regard to Price of
the Product.
12.2.8
Steroid 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, or consistently fails to deliver Product by the agreed date.
12.2.9
Steroid fails to achieve regulatory approval due to failure to submit correct
information and data in accordance with due dates set by regulatory authorities.
12.2.10
In the event of termination of this Agreement by Stegram or Steroid, another
manufacturer of the Product shall be appointed by Stegram.
12.3
Without prejudice to the foregoing, Bioenvision and/or Dechra will exit this
Agreement immediately by written notice to the other Parties if and to the
extent any of the following events occur:
12.3.1
Bioenvision and/or Dechra has committed a material breach of this Agreement (the
Breaching Party) other than for any breach caused by the Party seeking to rely
on this clause (the Non-breaching Party) which, in the case of a breach capable
of remedy, has not been remedied within 30 (thirty) days of the receipt by the
Breaching Party of a notice from Stegram specifying the breach and requiring its
remedy.
Page 17 of 20
12.3.2
An administrative order is made or a petition for such an order is presented in
respect of Bioenvision and/or Dechra.
12.3.3
A receiver (which expression shall include an administrative receiver) is
appointed in respect of Bioenvision and/or Dechra or any of Bioenvision's and/or
Dechra's assets.
12.3.4
Any voluntary arrangement is proposed under section 1 of the Insolvency Xxx 0000
in respect of Bioenvision and/or Dechra.
12.3.5
Bioenvision and/or Dechra ceases to carry on business (the winding-up of
Bioenvision and/or Dechra but not their moving, fusion, incorporation or sale to
other Persons).
12.3.6
Bioenvision and/or Dechra experiences catastrophic loss of business due to
withdrawal of the Product for regulatory or commercial reasons.
12.4
In the event of termination due to a breach caused by Breaching Party pursuant
to clauses 12.2 and 12.3, Steroid shall supply to Stegram and/or Bioenvision
and/or Dechra, as the case may be, deliveries of Product in connection with all
purchase orders delivered to Steroid prior to the date of termination.
12.5
The provisions of clauses 8, 9,10,11 and 12.4 all survive the expiry or
termination of this Agreement within the terms defined by English Law.
13. ENTIRE AGREEMENT
13.1
This Agreement constitutes the entire Agreement between the Parties and Steroid
in connection with its subject matter. The terms, provisions or conditions
contained in the conditions of sale or business of Steroid or in any quotation
invoice or other similar document of Steroid 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 Steroid has relied on any representation or promise except as
expressly set out in this Agreement.
13.3
This clause deleted.
Page 18 of 20
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, Steroid and the
Parties to it relating to its subject matter.
14. ASSIGNMENT
Steroid 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 Steroid is an independent contractor and nothing in this
agreement shall create or be deemed to create a partnership between the Parties
and Steroid or the relationship of principal or agent. Accordingly no Party or
Steroid shall have any right or authority to act on behalf of the other nor to
bind the other by contract or otherwise.
16. COSTS AND EXPENSES
Except as otherwise stated in this Agreement, each Party and Steroid 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 Steroid on separate counterparts, each of which, when so executed, shall
be an original, but all counterparts shall together constitute one and the same
instrument.
Page 19 of 20
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
Steroid, in the case of variation which specifically affects Steroid.
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 party 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 Steroid submit to the exclusive jurisdiction of the English
courts and agree that 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
Deleted.
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 Steroid to be served at that Party's or Steroid'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.
Page 20 of 20
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)
26-9-2005..................................... (date)
Bioenvision
/s/ C X.XXXX.................................. (signed)
X. X. Xxxx.................................... (print name)
CEO (company position)
26-10-05...................................... (date)
Dechra
/s/ E. TORR.................................. (signed)
E. Torr....................................... (print name)
Director...................................... (company position)
30/09/05...................................... (date)
Steroid
/s/ XXXXXXXX XXXXXX.......................... (signed)
Xxxxxxxx Xxxxxx............................... (print name)
C.E.O......................................... (company position)
19-09-2005.................................... (date)
