Exhibit 10.3
DATED 14th May 2003
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PENN PHARMACEUTICAL SERV ICES LIMITED
and
BIOENVISION, Inc.
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MASTER SERVICES AGREEMENT
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[GRAPHIC OMITTED]
CONTENTS
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Clause Heading Page
1 Interpretation................................................................................2
2 Provision of Services.........................................................................3
3 Payment of the Fees and other matters.........................................................4
4 Delivery and storage of Company Products and Finished Products................................4
5 Return and dispatch of Company Products and Finished Products.................................5
6 Sub-contracting by Penn.......................................................................5
7 Destruction of Company Products...............................................................5
8 Confidentiality...............................................................................6
9 Publicity.....................................................................................8
10 Provision of information by Company to Penn...................................................7
11 Provision of documentation....................................................................7
12 Ownership of Company Products and of Intellectual Property in Company Products and
Finished Products.............................................................................7
13 Warranties and limitation of liability........................................................8
14 Duration......................................................................................8
15 Termination...................................................................................9
16 Supply after termination......................................................................9
17 Force majeure.................................................................................9
18 Assignment...................................................................................10
19 Notices......................................................................................10
20 Waiver.......................................................................................10
21 Entire contract..............................................................................10
22 No partnership or agency.....................................................................10
23 Void provision...............................................................................10
24 Variation....................................................................................10
25 Costs........................................................................................11
26 Third Party Rights...........................................................................11
27 Law and Jurisdiction.........................................................................11
AN AGREEMENT made on 14th May 2003
BETWEEN:
1 PENN PHARMACEUTICAL SERVICES LIMITED (registered in England and Wales,
Company No. 1331447) whose registered office is at Xxxxx 00/00
Xxxxxxxxxxxx Xxxxxxxxxx Xxxxxx, Xxxxxxxx, Xxxxx, Xxxxx, XX00 0XX
("Penn"); and
2 BIOENVISION, INC. whose principal place of business is at 000 Xxxxxxx
Xxxxxx, Xxxxx 000, Xxx Xxxx, Xxx Xxxx 00000 ("the Company").
WHEREAS:
(A) Penn has knowledge, experience and regulatory approval to perform a
wide variety of services to companies in the pharmaceutical industry,
including but not limited to development of formulations and associated
regulatory support data and the manufacture, quality control, packaging
and distribution of proprietary medicinal products including clinical
trials supplies and samples and holds appropriate authorisations to
carry out such services;
(B) The Company has a requirement, in relation to certain of its
proprietary medicinal products, for the provisions of such services.
(C) Penn and the Company have entered into this Agreement with the intent
that Penn shall provide certain services to the Company upon and
subject to the terms of this Agreement and agreements entered into
pursuant to this Agreement.
NOW IT IS HEREBY AGREED as follows:
1 Interpretation
1.1 In this Agreement the following expressions shall save where the
context otherwise requires, have the following meanings:
"Commencement Date" means 14th May 2003;
"Company Products" means materials or products supplied to Penn by the
Company in order for Penn to perform the Services;
"Completion" means the completion by Penn of the Services or any part
or tranche thereof in accordance with the Technical Documents relating
to those Services;
"Fees" means the fees payable for the Services detailed in the Fee
Document;
"Fee Document" means the document detailing the Fees and the additional
payment terms relating to the provision of the Services such Fee
Document to refer to this Agreement and the relevant Technical
Documents and to be signed by both parties;
"Finished Products" means any materials or products produced by Penn
for the Company pursuant to the provision of the Services;
"Intellectual Property" means patents, registered designs, trade marks
and service marks (whether registered or not and including applications
for any of the foregoing), copyright, design right, rights in and to
software including source codes, rights in and to the technical
information and other confidential information and know-how, rights in
and to databases and all other intellectual property rights and similar
property rights of whatever nature subsisting in any part of the world;
"Intellectual Property Rights" means all rights existing anywhere in
the world in and to Intellectual Property;
"Life of this Agreement" means the period commencing on the
Commencement Date during which this Agreement is in full force and
effect as provided by clauses 14 and 15;
"Payment Terms" means the payment provisions detailed in clause 3 of
this Agreement and in the relevant Fee Document;
"Services" means the services to be carried out by Penn as detailed in
the Technical Documents;
"Technical Documents" means any one of or combination of a technical
specification, technical protocol or technical agreement comprising the
technical details of how the Services are to be performed, being a full
description of the nature, scope and subject matter of the Services
including but not limited to such information as material
specifications, product specifications, process details, special
conditions, timescales, test protocols, reporting obligations, delivery
arrangements and acceptance testing such Technical Documents to refer
to this Agreement, the relevant Fee Document and to be signed by both
parties.
1.2 In addition:
(a) words importing the male, female or neuter genders shall include the
other genders and words in the singular shall include the plural and
vice versa; and
(b) references to statutory provisions shall be construed as references to
those provisions as amended consolidated or re-enacted or as their
application is modified by other provisions from time to time, whether
before or after the date hereof and shall also include references to
past provisions (as from time to time amended consolidated re-enacted
or modified) of which they are re-enactments. 2 Provision of Services
2.1 The Company may from time to time request that Penn provide services.
On receipt by Penn of the Company's requirements in writing for such
services the parties shall negotiate in good faith the Technical
Documents and Fee Document relating to those Services. No agreement in
relation to any particular Services shall be binding on either party
until the Technical Documents and Fee Document relating to those
Services have been fully agreed and signed by personnel of each party
authorised to sign on its behalf.
2.2 Subject to the provisions of clause 2.1 above, in consideration of the
payment by the Company of the Fees Penn hereby agrees to provide the
Services to the Company in accordance with the Technical Documents and
upon the terms and conditions set out in this Agreement.
2.3 Penn warrants, represents and covenants that:
(a) it has (or will have prior to entering into the relevant Technical
Documents) and will maintain for so long as it is performing the
Services all authorisations, permissions, approvals or licences
required in connection with the performance of the Services (including
where relevant any necessary manufacturing, import, or wholesale dealer
authorisations and any relevant authorisation permitting the supply of
medicinal products on named patient or compassionate use grounds);
(b) it will perform the Services in compliance with all applicable laws,
regulations and guidelines (including all applicable laws, regulations
and guidelines governing the import, manufacture, supply or promotion
of medicinal products); and
(c) it will use its reasonable endeavours to notify the Company of any
laws, regulations and guidelines which would prevent or restrict the
Company from dealing with the Company Products or Finished Products in
the manner proposed by the Company in connection with the provision of
the Services.
3 Payment of the Fees and other matters
3.1 In consideration of the matters set forth in clause 2 the Company
agrees during the Life of this Agreement to pay the Fees in accordance
with the Payment Terms.
3.2 The Fees are exclusive of value added tax and customs duties which
shall be added to the Fees where appropriate for the Company's account
unless otherwise agreed to in writing by Penn provided that the Company
shall only be required to pay Value Added Tax on submission by Penn of
a valid Value Added Tax invoice in respect thereof.
3.3 Unless otherwise agreed in writing the Company shall not be entitled to
any discount.
3.4 The Company shall not purport to set-off or withhold any payment
claimed or due to Penn under this or any other agreement.
3.5 In the event of late payment, Penn may without prejudice to its other
rights and remedies hereunder charge interest at the rate of 3% per
annum above the base lending rate from time to time of The Royal Bank
of Scotland. Such interest will accrue from the date upon which payment
was due until payment in full. Such interest shall continue both before
and after judgement.
3.6 If the Company fails without cause to make any payment that is due
under this or any other contract with Penn, Penn may without prejudice
to its other rights and remedies suspend all Services being carried out
for the Company until all such payments, with interest thereon, have
been made in full.
3.7 Time of payment shall be of the essence of this Agreement.
4 Delivery and storage of Company Products and Finished Products
4.1 The Company shall give Penn reasonable advance notice of its desire to
ship Company Products to Penn in respect of the Services. Unless
otherwise agreed in writing Penn will arrange as necessary for
clearance through customs of all Company Products shipped to Penn
provided that all costs of and risk associated with delivery of Company
Products to Penn shall be borne by the Company.
4.2 Penn shall take reasonable care to hold Company Products and Finished
Products in a safe, secure and suitable environment at Penn's premises
and in accordance with the Company's reasonable and lawful instructions
and in accordance with all applicable laws, regulations and guidelines.
4.3 Penn will notify the Company immediately in the event that Penn:
(a) has not received instructions from Company in respect of any shipment
of Company Products;
(b) does not understand or is unclear as to any portion of the instructions
provided by the Company; or
(c) has knowledge of any inconsistency in the instructions provided by the
Company.
4.4 Company will provide to Penn details of the replacement costs of
Company Products and Finished Products and Penn will, subject to clause
4.5 below, effect and maintain at its own cost with a reputable
insurance company insurance against the risk of loss of Company
Products or Finished Products or damage thereto whilst on Penn's
premises, including any loss or damage arising from accident or
negligence, to at least their full replacement value and to produce to
the Supplier on demand full particulars of that insurance and the
receipt for the then current premium. Any proceeds of such insurance
shall be held on trust for the Company and Penn shall promptly account
to the Company for the same.
4.5 Where no details of the replacement values are provided pursuant to
clause 4.4 above, then risk of loss of Company Products or Finished
Products or damage thereto shall at all times remain with the Company.
Where the replacement values are such that an extra insurance premium
must be paid by Penn such extra premium may be claimed by Penn from the
Company.
5 Return and dispatch of Company Products and Finished Products
5.1 Upon Completion, or as otherwise agreed in writing by Penn and the
Company, Penn shall pack, dispatch and deliver Finished Products and
where agreed in writing Company Products, to the destination agreed
between the parties. Penn shall maintain and provide to the Company
appropriate up-to-date and accurate records to enable the immediate
recall of any batches of the Finished Products.
5.2 Subject to risk in Company Products and Finished Products remaining
with the Company pursuant to clause 4.5 above or, unless otherwise
agreed in writing, risk in the Company Products and Finished Products
shall pass to the Company or as the Company directs once the Company
Products and Finished Products have been delivered by Penn to the
agreed destination.
5.3 The cost of packing, dispatch and delivery of Finished Products shall
be included in the Fees.
6 Sub-contracting by Penn
The Company acknowledges that Penn may sub-contract any part of the
Services to any sub-contractor approved in writing in advance in the
Technical Documents by the Company provided that any such
sub-contracting shall not affect Penn's obligations under this
Agreement or the Technical Documents. Where the Services or part
thereof are sub-contracted by Penn, Penn shall carry out such
reconciliations, checks and testing as are reasonable to verify the
integrity of the work carried out by such sub-contractor and to verify
that all unused materials including but not limited to Company Products
provided by Penn to such sub-contractor are duly returned to Penn.
7 Return and Destruction of Company Products
7.1 Title to the Company Products and Finished Products shall remain with
the Company who shall be entitled to recover them from Penn at any
time. Pending such recovery or delivery to a third party in accordance
with the Company's instructions, Penn shall store the Company Products
and Finished Products separately from all other goods in such a way
that they remain readily identifiable as the Company's property. Penn
hereby grants the Company, its agents and employees an irrevocable
licence upon reasonable notice to Penn and at the Company's cost to
enter any premises where the Company Products and Finished Products are
or may be stored in order to inspect them or to recover them.
7.2 Penn shall, within 10 working days following Completion of the whole of
the Services, at the Company's sole cost, despatch any remaining
Company Products and Finished Products to the Company or as the Company
may direct or upon written request by the Company such request to be
made prior to or within 10 working days of the date of Completion of
the whole of the Services, arrange for the destruction of Company
Products and Finished Products so requested by the Company to be so
destroyed at the sole cost of the Company. Penn shall ensure
destruction of Company Products and Finished Products in accordance
with all prevailing statutory and other regulatory requirements and
shall upon written request furnish the Company promptly with a
certificate of such destruction.
8 Confidentiality
8.1 Subject to clause 8.2, Penn shall keep confidential all commercial,
business, scientific and technical information, data, specifications
and instructions (together with any information derived therefrom) in
relation to the Company, Company Products, Finished Products and
carrying out the Services and Company shall keep confidential all
technical commercial and business information concerning Penn,
including in each case the terms of this Agreement, the Technical
Documents and Fee Documents ("Information") and neither party shall :
(a) make use of the Information disclosed to it by the other, except in
connection with the provision of the Services; or
(b) disclose such Information to any third party.
8.2 The provisions of clause 8.1 shall not apply to any Information to the
extent that such information:-
(a) is or comes into the public domain otherwise than by reason of a breach
by the receiving party, its directors, officers, employees or agents of
the terms of this clause;
(b) is obtained by the receiving party from any other source having a right
of further disclosure;
(c) is already known to the receiving party at the time of such disclosure
to the receiving party;
(d) is required to be disclosed by the receiving party by law including but
not limited to disclosure for regulatory purposes provided that such
disclosure shall be limited to what is strictly required and the
receiving party shall notify the other party of such requirement and
endeavour (insofar as is appropriate) to preserve the confidentiality
of any such Information.
8.3 It is acknowledged that notwithstanding the provisions of clause 8.1
above each party shall be entitled to disclose any Information
disclosed to it by the other to its agents, representatives, employees
and consultants to the extent necessary to facilitate the performance
of its obligations under this Agreement and in connection with the
Services provided that any such disclosure shall be limited to what is
absolutely necessary in order to facilitate such performance and the
disclosing party shall procure that any such third party recipients
shall be bound by obligations of confidentiality substantially similar
to the provisions of this Clause 8.
8.4 The provisions of this clause 8 shall survive termination of the
Agreement.
9 Publicity
9.1 Subject to the provisions of clause 8 the Company hereby agrees to
permit Penn to use the name of or refer to the Company and/or the fact
that Penn provides services to the Company, in Penn's publicity
material, including but not limited to Penn's submissions to secure new
business or in promoting or marketing itself, provided that copies of
such materials are provided to the Company in advance and the Company
does not within 10 business days of receipt of such materials object to
such use. No details of any individual project undertaken for the
Company shall be disclosed.
9.2 Penn hereby agrees to permit Bioenvision to use the name of or refer to
Penn and/or the fact that Penn provides services to the Company in the
Company's publicly disclosed documents and otherwise on the same terms
as the Company provides Penn such rights under clause 9.1.
10 Provision of information by Company to Penn
10.1 The Company agrees to provide Penn with all the Company Products,
ancillary materials agreed between the parties and information required
by Penn for the purpose of enabling Penn to carry out the Services in
accordance with this Agreement and the Technical Documents.
11 Provision of documentation
11.1 The Company acknowledges that Penn must retain originals and/or copies
of certain documents generated by it in relation to the Services in
order to comply with statutory and other regulatory requirements and
Penn agrees to provide the Company upon reasonable written request and
at the Company's cost with copies of the same.
12 Ownership of Company Products and of Intellectual Property in Company
Products and Finished Products
12.1 The ownership of the Company Products, the Finished Products and all
Intellectual Property in Company Products and Finished Products shall
at all times remain with the Company and the Company hereby grants to
Penn and its employees, agents and sub-contractors a licence to use the
Intellectual Property in the Company Products and Finished Products to
the extent reasonably required in order to provide Services in
accordance with the terms and conditions of this Agreement.
12.2 Notwithstanding any other provision of this Agreement the Company
acknowledges that it has full responsibility for the safety and
efficiency of the Company Products and Finished Products and hereby
agrees to indemnify Penn and keep Penn indemnified against all costs,
losses (including but not limited to loss of profit, consequential or
indirect loss whether foreseeable or not), damages or expenses incurred
by Penn ("Losses") or claims, actions or litigation, in each case,
brought by third parties relating to the use of Intellectual Property
Rights in the Company Products or Finished Products or proceedings of
whatsoever nature involving Penn (each, a "Claim" and collectively, the
"Claims") in connection with or arising out of the use of any Company
Products or Finished Products by Penn, the Company or any third party
(which third parties shall include but not be limited to
sub-contractors, permitted assigns and agents in addition to consumers
and end users) provided that this indemnity shall not operate to the
extent that such Losses or Claims have arisen out of a failure by Penn
to comply with the terms of this Agreement or Penn has acted (including
any omission) negligently or with wilful misconduct.
12.3 Penn shall, immediately it becomes aware of a matter which may result
in a Claim:
(a) immediately give notice to the Company of the details of the matter;
(b) afford access to the Company and permit copies to be taken of any
materials, records or documents as the Company may require to take
action under sub-clause 12.3(c);
(c) allow the Company the exclusive conduct of any proceedings and/or take
whatever action as the Company shall direct to defend or resist the
matter, including the use of professional advisers nominated by the
Company; and
(d) not admit liability or settle the matter without the written consent of
the Company.
12.4 The provisions of this clause 12 shall survive termination of this
Agreement.
13 Warranties and limitation of liability
13.1 In substitution for all rights which the Company would or might have
but for these conditions Penn warrants that the Services carried out by
Penn will be performed in accordance with this Agreement and conform to
the Technical Documents and Penn will at its own cost and at its own
option re-perform Services or re-credit the Company with the Fees for
any Services or part thereof, provided that the Company can show, to
Penn's reasonable satisfaction that the Services have been performed
defectively and not in accordance with the Technical Documents.
13.2 Except as provided for in this Agreement any warranties, (whether
express or implied by statute or common law or a previous course of
dealing or trade custom or usage or otherwise howsoever) including but
without limitation those of satisfactory quality or of fitness for a
particular purpose (even if that purpose is made known expressly or by
implication to Penn) are (insofar as is permitted by law) hereby
excluded.
13.3 Subject to clause 13.4 Penn shall under no circumstances be liable for
any indirect, special or consequential loss, or loss of anticipated
profit or third party claims howsoever arising whether in contract,
tort (including negligence) or breach of statutory duty or otherwise.
13.4 Neither party seeks to exclude liability for loss arising from death or
personal injury caused by its negligence or any liability or fraud..
13.5 Subject to clause 13.3 the aggregate liability of Penn (whether in
contract, tort (including negligence) or breach of statutory duty or
otherwise) to the Company for any loss or damage (whether asserted by
the Company or third parties) of whatever nature and howsoever caused
shall be limited to two times the Fees for the Services or part thereof
from which such loss or damage flowed.
14 Duration
14.1 This Agreement shall come into effect on the Commencement Date and
shall subject to the provisions of clause 15 below remain in full force
and effect for a period of 12 months' ("the Initial Term") and shall
continue thereafter until terminated by either party upon not less than
three months' prior notice in writing expiring at the end of the
Initial Term or expiring on any anniversary of the Commencement Date
thereafter.
15 Termination
15.1 Notwithstanding clause 14, either party may without prejudice to its
other rights or remedies hereunder forthwith terminate this Agreement
and/or the provision of all or any Services pursuant to this Agreement
by notice in writing to the other if such other:
(a) commits a material breach of any of its obligations hereunder and does
not remedy such breach within 28 days after written notice has been
given to it by the other (specifically referring to this clause 15)
requiring such remedy;
(b) becomes insolvent or enters into liquidation or receivership or is the
subject of an application for an administration order or suffers an
administrative receiver to be appointed in relation to the whole or any
part of its assets or makes a composition or arrangement with its
creditors or suffers any judgement to be executed in relation to any of
its property or assets; or
(c) suffers a change in who has control (as the same is defined in Section
416, Income and Corporation Taxes Act 1988 and in this Agreement
referred to as "Control") of the other party.
15.2 Each party shall forthwith notify the other in the event that:
(a) there is a change of Control in it; or
(b) there is a material adverse change in its financial condition such that
it becomes likely that it will not be able to pay its debts as and when
they fall due for payment or perform its obligations under this
Agreement.
15.3 The Company shall be entitled to terminate this Agreement, the
Technical Documents and the Fee Documents a whole or in only in so far
as they relate to particular Services with immediate effect by written
notice to Penn if Penn ceases to be authorised to perform the Services
or any part of them.
15.4 Any termination of this Agreement (whether under this clause or
otherwise) shall not relieve any party of the obligations under this
Agreement which is expressed to continue after termination.
15.5 Upon termination of this Agreement, the Company agrees to pay Penn for
the Services which have reached Completion by Penn prior to termination
of this Agreement and, unless termination is a result of breach of the
Agreement by Penn, reasonable costs relating to the cessation of
Services, such costs being sustained by reasonable evidence if
required.
16 Supply after termination
16.1 If Penn continues to supply any service to the Company after the
termination of this Agreement this shall not be construed as a waiver
of such termination or as a renewal of this Agreement.
17 Force majeure
17.1 No party hereto shall incur any liability to the other in the event
that it is delayed in the performance of its obligations hereunder
solely by force majeure.
17.2 For the purpose of this Agreement force majeure shall mean any cause of
delay beyond the reasonable control of the party liable to perform
unless conclusive evidence to the contrary is provided and shall
include but not be limited to strikes, lockouts, industrial
disturbance, riots, sabotage, act of war or piracy, destruction of
essential equipment by fire, explosion, storm, flood, earthquake, or
delay caused by failure of power supplies or transport facilities,
inability to obtain materials or government action including but not
limited to priorities and quotas.
18 Assignment
18.1 This Agreement shall not be assignable by either party without the
prior written consent of the other (such consent not to be unreasonably
withheld or delayed), save that Penn may assign the Agreement to
members of the same group of companies as Penn without the requirement
for such consent.
19 Notices
19.1 Any notice to be served by either party hereunder shall be sent by
pre-recorded delivery or registered post or by facsimile transmission
to the other at the address stated at the head of this Agreement and
shall be deemed to have been received by the other, if sent by pre-paid
recorded delivery or registered post, one week after posting, or if
sent by facsimile transmission, on the date sent provided that the
correct answer back code is received and a confirmatory copy is sent by
pre-paid recorded delivery or registered post on the date of
transmission.
20 Waiver
20.1 No waiver by either party of any of the requirements hereof or of any
of its rights hereunder shall release the other from full performance
of its remaining obligations stated herein.
21 Entire contract
21.1 This Agreement and the provisions of any Technical Documents, Fee
Document and any variation in writing signed by both parties of this
Agreement, the Technical Documents or Fee Document, contain the entire
understanding between Penn and the Company relating to the Services and
supersedes all or any previous agreements between the parties. In the
event of any conflict between the terms of the Technical Documents, Fee
Document or this Agreement, the later to be executed will prevail.
22 No partnership or agency
22.1 Nothing herein shall be deemed to constitute, evidence or comprise a
partnership between the parties hereto nor to constitute either party
the agent of the other.
23 Void provision
23.1 Should any provision of this Agreement be void or voidable the
existence or avoidance thereof shall not prejudice the enforceability
of the remaining provisions hereof.
24 Variation
24.1 No variation or modification of this Agreement shall be binding until
agreed to in writing by Penn and the Company.
25 Costs
25.1 Each of the parties hereto shall bear its own costs and expenses
incidental to the negotiation hereof and the preparation and carrying
into effect of this Agreement.
26 Third Party Rights
26.1 A person who is not a party to this Agreement has no rights under the
Contracts (Rights of Third Parties) Xxx 0000 to enforce any term of
this Agreement but this does not affect any right or remedy of the
third party which exists or is available apart from that Act.
27 Law and Jurisdiction
This Agreement regardless of where executed shall be governed and
interpreted in accordance with English law and the parties hereby
submit to the non-exclusive jurisdiction of the English Courts.
IN WITNESS whereof the parties hereto have caused their respective
representatives to sign this Agreement the day and year first before written.
Signed by......... )
For and on behalf of ) /s/ Xxxxx Xxxxxxx
Penn Pharmaceutical ) Xxxxx Xxxxxxx, Director Business
Services Limited ) Development
Signed by )
For and on behalf of ) /s/ Xxxxx X. Xxxx
Bioenvision, Inc. ) Xxxxx X. Xxxx, Director of
Counsel Finance, General
