MASTER AGREEMENT
between
XXXXX (CHEMICALS) LIMITED, 0 Xxxxxxxx Xxxxxx, Xxx Xxxxxxxxx, Xx. Xxxxxx, Xxxxxxx
(hereinafter referred to as "XXXXX")
and
XXX PHARMA A/S, Xxxxxxxxxxxxxx 00, XX-0000 Xxxxxxxx, Xxxxxxx (hereinafter
referred to as "XXX").
Capitalized terms not otherwise defined herein shall have the meanings set forth
in Article 1.
WHEREAS, XXX has licensed certain rights to its compound Calcipotriene, a
vitamin D analogue with the formula C27H40O3 (the "Compound") to Xxxxxxx-Xxxxx
Squibb Company (hereinafter referred to as "BMS") in the United States of
America, its possessions and territories (hereinafter referred to as the
"Territory") and as BMS has marketed this compound in various presentations
under the trademark Dovonex(R) in the Territory for a number a years (the
"Products"); and
WHEREAS, BMS has entered into a co-promotion agreement (the "Co-promotion
Agreement") with XXXXX regarding the Products; and
WHEREAS XXXXX and BMS have entered into an option agreement (the "Option
Agreement") in which XXXXX has options exercisable no sooner than August 1, 2003
(with effect as of 1 January 2004) or later than August 1, 2005 (with effect as
of 1 January 2006) to acquire all of BMS's rights and to assume BMS's
obligations (the "Option") under the agreement dated September 28, 1989 between
BMS (as successor to X.X. Xxxxxx & Sons Inc.) and XXX, as amended July 6, 1992,
April 8, 1993 and as of the date hereof and the Product Supply Agreement between
Xxxxxxx-Xxxxx Squibb Company and XXX dated as of April 8, 1993 (each as may be
amended or supplemented by the parties in the future, collectively, the "BMS
Agreements") - a transaction which is described in more detail in the form of an
asset purchase agreement between XXXXX and BMS (the "Asset Purchase Agreement");
and
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WHEREAS, XXX has given its consent to the grant of co-promotion rights to XXXXX
under the Co-promotion Agreement and the grant of the Option to XXXXX; and
WHEREAS, XXX recently has developed a new combination product containing both
the Compound and Betamethasone Dipropionate in an ointment which it intends to
market under the trademark Dovobet(R) (the "Combination Product") and has filed
a patent application for the Combination Product and markets the product in
Europe; and
WHEREAS, all rights of BMS to the Combination Product in the Territory have
reverted to XXX; and
WHEREAS, XXXXX is interested in financial support of XXX in the development and
Registration of the Combination Product in the Territory as well as
collaborating with XXX regarding the commercialization of the Combination
Product in the Territory.
NOW THEREFORE, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "AB rated" means, with respect to any Product, a pharmaceutical product
which is an AB-rated equivalent to the Product, as defined in the 22nd
edition of Approved Drug Products with Therapeutic Equivalence Evaluations
issued by the United States Department of Health and Human Services.
1.2 "Action or Proceeding" means any action, suit, proceeding, arbitration or
Governmental or Regulatory Authority action, notification, investigation
or audit.
1.3 "Affiliate" means, with respect to any Person, any Person which, directly
or indirectly, controls, is controlled by, or is under common control
with, the specified Person. For purposes of this definition, the term
"control" as applied to any Person, means the possession, directly or
indirectly, of at least fifty-one per cent (51%) of the power to direct or
cause the direction of the management of that Person, whether through
ownership of voting securities or otherwise.
1.4 "Agreement" means this Master Agreement between XXXXX and XXX.
1.5 "FDA" means the United States Food and Drug Administration.
1.6 "FD&C Act" means the Federal Food, Drug and Cosmetic Act, as amended, and
all applicable regulations thereunder.
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1.7 "Governmental or Regulatory Authority" means any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of the
United States or any relevant country, state, province, county, city or
other political subdivision.
1.8 "Laws" means all laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of any Governmental or Regulatory
Authority.
1.9 "NDA" means a New Drug Application filed with the FDA for any product,
requesting permission to place a drug on the market in accordance with 21
C.F.R. Part 314 and all supplements filed pursuant to the requirements of
the FDA, including all documents, data and other information concerning
the Products which are necessary for FDA approval to market a product in
the United States.
1.10" Party" means XXXXX or XXX, as the case may be, and "Parties" means XXXXX
and XXX.
1.11 "Person" means any individual, firm, corporation, partnership, limited
liability company, trust, joint venture, Governmental or Regulatory
Authority, or other entity or organisation.
1.11 "Registrations" means the authorization to sell the Product in the
Territory as granted by the FDA or other relevant Governmental or
Regulatory Authority.
ARTICLE 2
OPERATIVE AGREEMENTS
2.1 Simultaneously with the signing of this Agreement the Parties have also
signed the following agreements (the "Operative Agreements"):
(a) Development Agreement regarding the development and Registration of the
Combination Product in the Territory (hereinafter referred to as the
"Development Agreement"), which is attached to this Agreement as Appendix
I;
(b) License and Supply Agreement regarding the marketing of the Products in
the Territory (hereinafter referred to as the "Dovonex(R) Agreement"),
which is attached to this Agreement as Appendix II.
(c) License and Supply Agreement regarding the marketing of the Combination
Product in the Territory (hereinafter referred to as the "Dovobet(R)
Agreement"), which is attached to this Agreement as Appendix III.
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ARTICLE 3
TERM AND TERMINATION
3.1 This Agreement will be effective when signed by both Parties provided that
the Co-promotion Agreement and the Option Agreement have been signed and
have come into force and provided also that said agreements do not
prohibit XXXXX from entering into the Dovonex(R) Agreement and the
Dovobet(R) Agreement. This Agreement will terminate when the Development
Agreement, the Dovonex(R) Agreement and the Dovobet(R) Agreement are all
terminated unless earlier terminated in accordance with the terms hereof.
3.2 In the event that one of the Parties hereto materially defaults or
breaches any of the provisions of this Agreement, the other Party shall
have the right to terminate this Agreement upon sixty (60) days' written
notice, provided, however, that if the Party in default within the sixty
day period referred to, remedies the said default or breach, the Agreement
shall continue in full force and effect. If this Agreement is terminated,
the Development Agreement, the Dovonex(R) Agreement and the Dovobet(R)
Agreement shall automatically terminate.
3.3 In the event of termination of this Agreement XXXXX shall not be relieved
of the duty and obligation to pay in full any payments due and unpaid at
the effective date of such termination.
3.4 The Operative Agreements will be effective as described below:
(a) The Development Agreement will be effective as of the date hereof.
(b) The Dovonex(R) Agreement will be effective when the rights and
obligations regarding the marketing of the Products have been bought by
XXXXX in accordance with the Option, provided that the Option shall have
been exercised by XXXXX by August 1, 2005.
(c) The Dovobet(R) Agreement will be effective when Registration for the
Combination Product is granted in the United States having the attributes
described in Article 4.1.3(c)(i), provided that both the Development
Agreement and the Dovonex(R) Agreement have come into force, provided,
however, that if XXXXX decides not to exercise the Option with effect as
of 1 January 2006 at the latest because (i) the aggregate turnover of the
Products in the U.S. during the period 1 July 2004 - 30 June 2005, as
measured by IMSHealth, is equal to or less than U.S.$50,000,000 (fifty
million dollars) or (ii) on or prior to August 1, 2005 a generic product
that is AB rated to any Product is approved by the FDA and has become
commercially available, the Dovobet(R) Agreement will be effective when
Registration for the Combination Product is granted in the United States
having the attributes described in Article 4.1.3(c)(i), provided, for
purposes of subclause (ii) above, that XXXXX has not provided assistance
to the
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holder of the registration for the AB rated product to obtain such
registration. In such case, and in the event that the Combination Product
obtains a Registration prior to August 1, 2005 and XXXXX has exercised the
Option but there has not yet been a Closing (as defined in the Option
Agreement), whether the Dovobet(R) Agreement becomes effective is not
dependent on whether the Dovonex(R) Agreement has become effective.
3.5 The Operative Agreements will terminate as described in said agreements.
The consequences of termination with regard to the Operative Agreements
are regulated separately in these agreements.
ARTICLE 4
CONSIDERATION AND MILESTONES
4.1 In consideration of the rights granted to XXXXX under this Agreement and
the Operative Agreements attached as Appendices I-III:
4.1.2 XXXXX shall on the same date and immediately after the assignment of the
BMS Agreements from BMS to XXXXX transfer to XXX all of GALEN's rights,
title and interests in any and all assets relating to the Dovonex(R)
product including but not limited to rights, title and interest to data,
studies, technical information, the IND, the NDA, the trademark,
publications and promotion material as assigned from BMS to XXXXX in
accordance with the Asset Purchase Agreement; and
4.1.3 XXXXX has made or shall make the following milestone payments to XXX:
(a) USD 2,000,000 (United States Dollars two million) option fee paid
upon signing of the Heads of Agreement on 17 December 2001;
(b) USD 5,000,000 (United States Dollars five million) within thirty
(30) days following the date hereof; and
(c) USD 40,000,000 (United States Dollars forty million) within thirty
(30) days following the FDA approval of the Registration for the
Combination Product, provided that:
(i) at the time of the approval of the Registration the indications
and dosages in the product labeling and package insert approved by
FDA is essentially equivalent to the SmPC approved for
Daivobet(R)/Dovobet(R) in Europe and Canada on the date hereof.
XXXXX recognizes that the daily dosing of Combination Product may be
once and/or twice daily.
(ii) XXX is ready and able to supply sufficient commercial
quantities of the Combination Product to XXXXX provided XXXXX has
given timely and firm orders and XXXXX has approved and delivered
the artwork for
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the packages to XXX within thirty days after FDA approval of the
Registration.
4.2 It is understood that none of the amounts paid pursuant to this Article
4.1.3 (a), (b) and (c) are refundable.
ARTICLE 5
REPRESENTATIONS AND WARRANTIES
5.1 XXX hereby represents, warrants, covenants and agrees as follows:
(a) XXX has the corporate power and authority to execute and deliver
this Agreement and to perform its obligations hereunder, and the execution,
delivery and performance of this Agreement and the Operative Agreements by XXX
have been duly and validly authorized and approved by proper corporate action on
the part of XXX, and XXX has taken all other action required by Law, its
certificate of incorporation, by-laws or any agreement to which it is a party or
to which it may be subject, required to authorize such execution, delivery and
performance. Assuming due authorization, execution and delivery on the part of
XXXXX, this Agreement constitutes and, when effective, the Operative Agreements
will each constitute a legal, valid and binding obligation of XXX, enforceable
against XXX in accordance with its terms, except as the enforceability thereof
may be limited by applicable bankruptcy, insolvency, reorganization or other
similar laws of general application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of this
Agreement and the Operative Agreements by XXX and the performance by XXX
contemplated hereunder will not violate any Laws.
(c) As of the date hereof, neither the execution and delivery of
this Agreement or the Operative Agreement nor the performance hereof or thereof
by XXX requires XXX to obtain any permits, authorizations or consents from any
Governmental or Regulatory Authority (except for FDA approval of the Combination
Product) or from any other Person, and such execution, delivery and performance
will not result in the breach of or give rise to any termination of any
agreement or contract to which XXX may be a party and which relates to Products
and/or Combination Product.
(d) As of the date hereof, Appendix V contains a correct and
complete list of all patents and patent applications issued or pending in the
Territory relating to the Combination Product which are owned by XXX or its
Affiliates. XXX is the owner of record of all patents and patent applications
listed on Appendix V. To the best knowledge of XXX, the claims included in such
patent and patent applications relate to patentable subject matter, and XXX is
not aware of any reason that such claims would be invalid or would not be
allowed to issue.
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(e) As of the date hereof, to the best knowledge of XXX, the
manufacture, use or sale of the Products or Combination Product does not or
would not infringe any patents of third parties, and, to the best knowledge of
XXX, no third party is infringing in the Territory any of the claims of the
patent or patent applications listed in Appendix V.
(f) As of the date hereof, there are no Actions or Proceedings
pending against XXX or any of its Affiliates, or, to the knowledge of XXX,
threatened against XXX or any of its Affiliates, at law or in equity, or before
or by any Governmental or Regulatory Authority relating to the Combination
Product in the Territory or any of the matters contemplated under this
Agreement. To the knowledge of XXX, there are no investigations, pending or
threatened against XXX or any of its Affiliates, at law or in equity, or before
or by any Governmental or Regulatory Authority relating to the Products, the
Combination Product or any of the matters contemplated under this Agreement.
(g) XXX will exercise reasonable diligence to ensure that the NDA
for the Combination Product to be filed with the FDA and all amendments thereto
will be prepared in accordance with all applicable requirements of the FD&C Act.
(h) XXX has heretofore disclosed to XXXXX all material information
known to XXX with respect to the safety and effectiveness of the Combination
Product or human risk factors relating thereto.
(i) XXX acknowledges that XXXXX is relying, and is entitled to rely,
on the foregoing representations, warranties and covenants.
5.2 XXXXX hereby represents, warrants, covenants and agrees as follows:
(a) XXXXX has the corporate power and authority to execute and deliver
this Agreement and the Operative Agreements and to perform its obligations
hereunder and thereunder, and the execution, delivery and performance of this
Agreement and the Operative Agreements by XXXXX have been duly and validly
authorized and approved by proper corporate action on the part of XXXXX, and
XXXXX has taken all other action required by Law, its certificate of
incorporation, by-laws or any agreement to which it is a party or to which it
may be subject, required to authorize such execution, delivery and performance.
Assuming due authorization, execution and delivery on the part of XXX, this
Agreement constitutes and the Operative Agreements, when effective will each
constitute, a legal, valid and binding obligation of XXXXX, enforceable against
XXXXX in accordance with its terms, except as the enforceability thereof may be
limited by applicable bankruptcy, insolvency, reorganization or other similar
laws of general application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of this Agreement
and the Operative Agreements by XXXXX and the performance by XXXXX contemplated
hereunder will not violate any Laws.
(c) As of the date hereof, neither the execution and delivery of this
Agreement and the Operative Agreements nor the performance hereof and
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thereof by XXXXX requires XXXXX to obtain any permits, authorizations or
consents from any Governmental or Regulatory Authority or from any other Person,
and such execution, delivery and performance will not result in the breach of or
give rise to any termination of any agreement or contract to which XXXXX may be
a party.
(d) As of the date hereof, there are no actions, suits, proceedings or
claims, pending against XXXXX or any of its Affiliates, or, to the knowledge of
XXXXX, threatened against XXXXX or any of its Affiliates, at law or in equity,
or before or by any Governmental or Regulatory Authority relating to any of the
matters contemplated under this Agreement. To the knowledge of XXXXX, there are
no investigations, pending or threatened against XXXXX or any of its Affiliates,
at law or in equity, or before or by any Governmental or Regulatory Authority
relating to the matters contemplated under this Agreement or which would
otherwise materially adversely affect GALEN's ability to perform its obligations
hereunder.
(e) The Option Agreement does not prohibit XXXXX from entering into this
Agreement and the Operative Agreements and after the transfer of the rights to
XXXXX in accordance with the Asset Purchase Agreement, BMS will no longer have
the right to market products containing the Compound under the trademark
Dovonex(R) in the Territory.
(f) XXXXX acknowledges that XXX is relying, and is entitled to rely, on
the foregoing representations, warranties and covenants.
ARTICLE 6
CONFIDENTIALITY
6.1 Each Party shall keep the terms of this Agreement and the Operative
Agreements confidential and shall not disclose the same to any third party
other than (i) by agreement of the Parties hereto, or (ii) as required by
Law or stock exchange regulation or an order of a competent Governmental
or Regulatory Authority; provided that prior to disclosure pursuant to
(ii) above, the disclosing Party shall - if possible - notify the
nondisclosing Party sufficiently prior to making such disclosure so as to
allow the nondisclosing Party adequate time to take whatever action it may
deem to be appropriate to protect the confidentiality of the information.
Notwithstanding anything herein to the contrary, any Party to this
Agreement (and any employee, representative, or other agent of any Party
to this Agreement) may disclose to any and all persons, without limitation
of any kind, the tax treatment and tax structure of the transactions
contemplated by this Agreement and all materials of any kind (including
opinions or other tax analyses) that are provided to it relating to such
tax treatment and tax structure. However, any such information relating to
the tax treatment or tax structure is required to be kept confidential to
the extent necessary to comply with any applicable federal or state
securities laws.
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6.2 Neither Party shall make any press release or other public announcement or
other disclosure to third parties relating to this Agreement or the
Operative Agreements without the prior consent of the other Party, which
consent shall not be unreasonably withheld, except where required by
applicable Law; provided that prior to disclosure, the disclosing Party
shall notify the nondisclosing Party sufficiently prior to making such
disclosure so as to allow the nondisclosing Party adequate time to take
whatever action it may deem to be appropriate to protect the
confidentiality of the information.
ARTICLE 7
ASSIGNABILITY
This Agreement shall be binding upon, and shall inure to the benefit of
successors of the Parties hereto, or to any assignee of all of the goodwill and
entire business assets of a Party hereto relating to pharmaceuticals, but shall
not otherwise be assignable without the prior written consent of the other
Party.
ARTICLE 8
AMENDMENT OF AGREEMENT; WAIVER; SEVERABILITY
8.1 This Agreement shall not be changed or modified orally.
8.2 Any term or condition of this Agreement may be waived at any time by the
Party that is entitled to the benefit thereof, but no such waiver shall be
effective unless set forth in a written instrument duly executed by or on
behalf of the Party waiving such term or condition. No waiver by either
Party of any term or condition of this Agreement, in any one or more
instances, shall be deemed to be or construed as a waiver of the same or
any other term or condition of this Agreement on any future occasion. All
remedies, either under this Agreement or by Law or otherwise afforded,
will be cumulative and not alternative.
8.3 If any provision of this Agreement is held to be illegal, invalid or
unenforceable under any applicable present or future Law, and if the
rights or obligations of any Party hereto under this Agreement will not be
materially and adversely affected thereby, (a) such provision will be
fully severable, (b) this Agreement will be construed and enforced as if
such illegal, invalid or unenforceable provision had never comprised a
part hereof, (c) the remaining provisions of this Agreement will remain in
full force and effect and will not be affected by the illegal, invalid or
unenforceable provision or by its severance herefrom and (d) in lieu of
such illegal, invalid or unenforceable provision, the Parties will add as
a part of this Agreement, a legal, valid and enforceable provision as
similar in terms to such illegal, invalid or unenforceable provision as
may be possible.
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ARTICLE 9
STATUS OF PRIOR AGREEMENTS
This Agreement together with the Development Agreement, the Dovonex(R) Agreement
and the Dovobet(R) Agreement constitute the entire agreement between the Parties
hereto with respect to the within subject matter and supersedes all previous
agreements, whether written or oral.
XXX and XXXXX agree that the BMS Agreements will automatically terminate on the
same date and immediately after said agreements are assigned from BMS to XXXXX
in accordance with the Asset Purchase Agreement and the termination of the BMS
Agreements and the coming into force of the Dovonex(R) Agreement shall be deemed
to be simultaneous.
ARTICLE 10
FORCE MAJEURE
The occurrence of an event which materially interferes with the ability of a
Party to perform its obligations or duties hereunder which is not within the
reasonable control of the Party affected, not due to malfeasance, and which
could not with the exercise of due diligence have been avoided ("Force Majeure")
including, but not limited to, fire, accident, labor difficulty, strike, riot,
civil commotion, act of God, delay or errors by shipping companies or change in
Law shall not excuse such Party from the performance of its obligations or
duties under this Agreement, but shall merely suspend such performance during
the continuation of Force Majeure. The Party prevented from performing its
obligations or duties because of Force Majeure shall promptly notify the other
Party hereto (the "Other Party") of the occurrence and particulars of such Force
Majeure and shall provide the Other Party, from time to time, with its best
estimate of the duration of such Force Majeure and with notice of the
termination thereof. The Party so affected shall use its best efforts to avoid
or remove such causes of non-performance. Upon termination of Force Majeure, the
performance of any suspended obligation or duty shall promptly recommence.
Neither Party shall be liable to the Other Party for any direct, indirect,
consequential, incidental, special, punitive or exemplary damages arising out of
or relating to the suspension or termination of any of its obligations or duties
under this Agreement by reason of the occurrence of Force Majeure. In the event
that Force Majeure has occurred and is continuing for a period of at least six
(6) months, the Other Party shall have the right to terminate this Agreement
upon thirty (30) days' notice.
ARTICLE 11
GUARANTEE OF XXXXX HOLDINGS PLC
On the date hereof, XXXXX shall deliver to XXX the guarantee of Xxxxx Holdings
PLC, its parent company, guaranteeing to XXX the performance of GALEN's
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obligations under this Agreement and the Operative Agreements, substantially in
the form of Appendix IV.
ARTICLE 12
PARTNERSHIP/AGENCY; THIRD PARTIES
None of the provisions of this Agreement shall be deemed to constitute the
relationship of partnership or agency between the Parties, and neither Party
shall have any authority to bind the other Party in any way except as provided
in this Agreement.
The Parties agree that no third party which is not a party to this Agreement is
intended to benefit from or shall have any right to enforce any provision of
this Agreement.
ARTICLE 13
GOVERNING LAW
THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE
INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE
PERFORMED ENTIRELY WITHIN SUCH STATE, WITHOUT REGARD TO THE CONFLICTS OF LAW
PRINCIPLES OF SUCH STATE OTHER THAN SECTIONS 5-1401 OF THE NEW YORK GENERAL
OBLIGATIONS LAW.
Each Party irrevocably submits to the exclusive jurisdiction of (a) the Supreme
Court of the State of New York, New York County, and (b) the United States
District Court for the Southern District of New York, for the purposes of any
suit, action or other proceeding arising out of this Agreement or any
transaction contemplated hereby or thereby. Each Party agrees to commence any
such action, suit or proceeding either in the United States District Court for
the Southern District of New York or if such suit, action or other proceeding
may not be brought in such court for jurisdictional reasons, in the Supreme
Court of the State of New York, New York County. Each Party further agrees that
service of any process, summons, notice or document by registered mail to such
Party's respective address set forth above shall be effective service of process
for any action, suit or proceeding in New York with respect to any matters to
which it has submitted to jurisdiction in this Article 13. Each Party
irrevocably and unconditionally waives any objection to the laying of venue of
any action, suit or proceeding arising out of this Agreement or the transactions
contemplated hereby and thereby in (i) the Supreme Court of the State of New
York, New York County or (ii) the United States District Court for the Southern
District of New York, and hereby and thereby further irrevocably and
unconditionally waives and agrees not to plead or claim in any such court that
any such action, suit or proceeding brought in any such court has been brought
in an inconvenient forum.
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Each Party hereto hereby waives to the fullest extent permitted by applicable
Law, any right it may have to a trial by jury in respect to any litigation
directly or indirectly arising out of, under or in connection with this
Agreement.
ARTICLE 14
NOTICES
Any notice hereunder shall be deemed to be sufficiently given if sent by
registered mail or by fax followed by mail to:
In the case of XXXXX:
XXXXX (CHEMICALS) LIMITED
0 Xxxxxxxx Xxxxxx
Xxx Xxxxxxxxx, Xx. Xxxxxx
Xxxxxxx
Fax: + 000 0 000 0000
With a copy to:
Xxxxx Holdings PLC
Att. Chief Executive Officer
000 Xxxxxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxx, Xxx Xxxxxx 00000
XXX
Fax: + 0 000 000 0000
In the case of XXX:
XXX PHARMA A/S
Att. CEO, President
Industriparken 00
XX-0000 Xxxxxxxx
Xxxxxxx
Fax: + 00 00 00 00 00
or such other address as the receiver shall have last furnished to the sender.
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IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be duly
executed in duplicate by their authorised officers as of the date last below
written.
Rockaway, April ___, 2003 Ballerup, April ___, 2003
XXXXX (CHEMICALS) LIMITED XXX Pharma A/S
-------------------------------------- --------------------------------------
Name: Xxxxx X. Xxxxxxxxxxxxx Name:
Title: Director Title:
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Appendix I: Form of Development Agreement
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Appendix II: Form of Dovonex Agreement
15
Appendix III: Form of Dovobet(R) Agreement
16
Appendix IV: Form of Guarantee
17
Appendix V: Patent and Patent Applications
18
LICENSE AND SUPPLY AGREEMENT
"DOVONEX(R) AGREEMENT"
between
XXXXX (CHEMICALS) LIMITED
and
XXX PHARMA A/S
DOVONEX(R) AGREEMENT
TABLE OF CONTENTS
I DEFINITIONS 3
II RIGHTS 7
III SUPPLY OF FINISHED PRODUCTS 8
IV MARKETING 18
V ACCOUNTING AND ROYALTY PAYMENT 20
VI PATENT PROTECTION AND VALIDITY 21
VII THIRD PARTIES INTELLECTUAL PROPERTY CLAIMS 22
VIII CONFIDENTIALITY 22
IX REGISTRATIONS 23
X TRADEMARKS 24
XI AUTHORISATIONS 25
XII QUALITY ASSURANCES 25
XIII SAFETY REPORTING, COMPLAINTS AND PRODUCT RECALL 25
XIV RESPONSIBILITIES OF PARTIES 26
XV TERM AND TERMINATION; CONSEQUENCES OF TERMINATION 27
XVI ASSIGNABILITY 30
XVII AMENDMENT OF AGREEMENT; WAIVER; SEVERABILITY 31
XVIII STATUS OF PRIOR AGREEMENT 31
XIX FORCE MAJEURE 32
XX NON-COMPETITION CLAUSE 32
XXI PARTNERSHIP/AGENCY; THIRD PARTIES 32
XXII GOVERNING LAW 33
XXIII NOTICES 34
APPENDICES:
Appendix I: Products
Appendix II: XXX Logo Guidelines
Appendix III: XXX Product Concept
Appendix IV: Patents
Appendix V: Batch Size and Minimum Order Quantity Per Delivery
Appendix VI: QA/QC Agreements
Appendix VII: GALEN's Pharmaceutical Import License
Appendix VIII: Pharmacovigilance Agreement
Appendix IX: Complaints and Product Recall
DOVONEX(R) AGREEMENT
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AGREEMENT
between
XXXXX (CHEMICALS) LIMITED of 0 Xxxxxxxx Xxxxxx, Xxx Xxxxxxxxx, Xx. Xxxxxx,
Xxxxxxx (hereinafter referred to as "XXXXX")
and
XXX PHARMA A/S of Xxxxxxxxxxxxxx 00, XX-0000 Xxxxxxxx, Xxxxxxx (hereinafter
referred to as "XXX").
Capitalized terms not otherwise defined herein shall have the meanings set forth
in Article I of this Agreement.
WHEREAS, XXX has discovered and developed the Compound and manufactures
pharmaceutical products containing the Compound for human therapeutic use; and
WHEREAS, XXXXX has marketing expertise within the field of dermatology; and
WHEREAS, XXXXX and XXX are interested in collaborating on the marketing of the
Compound in the Territory;
NOW THEREFORE, the Parties hereby agree as follows:
I - DEFINITIONS
1.1 "Action or Proceeding" shall mean any action, suit, proceeding,
arbitration or Governmental or Regulatory Authority action,
notification, investigation or audit.
1.2 "Affiliate" shall mean, with respect to any Person, any Person which,
directly or indirectly, controls, is controlled by, or is under common
control with, the specified Person. For purposes of this definition,
the term "control" as applied to any Person, means the possession,
directly or indirectly, of at least fifty-one per cent (51%) of the
power to direct or cause the direction of the management of that
Person, whether through ownership of voting securities or otherwise.
DOVONEX(R) AGREEMENT
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1.3 "Agreement" shall mean this License and Supply Agreement between XXXXX
and XXX.
1.4 "BMS" shall mean Xxxxxxx-Xxxxx Squibb Company.
1.5 "BMS Agreements" shall mean the agreement dated September 28, 1989
between BMS (as successor to X.X. Xxxxxx & Sons Inc.) and XXX, as
amended July 6, 1992, April 8, 1993 and as of the date hereof and the
Product Supply Agreement between BMS and XXX dated as of April 8, 1993,
each as may be amended or supplemented by the parties in the future.
1.6 "Combination Product" shall mean the pharmaceutical formulations
containing both the Compound and Betamethasone Dipropionate in an
ointment.
1.7 "Compound" shall mean the compound Calcipotriene, a vitamin D analogue
with the formula C27H4003.
1.8 "current Good Manufacturing Practices" shall mean the regulatory and
other standards of good manufacturing practice in the Territory, as in
effect from time to time, relating to the Manufacture of medicinal
products.
1.9 "Effective Date" shall mean the date on which XXXXX acquires the
interests and obligations of BMS in and to the Products, pursuant to
the Option Agreement dated as of even date herewith between XXXXX and
BMS and in accordance with the Asset Purchase Agreement referred to in
the Option Agreement.
1.10 "FDA" shall mean the United States Food and Drug Administration.
1.11 "Finished Product" shall mean the Products which are ready for sale to
customers in finished, final packaged form.
1.12 "XXXXX Information" shall mean any information (including, but not
limited to, technical improvements, financial and marketing
information) developed, made and/or generated by XXXXX relating to and
made as a result of its work with the Products.
DOVONEX(R) AGREEMENT
4
1.13 "Governmental or Regulatory Authority" shall mean any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of
the United States or any relevant country, state, province, county,
city or other political subdivision.
1.14 "Gross Margin" shall mean Net Sales less an amount equal to a
percentage of Net Sales determined by adding the purchase price, as set
forth in Section 3.2 and the applicable royalty rate, set forth in
Section 5.1.
1.15 "IND" shall mean the Investigational New Drug Application, as defined
in the United States Federal Food, Drug and Cosmetic Act and applicable
regulations promulgated thereunder as amended from time to time, filed
in the United States for the Product.
1.16 "Laws" shall mean all laws, statutes, rules, regulations, ordinances
and other pronouncements having the effect of law of any relevant
Governmental or Regulatory Authority.
1.17 "XXX Logo Guidelines" shall mean the guidelines for use of the XXX name
and the Assyrian Lion logo, Appendix II.
1.18 "XXX Product Branding" shall mean the Trademark, the XXX name, the
Assyrian Lion, the XXX Logo Guidelines, the XXX Product Concept, and
any domain names or websites related to the Product in the Territory.
1.19 "XXX Product Concept" shall mean the global concept for packaging and
promotional materials related to the Products developed by XXX,
Appendix III.
1.20 "Losses" shall mean any and all damages, fines, fees, penalties,
deficiencies, losses and expenses (including without limitation
interest, court costs, reasonable fees of attorneys, accountants and
other experts or other expenses of litigation or other proceedings or
of any claim, default or assessment).
1.21 "Manufacture" shall mean all the activities relating to production of
each Product, spanning from purchasing raw materials to packaging
Product including, but not limited to, purchasing raw materials,
packaging materials, production, quality control and assurance,
filling, labelling, packaging and finishing, release, holding and
storage and the tests and analyses conducted in connection therewith.
DOVONEX(R) AGREEMENT
5
1.22 "Manufacturing Authorization" shall mean the authorization to
Manufacture the Products as granted by the relevant Governmental or
Regulatory Authorities.
1.23 "NDA" shall mean the New Drug Application filed with the FDA for the
Product, requesting permission to place the Product on the market in
accordance with 21 C.F.R. Part 314 and all supplements filed pursuant
to the requirements of the FDA, including all documents, data and other
information concerning the Products which are necessary for FDA
approval to market a product in the United States.
1.24 "Net Sales" shall mean the adjusted gross invoice price, the adjusted
gross invoice price being the aggregate sales of XXXXX and its
Affiliates of the Product to unaffiliated third parties in the
Territory (but not including sales between XXXXX and its Affiliates)
less sales returns and allowances, including trade, quantity and cash
discounts and any other adjustments, including those granted on account
of price adjustments, billing errors, rejected goods, damaged goods,
Recalls, returns, rebates, chargeback rebates, fees, reimbursements or
similar payments granted or given to wholesalers or other distributors
(including retailers), buying groups, health care insurance carriers or
other institutions, freight and insurance charges billed to the
customers, customs or excise duties, sales tax and other taxes (except
income taxes) or duties relating to sales, and any payment in respect
of sales to any Governmental or Regulatory Authority in respect of any
Federal or state Medicaid, Medicare or similar program, all as
determined in accordance with generally accepted accounting principles
on a basis consistent with GALEN's audited financial statements,
provided, however, that the deductions from aggregate sales described
above shall in no event exceed eight percent (8%).
1.25 "Party" shall mean XXXXX or XXX, as the case may be, and "Parties"
shall mean XXXXX and XXX.
1.26 "Patents" shall mean the patents and patent applications owned and
controlled by XXX and listed in Appendix IV hereto, together with any
reissues, extensions, substitutions, confirmations, registrations,
revalidations, additions, divisions, continuations, or
continuations-in-part, of or to the aforesaid patents, and any other
patents owned by, or licensed to XXX in the Territory which, in the
absence of a license, would be infringed by the Manufacture, use or
sale of Products.
DOVONEX(R) AGREEMENT
6
1.27 "Person" shall mean any individual, firm, corporation, partnership,
limited liability company, trust, joint venture, Governmental or
Regulatory Authority or other entity or organization.
1.28 "Product" or "Products" shall mean the products listed in Appendix I,
which may be amended from time to time.
1.29 "Registrations" shall mean the authorization to sell the Product in the
Territory as granted by the FDA or other relevant Governmental or
Regulatory Authority.
1.30 "Technical Information" shall mean all information in the possession of
XXX and/or its Affiliates, and the information transferred from BMS to
XXXXX, regarding preclinical, chemical-pharmaceutical and clinical data
or other scientific information (including specifications, master batch
records, analytical methods including validation protocol and the drug
master file), or secret know-how about Product including, but not
limited to marketing know-how and show-how or uses for the Product in
the possession of XXX regarding the Product necessary for XXXXX to
fulfil its obligations under the Agreement.
1.31 "Territory" shall mean the fifty (50) states of the United States of
America, the District of Columbia, its territories and current
possessions.
1.32 "Trademark" shall mean the trademark Dovonex(R) owned by XXX.
II - RIGHTS
2.1 Grant. XXX hereby grants XXXXX, and XXXXX accepts from XXX, subject to
the terms, conditions and provisions of this Agreement, an exclusive
license subject to Article 4.1, with the right to sublicense GALEN's
Affiliates, under the Trademark, Patents and Technical Information
owned by, or licensed to, XXX to import, store, distribute, use and
sell the Products in the Territory.
2.2 XXXXX acknowledges that the FDA has required carcinogenicity studies,
which started November 2001. If the studies are still running when this
Agreement becomes effective XXXXX agrees to pay fifty percent (50%) of
the documented expenses for these studies for which XXX is responsible
incurred after the date hereof. The estimated costs and timelines are
described below.
DOVONEX(R) AGREEMENT
7
BMS-181161 (CALCIPOTRIENE): 2-YEAR DERMAL CARCINOGENICITY STUDY IN
MICE.
CRO: Huntingdon Life Sciences, NJ, USA.
Fee: USD 1,128,200
Start: November 2001
Audited draft report: September 2004
Remarks: BMS will monitor study, incl. GLP compliance
inspections. XXX will provide test article
and do analytical work (TK plasma
concentration analysis and test article
reanalysis)
BMS-181161 (CALCIPOTRIENE) SOLUTION: 12-MONTH PHOTOCARCINOGENESIS STUDY
WITH ULTRAVIOLET RADIATION IN HAIRLESS MICE.
CRO: Argus Research, PA, USA (Xxxxxxx River
Laboratories Discovery and Development
Services).
Fee: USD 791,000
Start: November 2001
Audited draft report: March 2003
Remarks: BMS will monitor study, incl. GLP compliance
inspections. XXX will provide test article
and do analytical work (test article
reanalysis)
2.3 XXX shall disclose to XXXXX full details of all work undertaken in
connection with the carcinogenicity studies. XXX shall provide to XXXXX
written progress reports at intervals of not more than three (3)
months. Meetings between XXX and XXXXX shall be held at least two (2)
times per year in order to review the progress of the studies and to
determine further courses of action, as necessary.
2.4 XXX, its affiliates and its partners will be free to use XXXXX
Information (other than confidential financial information regarding
XXXXX), but shall be subject to the same confidentiality obligations
set forth Article VIII.
III - SUPPLY OF FINISHED PRODUCTS
3.1 Supply. In order to ensure the quality of the Products to be sold by
XXXXX, XXXXX shall purchase from XXX, and XXX shall supply to XXXXX,
according to supply conditions as laid down in this Agreement, either
from XXX or from such other sources as XXX shall authorise subject to
Article 3.9.1(b), GALEN's total requirements of the Products for use
and sale for the term of this Agreement.
DOVONEX(R) AGREEMENT
8
3.2 Purchase Price. The purchase price will be twenty percent (20%)
calculated on the Net Sales of Product sold by XXXXX or its Affiliates
in the Territory. It is understood that XXX has no obligation to
deliver Products at a floor price below four (4) times the XXX group
variable cost at all times (raw materials, packaging materials
including art work, energy, labour etc.) of the manufacture of the
Products.
3.3 Invoicing. XXX shall issue an invoice with each shipment of Products
pursuant to this Agreement and XXXXX agrees to pay such invoice in
immediately available funds within end of month + thirty (30) days from
the date of invoice. Invoicing and payments for Products shall be
denominated in United States Dollars. Payment shall be made to an
account designated by XXX in writing. The supply price of Products
reflects shipping terms of FCA Site of Production (ICC Incoterms 2000).
3.3.1 Invoice Adjustments. Because the Purchase Price is based on Net
Sales and will not be known precisely at the time of shipment of
Products by XXX, the invoice price shall reflect the estimated Purchase
Price agreed by the Parties.
Each year on 1 August an invoice price will be established for the
following calendar year based on the expected Net Sales and on 1
January the invoice price of the stock of goods at XXXXX will be
adjusted to the new invoice price agreed for that new year.
Adjustments to correct the invoiced amount shall be made quarterly
following receipt of information on the actual Net Sales realized on
the sale of Products ex XXXXX.
XXXXX shall render to XXX, within sixty (60) days after the end of each
calendar quarter, a detailed report setting forth Net Sales for the
preceding calendar quarter, the corresponding units by SKU represented
by such Net Sales, the manner in which Net Sales have been calculated,
as well as a calculation of said adjustments to invoice prices.
Settlement is to take place at the time of delivery of the report.
Any payment made by XXXXX hereunder after the date such payment is due,
shall bear interest at the lesser of: (a) one and one half percent
(1.5%) per month or (b) the maximum rate permitted by applicable Law.
The interest on late payments shall be calculated from the date payment
was due until actually received by XXX.
DOVONEX(R) AGREEMENT
9
3.4 Forecasts/Firm Orders.
(a) On the Effective Date, XXXXX will provide XXX with a firm order for
the period from the Effective Date up to and including the end of the
fourth full month following the Effective Date. XXX will supply the
quantities set forth in such firm order in accordance with the delivery
schedule set forth therein, and to the extent such firm order is not
sufficient to meet GALEN's actual requirements of the Product for such
period, XXX will use commercially reasonable efforts to supply XXXXX
with its requirements beyond the amounts specified in such firm order.
It is understood that quantities supplied by XXX pursuant to the firm
order delivered on the Effective Date will bear the trademarks and
trade dress of the Product as marketed by BMS. Xxxxx represents and
warrants to XXX that it has a limited license from BMS pursuant to the
terms of that certain Asset Purchase Agreement between Xxxxx and BMS,
pursuant to which Xxxxx acquired rights to the Product, to sell Product
bearing the trademarks and trade dress of the Product as marketed by
BMS for up to six months. XXXXX understands and acknowledges that the
lead time for shipment of Products following the receipt of such firm
orders will be three (3) months. Notwithstanding the foregoing, XXX
agrees that to the extent that BMS has placed firm orders for Product
with XXX within the four months prior to the Effective Date, delivery
of those orders scheduled for after the Effective Date will be based
upon the lead times and the delivery dates set forth in the forecasts
delivered by BMS pursuant to the BMS Agreements.
On the Effective Date, XXXXX shall provide to XXX final specifications
for the revised labeling and packaging of each presentation of the
Product identifying XXX as the manufacturer of the Product and XXXXX
(or its subsidiary, Xxxxxx Xxxxxxxx, Inc.) as the distributor thereof,
including all necessary photo-ready art (or its substantial equivalent)
reflecting such modification. XXXXX understands and acknowledges that
the lead time for the first shipment of Product following the receipt
of such final specifications shall be four (4) months.
For periods thereafter, firm orders shall be filled by XXX in
accordance with the firm orders placed by XXXXX pursuant to Article
3.4. (b).
(b) Within five (5) working days following the end of each calendar
month XXX will receive from XXXXX a rolling forecast covering twenty
four (24) months of
DOVONEX(R) AGREEMENT
10
which the first four (4) months must be covered by firm orders
(consisting of the then current month and the following three (3)
months). XXX shall, to the best of its ability, supply the exact amount
of Finished Products that XXXXX has ordered. XXXXX accepts that a
variation in deliveries of +/- ten percent (10%) may occur. If XXX is
not in the position to deliver Finished Products at the delivery dates
stated in the respective firm order for technical reasons, XXX shall
immediately inform XXXXX. Both Parties will agree to a postponement or
cancellation of the firm order affected. In the event of a
postponement, XXX shall deliver within four weeks of the original
delivery date. If XXX is not in the position to deliver Finished
Products at the delivery dates stated in the respective firm order for
any reasons other than technical reasons or at a date otherwise agreed
upon with XXXXX, XXX shall deliver within four weeks of the original
delivery date. XXXXX shall maintain at least two (2) months' inventory
of the Product (two (2) months inventory of each stock keeping unit
(SKU)).
If the Agreement is terminated, and such termination results from the
breach of XXXXX, then any amounts owed by XXXXX to XXX in respect of
firm orders as of the date of termination must be paid by XXXXX
(c) The batch-size and minimum order quantity per delivery shall be as
set forth in Appendix V hereto.
3.5 Delivery. All shipments shall be shipped to such named place as XXXXX
shall with reasonable notice designate in writing, and will be in
accordance with the delivery instructions and with the specifications
for shipping and packing included with each purchase order. Delivery
will be made by XXX to a common carrier as XXXXX shall direct or to any
special carrier which XXXXX shall designate, along with a certificate
of compliance and analysis in accordance with Article 3.9.12. All risk
of loss, delay or damage in transit after delivery to such carrier
shall be borne by XXXXX. XXXXX shall pay freight and insurance on all
such shipments and all customs brokers' fees.
3.6 Controlling Provisions. In ordering and delivering, XXXXX and XXX may
employ their standard forms, but nothing in those forms shall be
construed to modify or amend the terms of this Agreement and in case of
conflict herewith, this Agreement shall control.
3.7 Acceptance of Shipments.
DOVONEX(R) AGREEMENT
11
3.7.1 Initial Acceptance. After receipt of a Product shipment, XXXXX
shall, within thirty (30) days, visually inspect the Product shipment
and communicate acceptance or rejection to XXX in writing. The Parties
agree that GALEN's visual inspection consists of (i) comparing the
applicable order against the documentation accompanying the shipment to
verify that the delivery date, identity, quantity and exterior shipment
labelling comply with the order and (ii) visually inspecting the
exterior of the Product shipment to verify that the shipment appears to
be in good condition.
3.7.2 Return and Replacement. Any quantities of the Products that are
rejected and/or returned by XXXXX in accordance with this Agreement and
the rejection has been accepted by XXX shall be returned to XXX at the
expense of XXX and at GALEN's option (a) shall be replaced by XXX as
quickly as possible at its sole expense and the payment in respect of
such quantities postponed until such replacement quantities are
received and accepted by XXXXX or (b) XXX shall refund any amounts paid
in respect of such quantities to XXXXX.
3.7.3 Independent Verification. If XXX does not agree to the rejection
of the Product the Parties will seek the opinion of an independent
laboratory reasonably acceptable to both Parties, whose opinion shall
be final and binding. The expenses for such expert opinion shall be
borne by the Party shown to be wrong, or, if the expert cannot identify
the responsible Party, then the Parties shall share equally the
expenses connected with the expert and the expenses connected with the
Products rejected and/or returned.
3.8 Representations, Warranties and Covenants of XXXXX. XXXXX hereby
represents, warrants and covenants to XXX as follows:
3.8.1 Packaging Components. Subject to Article 3.9.8, XXXXX shall
provide XXX with all artwork or other material developed or produced by
XXXXX for product labels, product inserts and other printed packaging
material. XXXXX shall be responsible for ensuring that Product labels
and Product inserts that it provides pursuant to Article 3.9.8, and any
other printed materials it provides, comply with all applicable Laws
and with conditions laid down in the Registration. XXX has the right to
purchase packaging components for six (6) months' use based on the
forecasts delivered at the time when XXX purchases and XXXXX shall
reimburse XXX for costs involved in connection with discarded
components due to changes wanted by XXXXX in such components. The same
applies if sale of a package size is
DOVONEX(R) AGREEMENT
12
discontinued, including, but not limited to, in case of termination of
this Agreement by XXX due to a breach by XXXXX, but excluding
discontinuation or withdrawal in the case of termination of this
Agreement by XXXXX due to a breach by XXX.
3.8.2 Storage. XXXXX represents and warrants that Products delivered
hereunder will be stored in full accordance with the applicable Laws in
the Territory, and with the instructions given by XXX, and the national
health authorities in the Territory. XXX has the right at any time
during normal business hours, upon reasonable notice, to audit premises
used by XXXXX for holding and storage of Products in Territory and
examine those parts of the premises, procedures and documentation
involved in the activities of this Agreement.
3.8.3 Changes in Product Labels and Printed Materials. In the event
that XXXXX requests changes in product labels, printed packaging
materials or packaging inserts for Products and XXX has components for
such materials in stock that it has purchased specifically for such
Product that can no longer be used as a result of such changes, XXXXX
shall have the obligation to purchase the lesser of (a) all of the XXX
stock of such components and (b) six months supply of the XXX stock of
such components, at cost. XXXXX shall give XXX at least four (4)
months' notice in advance of any changes required to be made to the
packaging materials. In case of termination of this Agreement, caused
solely by GALEN's breach, XXXXX shall reimburse XXX the cost of all
packaging materials in stock, purchased specifically for the Products,
at the time of such termination.
3.8.4 Repackaging. XXXXX is not allowed to repack the Products or in
any way change the original packaging of Products.
3.9 Representations, Warranties and Covenants of XXX. XXX hereby
represents, warrants and covenants to XXXXX as follows:
3.9.1 Valid Manufacturing Authorization. (a) XXX owns a valid
Manufacturing Authorization issued by the relevant Governmental or
Regulatory Authority.
(b) XXX is only allowed to make changes or take actions which will
require XXXXX to amend any Registration for good reasons and at its
sole expense, including but not limited to transfer of any Product to
alternative manufacturing facilities or changes in or replacement of
equipment or a change in the
DOVONEX(R) AGREEMENT
13
Specifications, with the prior written consent of XXXXX, which consent
shall not be unreasonably withheld.
3.9.2 Conformity with Specifications and Laws. Each Product delivered
by XXX to XXXXX hereunder has been Manufactured using a process that
has been validated in accordance with current Good Manufacturing
Practices and has been Manufactured in compliance with the
specifications for such Product and with current Good Manufacturing
Practices and all Laws with respect to the Manufacture of each Product.
Each Product conforms to any further affirmation of fact as may be made
on or in any other documentation associated with or related to such
Products.
3.9.3 Creation and Retention of Records. XXX shall be responsible for
creating and retaining all records relating to Manufacturing, analysis,
testing and release of materials, production and quality control
(including in-process controls) for each Product, all in accordance
with current Good Manufacturing Practices and shall provide copies to
XXXXX upon its reasonable request.
3.9.4 Stability Studies. XXX shall conduct relevant stability studies
on each Product to assure validity of such Product for its shelf life.
3.9.5 Raw Materials and Products Provided by XXX. Except as otherwise
specifically agreed between the Parties in writing, XXX shall be
responsible for procuring all raw materials and other components for
each Product. All raw materials and components procured by XXX and used
in the Products shall be tested (by XXX or the supplier thereof) to
assure that they meet applicable specifications and quality standards.
3.9.6 Packaging Material. Unless required by Law no changes may be made
by XXX to the packaging material for any Product without the prior
written consent of XXXXX. If changes are required by Law XXX shall
consult with XXXXX prior to the implementation of such changes.
3.9.7 Storage. XXX shall store the raw materials, excipients, packaging
articles, intermediate products and the Products under such conditions
that the quality of such materials and the Products Manufactured
therefrom are not affected.
DOVONEX(R) AGREEMENT
14
3.9.8 Approval of Product Labels, Printed Packaging Materials and
Inserts. Prior to the first production of each Product for XXXXX, XXX
shall provide XXXXX with information regarding the possible dimensions
and parameters of product labels, printed packaging materials and
inserts. Unless required by Law XXX will make no change to Product
labels or Product inserts, submitted by XXXXX in accordance with
Article 3.8.1, without the prior written approval of XXXXX. If changes
are required by Law XXX shall consult with XXXXX prior to the
implementation of such changes.
3.9.9 Reference Samples. XXX shall retain reference samples from each
batch of Finished Products for the period of time required by
applicable Law after the expiry date. Finished Products will be kept in
their final packaging and stored under the recommended conditions.
Samples of starting materials (other than solvents, gases and water)
will be retained for the period of time required by applicable Law
after the expiry date of the corresponding Finished Product. XXX shall
retain samples sufficient to conduct at least two (2) re-examinations.
XXX shall make reference samples available for inspection, testing,
analysis and examination by XXXXX and any relevant Governmental or
Regulatory Authority, promptly upon request of XXXXX.
3.9.10 Validation.
(a) The equipment and facilities used for manufacturing must be
validated and qualified by XXX. The results must be documented in
writing.
(b) In the event that changes in the manufacturing process or in the
Specifications take place pursuant to this Agreement, XXX shall perform
such validations or revalidations as may be required by current Good
Manufacturing Practices or reasonably requested by XXXXX in writing.
3.9.11 Control Tests.
(a) XXX shall perform all control tests set forth in the
Specifications. XXX shall confirm compliance in the form of a statement
on each certificate of analysis which follows the goods.
(b) At GALEN's reasonable request, XXX shall make samples from each
batch available to XXXXX. If control tests which XXXXX elects to have
carried out on the samples or the Products reveal any failure thereof
to comply with the
DOVONEX(R) AGREEMENT
15
Specifications, XXXXX shall promptly notify a named qualified person of
XXX of said failure. In the event that the results of such control
tests performed by XXXXX shall differ from findings of XXX and no
mutual agreement can be reached in respect thereof, then the Parties
shall jointly designate an independent laboratory for the purpose of
having that sample or Product subjected to a third control test as
promptly as practicable. Should non-compliance of the Product in
question be confirmed by such outside control, XXX undertakes to refund
any payment already made to it with respect to such non-complying
Product and to bear the cost of the third control test by such outside
laboratory and replace such non-complying Product in accordance with
Article 3.7. XXX shall bear the full cost of proper destruction of any
non-complying Product. Should compliance of the Product in question be
confirmed by such outside control, XXXXX undertakes to bear the cost of
such third control test and to pay for the Products in question. If the
outside control is unable to determine conclusively whether the Product
in question is in compliance or not, the Parties shall share equally
the expenses connected with the outside control and the expenses
connected with the replacement and destruction of the allegedly
non-complying Product.
3.9.12 Batch Release. XXX shall ensure that each Product has been
Manufactured in compliance with the requirements of the Registration
and shall release only batches accompanied by a certificate of
compliance signed by a qualified person of XXX that the Product has
been Manufactured by XXX according to the Specifications and that XXX
is committed to inform XXXXX in the event of any change in the
manufacturing process or in the analytical specification, in accordance
with the terms of this Agreement, and of any noted incident occurring
during the Manufacture of the Product. In preparing the certificate of
compliance, qualified person of XXX shall take into account analytical
results, essential information such as the production conditions, the
results of in-process controls and the examination of manufacturing
documents. XXX shall create and retain records relating to each batch
of the Product Manufactured hereunder in accordance with applicable
Law.
3.9.13 XXX Resources. XXX has appropriately qualified and trained
personnel, adequate premises and space, suitable equipment and
services, correct materials, containers and labels, suitable storage
and the knowledge and experience to carry out satisfactorily the supply
of Finished Product to XXXXX.
3.9.14 Key Personnel. XXX shall provide XXXXX with a list of its Key
Personnel for QC release along with specimens of their signatures or
other appropriate
DOVONEX(R) AGREEMENT
16
identifiers such as electronic identification codes subject to adequate
security measures and shall keep XXXXX informed as to changes in its
Key Personnel from time to time.
3.9.15 Quality. XXX shall refrain from any activity that will adversely
affect the quality of any of the Products Manufactured for XXXXX.
3.9.16 Quality Audit. XXX shall make that portion of its manufacturing
facilities where the Products are Manufactured, including all records
and reference samples related to the Products, available for inspection
by XXXXX and representatives of applicable Governmental or Regulatory
Authorities during business hours. Records made available for
inspection hereunder shall include all records relevant to assessing
the quality of a product in the event of a complaint or a suspected
defect. Inspections by XXXXX shall be conducted only by a duly
authorized representative of XXXXX or the relevant Governmental or
Regulatory Authority and shall be limited to determining whether there
is compliance with current Good Manufacturing Practices, the
Registration and other requirements of this Agreement and of applicable
Law. In addition, the Parties agree that a member of GALEN'S
pharmaceutical quality assurance team may be present at all such
inspections. In the event such representatives conclude that any
non-conformity with such requirements is continuing, the Parties shall
use their respective best efforts to resolve the issue as quickly as
possible.
3.9.17 Environmental; Health and Safety Matters.
(a) XXX shall perform all of the services provided herein in
compliance with all environmental Laws and shall be solely
responsible for all environmental Losses at sites controlled
by XXX.
(b) XXX shall be solely responsible for implementing and
maintaining health and safety procedures for the manufacture,
generation, packaging, handling and storage of the raw
materials, hazardous materials, waste, packaging components
and Products as provided herein. Such procedures shall comply
with all relevant environmental Laws. XXXXX shall have no
responsibility for developing, implementing or overseeing
health and safety programs at XXX.
3.10 As soon as possible and no later than three (3) months following the
Effective Date of this Agreement, XXX, XXX Laboratories Limited (an
Affiliate of XXX) and XXXXX
DOVONEX(R) AGREEMENT
17
will enter into QA/QC Agreements substantially in the form of Appendix
VI A and B. Until such agreements have been signed, the terms of
Appendix VI A and B shall apply. To the extent of any conflict or
inconsistency between this Agreement and such QA/QC Agreements, the
terms of this Agreement shall control, unless otherwise agreed to in
writing between the Parties.
3.11 Products shall have a minimum shelf life of sixteen (16) months from
the date of shipment.
3.12 Notice of Noted Incidents and Abnormal Results. The Parties shall
promptly inform each other in writing of any incident that would be
reportable to the applicable Governmental or Regulatory Authority.
IV - MARKETING
4.1 XXXXX shall bear all of the cost and expense of advertising and
promoting the Products in the Territory. GALEN's advertising and
promotional materials shall be in accordance with the claims approved
by the FDA. XXXXX shall not use any advertising or promotional
materials, which are not consistent with the basic statements of XXX
regarding the Products. The respective departments within XXX and XXXXX
will communicate to discuss any relevant issues regarding basic
statements. XXXXX shall provide XXX with samples of its promotional
material.
Regular meetings will be held between XXXXX and XXX in order to discuss
the ongoing business. XXXXX shall annually prepare a business plan for
the forthcoming calendar year. The business plan shall contain a
forecast of sales based on market information data and allocation of
resources. XXXXX shall deliver a draft business plan by 1 August and a
final business plan by 30 October of each successive calendar year. The
Parties shall discuss each such business plan at a meeting to be held
no later than 15 September of each year, and XXXXX shall in good faith
take into account changes to such business plan recommended by XXX.
XXXXX shall provide XXX with quarterly market updates. XXXXX and XXX
shall at the above mentioned business plan meeting in September each
year agree upon minimum sales for the ensuing year, taking into
account, among other things, market conditions, regulatory issues and
competition. If XXXXX and XXX are unable to agree upon minimum sales or
any other matter to be agreed under this Agreement, the matter shall be
referred to the Chief Executive Officers of each
DOVONEX(R) AGREEMENT
18
Party for good faith resolution. If the Chief Executive Officers of
each Party are unable to agree upon minimum sales within 45 days the
minimum sales will be fixed by an independent third party acceptable to
both Parties, the cost of such third party to be shared equally by the
Parties. In the event of circumstances that change the assumptions made
at the time the minimum sales were agreed, e.g., introduction of a
generic of the Product or serious limitations in the use of the Product
for psoriasis become apparent, then the Parties shall meet in good
faith and adjust the minimums.
If XXXXX is unable to achieve the agreed minimum sales then this
License and Supply Agreement can be made non-exclusive upon 90 days'
written notice to XXXXX, provided, however, that XXXXX shall be
permitted during such 90 day period to pay an amount equal to the
shortfall between the minimum purchase quantities and the actual
quantity of Product purchased, and upon such payment to avoid the
conversion of this License and Supply Agreement to a non-exclusive
agreement.
4.2 Reasonable quantities of Product samples required in accordance with
GALEN's marketing plans will be delivered at the sample price. At the
time of signing of this Agreement the sample price is USD 0.45 for a 3
gram or 8 ml sample. The minimum sample price shall be adjusted for
inflation once each year effective 1 January, in an amount equal to the
increase according to the latest update in the official "Summarisk
lonindeks for den private sektor i Danmark" (Danish Index of Average
Earnings by Industry in the Private Sector), see xxx.xxx.xx.
4.3 Within five (5) working days following the end of any calendar month
XXXXX shall send to XXX a sales and stock report in a form that XXX may
from time to time specify, showing in respect of each particular size
and type of Products the number of and the value in USD of units sold
during the previous calendar month, the stock of Products and monthly
sales forecasts for the following twenty-four (24) months.
4.4 XXXXX shall keep its accounts updated in such a manner that control of
sales of the Products and other XXXXX Information regarding payment can
be made by XXX who shall be entitled to audit GALEN's accounts in
accordance with Article 5.3.
4.5 XXXXX is not entitled to perform any pre-clinical or clinical studies,
seeding trials, observational studies or any other pre or post
marketing studies, or any other activities relation hereto, without the
prior written consent of XXX and the prior
DOVONEX(R) AGREEMENT
19
written approval of the protocols by XXX, such consent and approval not
to be unreasonably withheld. Products to be used in any such
pre-clinical or clinical studies shall be delivered by XXX to XXXXX at
a price equivalent to 75% of the purchase price as defined in Article
3.2.
4.6 XXXXX shall keep XXX currently informed of any relevant new
developments in the pharmaceutical market in the Territory, e.g.
changes in governmental policies which may affect the Registrations
obtained or applied for, import and sales of the Products, competitors'
activities and attitudes among the medical profession. Further, the
Parties shall keep each other fully informed about all new information
relevant for Products in the Territory.
XXXXX shall also keep XXX informed of GALEN's chains of distribution
for Products in the Territory.
V - ACCOUNTING AND ROYALTY PAYMENT
5.1 In consideration of the rights granted in Article II XXXXX shall pay to
XXX a royalty calculated on the Net Sales of Products sold by XXXXX or
its Affiliates in the Territory in consideration of the Patent,
Technical Information and Trademark licenses granted by XXX to XXXXX in
Article II. The royalty rate will be ten percent (10%) on Net Sales for
as long as no generic competition exists. Generic competition within
the meaning of this Article 5.1 means ten percent (10%) or more in
terms of IMS unit sale market share. If generic competition arises the
royalty rate will be reduced to five percent (5%).
5.2 The report rendered by XXXXX pursuant to Article 3.3.1 shall also
include a calculation of royalty payments due pursuant to Article 5.1
for the preceding calendar quarter, such royalties to be paid at the
time of delivery of the report.
5.3 XXXXX agrees to keep accurate records in sufficient detail to enable
the royalties payable hereunder and the invoice adjustments as
mentioned in Article 3.3.1 to be determined, and upon the request of
XXX, shall permit an independent, certified public accountant selected
by XXX (except one to whom XXXXX has some reasonable objection), at the
sole expense of XXX , to have access during ordinary business hours to
GALEN's records (a) to determine the correctness of any report and/or
payments made under this Agreement or (b) to obtain information as to
the royalty payable for any such period in case of GALEN's failure to
report or pay
DOVONEX(R) AGREEMENT
20
pursuant to this Agreement. Notwithstanding the prior sentence, in the
event such inspection discloses that any payments made to XXX pursuant
to Articles 5.1 or 3.3 hereunder for any accounting period were
deficient by more than 5%, XXXXX shall reimburse XXX for the cost of
such inspection. This right of review shall terminate three (3) years
after receipt by XXX of GALEN's quarterly account. Said accountant
shall not disclose to XXX any information other than information
relating to the accuracy of the reports and payments made under this
Agreement and in no event are the quantities and prices to individual
customers to be disclosed to XXX.
5.4 Royalties shall be computed upon Net Sales sold by XXXXX and shall be
remitted in United States Dollars via bank transfer to an account
designated by XXX in writing.
5.5 If Laws require withholding of taxes imposed upon XXX on account of
royalties accruing under this Agreement, such taxes will be deducted by
XXXXX from such remittable royalty and will be paid by XXXXX to the
proper taxing authority. Proof of payment shall be secured and sent to
XXX as evidence of such payment.
5.6 In no case shall the sums received by XXX as royalties for sale of
Products be returned to XXXXX unless found to be in error.
VI - PATENT PROTECTION AND VALIDITY
6.1 XXX agrees to prosecute and maintain the Patents within the Territory.
6.2 XXX agrees within reasonable limits to protect from infringement of the
Patents and XXXXX shall notify XXX of any such infringement. When a
third party, in GALEN's opinion, infringes the Patents and the
infringement is expected to constitute a substantial unlicensed
competition, XXXXX shall provide XXX with any available evidence of the
infringement. XXX shall use all reasonable measures, whether by Action
or Proceeding or otherwise to prevent such infringement. All costs and
expenses of such Action or Proceeding or other activity, unless
collected from the third party against which the same is brought, shall
be borne by XXX. XXXXX shall, at the request of XXX, co-operate with
XXX in all respects including, but not limited to, making available to
XXX or its legal representative, all relevant papers, records,
information, samples, specimen, and the like. XXXXX shall use its
influence to make any of its employees testify when requested by XXX.
Any recovery obtained by XXX as the result of such Action or
Proceeding, by settlement or otherwise, shall
DOVONEX(R) AGREEMENT
21
after deduction of costs and expenses involved in such a proceeding be
shared equally by the Parties.
VII - THIRD PARTIES INTELLECTUAL PROPERTY CLAIMS
7.1 If an Action or Proceeding is filed by any third party against XXXXX as
defendant alleging that GALEN's operation under the licensed Patents,
Trademark and/or the Technical Information constitutes an infringement
of the intellectual property rights of the said third party, XXX, upon
GALEN's request, shall use its best efforts to make available to XXXXX
any relevant records, papers, expert information, samples, formulae and
the like, and shall co-operate in such defence with XXXXX as may be
reasonably requested by it.
7.2 In case of such Action or Proceeding or threat thereof, XXXXX shall
notify XXX promptly. Should XXXXX decide not to take up the defence,
XXX may at its entire discretion take up the defence itself, but is
under no obligation to do so. If and when XXX takes up a defence XXXXX
shall, upon the request of XXX, assist XXX to the best of its ability
with legal and technical advice and assistance, evidence and
documentation. Fifty percent (50 %) of the royalty payments
necessitated by a settlement may be deducted from GALEN's obligation
under Article 5.1, provided that this deduction does not reduce the
royalty payments in Article 5.1 by more than fifty percent (50 %).
However, XXXXX shall consult with XXX in case such settlement may
involve other payments.
7.3 This Agreement is deemed to continue in full force, including GALEN's
obligation to pay full royalty during a pending action or proceeding
instituted by third party due to GALEN's working under licensed Patent
or Trademark rights and/or Technical Information granted hereunder.
However, for as long as such action or proceeding is pending XXXXX
shall escrow the royalty due in a bank acceptable to XXX. If XXXXX is
ultimately held liable to any third party who brings suit, then XXXXX
can deduct any payments made to said third party in the form of damages
or royalty payments from the above escrow account and then from its
obligation under Article 5.1.
VIII - CONFIDENTIALITY
8.1 All Technical Information disclosed to XXXXX and all XXXXX Information
disclosed to XXX shall be considered confidential regardless of
designation, and shall not be
DOVONEX(R) AGREEMENT
22
disclosed by the receiving Party to any third party or used outside the
scope of this Agreement without the prior written consent of the
disclosing Party except to a duly authorised Governmental or Regulatory
Authority in connection with the Registration or regulation of the
Products or if otherwise required by Law. In the event that a receiving
Party is asked to disclose any confidential information to a
Governmental or Regulatory Authority, such receiving Party will - if
possible - notify the disclosing Party sufficiently prior to making
such disclosure so as to allow the non-disclosing Party adequate time
to take whatever action it may deem to be appropriate to protect the
confidentiality of the information. The obligation not to disclose
Technical Information and XXXXX Information shall not apply to (a) any
information that now or later becomes publicly available through no
fault of the receiver, its officers, employees or agents; (b) any
information that the receiver obtains from a third party not under a
confidentiality obligation to the discloser with respect to such
information; (c) any information that the receiver already has in its
possession as indicated in its written records; and (d) any information
that is independently developed or created by the receiver.
8.2 XXXXX may have its officers, employees and outside investigators
acquainted with the said Technical Information within the limit of
necessity for use of Products imposing upon them the same secrecy
obligations as XXXXX owes hereunder.
8.3 This Article VIII shall survive termination of this Agreement for a
period of ten (10) years, provided, however, that following the
termination of this Agreement XXX shall be free to use all data,
information or other confidential information relating to the Product
and following the termination of this Agreement, XXXXX shall be free to
use all XXXXX Information.
IX - REGISTRATIONS
9.1 XXX will be the owner and holder of the Registrations for the Products
in the Territory. XXX will, at the time of transfer of said
documentation to XXX, provide XXXXX with a complete copy including any
correspondence with the FDA as well as other relevant documents in the
possession or control of XXX. XXX will appoint XXXXX as its U.S. agent
for purposes of the NDA and will timely supply XXXXX with all
information in its possession or control necessary to prepare and file
reports required by the FDA. XXXXX will act as U.S. agent and will keep
Registrations updated, including, but not limited to, to maintaining
the NDA and the IND and forthwith to inform and copy XXX with the
updates.
DOVONEX(R) AGREEMENT
23
9.2 Both Parties are entitled to participate in and shall be notified in
advance by the other Party of all important meetings with the FDA
provided such participation does not result in any significant delay.
X - TRADEMARKS
10.1 XXX is responsible for registration, maintenance and defense of the
Trademark of the Products in the Territory. XXXXX shall, immediately
upon its knowledge hereof, be obliged to inform XXX of any possible
infringement of the Trademark. XXXXX agrees to use the Trademark only
in accordance with standards and guidelines communicated by XXX from
time to time during the term of this Agreement. XXXXX agrees that its
use of the Trademark shall be in a commercially acceptable and
responsible manner, and that no use by it of the Trademark shall
reflect adversely upon the good name of XXX. All goodwill deriving from
the use by XXXXX of the Trademark pursuant to the terms of this
Agreement or otherwise arising out of this Agreement shall accrue
solely and exclusively to XXX.
10.2 XXXXX shall not at any time register, or cause to be registered, in its
name or in the name of another, or authorize the use of, during or
after the term of this Agreement, the Trademark or any other trademark,
name or design resembling or similar to the Trademark. XXXXX shall not
use the Trademark in combination with another, as part of a trade name
or service xxxx of any corporation or other business organization
except with the prior written consent of XXX.
10.3 XXXXX and XXX are not, without the other Party's written consent, in
any way electronically on the Internet or otherwise, entitled to use or
register any of the other Party's intellectual property rights such as,
but not limited to, trademarks, product names, descriptions etc. XXXXX
is not, without the written consent of XXX, in any way entitled to sell
or promote any of the Products via the Internet. It being understood
that sale of the Products via the Internet by a customer of XXXXX does
not constitute a breach of this provision.
10.4 All packaging and promotional material shall include the XXX logo and
the Assyrian lion. The packaging and promotional material shall adhere
to the XXX Logo Guidelines.
DOVONEX(R) AGREEMENT
24
XI - AUTHORISATIONS
In accordance with legislation of the European Union, recipients of supplies of
medicinal products must be in possession of a manufacturing or importing
authorisation for medicinal products or an authorisation to engage in activity
as a wholesaler of medicinal products. Accordingly, for the duration of this
Agreement XXXXX shall be in possession of relevant and valid authorisation(s)
covering the Territory. A copy of the present authorisation(s) is attached as
Appendix VII. XXXXX shall forward copies of renewals of relevant authorisations
to XXX whenever such authorisations expire and are renewed.
XII - QUALITY ASSURANCES
12.1 XXX warrants that Products sold to XXXXX is of pharmaceutical grade and
quality suitable for human use and that it meets the specifications
approved by the applicable Governmental or Regulatory Authorities as
such specifications may be revised from time to time as provided herein
and that such Products conform to any further affirmations of fact as
may be made on or in any other documentation associated or related to
such Products.
12.2 In the event XXXXX determines that any Products already in interstate
commerce in the Territory presents a risk or injury or gross deception
or is otherwise defective and that recall of such Products is
appropriate, XXXXX shall conduct such recall in accordance with FDA
guidelines and with the provisions as set out in Article 13.2. XXX
shall fully co-operate with XXXXX in the investigation of the cause of
the recall. If the Parties agree that the cause of the recall was the
fault of XXX, XXX shall reimburse the XXXXX cost and expense associated
with such recall provided, however, that liability of XXX under this
provision shall not extend to any consequential damages associated with
such recall.
XIII - SAFETY REPORTING, COMPLAINTS AND PRODUCT RECALL
13.1 As soon as possible and no later than three (3) months following the
Effective Date of this Agreement, XXX and XXXXX will enter into a
Pharmacovigilance Agreement substantially in the form of Appendix VIII.
Until such agreement has been signed by both Parties, the terms of
Appendix VIII shall apply. To the extent of any conflict or
inconsistency between this Agreement and such Pharmacovigilance
Agreement, the terms of this Agreement shall control, unless otherwise
agreed to in writing between the Parties.
DOVONEX(R) AGREEMENT
25
13.2 XXXXX must put in place a system for handling of customer complaints
and product recall, which is in compliance with the guidelines
furnished by XXX. XXX Guidelines "Group Policy - GP 07 Investigation of
Customer Complaints" and "Group Policy - GP-08 Recall of XXX Products",
Appendix IX.
XIV - RESPONSIBILITIES OF PARTIES
14.1 Compliance with Laws. Both XXX and XXXXX shall observe all applicable
Laws in effect in fulfilling their obligations under this Agreement.
14.2 Indemnification.
14.2.1 Indemnification by XXX. In addition to the remedies set forth in
Article 3.7, XXX shall indemnify and hold XXXXX and its agents,
directors, officers and employees and representatives harmless from and
against any and all Losses which they may at any time incur by reason
of any Action or Proceeding brought by any Governmental or Regulatory
Authority or other third party against XXXXX arising out of or
resulting from (a) any misrepresentation, breach of warranty or
non-fulfilment of or failure to perform any agreement or covenant made
by XXX in this Agreement, (b) the use by XXXXX of any Product delivered
by XXX (including Product delivered by XXX to BMS which is acquired by
XXXXX) which does not comply with the Specifications therefor, or (c)
any other negligent act or omission of XXX.
14.2.2 Indemnification by XXXXX. XXXXX shall indemnify and hold XXX and
its agents, directors, officers and employees and representatives
harmless from and against any and all Losses which they may at any time
incur by reason of any Action or Proceeding brought by any Governmental
or Regulatory Authority or other third party against XXX arising out of
or resulting from (a) any misrepresentation, breach of warranty or
non-fulfilment of or failure to perform any agreement or covenant made
by XXXXX in this Agreement, (b) product liability claims other than
those against which XXX has indemnified XXXXX pursuant to Article
14.2.1, including, but not limited to, liability claims arising from
improper storage of Products by XXXXX or damage in transit to Products,
or (c) any other negligent act or omission of XXXXX.
14.2.3 Survival. The obligation of the Parties in this Article XIV
shall survive the expiration or earlier termination of this Agreement
to the extent permitted by applicable Law.
DOVONEX(R) AGREEMENT
26
14.3 In any case under the preceding Article 14.2, where XXXXX or XXX is to
indemnify the other, the control of the defence of any Action or
Proceeding and negotiations for settlement and compromise thereof,
shall repose with the indemnifying Party, except that nothing in this
paragraph shall be construed to relieve either Party hereto of the
obligation to give the other all reasonable co-operation, assistance
and authority necessary to permit full and complete defense of any
Action or Proceeding; provided, however, that no Party will settle any
of such claims without consent of the other Party; however, such
consent shall not be unreasonably withheld. Both Parties shall, if
desired, be allowed to participate, at their own expense, directly or
through a representative e.g. their product liability insurers, in any
Action or Proceeding.
XV - TERM AND TERMINATION; CONSEQUENCES OF TERMINATION
15.1 This Agreement shall become effective on the Effective Date, and shall
continue in full force and effect as provided herein, unless modified
or terminated in accordance with any of the provisions hereof, until
the later of (A) the expiration of the term of the Agreement of even
date between the Parties regarding the Combination Product, (B) the
expiration of the last to expire Patent in the Territory, and (C) 27
January 2020.
15.2 In the event that
- XXXXX does not exercise its option to purchase the rights and assume
the obligations of BMS under the BMS Agreements (the "Option"), on or
before August 1, 2005; or
- XXXXX - before August 1, 2005 - decides not to exercise the Option;
then XXX shall have the right to terminate this agreement with
immediate effect by written notice.
15.3 In the event that XXXXX and XXX agree, at any time after the seventh
anniversary of the Effective Date, that further commercialisation of
Products no longer are sound due to therapeutic or economic reasons,
then either Party can with six (6) months' prior notice terminate this
Agreement.
DOVONEX(R) AGREEMENT
27
15.4 In the event that one of the Parties hereto materially defaults or
breaches any of the provisions of this Agreement, the other Party shall
have the right to terminate this Agreement upon sixty (60) days'
written notice, provided, however, that if the Party in default within
the sixty day period referred to, remedies the said default or breach,
the Agreement shall continue in full force and effect.
15.5 In the event that the FDA does not approve a Registration for the
Combination Product and there is no reasonable possibility to obtain
approval, XXXXX shall - within 90 days - have the right to terminate
this Agreement upon ninety (90) days' written notice.
15.6 In the event that the patent application filed by XXX with the United
States Patent and Trademark Office for the Combination Product is
rejected by the Patent Examiner and the route of appeal of such
rejection has been exhausted or is not diligently pursued by XXX or XXX
has not obtained a U.S. patent within five (5) years from the date of
filing of such application with the United States Patent and Trademark
Office, then XXXXX may terminate this Agreement within ninety (90) days
of such rejection of appeal, or on ninety (90) days' notice to XXX that
XXX is not diligently pursuing such appeal, without any further
obligation to XXX.
15.7 In the event that one of the Parties hereto enters into liquidation
whether compulsorily or voluntarily (otherwise than for the purposes of
amalgamation or reconstruction), compounds with its creditors, has a
receiver or manager appointed in respect of all or any part of its
assets, or is the subject of an application for an administration order
or undergoes any analogous or similar act or proceeding under the laws
of any other jurisdiction in consequence of debt the other Party shall
have the right to terminate this Agreement with immediate effect by
written notice.
15.8 If XXXXX - for any three (3) consecutive calendar years - is unable to
achieve the agreed minimum sales, XXX shall have the right to terminate
this Agreement upon sixty (60) days' written notice.
15.9 In the event of termination of this Agreement under the provisions of
this Article XV XXXXX shall not be relieved of the duty and obligation
to pay in full all payments, including but not limited to royalties,
accrued and unpaid at the effective date of such termination. In such
event:
DOVONEX(R) AGREEMENT
28
15.9.1 XXXXX shall return any and all Technical Information and any
other information relating to the Product provided to XXXXX and make no
further use thereof;
15.9.2 XXXXX shall cease to make use of the Trademark, the other XXX
Product Branding and all other information related to the Product, and
all rights in the Trademark, the other XXX Product Branding and all
other information relating to the Product will promptly revert to XXX
and be transferred to XXX;
15.9.3 if XXXXX is then the owner of any patents specifically related
to Product, XXXXX shall transfer such ownership to XXX, except for XXX
being in breach in which case XXXXX will sell said patents and XXX will
purchase said patents at a price equal to the expenses XXXXX has borne
in relation to developing, establishing and maintaining said patent
rights;
15.9.4 if XXXXX is then the owner of any patents, which in part relates
to Product then XXX, its Affiliates and partners shall have a royalty
free license to such patents for the term of the patents;
15.9.5 if XXXXX is then the owner of any data related to the Product,
including but not limited to, any data related to any study performed
under this Agreement such data shall be transferred to XXX. At such
time, XXX shall have the right, but not the obligation, to have
assigned to XXX any then pending third party clinical agreement;
15.9.6 XXXXX shall transfer all Registrations held by XXXXX, if any, to
XXX or its designee.
In the event that XXX terminates this agreement pursuant to (a)
Articles 15.4, 15.7 or 15.8, or (b) 15.2 in the event that XXXXX has
not exercised the Option for reasons not including that (i) the
aggregate turnover of the Products in the U.S. during the period 1 July
2004 - 30 June 2005, as measured by IMSHealth, is equal to or less than
US$50,000,000 (fifty million dollars) or (ii) on or prior to August 1,
2005 a generic product that is AB rated to any Product is approved by
the FDA and has become commercially available, provided, for purposes
of this subclause (ii), that Xxxxx has not provided assistance to the
holder of the registration for the AB rated product to obtain such
registration,, the transfers required under Articles
DOVONEX(R) AGREEMENT
29
15.9.1, 15.9.2, 15.9.3, 15.9.5 and 15.9.6 shall be made free of charge
to XXX. Otherwise, the costs of transfers shall be split evenly between
the Parties.
15.10 It is understood that XXXXX - also after termination of the Agreement -
shall be solely liable for any and all chargebacks and returns of
Products sold by XXXXX under the Agreement. XXXXX shall destroy all
returns of Products it receives also after the termination of the
Agreement. Following such destruction, XXXXX shall certify the
destruction to XXX upon the written request of XXX.
XVI - ASSIGNABILITY
16.1 This Agreement and the licenses and rights herein granted shall be
binding upon, and shall inure to the benefit of successors of the
Parties hereto, or to any assignee of all of the good will and entire
business assets of a Party hereto relating to pharmaceuticals, but
shall not otherwise be assignable without the prior written consent of
the other Party.
16.2 Furthermore, in the event XXXXX xxxxxx with or is acquired by a company
and the new entity no longer gives priority to dermatology or in the
event XXXXX xxxxxx with or is acquired by a company having a product
which is a topical vitamin D3 or any analog thereof or a fixed
combination of vitamin D3 or any analog thereof with a corticosteriod
with indications that directly compete with the indications approved
for the Product and such product has sales, at the time of such
transaction, equal to at least 10% of the Net Sales of Products, and
such products are not divested or out-licensed, then the rights granted
herein are not assignable without the prior written consent of XXX,
which consent shall not be unreasonably withheld. If XXX does not
consent, then XXX is obliged to acquire the rights granted XXXXX
including all necessary approvals for marketing of the Product by
paying to XXXXX one (1) times GALEN's Gross Margin for the Products for
the twelve (12) months preceding the event, or if there is less than
twelve (12) months of sales by XXXXX, the Xxxxx Margin of such pro rata
period multiplied to equal a period of twelve (12) months.
16.3 For the avoidance of doubt, XXX agrees and acknowledges that XXXXX may
perform any or all of its obligations under this Agreement through its
U.S. Affiliate, Xxxxxx Xxxxxxxx, Inc., provided however, that XXXXX
shall remain jointly and severally liable for the performance of any
obligations that are delegated to Xxxxxx Xxxxxxxx, Inc.
DOVONEX(R) AGREEMENT
30
XVII - AMENDMENT OF AGREEMENT; WAIVER; SEVERABILITY
17.1 The Agreement shall not be changed or modified orally.
17.2 Any term or condition of this Agreement may be waived at any time by the
Party that is entitled to the benefit thereof, but no such waiver shall be
effective unless set forth in a written instrument duly executed by or on behalf
of the Party waiving such term or condition. No waiver by either Party of any
term or condition of this Agreement, in any one or more instances, shall be
deemed to be or construed as a waiver of the same or any other term or condition
of this Agreement on any future occasion. All remedies, either under this
Agreement or by Law or otherwise afforded, will be cumulative and not
alternative.
17.3 If any provision of this Agreement is held to be illegal, invalid or
unenforceable under any applicable present or future Law, and if the rights or
obligations of any Party hereto under this Agreement will not be materially and
adversely affected thereby, (a) such provision will be fully severable, (b) this
Agreement will be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement will remain in full force and effect and will not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom and (d) in lieu of such illegal, invalid or unenforceable
provision, the Parties will add as a part of this Agreement, a legal, valid and
enforceable provision as similar in terms to such illegal, invalid or
unenforceable provision as may be possible.
XVIII - STATUS OF PRIOR AGREEMENT
This Agreement, together with the Master Agreement, the Development Agreement
dated as of even date herewith between XXX and XXXXX and the License and Supply
Agreement dated as of even date herewith between XXX and XXXXX relating to the
license and supply of the Combination Product, constitutes the entire Agreement
between the Parties with respect to the within subject matter and supersedes all
previous agreements, whether written or oral.
DOVONEX(R) AGREEMENT
31
XIX - FORCE MAJEURE
The occurrence of an event which materially interferes with the ability of a
Party to perform its obligations or duties hereunder which is not within the
reasonable control of the Party affected, not due to malfeasance, and which
could not with the exercise of due diligence have been avoided ("Force
Majeure"), including, but not limited to, fire, accident, labor difficulty,
strike, riot, civil commotion, act of God, delay or errors by shipping companies
or change in Law shall not excuse such Party from the performance of its
obligations or duties under this Agreement, but shall merely suspend such
performance during the continuation of Force Majeure. The Party prevented from
performing its obligations or duties because of Force Majeure shall promptly
notify the other Party hereto (the "Other Party") of the occurrence and
particulars of such Force Majeure and shall provide the Other Party, from time
to time, with its best estimate of the duration of such Force Majeure and with
notice of the termination thereof. The Party so affected shall use its best
efforts to avoid or remove such causes of nonperformance. Upon termination of
Force Majeure, the performance of any suspended obligation or duty shall
promptly recommence. Neither Party shall be liable to the Other Party for any
direct, indirect, consequential, incidental, special, punitive or exemplary
damages arising out of or relating to the suspension or termination of any of
its obligations or duties under this Agreement by reason of the occurrence of
Force Majeure. In the event that Force Majeure has occurred and is continuing
for a period of at least six (6) months, the Other Party shall have the right to
terminate this Agreement upon thirty (30) days' notice.
XX - NON-COMPETITION CLAUSE
During the term of this Agreement XXXXX is not allowed to purchase, distribute,
market and/or sell any product which is a topical vitamin D3 or any analog
thereof or a fixed combination of vitamin D3 or any analog thereof with a
corticosteriod with indications that directly compete with the indications
approved for the Product, except the Combination Product.
XXI - PARTNERSHIP/AGENCY; THIRD PARTIES
None of the provisions of this Agreement shall be deemed to constitute the
relationship of partnership or agency between the Parties and neither Party
shall have any authority to bind the other Party in any way except as provided
in this Agreement.
DOVONEX(R) AGREEMENT
32
The Parties agree that no third party which is not a Party to this Agreement is
intended to benefit from or shall have any right to enforce any provision of
this Agreement.
XXII - GOVERNING LAW
THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE
INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE
PERFORMED ENTIRELY WITHIN SUCH STATE, WITHOUT REGARD TO THE CONFLICTS OF LAW
PRINCIPLES OF SUCH STATE OTHER THAN SECTIONS 5-1401 OF THE NEW YORK GENERAL
OBLIGATIONS LAW.
Each Party irrevocably submits to the exclusive jurisdiction of (a) the Supreme
Court of the State of New York, New York County, and (b) the United States
District Court for the Southern District of New York, for the purposes of any
suit, action or other proceeding arising out of this Agreement or any
transaction contemplated hereby or thereby. Each Party agrees to commence any
such action, suit or proceeding either in the United States District Court for
the Southern District of New York or if such suit, action or other proceeding
may not be brought in such court for jurisdictional reasons, in the Supreme
Court of the State of New York, New York County. Each Party further agrees that
service of any process, summons, notice or document by registered mail to such
Party's respective address set forth above shall be effective service of process
for any action, suit or proceeding in New York with respect to any matters to
which it has submitted to jurisdiction in this Article XXII. Each Party
irrevocably and unconditionally waives any objection to the laying of venue of
any action, suit or proceeding arising out of this Agreement or the transactions
contemplated hereby and thereby in (i) the Supreme Court of the State of New
York, New York County or (ii) the United States District Court for the Southern
District of New York, and hereby and thereby further irrevocably and
unconditionally waives and agrees not to plead or claim in any such court that
any such action, suit or proceeding brought in any such court has been brought
in an inconvenient forum.
Each Party hereto hereby waives to the fullest extent permitted by applicable
Law, any right it may have to a trial by jury in respect to any litigation
directly or indirectly arising out of, under or in connection with this
Agreement.
DOVONEX(R) AGREEMENT
33
XXIII - NOTICES
Any notice hereunder shall be deemed to be sufficiently given if sent by
registered mail or by fax followed by mail to:
In the case of XXXXX: Xxxxx (Chemicals) Limited
0 Xxxxxxxx Xxxxxx
Xxx Xxxxxxxxx, Xx. Xxxxxx
Xxxxxxx
Fax: + 000 0 000 0000
With a copy to: Xxxxx Holdings PLC
Att. Chief Executive Officer
000 Xxxxxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxx, Xxx Xxxxxx 00000
XXX
Fax: + 0 000 000 0000
In the case of XXX: XXX Pharma A/S
Att. The President
Industriparken 00
XX-0000 Xxxxxxxx
Xxxxxxx
Fax: + 00 00 00 00 00
or to such other address as the sender shall have last furnished to the
receiver.
[end of text - signature page to follow]
DOVONEX(R) AGREEMENT
34
IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be duly
executed in duplicate by their authorised officers as of the date last below
written.
XXXXX(CHEMICALS) LIMITED XXX Pharma A/S
By: __________________________ By: _________________________
Xxxxx X. Xxxxxxxxxxxxx
Title: Director Title: ______________________
Date: April ____, 2003 Date: _______________________
DOVONEX(R) AGREEMENT
35
LICENSE AND SUPPLY AGREEMENT
"DOVOBET(R) AGREEMENT"
between
XXXXX (CHEMICALS) LIMITED
and
XXX PHARMA A/S
TABLE OF CONTENTS
I DEFINITIONS 3
II RIGHTS 7
III SUPPLY OF FINISHED PRODUCTS 8
IV MARKETING 17
V ACCOUNTING AND ROYALTY PAYMENT 19
VI PATENT PROTECTION AND VALIDITY 21
VII THIRD PARTIES INTELLECTUAL PROPERTY CLAIMS 21
VIII CONFIDENTIALITY 22
IX REGISTRATIONS 23
X TRADEMARKS 23
XI AUTHORISATIONS 24
XII QUALITY ASSURANCES 24
XIII SAFETY REPORTING, COMPLAINTS AND PRODUCT RECALL 25
XIV RESPONSIBILITIES OF PARTIES 25
XV TERM AND TERMINATION; CONSEQUENCES OF TERMINATION 26
XVI ASSIGNABILITY 30
XVII AMENDMENT OF AGREEMENT; WAIVER; SEVERABILITY 31
XVIII STATUS OF PRIOR AGREEMENT 31
XIX FORCE MAJEURE 32
XX NON-COMPETITION CLAUSE 32
XXI PARTNERSHIP/AGENCY; THIRD PARTIES 32
XXII GOVERNING LAW 33
XXIII NOTICES 34
APPENDICES:
Appendix I: Products
Appendix II: XXX Logo Guidelines
Appendix III: XXX Product Concept
Appendix IV: Patents
Appendix V: Batch Size and Minimum Order Quantity Per Delivery
Appendix VI: QA/QC Agreement
Appendix VII: GALEN's Pharmaceutical Import License
Appendix VIII: Pharmacovigilance Agreement
Appendix IX: Complaints and Product Recall
2
AGREEMENT
between
XXXXX (CHEMICALS) LIMITED of 0 Xxxxxxxx Xxxxxx, Xxx Xxxxxxxxx, Xx. Xxxxxx,
Xxxxxxx (hereinafter referred to as "XXXXX")
and
XXX PHARMA A/S of Xxxxxxxxxxxxxx 00, XX-0000 Xxxxxxxx, Xxxxxxx (hereinafter
referred to as "XXX").
Capitalized terms not otherwise defined herein shall have the meanings set forth
in Article I of this Agreement.
WHEREAS, XXX has discovered and developed and owns proprietary information to a
Combination Product consisting of the Compound and Betamethasone Dipropionate in
an ointment and has filed a patent for the Combination Product; and
WHEREAS, XXXXX has marketing expertise within the field of dermatology; and
WHEREAS, XXXXX and XXX are interested in collaborating on the marketing of
the Combination Product in the Territory;
NOW THEREFORE, the Parties hereby agree as follows:
I - DEFINITIONS
1.1 "Action or Proceeding" shall mean any action, suit, proceeding, arbitration
or Governmental or Regulatory Authority action, notification, investigation
or audit.
1.2 "Affiliate" shall mean, with respect to any Person, any Person which,
directly or indirectly, controls, is controlled by, or is under common
control with, the specified Person. For purposes of this definition, the
term "control" as applied to any Person, means the possession, directly or
indirectly, of at least fifty-one per cent (51%) of
3
the power to direct or cause the direction of the management of that
Person, whether through ownership of voting securities or otherwise.
1.3 "Agreement" shall mean this License and Supply Agreement between XXXXX and
XXX.
1.4 "BMS" shall mean Xxxxxxx-Xxxxx Squibb Company.
1.5 "BMS Agreements" shall mean the agreement dated September 28, 1989 between
BMS (as successor to X.X. Xxxxxx & Sons Inc.) and XXX, as amended July 6,
1992, April 8, 1993 and on the date hereof and the Product Supply Agreement
between BMS and XXX dated as of April 8, 1993, each as may be amended or
supplemented by the parties in the future.
1.6 "Combination Product" shall mean the pharmaceutical formulations containing
both the Compound and Betamethasone Dipropionate in an ointment.
1.7 "Compound" shall mean the compound Calcipotriene, a vitamin D analogue with
the formula C27H4003.
1.8 "current Good Manufacturing Practices" shall mean the regulatory and other
standards of good manufacturing practice in the Territory, as in effect
from time to time, relating to the Manufacture of medicinal products.
1.9 "Dovonex(R) Agreement" shall mean the License and Supply Agreement dated as
of even date herewith between XXX and XXXXX relating to the Dovonex(R)
Product.
1.10 "Dovonex(R) Product" shall mean products containing the Compound and sold
under the trademark Dovonex(R) in the Territory.
1.11 "Effective Date" shall mean the date on which this Agreement becomes
effective pursuant to Section 3.4(c) of the Master Agreement dated as of
even date herewith between XXX and XXXXX.
1.12 "FDA" shall mean the United States Food and Drug Administration.
1.13 "Finished Product" shall mean the Products which are ready for sale to
customers in finished, final packaged form.
4
1.14 "XXXXX Information" shall mean any information (including, but not limited
to, technical improvements, financial and marketing information) developed,
made and/or generated by XXXXX relating to and made as a result of its work
with the Products.
1.15 "Governmental or Regulatory Authority" shall mean any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of the
United States or any relevant country, state, province, county, city or
other political subdivision.
1.16 "Gross Margin" shall mean Net Sales less an amount equal to a percentage of
Net Sales determined by adding the purchase price, as set forth in Section
3.2 and the applicable royalty rate, set forth in Section 5.1.
1.17 "IND" shall mean the Investigational New Drug Application, as defined in
the United States Federal Food, Drug and Cosmetic Act and applicable
regulations promulgated thereunder as amended from time to time, filed in
the United States for the Product.
1.18 "Laws" shall mean all laws, statutes, rules, regulations, ordinances and
other pronouncements having the effect of law of any relevant Governmental
or Regulatory Authority.
1.19 "XXX Logo Guidelines" shall mean the guidelines for use of the XXX name and
the Assyrian Lion logo, Appendix II.
1.20 "XXX Product Branding" shall mean the Trademark, the XXX name, the Assyrian
Lion, the XXX Logo Guidelines, the XXX Product Concept, and any domain
names or websites related to the Product in the Territory.
1.21 "XXX Product Concept" shall mean the global concept for packaging and
promotional materials related to the Products developed by XXX, Appendix
III.
1.22 "Losses" shall mean any and all damages, fines, fees, penalties,
deficiencies, losses and expenses (including without limitation interest,
court costs, reasonable fees of attorneys, accountants and other experts or
other expenses of litigation or other proceedings or of any claim, default
or assessment).
5
1.23 "Manufacture" shall mean all the activities relating to production of each
Product, spanning from purchasing raw materials to packaging Product
including, but not limited to, purchasing raw materials, packaging
materials, production, quality control and assurance, filling, labelling,
packaging and finishing, release, holding and storage and the tests and
analyses conducted in connection therewith.
1.24 "Manufacturing Authorization" shall mean the authorization to Manufacture
the Products as granted by the relevant Governmental or Regulatory
Authorities.
1.25 "NDA" shall mean the New Drug Application filed with the FDA for the
Product, requesting permission to place the Product on the market in
accordance with 21 C.F.R. Part 314 and all supplements filed pursuant to
the requirements of the FDA, including all documents, data and other
information concerning the Products which are necessary for FDA approval to
market a product in the United States.
1.26 "Net Sales" shall mean the adjusted gross invoice price, the adjusted gross
invoice price being the aggregate sales of XXXXX and its Affiliates of the
Product to unaffiliated third parties in the Territory (but not including
sales between XXXXX and its Affiliates) less sales returns and allowances,
including trade, quantity and cash discounts and any other adjustments,
including those granted on account of price adjustments, billing errors,
rejected goods, damaged goods, Recalls, returns, rebates, chargeback
rebates, fees, reimbursements or similar payments granted or given to
wholesalers or other distributors (including retailers), buying groups,
health care insurance carriers or other institutions, freight and insurance
charges billed to the customers, customs or excise duties, sales tax and
other taxes (except income taxes) or duties relating to sales, and any
payment in respect of sales to any Governmental or Regulatory Authority in
respect of any Federal or state Medicaid, Medicare or similar program, all
as determined in accordance with generally accepted accounting principles
on a basis consistent with GALEN's audited financial statements, provided,
however, that the deductions from aggregate sales described above shall in
no event exceed eight percent (8%).
1.27 "Party" shall mean XXXXX or XXX, as the case may be, and "Parties" shall
mean XXXXX and XXX.
1.28 "Patents" shall mean the patents and patent applications owned and
controlled by XXX and listed in Appendix IV hereto, together with any
reissues, extensions, substitutions, confirmations, registrations,
revalidations, additions, divisions,
6
continuations, or continuations-in-part, of or to the aforesaid patents and
patent applications and/or any patents issuing thereon, and any other
patents owned by, or licensed to XXX in the Territory which, in the absence
of a license, would be infringed by the Manufacture, use or sale of
Products.
1.29 "Person" shall mean any individual, firm, corporation, partnership, limited
liability company, trust, joint venture, Governmental or Regulatory
Authority or other entity or organization.
1.30 "Product" or "Products" shall mean the Combination Product(s) listed in
Appendix I, which may be amended from time to time.
1.31 "Registrations" shall mean the authorization to sell the Product in the
Territory as granted by the FDA or other relevant Governmental or
Regulatory Authority.
1.32 "Technical Information" shall mean all information in the possession of XXX
and/or its Affiliates, and the information transferred from BMS to XXXXX,
regarding preclinical, chemical-pharmaceutical and clinical data or other
scientific information (including specifications, master batch records,
analytical methods including validation protocol and the drug master file),
or secret know-how about Product including, but not limited to marketing
know-how and show-how or uses for the Product in the possession of XXX
regarding the Product necessary for XXXXX to fulfil its obligations under
the Agreement.
1.33 "Territory" shall mean the fifty (50) states of the United States of
America, the District of Columbia, its territories and current possessions.
1.34 "Trademark" shall mean the trademark Dovobet(R) owned by XXX, or any other
trademark XXX may select for the Product.
II - RIGHTS
2.1 Grant. XXX hereby grants XXXXX, and XXXXX accepts from XXX, subject to the
terms, conditions and provisions of this Agreement, an exclusive license
subject to Article 4.1, with the right to sublicense GALEN's Affiliates,
under the Trademark, Patents and Technical Information owned by, or
licensed to, XXX to import, store, distribute, use and sell the Products in
the Territory.
7
2.2 XXX, its affiliates and its partners will be free to use XXXXX Information
(other than confidential financial information regarding XXXXX), but shall
be subject to the same confidentiality obligations set forth Article VIII.
III - SUPPLY OF FINISHED PRODUCTS
3.1 Supply. In order to ensure the quality of the Products to be sold by XXXXX,
XXXXX shall purchase from XXX, and XXX shall supply to XXXXX, according to
supply conditions as laid down in this Agreement, either from LEO or from
such other sources as LEO shall authorise subject to Article 3.9.1(b),
GALEN's total requirements of the Products for use and sale for the term of
this Agreement.
3.2 Purchase Price. The purchase price will be a percentage calculated on the
Net Sales of Product sold by GALEN or its Affiliates in the Territory
calculated as follows for the first period, i.e. the period running from
the Effective Date until the end of the calendar year in which the
Agreement becomes effective and the subsequent periods of twelve (12)
months (calendar years) :
Supply Price Annual US Net Sales Increment
------------ -----------------------------
25% Up to USD 50 million
22.5% Between USD 50 million and USD 100 million
20% Over USD 100 million
It is understood that LEO has no obligation to deliver Products at a floor
price below four (4) times the LEO group variable cost at all times (raw
materials, packaging materials including art work, energy, labour etc.) of
the manufacture of the Products.
3.3 Invoicing. LEO shall issue an invoice with each shipment of Products
pursuant to this Agreement and GALEN agrees to pay such invoice in
immediately available funds within end of month + thirty (30) days from the
date of invoice. Invoicing and payments for Products shall be denominated
in United States Dollars. Payment shall be made to an account designated by
LEO in writing. The supply price of Products reflects shipping terms of FCA
[Site of Production] (ICC Incoterms 2000).
3.3.1 Invoice Adjustments. Because the Purchase Price is based on Net Sales
and will not be known precisely at the time of shipment of Products by LEO,
the invoice price shall reflect the estimated Purchase Price agreed by the
Parties.
8
Each year on 1 August an invoice price will be established for the
following calendar year based on the expected Net Sales and on 1 January
the invoice price of the stock of goods at GALEN will be adjusted to the
new invoice price agreed for that new year.
Adjustments to correct the invoiced amount shall be made quarterly
following receipt of information on the actual Net Sales realized on the
sale of Products ex GALEN.
GALEN shall render to LEO, within sixty (60) days after the end of each
calendar quarter, a detailed report setting forth Net Sales for the
preceding calendar quarter, the corresponding units by SKU represented by
such Net Sales, the manner in which Net Sales have been calculated, as well
as a calculation of said adjustments to invoice prices. Settlement is to
take place at the time of delivery of the report.
Any payment made by GALEN hereunder after the date such payment is due,
shall bear interest at the lesser of: (a) one and one half percent (1.5%)
per month or (b) the maximum rate permitted by applicable law. The interest
on late payments shall be calculated from the date payment was due until
actually received by LEO.
3.4 Forecasts/Firm Orders.
(a) To the extent possible, taking into account the Registration process,
as soon as practicable prior to the Effective Date, GALEN will provide LEO
with a firm order for the period from the Effective Date up to and
including the end of the fourth full month following the Effective Date.
LEO will supply the quantities set forth in such firm order in accordance
with the delivery schedule set forth therein, and to the extent such firm
order is not sufficient to meet GALEN's actual requirements of the Product
for such period, LEO will use commercially reasonable efforts to supply
GALEN with its requirements beyond the amounts specified in such firm
order.
To the extent possible, taking into account the Registration process, as
soon as practicable prior to the Effective Date, or if not possible, as
soon as practicable after the Effective Date, GALEN shall provide to LEO
final specifications for the labeling and packaging of each presentation of
the Product identifying LEO as the manufacturer of the Product and GALEN
(or its subsidiary, Warner Chilcott, Inc.) as
9
the distributor thereof, including all necessary photo-ready art (or its
substantial equivalent). GALEN understands and acknowledges that the lead
time for the first shipment of Product following the receipt of such final
specifications shall be four (4) months.
For supplies thereafter, firm orders shall be filled by LEO in accordance
with the firm orders placed by GALEN pursuant to Article 3.4. (b).
(b) LEO will with five (5) working days following the end of each calendar
month receive from GALEN a rolling forecast covering twenty four (24)
months of which the first four (4) months must be covered by firm orders
(consisting of the then current month and the following three (3) months).
LEO shall, to the best of its ability, supply the exact amount of Finished
Products that GALEN has ordered. GALEN accepts that a variation in
deliveries of +/- ten percent (10%) may occur. If LEO is not in the
position to deliver Finished Products at the delivery dates stated in the
respective firm order for technical reasons, LEO shall immediately inform
GALEN. Both Parties will agree to a postponement or cancellation of the
firm order affected. In the event of a postponement, LEO shall deliver
within four weeks of the original delivery date. If LEO is not in the
position to deliver Finished Products at the delivery dates stated in the
respective firm order for any reasons other than technical reasons or at a
date otherwise agreed upon with GALEN, LEO shall deliver within four weeks
of the original delivery date. GALEN shall maintain at least two (2)
months' inventory of the Product (two (2) months inventory of each stock
keeping unit (SKU)).
If the Agreement is terminated, and such termination results from the
breach of GALEN, then any amounts owed by GALEN to LEO in respect of firm
orders as of the date of termination must be paid by GALEN
(c) The batch-size and minimum order quantity per delivery shall be as set
forth in Appendix V hereto.
3.5 Delivery. All shipments shall be shipped to such named place as GALEN shall
with reasonable notice designate in writing, and will be in accordance with
the delivery instructions and with the specifications for shipping and
packing included with each purchase order. Delivery will be made by LEO to
a common carrier as GALEN shall direct or to any special carrier which
GALEN shall designate, along with a certificate of compliance and analysis
in accordance with Article 3.9.12. All risk of loss, delay
10
or damage in transit after delivery to such carrier shall be borne by
GALEN. GALEN shall pay freight and insurance on all such shipments and all
customs brokers' fees.
3.6 Controlling Provisions. In ordering and delivering, GALEN and LEO may
employ their standard forms, but nothing in those forms shall be construed
to modify or amend the terms of this Agreement and in case of conflict
herewith, this Agreement shall control.
3.7 Acceptance of Shipments.
3.7.1 Initial Acceptance. After receipt of a Product shipment, GALEN shall,
within thirty (30) days, visually inspect the Product shipment and
communicate acceptance or rejection to LEO in writing. The Parties agree
that GALEN's visual inspection consists of (i) comparing the applicable
order against the documentation accompanying the shipment to verify that
the delivery date, identity, quantity and exterior shipment labelling
comply with the order and (ii) visually inspecting the exterior of the
Product shipment to verify that the shipment appears to be in good
condition.
3.7.2 Return and Replacement. Any quantities of the Products that are
rejected and/or returned by GALEN in accordance with this Agreement and the
rejection has been accepted by LEO shall be returned to LEO at the expense
of LEO and at GALEN's option (a) shall be replaced by LEO as quickly as
possible at its sole expense and the payment in respect of such quantities
postponed until such replacement quantities are received and accepted by
GALEN or (b) LEO shall refund any amounts paid in respect of such
quantities to GALEN.
3.7.3 Independent Verification. If LEO does not agree to the rejection of
the Product the Parties will seek the opinion of an independent laboratory
reasonably acceptable to both Parties, whose opinion shall be final and
binding. The expenses for such expert opinion shall be borne by the Party
shown to be wrong, or, if the expert cannot identify the responsible Party,
then the Parties shall share equally the expenses connected with the expert
and the expenses connected with the Products rejected and/or returned.
3.8 Representations, Warranties and Covenants of GALEN. GALEN hereby
represents, warrants and covenants to LEO as follows:
11
3.8.1 Packaging Components. Subject to Article 3.9.8, GALEN shall provide
LEO with all artwork or other material developed or produced by GALEN for
product labels, product inserts and other printed packaging material. All
such art work and other material shall be consistent with the LEO Product
Concept wherever and whenever legally possible. GALEN shall be responsible
for ensuring that Product labels and Product inserts that it provides
pursuant to Article 3.9.8, and any other printed materials it provides,
comply with all applicable Laws and with conditions laid down in the
Registration. LEO has the right to purchase packaging components for six
(6) months' use based on the forecasts delivered at the time when LEO
purchases and GALEN shall reimburse LEO for costs involved in connection
with discarded components due to changes wanted by GALEN in such
components. The same applies if sale of a package size is discontinued,
including, but not limited to, in case of termination of this Agreement by
LEO due to a breach by GALEN, but excluding discontinuation or withdrawal
in the case of termination of this Agreement by GALEN due to a breach by
LEO.
3.8.2 Storage. GALEN represents and warrants that Products delivered
hereunder will be stored in full accordance with the applicable Laws in the
Territory, and with the instructions given by LEO, and the national health
authorities in the Territory. LEO has the right at any time during normal
business hours, upon reasonable notice, to audit premises used by GALEN for
holding and storage of Products in Territory and examine those parts of the
premises, procedures and documentation involved in the activities of this
Agreement.
3.8.3 Changes in Product Labels and Printed Materials. In the event that
GALEN requests changes in product labels, printed packaging materials or
packaging inserts for Products and LEO has components for such materials in
stock that it has purchased specifically for such Product that can no
longer be used as a result of such changes, GALEN shall have the obligation
to purchase the lesser of (a) all of the LEO stock of such components and
(b) six months supply of the LEO stock of such components, at cost. GALEN
shall give LEO at least four (4) months' notice in advance of any changes
required to be made to the packaging materials. In case of termination of
this Agreement, caused solely by GALEN's breach, GALEN shall reimburse LEO
the cost of all packaging materials in stock, purchased specifically for
the Products, at the time of such termination.
3.8.4 Repackaging. GALEN is not allowed to repack the Products or
in any way change the original packaging of Products.
12
3.9 Representations, Warranties and Covenants of LEO. LEO hereby represents,
warrants and covenants to GALEN as follows:
3.9.1 Valid Manufacturing Authorization. (a) LEO owns a valid Manufacturing
Authorization issued by the relevant Governmental or Regulatory Authority.
(b) LEO is only allowed to make changes or take actions which will require
GALEN to amend any Registration for good reasons and at its sole expense,
including but not limited to transfer of any Product to alternative
manufacturing facilities or changes in or replacement of equipment or a
change in the Specifications, with the prior written consent of GALEN,
which consent shall not be unreasonably withheld.
3.9.2 Conformity with Specifications and Laws. Each Product delivered by
LEO to GALEN hereunder has been Manufactured using a process that has been
validated in accordance with current Good Manufacturing Practices and has
been Manufactured in compliance with the specifications for such Product
and with current Good Manufacturing Practices and all Laws with respect to
the Manufacture of each Product. Each Product conforms to any further
affirmation of fact as may be made on or in any other documentation
associated with or related to such Products.
3.9.3 Creation and Retention of Records. LEO shall be responsible for
creating and retaining all records relating to Manufacturing, analysis,
testing and release of materials, production and quality control (including
in-process controls) for each Product, all in accordance with current Good
Manufacturing Practices and shall provide copies to GALEN upon its
reasonable request.
3.9.4 Stability Studies. LEO shall conduct relevant stability studies on
each Product to assure validity of such Product for its shelf life.
3.9.5 Raw Materials and Products Provided by LEO. Except as otherwise
specifically agreed between the Parties in writing, LEO shall be
responsible for procuring all raw materials and other components for each
Product. All raw materials and components procured by LEO and used in the
Products shall be tested (by LEO or the supplier thereof) to assure that
they meet applicable specifications and quality standards.
13
3.9.6 Packaging Material. Unless required by Law no changes may be made by
LEO to the packaging material for any Product without the prior written
consent of GALEN. If changes are required by Law LEO shall consult with
GALEN prior to the implementation of such changes.
3.9.7 Storage. LEO shall store the raw materials, excipients, packaging
articles, intermediate products and the Products under such conditions that
the quality of such materials and the Products Manufactured therefrom are
not affected.
3.9.8 Approval of Product Labels, Printed Packaging Materials and Inserts.
Prior to the first production of each Product for GALEN, LEO shall provide
GALEN with information regarding the possible dimensions and parameters of
product labels, printed packaging materials and inserts. Unless required by
Law LEO will make no change to Product labels or Product inserts, submitted
by GALEN in accordance with Article 3.8.1, without the prior written
approval of GALEN. If changes are required by Law LEO shall consult with
GALEN prior to the implementation of such changes.
3.9.9 Reference Samples. LEO shall retain reference samples from each batch
of Finished Products for the period of time required by applicable Law
after the expiry date. Finished Products will be kept in their final
packaging and stored under the recommended conditions. Samples of starting
materials (other than solvents, gases and water) will be retained for the
period of time required by applicable Law after the expiry date of the
corresponding Finished Product. LEO shall retain samples sufficient to
conduct at least two (2) re-examinations. LEO shall make reference samples
available for inspection, testing, analysis and examination by GALEN and
any relevant Governmental or Regulatory Authority, promptly upon request of
GALEN.
3.9.10 Validation.
(a) The equipment and facilities used for manufacturing must be validated
and qualified by LEO. The results must be documented in writing.
(b) In the event that changes in the manufacturing process or in the
Specifications take place pursuant to this Agreement, LEO shall perform
such validations or revalidations as may be required by current Good
Manufacturing Practices or reasonably requested by GALEN in writing.
14
3.9.11 Control Tests.
(a) LEO shall perform all control tests set forth in the Specifications.
LEO shall confirm compliance in the form of a statement on each certificate
of analysis which follows the goods.
(b) At GALEN's reasonable request, LEO shall make samples from each batch
available to GALEN. If control tests which GALEN elects to have carried out
on the samples or the Products reveal any failure thereof to comply with
the Specifications, GALEN shall promptly notify a named qualified person of
LEO of said failure. In the event that the results of such control tests
performed by GALEN shall differ from findings of LEO and no mutual
agreement can be reached in respect thereof, then the Parties shall jointly
designate an independent laboratory for the purpose of having that sample
or Product subjected to a third control test as promptly as practicable.
Should non-compliance of the Product in question be confirmed by such
outside control, LEO undertakes to refund any payment already made to it
with respect to such non-complying Product and to bear the cost of the
third control test by such outside laboratory and replace such
non-complying Product in accordance with Article 3.7. LEO shall bear the
full cost of proper destruction of any non-complying Product. Should
compliance of the Product in question be confirmed by such outside control,
GALEN undertakes to bear the cost of such third control test and to pay for
the Products in question. If the outside control is unable to determine
conclusively whether the Product in question is in compliance or not, the
Parties shall share equally the expenses connected with the outside control
and the expenses connected with the replacement and destruction of the
allegedly non-complying Product.
3.9.12 Batch Release. LEO shall ensure that each Product has been
Manufactured in compliance with the requirements of the Registration and
shall release only batches accompanied by a certificate of compliance
signed by a qualified person of LEO that the Product has been Manufactured
by LEO according to the Specifications and that LEO is committed to inform
GALEN in the event of any change in the manufacturing process or in the
analytical specification, in accordance with the terms of this Agreement,
and of any noted incident occurring during the Manufacture of the Product.
In preparing the certificate of compliance, qualified person of LEO shall
take into account analytical results, essential information such as the
production conditions, the results of in-process controls and the
examination
15
of manufacturing documents. LEO shall create and retain records relating to
each batch of the Product Manufactured hereunder in accordance with
applicable Law.
3.9.13 LEO Resources. LEO has appropriately qualified and trained
personnel, adequate premises and space, suitable equipment and services,
correct materials, containers and labels, suitable storage and the
knowledge and experience to carry out satisfactorily the supply of Finished
Product to GALEN.
3.9.14 Key Personnel. LEO shall provide GALEN with a list of its Key
Personnel for QC release along with specimens of their signatures or other
appropriate identifiers such as electronic identification codes subject to
adequate security measures and shall keep GALEN informed as to changes in
its Key Personnel from time to time.
3.9.15 Quality. LEO shall refrain from any activity that will adversely
affect the quality of any of the Products Manufactured for GALEN.
3.9.16 Quality Audit. LEO shall make that portion of its manufacturing
facilities where the Products are Manufactured, including all records and
reference samples related to the Products, available for inspection by
GALEN and representatives of applicable Governmental or Regulatory
Authorities during business hours. Records made available for inspection
hereunder shall include all records relevant to assessing the quality of a
product in the event of a complaint or a suspected defect. Inspections by
GALEN shall be conducted only by a duly authorized representative of GALEN
or the relevant Governmental or Regulatory Authority and shall be limited
to determining whether there is compliance with current Good Manufacturing
Practices, the Registration and other requirements of this Agreement and of
applicable Law. In addition, the Parties agree that a member of GALEN'S
pharmaceutical quality assurance team may be present at all such
inspections. In the event such representatives conclude that any
non-conformity with such requirements is continuing, the Parties shall use
their respective best efforts to resolve the issue as quickly as possible.
3.9.17 Environmental; Health and Safety Matters.
(a) LEO shall perform all of the services provided herein in compliance
with all environmental Laws and shall be solely responsible for all
environmental Losses at sites controlled by LEO.
16
(b) LEO shall be solely responsible for implementing and maintaining
health and safety procedures for the manufacture, generation,
packaging, handling and storage of the raw materials, hazardous
materials, waste, packaging components and Products as provided
herein. Such procedures shall comply with all relevant environmental
Laws. GALEN shall have no responsibility for developing, implementing
or overseeing health and safety programs at LEO.
3.10 As soon as possible and no later than three (3) months following the
Effective Date, LEO and GALEN will enter into a QA/QC Agreement
substantially in the form of Appendix VI . Until such agreement has been
signed, the terms of Appendix VI shall apply. To the extent of any conflict
or inconsistency between this Agreement and such QA/QC Agreement, the terms
of this Agreement shall control, unless otherwise agreed to in writing
between the Parties.
3.11 Products shall have a minimum shelf life of sixteen (16) months from the
date of shipment.
3.12 Notice of Noted Incidents and Abnormal Results. The Parties shall promptly
inform each other in writing of any incident that would be reportable to
the applicable Governmental or Regulatory Authority.
IV - MARKETING
4.1 GALEN shall bear all of the cost and expense of advertising and promoting
the Products in the Territory. GALEN's advertising and promotional
materials shall be in accordance with the claims approved by the FDA and in
accordance with the LEO Product Branding wherever and whenever legally
possible. GALEN shall not use any advertising or promotional materials,
which are not consistent with the basic statements of LEO regarding the
Products. The respective departments within LEO and GALEN will communicate
to discuss any relevant issues regarding basic statements. GALEN shall
provide LEO with samples of its promotional material.
Regular meetings will be held between GALEN and LEO in order to discuss the
ongoing business. GALEN shall annually prepare a business plan for the
forthcoming calendar year. The business plan shall contain a forecast of
sales based on market information data and allocation of resources. GALEN
shall deliver a draft business plan by 1 August and a final business plan
by 30 October of each
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successive calendar year. The Parties shall discuss each such business plan
at a meeting to be held no later than 15 September of each year, and GALEN
shall in good faith take into account changes to such business plan
recommended by LEO.
GALEN shall provide LEO with quarterly market updates. GALEN and LEO shall
at the above mentioned business plan meeting in September each year agree
upon minimum sales for the ensuing year, taking into account, among other
things, market conditions, regulatory issues and competition. If GALEN and
LEO are unable to agree upon minimum sales or any other matter to be agreed
under this Agreement, the matter shall be referred to the Chief Executive
Officers of each Party for good faith resolution. If the Chief Executive
Officers of each Party are unable to agree upon minimum sales within 45
days the minimum sales will be fixed by an independent third party
acceptable to both Parties, the cost of such third party to be shared
equally by the Parties. In the event of circumstances that change the
assumptions made at the time the minimum sales were agreed, e.g.,
introduction of a generic of the Product or serious limitations in the use
of the Product for psoriasis become apparent, then the Parties shall meet
in good faith and adjust the minimums.
If GALEN is unable to achieve the agreed minimum sales then this License
and Supply Agreement can be made non-exclusive upon 90 days' written notice
to GALEN, provided, however, that GALEN shall be permitted during such 90
day period to pay an amount equal to the shortfall between the minimum
purchase quantities and the actual quantity of Product purchased, and upon
such payment to avoid the conversion of this License and Supply Agreement
to a non-exclusive agreement.
4.2 Reasonable quantities of Product samples required in accordance with
GALEN's marketing plans will be delivered at the sample price. At the time
of signing of this Agreement the sample price is two thirds (2/3) of the
supply price otherwise applicable for the corresponding smallest sales
package of 3 gram tubes. The minimum sample price for a 3 gram tube is 0.55
USD. The minimum sample price shall be adjusted for inflation once each
year effective 1 January, in an amount equal to the increase according to
the latest update in the official "Summarisk lonindeks for den private
sektor i Danmark" (Danish Index of Average Earnings by Industry in the
Private Sector), see xxx.xxx.xx.
18
4.3 Within five (5) working days following the end of any calendar month GALEN
shall send to LEO a sales and stock report in a form that LEO may from time
to time specify, showing in respect of each particular size and type of
Products the number of and the value in USD of units sold during the
previous calendar month, the stock of Products and monthly sales forecasts
for the following twenty-four (24) months.
4.4 GALEN shall keep its accounts updated in such a manner that control of
sales of the Products and other GALEN Information regarding payment can be
made by LEO who shall be entitled to audit GALEN's accounts in accordance
with Article 5.3.
4.5 GALEN is not entitled to perform any pre-clinical or clinical studies,
seeding trials, observational studies or any other pre or post marketing
studies, or any other activities relation hereto, without the prior written
consent of LEO and the prior written approval of the protocols by LEO, such
consent and approval not to be unreasonably withheld. Products to be used
in any such pre-clinical or clinical studies shall be delivered by LEO to
GALEN at a price equivalent to 75% of the purchase price as defined in
Article 3.2.
4.6 GALEN shall keep LEO currently informed of any relevant new developments in
the pharmaceutical market in the Territory, e.g. changes in governmental
policies which may affect the Registrations obtained or applied for, import
and sales of the Products, competitors' activities and attitudes among the
medical profession. Further, the Parties shall keep each other fully
informed about all new information relevant for Products in the Territory.
GALEN shall also keep LEO informed of GALEN's chains of distribution for
Products in the Territory.
V - ACCOUNTING AND ROYALTY PAYMENT
5.1 In consideration of the rights granted in Article II GALEN shall pay to LEO
a royalty calculated on the Net Sales of Products sold by GALEN or its
Affiliates in the Territory in consideration of the Patent, Technical
Information and Trademark licenses granted by LEO to GALEN in Article II.
The royalty rate will be calculated as follows for the first period, i.e.
the period running from the Effective Date of the Agreement until the end
of the calendar year
19
in which the Agreement becomes effective, and the subsequent periods of
twelve (12) months (calendar years):
Royalty Rates Annual US Net Sales Increment
------------- -----------------------------
15% Up to USD 50 million
12.5% Between USD 50 million and USD 100 million
10% Over USD 100 million
5.2 The report rendered by GALEN pursuant to Article 3.3.1 shall also include a
calculation of royalty payments due pursuant to Article 5.1 for the
preceding calendar quarter, such royalties to be paid at the time of
delivery of the report.
5.3 GALEN agrees to keep accurate records in sufficient detail to enable the
royalties payable hereunder and the invoice adjustments as mentioned in
Article 3.3.1 to be determined, and upon the request of LEO, shall permit
an independent, certified public accountant selected by LEO (except one to
whom GALEN has some reasonable objection), at the sole expense of LEO , to
have access during ordinary business hours to GALEN's records (a) to
determine the correctness of any report and/or payments made under this
Agreement or (b) to obtain information as to the royalty payable for any
such period in case of GALEN's failure to report or pay pursuant to this
Agreement. Notwithstanding the prior sentence, in the event such inspection
discloses that any payments made to LEO pursuant to Articles 5.1 or 3.3
hereunder for any accounting period were deficient by more than 5%, GALEN
shall reimburse LEO for the cost of such inspection. This right of review
shall terminate three (3) years after receipt by LEO of GALEN's quarterly
account. Said accountant shall not disclose to LEO any information other
than information relating to the accuracy of the reports and payments made
under this Agreement and in no event are the quantities and prices to
individual customers to be disclosed to LEO.
5.4 Royalties shall be computed upon Net Sales sold by GALEN and shall be
remitted in United States Dollars via bank transfer to an account
designated by LEO in writing.
5.5 If Laws require withholding of taxes imposed upon LEO on account of
royalties accruing under this Agreement, such taxes will be deducted by
GALEN from such remittable royalty and will be paid by GALEN to the proper
taxing authority. Proof of payment shall be secured and sent to LEO as
evidence of such payment.
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5.6 In no case shall the sums received by LEO as royalties for sale of Products
be returned to GALEN unless found to be in error.
VI - PATENT PROTECTION AND VALIDITY
6.1 LEO agrees to prosecute and maintain the Patents within the Territory.
6.2 LEO agrees within reasonable limits to protect from infringement of the
Patents and GALEN shall notify LEO of any such infringement. When a third
party, in GALEN's opinion, infringes the Patents and the infringement is
expected to constitute a substantial unlicensed competition, GALEN shall
provide LEO with any available evidence of the infringement. LEO shall use
all reasonable measures, whether by Action or Proceeding or otherwise to
prevent such infringement. All costs and expenses of such Action or
Proceeding or other activity, unless collected from the third party against
which the same is brought, shall be borne by LEO. GALEN shall, at the
request of LEO, co-operate with LEO in all respects including, but not
limited to, making available to LEO or its legal representative, all
relevant papers, records, information, samples, specimen, and the like.
GALEN shall use its influence to make any of its employees testify when
requested by LEO. Any recovery obtained by LEO as the result of such Action
or Proceeding, by settlement or otherwise, shall after deduction of costs
and expenses involved in such a proceeding be shared equally by the
Parties.
VII - THIRD PARTIES INTELLECTUAL PROPERTY CLAIMS
7.1 If an Action or Proceeding is filed by any third party against GALEN as
defendant alleging that GALEN's operation under the licensed Patents,
Trademark and/or the Technical Information constitutes an infringement of
the intellectual property rights of the said third party, LEO, upon GALEN's
request, shall use its best efforts to make available to GALEN any relevant
records, papers, expert information, samples, formulae and the like, and
shall co-operate in such defence with GALEN as may be reasonably requested
by it.
7.2 In case of such Action or Proceeding or threat thereof, GALEN shall notify
LEO promptly. Should GALEN decide not to take up the defence, LEO may at
its entire discretion take up the defence itself, but is under no
obligation to do so. If and when LEO takes up a defence GALEN shall, upon
the request of LEO, assist LEO to the best of its ability with legal and
technical advice and assistance, evidence and
21
documentation. Fifty percent (50 %) of the royalty payments necessitated by
a settlement may be deducted from GALEN's obligation under Article 5.1,
provided that this deduction does not reduce the royalty payments in
Article 5.1 by more than fifty percent (50 %). However, GALEN shall consult
with LEO in case such settlement may involve other payments.
7.3 This Agreement is deemed to continue in full force, including GALEN's
obligation to pay full royalty during a pending action or proceeding
instituted by third party due to GALEN's working under licensed Patent or
Trademark rights and/or Technical Information granted hereunder. However,
for as long as such action or proceeding is pending GALEN shall escrow the
royalty due in a bank acceptable to LEO. If GALEN is ultimately held liable
to any third party who brings suit, then GALEN can deduct any payments made
to said third party in the form of damages or royalty payments from the
above escrow account and then from its obligation under Article 5.1.
VIII - CONFIDENTIALITY
8.1 All Technical Information disclosed to GALEN and all GALEN Information
disclosed to LEO shall be considered confidential regardless of
designation, and shall not be disclosed by the receiving Party to any third
party or used outside the scope of this Agreement without the prior written
consent of the disclosing Party except to a duly authorised Governmental or
Regulatory Authority in connection with the Registration or regulation of
the Products or if otherwise required by Law. In the event that a receiving
Party is asked to disclose any confidential information to a Governmental
or Regulatory Authority, such receiving Party will - if possible - notify
the disclosing Party sufficiently prior to making such disclosure so as to
allow the non-disclosing Party adequate time to take whatever action it may
deem to be appropriate to protect the confidentiality of the information.
The obligation not to disclose Technical Information and GALEN Information
shall not apply to (a) any information that now or later becomes publicly
available through no fault of the receiver, its officers, employees or
agents; (b) any information that the receiver obtains from a third party
not under a confidentiality obligation to the discloser with respect to
such information; (c) any information that the receiver already has in its
possession as indicated in its written records; and (d) any information
that is independently developed or created by the receiver.
22
8.2 GALEN may have its officers, employees and outside investigators acquainted
with the said Technical Information within the limit of necessity for use
of Products imposing upon them the same secrecy obligations as GALEN owes
hereunder.
8.3 This Article VIII shall survive termination of this Agreement for a period
of ten (10) years, provided, however, that following the termination of
this Agreement LEO shall be free to use all data, information or other
confidential information relating to the Product and following the
termination of this Agreement, GALEN shall be free to use all GALEN
Information.
IX - REGISTRATIONS
9.1 LEO will be the owner and holder of the Registrations for the Products in
the Territory. LEO will, at the request of GALEN, provide GALEN with a
complete copy including any correspondence with the FDA as well as other
relevant documents in the possession or control of LEO. LEO will appoint
GALEN as its U.S. agent for purposes of the NDA and will timely supply
GALEN with all information in its possession or control necessary to
prepare and file reports required by the FDA. GALEN will act as U.S. agent
and will keep Registrations updated, including, but not limited to, to
maintaining the NDA and the IND and forthwith to inform and copy LEO with
the updates.
9.2 Both Parties are entitled to participate in and shall be notified in
advance by the other Party of all important meetings with the FDA provided
such participation does not result in any significant delay.
X - TRADEMARKS
10.1 LEO is responsible for registration, maintenance and defense of the
Trademark of the Products in the Territory. GALEN shall, immediately upon
its knowledge hereof, be obliged to inform LEO of any possible infringement
of the Trademark. GALEN agrees to use the Trademark only in accordance with
standards and guidelines communicated by LEO from time to time during the
term of this Agreement. GALEN agrees that its use of the Trademark shall be
in a commercially acceptable and responsible manner, and that no use by it
of the Trademark shall reflect adversely upon the good name of LEO. All
goodwill deriving from the use by GALEN of the Trademark pursuant to the
terms of this Agreement or otherwise arising out of this Agreement shall
accrue solely and exclusively to LEO.
23
10.2 GALEN shall not at any time register, or cause to be registered, in its
name or in the name of another, or authorize the use of, during or after
the term of this Agreement, the Trademark or any other trademark, name or
design resembling or similar to the Trademark. GALEN shall not use the
Trademark in combination with another, as part of a trade name or service
mark of any corporation or other business organization except with the
prior written consent of LEO.
10.3 GALEN and LEO are not, without the other Party's written consent, in any
way electronically on the Internet or otherwise, entitled to use or
register any of the other Party's intellectual property rights such as, but
not limited to, trademarks, product names, descriptions etc. GALEN is not,
without the written consent of LEO, in any way entitled to sell or promote
any of the Products via the Internet. It being understood that sale of the
Products via the Internet by a customer of GALEN does not constitute a
breach of this provision.
10.4 All packaging and promotional material shall include the LEO logo and the
Assyrian lion. The packaging and promotional material shall adhere to the
LEO Product Branding wherever and whenever legally possible.
XI - AUTHORISATIONS
In accordance with legislation of the European Union, recipients of supplies of
medicinal products must be in possession of a manufacturing or importing
authorisation for medicinal products or an authorisation to engage in activity
as a wholesaler of medicinal products. Accordingly, for the duration of this
Agreement GALEN shall be in possession of relevant and valid authorisation(s)
covering the Territory. A copy of the present authorisation(s) is attached as
Appendix VII. GALEN shall forward copies of renewals of relevant authorisations
to LEO whenever such authorisations expire and are renewed.
XII - QUALITY ASSURANCES
12.1 LEO warrants that Products sold to GALEN is of pharmaceutical grade and
quality suitable for human use and that it meets the specifications
approved by the applicable Governmental or Regulatory Authorities as such
specifications may be revised from time to time as provided herein and that
such Products conform to any further affirmations of fact as may be made on
or in any other documentation associated or related to such Products.
24
12.2 In the event GALEN determines that any Products already in interstate
commerce in the Territory presents a risk or injury or gross deception or
is otherwise defective and that recall of such Products is appropriate,
GALEN shall conduct such recall in accordance with FDA guidelines and with
the provisions as set out in Article 13.2. LEO shall fully co-operate with
GALEN in the investigation of the cause of the recall. If the Parties agree
that the cause of the recall was the fault of LEO, LEO shall reimburse the
GALEN cost and expense associated with such recall provided, however, that
liability of LEO under this provision shall not extend to any consequential
damages associated with such recall.
XIII - SAFETY REPORTING, COMPLAINTS AND PRODUCT RECALL
13.1 As soon as possible and no later than three (3) months following the
Effective Date, LEO and GALEN will enter into a Pharmacovigilance Agreement
substantially in the form of Appendix VIII. Until such agreement has been
signed by both Parties, the terms of Appendix VIII shall apply. To the
extent of any conflict or inconsistency between this Agreement and such
Pharmacovigilance Agreement, the terms of this Agreement shall control,
unless otherwise agreed to in writing between the Parties.
13.2 GALEN must put in place a system for handling of customer complaints and
product recall, which is in compliance with the guidelines furnished by
LEO. LEO Guidelines "Group Policy - GP 07 Investigation of Customer
Complaints" and "Group Policy - GP-08 Recall of LEO Products", Appendix IX.
XIV - RESPONSIBILITIES OF PARTIES
14.1 Compliance with Laws. Both LEO and GALEN shall observe all applicable Laws
in effect in fulfilling their obligations under this Agreement.
14.2 Indemnification.
14.2.1 Indemnification by LEO. In addition to the remedies set forth in
Article 3.7, LEO shall indemnify and hold GALEN and its agents, directors,
officers and employees and representatives harmless from and against any
and all Losses which they may at any time incur by reason of any Action or
Proceeding brought by any Governmental or Regulatory Authority or other
third party against GALEN arising out of or resulting from (a) any
misrepresentation, breach of warranty or
25
non-fulfilment of or failure to perform any agreement or covenant made by
LEO in this Agreement, (b) the use by GALEN of any Product delivered by LEO
which does not comply with the Specifications therefor, or (c) any other
negligent act or omission of LEO.
14.2.2 Indemnification by GALEN. GALEN shall indemnify and hold LEO and its
agents, directors, officers and employees and representatives harmless from
and against any and all Losses which they may at any time incur by reason
of any Action or Proceeding brought by any Governmental or Regulatory
Authority or other third party against LEO arising out of or resulting from
(a) any misrepresentation, breach of warranty or non-fulfilment of or
failure to perform any agreement or covenant made by GALEN in this
Agreement, (b) product liability claims other than those against which LEO
has indemnified GALEN pursuant to Article 14.2.1, including, but not
limited to, liability claims arising from improper storage of Products by
GALEN or damage in transit to Products, or (c) any other negligent act or
omission of GALEN.
14.2.3 Survival. The obligation of the Parties in this Article XIV shall
survive the expiration or earlier termination of this Agreement to the
extent permitted by applicable Law.
14.3 In any case under the preceding Article 14.2, where GALEN or LEO is to
indemnify the other, the control of the defence of any Action or Proceeding
and negotiations for settlement and compromise thereof, shall repose with
the indemnifying Party, except that nothing in this paragraph shall be
construed to relieve either Party hereto of the obligation to give the
other all reasonable co-operation, assistance and authority necessary to
permit full and complete defense of any Action or Proceeding; provided,
however, that no Party will settle any of such claims without consent of
the other Party; however, such consent shall not be unreasonably withheld.
Both Parties shall, if desired, be allowed to participate, at their own
expense, directly or through a representative e.g. their product liability
insurers, in any Action or Proceeding.
XV - TERM AND TERMINATION; CONSEQUENCES OF TERMINATION
15.1 This Agreement shall become effective on the Effective Date and shall
continue in full force and effect as provided herein, unless modified or
terminated in accordance with any of the provisions hereof, until the later
of (A) the expiration of the term of the Dovonex(R) Agreement and (B) 27
January 2020.
26
15.2 In the following events, LEO shall have the right to terminate this
Agreement with immediate effect by written notice:
15.2.1 If GALEN does not exercise the Option on or before August 1, 2005
(with effect as of 1 January 2006 at the latest), provided, however, that
if GALEN decides not to exercise the Option with effect as of 1 January
2006 at the latest because (i) the aggregate turnover of the Dovonex(R)
Product in the U.S. during the period 1 July 2004 - 30 June 2005, as
measured by IMSHealth, is equal to or less than U.S.$50,000,000 (fifty
million dollars) or (ii) on or prior to August 1, 2005 a generic product
that is AB rated to any Dovonex(R) Product is approved by the FDA and has
become commercially available, provided, for purposes of subclause (ii)
above, that GALEN has not provided assistance to the holder of the
registration for the AB rated product to obtain such registration, then LEO
shall not have such right to terminate the Agreement.
15.2.2 If the Combination Product obtains a Registration prior to 1 August
2005 and GALEN has exercised the Option but there has not yet been a
Closing when this Agreement becomes effective, and Closing does not occur
on or prior to 14 January 2006 and there is no reasonable possibility that
a Closing will occur thereafter.
15.2.3 If the Dovonex(R) Agreement is terminated due to GALEN's default or
breach of said agreement.
15.3 In the event that GALEN and LEO agree, at any time after the seventh
anniversary of the Effective Date, that further commercialisation of
Products no longer are sound due to therapeutic or economic reasons, then
either Party can with six (6) months' prior notice terminate this
Agreement.
15.4 In the event that one of the Parties hereto materially defaults or breaches
any of the provisions of this Agreement, the other Party shall have the
right to terminate this Agreement upon sixty (60) days' written notice,
provided, however, that if the Party in default within the sixty day period
referred to, remedies the said default or breach, the Agreement shall
continue in full force and effect.
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15.5 In the event that the FDA does not approve a Registration for the Product
and there is no reasonable possibility to obtain approval, GALEN shall -
within 90 days - have the right to terminate this Agreement upon ninety
(90) days' written notice.
15.6 In the event that the patent application filed by LEO with the United
States Patent and Trademark Office for the Combination Product is rejected
by the Patent Examiner and the route of appeal of such rejection has been
exhausted or is not diligently pursued by LEO or LEO has not obtained a
U.S. patent within five (5) years from the date of filing of such
application with the United States Patent and Trademark Office, then GALEN
may terminate this Agreement within ninety (90) days of such rejection of
appeal, or on ninety (90) days' notice to LEO that LEO is not diligently
pursuing such appeal, without any further obligation to LEO.
15.7 In the event that one of the Parties hereto enters into liquidation whether
compulsorily or voluntarily (otherwise than for the purposes of
amalgamation or reconstruction), compounds with its creditors, has a
receiver or manager appointed in respect of all or any part of its assets,
or is the subject of an application for an administration order or
undergoes any analogous or similar act or proceeding under the laws of any
other jurisdiction in consequence of debt the other Party shall have the
right to terminate this Agreement with immediate effect by written notice.
15.8 If GALEN - for any three (3) consecutive calendar years - is unable to
achieve the agreed minimum sales, LEO shall have the right to terminate
this Agreement upon sixty (60) days' written notice.
15.9 In the event of termination of this Agreement under the provisions of this
Article XV GALEN shall not be relieved of the duty and obligation to pay in
full all payments, including but not limited to royalties, accrued and
unpaid at the effective date of such termination. In such event:
15.9.1 GALEN shall return any and all Technical Information and any other
information relating to the Product provided to GALEN and make no further
use thereof;
15.9.2 GALEN shall cease to make use of the Trademark, the other LEO
Product Branding and all other information related to the Product, and all
rights in the Trademark, the other LEO Product Branding and all other
information relating to the Product will promptly revert to LEO and be
transferred to LEO;
28
15.9.3 if GALEN is then the owner of any patents specifically related to
Product, GALEN shall transfer such ownership to LEO, except for LEO being
in breach in which case GALEN will sell said patents and LEO will purchase
said patents at a price equal to the expenses GALEN has borne in relation
to developing, establishing and maintaining said patent rights;
15.9.4 if GALEN is then the owner of any patents, which in part relates to
Product then LEO, its Affiliates and partners shall have a royalty free
license to such patents for the term of the patents;
15.9.5 if GALEN is then the owner of any data related to the Product,
including but not limited to, any data related to any study performed under
this Agreement such data shall be transferred to LEO. At such time, LEO
shall have the right, but not the obligation, to have assigned to LEO any
then pending third party clinical agreement;
15.9.6 GALEN shall transfer all Registrations held by GALEN - if any - to
LEO or its designee.
In the event that LEO terminates this agreement pursuant to:
(a) Articles 15.4, 15.7 or 15.8,;or
(b) Article 15.2.1 in the event that GALEN has not exercised the Option for
reasons not including that (i) the aggregate turnover of the Dovonex(R)
Products in the U.S. during the period 1 July 2004 - 30 June 2005, as
measured by IMSHealth, is equal to or less than US$50,000,000 (fifty
million dollars) or (ii) on or prior to August 1, 2005 a generic product
that is AB rated to any Product is approved by the FDA and has become
commercially available, provided, for purposes of this subclause (ii), that
Galen has not provided assistance to the holder of the registration for the
AB rated product to obtain such registration; or
(c) Article 15.2.2 in the event that the Combination Product obtains a
Registration prior to 1 August 2005 and GALEN has exercised the Option but
there has not yet been a Closing when this Agreement becomes effective, and
Closing does not occur on 1 January 2006 at the latest;
29
then the transfers required under Articles 15.9.1, 15.9.2, 15.9.3, 15.9.5
and 15.9.6 shall be made free of charge to LEO. Otherwise, the costs of
transfers shall be split evenly between the parties.
15.10 It is understood that GALEN - also after termination of the Agreement
- shall be solely liable for any and all chargebacks and returns of
Products sold by GALEN under the Agreement. GALEN shall destroy all returns
of Products it receives also after the termination of the Agreement.
Following such destruction, GALEN shall certify the destruction to LEO upon
the written request of LEO.
XVI - ASSIGNABILITY
16.1 This Agreement and the licenses and rights herein granted shall be binding
upon, and shall inure to the benefit of successors of the Parties hereto,
or to any assignee of all of the good will and entire business assets of a
Party hereto relating to pharmaceuticals, but shall not otherwise be
assignable without the prior written consent of the other Party.
16.2 Furthermore, in the event GALEN merges with or is acquired by a company and
the new entity no longer gives priority to dermatology or in the event
GALEN merges with or is acquired by a company having a product which is a
topical vitamin D3 or any analog thereof or a fixed combination of vitamin
D3 or any analog thereof with a corticosteriod with indications that
directly compete with the indications approved for the Product and such
product has sales, at the time of such transaction, equal to at least 10%
of the Net Sales of Products, and such products are not divested or
out-licensed, then the rights granted herein are not assignable without the
prior written consent of LEO, which consent shall not be unreasonably
withheld. If LEO does not consent, then LEO is obliged to acquire the
rights granted GALEN including all necessary approvals for marketing of the
Product by paying to GALEN one (1) times GALEN's Gross Margin for the
Products for the twelve (12) months preceding the event, or if there is
less than twelve (12) months of sales by GALEN, the Gross Margin of such
pro rata period multiplied to equal a period of twelve (12) months.
16.3 For the avoidance of doubt, LEO agrees and acknowledges that GALEN may
perform any or all of its obligations under this Agreement through its U.S.
Affiliate, Warner Chilcott, Inc., provided however, that GALEN shall remain
jointly
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and severally liable for the performance of any obligations that are
delegated to Warner Chilcott, Inc.
XVII - AMENDMENT OF AGREEMENT; WAIVER; SEVERABILITY
17.1 The Agreement shall not be changed or modified orally.
17.2 Any term or condition of this Agreement may be waived at any time by the
Party that is entitled to the benefit thereof, but no such waiver shall be
effective unless set forth in a written instrument duly executed by or on behalf
of the Party waiving such term or condition. No waiver by either Party of any
term or condition of this Agreement, in any one or more instances, shall be
deemed to be or construed as a waiver of the same or any other term or condition
of this Agreement on any future occasion. All remedies, either under this
Agreement or by Law or otherwise afforded, will be cumulative and not
alternative.
17.3 If any provision of this Agreement is held to be illegal, invalid or
unenforceable under any applicable present or future Law, and if the rights or
obligations of any Party hereto under this Agreement will not be materially and
adversely affected thereby, (a) such provision will be fully severable, (b) this
Agreement will be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement will remain in full force and effect and will not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom and (d) in lieu of such illegal, invalid or unenforceable
provision, the Parties will add as a part of this Agreement, a legal, valid and
enforceable provision as similar in terms to such illegal, invalid or
unenforceable provision as may be possible.
XVIII - STATUS OF PRIOR AGREEMENT
This Agreement, together with the Master Agreement, the Development Agreement
dated as of even date herewith between LEO and GALEN and the License and Supply
Agreement dated as of even date herewith between LEO and GALEN relating to the
license and supply of the Combination Product, constitutes the entire Agreement
between the Parties with respect to the within subject matter and supersedes all
previous agreements, whether written or oral.
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XIX - FORCE MAJEURE
The occurrence of an event which materially interferes with the ability of a
Party to perform its obligations or duties hereunder which is not within the
reasonable control of the Party affected, not due to malfeasance, and which
could not with the exercise of due diligence have been avoided ("Force
Majeure"), including, but not limited to, fire, accident, labor difficulty,
strike, riot, civil commotion, act of God, delay or errors by shipping companies
or change in Law shall not excuse such Party from the performance of its
obligations or duties under this Agreement, but shall merely suspend such
performance during the continuation of Force Majeure. The Party prevented from
performing its obligations or duties because of Force Majeure shall promptly
notify the other Party hereto (the "Other Party") of the occurrence and
particulars of such Force Majeure and shall provide the Other Party, from time
to time, with its best estimate of the duration of such Force Majeure and with
notice of the termination thereof. The Party so affected shall use its best
efforts to avoid or remove such causes of nonperformance. Upon termination of
Force Majeure, the performance of any suspended obligation or duty shall
promptly recommence. Neither Party shall be liable to the Other Party for any
direct, indirect, consequential, incidental, special, punitive or exemplary
damages arising out of or relating to the suspension or termination of any of
its obligations or duties under this Agreement by reason of the occurrence of
Force Majeure. In the event that Force Majeure has occurred and is continuing
for a period of at least six (6) months, the Other Party shall have the right to
terminate this Agreement upon thirty (30) days' notice.
XX - NON-COMPETITION CLAUSE
During the term of this Agreement GALEN is not allowed to purchase, distribute,
market and/or sell any product which is a topical vitamin D3 or any analog
thereof or a fixed combination of vitamin D3 or any analog thereof with a
corticosteriod with indications that directly compete with the indications
approved for the Product except for the Dovonex(R) Product.
XXI - PARTNERSHIP/AGENCY; THIRD PARTIES
None of the provisions of this Agreement shall be deemed to constitute the
relationship of partnership or agency between the Parties and neither Party
shall have any authority to bind the other Party in any way except as provided
in this Agreement.
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The Parties agree that no third party which is not a Party to this Agreement is
intended to benefit from or shall have any right to enforce any provision of
this Agreement.
XXII - GOVERNING LAW
THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE
INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE
PERFORMED ENTIRELY WITHIN SUCH STATE, WITHOUT REGARD TO THE CONFLICTS OF LAW
PRINCIPLES OF SUCH STATE OTHER THAN SECTIONS 5-1401 OF THE NEW YORK GENERAL
OBLIGATIONS LAW.
Each Party irrevocably submits to the exclusive jurisdiction of (a) the Supreme
Court of the State of New York, New York County, and (b) the United States
District Court for the Southern District of New York, for the purposes of any
suit, action or other proceeding arising out of this Agreement or any
transaction contemplated hereby or thereby. Each Party agrees to commence any
such action, suit or proceeding either in the United States District Court for
the Southern District of New York or if such suit, action or other proceeding
may not be brought in such court for jurisdictional reasons, in the Supreme
Court of the State of New York, New York County. Each Party further agrees that
service of any process, summons, notice or document by registered mail to such
Party's respective address set forth above shall be effective service of process
for any action, suit or proceeding in New York with respect to any matters to
which it has submitted to jurisdiction in this Article XXII. Each Party
irrevocably and unconditionally waives any objection to the laying of venue of
any action, suit or proceeding arising out of this Agreement or the transactions
contemplated hereby and thereby in (i) the Supreme Court of the State of New
York, New York County or (ii) the United States District Court for the Southern
District of New York, and hereby and thereby further irrevocably and
unconditionally waives and agrees not to plead or claim in any such court that
any such action, suit or proceeding brought in any such court has been brought
in an inconvenient forum.
Each Party hereto hereby waives to the fullest extent permitted by applicable
Law, any right it may have to a trial by jury in respect to any litigation
directly or indirectly arising out of, under or in connection with this
Agreement.
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XXIII - NOTICES
Any notice hereunder shall be deemed to be sufficiently given if sent by
registered mail or by fax followed by mail to:
In the case of GALEN: Galen (Chemicals) Limited
4 Adelaide Street
Dun Laoghaire, Co. Dublin
Ireland
Fax: +353 1 214 8477
With a copy to: Galen Holdings PLC
Att. Chief Executive Officer
100 Enterprise Drive, Suite 280
Rockaway, New Jersey 07866
USA
Fax: + 1 973 442 3362
In the case of LEO: LEO Pharma A/S
Att. The President
Industriparken 55
DK-2750 Ballerup
Denmark
Fax: + 45 44 64 15 80
or to such other address as the sender shall have last furnished to the
receiver.
[end of text - signature page to follow]
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IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be duly
executed in duplicate by their authorised officers as of the date last below
written.
GALEN(CHEMICALS) LIMITED LEO Pharma A/S
By: ____________________________ By: _________________________
Roger M. Boissonneault
Title: Director Title: ______________________
Date: April ____, 2003 Date: _______________________
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