Exhibit 4.36
DEVELOPMENT AGREEMENT
between
XXX PHARMA A/S of Xxxxxxxxxxxxxx 00, XX-0000 Xxxxxxxx, Xxxxxxx (hereinafter
referred to as "XXX") ---
and
XXXXX (CHEMICALS) LIMITED of 0 Xxxxxxxx Xxxxxx, Xxx Xxxxxxxxx, Xx. Xxxxxx,
Xxxxxxx (hereinafter referred to as "XXXXX").
Capitalized terms not otherwise defined herein shall have the meanings set forth
in Article I of this Agreement.
WHEREAS Xxxxxxx-Xxxxx Squibb Company (BMS) has entered into a co-promotion
agreement with XXXXX regarding Dovonex(R) Product in the Territory (the
"Co-promotion Agreement").
WHEREAS XXXXX and BMS have entered into an option agreement (the "Option
Agreement") in which XXXXX has options 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 and 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"); and
WHEREAS BMS has given up its rights under the BMS Agreements to a pharmaceutical
preparation containing both the Compound and Betamethasone Dipropionate in an
ointment (the "Combination Product") as of the date hereof; and
WHEREAS XXX has developed and owns proprietary information regarding the
Combination Product, and has filed a patent application for the Combination
Product; and
WHEREAS XXXXX has marketing expertise within the dermatological field; and
WHEREAS XXX and XXXXX have entered into a License and Supply Agreement dated as
of even date herewith between XXX and XXXXX regarding the Combination Product
(the "Dovobet(R) Agreement") and subject to the coming into force of that
Agreement under its terms, XXX has appointed XXXXX as its exclusive distributor
in the Territory of the Combination Product expected to be marketed under the
trademark Dovobet(R); and
WHEREAS XXXXX and XXX have entered into a License and Supply Agreement dated as
of even date herewith pursuant to which XXXXX will be the exclusive distributor
of Dovonex(R) Product in the Territory subsequent to the exercise of the Option
by XXXXX and the acquisition of BMS's rights and assumption of BMS's obligations
under the BMS Agreements by XXXXX (the "Dovonex(R) Agreement"); and
WHEREAS XXXXX, if the FDA mandates an additional pivotal phase III clinical
trial for the Combination Product, will financially support XXX;
NOW THEREFORE the Parties hereby agree as follows:
I - DEFINITIONS
1.1 "AB rated" means, with respect to any Product (as defined in the
Dovonex(R) Agreement), 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 Development Agreement between XXX and XXXXX.
1.5 "Compound" means the compound Calcipotriene, a vitamin D analogue with
the formula C27H4003.
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1.6 "Dovonex(R) Product" means the Compound marketed in the Territory under
the trademark Dovonex(R).
1.7 "FDA" means the United States Food and Drug Administration.
1.8 "XXXXX Information" means 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 Combination Product.
1.9 "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.
1.10 "IND" means the Investigational New Drug Application, as defined by 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 Combination Product.
1.11 "Laws" means all laws, statutes, rules, regulations, ordinances and
other pronouncements having the effect of law of any relevant
Governmental or Regulatory Authority.
1.12 "XXX Logo Guidelines" means the guidelines for use of the XXX name and
the Assyrian Lion logo attached to the Dovobet(R) Agreement.
1.13 "XXX Product Branding" means 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 Combination Product in the Territory.
1.14 "XXX Product Concept" means the global design concept for packaging and
promotional materials related to the Combination Product developed by
XXX.
1.15 "Losses" means 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).
1.16 "Master Agreement" means the Master Agreement dated as of even date
herewith between XXX and XXXXX.
1.17 "NDA" means a New Drug Application filed with the FDA for the
Combination 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
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information concerning the Combination Product which are necessary for
FDA approval to market a product in the United States.
1.18 "Party" means XXXXX or XXX, as the case may be, and "Parties" means
XXXXX and XXX.
1.19 "Person" means any individual, firm, corporation, partnership, limited
liability company, trust, joint venture, Governmental or Regulatory
Authority or other entity or organization.
1.20 "Technical Information" means all information in the possession of XXX
and/or its Affiliates, and any 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 the Combination Product
including, but not limited to marketing know-how and show-how or uses
for the Combination Product in the possession of XXX regarding the
Combination Product necessary for XXXXX to fulfil its obligations under
the Agreement.
1.21 "Territory" means the fifty (50) states of the United States of
America, the District of Columbia, its territories and current
possessions.
1.22 "Trademark" means the trademark Dovobet(R) or any other trademark XXX
may select for the Combination Product.
II - WORK BY XXX
2.1 XXX has performed any and all preclinical, clinical and other studies
necessary to obtain marketing approval for the Combination Product in
Europe and has borne all costs and expenses associated therewith.
Furthermore, XXX will perform any and all additional studies, required
specifically by the FDA and will bear all costs and expenses associated
therewith except for the obligation of XXXXX described in Article 3.1.
A development plan is attached as Appendix I
2.2 XXX is responsible for obtaining approval of the NDA in the United
States.
III - OBLIGATIONS OF XXXXX
3.1 If the FDA mandates that a second pivotal phase III clinical trial for
the Combination Product is required for registration in the United
States, XXXXX agrees to pay 50% of the reasonable costs for
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said study, such costs to be invoiced by XXX on a quarterly basis. The
payments are non-refundable.
3.2 XXXXX will provide reasonable assistance to XXX in its endeavours to
obtain approval of the NDA in the United States.
3.3 Within thirty (30) days after the date hereof, XXXXX will pay to XXX
US$5,000,000 (five million United States dollars) to reimburse XXX for
a portion of the actual development costs that have been incurred by
XXX. This payment is non-refundable.
IV - INDEMNIFICATION
4.1 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 of the Combination Product in any clinical trial, or (c) any
other negligent act or omission of XXX.
4.2 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,
or (b) any other negligent act or omission of XXXXX.
4.3 The obligation of the Parties in this Article IV shall survive the
expiration or earlier termination of this Agreement to the extent
permitted by applicable Law.
4.4 In any case under this Article IV, 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 defence 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.
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V - CONFIDENTIALITY
5.1 All Technical Information disclosed to XXXXX and all XXXXX Information
disclosed to XXX shall be considered confidential regardless of
designation, and shall not be 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 Combination Product or if otherwise
required by Law. In the event that a Party is asked to disclose any
confidential information to a Governmental or Regulatory Authority,
such Party will - 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.
The obligation not to disclose Technical Information and XXXXX
Information shall not apply to (a) any information that it 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.
5.2 Each Party shall keep the terms of this Agreement 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.
5.3 Neither Party shall make any press release or other public announcement
or other disclosure to third Parties relating to this Agreement 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.
5.4 This Article V shall survive the 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
Combination Product and following termination of this Agreement, XXXXX
shall be free to use all XXXXX Information.
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VI - COMPLIANCE WITH LAWS
Both XXX and XXXXX shall observe all applicable Laws in effect in fulfilling
their obligations under this Agreement.
VII - TERM AND TERMINATION - CONSEQUENCES OF TERMINATION
7.1 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.
7.2 This Agreement shall terminate if (a) the Dovonex(R) Agreement is
terminated by XXX pursuant to Articles 15.4, 15.7 or 15.8 thereof or
(b) the Dovonex(R) Agreement is terminated by XXX pursuant to Article
15.2 thereof 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 (as defined in the Dovonex(R) Agreement) 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, or (c) the Dovobet(R) Agreement comes into
force and XXXXX has fulfilled its obligations under this Agreement,
unless prior terminated in accordance with any of the provisions
hereof.
7.3 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.
7.4 In the event of termination of this Agreement under the provisions of
this Article VII XXXXX shall not be relieved of the duty and
obligations to pay in full, any payments due and unpaid at the
effective date of such termination. In such event XXXXX shall:
(a) return any and all Technical Information and any other
information relating to the Combination Product provided to
XXXXX and shall make no further use thereof;
(b) cease to make use of the Trademark, the other XXX Product
Branding and all other information related to the Combination
Product, and all rights in the Trademark, the other
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XXX Product Branding and all other information relating to the
Combination Product will promptly revert to XXX and be
transferred to XXX;
(c) if XXXXX is then the owner of any patents specifically related
to the Combination 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;
(d) if XXXXX is then the owner of any patents, which in part
relates to the Combination Product then XXX, its Affiliates
and partners shall have a royalty free license to such patents
for the term of the patents;
(e) if XXXXX is then the owner of any data related to the
Combination 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
third party clinical agreement then pending;
(f) XXXXX shall transfer the NDA, the IND and any other relevant
registrations related to the Combination Product held by
XXXXX, if any, to XXX or its designee.
In the event that XXX terminates this Agreement pursuant to Article 7.3
or Article 7.2(a) or (b), the transfers required under Article 7.4 (a),
(b), (c), (e) and (f) shall be made free of charge to XXX. Otherwise,
the costs of transfers shall be split evenly between the parties.
VIII - 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.
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. Affiliates,
Xxxxxx Xxxxxxxx, Inc..
IX - AMENDMENT OF AGREEMENT; WAIVER; SEVERABILITY
9.1 This Agreement shall not be changed or modified orally.
9.2 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
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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.
9.3 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.
X - STATUS OF PRIOR AGREEMENTS
This Agreement together with the Master Agreement, the Dovonex(R) Agreement and
the Dovobet(R) Agreement constitute the entire agreement between the Parties
hereto with respect to the subject matter and supersede all previous agreements,
whether written or oral.
XI - 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, labour 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
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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.
XII - PARTNERSHIP/AGENCY; THIRD PARTIES
12.1 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.
12.2 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.
XIII - 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 XIII. 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.
XIV - 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: