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EXHIBIT 10.2
Agreement between the Registrant and Xxxxx Group, Inc. (now know as
Xxxxx-Xxxxxxx Xxxxx, Inc.) dated April 27, 1989 (with certain provisions
omitted pursuant to Rule 24b-2), as amended on June 22, 1990 (with certain
provisions omitted pursuant to Rule 24b-2).
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A G R E E M E N T
Between
XXXXX GROUP INC.
And
NOVEN PHARMACEUTICALS, INC.
* CERTAIN PORTIONS HEREOF HAVE BEEN OMITTED PURSUANT TO RULE 24b-2 AND FILED
SEPARATELY WITH THE COMMISSION.
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TABLE OF CONTENTS
Article Section Page
RECITALS............................................. 1
I DEFINITIONS.......................................... 2
1.1 Affiliates..................................... 2
1.2 Control........................................ 2
1.3 Costs.......................................... 3
1.4 Clinical and Product Development Program....... 3
1.5 Estrogen Transdermal Drug Delivery System...... 3
1.6 Noven's Technology............................. 4
1.7 Noven's Patent Rights.......................... 4
1.8 Licensed Product............................... 5
1.9 Net Sales...................................... 5
1.10 Standard Packaging............................. 5
1.11 Sublicensee.................................... 6
1.12 The Territory.................................. 6
II OBLIGATIONS OF NOVEN................................. 6
2.1 Level of Effort................................ 6
2.2 Assignment of Invention Rights................. 6
2.3 Progress Reports............................... 7
2.4 Improvements................................... 7
2.5 Program Updates................................ 8
2.6 Term of Clinical and Product Development
Program........................................ 8
2.7 Supply and Use of Information.................. 8
III OBLIGATIONS OF XXXXX................................. 9
3.1 Clinical Testing............................... 9
3.2 Skin Testing................................... 10
3.3 Governmental Approvals......................... 10
3.4 Supply of Information.......................... 10
3.5 Best Efforts................................... 11
3.6 Time for Reimbursement......................... 11
3.7 Estimate of Costs.............................. 11
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TABLE OF CONTENTS (Cont'd.)
Article Section Page
IV GRANT................................................ 12
4.1 License........................................ 12
4.2 Sublicense..................................... 13
V PAYMENTS............................................. 13
5.1 Initial Payments............................... 13
5.2 Fee............................................ 14
5.3 Minimum Fee.................................... 17
5.4 Payments....................................... 18
5.5 Currency....................................... 18
5.6 Records........................................ 18
5.7 One Royalty.................................... 19
5.8 Compulsory License............................. 19
VI SUPPLY............................................... 19
6.1 Agreement to Supply............................ 19
VII PATENTS.............................................. 20
7.1 Noven Inventions............................... 20
7.2 Joint Inventions............................... 20
VIII CONFIDENTIALITY OBLIGATIONS.......................... 21
8.1 Confidentiality................................ 21
IX TERM AND TERMINATION................................. 22
9.1 Term........................................... 22
9.2 Termination.................................... 22
X NOVEN WARRANTIES..................................... 24
10.1 Ownership...................................... 24
10.2 Right to Enter Agreement....................... 24
10.3 Product Warranty............................... 24
10.4 Foreign Product Warranty....................... 24
10.5 Patent Infringement Warranty................... 25
10.6 Limitation On Damages.......................... 25
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TABLE OF CONTENTS (Cont'd)
Article Section Page
XI ARBITRATION.......................................... 25
11.1 Arbitration.................................... 25
11.2 Notification of Breach......................... 25
XII MISCELLANEOUS........................................ 26
12.1 Relationship of Parties........................ 26
12.2 Inspection of Facilities....................... 26
12.3 Entire Agreement............................... 26
12.4 Force Majeure.................................. 27
12.5 Severability................................... 27
12.6 Assignment..................................... 28
12.7 Governing Law.................................. 28
12.8 Notices........................................ 28
12.9 Counterparts................................... 29
EXHIBIT A - CLINICAL AND PRODUCT DEVELOPMENT PROGRAM PROTOCOL
EXHIBIT B - NOVEN'S PATENT RIGHTS
EXHIBIT C - TRANSDERMAL ESTROGEN SKIN PATCH PRODUCT
SPECIFICATIONS
EXHIBIT D - SUPPLY AGREEMENT
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LICENSE AGREEMENT
AGREEMENT ("License Agreement") made as of the 27th day of April, 1989,
by and between XXXXX GROUP Inc., a Pennsylvania corporation having a place of
business at 000 Xxxxxxxx Xxxxx, Xxxx Xxxxxxxxxx, Xxxxxxxxxxxx 00000 (herinafter
"Xxxxx"), and NOVEN PHARMACEUTICALS, INC., a Delaware corporation having a
place of business at 00000 X.X. 000xx Xxxxxx, Xxxxx, Xxxxxxx 00000 (hereinafter
"Noven").
WITNESSETH
WHEREAS, Noven represents and warrants that it has developed certain
information relating to and is the owner of the entire right, title and
interest in and to certain patent applications having claims covering a
Transdermal Estrogen Drug Delivery System (hereinafter defined as "Licensed
Product"); and
WHEREAS, Noven has available as employees and independent contractors a
group of scientists with the expertise and desire to implement the program
described in Exhibit A (hereinafter defined as the "Clinical and Product
Development Program"), said Exhibit A being a part of this License Agreement;
and
WHEREAS, Xxxxx is willing to fund said Clinical and Product Development
Program with the understanding that the benefits of all such programs shall be
available to Xxxxx and its Affiliates (as hereinafter defined) for further
evaluation,
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and for commercial exploitation solely pursuant to its sale of a Transdermal
Estrogen Drug Delivery System throughout the Territory (as hereinafter
defined).
NOW THEREFORE, it is mutually agreed between the parties hereto as
follows:
ARTICLE I - DEFINITIONS
1.1 Affiliates. The term "Affiliate" or "Affiliates" means any entity
that is Controlled directly or indirectly by the party referred to, or any
entity that directly or indirectly Controls the party referred to, or any
entity that is directly or indirectly Controlled by an entity which also
directly or indirectly controls the party referred to, so that the term shall
include any parent of the entity referred to or a directly or indirectly held
subsidiary of the parent or of the entity referred to, and entities in common
control with the entity referred to.
1.2 Control. The term "Control," "Controls" or "Controlled" means the
ownership, directly or indirectly, of at least fifty percent (50%) of the
voting rights attached to issued voting shares or the power to control
decisions made by any person or entity other than entities having shares. In
addition if any company or its Affiliate, which is one of the fifty largest in
terms of pharmaceutical sales, in the United States acquires sufficient shares
of Noven to exert de facto control, then such shall be considered control
hereunder.
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l.3 Costs. The term "Costs" shall mean the fully allocated costs of
the party referred to including but not limited to the fully allocated cost of
goods and services and the manufacturing overhead related thereto and, only in
the case of the Clinical and Product Development Program, an allocation of all
administrative and general expenses of the entity referred to, in the same
proportion that the man hours devoted to the provision of the goods and
services bears to the total of man hours consumed by the entity referred to.
Cost shall be determined by generally accepted accounting principles, applied
on a consistent basis, as determined by the independent certified public
accountant retained by the entity whose costs are being accounted for.
1.4 Clinical and Product Development Proqram. The term "Clinical and
Product Development Program" shall mean research conducted as a part of Noven's
pre-clinical and clinical activities, the Cost of which is to be wholly paid
for by Xxxxx, and which is required or reasonably necessary to obtain
governmental health approvals for Licensed Product during the term of this
License Agreement including the program substantially as set forth in Exhibit
A.
l.5 Estrogen Transdermal Drug Delivery System. The term "Estrogen
Transdermal Drug Delivery System" means an estrogen in a
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adapted for transdermal delivery by application to the epidermis.
1.6 Noven's Technology. The term "Noven Technology" shall mean any and all
data, information, technology, know-how, process, technique, method, skill,
proprietary information, trade secret, development, discovery, and inventions,
owned or controlled by Noven and specifically related to an Estrogen
Transdermal Drug Delivery System now existing or developed in the future under
and during the course of the Clinical and Product Development Program. Noven
Technology shall not include information related to the manufacture of Licensed
Product and specifications and procedures related thereo, except to the extent
required for health registration of Licensed Product and except to the extent
of any license to manufacture granted under this License Agreement.
1.7 Noven's Patent Riqhts. The term "Noven Patent Rights" shall mean any
and all patents and patent applications the claims of which cover the Licensed
Product including reissues, extensions and patents of addition, which are owned
by Noven or to which Noven has any right to control or to license third parties
(whether in whole or in part) at any time during the term of this License
Agreement. Patents on inventions made after December 31, 1994 shall be included
only to the extent based on inventions which are conceived or reduced to
practice by either party hereto during and under the
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Clinical and Product Development Program, The presently existing rights are set
forth in Exhibit B, said Exhibit B being a part of this License Agreement.
1.8 Licensed Product. The term "Licensed Product" shall mean any Estrogen
Transdermal Drug Delivery System embodying any part of Noven's Technology or
covered in whole or in part by any of Noven's Patent Rights or which meet the
product specifications set forth in Exhibit C, said Exhibit C being part of
this License Agreement.
1.9 Net Sales. The term "Net Sales" shall mean the gross amount invoiced by
Xxxxx, its Affiliates and Sublicensees on all sales of Licensed Products less
(a) discounts actually allowed, (b) credits actually allowed for claims,
allowances, retroactive price reductions or returned goods, (c) prepaid
freight, and (d) sales taxes, duties and other governmental charges actually
paid in connection with the sale, to the extent not reimbursed, (but excluding
what is commonly known as income taxes).
1.10 Standard Packaging. The term "Standard Packaging" shall mean an
Estrogen Transdermal Drug Delivery System Licensed Product meeting the
specifications set forth in Exhibit C packaged in individual pouches and in
individual foldings cartons consisting of eight (8) pouch units per carton and
containing any labels and labelling required therefor by the United States Food
and Drug Administration and provided in
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packages of twenty four (24) individual folding cartons per shipping container,
and produced at a Noven facility in the United States, the grade and quality of
the labels, labelling and packaging materials being as specified in the
Abbreviated New Drug Application therefor.
1.11 Sublicensee. The term "Sublicensee" and "Sublicensees" shall mean any
entity to whom Xxxxx shall grant any right or license to use Noven's Technology
or to make, use or sell under all or any part of Noven's Patent Rights or to
make, use or sell any product which meets the specifications set forth in
Exhibit C.
1.12 The Territory. The term "Territory" shall mean all countries and
territories worldwide except Japan.
ARTICLE II - OBLIGATIONS OF NOVEN
2.1 Level of Effort. The officers and employees of Noven shall devote a
sufficient amount of their time and efforts to the Clinical and Product
Development Program and employ a sufficient number of technically qualified
officers and employees to complete the Clinical and Product Development Program
within the terms set forth in this Article II.
2.2 Assignment of Invention Riqhts. Immediately upon execution of this
Agreement, Noven shall promptly undertake the implementation of the Clinical
and Product Development Program, devoting to the Clinical and Product
Development Program the services of its officers and employees. It is
understood and
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agreed that all employees and, to the extent reasonably practicable, agents and
consultants of Noven employed in or for the Clinical and Product Development
Program shall execute written agreements acceptable to both Noven and Xxxxx
requiring assignment to Noven of any developments, discoveries, improvements
and/or inventions in Licensed Product made by such employees, agents and
consultants under and during the course of the Clinical and Product Development
Program.
2.3 Progress Reports. Noven shall from time to time, but not less
frequently than once each month, inform Xxxxx in writing of the progress of the
Clinical and Product Development Program and the commencement of any project
within the Clinical and Product Development Program.
2.4 Improvements. During the term of this License Agreement and any
extension thereof, Noven shall promptly disclose to Xxxxx in writing, to the
extent legally permitted and in reasonable detail, any developments,
discoveries, improvements or inventions in an Estrogen Transdermal Drug
Delivery System relating to Licensed Product owned or controlled by Noven, its
employees or agents or consultants who have the duty to assign such
applications to the extent such are made prior to December 31, 1994 or at any
time during the Clinical and Product Development Program. Such shall be
automatically deemed Noven's Patent Rights unless Xxxxx notifies Noven in
writing to the contrary, within sixty (60)
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days of receipt of the initial information concerning the same. No such future
developments, discoveries, improvements or inventions shall be automatically
included within the scope of Noven's Patent Rights unless funded under the
Clinical and Product Development Program.
2.5 Program Updates. On a date which shall be approximately three (3)
months after the commencement of the Clinical and Product Development Program,
and at three-month intervals thereafter, representatives of Noven and of Xxxxx
shall meet to review the progress and status of the Clinical and Product
Development Program then underway. At such meetings, Xxxxx shall have the right
to assign or reassign priorities to the various projects comprising the
Clinical and Product Development Program and to suggest procedures for their
implementation, except for projects for use in obtaining regulatory approval to
market Licensed Product in the United States and Canada. However, Xxxxx'x input
shall be reasonably considered.
2.6 Term of Clinical and Product Development Program. Noven will use its
best efforts to complete its work pursuant to the Clinical and Product
Development Program needed to file an Abbreviated New Drug Application for
Licensed Product in the United States, on or about December 31, 1989.
2.7 Supply and Use of Information. Noven shall promptly provide to Xxxxx,
for Xxxxx'x exclusive use, all
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Noven's Technology relating to Licensed Product, subject only to the concurrent
right of Noven and Noven's Affiliates to use the same in the United States and
Canada. The parties shall, as promptly as possible, provide to each other with
any information that comes to the knowledge of a responsible officer of any
party relating to any adverse reaction occasioned during research on or use of
a Licensed Product. In countries where Xxxxx needs manufacturing information to
obtain a product license, Noven shall supply the necessary information solely
for use in obtaining such license and subject to the confidentiality
obligations of Article VIII.
ARTICLE III - DEVELOPMENT OBLIGATIONS
3.1 Clinical Testing. All pre-clinical, clinical and post-clinical testing
and stability testing including but not limited to the Clinical Product
Development Program required for government health care approvals in the
Territory of a Licensed Product developed by Noven shall be conducted by Noven
and Xxxxx, at Xxxxx'x sole expense, it being understood that Noven shall
perform the clinical testing for the United States and Canada at Xxxxx'x sole
expense. However, before clinical testing of a product is commenced, Noven
shall complete all of Xxxxx'x pre-clinical testing requirements set forth in
Exhibit A for the Licensed Product except for the U.S. and Canada.
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3.2 Skin Testing. At the earliest possible date, but no later than
December 31, 1989, Xxxxx may require adhesion and skin irritation studies.
3.3 Governmental Approvals. Xxxxx shall file requests with the appropriate
government agencies within the Territory for approval of Licensed Product,
except as to the United States of America and Canada. The decision regarding
the timing of said filings shall be in Xxxxx'x sole discretion, except for the
United States and Canada. Xxxxx shall have full and complete ownership of all
governmental approvals, except for the United States and Canada, relating to
Licensed Products. The parties shall provide each other with full copies of and
a right of reference to any application for registrations and any registration
in the United States and Canada.
3.4 Supply of Information. Xxxxx shall promptly and on a continuing basis
provide Noven, for use by Noven, with all information regarding Xxxxx'x
technology related to Licensed Product, on a royalty-free basis.
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3.5 Best Efforts. Xxxxx shall use its best efforts to file and obtain
approval of appropriate governmental agencies for the sale of Licensed Product
in
Xxxxx shall use its best efforts to sell Licensed Product in
Xxxxx shall use efforts to file and obtain approval of appropriate
governmental agencies, and sell Licensed Product as it would for its own
products.
3.6 Time for Reimbursement. Payment shall be made for Noven's Costs
pursuant to this Article III by Xxxxx in Miami, Florida within thirty (30) days
of receipt of a Noven invoice itemizing the nature of charges incurred
hereunder.
3.7 Estimate of Costs. The parties acknowledge that the Costs of clinical
testing and obtaining any necessary governmental regulatory approvals cannot be
estimated. Without intending to be bound hereby or by the estimates for the
same set forth in Exhibit A, Noven estimates that its Costs of clinical testing
and obtaining an Abbreviated New Drug Application for Licensed Product in the
United States will be approximately One Million (U.S. $ 1,000,000.00) United
States Dollars and the Costs of additional clinical testing for regulatory
filings in
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will be approximately an additional One Million (U.S.
$ 1,000,000.00) United States Dollars. Any costs exceeding the program of
Exhibit A must be agreed to in writing by Xxxxx.
ARTICLE IV - GRANT
4.1 License.
(a) Noven hereby grants to Xxxxx, with the right to sublicense Xxxxx'x
Affiliates and Sublicensees subject to the provisions of Article 4.2 hereof,
the exclusive right and license in the territory to use, sell, or otherwise
dispose of Licensed Products under Noven's Patent Rights and Noven's
Technology; provided, however, Noven ond its Affiliates shall retain the
non-exclusive right to use and sell licensed product in the United States and
Canada. Said retained right to use and sell cannot be licensed by Noven to any
third party, other than Noven or its Affillates. Noven's and its Affiliates
retained right to use and sell in the United States and Canada shall cease, at
Xxxxx'x option, if there is a change of Control of Noven.
(b) No right or license to make, use or sell under Noven's Technology
or Noven's Patent Rights is granted herein except as provided herein and with
reference to Licensed Product. No right of Xxxxx, its Affiliates or sublicensees
to manufacture Licensed Product is granted except to the extent stated herein.
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(c) The term "exclusive" used here means that Noven shall not
voluntarily grant a right to any third parties under Noven's Technology or
Noven's Patent Rights and Xxxxx shall have the benefit of Article 5.8 hereof
with respect to such grant.
4.2 Sublicense. As part of the rights granted in Article 4.1, Xxxxx shall
have the right throughout the Territory to grant sublicenses to Sublicensees,
only with the prior written approval of Noven, which approval shall not be
unreasonably withheld. Such written approval by Noven shall not be required for
sublicenses to Xxxxx Affiliates. Any such Sublicensee shall agree to assume the
duties of Xxxxx hereunder with respect to the Territory involved, provided,
however, that such sublicense shall not release Xxxxx from any liability for
performance under this License Agreement. Noven shall have no duty to approve
any such sublicense until it receives a copy of the proposed sublicense
agreement, from which Xxxxx shall have the right to delete the financial terms.
ARTICLE V - PAYMENTS
5.1 Initial Payments. As consideration for the rights herein granted,
Xxxxx shall pay to Noven the sum of
payable as follows:
upon execution of this License Agreement;
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when Noven files an Abbreviated New Drug Application in the
United States for a licensed Product;
when Xxxxx files for health registration for a Licensed Product
in one of the following countries:
upon first health registration and any required price or
insurance reimbursement approval for Licensed Product in one of the
following countries: and
upon approval for sale by the United States Food and Drug
Administration of Licensed Product.
5.2 Fee.
(a) Xxxxx shall pay to Noven a fee of of Xxxxx'x, its
Affiliates and Sublicensees Net Sales, which fee shall include the
compensation for supplying Licensed Product in Standard Packaging, subject to
the provisions set forth in Article 5.2. Costs above the Standard Packaging
Cost shall be allocated to Xxxxx and to Noven.
(b) The fee to be paid hereunder shall be no less than
bulk bandage in Standard Packaging and no more than
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per such unit ex Noven's
factory
(c) After 1989, this minimum and maximum shall be adjusted annually
pursuant to the "Consumer Price Index" published by the U.S. Department of
Labor, Bureau of Labor Statistics, as the U.S. City Average, all items
1982-1984 = 100 (hereinafter referred to as the "Index"). The minimum and the
maximum applicable during years subseguent to 1989 shall be determined by
multiplying the minimums and maximums for 1989, by the fraction, the numerator
of which shall be the Index for January of the year for which the computation
is made, and the denominator of which shall be the Index for January 1989.
Should the publication of said Index be discontinued by said Bureau of Labor
Statistics, then such other indexes may be published by said Bureau most
nearly approaching said discontinued Index shall be used in determining the
adjustment hereunder. Should said Bureau discontinue the publication of any
such index, then such indexes may be published by another United States
governmental agency, as most nearly approximating the Index, shall govern and
be substituted as the Index hereunder.
(d) Notwithstanding the foregoing, if Noven's Cost of Licensed Product
increases at a rate greater than the rate of increase of said Index, or if
Xxxxx'x weighted average gross margin computed excluding samples and sales at
or below
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cost for the product is reduced below with
respect to any country in the Territory, then Xxxxx and Noven shall negotiate
in good faith for a revised royalty with respect to the countries involved. In
the absence of the parties being able to reach a mutually satisfactory
agreement, Noven shall grant to Xxxxx a non-exclusive license to manufacture
Licensed Product under Noven's Technology and Noven's Patent Rights in return
for royalty of
of Net Sales, in addition to other terms and
conditions as reasonably agreed between the parties. Such license shall only
be for sales of Licensed Product in the countries which occasioned the
negotiation.
(e) The foregoing minimums and the maximums are based on an Estrogen
Transdermal Drug Delivery System containing a weighted average of of
. To the extent a greater weighted average of
containing bandages is purchased in any calendar
quarter, then the minimums and maximums for such purchases for said calendar
quarter shall be established by multiplying the price as set forth under
Paragraph 5.2(b) and 5.2(c) above times a number, the numerator of which is
the weighted average milligrams of
in the units purchased and the denominator of which is
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5.3 Minimum Fee.
(a) Xxxxx shall pay Noven a minimum fee per year beginning with the
first calendar year after product registration in the following countries as
follows:
MINIMUM FEE
PER CALENDAR YEAR FROM PRODUCT REGISTRATION
(YEAR 1 - YEAR OF PRODUCT REGISTRATION)
(U.S $ in thousands)
Year 1 Year 2 Year 3 Year 4 Year 5
(b) For year 6 and subsequent years the minimum royalty shall be the
same as for Year 5 multiplied by a number, the numerator of which is the total
transdermal estrogen market in the country in question for which the
calculation is made and the denominator of which is the total transdermal
estrogen market in the country in question in Year 5.
(c) To the extent there is a difference in any country at the end of
each calendar year between any amount set
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forth in Article 5.3(a) in the amounts set forth in Article 5.2(a) above, Xxxxx
shall pay the difference between the minimums and the amount actually pald
within sixty (60) days of year end or this License Agreement will become
non-exclusive in that country.
5.4 Payments. The fee due hereunder shall be payable as follows: The
miniumum price of Paragraph 5.2(a) and subject to the adjustments set forth in
Paragraph 5.2(b) shall be due and payable within thirty (3O) days of Noven's
invoice for such Licensed Product. The remainder of any payment due under
Article V hereof shall be due and payable within sixty (60) days of the end of
each calendar quarter in which Xxxxx, Xxxxx'x Affiliates or Xxxxx'x Sublicensees
received payment for such Licensed Product.
5.5 Currency. Fees and royalties based on sales in a currency other than
United States dollars shall be converted to U.S. dollars at the closing spot
rate for the purchase of U.S. dollars on the last business date of the calendar
quarter for which payments are being accounted as published by the Chase
Manhattan Bank, New York.
5.6 Records. Xxxxx, its Affiliates and Sublicensees shall keep accurate
records in any way related to Licensed Product in accordance with generally
accepted accounting practices uniformly applied. At Noven's request, such
records shall be made available for examination by independent
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certified public accountants or auditors designated by Noven and approved by
Xxxxx which approval shall not be unreasonably withheld.
5.7 One Royalty. Only one royalty shall be paid on any Sale of Licensed
Product, namely the sale by Xxxxx, its Affiliate or Sublicensee to an unrelated
third party.
5.8 Compulsory License. As an alternative, but not in addition to this
License Agreement, Xxxxx shall have the benefit of the royalty provided for in
any compulsory license but to the exclusion of the benefits or rights under
this License Agreement for such country.
ARTICLE VI - SUPPLY
6.1 Agreement to Supply. Noven shall use its best efforts to supply and
Xxxxx shall purchase all of Xxxxx'x, its Affiliates' and Sublicensees'
requirements of Licensed Product from Noven according to the terms and
conditions set forth in the Supply Agreement set forth in Exhibit D, which
forms a part of this License Agreement; however, should Noven be unable to meet
Xxxxx'x requirements of Licensed Product of Xxxxx or by reason of force majeure
is unable to import Licensed Product into a country and if the parties, after
having consulted in good faith to resolve the matter, are unable to do so,
Xxxxx'x sole remedy for Noven's failure to supply shall be the right to a
non-exclusive license to make or have made Licensed Product under Noven's
Technology and Noven's Patent Rights under all
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other terms and conditions of this Agreement in return for a royalty for a
royalty of of Net Sales.
ARTICLE VII - PATENTS
7.1 Noven Inventions. On all inventions conceived or made under and during
the scope of the Clinical and Product Development Program for which Noven
(through its employees and consultants) is the sole inventor, Noven shall
obtain at its own expense and own any patents in the countries requested by
Xxxxx and these inventions shall become a part of Noven's Patent Rights. Xxxxx
shall decide unilaterally in which countries Xxxxx wishes patent protection and
Noven shall, at Noven's expense, file patent applications in such countries in
the name of Noven, and Noven shall have all right, title and interest
subject to the other provisions of this Agreement. Except for the United States
and Canada, Xxxxx shall have the duty to pay all costs and fees for such
filings in any and all said countries for so long as Xxxxx is not selling
Licensed Product in such country or is not paying the minimum royalties with
respect to such countries.
7.2 Joint Inventions. On all inventions conceived or made under and during
the scope of the Clinical and Product Development Program which are joint
inventions of an employee(s) or consultants of Noven and an employee(s) or
consultants of Xxxxx, or an Affiliate of Xxxxx, the parties to this Agreement
shall have joint ownership of any patent
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applications and patents obtained thereon, and Xxxxx shall pay all costs and
expenses of obtaining and maintaining such patent rights, provided, however,
that one-half (1/2) of all such expenses in a country payable by Xxxxx shall be
a credit against one-half (l/2) of any royalties otherwise due Noven in such
country. Xxxxx shall have the sole right to decide in which countries Xxxxx
wishes patent protection on an invention developed hereunder. Xxxxx shall keep
Noven fully and promptly informed with respect to the countries in which Xxxxx
elects to obtain patent protection, and Noven may, at its own espense, apply
for and obtain patent protection in any country in which Xxxxx does not elect
to obtain such patent protection.
ARTICLE VIII - CONFIDENTIALITY OBLIGATIONS
8.1 Confidentiality. Except to the extent that any of the data,
information or know-how developed by either party, including but not limited to
Noven's Technology, is in the public domain at the time of disclosure or
subsequently enters the public domain without fault on the part of a party
hereto, each party shall hold all such data, information, or know-how received
from the other prior to or during the term of this License Agreement in
confidence and shall not disclose it to any other entities during the term of
this License Agreement or thereafter without the other party's permission in
writing. Such permission shall not be withheld (a) to the extent disclosure
is required by legal process to which process the
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generating party is permitted to object or (b) to information required to be
submitted to governmental authorities in order to obtain any necessary health
registration or price reimbursement. Such permission shall not be unreasonably
withheld as to other information reasonably required for obtaining health
registration or insurance reimbursement approval or in marketing Licensed
Product. Notwithstanding the foregoing, Xxxxx shall have the riqht to use and
disclose after the year 2010 Noven's Technology existing on the date of signing
of this License Agreement or twenty (20) years after its disclosure as to data
generated after the execution of this Agreement, if this Agreement expires by
its normal terms, as set forth under paragraph 9.1 below.
ARTICLE IX - TERM AND TERMINATION
9.1 Term. The term of this License Agreement shall be for the last to
expire of Noven's Patent Rights on a country-by-country basis. In countries
where Noven has no Patent Rights, the term of this License Agreement shall be
for ten (10) years and shall automatically be renewed for a five (5) year term.
9.2 Termination
(a) If either Xxxxx or Noven should fail to discharge fully and
promptly any of its obligations under this License Agreement, including but not
limited to the Supply Agreement, attached as Exhibit D, including the
obligation to
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make payments, and should such party failing to discharge any of its
obligations fail to rectify such failure within ten (10) to make payments or
within sixty (60) days for other failures after notice in writing thereof by
the other party, this Agreement can thereupon be terminated at the other
party's option upon receipt of notice to that effect.
(b) Any one party hereto shall have the right to terminate this License
Agreement with immediate effect in the event of any proceeding under a
Bankruptcy Act or any insolvency, receivership or dissolution proceeding
directed against the other party.
(c) Noven shall have the right to terminate this Agreement at any time
upon thirty (30) days' notice in the event that Xxxxx or any Xxxxx Affiliate or
Sublicensee or any entity to whom Xxxxx sells its ethical pharmaceutical
business markets, sells or distributes any Estrogen Transdermal Drug Delivery
System other than Licensed Product.
(d) Upon termination, all information and data, relating to Licensed
Product including but not limited to Noven's Technology, and information
obtained from, incorporating or based on Noven's Technology shall be returned
to Noven. Xxxxx, its Affiliates and Sublicensees shall make no further use of
the same. The foregoing shall not apply to information solely generated by
Xxxxx, if termination is by
-23-
29
Xxxxx for cause of Noven or by expiration of the term specified in Article 9.1
ARTICLE X - NOVEN WARRANTIES
10.1 Ownership. Noven represents and warrants that it has developed
Noven's Technology and it owns the entire right, title and interest in the
patent and patent applications now set forth in Exhibit B.
10.2 Riqht to Enter Aqreement. Noven warrants that it has the right to
enter into this License Agreement, and that there are no outstanding
assignments, grants, licenses, encumbrances, obligations or agreements, either
written, oral or implied, inconsistent with this License Agreement.
10.3 Product Warranty. Noven represents and warrants that Licensed Product
in the form delivered to Xxxxx shall conform to specifications for any such
product and approved in any United States Abbreviated New Drug Application
pertaining thereto including composition, purity, appearance and stability and
shall be capable of maintaining such until any expiration date for such
Licensed Product; and shall not be misbranded in violation of Sections 501, 502
and 505 of the Federal Food, Drug and Cosmetic Act, as amended from time to
time.
10.4 Foreiqn Product Warranty. Noven will use its best efforts to comply
with manufacturing specifications of foreign countries of which Xxxxx has given
Noven notice, provided that Xxxxx pays all Cost of such compliance.
-24-
30
10.5 Patent Infringement Warranty. Noven represents and warrants that it
has no present knowledge of any patent, the claims of which cover Licensed
Product.
10.6 Limitation On Damages. In the event of any breach of any
representation and warranty of Noven under this Article X damages shall be
limited to actual damages and shall not exceed the royalty payable to Noven
hereunder in any calendar year or, in the case of the warranty against patent
infringement, shall not exceed fifty (50%) percent of the royalties paid to
Noven in any such calendar year for the country in question.
ARTICLE XI - ARBITRATION
11.1 Arbitration. Any claim or controversy arising between the parties
hereto in connection with this License Agreement or the breach thereof which
cannot be settled satisfactorily by correspondence or by mutual conference
shall be determined by arbitration in New York, New York, by three arbitrators
in accordance with the then prevailing rules of the American Arbitration
Association upon the request by either party. Judgment upon the award rendered
may be entered in any court having jurisdiction thereof.
11.2 Notification of Breach. In the event one party notifies the other
party of a breach of this License Agreement, and such breach is not cured
within the applicable notice
-25-
31
period, such other party shall have the right within said sixty (60) day period
to bring such dispute to arbitration.
ARTICLE XII - MISCELLANEOUS
12.1 Relationship of Parties. The parties hereto have the relationship
of independent contractors, and neither party shall enter into any agreements,
understandings or commitments on behalf of the other party without the other
party's express permission in writing.
12.2 Inspection of Facilities. At any time during the term of this
License Agreement and any extension thereof, Xxxxx may from time to time during
normal working hours have employees of its choosing visit and inspect the
facilities of Noven, and may discuss with Noven employees the progress of
projects under development by Noven.
12.3 Entire Agreement. This License Agreement represents the entire
understanding between the parties and supersedes any and all previous
understandings, both oral and written, with respect to the subject matter
hereof. The terms, conditions and provisions of this License Agreement shall
prevail over any inconsistent statements, terms, conditions or provisions
contained in any document passing between the parties hereto including, but not
limited to, any acknowledgment, confirmation or notice. This License Agreement
may not be amended, supplemented, or otherwise modified except by an instrument
in writing designated as an amendment,
-26-
32
supplement or modification which is signed by both parties hereto.
12.4 Force Majeure. If the performance of this License Agreement or any
obligation reasonably related thereto is prevented or hindered, by reason of any
cause beyond the control of the affected party, including but not limited to,
fire, flood, riot, strikes or any governmental action, then the party so
affected, upon notice to the other party, shall be excused from such
performance, provided that the party so affected shall use its best efforts to
avoid or remove such cause or causes of non-performance and shall continue to
perform thereunder with the utmost dispatch whenever such cause or causes are
removed. If, as a result of any such action, the performance of this Agreement
is prevented for a continuous period of one hundred eighty (180) days, either
party shall have the right to terminate this agreement as to the country or
countries involved by providing the other party with written notice of
termination.
12.5 Severability. If any provision of this License Agreement shall be
held invalid or unenforceable, such invalidity or unenforceability shall attach
only to such provision and shall not in any manner effect or render invalid or
unenforceable any other severable provision of this License Agreement, and this
License Agreement shall be carried out as
-27-
33
if any such invalid or unenforceable provision were not contained herein.
12.6 Assignment. This License Agreement shall inure to the benefit of
the parties and to the successors and assigns of that part of the business of
Xxxxx to which the subject matter of this License Agreement is related. This
License Agreement, or any rights thereunder, shall not otherwise be sold,
assigned, transferred or encumbered by either party without first obtaining the
consent of the other party in writing.
12.7 Governing Law. This License Agreement shall be interpreted in
accordance with and governed by the laws of the State of New York, without
references to the conflict of law rules. Both parties forever waive any New York
law cannot be validly applied to this Agreement and that an agreement to use
"best efforts" is unenforceable under New York law.
12.8 Notices. Any notice or report required or permitted hereunder shall
be given in writing, hand delivered or by registered or certified mail, to the
following addresses:
(1) Noven Pharmaceuticals, Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, Xxxxxxx 00000
Attention: President
With a copy to: Xxxxx Xxxxx, Esq.
Ruden, Barnett, McClosky, Smith,
Xxxxxxxx & Russell, P.A.
000 Xxxxxxxx Xxxxxx
Xxxxx, Xxxxxxx 00000
-28-
34
(2) Xxxxx Group Inc.
000 Xxxxxxxx Xxxxx
Xxxx Xxxxxxxxxx, Xxxxxxxxxxxx 00000
Attention: President
With a copy to: Xxxxxx Xxxxxxxx, III, Esq.
Patent Counsel
Xxxxx Group Inc.
000 Xxxxxxxx Xxxxx
Xxxx Xxxxxxxxxx, Xxxxxxxxxxxx 00000
or to such other address or in care of such other person as hereafter shall be
designated in writing by either party to the other, and shall be deemed to have
been given as of the date of mailing.
12.9 Counterparts. This License Agreement and any amendments may be
executed in one or more counterparts, each of which shall be deemed an original
but all of which together will constitute one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have caused this instrument to be
executed in duplicate and their seals to be hereunto affixed as of the day and
year first written above.
XXXXX GROUP INC.
By:
--------------------------------
Title:
-----------------------------
Date:
-----------------------------
NOVEN PHARMACEUTICALS, INC.
By: /s/ Xxxxxx Xxxxxxxxx
-------------------------------
Title: President
-----------------------------
Date: 4-27-89
-----------------------------
-29-
35
(2) Xxxxx Group Inc
000 Xxxxxxxx Xxxxx
Xxxx Xxxxxxxxxx, Xxxxxxxxxxxx 00000
Attention: President
With a copy to: Xxxxxx Xxxxxxxx III, Esq.
Patent Counsel
Xxxxx Group Inc
000 Xxxxxxxx Xxxxx
Xxxx Xxxxxxxxxx, Xxxxxxxxxxxx 00000
or to such other address or in care of such other person as hereafter shall be
designated in writing by either party to the other, and shall be deemed to have
been given as of the date of mailing.
12.9 Counterparts. This License Agreement and any amendments may be
executed in one or more counterparts, each of which shall be deemed an original
but all of which together will constitute one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have caused this instrument to be
executed in duplicate and their seals to be hereunto affixed as of the day and
year first written above.
XXXXX GROUP INC.
By: /s/
------------------------------
Title: Senior V.P.-Finance and CFO
----------------------------
Date: April 27, 1989
-----------------------------
NOVEN PHARMACEUTICALS, INC.
By:
-------------------------------
Title:
----------------------------
Date:
-----------------------------
-29-
36
EXHIBIT A
CLINICAL AND PRODUCT DEVELOPMENT PROGRAM
================================================================================
ESTRADIOL TRANSDERMAL COST EST.
$
ACTIVITY 1 MILLION
37
EXHIBIT B
NOVEN'S PATENT RIGHTS
38
EXHIBIT C
TRANSDERMAL ESTROGEN SKIN PATCH PRODUCT SPECIFICATIONS
An estrogen in a
in a
form suitable for application to and delivery through the
skin meeting the specifications now employed by Noven and
any such amended or revised specifications, as set forth in the
approved new drug application for such product by Federal Food and
Drug application.
39
EXHIBIT D
SUPPLY AGREEMENT
This Agreement, made this 27th day of April, 1989, by and between XXXXX
GROUP INC , a Pennsylvania corporation, having a place of business at 000
Xxxxxxxx Xxxxx, Xxxx Xxxxxxxxxx, Xxxxxxxxxxxx 00000 (hereinafter "Xxxxx"), and
NOVEN PHARMACEUTICALS, INC , a Delaware corporation, having a place of business
at 00000 X.X. 000xx Xxxxxx, Xxxxx, Xxxxxxx 00000 (hereinafter "Noven").
W I T N E S S E T H
WHEREAS, Noven has licensed Xxxxx the right to market an estrogen drug
delivery system, specifications of which are attached to said License Agreement
as Exhibit C (herein "Licensed Product");
WHEREAS, XXXXX desires to purchase all of its requirements of the
Licensed Product from Noven; and
WHEREAS, Noven desires to supply Xxxxx with all of its requirements of
the Licensed Product.
NOW, THEREFORE, it is mutualIy agreed between the parties hereto as
follows:
40
ARTICLE I - DEFINITIONS
1.01 In General. All terms used in this Supply Agreement shall have the
same definition as in the License Agreement entered into by the parties hereto
concurrently with the execution of this Supply Agreement.
ARTICLE II - SUPPLY
2.01 Agreement to Supply.
(a) Noven shall use its best efforts to supply and Xxxxx shall
purchase, in Standard Packaging, all of Xxxxx'x, its Affiliates' and its
Sublicensees' requirements for the Licensed Product subject to the terms and
limitations herein contained.
(b) Licensed Product shall meet the following specifications:
A laminate with a colorless plastic backing juxtaposed to a
where the
in a form suitable for delivery
through the skin. The adhesive has a
contained in a heat sealed. The units will be available in
the following dosages:
-2-
41
2.02 Price. The price to be paid by Xxxxx to Noven for the Licensed
Product which Xxxxx purchases from Noven pursuant to this Supply Agreement, is
set forth in Article 5.2 of the License Agreement.
2.03 Payment. Payment for each delivery of Licensed Product shall be
made in accordance with the provisions of Article 5.2 of the License Agreement.
2.04 Price Increases. The minimum and maximum initial payment for
Licensed Product shall be increased as set forth in Article 5.2 of the License
Agreement.
2.05 Records of Costs. Noven shall keep accurate accounting records for
the calculation of Noven's Cost of Licensed Product supplied Xxxxx Licensed
Product.
2.06 Manufacturing Standards.
(a) The Licensed Product supplied by Noven hereunder shall be
manufactured, assayed, and packaged in accordance with Good Manufacturing
Practices ("GMP") as such
-3-
42
term is defined under the United States Federal Food, Drug and Cosmetic Act of
1938, as amended from time to time, and regulations and guidelines promulgated
pursuant thereto and in an establishment licensed for such purpose by the United
States Food & Drug Administration or any successor agency of the United States
government, and shall fully conform with the specifications attached to the
License Agreement as Exhibit C and with all United States governmental
requirements in effect at the time of shipment. Furthermore, the Licensed
Product supplied by Noven for sale in countries other than the United States
shall conform with the standards of that country and shall be manufactured in a
facility approved for that purpose by the proper authorities of each country to
the extent Xxxxx specifically notifies Noven of the same and pays the cost of
any changes in specifications or manufacturing practices required.
(b) Xxxxx shall provide a rolling forecast of needs on a calendar
quarter year in advance of such forecasted need, which forecast shall be updated
on a calendar quarter basis. Xxxxx shall be required to purchase ninety (90%)
percent of such forecast made six (6) months in advance of the specified
delivery date and Noven shall have no duty to deliver units in excess of one
hundred ten (110%) percent of such forecast, in addition to and independent of
the limits based on Xxxxx'x Moving Average.
-4-
43
(c) Noven shall deliver to Xxxxx with each shipment of the Licensed
Product a certificate of analysis for each lot of Licensed Product.
2.07 Forecasts and Orders. Xxxxx orders for the Licensed Product shall
indicate the quantity to be delivered and specific delivery dates on a monthly
basis and shall be sent to Noven at least 120 days prior to the earliest
specified delivery date. Xxxxx shall attempt to minimize fluctuations in the
amounts of such orders to the extent feasible Xxxxx'x orders shall not call for
delivery of more than ten thousand (10,000) units in any calendar month during
the first year of marketing in any country under this agreement. Thereafter, any
order for delivery in any month of more than one hundred twenty (120%) percent
of Xxxxx'x Moving Average (as hereinafter defined) shall be sent to Noven at
least six (6) months prior to the earliest specified delivery date, but no such
order shall call for delivery of more than one hundred fifty (150%) percent of
said Xxxxx'x Moving Average. If Xxxxx'x requirements exceed the limitations set
forth above, the parties shall consult in good faith regarding the best way in
which to fulfill them.
2.08 Movinq Average. "Xxxxx'x Moving Average" as used herein shall
mean the average monthly number of patches ordered by Xxxxx during the six (6)
month period immediately preceding the date of the order being considered.
-5-
44
ARTICLE III - REPRESENTATIONS, WARRANTIES AND INDEMNITY
3.01 Ownership. Noven represents and warrants that it has developed
Noven's Technology and it owns the entire right, title and interest in the
patent applications now set forth in Exhibit B.
3.02 Right to Enter Agreement. Noven warrants that it has the right to
enter into this Supply Agreement, and that there are no outstanding assignments,
grants, licenses, encumbrances, obligations or agreements, either written, oral
or implied, inconsistent with this Supply Agreement.
3.03 Product Indemnity. Noven represents and warrants that Licensed
Product in the form delivered to Xxxxx shall conform to specifications for any
such product and proved in any United States abbreviated New Drug Application
pertaining thereto including composition, purity, appearance and stability and
shall be capable of maintaining such until any expiration date for such Licensed
Product; and Noven represents and warrants that it will use its best efforts
comply with all rules and regulations, including all current Good Manufacturing
Practices, as that term is defined by the United States Food and Drug
Administration, applicable to the manufacture, filling, labeling, packaging,
storage and shipment of Licensed Product which are in force or hereafter adopted
by the United States Food and Drug Administration or any successor agency
thereto or any agency Oe the state within the Territory and
-6-
45
shall not be misbranded in violation of Sections 501, 502 and 505 of the Federal
Food, Drug and Cosmetic Act, as amended from time to time.
3.04 Foreign Product Warranty. Noven will use its best efforts to
comply with manufacturing specifications of foreign countries of which Xxxxx has
given Noven specific notice, provided that Xxxxx pays all Cost of such
compliance.
3.05 No Other Warranties. Except as stated above, Noven makes no other
warranties or indemnities, express or implied, with respect to Noven's
Technology, Noven's Patent Rights or Licensed Product.
3.06 Limitation On Damages. In the event of any breach of any
representation and warranty of Noven under this Article III damages shall be
limited to actual damages and shall not exceed the royalty payable to Noven
under the License Agreement in any calendar year except in the case of the
warranty against patent infringement, which shall not exceed fifty (50%) percent
of the royalties paid to Noven in any such calendar year for such country.
ARTICLE IV - CONFIDENTIALITY
4.01 Confidentiality. Except to the extent that any of the data,
information or know-how developed by either party, including but not limited to
Noven's Technology, is in the public domain at the time of disclosure or
subsequently enters the public domain without fault on the part of a party
hereto,
-7-
46
each party shall hold all such data, information, or know-how received from the
other prior to or during the term of this License Agreement in confidence and
shall not disclose it to any other entities during the term of this License
Agreement or thereafter without the other party's permission in writing. Such
permission shall not be withheld (a) to the extent disclosure is required by
legal process to which process the generating party is permitted to object or
(b) to information required to be submitted to governmental authorities in order
to obtain any necessary health registration or price reimbursement. Such
permission shall not be unreasonably withheld as to other information reasonably
required for obtaining health registration or insurance reimbursement approval
or in marketing Licensed Product. Notwithstanding the foregoing, Xxxxx shall
have the right to use and disclose after the year 2010 Noven's Technology
existing on the date of signing of this License Agreement or twenty (20) years
after its disclosure as to data generated after the execution of this Agreement,
if this Agreement expires by its normal forms, as set forth under paragraph 9.1
below.
ARTICLE V - PRODUCT RECALL
5.01 Recall. If an authorized government agency of the United or any
country or territory based on requirements specifically notified to Noven by
Xxxxx thereof shall seize any Licensed Product or if Xxxxx deems it necessary
- 8 -
47
to initiate a voiuntary recall of any Licensed Product for any reason, Xxxxx
shall immediately notify Noven of such seizure or recall and shall consult with
Noven regarding the timely compliance with all pertinent state or federal
regulations pertaining thereto. Furthermore, Xxxxx shall make a permanent record
of all costs incurred thereby, a copy of which shall be delivered to Noven as
soon after the completion of such recall or seizure as practically may be done.
When the reason of said recall or seizure resides in the negligent failure of
Noven to manufacture Licensed Product in accordance with its specifications,
compendium requirements, or government rules and regulations, or in the failure
of Licensed Product to maintain stability for the period described in the
product labeling, Noven shall reimburse Xxxxx for all reasonable costs incurred
by Xxxxx in effecting such recall or seizure, including all reasonable credits
extended to Xxxxx'x customers as a result thereof. When the cause or reason of
said recall or seizure directly resides in the failure of Xxxxx to properly
store, transport or care for Licensed Product while Licensed Product was in
Xxxxx'x possession, Xxxxx shall bear all costs of such recall or seizure and
indemnity Noven therefrom.
ARTICLE VI - TERM AND TERMINATION
6.01 Term. The term of this Supply Agreement shall be the same as the
term set forth in Paragraph 9.1 of the License Agreement, unless earlier
terminated in accordance with Paragraph 6.02 of this Supply Agreement.
- 9 -
48
6.02 Termination. Each party shall have the right to terminate this
Supply Agreement at any time on ninety (90) days' written notice that the other
party is in default and the reasons therefore, and if such other party fails to
cure such default within such period, this Supply Agreement shall terminate upon
the date set in such notice; provided, however, that if this Supply Agreement is
terminated (i) Xxxxx shall have the right to sell all Licensed Product then in
its inventory, and (ii) in the event such termination is through no fault of
Xxxxx, if Xxxxx so elects; it shall have the right to receive from Noven, and to
se11, all of Xxxxx'x orders for Licensed Product accepted by Noven prior to such
notice of default. The provisions of this Supply Agreement shall apply to all
such orders notwithstanding its termination.
6.03 Force Majeure. If the performance of this Supply Agreement or any
obligation hereunder is prevented or hindered, by reason of any cause beyond
control of the affected party, including, but not limited to, fire, flood, riot,
strikes or any governmental action, the party so affected, upon immediate notice
to the other party, shall be excused from such performance, provided that the
party so affected shall use its best efforts to avoid or remove such cause or
causes of non-performance and shall continue to perform hereunder with the
utmost dispatch whenever such cause or causes are removed. If as a result of
any governmental action, the performance of
-10-
49
this Supply Agreement or any obligation hereunder is prevented for a continuous
period of one hundred eighty (180) days, either party shall have the right to
terminate this Agreement by providing the other party with written notice of
termination.
ARTICLE VII - NOTICE
7.01 Notices. Any notice or report required or permitted hereunder shall
be given in writing, by registered or certified mail, to the following
addresses:
(1) Noven Pharmaceuticals, Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, Xxxxxxx 00000
Attention: President
With a copy to: Xxxxx Xxxxx, Esq.
Ruden, Barnett, McClosky, Smith,
Xxxxxxxx & Russell, P.A.
000 Xxxxxxxx Xxxxxx
Xxxxx , Xxxxxxx 00000
(2) Xxxxx Group Inc.
000 Xxxxxxxx Xxxxx
Xxxx Xxxxxxxxxx, Xxxxxxxxxxxx 00000
Attention: President
With a copy to: Xxxxxx Xxxxxxxx, Esq.
Patent Counsel
Xxxxx Group Inc.
000 Xxxxxxxx Xxxxx
Xxxx Xxxxxxxxxx, Xxxxxxxxxxxx 00000
or to such other address or in care of such other person as hereafter shall be
designated in writing by either party to the other, and shall be deemed to have
been given as of the date of mailing.
-11-
50
ARTICLE VIII - MISCELLANEOUS
8.01 Relationship of Parties. The parties hereto have the relationship
of independent contractors, and neither party shall enter into any agreements,
understandings or commitments on behalf of the other party without the other
party's express permission in writing.
8.02 Entire Agreement. This Supply Agreement and the License Agreement
and Exhibits attached thereto which this Supply Agreement forms a part thereof,
represent the entire understanding between the parties and supersedes any and
all previous understandings, both oral and written, with respect to the subject
matter hereof. This Supply Agreement may not be amended, supplemented, or
otherwise modified except by an instrument in writing designated as an
amendment, supplement or modification which is signed by both parties hereto.
8.03 Severability. If any provision of this Supply Agreement shall be
held invalid or unenforceable, such invalidity or unenforceability shall attach
only to such provision and shall not in any manner effect or render invalid or
unenforceable any other severable provision of this Supply Agreement, and this
Supply Agreement shall be carried out as if any such invalid or unenforceable
provision were not contained herein.
8.04 Arbitration. Any dispute arising from or relating to this Supply
Agreement shall be finally and
-12-
51
bindingly settled by arbitration in accordance with the then obtaining rules of
the American Arbitration Association by one or more arbitrators designated in
conformity with those rules at a site mutually agreed upon by the parties, or,
if there is no such agreement, then in New York, New York, and judgment upon any
award thereunder may be entered in any court having jurisdiction thereof.
8.05 Assiqnment. This Supply Agreement shall inure to the benefit of the
parties and to the successors and assigns of that part of the business of Xxxxx
to which the subject matter of this Supply Agreement is related. This Supply
Agreement, or any rights thereunder, shall not otherwise be sold, assigned,
transferred or encumbered by either party without first obtaining the consent
of other other party in writing.
8.06 Governinq Law. This Supply Agreement shall be construed, and the
respective rights of the parties hereto determined, according to the substantive
laws of the State of New York, without reference to the conflict of law rules.
lN WITNESS WHEREOF, the parties hereto have caused this Supply Agreement
to be executed by their duly authorized officers upon the date above written.
ATTEST: NOVEN PHARMACEUTICALS, INC.
/s/ Xxxxxxxx Xxxxx
--------------------------------- By: /s/ Xxxxxx Xxxxxxxxx
-------------------------------
Title: President
-----------------------------
Date: 4-27-89
-----------------------------
(SIGNATURES CONTINUED ON NEXT PAGE)
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52
(SIGNATURES CONTINUED)
ATTEST: XXXXX GROUP INC.
/s/ Xxxxxx X. Xxxxxxxx
-----------------------------
Xxxxxx X. Xxxxxxxx By: /s/
-----------------------------
Title: Senior V.P.-Finance and CFO
---------------------------
Date: April 27, 1989
---------------------------
-14-
53
AMENDMENT TO LICENSE AGREEMENT
This amends the License Agreement of April 27, 1989 between Noven
Pharmaceuticals, Inc. (Noven) and Xxxxx Group Inc. (Xxxxx).
WHEREAS, Noven and Xxxxx entered into a license agreement covering the
development, marketing, supply and sale of Licensed Product, as that term is
defined in the License Agreement of April 27, 1989 (the License Agreeement);
WHEREAS, the License Agreement covered all countries and territories
worldwide, except Japan;
WHEREAS, Xxxxx is willing to surrender its U.S. and Canadian rights to
the Licensed Products under the circumstances described below; and
WHEREAS, Xxxxx and Noven intend to continue their collaboration on the
Licensed Products outside the United States and Canada;
NOW, THEREFORE, intending to be legally bound, Noven and Xxxxx hereby
amend the License Agreement as follows:
I. Surrender of U.S. and Canadian License Rights
Xxxxx hereby surrenders and grants back to Noven all license rights
covered by Article IV of the License Agreement with respect to the United
States and Canada. The foregoing grant back and surrender of license rights
applies only to the U.S. and Canada, and not to any other area of the
Territory, as that term is defined in the License Agreement.
II. Xxxxx Relieved of Obligation to Fund the U.S. Clinical and Product
Development Program
Xxxxx shall be excused and released from funding any work conducted
after March 31, 1990 on the U.S. and Canadian Clinical and Product Development
Program, as that term is defined in the License Agreement.
III. Contingent Reimbursement of Xxxxx of its Prior U.S. and Canadian
Clinical and Product Development Program Costs
Noven shall reimburse Xxxxx the approximately in costs paid to
third-parties in connection with clinical trials 1001, 1002 and 1005 for the
U.S. and Canadian Clinical and Product Development Program, if that program's
studies are used by Noven for any purpose and are not used by Xxxxx to secure
regulatory approval outside the U.S. or Canada and provided that Noven either
commercializes the Licensed Product in the U.S. or Canada or receives payments
from a third party in return for the U.S. or Canadian rights to the Licensed
54
Product. In the latter event, if Noven receives a lump sum payment from a
third party in return for such rights, Noven shall immediately reimburse Xxxxx
the entire amount required under this section, up to the amount of the lump sum
payment(s). Any remaining balance -- or in the event no lump sum payment is
received from a third party, the entire amount to be reimbursed -- shall be
paid by Noven commencing on commercialization of the Licensed Product. In such
event, percent of the operating profit Noven makes on the Licensed Product in
each calendar quarter -- whether such profit is derived from sales, royalties,
manufacturing or any other source -- shall be paid over to Xxxxx within thirty
days of the end of that calendar quarter, until Xxxxx has been fully reimbursed
as required by this section.
IV. Contingent Reimbursement Of Xxxxx Of One Half Of The Payment Made To
Noven On Execution Of License Agreement
If Noven commercializes the Licensed Product in the United States or
Canada, or enters into an agreement with a third party covering the U.S. or
Canadian rights to the Licensed Product, Noven shall reimburse Xxxxx
dollars, an amount that represents the payment
Xxxxx made to Noven on execution of the License Agreement. Such reimbursement
will be made immediately, to the extent of any lump sum payments Noven receives
from a third-party for the U.S. or Canadian rights to the Licensed Product.
If such lump sum payments from third-parties in the aggregate are less than
, then Noven shall pay Xxxxx within thirty days of the close of
each calendar quarter following U.S. or Canadian commercialization,
percent of the operating profit Noven makes in that quarter from the Licensed
Product -- whether such profit is derived from sales, royalties, manufacturing
or any other source -- until Xxxxx has been reimbursed the full
payment.
V. Previous U.S. ANDA Milestone Payment To Be Applied Against Future
International Milestone Payments
The previously paid by Xxxxx to Noven as an advance
payment in anticipation that Noven would shortly file a completed U.S. ANDA
will be applied and credited against the remaining International milestone
payments specified in Article 5.1 of the License Agreement.
VI. Notices, Records and Audit Rights
Noven shall immediately notify Xxxxx, if Noven either commercializes
the Licensed Product in the U.S. or Canada or enters into an agreement with a
third-party covering the rights thereto in those countries. All reimbursement
payments
-2-
55
required by Sections III and IV hereof shall be accompanied by a statement in
reasonable detail, permitting Xxxxx to ascertain whether the amount of the
payment is correct. On reasonable notice and at reasonable times, Xxxxx, not
more than twice a year, shall have the right to audit relevant books and
records of Noven to ensure that Noven is not in breach of its obligations to
make the aforesaid reimbursement payments.
VII. Release Of Xxxxx From Further U.S. and Canadian Obligations Relating
To The Licensed Product
Noven hereby releases Xxxxx from any and all further obligations,
whether contractual or otherwise, relating to the development, sale,
distribution, manufacture or any other aspect of the Licensed Products in the
U.S. or Canada.
VIII. Reciprocal Rights To Exploit Data
Xxxxx shall have the unrestricted right to use any data derived from
any existing or future study on the Licensed Product, whether conducted by
Xxxxx, Xxxxx or a third party, in any country or area of the Territory other
than the United States and Canada. Noven shall similarly have the unrestricted
right to use any such data, but only in the United States, Canada and Japan.
IX. Ceiling On International Clinical And Product Development Program
Notwithstanding any provision or term of the License Agreement, Noven
shall charge Xxxxx no more than the following monthly sums for all work
performed, and all Licensed Product furnished, by Noven in 1990 in connection
with the International Product Development Program for the Licensed Products
(the "Ceiling Sums").
Month Ceiling Sum in $000s
April
May
June
July
August
September
October
November
December
Total
The foregoing Ceiling Sums, which shall cover all direct and indirect costs
including overhead and legal fees, may not be exceeded without the express
written consent of Xxxxx. Noven shall provide all services specified in a
letter from X. Xxxxxx
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to X. Xxxxxxx dated 3/21/90, a copy of which is attached as Exhibit A. Noven
will forward to Xxxxx Xxxxxxxx and Xxxxx Xxxxxx invoices covering actual
monthly expenses up to the Ceiling Sums.
X. Effect Of Amendment On License Agreement
Except as provided in this amendment, all other terms and provisions
of the License Agreement shall remain in full force and effect.
NOVEN PHARMACEUTICALS INC. XXXXX GROUP INC.
BY: /s/ Xxxxxx Xxxxxxxxx BY: /s/
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DATE: 5-10-90 DATE: 6/22/90
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