Exhibit 10.25
2 August 2001
LICENSE AGREEMENT
This Agreement is made and entered into this 2 day of August, 2001 (the
"Effective Date"), by and between NASTECH PHARMACEUTICAL COMPANY INC., a
corporation duly organized and existing under the laws of Delaware and having
its principal office at ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇.▇.▇.
("Nastech"), and ▇. ▇▇▇▇ BOSKAMP GmbH & Co., a limited partnership duly
organized and existing under the laws of Germany and having its principal office
at ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇, ▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ (hereinafter referred to
as "▇▇▇▇-▇▇▇▇▇▇▇").
WITNESSETH
WHEREAS, Nastech owns all right, title and interest in and to certain
proprietary Nasal Morphine Technology (as defined below), including (i) United
States and foreign patents and patent applications relating to the nasal
delivery of morphine as defined in Article 1.4 below (the "Patents Rights"), and
(ii) certain trade secrets and other know-how related to formulations for the
nasal delivery of morphine as defined in Article 1.3 below (the "Know How"); and
WHEREAS, Nastech has the right to grant licenses under the Patents Rights
and/or the Know How and desires to grant to ▇▇▇▇ Boskamp rights to use the
Patent Rights and/or the Know How in the Territory as hereinafter set forth; and
WHEREAS, ▇▇▇▇ Boskamp desires to obtain such license upon the terms and
conditions hereinafter set forth in order to commercially introduce products for
the nasal delivery of morphine in the Territory;
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein, the parties hereto agree as follows:
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ARTICLE I - DEFINITIONS
For the purposes of this Agreement, the following words and phrases shall
have the following meanings:
1.1 Affiliate means any corporation, company, partnership, joint venture
or firm which controls, is controlled by or is under common control with ▇▇▇▇
Boskamp or Nastech, as the case may be. For purposes of this definition,
"control" shall mean (a) in the case of corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the stock or shares entitled to
vote for the election of directors, managing directors and/or, in case of a
German stock corporation (AG), of the members of the supervisory board; and (b)
in the case of non-corporate entities, direct or indirect ownership of at least
fifty percent (50%) of the equity interest with the power to direct the
management and policies of such non-corporate entities.
1.2 Field of Use shall mean the delivery of morphine and/or its salts via
the nasal mucosa.
1.3 Know-How shall mean any and all present and future proprietary
know-how or other confidential scientific or technical information of Nastech,
or licensed to Nastech, not in the public domain, relating to the systemic nasal
delivery of morphine and/or its salts via absorption through the nasal membrane,
whether or not patentable, and including but not limited to any and all data,
techniques, inventions, tests, reports, procedures, processes, methods, models,
manuals, formulae, specifications, results, experiments, samples, statistics,
records, tables, operating conditions and test analyses relating thereto as
further specified in, but not limited to, Schedule A.
1.4 Patent Rights shall mean the following:
(a) any and all present and future patent applications and patents
which issue from the patent applications set forth on Schedule B, and any
present and future patents or patent applications which embody and/or which
relate to any of the Know-How and any continuations, divisions or
continuations-in-part of the foregoing patents or patent applications, and any
and all foreign counterparts of any of the foregoing; and
02-08-2001 - Page 3 of 24
(b) any reissues, reexaminations or extensions of the patents or
patent applications described in clause (a) above.
1.5 Nasal Morphine Technology shall mean the Patent Rights and the
Know-How.
1.6 Products shall mean any product manufactured or otherwise produced
under or using any of the Nasal Morphine Technology for sale in the Field of
Use.
1.7 Net Sales shall mean the gross amount invoiced by ▇▇▇▇ Boskamp, its
Affiliates or sublicensees on sales of the Products less the sum of the
following:
(a) customary cash discounts and rebates actually allowed and taken;
and
(b) amounts repaid or credited by reason of rejection or return.
Net Sales shall not include any transfer between ▇▇▇▇ Boskamp or any of
its Affiliates or sublicensees but shall include the resale from an Affiliate or
sublicensee to an independent third party. No deductions or offsets shall be
made against Net Sales for commissions paid to employees of ▇▇▇▇ Boskamp, its
Affiliates or sublicensees, cost of collections, bad debts or sales, marketing
and promotional expenses of any kind.
1.8 Territory shall mean the countries of the world with the exception of
the Exclusive Territory and the American continent, the latter consisting of,
but not limited to, the United States, Canada, Mexico, Argentina, Bolivia,
Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras,
Nicaragua, Panama, Peru, Uruguay and Venezuela (the "American Continent").
1.9 Exclusive Territory shall mean the countries of
(a) Austria, Belgium, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden and United
Kingdom (Member States of the European Union) as well as the Isle of Man,
Channel Islands, Andorra, Monaco, San Marino, and
(b) Iceland, Liechtenstein, Norway (Member States of the European
Economic Area) and Switzerland (Member States of the EFTA (European Free Trade
Association)), and
02-08-2001 - Page 4 of 24
(c) Estonia, Latvia, Lithuania, Poland, Czech Republic, Slovakia,
Hungary, Rumania, Bulgaria, Turkey, Malta, Cyprus, Yugoslavia, Slovenia,
Croatia, Bosnia-Herzegovina, Macedonia (prospective members of the European
Union).
ARTICLE II - GRANT OF LICENSES
2.1 Territory License
(a) Exclusive License. Nastech hereby grants to ▇▇▇▇ Boskamp and its
Affiliates an unlimited exclusive license within the Exclusive Territory, with
the right to sublicense as set forth in Article 2.3 (subject to Article IX
hereof), to use the Nasal Morphine Technology in order to make, have made,
develop, use, promote, market, distribute and sell the Products in the Exclusive
Territory. Nastech shall not, and shall procure that none of its Affiliates, use
the Nasal Morphine Technology for the development, use, promotion,
manufacturing, marketing, distributing and sale of Products in the Exclusive
Territory or license the Nasal Morphine Technology to third parties for that
purpose even if the production takes place outside of the Exclusive Territory.
(b) Non-Exclusive License. Notwithstanding the exclusive license for
the Exclusive Territory pursuant to Article 2.1 a) above, Nastech grants to ▇▇▇▇
Boskamp and its Affiliates an unlimited, non-exclusive license within the
Territory, with the right to sublicense as set forth in Article 2.3 (subject to
Article IX hereof), to use the Nasal Morphine Technology in order to make, have
made, develop, use, promote, market, distribute and sell Products in the
Territory.
(c) Restriction. ▇▇▇▇ Poskamp shall not make, have made, develop,
use, actively promote, market, distribute and sell Products on the American
Continent as well as in all countries of the Territory in which Nastech holds
valid patents regarding the Patent Rights. This restriction shall, however, not
apply to the Exclusive Territory. For the avoidance of doubt, the exclusive
license granted to ▇▇▇▇-▇▇▇▇▇▇▇ under Article 2.1 (a) above shall not be
restricted in any way in the event that Nastech acquires or holds valid patents
regarding the Patent Rights in any country in the Exclusive Territory.
2.2 No Rights by Implication. Nothing contained in this Agreement shall be
construed to confer upon ▇▇▇▇ Boskamp or its Affiliates or sublicensees any
license rights not expressly granted to ▇▇▇▇ Boskamp and its Affiliates under
this Agreement.
02-08-2001 - Page 5 of 24
2.3 Grant of Sublicenses. ▇▇▇▇ Boskamp may grant sublicenses to third
parties with respect to the use of the Nasal Morphine Technology in order to
make, have made, develop, use, promote, market, distribute and sell Products in
the Territory and Exclusive Territory, provided that: (i) the licenses granted
to such sublicensees are not inconsistent with the licenses granted to ▇▇▇▇
Boskamp under this Article II and (ii) each sublicensee executes a sublicense
agreement which contains confidentiality provisions on substantially the same
terms as set forth herein. ▇▇▇▇ Boskamp shall inform Nastech of the execution of
each sublicense agreement and shall provide Nastech with a certification by an
officer of ▇▇▇▇ Boskamp that it complied with clauses (i) and (ii) above.
2.4 Improvements and New Developments. Nastech shall inform ▇▇▇▇ Boskamp
of all improvements and new development of the Nasal Morphine Technology.
Nastech shall license such improvements and new developments owned by Nastech or
sub-license such improvements and new developments in relation to which Nastech
has a license and the ability to grant a sub-license to ▇▇▇▇ Boskamp on the same
terms as the licenses granted in Articles 2.1 save that no additional royalties
shall be paid by ▇▇▇▇ Boskamp for such licenses or sub-licences (as the case may
be).
ARTICLE III - FEES, ROYALTIES; REPORTS AND RECORDS
3.1 Initial Fee. ▇▇▇▇ Boskamp shall pay to Nastech an initial,
non-revocable lump sum fee of US $100,000 (the "Initial Fee") upon the Effective
Date. This will entitle ▇▇▇▇-▇▇▇▇▇▇▇ to get complete and full access, but not
the right to subsequently use without payment of the license fee noted in
Section 3.2(a), at the offices of Nastech to the Know How and the Patent Rights
including but not limited to any and all data, techniques, inventions, tests,
reports, procedures, processes, methods, models, manuals, formulae,
specifications, results, experiments, samples, statistics, records, tables,
operating conditions and test analyses relating thereto as further described in,
but not limited to, Schedules A and B in order to enable ▇▇▇▇-▇▇▇▇▇▇▇ to
evaluate the merchantability and commercial viability of the Nasal Morphine
Technology and the patentability of the Patent Rights. Six (6) weeks after the
Effective Date ▇▇▇▇-▇▇▇▇▇▇▇ shall, at its free discretion, be entitled either to
terminate this Agreement pursuant to Article 10.2 or to decide, with written
notice to Nastech, to use the rights, privileges and licenses granted under
Article II hereof.
02-08-2001 - Page 6 of 24
3.2 License Fee and Patent Fee. In the event that ▇▇▇▇ Boskamp decides to
use the rights, privileges and licenses granted under Article II pursuant to
Article 3.1, it shall pay to Nastech
(a) a lump sum license fee of US $ 400,000 (the "License Fee"). This shall
entitle ▇▇▇▇ Boskamp to use the rights, privileges and licenses granted under
Article II and to receive from Nastech, free of charge, all documentation
relating to the Nasal Morphine Technology needed by ▇▇▇▇ Boskamp to exercise the
licenses under this Agreement. Nastech shall transmit to ▇▇▇▇ Boskamp such
documents, data, reports, models, manuals, samples, statistics, records, tables
and test analyses, and in particular, but not limited to, those listed in
Schedules A and B within a period of one (1) month after ▇▇▇▇ Boskamp`s
declaration pursuant to Article 3.1.
(b) lump sum fees (each a "Patent Fee") for the first patent to issue
arising from the applications contained in Schedule B which is validly granted
to Nastech in a country of the Exclusive Territory as further described in
Schedule C. The Patent Fees will only be payable upon the valid issuance to
Nastech of each patent in the countries mentioned in Schedule C.
3.3 Royalty Payments. For sales of the Product in those countries of the
Exclusive Territory where a patent concerning the Patent Rights has been validly
granted to Nastech, ▇▇▇▇ Boskamp shall pay [***] royalties to Nastech equal to
[***] of the Net Sales of the Products in the respective country (the
"Royalties"). For sales of the Product in those countries of the Exclusive
Territory where a patent is pending concerning the Patent Rights, ▇▇▇▇ Boskamp
shall pay royalties to Nastech equal to [***] of the Net Sales of the Products
in the respective country (the "Royalties"). [***] royalties or fees have to be
paid by ▇▇▇▇ Boskamp for the sales of the Product in the Territory.
[***] Confidential treatment has been requested for privileged and confidential
commercial and financial information, pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended. Omitted portions have been
filed separately with the Commission.
3.4 Payment of Royalties. Royalties shall be paid within forty-five (45)
days of the last business day of each calendar quarter, in arrears, by bank or
cashier's check or other immediately available funds in United States dollars in
New York, New York, or at such other place as Nastech may reasonably designate
to ▇▇▇▇ Boskamp in writing consistent with applicable laws and regulations in
all relevant jurisdictions. If any currency conversion shall be required in
connection with the payment of Royalties, such conversion shall be made by using
the average of the official exchange rate announced by
02-08-2001 - Page 7 of 24
New York Federal Reserve Bank (source ▇▇▇.▇-▇▇▇▇▇.▇▇▇) on the last business day
of each calendar month of the quarterly period to which such Royalty payments
relate.
3.5 Records and Audit. ▇▇▇▇ Boskamp, its Affiliates and sublicensees shall
keep full, true and accurate books of account containing all particulars that
may be necessary for the purpose of showing the amounts payable to Nastech as
Royalties. Such books of account shall be kept at ▇▇▇▇ Boskamp's principal place
of business or the principal place of business of the appropriate Affiliate or
sublicensee of ▇▇▇▇ Boskamp to which this Agreement relates. Such books and the
supporting data shall be open, at all reasonable times and upon reasonable
written notice during the term of this Agreement and for two (2) years after its
termination, to the inspection of a firm of certified public accountants
selected by Nastech and acceptable to ▇▇▇▇ Boskamp, which consent shall not be
unreasonably withheld (the cost of which is to be paid by Nastech), for the
purpose of verifying ▇▇▇▇ Boskamp's Royalty statements; provided, however, that
such examination shall not take place more often than once each calendar year
and shall not cover more than the preceding three (3) years, with no right to
audit any period previously audited. In the event that any such inspection
reveals a deficiency in excess of 5% of the reported Royalty for the period
covered by the inspection, ▇▇▇▇ Boskamp shall promptly pay Nastech the
deficiency, plus interest at 8% per annum, and shall reimburse Nastech for the
fees and expenses paid to such accountants in connection with their inspection.
The parties agree that neither party shall be required to retain books and
records with respect to the above other than books and records relating to the
current calendar year and the immediately preceding three (3) calendar years.
3.6 Quarterly Reports of Royalties. ▇▇▇▇ Boskamp shall within thirty (30)
days after the end of each calendar quarter, deliver to Nastech true and
accurate reports, certified by an authorized official of ▇▇▇▇ Boskamp, giving
such particulars of the business conducted during the preceding three-month
period under this Agreement as shall be pertinent to a Royalty accounting
hereunder. Such reports shall include the following: Net Sales of ▇▇▇▇ Boskamp,
its Affiliates and sublicensees, as applicable, total Royalties due, and if any
currency conversion is required, a copy of the official exchange rate under
Article 3.4, as applicable. If no Royalties shall be due, ▇▇▇▇ Boskamp shall so
report.
3.7 Overdue Payments. The Royalty payments set forth in this Agreement
shall, if overdue, bear interest until payment at a per annum rate equal to one
and a half percent (1-1/2%) above the base rate of the European Central Bank on
the due date, not to exceed the maximum permitted by law. The payment of such
interest shall not preclude Nastech from exercising any other rights it may have
as a consequence of the lateness of any Royalty payment.
02-08-2001 - Page 8 of 24
ARTICLE IV - DEVELOPMENT PROGRAM
4.1 Development Program. In the event that ▇▇▇▇ Boskamp serves notice to
Nastech of its intention to use the rights privileges and licenses granted under
Article II hereof pursuant to Article 3.1, ▇▇▇▇ Boskamp shall promptly commence
a development program with respect to the Nasal Morphine Technology and ▇▇▇▇
Boskamp agrees to use reasonable efforts to effect introduction of the Product
(by itself or through third parties) into the commercial market in one or
several countries of the Exclusive Territory as soon as practicable and in a
manner consistent with its development program and ▇▇▇▇-▇▇▇▇▇▇▇`s sound and
reasonable business practices and judgment.
4.2 Development Costs. ▇▇▇▇ Boskamp will bear the costs of and be
responsible for the development program, including without limitation completing
any formulations, preclinical and clinical studies required to obtain regulatory
approval of the Products including the Chemistry and Manufacturing Section,
clinical and regulatory costs and expenses.
4.3 Preclinical and Clinical Data. ▇▇▇▇ Boskamp will provide Nastech, at
no cost to Nastech, with any and all preclinical and clinical data generated by
▇▇▇▇ Boskamp as part of ▇▇▇▇ Boskamp's development of the Nasal Morphine
Technology, including any dossier prepared by ▇▇▇▇ Boskamp to obtain regulatory
approval. Additionally ▇▇▇▇ Boskamp shall provide Nastech at no cost with all
rights necessary to commercialize the Product outside the Exclusive Territory.
Nastech shall be free to use such data and information solely for the purpose of
developing and marketing the Products outside of the Exclusive Territory.
Nastech will provide ▇▇▇▇ Boskamp, at no cost to ▇▇▇▇ Boskamp, with any and all
preclinical and clinical data on the Nasal Morphine Technology in the possession
of Nastech. ▇▇▇▇ Boskamp shall be free to use such data and information for the
purpose of developing and marketing the Products in the Territory and Exclusive
Territory.
ARTICLE V - PATENT PROSECUTION
5.1 Nastech's Responsibility for Patent Prosecution. Nastech shall
prosecute, file and maintain all Patent Rights in the Exclusive Territory.
Nastech shall provide a copy of all relevant correspondence relating thereto to
▇▇▇▇ Boskamp.
02-08-2001 - Page 9 of 24
5.2 Payment of Fees. Subject to the stipulations in Article 3.2 above,
payment of all fees and costs relating to the filing, prosecution, and
maintenance of the Patent Rights in the Exclusive Territory, including costs for
invalidity proceedings, shall be the responsibility of Nastech.
5.3 Right of ▇▇▇▇ Boskamp to Prosecute Patent Applications.
(a) If Nastech or any of its Affiliates or sub-licensees elects not
to seek or continue to seek, use or maintain patent protection on any of the
Patent Rights in the Territory, ▇▇▇▇ Boskamp shall have the right but no
obligation to file, procure or maintain, in its own name and at its own costs,
the patents in such countries of the Territory and ▇▇▇▇ Boskamp shall provide a
copy of all relevant correspondence relating thereto to Nastech. The same
principles shall apply if Nastech or any of its Affiliates or sub-licensees
elects not to file a patent application or application for certificate of
invention, not to maintain a patent or certificate of invention, or to abandon a
pending patent application or application for a certificate of invention in the
Territory. In such a case ▇▇▇▇ Boskamp shall have the right but no obligation to
file in its own name such application, maintaining such patent or certificate of
invention or continuing to attempt to obtain protection on the subject matter
disclosed in such pending application. Nastech undertakes to assign to ▇▇▇▇
Boskamp all rights needed for the filing, use or maintaining of such patents in
the name of ▇▇▇▇ Boskamp and undertakes to make all necessary declarations in
this respect. In connection with the foregoing ▇▇▇▇ Boskamp, however: (i) shall
notify Nastech as required by Article 8.1(e), and (ii) shall not include in such
patent applications any more of the Know-How than is required to be disclosed by
any patent examining authority or than Nastech has previously included in a
patent application (where such patent application was or is required to be
published by any patent examining authority). In the event ▇▇▇▇ Boskamp
determines to disclose any additional Know-How in such patent application, ▇▇▇▇
Boskamp and Nastech shall mutually agree the extent of Know-How to be disclosed
in such patent application. Each party shall sign or use its best efforts to
have signed all legal documents necessary to file and prosecute patent
applications or applications for certificates of invention or to obtain or
maintain patents or certificates of invention at no charge to the other party.
(b) Nastech agrees to advise ▇▇▇▇ Boskamp in writing at least one
hundred and twenty (120) days in advance of ceasing not to pursue patent
protection on any of the Patent Rights in the Exclusive Territory and to provide
▇▇▇▇ Boskamp with all documentation needed by ▇▇▇▇ Boskamp in order to allow
▇▇▇▇ Boskamp to protect its rights under this Article 5.3 in the Exclusive
Territory.
02-08-2001 - Page 10 of 24
(c) In case that ▇▇▇▇ Boskamp seeks, uses or maintains patent protection
pursuant to Article 5.3 (a) above, ▇▇▇▇ Boskamp shall grant Nastech a
non-exclusive, non-transferable license to use such patents outside of the
Exclusive Territory.
ARTICLE VI - INFRINGEMENT
6.1 Notice of Alleged Infringement. Each party shall inform the other
party promptly in writing of (i) any alleged or suspected infringement of the
Nasal Morphine Technology by a third party, or (ii) any unauthorized use or
misappropriation of the Nasal Morphine Technology by a third party of which it
becomes aware, and shall provide the other party with any available evidence
thereof.
6.2 Infringement of Nasal Morphine Technology. During the term of this
Agreement, Nastech shall defend and prosecute at its own expense all material
infringements of the Patent Rights or any material misappropriation of the
Know-How relating to the Products that affect use of the Product in the
Exclusive Territory. Nastech shall have the sole and exclusive right to select
counsel and shall pay all expenses including without limitation, attorney's fees
and court costs. Nastech shall keep any recovery or damages for past
infringement or misappropriation derived therefrom as long as such infringements
or misappropriations do not affect the use of the Patent Rights in the Exclusive
Territory after the Effective Date. In case that an infringement or
misappropriation affects the use of the Products in the Exclusive Territory
after the Effective Date, any recovery or damages shall be shared between the
parties in proportion to the damages each party incurs as a result of such
infringement or misappropriation. At Nastech's request, ▇▇▇▇ Boskamp shall offer
reasonable assistance to Nastech subject to reimbursement of ▇▇▇▇ Boskamp by
Nastech of reasonable out-of-pocket expenses incurred in rendering such
assistance.
6.3 Third Party Rights. If ▇▇▇▇ Boskamp is ordered to stop or otherwise
prevented from using the Nasal Morphine Technology, until such time as Nastech
may secure that such order is lifted or the relevant encumbrance removed, ▇▇▇▇
Boskamp shall be entitled to immediately stop the payment of the Royalties,
provided however, that no royalties paid up to this point shall be repaid by
Nastech. In addition, Nastech shall indemnify ▇▇▇▇ Boskamp in respect of all and
any damages ▇▇▇▇ Boskamp incurs or becomes liable to pay as a result of any such
order being made.
02-08-2001 - Page 11 of 24
ARTICLE VII - INDEMNIFICATION AND REPRESENTATIONS
7.1 Indemnification.
(a) ▇▇▇▇ Boskamp shall defend, indemnify and hold harmless Nastech
from and against all losses, liabilities and expenses (including reasonable
attorneys' fees) for (i) personal injury or property damage to a third party
arising out of the use of the Products manufactured or marketed by ▇▇▇▇ Boskamp,
its Affiliates or sublicensees insofar as any such claim for loss, liability and
expense is based upon product liability or negligence of ▇▇▇▇ Boskamp, its
Affiliates or sublicensees in the manufacture or marketing of such Product or
(ii) any suit or proceeding brought against Nastech insofar as such suit or
proceeding is based on a claim that any additional technology, methods or
compositions which have been incorporated into or made a part of the Products by
▇▇▇▇ Boskamp constitutes an infringement of any patent, copyright, trade secret
or other intellectual property right of any person other than Nastech or ▇▇▇▇
Boskamp. Nastech shall give ▇▇▇▇ Boskamp prompt written notice of any such
claim. ▇▇▇▇ Boskamp shall be entitled to assume complete control of the defense
of such claim. Nastech shall render such assistance to ▇▇▇▇ Boskamp as may be
reasonably requested by ▇▇▇▇ Boskamp and ▇▇▇▇ Boskamp shall reimburse Nastech
for its reasonable out-of-pocket expenses incurred in rendering such assistance.
(b) Nastech shall defend, indemnify and hold harmless ▇▇▇▇ Boskamp
from and against all losses, liabilities and expenses (including reasonable
attorneys' fees) for (i) personal injury or damage arising out of the use of the
Products manufactured or marketed by Nastech, its Affiliates or licensees
provided the claim for such loss, liability and expense is based upon product
liability or negligence of Nastech, its Affiliates or licensees in the
manufacture or marketing of such Product or (ii) any suit or proceeding brought
against ▇▇▇▇ Boskamp insofar as such suit or proceeding is based on a claim that
the Nasal Morphine Technology or any Product (save to the extent that the
Product concerned, or any part thereof, has been developed as a result of
additional technology methods or compositions of ▇▇▇▇ Boskamp) constitutes an
infringement of any patent, copyright, trade secret or other intellectual
property right of any person other than Nastech or ▇▇▇▇ Boskamp. ▇▇▇▇ Boskamp
shall give Nastech prompt written notice of any such claim. Nastech shall be
entitled to assume complete control of the defense of such claim. ▇▇▇▇ Boskamp
shall render such assistance to Nastech as may be reasonably requested by
Nastech and Nastech shall reimburse ▇▇▇▇ Boskamp for its reasonable
out-of-pocket expenses incurred in rendering such assistance.
02-08-2001 - Page 12 of 24
7.2 Adverse Events and Product Recall. ▇▇▇▇ Boskamp shall be responsible
for and maintain a database of any and all reported adverse events associated
with the use of the Products in the Exclusive Territory. Reports shall be
provided to Nastech upon request. ▇▇▇▇ Boskamp shall be responsible for any and
all product recall(s) issued by a government agency or other proper authority
within the Exclusive Territory. ▇▇▇▇ Boskamp shall assume the costs associated
with compliance with any such recall. The same shall apply for Nastech in
connection with the Products manufactured or marketed by Nastech, its Affiliates
or licensees outside of the Exclusive Territory. Reports shall be provided to
▇▇▇▇ Boskamp upon request.
7.3 Liability Insurance. In the event that the parties manufacture or
market Products, then prior to the manufacture or introduction of such Products,
they shall obtain and carry in full force and effect adequate product liability
insurance deemed reasonable and customary within the country of the Territory
concerned.
7.4 Representations re Organization; Corporate Action; No Conflicts. Each
of Nastech and ▇▇▇▇ Boskamp severally represents and warrants that it is a duly
organized and validly existing corporation and/or partnership under the laws of
its jurisdiction of incorporation, and has taken all required corporate action
to authorize the execution, delivery and performance of this Agreement; it has
the full right, power and authority to enter into this Agreement and perform all
of its obligations hereunder; the execution and delivery of this Agreement and
the consummation of the transactions contemplated herein do not violate,
conflict with, or constitute a default under its charter or similar
organizational document, its by-laws or the terms or provisions of any material
agreement or other instrument to which it is a party or by which it is bound, or
any order, award, judgment or decree to which it is a party or by which it is
bound; and upon execution and delivery, this Agreement will constitute the
legal, valid and binding obligation of it.
7.5 Nastech's Representations and Warranties. Nastech hereby represents
and warrants that as of the Effective Date (i) to the best of its knowledge, the
use or practice of the Nasal Morphine Technology does not infringe any patent
right owned by any third party, (ii) Nastech is the sole record and beneficial
owner of the Nasal Morphine Technology and (iii) that Nastech has not granted
any other licenses or rights of any kind in the Nasal Morphine Technology to any
third party. The parties expressly acknowledge, however, that except as
otherwise expressly set forth in this Agreement, Nastech does not warrant the
actual enforceability of any patent or patent application which may be a part of
the Patent
02-08-2001 - Page 13 of 24
Rights or Know-How nor does Nastech warrant or covenant as to the commercial
viability or success of the Products.
7.6 Limitation of Liability.
EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NASTECH AND ▇▇▇▇
BOSKAMP MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY OF PATENT RIGHTS OR PATENT
CLAIMS, ISSUED OR PENDING OR AS TO THE COMMERCIAL VIABILITY OF THE PRODUCTS.
EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT AND EXCEPT FOR A
BREACH OR DEFAULT OF THIS AGREEMENT BY EITHER PARTY, INCLUDING BUT NOT LIMITED
TO THE REPRESENTATIONS AND WARRANTIES AND CONFIDENTIALITY AND NON-DISCLOSURE SET
FORTH HEREIN, NEITHER ▇▇▇▇ BOSKAMP NOR NASTECH, AS BETWEEN EACH OTHER, SHALL
HAVE ANY LIABILITY FOR DAMAGES OF ANY KIND, INCLUDING SPECIAL, PUNITIVE,
INDIRECT OR CONSEQUENTIAL DAMAGES, LOST PROFITS, LOSS OF GOODWILL, OR OTHER
ECONOMIC LOSS (WHETHER IN TORT, CONTRACT OR OTHERWISE) IN CONNECTION WITH THIS
AGREEMENT OR WITH RESPECT TO THE PATENT RIGHTS OR KNOW-HOW OR AS TO THE
COMMERCIAL VIABILITY OF THE PRODUCTS.
02-08-2001 - Page 14 of 24
ARTICLE VIII - CONFIDENTIALITY AND NON-DISCLOSURE
8.1 Confidential Treatment of Information. Except as otherwise provided in
this Article VIII, each of Nastech and ▇▇▇▇ Boskamp (on behalf of themselves and
each of their respective Affiliates) agrees to retain in strict confidence any
proprietary confidential information and trade secrets of the other party,
whether disclosed prior to or after the date hereof, and not to use or disclose
to third parties, and to use its best efforts to cause its employees, agents or
consultants not to use or disclose to third parties, such proprietary
confidential information and trade secrets to or for any third party without the
prior approval in writing of a duly authorized officer of the other party,
unless one or more of the following conditions exist:
(a) Such information has been previously published and is a matter
of public record or otherwise in (or becomes available in) the public domain
through no fault of such party.
(b) Such information has been previously known to the recipient of
the information and such recipient can prove this fact by documents dated prior
to the date of disclosure of such information to the recipient by the other
party;
(c) Such information shall hereafter become known to the recipient
by its own independent development or from a source other than the other party
(through no violation of any confidentiality agreement or obligation between
such other party and any other person);
(d) Such information is required by law to be disclosed, whether
pursuant to the statutes, rules and regulations of the Food and Drug
Administration, the Securities and Exchange Commission or any other foreign,
federal or state governmental agency or administrative body; or
(e) Such information shall hereafter be published by a patent
examining authority as required by law in connection with any pending patent
application within the Patent Rights; provided, however, that ▇▇▇▇ Boskamp shall
notify Nastech in writing at least sixty (60) days in advance of filing any
patent application in any country in which the provisions of this Article 8.1(e)
may be invoked.
8.2 Disclosure Required by Law or Regulation. Except as may be required by
law or regulation, or in response to a valid subpoena, or as required by
generally accepted accounting principles or required by Nastech or ▇▇▇▇ Boskamp
in connection with its filings with any governmental authorities,
02-08-2001 - Page 15 of 24
including the Securities and Exchange Commission or any similar governmental
body of any foreign jurisdiction, none of the parties hereto shall disclose the
terms of this Agreement without the prior written consent of the other party
hereto, except that (a) upon Effective Date, the parties may jointly issue a
press release; (b) the parties may state that ▇▇▇▇ Boskamp is licensed by
Nastech under the Nasal Morphine Technology. Without limiting the foregoing
sentence, it is understood that (i) Nastech may make reasonable disclosure of
this Agreement, at its own discretion, and the financial and other terms hereof
in its Form 10-K, Form 10-Q and the footnotes to its financial statements, (ii)
Nastech may, at its discretion, file this Agreement as an exhibit to its Form
10-K or Form 10-Q; (iii) Nastech may, describe royalties received by it under
this Agreement in the "Management's Discussion and Analysis of Financial
Condition and Results of Operations" section of its filings with the Securities
and Exchange Commission.
8.3 Disclosure of Know-How, Etc. Each party shall not disclose any
confidential information or trade secrets relating to the Nasal Morphine
Technology to any third party unless (i) prior to such disclosure the third
party enters into a confidentiality agreement with such party with
confidentiality provisions on substantially the same terms as contained herein;
and (ii) ▇▇▇▇ Boskamp receives written consent from Nastech and such consent
shall not be unreasonably withheld; or (iii) one or more of the exceptions set
forth in Article 8.1 apply.
8.4 Survival of Confidentiality Obligations. The confidentiality
obligations of parties shall remain binding on both parties for a period of
sixty (60) calendar months after the termination or expiration of this
Agreement, regardless of the cause of termination. The parties acknowledge that
any breach of this Article VIII will constitute irreparable harm, and that
either party shall be entitled to specific performance or injunctive relief to
enforce this Article VIII in addition to whatever remedies such party may
otherwise be entitled to at law or in equity.
ARTICLE IX - ASSIGNMENT
Assignment. Notwithstanding the right to grant sublicenses under Article 2.3
above, ▇▇▇▇ Boskamp shall not assign any of its rights hereunder without the
prior written consent of Nastech; provided, however, ▇▇▇▇ Boskamp shall have the
right, without the prior written consent of Nastech, to assign its rights
hereunder to another entity (an "Acquiror") in connection with the transfer or
sale of all or substantially all of its assets to such Acquiror, the sale of all
or substantially all of its shares to such Acquiror, or the merger or
consolidation of it into or with such Acquiror, or any similar transaction (an
"Acquisition"); provided, that the Acquiror shall agree in writing to be bound
by the terms and conditions of this
02-08-2001 - Page 16 of 24
Agreement and to assume all of its obligations hereunder. ▇▇▇▇ Boskamp agrees
that it shall not sublicense the Nasal Morphine Technology to any third party
where the effect of such sublicense is an assignment of all of its rights and a
delegation of all its obligations under this Agreement.
ARTICLE X - TERM AND TERMINATION
10.1 Term. This Agreement becomes effective upon the Effective Date and
shall continue to be in force until, whatever is later, (i) for each country of
the Territory and Exclusive Territory, separately, for as long as a patent under
the Nasal Morphine Technology is in existence in the respective country, or (ii)
a period of ten (10) years from the first introduction of the Product in the
market of the Territory and Exclusive Territory.
10.2 Termination by ▇▇▇▇ Boskamp. ▇▇▇▇ Boskamp is entitled to terminate
this Agreement, at its free discretion, for whatever reason after completion of
its evaluation pursuant to Article 3.1. A termination of this Agreement under
this provision shall not entitle Nastech to any claims whatsoever, in
particular, but not limited to, any claims for compensation of damages, costs or
expenses.
10.3 Termination for Overdue Payments. If ▇▇▇▇ Boskamp fails to pay
Nastech any amounts due and payable to Nastech hereunder, Nastech shall give
▇▇▇▇ Boskamp prompt written notice of such overdue payment. If such overdue
payments are not made by ▇▇▇▇ Boskamp within thirty (30) days after delivery of
such notice, Nastech shall have the right to (i) terminate this Agreement
immediately and institute an action to collect such amounts or (ii) institute an
action to collect such amounts without terminating this Agreement.
10.4 Termination for Material Breach or Default. Upon any material breach
or default under this Agreement by ▇▇▇▇ Boskamp, other than those occurrences
described in Articles 10.3 above, or upon any material breach or default under
this Agreement by Nastech, the party not in default or breach (the
"Non-Breaching Party") may (i) terminate this Agreement upon sixty (60) days
written notice to the party in default or breach (the "Breaching Party"), with
such termination to become effective upon expiration of said sixty (60) day
period, unless within said sixty (60) day period the Breaching Party shall have
cured such breach or default, or (ii) seek specific performance of this
Agreement. Seeking specific performance or damages shall not constitute or
provide grounds for termination of this Agreement.
02-08-2001 - Page 17 of 24
10.5 Performance Obligation of ▇▇▇▇ Boskamp
In the event ▇▇▇▇ Boskamp fails to file the regulatory dossier in one country of
the Exclusive Territory on or before 1 June 2004, Nastech shall receive
non-exclusive marketing rights in the Exclusive Territory.
10.6 Rights Upon Termination.
(a) Upon termination of this Agreement by Nastech due to a material breach
of this Agreement by ▇▇▇▇ Boskamp all right and interest of ▇▇▇▇ Boskamp in and
to the Nasal Morphine Technology shall revert to Nastech; provided, however,
▇▇▇▇ Boskamp may sell all Products held in inventory or in the process of
production at the time of such termination, provided that ▇▇▇▇ Boskamp shall pay
to Nastech any payments or amounts which would have been required to be paid
under this Agreement through the date of final sale of all Products.
(b) Upon expiration of the term of this Agreement pursuant to Article 10.1
or in case of a material breach of this Agreement by Nastech pursuant to Article
10.4, ▇▇▇▇ Boskamp shall have a fully paid-up, royalty free license to use the
Nasal Morphine Technology in the Exclusive Territory. Upon expiration of the
term of this Agreement pursuant to Article 10.1 both parties shall equally be
entitled to use the Nasal Morphine Technology within the Territory and Exclusive
Territory.
(c) Upon mutual termination of this Agreement by the parties, the rights
upon such termination shall be mutually agreed to by the parties.
10.7 Survival of Specified Obligations. Notwithstanding anything to the
contrary stated in this Agreement, no termination of this Agreement shall
terminate (i) any obligation of either party pursuant to Articles 2.5, VII,
VIII, 10.6 (b), 10.7 and Article XI of this Agreement or (ii) any obligation of
▇▇▇▇ Boskamp under Article III with respect to sales of Products made prior to
termination of this Agreement. Upon termination of this Agreement for any
reason, nothing herein shall be construed to release either party from any
obligation that matured or accrued prior to the effective date of such
termination.
02-08-2001 - Page 18 of 24
ARTICLE XI - BANKRUPTCY
11.1 No Termination. The parties agree that the rights, privileges and
licenses granted under this Agreement shall not be affected by a petition in
bankruptcy or for the institution of composition proceedings with respect to a
party or if a trustee is appointed (a "Bankruptcy") as long as both parties
continue to fulfill their contractual obligations. A Bankruptcy shall not
entitle any party to terminate this Agreement. Both parties acknowledge that
this Agreement is an executory contract subject to Section 365 (n) of the U.S.
Bankruptcy Code.
11.2 Assignment. Nastech hereby assigns to ▇▇▇▇ Boskamp all rights,
privileges and licenses granted under Article II, including, but not limited to,
all rights and interests in connection with the Know How and the Patent Rights
and ▇▇▇▇ Boskamp accepts this assignment. This assignment, however, is
contingent to and shall only shall have effects in case of a Bankruptcy of
Nastech.
11.3 Regulatory Approvals. In case of a Bankruptcy of ▇▇▇▇-▇▇▇▇▇▇▇,
Nastech shall be entitled to use all regulatory approvals of ▇▇▇▇-▇▇▇▇▇▇▇ for
the distribution of the Products.
ARTICLE XII - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
Notices. Any notices or other communications pursuant to this Agreement shall be
in writing and shall be delivered (i) by express overnight courier service (it
being understood that payments to Nastech shall be wire transferred to Nastech's
bank account specified by Nastech with a copy of a notice of wire transfer sent
as set forth in this Article XII or (ii) by facsimile transmission (with
confirming copy to follow by express overnight courier service):
(a) if to ▇▇▇▇ Boskamp, at ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇, D-25551
Hohenlockstedt, Germany, Attention: Geschaftsfuhrung, or at such other address
or addresses as may have been furnished in writing by ▇▇▇▇ Boskamp to Nastech;
or
(b) if to Nastech at ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇,
Attention: President, with a copy to General Counsel, or at such other address
or addresses as may have been furnished in writing by Nastech to ▇▇▇▇ Boskamp.
02-08-2001 - Page 19 of 24
Notices provided in accordance with this Article XII shall be deemed
delivered upon receipt of the notice by the party being sent the notice.
Article XIII - FORCE MAJEURE
The parties hereto shall not be liable for any damage if the performance of all
or parts of this Agreement is hindered or prevented by causes beyond the
performing party's control and without its fault or negligence, including but
not limited to acts of God or of public enemy, nuclear incidents, acts, laws,
orders or regulations of any government or department or agency thereof acting
in either its sovereign or contractual capacity, fires, floods, epidemics,
quarantine restrictions, strikes, work stoppages, slowdowns or other job
actions, freight embargoes, shortages of fuel or other items, delays in
transportation, boycotts, unusually severe weather and riots, insurrections,
revolutions, wars or other civil or military disturbances.
ARTICLE XIV - MISCELLANEOUS PROVISIONS
14.1 Governing Law. This Agreement shall be construed, governed,
interpreted and applied in accordance with the laws of England, except that
questions affecting the construction and effect of any patent shall be
determined by the law of the country in which the patent was granted. Any legal
action or proceeding arising out of or relating to this Agreement shall be
determined by the English courts in London. Except where clearly prevented by
the area in dispute, both parties agree to continue performing their respective
obligations under this Agreement while the dispute is being resolved.
14.2 Entire Agreement; Modification. The parties hereto acknowledge that
this Agreement and all Schedules hereto set forth the entire agreement and
understanding of the parties hereto as to the subject matter hereof, and shall
not be subject to any change or modification except by the execution of a
written instrument subscribed to by the parties hereto.
14.3 No Waiver. The failure of either party to assert a right hereunder or
to insist upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other party.
14.4 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.
02-08-2001 - Page 20 of 24
14.5 Independent Contractors. The parties hereto are independent
contractors and nothing contained in this Agreement shall be deemed to create
the relationship of partners, joint venturers, or of principal and agent,
franchisor and franchisee, or of any association or relationship between the
parties other than as expressly provided in this Agreement. ▇▇▇▇ Boskamp
acknowledges that it does not have, and ▇▇▇▇ Boskamp shall not make
representations to any third party, either directly or indirectly, indicating
that ▇▇▇▇ Boskamp has any authority to act for or on behalf of Nastech or to
obligate Nastech in any way whatsoever. Nastech acknowledges that it does not
have, and it shall not make any representations to any third party, either
directly or indirectly, indicating that it has any authority to act for or on
behalf of ▇▇▇▇ Boskamp or to obligate ▇▇▇▇ Boskamp in any way whatsoever.
14.6 Severability. If at any time any provision of this Agreement shall be
deemed to be invalid or unenforceable, then such provision shall be considered
divisible and shall, if possible, consistent with the clear intent of the
parties expressed by this written Agreement, become and be immediately amended
to the extent necessary to make it valid and enforceable by the court or other
body having jurisdiction over this Agreement, but only to the extent that such
divisibility and amendment does not cause this Agreement to fail of its
essential purpose; and the parties expressly agree that such provision, as so
amended, shall be valid and binding as though any invalid or unenforceable
provision had not been included herein. Except as set forth above, the
invalidity or lack of enforceability of any provision of this Agreement shall
not affect the validity and continuing effectiveness of any other provision of
this Agreement.
02-08-2001 - Page 21 of 24
IN WITNESS WHEREOF, the parties hereto have duly executed this License
Agreement under seal as of the day and year set forth above.
NASTECH PHARMACEUTICAL COMPANY INC.
Signed in two exemplars on August 02, 2001
By: ▇▇ ▇▇▇▇▇ ▇▇▇▇
Title: Chief Executive Officer
▇. ▇▇▇▇ BOSKAMP GMBH & CO.
Signed in two exemplars on August 02, 2001
By: ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: President and General Manager
02-08-2001 - Page 22 of 24
Schedule A
Know How
License Agreement between Nastech and ▇▇▇▇ Boskamp - 02-08-2001
o Data about various formulation findings, including stability data
o The final formulation of the morphine nasal solution and the final pump
system
o Stability data of the final formulation in the final container
- At least 12 months stability data according to ICH guidelines
- Specification of the self life (Indicating stability e.g.
content of the active ingredient, absence of degradation
products, pH value, appearance of the solution, etc.)
- Validation of analytical methods
o Data about the content uniformity of the final pump system
o Pilot Phase II Study according to ICH/GCP guidelines
Study includes the data of 13 patients suffering moderate-to-severe
chronic pain with daily episodes of breakthrough pain. Including
validation of the analytical methods e.g. measurement of blood
levels
[Studies presented at International Conference and described in a
press release dated October 12, 2000.]
o Pilot pharmacokinetic studies in healthy volunteers according to
ICH/GCP-guidelines Data of ascending doses of intranasal morphine. Study
results indicate that escalating doses of intranasal morphine show
morphine blood levels in a relatively proportionate fashion. Additionally
Pilot studies of its intranasal morphine sulfate showed rapid peak levels
superior to oral dosage forms and comparable to intramuscular delivery.
[Studies described in a press release dated June 16, 1999]
o Pre-clinical studies according to ICH/GLP-guidelines
- Tolerability studies of the final formulation - and if
available of other formulations in animals
- Pharmacokoinetic studies of the final formulation - and if
available of other formulations - in animals
- Various pharmacological/toxicological studies
o Pre-clinical expert report including literature
02-08-2001 - Page 23 of 24
Schedule B
Patents
License Agreement between Nastech and ▇▇▇▇ Boskamp - 02-08-2001
1. International Application No: PCT/US00/14157
International Publication No: WO/00/76506 A1
International Filing Date: May 23, 2000
Priority Date: June 16, 1999
2. International Application No: PCT/US00/14663
International Publication No: WO/00/76477 A1
International Filing Date: May 26, 2000
Priority Date: June 16, 1999
3. International Application No: PCT/US00/14662
International Publication No: WO/00/76507 A1
International Filing Date: May 26, 2000
Priority Date: June 16, 1999
4. International Application No: PCT/US00/14150
International Publication No: WO/00/76314 A1
International Filing Date: May 23, 2000
Priority Date: June 16, 1999
(granted as US patent 6,225,343 dated May 1, 2001)
02-08-2001 - Page 24 of 24
Schedule C
Patent Fees
License Agreement between Nastech and ▇▇▇▇ Boskamp - 02-08-2001
(a) Austria [***]
Belgium [***]
Denmark [***]
Finland [***]
France [***]
Germany [***]
Greece [***]
Ireland [***]
Italy [***]
Luxembourg [***]
Netherlands [***]
Portugal [***]
Spain [***]
Sweden [***]
United Kingdom [***]
Monaco [***]
(b) Iceland [***]
Liechtenstein [***]
Norway [***]
Switzerland [***]
(c) Estonia [***]
Latvia [***]
Lithuania [***]
Poland [***]
Czech Republic [***]
Slovakia [***]
Hungary [***]
Rumania [***]
Bulgaria [***]
Turkey [***]
Malta [***]
Cyprus [***]
Yugoslavia [***]
Slovenia [***]
Croatia [***]
Bosnia-Herzegovina [***]
Macedonia [***]
[***] Confidential treatment has been requested for privileged and confidential
commercial and financial information, pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended. Omitted portions have been
filed separately with the Commission.