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LICENSE AND SUPPLY AGREEMENT
This LICENSE AND SUPPLY AGREEMENT ("Agreement"), dated as of September 29,1997,
is by and between NASTECH PHARMACEUTICAL COMPANY INC., a Delaware corporation
("Nastech"), and MEDA AB, a Swedish corporation ("Meda").
W I T N E S S E T H
WHEREAS, Nastech is engaged, among other things, in the business of
research, development, manufacturing and commercialization of nasally
administered forms of pharmaceutical products;
WHEREAS, Meda is engaged among other things, through wholly owned
subsidiaries, in the business of marketing and selling of pharmaceutical
products in the ScandiBaltic area;
WHEREAS, Nastech wishes to find a partner in the ScandiBaltic area for
its intranasal cyanocobalamine product and Meda is interested in obtaining
marketing rights in such territory and to obtain a product license in its own
name and at its own expense; and
WHEREAS, subject to the terms and conditions set forth in this
Agreement, Nastech wishes to license to Meda and Meda wishes to license from
Nastech certain rights under certain of the assets which Nastech uses in the
conduct of its intranasal pharmaceutical business;
NOW, THEREFORE, the parties hereto, intending to be legally bound,
hereby agree as follows:
1.0 Definitions
1.1 "Product" shall mean a pharmaceutical preparation in intranasal form
containing cyanocobalamine as the active therapeutic ingredient as well as any
future developments thereof.
1.2 "Territory" shall mean the ScandiBaltic area comprising Sweden,
Denmark, Norway, Finland, Iceland, Estonia, Lithuania, Latvia and Russia.
1.3 "Patents" shall mean letters patent granted and patent applications
pending or filed by Nastech or its Affiliates (or the rights to which have been
assigned to Nastech) as of the date hereof relating to the Product and those
patents set forth on Schedule 6.1 hereto including any patent application or
patent which constitutes an extension, registration, confirmation, reissue,
renewal, reexamination or continuation-in-part of such patent application or
patent.
1.4 "Party", "Parties" mean Nastech, Meda, either Nastech or Meda or both
as the case may be.
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1.5 "Proprietary Information" shall mean the information submitted to the
United States Food and Drug Administration ("FDA") with respect to the
manufacture and regulatory approval of dosage forms of the Product.
1.6 "Effective Date" shall mean the last date of signing this Agreement.
1.7 "Launch Date" shall mean the date when the Product is put on the
market in Sweden.
2.0 Marketing rights
2.1 Nastech hereby grants to Meda a license solely for the purpose of
promoting, marketing, selling and distributing the Product in the Territory.
As long as this Agreement is in force and effect Nastech shall refrain from
granting rights to market and sell the Product in the Territory to any third
party.
2.2 Meda shall market the Product at its choice under a trademark of its
own or under Nastech's trademark "Nascobal", providing that such xxxx can be
registered in the Territory. The proprietary rights to the trademark "Nascobal"
shall be licensed to Meda in the Territory solely for the term of this
Agreement. Meda may use Nastech's name and derivations thereof in promoting,
marketing and selling the Product in the Territory; provided, however, that the
particular formulation of any reference to Nastech's name in any promotional
material shall be subject to Nastech's review and consent.
2.3 The licenses granted herein shall not be sublicensed by Meda without
the prior written consent of Nastech, except that Meda shall have the right to
sub-license its rights to its wholly owned subsidiaries in the Nordic countries
as well as to MediNet International Ltd. within the Baltic countries and
Russia.
2.4 Anything herein contained to the contrary notwithstanding, Nastech
shall retain at all times during the term of this Agreement, and shall bear all
costs associated with, all rights necessary: (a) to manufacture, or to have
manufactured, the Product for Meda hereunder and otherwise fulfill its
obligations under this Agreement, (b) to manufacture or have the Product
manufactured in the Territory, (c) to make such changes as Nastech may deem
reasonably appropriate in connection with any differing approach to
manufacturing it may adopt in a facility(ies) in which any of the components of
the Product are produced, as long as Meda is furnished with necessary
regulatory documentation as to enable Meda to obtain required regulatory
approval prior to the introduction of any modified Product.
2.5 Meda shall use reasonable and adequate efforts to market the Product
in the Territory. Meda shall direct its marketing efforts to the Territory only
and shall refrain from seeking customers, from establishing any branch and from
maintaining any distribution depot in any
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country outside the Territory. Any inquiries or orders received from customers
outside the Territory, shall be forwarded from Meda to Nastech, however solely
for information purposes.
3. Purchase of the Product; Other Obligations
3.1 During the term of this Agreement, Meda agrees to purchase from
Nastech and Nastech agrees to supply Meda with all of its requirements for the
Product for its subsequent use, sale, lease or transfer by Meda. Nastech
assumes the obligation to supply the Product to Meda upon firm orders given by
Meda and confirmed by Nastech in sufficient quantities to satisfy Meda's
marketing requirements, provided such requirements do not exceed 120% of the
yearly forecasts submitted by Meda pursuant to Section 3.4.
3.2 Meda assumes the obligation to purchase and receive the Product
exclusively from Nastech. The purchase price and terms of delivery agreed
between the Parties are set out in Schedule 3.2 to this Agreement.
3.3 From the Launch Date and during the term of this Agreement, Meda shall
place minimum quantity orders for the Products as follows:
3.3.1 for the first twelve (12) months from Launch Date eighty (80)
% of the volume forecast according to Clause 3.4 below, shall be guaranteed by
Meda.
3.3.2 for each of the first four (4) calendar years, following the
expiry of the twelve (12) months period according to Clause 3.3.1, at least
fifty (50) %, calculated during a period of two (2) consecutive calendar years
of the purchase volume according to the renegotiated forecast in Clause 3.4.2
below, shall be guaranteed by Meda.
3.3.3 if Meda during any period of two (2) consecutive calendar
years of the period in Clause 3.3.2 should fail to reach at least (fifty) 50%
of the volume forecast, then Nastech is entitled to terminate this Agreement by
giving (12) months notice in writing to Meda, always provided that Nastech
exercises its rights to terminate not later than March 31 following the end of
such period of two calendar years. In this event, such termination shall be
in full and final settlements of Meda's obligations regarding such minimum
anticipated quantities. Nastech shall, however, give Meda an opportunity to
explain the reasons for the failure to perform under the minimum obligations
and Nastech shall take them into consideration.
3.4 During the term of this Agreement Meda shall submit to Nastech written
forecast of the quantity of the Product, which Meda anticipates to purchase
from Nastech as follows:
3.4.1 For the period of twelve (12) months from Launch Date, this
forecast to be
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submitted not later than fourteen (14) days from CPMP approval being obtained
in each country, together with a preliminary forecast for the subsequent four
(4) calendar years.
3.4.2 Following the expiry of the first twelve (12) month period
from Launch Date, the Parties shall in good faith renegotiate the anticipated
volume to be purchased during the following four (4) calendar years.
3.4.3 In addition thereto, Meda shall submit to Nastech in July of
every year during the term of this Agreement a revised written forecast of the
quantity of the Product which Meda anticipate to purchase during the next
calendar year. These forecasts will, if necessary be revised in each
succeeding quarter.
3.4.4 If, at any time, Meda should find that a given forecast is
inaccurate, Meda shall inform Nastech thereof without delay and submit a
modified forecast for the period in question.
3.4.5 Should Meda be exposed to competition within the Territory or
in any individual country thereof from generic versions of the Product or other
directly competing products in intranasal form, Meda shall have the right to
ask for renegotiation in good faith of the terms of this Agreement in order to
reflect Meda's new position on the market. Should the parties fail to reach an
agreement within three (3) months from Meda's request for renegotiation, either
Party may terminate this Agreement prematurely by giving twelve (12) months
notice in writing to the other Party.
3.5 Upon the written request of Nastech, Meda shall apply for and obtain
marketing authorization for the Product in the Territory in its own name and at
its own cost. Nastech shall reasonably cooperate and provide Meda with such
Proprietary Information, to the extent such data presently exists and is
possessed by Nastech, as may be necessary to pursue such marketing
authorization. Meda will promptly provide Nastech with copies of, among other
things, all of the following documents, such list is not meant to be
exhaustive: (i) License Application, (ii) License Approval, (iii) Any
communication to and from regulatory authorities, and (iv) Marketing
information relating to reimbursement and other activities.
3.6 Nastech will make its best efforts to promptly make available to Meda
any documentation, clinical results, training material, marketing or promotion
or sales support documentation, developed by Nastech or by other licensees of
Nastech.
4.0 Warranties
4.1 Nastech assumes the obligation to manufacture the Product in
accordance with the health registration granted by the health authorities in
the Territory for the Product. Nastech will submit a sample of the Product to
Meda for its approval ("Approved Samples") and shall make available
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to Meda a certificate of analysis for every Production batch of Product
supplied to Meda. Nastech warrants that the Product supplied to Meda will
conform to the Approved Samples and will be manufactured in accordance with
applicable good manufacturing practices as promulgated by the proper
authorities within each country of the Territory. Meda's sole remedy for
breach of warranty shall be to require Nastech to replace any Product that does
not substantially conform to the Approved Samples. In no event shall Nastech be
liable to Meda for consequential or incidental damages including, without
limitation, expenditures of any kind, loss of profits or prospective profits of
any kind. Nastech HEREBY DISCLAIMS ANY WARRANTY OTHER THAN THOSE SET FORTH
ABOVE WHETHER EXPRESS OR IMPLIED INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY OR WARRANTY THAT THE Product IS FIT FOR ANY SPECIFIC PURPOSE.
4.2 Meda warrants that (i) it will not make any claim either orally or in
writing with respect to the Product which will violate any law in the
Territory, (ii) it shall store and handle the Product according to label and
shipping carton directions or as may be specified from time to time by Nastech,
(iii) all trade names and trademarks which itrequests Nastech to affix to the
Product are either owned by it or it has obtained the legal right to use the
same and it agrees to indemnify and hold Nastech harmless against any claim,
liability, loss, cost, damage, amount paid in settlement and/or reasonable and
actual expense (including, without limitation, the reasonable costs of
investigation and attorney's fees incurred in litigation or otherwise) based
upon the use of any such trade name or trademark.
5.0 Insurance and Indemnification
5.1 Nastech shall name Meda as an additional insured on product liability
insurance it may carry, if any, and shall provide Meda with a certificate of
insurance so naming Meda as an additional insured. The foregoing shall not be
construed to require Nastech to carry Product liability insurance.
5.2 Nastech shall indemnify and hold Meda harmless against any claim,
liability, loss, cost, damage, amount paid in settlement and/or reasonable and
actual expense (including, without limitation, the reasonable costs of
investigation and attorney's fees incurred in litigation or otherwise), to
which Meda may become subject arising out of or based upon the sale or use of
any Product manufactured by Nastech which does not conform to the Approved
Samples; provided Nastech is promptly notified of any such claim and is given
the opportunity to defend the same with counsel of its own choice.
5.3 Meda shall name Nastech as an additional insured on product liability
insurance it may carry, if any, and shall provide Nastech with a certificate of
insurance so naming Nastech as an additional insured. The foregoing shall not
be construed to require Meda to carry product liability insurance.
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5.4 Meda shall indemnify and hold Nastech harmless against any claim,
liability, loss, cost, damage, amount paid in settlement and/or reasonable and
actual expense (including, without limitation, the reasonable costs of
investigation and attorney's fees incurred in litigation or otherwise), to
which Nastech may become subject arising out of or based upon Meda's promotion,
distribution or sale of the Product, including without limitation any claim
made by Meda with respect to the effects of the Product in the marketing of the
Product or by reason of Meda's failure to properly store or handle the Product.
5.5 The Parties shall cooperate in the defense of any claim or suits
against one of them arising out of their activities under this Agreement.
6.0 Patent Rights
6.1 Set forth on Schedule 6.1 hereto is a list of all Patents issued and
applied for by Nastech relating to the Product. Nastech shall be solely
responsible for filing, prosecuting, and maintaining all of the Patents and
Nastech shall pay the costs associated therewith. Nastech shall file,
prosecute, and maintain all Patents so as to fully continue the benefits under
the licenses granted to Meda hereunder. Meda and Nastech agree that, where
applicable, all packaging of the Product shall identify (i) the number of the
Patents and (ii) Nastech as the owner.
6.2 Each party shall promptly notify the other of any alleged infringement
by third parties of any Patent and provide any information available to that
party relating to such alleged infringement. Nastech shall have the
responsibility to investigate such alleged infringement and act diligently to
end any infringement of such rights, including, but not limited to, bringing
suit against such third party infringer. No settlement, consent judgment or
other voluntary final disposition of the suit may be entered into without the
consent of Nastech and any recovery of damages in any such suit shall be
retained by Nastech. In the event of any infringement suit against a third
party brought by Nastech Meda shall cooperate in all respects, execute any
documents reasonably necessary to permit Nastech to prosecute such suit, and to
the extent reasonable shall make available its employees and relevant records
to provide evidence for such suit.
7.0 Payments
7.1 For the marketing rights, the right to refer to the Proprietary
information and the reasonable assistance of Nastech in assisting Meda to
obtain marketing authorizations in the Territory, the following amounts shall
be paid by Meda to Nastech:
7.1.1 Meda shall pay to Nastech a License Fee of USD $350,000.00
(three hundred fifty thousand Dollars) which is payable to Nastech.
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a.) with USD 150.000 within seven (7) days from CPMP's
approvals being obtained in Sweden, Denmark, Finland
and Norway,
b.) with USD 50.000 within four (4) months after CPMP
approval or, within seven (7) days from reimbursement
acceptance in the said four countries of the
Territory, whichever occurs first,
c.) with USD 100.000 within seven (7) days from
reimbursement acceptance in Sweden and
d.) with USD 50.000 upon the date of receiving the
initial shipment of the Product from Nastech to Meda.
7.1.2 Nastech shall notify Meda within thirty (30) days of the date
of this Agreement as to whether Meda or another third party licensee of Nastech
will apply for marketing approval under the CPMP or other regulatory procedure.
7.1.3 In the event that Meda is required to perform additional
clinical or pharmaceutical studies to obtain marketing approval it shall
promptly notify Nastech. In the event that Nastech elects for Meda to continue
with the application for marketing approval in the Territory it shall share the
costs of such additional studies equally with Meda and any study so generated
shall be the property of both parties. In the event that Nastech requests Meda
to apply for a license under the CPMP mutual recognition the additional costs
for this will be born by Nastech or their partners in the other territories.
8.0 Nondisclosure
8.1 During the term of this Agreement and thereafter, for a period of
three years, Meda assumes the obligation to maintain in strict confidence all
the information, including but not limited to the Proprietary Information,
received from Nastech hereunder and / or contained in its documentation for
government health registration for the Product, except disclosures to
government bodies for registration purposes. Meda shall impose a similar
secrecy obligation on its employees, consultants and clinicians as well as on
third parties to whom any information is given for the purpose of this
Agreement. Meda shall not sell, disclose or otherwise make available the
health registration documentation to third parties and shall not use it outside
the Territory.
8.2 The following are not subject of the secrecy-obligations hereunder:
8.2.1 information, which at the time of disclosure, is in the public
domain;
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8.2.2 information, which after disclosure, becomes part of the
public domain by publication or otherwise, except by breach of this Agreement
by Meda;
8.2.3 information, which Meda can establish by competent proof, was
in Meda's possession at the time of disclosure by Nastech and was not acquired
either directly or indirectly from Nastech;
8.2.4 information, which Meda receives from a third party, provided
however, that such information was not obtained by said party directly or
indirectly from Nastech;
8.2.5 information, which Meda develops independently of Nastech, as
evidenced in writing.
8.3 During the period of secrecy specified under Section 8.1. Meda shall
not undertake, either directly or indirectly, to develop the manufacture of the
Product based on Nastech's confidential information or otherwise.
9.0 Additional Covenants and Agreements of the Parties
9.1 No liability shall result from delay in performance in whole or in part
hereunder by the occurrence of a contingency, the nonoccurrence of which is
basic assumption on which this Agreement is made, including, but not limited
to, acts of God, fire, flood, accident, riot, war, sabotage, strike, labor
trouble, supply shortage or embargo. If any such circumstances affect only a
part of Nastech's capacity tp perform, quantities affected by this section may,
at the option of either party, be eliminated from the Agreement without
liability, but the Agreement shall remain otherwise unaffected. A party shall
be excused from performance under this Agreement to the extent that and for so
long as such performance is substantially hindered or prevented by causes
beyond its reasonable control; provided, however, that this Section shall not
be construed to excuse performance unless prompt written notice of such
inability xxx perform is given to the other party.
9.2 Meda and Nastech shall jointly develop written procedures and define
responsibilities for (i) the reporting of adverse drug experiences, (ii) the
administration and analysis of and response to complaints concerning the
Product, and (v) the development of training materials related to the Product.
Meda and Nastech shall each comply with the provisions of such written
procedures.
9.3 Meda and Nastech shall each comply with all laws and regulations
applicable to manufacturing, marketing and selling the Product in the Territory
and the performance of their respective obligations hereunder. Nastech and
Meda each shall keep all records and reports required to be kept by applicable
laws and regulations, and each shall make its facilities available at
reasonable times during business hours for inspection by representatives of
governmental agencies. Nastech and Meda each shall notify the other within
twenty-four (24) hours of receipt
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of any notice or any other indication whatsoever of any governmental agency
inspection, investigation or other inquiry, or other material notice or
communication of any type, involving the Product. Meda and Nastech shall
cooperate with each other during any such inspection, investigation or other
inquiry including, but not limited to, allowing upon request a representative
of the other to be present during the applicable portions of any such
inspection, investigation or other inquiry and providing copies of all relevant
documents.
9.4 If either party shall become engaged in or participate in any
investigation, claim, litigation or other proceeding with any third party,
relating in any way to the Product, the other party shall cooperate in all
reasonable respects with such party in connection therewith, including, without
limitation, using its reasonable efforts to make available to the other such
employees who may be helpful with respect to such investigation, claim,
litigation or other proceeding, provided that, for purposes of this provision,
reasonable efforts to make available any employee shall be deemed to mean
providing a party with reasonable access to any such employee at no cost for a
period of time not to exceed 24 hours (e.g., three 8-hour business days).
Thereafter, any such employee shall be made available for such time and upon
such terms and conditions (including, but not limited to, compensation) as the
parties may mutually agree.
9.5 Nastech and Meda shall each bear their own direct and indirect
expenses incurred in connection with the negotiation and preparation of this
Agreement and, except as set forth in this Agreement, the performance of the
obligations contemplated hereby.
9.6 Nastech and Meda each hereby agrees to use all reasonable efforts to
take, or cause to be taken, all actions and to do, or cause to be done all
things necessary or proper to make effective the transactions contemplated by
this Agreement, including such actions as may be reasonably necessary to obtain
approvals and consents of governmental applicable governmental agencies.
10.0 Duration and Termination
10.1 This Agreement shall commence on the Effective Date and shall
thereafter remain in force, unless terminated prematurely by mutual agreement
or according to Clause 3.3.3 or 3.4.5, 10.1.1 or 10.1.2, up to and including
December 31 of the fifteenth year following the Effective Date. The Agreement
shall thereafter be automatically renewed for another period of two (2) years
each time, unless terminated by either Party giving twelve (12) months notice
in writing to the other Party before the expiry of the initial fifteen (15)
year period or any subsequent extension. Notwithstanding the foregoing, this
Agreement may be terminated prematurely as follows:
10.1.1 If either Nastech or Meda makes a general assignment for
the benefit of creditors or becomes insolvent; (ii) files an insolvency
petition in bankruptcy; (iii) petitions for or acquiesces in the appointment of
any receiver, trustee or similar officer to liquidate or conserve its business
or any substantial part of its assets; (iv) commences under the laws of any
jurisdiction
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any proceeding involving its insolvency, bankruptcy, reorganization, adjustment
of debt, dissolution, liquidation or any other similar proceeding for the
release of financially distressed debtors; or (v) becomes a party to any
proceeding or action of the type described above in (iii) or (iv) and such
proceeding or action remains undismissed or unstayed for a period of more than
60 days, then the other party may by written notice terminate this Agreement in
its entirety with immediate effect.
10.1.2 Nastech and Meda each shall have the right to terminate
this Agreement for default upon the other's failure to comply in any material
respect with the terms and conditions of this Agreement. At least 30 days
prior to any such termination for default, the party seeking to so terminate
shall give the other written notice of its intention to terminate this
Agreement in accordance with the provisions of this Section 10.1.2, which
notice shall set forth the default(s) which form the basis for such
termination. If the defaulting party fails to correct such default(s) within
30 days after receipt of notification, or if the same cannot reasonably be
corrected or remedied within 30 days, then if the defaulting party has not
commenced curing said default(s) within said 30 days and be diligently pursuing
completion of same, then such party immediately may terminate this Agreement.
10.1.3 Termination of this Agreement for any reason shall not
relieve the parties of any obligation accruing prior thereto with respect to
the Product and any ongoing obligations hereunder with respect to the remaining
Product and shall be without prejudice to the rights and remedies of either
party with respect to any antecedent breach of the provisions of this
Agreement. Without limiting the generality of the foregoing, no termination of
this Agreement, whether by lapse of time or otherwise, shall serve to terminate
the obligations of the parties hereto under Sections 5.0, 8.0, 9.0, 10.0 and
11.0 hereof, and such obligations shall survive any such termination.
10.2 In addition to the foregoing, Nastech may terminate this Agreement (i)
in the event that Meda fails to purchase the minimum quantities of the Product
as required by Section 3.3.3 hereof for the time periods specified in that
Section, and (ii) if Meda fails to obtain marketing approval for the Product in
the Territory within twenty four (24) months of the Effective Date of this
Agreement provided such failure is due to Meda's negligence or inability when
handling the registration of application process for Nascobal and further
provided that such failure is not due to Nastech's refusal or failure to
provide necessary Proprietary Information. If terminated in advance Meda may
sell its existing stock of Nascobal.
11.0 General Provisions
11.1 This Agreement shall be binding upon and shall inure to the benefit of
the parties hereto and their respective successors and permitted assigns;
provided, however, that neither Nastech nor Meda may assign any of its rights,
duties or obligations hereunder without the prior written
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consent of the other, which consent shall not be unreasonably withheld, except
that no prior written consent shall be required in the event that a third party
acquires substantially all of the assets or outstanding shares of, or merges
with, Meda or Nastech, as the case may be.
11.2 All notices or other communications required or permitted to be given
hereunder shall be in writing and shall be deemed to have been duly given if
delivered by hand or facsimile and confirmed in writing, or mailed first class,
postage prepaid, by registered or certified mail, return receipt requested
(mailed notices and notices sent by facsimile shall be deemed to have been
given on the date received) as follows:
If to Nastech, as follows:
Nastech Pharmaceutical Company Inc.
00 Xxxxxx Xxxxx
Xxxxxxxxx, Xxx Xxxx 00000
Facsimile: 000-000-0000
Attention: President
If to Meda, as follows:
Meda AB
Xxx 000
X-000 00 Xxxxxxxx
Xxxxxxxxx: x00 00 000 00 00
Attention: President
or in any case to such other address or addresses as hereafter shall be
furnished as provided in this Section 11.2 by any party hereto to the other
party.
11.3 Any term or provision of this Agreement may be waived at any time by
the party entitled to the benefit thereof by a written instrument executed by
such party. No delay on the part of Nastech or Meda in exercising any right,
power or privilege hereunder shall operate as a waiver thereof, nor shall any
waiver on the part of either Nastech or Meda of any right, power or privilege
hereunder operate as a waiver of any other right, power or privilege hereunder
nor shall any single or partial exercise of any right, power or privilege
hereunder preclude any other or further exercise thereof or the exercise of any
other right, power or privilege hereunder. The indemnification provided in
Section 5.0 shall be the sole remedy available for any damages arising out of
or in connection with this Agreement except for any rights or remedies which
the parties hereto may otherwise have in equity.
11.4 The parties hereto are independent contractors, and nothing contained
in this Agreement
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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. Meda acknowledges that it does not have, and Meda shall not make
representations to any third party, either directly or indirectly, indicating
that Meda 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
Meda or to obligate Meda in any way whatsoever.
11.5 This Agreement constitutes the entire agreement between the parties
with respect to the subject matter hereof and supersedes all prior agreements
or understandings of the parties relating thereto.
11.6 This Agreement may be modified or amended only by written agreement of
the parties hereto.
11.7 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 a
single instrument.
11.8 This Agreement shall be governed and construed in accordance with the
laws of the State of New York excluding any choice of law rules which may
direct the application of the law of another state.
11.9 Any dispute, controversy or claim arising out of or in connection with
this Agreement shall be determined and settled by arbitration in New York, New
York, pursuant to the Rules of Arbitration then in effect of the American
Arbitration Association. Any award rendered shall be final and conclusive upon
the parties and a judgment thereon may be entered in a court having competent
jurisdiction. Any arbitration hereunder shall be (i) submitted to an
arbitration tribunal comprised of three (3) independent members knowledgeable
in the pharmaceutical industry, one of whom shall be selected by Meda, one of
whom shall be selected by Nastech, and one of whom shall be selected by the
other two arbitrators; (ii) allow for the parties to request discovery pursuant
to the rules then in effect under the Federal Rules of Civil Procedure for a
period not to exceed 90 days; and (iii) require the award to be accompanied by
findings of fact and a statement of reasons for the decision. Each party shall
bear its own costs and expenses, including attorney's fees incurred in any
dispute which is determined and/or settled by arbitration pursuant to this
Section. 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. Arbitration shall not prevent any party
from seeking injunctive relief where such remedy is an appropriate form of
remedy under the circumstances.
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11.10 All section titles or captions contained in this Agreement, in any
Schedule referred to herein or in any Exhibit annexed hereto, and the table of
contents, if any, to this Agreement are for convenience only, shall not be
deemed a part of this Agreement and shall not affect the meaning or
interpretation of this Agreement.
11.11 No provision of this Agreement shall be deemed or construed in any
way to result in the creation of any rights or obligation in any person not a
party or not affiliated with a party to this Agreement.
11.12 If any provision of this Agreement is found or declared to be invalid
or unenforceable by any court or other competent authority having jurisdiction,
such finding or declaration shall not invalidate any other provision hereof,
and this Agreement shall thereafter continue in full force and effect.
11.13 All Schedules, Exhibits and other attachments to this Agreement are by
this reference incorporated herein and made a part of this Agreement.
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed and delivered on the day and year first above written.
NASTECH PHARMACEUTICAL
COMPANY INC.
By:
---------------------------------
Name: Xxxxxxx X. Xxxxx, Ph.D.
Title: President
MEDA AB.
By:
---------------------------------
Name: Xxxxx Xxxxxxxxxx
Title: President
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SCHEDULE 3.2
Purchase Price and Terms
The following terms and conditions complete Section 3.2 of the License and
Supply Agreement as follows:
Product is available for supply in packages of 5ml bottles equivalent to 8
doses.
Firms Orders shall be placed by Meda at least three (3) months before required
delivery date and shall be subject to confirmation by Nastech.
Meda shall supply to Nastech artwork including films, which must be available
at Nastech at least ninety (90) days before the required delivery dates.
The following prices shall be applicable for delivery until December 1999:
No price increase shall be effective before January 1st, 2000 and any increase
shall be notified in writing at least 60 (sixty) days before such date. The
base index figure shall be $15.00 as of the Effective Date of the Agreement.
The above prices are subject to yearly revision by January 1st, based on the
price increases for the pharmaceuticals in the Territory, as calculated by LSAB
in Sweden in October and corresponding institutions in other countries in the
Territory. However, Nastech can only claim price increases if Meda is granted
price increases for Nascobal in the Territory.
Nastech shall not revise its prices more than once a year.
Payment conditions: Invoices are payable net without discount within sixty
(60) days after the date of invoice. Payment to be made in U.S. dollars.
Interest shall be paid on overdue amounts at a rate of four (4%) percent over
the prime rate of interest as announced and in effect, from time to time, by
the Chase Manhattan Bank.
Delivery terms: Delivery shall be CIF Meda warehouse (Incoterms 1990).
This Schedule shall form an integral part of the License and Supply Agreement
of same date between the Parties.
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SCHEDULE 2.5
Patents for the Product Relating to the Territory
Danish Patent Application No. 6038/86
Norwegian Patent No. 174.182
Swedish Patent No. 86902732.6
Swedish Patent Nol 86902640.1
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