Exhibit 10.34
LICENSE, DEVELOPMENT, MARKETING AND CLINICAL TRIALS SUPPLY AGREEMENT
THIS LICENSE ,DEVELOPMENT, MARKETING AND CLINICAL TRIALS SUPPLY
AGREEMENT ("Agreement") is effective as of July 20, 1998, and is by and among
OPOCRIN S.p.A., a corporation organized and existing under the laws of Italy
("OPOCRIN"), and INTERCARDIA, INC. ("INTERCARDIA"), a corporation organized and
existing under the laws of Delaware.
WITNESSETH:
WHEREAS, OPOCRIN owns the OPOCRIN Know-How (as hereinafter defined) and
the Patent Rights (as hereinafter defined);
WHEREAS, INTERCARDIA and OPOCRIN desire to enter into a definitive
development, marketing and clinical supply license agreement to develop and
market the Licensed Compound (as hereinafter defined) upon terms and conditions
which are more specifically set forth herein;
WHEREAS, INTERCARDIA desires to obtain a license under the Patent
Rights and OPOCRIN Know-How, upon the terms and conditions set forth herein; and
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as follows:
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND
FILED SEPARATELY WITH THE SEC.
ARTICLE I
DEFINITIONS
Unless specifically set forth to the contrary herein, the following
terms, whether used in the singular or plural, shall have the respective
meanings set forth below:
1.1 "Affiliate" means with respect to each party (i) any corporation
or business entity of which fifty (50%) percent or more of the securities or
other ownership interests representing the equity, the voting stock or general
partnership interest are owned, controlled or held, directly or indirectly, by
such party; (ii) any corporation or business entity which, directly or
indirectly, owns, controls or holds fifty (50%) percent (or the maximum
ownership interest permitted by law) or more of the securities or other
ownership interests representing the equity, the voting stock or, if applicable,
the general partnership interest, of such party; or (iii) any corporation or
business entity which is under common control by such party.
1.2 "Calendar Quarter" means the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September 30 and
December 31.
1.3 "Calendar Year" means each successive period of twelve (12)
months commencing on January 1 and ending on December 31.
1.4 "Collaboration Information and Inventions" means OPOCRIN
Information and Inventions, INTERCARDIA Information and Inventions and Joint
Information and Inventions as such terms are defined in Section 2.7.
1.5 "Effective Date" means the date first written above.
2
1.6 "EC" means the European Community member states which include the
countries of Germany, Belgium, France, Italy, Luxembourg, The Netherlands, The
Republic of Ireland, United Kingdom, Greece, Portugal, Spain, Austria, Finland,
Sweden and Denmark.
1.7 "Independent Third Party Knowledgeable in the Field" shall mean
an independent arbitor who will be chosen in the manner described in 13.6.
1.8 "INTERCARDIA Know-How" means any INTERCARDIA information and
materials, including but not limited to, discoveries, Improvements, processes,
manufacturing batch records, formulas, data, inventions, know-how and trade
secrets, patentable or otherwise, which during the term of this Agreement (i)
are in INTERCARDIA's possession, (ii) are developed by INTERCARDIA or its
licensees or its Affiliates in the INTERCARDIA Territory, (iii) are not
generally known and (iv) which arise out of this Agreement or which relate to
the development, manufacture, marketing, use or sale of the Licensed Compound or
the Licensed Products.
1.9 "INTERCARDIA Territory" means all countries except for Japan and
Korea.
1.10 "Improvements" means any findings, developments, discoveries,
inventions, additions, modifications, formulations, or changes made by
INTERCARDIA or its Affiliates and licensees or by OPOCRIN or its Affiliates and
licensees during the term of this Agreement which are necessary or useful to the
development, manufacture or commercialization of the Licensed Compound or
Licensed Products, including without limitation, new or improved methods of
synthesis, manufacture, ingredients, preparation, presentation, means of
delivery, dosage, formulation, analysis, packaging or labeling of the Licensed
Compound or Licensed Products.
1.11 "Licensed Compound" means the compound designated as OP2000, and
described in the patents listed on Exhibit A and Exhibit B, and the Patent
Rights.
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1.12 "Licensed Product" means any pharmaceutical formulation that is
created and developed by INTERCARDIA, which contains the Licensed Compound in a
form ready for use by the final customer, the use or sale of which by
INTERCARDIA would be prohibited but for the licenses granted by OPOCRIN to
INTERCARDIA herein (collectively, the "Licensed Products").
1.13 "Licensed Compound Specifications" means the specifications used
to formulate, manufacture, test, release or package Licensed Compound in the
License Product description included by INTERCARDIA in its IND, NDA or
registration package and approved by regulatory authorities, and any
modifications or changes thereto specified by INTERCARDIA.
1.14 "Major EC Member State" means Germany, France, Italy, Spain or
the United Kingdom.
1.15 "Net Sales" shall mean Net Sales as that term is defined in
Section 5.2.
1.16 "OPOCRIN Know-How" means any OPOCRIN information and materials,
including but not limited to, discoveries, Improvements, processes,
manufacturing batch records, formulas, analytical test methods, data,
inventions, know-how and trade secrets, patentable or otherwise, which during
the term of this Agreement (i) are in OPOCRIN's possession or control, (ii) are
developed by OPOCRIN or its licensees or Affiliates in the OPOCRIN Territory,
(iii) are not generally known and (iv) which arise out of the this Agreement or
which relate to the development, manufacture, marketing, use or sale of the
Licensed Compound or the Licensed Products.
1.17 "OPOCRIN Territory" means Japan and Korea.
1.18 "Patent Rights" means any and all patents and patent
applications (which for the purposes of this Agreement shall be deemed to
include certificates of invention and applications for certificates of
invention) which during the term of this Agreement are owned by OPOCRIN or to
which OPOCRIN through license or otherwise acquires rights, including, but not
limited to, those listed on Exhibit A and
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Exhibit B, which: (i) relate to the Licensed Compound or the Licensed Products;
or (ii) relate to Collaboration Information and Inventions (as defined in
Section 2.7); or (iii) are divisions, continuations, continuations-in-part,
reissues, renewals, extensions, supplementary protection certificates or the
like of any such patents and patent applications provided that such patents have
not expired, been cancelled or become abandoned and have not been declared
invalid by an unreversed or unappealable decision or judgment of a court of
competent jurisdiction; or (iv) are claiming Improvements to the Licensed
Compound or the Licensed Products.
1.19 "Proprietary Information" means all OPOCRIN Know-How,
INTERCARDIA Know-How, and all other scientific, clinical, development,
regulatory, marketing, manufacturing, financial and commercial information or
data, whether communicated in writing or oral, electronically or by sensory
detection, which is provided by one party to the other party in connection with
this Agreement.
1.20 "Reasonable Commercial Efforts" shall mean INTERCARDIA's, its
sub-licensees' or Affiliates' active conduct of any preclinical or clinical
trials in any country, or at any time subsequent to the grant of a Regulatory
Approval in any country, INTERCARDIA's, its licensees' or Affiliates'
preparation for launch of the Licensed Product.
1.21 "Regulatory Approval" means with respect to any country in the
OPOCRIN Territory or the INTERCARDIA Territory, each approval issued by a
regulatory authority necessary or appropriate to authorize and commence the
manufacture, use or sale, including pricing approval, toxicology studies,
preclinical and clinical trials and IND and NDA filings with the FDA or other
registration dossiers filed with other appropriate regulatory authorities, of
the Licensed Compound or a Licensed Product in such country.
1.22 "Standard Manufacturing Direct Cost" shall mean the direct
manufacturing costs incurred by OPOCRIN to manufacture Licensed Compounds. Such
costs shall include normal direct manufacturing
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costs as determined in accordance with U.S. generally accepted accounting
principles ("GAAP"). These costs may include raw materials, direct manufacturing
supplies, direct manufacturing labor and direct manufacturing burden applied in
accordance with GAAP in a manner consistent with OPOCRIN's other products, but
shall exclude any manufacturing indirect costs and any overhead, administrative
charges or any other costs or expenses not directly related to the manufacturing
of Licensed Compounds. These costs take into account overhead costs directly
related to the manufacture of Licensed Compound but do not include overhead
costs that are not directly related to the manufacture of Licensed Compound,
such as senior management costs.
1.23 "United States" or "U.S." means the United States of America,
and its territories and possessions.
1.24 "Valid Patent Claim" means a claim of an issued and unexpired
patent included within the Patent Rights, which has not been revoked or held
unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed with the time allowed for
appeal, and which has not been disclaimed, denied or admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise.
ARTICLE II
EXCHANGE OF INFORMATION; DEVELOPMENT AND COMMERCIALIZATION
2.1 General. OPOCRIN and INTERCARDIA shall engage in this Agreement
upon the terms and conditions set forth in this Agreement. In the course of
this Agreement, each party shall (i) cooperate with the other party in good
faith, particularly with respect to unknowns or contingencies, in order to
achieve the objectives of this Agreement; (ii) furnish, maintain and preserve
suitable and sufficient facilities and personnel for the work to be
accomplished by each party hereunder; and (iii) perform its obligations
hereunder in good faith in a commercially reasonable, diligent and workmanlike
manner and in
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compliance in all material respects with the standards, laws, rules and
regulations of each and every regulatory authority having jurisdiction over the
material activities of each party in the OPOCRIN Territory and the INTERCARDIA
Territory. OPOCRIN will work exclusively with INTERCARDIA to develop and
commercialize the Licensed Compound and Licensed Products in INTERCARDIA's
Territory.
2.2 Agreement Objectives. The parties desire to enter into this
Agreement which aligns technological innovation and organizational resources
including access to manufacturing, research and development, sales and
marketing, distribution, regulatory and management expertise for successful
completion of the development, commercialization and manufacturing of the
Licensed Compound and the Licensed Products.
2.3 Development of Licensed Products. The overall development program
in the INTERCARDIA Territory will be conducted and controlled by INTERCARDIA.
After the first meeting of the Advisory Committee, as defined below, INTERCARDIA
will present a development plan to OPOCRIN, which shall be updated and revised
approximately annually. INTERCARDIA will conduct development of the Licensed
Compound or the Licensed Products in the INTERCARDIA Territory in a manner
consistent with a Reasonable Commercial Effort. INTERCARDIA shall have final
approval on all preclinical and clinical studies performed in the INTERCARDIA
Territory. Decisions regarding preclinical and clinical trials and other studies
performed in the OPOCRIN Territory which could reasonably be determined to
affect any Regulatory Approvals or commercialization of the Licensed Compound or
the Licensed Products in the INTERCARDIA Territory shall be mutually agreed upon
by INTERCARDIA and OPOCRIN.
2.4 Advisory Committee. The parties hereby establish an advisory
committee (the "Advisory Committee") to facilitate the research, development and
manufacture of Licensed Compound and Licensed Products under this Agreement as
follows:
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2.4.1 Composition of the Advisory Committee. The Advisory Committee
shall be comprised of equal representation of not more than two (2) named
representatives of INTERCARDIA and not more than two (2) named representatives
of OPOCRIN. The initial representatives for each party hereto shall be set forth
on Schedule 2.4.1. Each party shall appoint its respective representatives to
the Advisory Committee and may substitute one or more of its representatives, in
its sole discretion, effective upon notice to the other party of such change. It
is anticipated that these representatives shall be multi-disciplinary in their
fields of expertise and shall have appropriate technical credentials and
knowledge together with an ongoing familiarity of the objectives of this
Agreement. Additional representatives or consultants may from time to time, by
mutual consent of the parties, be invited to attend Advisory Committee meetings,
subject to compliance with Section 9.1.
2.4.2 Meetings. INTERCARDIA and OPOCRIN intend for the Advisory
Committee to meet at least twice each Calendar Year, with the location for such
meetings alternating between Italy and the United States (or such other location
as is determined by the Advisory Committee). With the consent of both parties,
alternatively, the Advisory Committee may meet by means of conference call or
other similar communications equipment. Each party may request additional
meetings; provided that such meeting shall be held in the country (Italy or the
United States) of the party receiving the request. Each party shall be
responsible for its own time and travel expenses incurred in conjunction with
the Advisory Committee.
2.4.3 Advisory Committee Role. The Advisory Committee shall provide a
venue for the free exchange of information covered under this Agreement
regarding the development of Licensed Compound and Licensed Products in each
party's Territory. The Advisory Committee shall be permitted to have access to
INTERCARDIA Know-How and OPOCRIN Know-How. The Advisory Committee shall review
and discuss the information, including both parties' development plans, review
of timetables for the development and manufacturing of the Licensed Compound and
the Licensed Products; provided, however, the role of the Advisory Committee
shall be advisory.
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2.4.4 Termination of Advisory Committee. The Advisory Committee shall
be dissolved one year after the receipt of the first Regulatory Approval in
INTERCARDIA's Territory. By mutual consent, both parties may agree to extend the
life of the Advisory Committee.
2.5 Exchange of Information. During the term of this Agreement, each
party shall promptly disclose to the other party in English and in writing on an
ongoing basis all OPOCRIN Know-How and INTERCARDIA Know-How and other useful
information relating to the Licensed Compound and Licensed Products developed by
either party, their licensees or Affiliates.
2.6 Records and Reports.
2.6.1 Records. OPOCRIN and INTERCARDIA shall each maintain records, in
sufficient accounting detail and in good scientific manner appropriate for
financial, patent, research, development and regulatory purposes, which shall be
complete and accurate and shall fully and properly reflect all work done and
results achieved in the performance of this Agreement.
2.6.2 Copies and Inspection of Records. Each of OPOCRIN and INTERCARDIA
shall have the right, during normal business hours and upon reasonable notice,
to inspect and copy all such records of the other party as referred to in
Section 2.6.1. OPOCRIN and INTERCARDIA shall each maintain such records and the
information disclosed therein in confidence in accordance with Section 9.1. Each
party hereto shall have the right to arrange for its employees and outside
consultants involved in this Agreement to visit the other party at its
respective offices and laboratories during normal business hours and upon
reasonable notice, and to discuss the work under this Agreement and its results
in detail with the technical personnel and consultants of OPOCRIN or
INTERCARDIA, as the case may be.
2.6.3 INTERCARDIA Semi-Annual Progress Reports. Within forty five (45)
days following the end of each month of June and December during the term of
this Agreement, INTERCARDIA shall provide
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to the Advisory Committee a brief written progress report which shall summarize
the work performed during the prior six month period on this Agreement, the
results of any clinical development or other studies in progress, any regulatory
submissions regarding the Licensed Products, the status of any regulatory action
and such other information reasonably requested by the Advisory Committee
relating to the progress of the goals or performance of this Agreement. The
Advisory Committee shall provide such materials to OPOCRIN.
2.6.4 OPOCRIN Semi-Annual Progress Report. OPOCRIN shall within forty
five (45) days following the end of each month of June and December during the
term of this Agreement, provide the Advisory Committee with information
described in Section 2.6.3 regarding the Licensed Compound and any products
containing the Licensed Compound being developed in the OPOCRIN Territory by
OPOCRIN or its licensees.
2.7 Collaboration Information and Inventions Ownership. The entire
right, title and interest in all discoveries, Improvements, processes, formulas,
data, inventions, know-how and trade secrets, patentable or otherwise, arising
from this Agreement (all being "Collaboration Information and Inventions")
developed or invented:
(a) solely by employees of OPOCRIN shall be owned solely by OPOCRIN
("OPOCRIN Information and Inventions");
(b) solely by employees of INTERCARDIA shall be owned solely by
INTERCARDIA ("INTERCARDIA Information and Inventions"); and
(c) jointly by employees of OPOCRIN and INTERCARDIA shall be owned
jointly by OPOCRIN and INTERCARDIA ("Joint Information and Inventions").
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Each party shall disclose to the other parties hereto the development,
making, conception or reduction to practice of Collaboration Information and
Inventions.
2.8 Regulatory Matters. INTERCARDIA shall own, control and shall retain
legal responsibility for the preparation, filing and prosecution of all filings
and applications required to obtain all Regulatory Approvals to commercially
sell and use the Licensed Products in the INTERCARDIA Territory. OPOCRIN shall
supply INTERCARDIA with any materials OPOCRIN possesses prepared in connection
with but not limited to the promotion, packaging, manufacture, adverse event
experience or other activities related to the Licensed Compound or Licensed
Products in order to prosecute, complete or maintain any and all Regulatory
Approvals, filings or submissions required by any regulatory authority. It is
the intention of INTERCARDIA to file for Regulatory Approval in all major
markets during the term of this Agreement. The decision as to timing of any such
filing or the decision not to file in any market shall be in the sole and
absolute discretion of INTERCARDIA.
(a) Upon Regulatory Approval in the INTERCARDIA Territory by each
country's regulatory authority, INTERCARDIA's obligation to maintain such
Regulatory Approval shall be subject to INTERCARDIA's or its Licensee's economic
analysis of any such country's revenue potential, in such party's sole
discretion. INTERCARDIA will promptly notify OPOCRIN of any decisions relating
to such Regulatory Approval affected by INTERCARDIA's economic analysis.
(b) During the term hereof each party shall within 48 hours of notice
thereof furnish to the other party information concerning serious side effects,
life threatening effects or unexpected consequences attributable to the Licensed
Compound or the Licensed Products. Each party shall report to the other party
any other side effects on an annual basis at mutually agreeable times.
(c) Upon request, the requesting party shall from the date of such
request receive from the other party copies of all correspondence with, and all
documents and applications filed with or submitted by any
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regulatory authority in each party's Territory with respect to the Licensed
Compound or the Licensed Products including but not limited to copies of all
label statements, expert summaries and any information not previously included
in any applications for Regulatory Approvals. Such copies of the aforementioned
correspondence and documentation shall be sent to the receiving party within 30
days of submission to or receipt from any regulatory authority.
(d) Each party shall within 30 days of notice thereof provide to the
other party all data and documents to which each party has access in order to
support the compilation of registration dossiers and subsequent Regulatory
Approvals.
2.9 Trademark. The Licensed Products shall be sold by INTERCARDIA or
its sublicensees in the INTERCARDIA Territory under a trademark or trademarks
owned and maintained by INTERCARDIA.
2.10 Manufacture of Commercial Supplies. INTERCARDIA and OPOCRIN will
undertake to enter into a separate Manufacturing Supply Agreement ("Commercial
Manufacturing Supply Agreement"), within six (6) months following the initiation
of Phase III clinical trials in a major market, wherein OPOCRIN shall negotiate
for the right to manufacture Licensed Compound based upon the following general
terms: (a) the cost of Licensed Compound shall be based upon OPOCRIN's Standard
Manufacturing Direct Cost plus [*]%, but in no case to exceed [*]% of
INTERCARDIA's or it's sublicensees or Affiliate's Net Sales, as defined in 5.2
below, of Licensed Product for the United States; (b) the cost of Licensed
Compound shall be based upon OPOCRIN's Standard Manufacturing Direct Cost plus
[*]%, but in no case to exceed [*]% of INTERCARDIA's or it's sublicensees or
Affiliate's Net
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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Sales, as defined in 5.2 below, of Licensed Product for the INTERCARDIA
Territory other than the United States; (c) the price charged by OPOCRIN for
Licensed Compound will be subject to adjustment based upon price increases or
decreases of starting reagents and other raw materials and manufacturing costs;
(d) all calculations relating to the costs of manufacturing Licensed Compound
shall be provided to INTERCARDIA or its sublicensees or Affiliates on a
quarterly basis; (e) upon determination by INTERCARDIA or OPOCRIN that
manufacture of Licensed Compound cannot be reliably or consistently manufactured
in a timely manner within reference parameters including the costs defined in a
and b, above, either party may terminate the to-be-executed Commercial
Manufacturing Supply Agreement and OPOCRIN shall transfer to INTERCARDIA all
information relevant to the manufacture of Licensed Compound. Both parties agree
to diligently pursue the negotiation and execution of this separate Commercial
Manufacturing Supply Agreement.
ARTICLE III
LICENSE
3.1 License Grants.
(a) OPOCRIN hereby grants to INTERCARDIA and its Affiliates in the
INTERCARDIA Territory an exclusive license, with the right to sublicense, (i)
to practice under the Patent Rights described on Exhibit A and the
Improvements, and (ii) to use OPOCRIN Know-How to develop, make, have made, use
and sell the Licensed Products in the INTERCARDIA Territory. OPOCRIN hereby
grants to INTERCARDIA and its Affiliates in the INTERCARDIA Territory a
non-exclusive license to practice under the Patent Rights described on Exhibit
B and the Improvements needed or required in any manner, as determined in the
sole discretion of INTERCARDIA, to develop, make, have made, use and sell the
Licensed Products in the INTERCARDIA Territory. The patents described in
Exhibit B are derivative of and supportive of the Licensed Compound patents
described in Exhibit A. OPOCRIN shall take any and
13
all actions required by INTERCARDIA to perfect the grant to INTERCARDIA of the
Exhibit A and Exhibit B Patent Rights.
(b) INTERCARDIA shall have the right to sublicense the Licensed
Products in INTERCARDIA Territory; provided, however, that OPOCRIN shall have
the right to approve INTERCARDIA's sublicensees prior to the execution of any
such agreement in the United States, Germany, France, Italy, Spain and the
United Kingdom; provided further however that such right of approval shall not
be unreasonably withheld and shall be exercised, if at all, within fifteen (15)
working days of written notice by INTERCARDIA of any such sublicensee or such
sublicensee shall be deemed approved under this Agreement for all purposes and
all countries. INTERCARDIA shall within fifteen (15) days of execution of any
sublicensing agreement, provide OPOCRIN with copies of such agreements for
OPOCRIN's use in validating milestone payments as defined in Section 4.1(e) and
royalty payments as defined in Article V.
3.2 Additional License Grant. In the event (i) there exists a claim or
claims of issued letters patent which OPOCRIN owns or has the rights to license;
and (ii) in the event that any such claim or claims are believed by OPOCRIN or
INTERCARDIA to be superior to the grant by OPOCRIN to INTERCARDIA in Section
3.1; and (iii) which claim or claims are not covered by the grant in Section
3.1, above, OPOCRIN hereby grants to INTERCARDIA, an exclusive, royalty-free
license in the INTERCARDIA Territory under such claim or claims contained in
issued letters patent for INTERCARDIA to develop, make, have made use and sell
such Licensed Compound or Licensed Product in the INTERCARDIA Territory.
3.3 Additional Rights.
(a) If OPOCRIN elects not to actively pursue, (e.g. terminates
substantially all of its activities with regard to) the development or marketing
or sub-licensing of the Licensed Compound or the Licensed Product in a country
included in the OPOCRIN Territory, INTERCARDIA shall be granted at no
14
additional cost a license to use OPOCRIN Know-How to develop, make, have made,
use and sell the Licensed Product in the OPOCRIN Territory consistent with the
exclusive license granted to INTERCARDIA in the INTERCARDIA Territory.
(b) INTERCARDIA hereby grants to OPOCRIN a royalty-free, nonexclusive
right and license to use and grant third parties the right to use, solely in the
OPOCRIN Territory, all the data and information relating to the Licensed
Compound and the Licensed Product developed by or on the behalf of INTERCARDIA
under this Agreement and for which INTERCARDIA has the right to transfer.
INTERCARDIA shall have a royalty-free, nonexclusive right and license to use,
and grant sub-licensees to use, in the INTERCARDIA Territory all the data and
information relating to the Licensed Compound and the Licensed Product developed
by or on the behalf of OPOCRIN.
ARTICLE IV
CERTAIN PAYMENTS
4.1 Certain Milestone Payments. INTERCARDIA shall pay to OPOCRIN the
following one-time, non-refundable and non-creditable milestone payments:
(a) One Million Dollars (US$ 1,000,000) within ten ( 10) working days
following the date of the signature of the last to sign this Agreement; and
(b) [*********************************************] Dollars
(US$[**********]) within ten ( 10) working days following the treatment of the
first patient in Phase III clinical trials; and
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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(c) [*****************************] Dollars (US$[*************]) within
ten (10) working days following filing of the first New Drug Application ("NDA")
submitted hereunder to the FDA or within ten (10) working days following the
filing of the first European PLA, whichever occurs first; and
(d) [*****************************] Dollars (US$[*************]) within
ten (10) working days following NDA approval in the United States or following
the grant of Regulatory Approval in at least two countries among the Major EC
Member States, whichever occurs first, of the first Licensed Product hereunder;
and
(e) [*******************] percent of [**************************], up
to a cumulative total of [*****************] Dollars (US$[********************])
; and
(f) [*******************] Dollars (US$[****************]) upon
[*********************]; and
(g) An additional [**********************] Dollars (US$[************])
upon [***********************].
(h) If, prior to any notice of termination of this Agreement, the
initiation of Phase III trials is delayed by INTERCARDIA to a date which is the
later of (i) [*****************], or (ii) [**************] years subsequent to
the date of the receipt by INTERCARDIA of Licensed Compound for clinical trials
which has been manufactured in accordance with cGMP's and the terms and
conditions of this Agreement, OPOCRIN shall at such time receive the milestone
payment otherwise due upon initiation of Phase III trials in the amount of
[***********************] Dollars (US$[***********]) within thirty (30) working
days of [***************]; provided, however, that no such payment shall be due
until actual initiation of Phase III trials if such delay is, due to delay in
receipt of either Licensed Compound or Licensed Products from suppliers or
circumstances beyond the control of INTERCARDIA and INTERCARDIA is proceeding in
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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good faith with development hereunder. Activities by INTERCARDIA in any
pre-clinical or clinical trials or negotiations with any regulatory authority
while such trials are suspended shall be deemed to be proceeding in good faith
on the part of INTERCARDIA.
All amounts shall be paid in U.S. dollars. During the term of this
Agreement once payments to OPOCRIN under a section of Sections 4.1(a), 4.1(b),
4.1(c), 4.1(d), 4.1(e), 4.1(f), and 4.1(g) have been paid for an indication, no
additional payments under such section shall be payable to OPOCRIN,
notwithstanding the submission by INTERCARDIA of Licensed Compound or Licensed
Products for more than one or additional targets or indications.
ARTICLE V
ROYALTIES
5.1 Royalties Payable by INTERCARDIA. INTERCARDIA shall pay to OPOCRIN
a royalty for the OPOCRIN Know-How, the Patent Rights and Improvements in the
INTERCARDIA Territory. The royalty shall be equal to: (i) [***] percent of the
first $[****************] of Net Sales of Licensed Product covered by a Valid
Patent Claim or market exclusivity in any Calendar Year; (ii) [***] percent of
Net Sales in excess of $[****************] of Licensed Product covered by a
Valid Patent Claim or market exclusivity in any Calendar Year; and (iii) for all
periods of time after expiration of the Patent Rights or market exclusivity in
any country, and in lieu of any other royalty or other payments hereunder,
including payments under subparagraphs (i) and (ii) above, [***] percent of Net
Sales. The royalty payable to OPOCRIN for the Net Sales of each Calendar Quarter
will be converted to U.S. dollars using the exchange
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
17
rate published in the Wall Street Journal for the last day of such Calendar
Quarter and shall be paid in U.S. dollars within thirty (30) working days after
the end of the Calendar Quarter.
5.2 Net Sales shall mean the gross invoice price of Licensed Product
sold by INTERCARDIA, its Affiliates or sublicensees (which term does not include
distributors) to the first independent third party after deducting, if not
previously deducted, from the amount invoiced:
(a) trade, cash and quantity discounts;
(b) credits and allowances on account of returned or rejected
products;
(c) rebates, chargebacks and other amounts paid on sale or
dispensing of Licensed Product;
(d) retroactive price reductions;
(e) with regard to sales in the United States, a fixed amount equal to
five percent (5%) of the amount invoiced to cover bad debt, sales or excise
taxes, transportation and insurance charges; and with regard to sales outside
the United States, a fixed amount equal to ten percent (10%) of the amount
invoiced to cover the above and additional special transportation, custom
duties, and other governmental charges; and
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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(f) the inventory cost or devices or delivery systems used for
dispensing or administering Licensed Product, special packaging of Licensed
Product and diluents or similar exogenous materials which accompany Licensed
Product as it is sold.
With respect to sales of Licensed Product sold in combination with one
or more other ingredients ("Combination Products"), Net Sales shall be
calculated on the basis of the invoice price of Licensed Product(s) containing
the same weight of the Licensed Compound sold without other active ingredients.
If such Licensed Product is not sold without other active ingredients, Net Sales
shall be calculated on the basis of the invoice price of the Combination Product
multiplied by a fraction, the numerator of which shall be the inventory cost of
the Licensed Compound in the Licensed Product and the denominator of which shall
be the inventory cost of all of the active ingredients in the Combination
Product. Inventory cost shall be determined in accordance with INTERCARDIA's
regular accounting methods.
ARTICLE VI
CERTAIN FUNDING
6.1 Funding Responsibility. INTERCARDIA and OPOCRIN shall each be
responsible for the expenses incurred in the development, registration and
commercialization of the Licensed Product in the INTERCARDIA Territory and the
OPOCRIN Territory respectively, based upon the terms, conditions and agreements
set forth in this Agreement and the exhibits and schedules attached hereto.
6.2 Sales and Marketing. Each party shall be responsible for all sales
and marketing activities and expenses in its respective territory, including but
not limited to, the registration of applicable Licensed Product trademarks,
trade names, and logos.
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ARTICLE VII
ACCOUNTING REPORTS, PAYMENTS AND TAXES
7.1 Reports. During the term of this Agreement, INTERCARDIA will
maintain accounting systems which will report its or its Licensees respective
Net Sales and which are capable of accurately calculating the royalties due to
OPOCRIN pursuant to this Agreement. Reports shall be provided as follows:
Within thirty (30) calendar days after the end of each month,
INTERCARDIA shall report to OPOCRIN its estimate of respective Net Sales.
Within forty five (45) calendar days after the end of each Calendar
Quarter, INTERCARDIA shall send OPOCRIN a report detailing the results of such
Calendar Quarter. This report shall detail the calculation of the royalty in
such previous Calendar Quarter.
Within seventy-five (75) calendar days after the end of each Calendar
Year, INTERCARDIA shall issue a full report to OPOCRIN detailing the calculation
of the royalty payments made for the previous calendar year. Any changes from
the previously submitted quarterly reports shall be explained in detail.
Upon reasonable advance notice, and for purposes of calculating
royalties due hereunder or calculation of manufacturing costs hereunder, a party
(the "Investigating Party") shall be entitled to hire a third party to audit the
other party's (the "Audited Party") accounting systems and components of the
other party's royalty or manufacturing cost calculation. The Audited Party will
cooperate and assist in such audits as appropriate. If the results of such audit
indicate that the Audited Party has underpaid its royalty obligation by ten
(10%) percent or more or overstated its manufacturing cost by ten (10%) percent
or more for any twelve (12) month period examined, the Audited Party shall bear
the expenses of such audit. Upon completion of the audit, if the audit reveals
an underpayment or overpayment, such underpayment or
20
overpayment shall be paid to the party owed such amount within thirty (30) days
of such audit report. Any such underpayments or overpayments shall accrue
interest as of the date due, calculated at the prime interest rate quoted in the
WALL STREET JOURNAL for such period. All audits shall be conducted by a major
U.S./ international accounting firm acceptable to both parties.
7.2 Payments . All payments to be made by INTERCARDIA to OPOCRIN under
this Agreement shall be made in United States Dollars and shall be paid by
check, bank wire transfer or by automated clearinghouse (electronic funds
transfer) in immediately available funds to such bank account as designated in
writing by OPOCRIN from time to time.
7.3 Late Payments. Each party shall pay interest to the other party on
the aggregate amount of undisputed payments due that are not paid on or before
the date such payments are due under this Agreement at a rate per annum equal to
the Prime Rate as reported from time to time in the WALL STREET JOURNAL.
Disputed amounts which are paid upon resolution of any such dispute shall bear
interest at such rate until paid.
7.4 Taxes. Each party shall be responsible for its own taxes on
income.
7.5 Taxes on Payments to OPOCRIN. With respect to any taxes which are
levied by the authorities in the U.S. in connection with any sums payable
hereunder to OPOCRIN, INTERCARDIA shall be entitled to deduct such taxes from
such sums, pay such taxes to local authorities on behalf of OPOCRIN and remit to
OPOCRIN, in full satisfaction of its payment obligations hereunder, the net
amount after such deduction together with the relevant receipt evidencing the
payment of such taxes. INTERCARDIA shall use reasonable efforts to cooperate
with OPOCRIN with respect to its tax planning.
21
ARTICLE VIII
CLINICAL TRIAL SUPPLIES
8.1 Manufacturing and Supply of Licensed Compound for Clinical Trials.
Subject to the requirements described below, OPOCRIN shall manufacture and
supply all of INTERCARDIA's (and its licensees and Affiliates) requirements for
Licensed Compound which, in the reasonable discretion of INTERCARDIA, are needed
to complete the development of the Licensed Products including, but not limited
to, the conduct of preclinical or clinical trials. OPOCRIN and INTERCARDIA shall
collaborate on forecasts in order to insure the uninterrupted availability of
the Licensed Compound in sufficient quantities to support the development of the
Licensed Compound and Licensed Products. In the event that OPOCRIN is unable to
meet INTERCARDIA's requirements, it shall notify INTERCARDIA immediately. In
addition, in order to assure an uninterrupted supply of Licensed Compound,
INTERCARDIA shall have the right throughout the period of the term of this
License Agreement to identify and qualify and buy from secondary manufacturers
and suppliers any or all of INTERCARDIA's requirements for the development of
Licensed Products or the conduct of clinical or preclinical trials with the
Licensed Compound.
8.2 Manufacturing Procedures and Facilities. OPOCRIN shall comply with
acceptable procedures to manufacture the Licensed Compound, including compliance
with the regulations and guidelines promulgated from time to time by the FDA and
other regulatory authorities and current Good Manufacturing Practices ("cGMP").
8.3 Storage Requirements. OPOCRIN shall maintain an adequate inventory
of the Licensed Compound so that shipment of the Licensed Compound for use by
INTERCARDIA shall be made in a timely manner. Each shipment of the Licensed
Compound shall be accompanied by a certificate of analysis (the "Certificate of
Analysis"), a Material Safety Data Sheet ("MSDS") and a written statement from
22
OPOCRIN that the shipment is in compliance with the Licensed Compound
Specifications for such delivered Licensed Compound.
8.4 Inspection of Premises and Records. While this Agreement is in
effect, OPOCRIN shall give to duly accredited representatives of INTERCARDIA,
upon reasonable notice, and at all reasonable times during regular business
hours, access to its facilities for the purpose of inspecting, consulting and
periodically reviewing the techniques and records of OPOCRIN including, but not
limited to, records related to manufacturing, testing, warehousing and shipping
of the Licensed Compound to assure they are manufactured, tested, shipped and
warehoused in strict compliance with Licensed Compound Specifications, cGMP's
and are otherwise appropriate, adequate and correctly performed. Any such
inspection made by INTERCARDIA shall not relieve OPOCRIN of any of its
contractual or regulatory responsibilities.
8.5 Receipt of Licensed Compound.
(i) INTERCARDIA may, at its option, inspect shipments of Licensed
Compound upon receipt thereof. Such inspection may include, without limitation,
a quality control analysis in accordance with agreed upon procedures to
determine whether the Licensed Compound meets the Licensed Compound
Specifications of the Certificate of Analysis accompanying each shipment of the
Licensed Compound. At INTERCARDIA's expense, INTERCARDIA may utilize contract
facilities to conduct such analysis. OPOCRIN shall retain samples of each
production lot of the Licensed Compound and, INTERCARDIA may, at its sole
discretion, maintain samples of each shipment lot of the Licensed Compound for
retention purposes in accordance with its respective standard operating
procedures.
(ii) INTERCARDIA may reject any shipment that fails to meet the
Licensed Compound Specifications ("Rejected Licensed Compound"). To properly
reject a shipment of Licensed Compound, INTERCARDIA shall, subsequent to receipt
of the Licensed Compound (not to exceed one (1) year from
23
receipt) (the "Rejection Period"), notify OPOCRIN in writing or by telecopy of
INTERCARDIA's rejection of such Licensed Compound, stating the reason for such
rejection. INTERCARDIA shall provide OPOCRIN the opportunity to inspect the
Rejected Licensed Compound prior to return to OPOCRIN. In the event that
OPOCRIN, in OPOCRIN's sole discretion, desires that INTERCARDIA return a
Rejected Licensed Compound to OPOCRIN, INTERCARDIA shall return same to OPOCRIN,
freight prepaid. OPOCRIN will provide INTERCARDIA a credit to be applied against
INTERCARDIA's future payments equal to the Price of the Licensed Compound (as
defined below), all out-of-pocket costs relating to the Rejected Licensed
Compound and the return freight charges paid by INTERCARDIA for a properly
Rejected Licensed Compound. As promptly as reasonably possible but no later than
thirty (30) working days after receipt by OPOCRIN of a properly Rejected
Licensed Compound, OPOCRIN shall replace such Licensed Compound, and at such
time, OPOCRIN shall be entitled to invoice INTERCARDIA for such Licensed
Compound in accordance with its standard billing procedures. OPOCRIN shall pay
shipping charges in connection with shipment of the replaced Licensed Compound
to INTERCARDIA for a properly Rejected Licensed Compound.
Any dispute arising hereunder relating to conformity with technical
specifications shall be finally resolved by arbitration by an independent
technical expert accepted by both parties. The cost of arbitration shall be
borne by the party whose test results prove to be inaccurate.
8.6 Shipment. All Licensed Compound shall be shipped in the manner and
to the location specified by INTERCARDIA, its Affiliates or sublicensees.
OPOCRIN shall pay all shipping, handling and storage costs necessary or required
to transport Licensed Compound from OPOCRIN's manufacturing facility to
INTERCARDIA's designated facility. All shipments of the Licensed Compound shall
be delivered as specified by INTERCARDIA to a specified INTERCARDIA facility,
or, as otherwise agreed to by the parties. Title and risk of loss to the
Licensed Compound shall pass upon receipt and acceptance of the items by
INTERCARDIA or its agents.
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8.7 Packaging and Labeling. Unless otherwise specified by INTERCARDIA,
all Licensed Compound supplied to INTERCARDIA hereunder shall:
(a) Packaging. OPOCRIN shall package Licensed Compound in containers in
accordance with the Packaging Specifications approved by INTERCARDIA.
(b) Labeling. Prior to shipping Licensed Compound, OPOCRIN will label
all containers in accordance with the Labeling Specifications mutually agreed
upon by INTERCARDIA and OPOCRIN.
8.8 Licensed Compound Supply Price. OPOCRIN shall provide INTERCARDIA
or its sublicensees with Licensed Compound supplies at OPOCRIN's Standard
Manufacturing Direct Cost for all periods of time during which INTERCARDIA is
developing the Licensed Compound or conducting any clinical trials in a country.
The price charged by OPOCRIN will be subject to adjustment upon forty five (45)
days advance notice based upon actual price increases or decreases of starting
reagents and other raw materials and manufacturing costs of materials included
in Licensed Compound, but the rate of change shall not exceed the percentage
change for the previous twelve months such adjustment to be determined by
reference to (i) the variation of the Producer Price Index of the industrial
products relevant to chemical basic products issued by ISTAT (lstituto Nazionale
di Statistica); and (ii) the variation of the Index of the average labour cost
for each worker in the industrial field, where each index will be weighted
equally in the calculation of the percentage change and the variations will be
certified by ISTAT. All calculations and supporting data, information, invoices
and materials relating to the cost of manufacturing the Licensed Compound shall
be disclosed to INTERCARDIA or its sublicensees upon request.
8.9 Termination of Supply. Upon determination by INTERCARDIA or OPOCRIN
that manufacture of the Licensed Compound cannot be manufactured within the
reference parameters and provisions of this Article VIII, either party may
terminate the supply and manufacturing provisions of this
25
Agreement, and OPOCRIN shall transfer to INTERCARDIA all information relevant to
the manufacture of the Licensed Compound.
8.10 Manufacturing and Supply Warranties.
(a) OPOCRIN warrants and represents to INTERCARDIA at the time of
delivery of the Licensed Compound to INTERCARDIA such Licensed Compound (i) will
have been manufactured and shipped in accordance with (a) cGMP and all other
applicable laws, rules, regulations and requirements, (b) the Licensed Compound
Specifications and quality control testing procedures for the Licensed Compound,
as provided by INTERCARDIA to OPOCRIN, and as amended or supplemented by
INTERCARDIA from time to time, and (c) the chemistry, manufacturing, and
controls section (the "CMC") included in any application for Regulatory
Approval, and (ii) will not be adulterated or misbranded under the laws of any
regulatory authority, and may be introduced into interstate or international
commerce pursuant to laws of any regulatory authority.
(b) OPOCRIN shall comply with all quality control testing requirements
applicable to the Licensed Compound which are set forth in or required by cGMPs,
other applicable law and regulations, or the Licensed Compound Specifications.
(c) OPOCRIN, at its own expense, shall perform validation testing at
its facility in order to validate all production, cleaning, and packaging
processes employed in the manufacturing process at its facility, in accordance
with any procedures established by INTERCARDIA, cGMPs, and all other applicable
laws and regulations and as approved by INTERCARDIA.
(d) OPOCRIN shall conduct a self-audit as necessary, but at least
annually, to ensure that it is complying with cGMPs, any NDA, other applicable
laws and regulations, and the Licensed Compound
26
Specifications. Upon completion of the audit and on an annual basis, OPOCRIN
shall provide to INTERCARDIA a written report summarizing the results of such
audit.
(e) OPOCRIN shall obtain and maintain all governmental licenses,
registrations, and approvals required in connection with the manufacturing of
the Licensed Compound and to comply with all applicable laws, rules, regulations
or requirements in manufacturing the Licensed Compound. OPOCRIN shall keep
complete and accurate books and records pertaining to the manufacture of the
Licensed Compound, including without limitation such books and records as may be
required by applicable law and to retain such books and records for at least
five (5) years after the termination of this Agreement, or for such longer
period as required by applicable law. OPOCRIN shall not be entitled to
sublicense the manufacturing rights to the Licensed Compound. OPOCRIN shall
have, contingent upon the prior written approval of INTERCARDIA, the right to
sub-contract the manufacture of Licensed Compound.
(f) OPOCRIN shall procure and provide to INTERCARDIA such information
and assistance relating to the manufacture of the Licensed Compound as
INTERCARDIA may reasonably require in connection with any submission relating to
a Regulatory Approval, including without limitation providing INTERCARDIA with
documentation for the CMC section of any submission relating to a Regulatory
Approval and all reports, authorizations, certifications, methodologies,
manufacturing processes and other documentation in the possession or under the
control of OPOCRIN relating to the Licensed Compound. OPOCRIN hereby grants to
INTERCARDIA the right at INTERCARDIA's sole discretion to submit such
information to regulatory agencies in the INTERCARDIA Territory or to reference
any such information in connection with any submission relating to a Regulatory
Approval.
(g) OPOCRIN shall notify INTERCARDIA in writing, promptly after receipt
of notice of any proposed or unannounced visit or inspection of OPOCRIN'S
manufacturing or other facilities or records by any governmental agency or
authority, and shall permit INTERCARDIA or its agents to be present and
27
participate in such visit or inspection relating in any manner to Licensed
Compound. OPOCRIN shall provide to INTERCARDIA a copy of any report and other
written communications received from such agency or authority in connection with
such visit or inspection, and any written communications received from any
agency or authority relating to the Licensed Compound, manufacturing facility or
the manufacturing process, within one business day after receipt thereof, and
shall consult with INTERCARDIA concerning the response to each such
communication. OPOCRIN shall provide INTERCARDIA with a copy of all such draft
responses as soon as possible, and all such final responses, within one business
day after submission thereof.
ARTICLE IX
CONFIDENTIALITY AND PUBLICATION
9.1 Nondisclosure Obligation. All Proprietary Information shall be
maintained in confidence and shall not be disclosed to any other person, or any
corporation or other business entity, or any government or any agency or
political subdivision thereof without the prior written consent of the other
party, except to the extent that such Proprietary Information:
(a) is known by recipient at the time of its receipt, and not through a
prior disclosure by the disclosing party, as documented by business records;
(b) is properly in the public domain;
(c) is subsequently disclosed to a receiving party by a third party who
may lawfully do so and is not under an obligation of confidentiality to the
disclosing party;
(d) is disclosed to governmental or other regulatory agencies in order
to obtain patents or to gain approval to conduct clinical trials or to market
the Licensed Products, but such disclosure may be only to the extent reasonably
necessary to obtain patents or authorizations;
28
(e) is necessary to be disclosed to sublicensees, agents, consultants,
Affiliates and/or other third parties for the research and development,
manufacturing and/or marketing of the Licensed Products (or for such parties to
determine their interest in performing such activities in its respective
territory) in accordance with this Agreement on the condition that such third
parties agree to be bound by the confidentiality obligations contained in this
Agreement; provided, however, the term of confidentiality for such third parties
shall be no less than five (5) years; or
(f) is required to be disclosed by law or court order, provided that
notice is delivered to the other party in order to provide an opportunity to
challenge or limit the disclosure obligations; provided, however, without
limiting any of the foregoing provisions of Section 9.1, it is understood that
(i) either party hereto, including any Affiliate, may make reasonable disclosure
of this Agreement, at its own discretion, and the financial and other terms
hereof in any filings required by the Securities and Exchange Commission (the
"SEC"), in connection with and subsequent to any offering of either party's
securities to the public, on Form S-1 (or other applicable initial registration
form), Form 10-K, Form 10-Q, Form 8-K or other applicable SEC form, and in the
footnotes to any financial statements; (ii) either party may file this Agreement
as an exhibit to any Form ▇-▇, ▇▇▇▇ ▇-▇, Form 10-K, Form 10-Q, Form 8-K or other
applicable SEC form; (iii) either party may describe this Agreement including
the milestones and royalty provisions in the "Management's Discussions and
Analysis of Financial Conditions and Results of Operations" section of any
filings with the SEC; and (iv) either party may distribute any such filing made
to the SEC (other than matters for which Confidential Treatment have been
requested) in the ordinary course of its business (e.g. to financial analysts
and to stockholders). Any press release mentioning the other party by name
proposed by INTERCARDIA or OPOCRIN shall be submitted to the other party as
designated from time to time by each party for review and comment prior to
release thereof, except as permitted in this Section 9.1(f).
29
Not withstanding the above, each party shall maintain confidential any
information deemed proprietary by either party pursuant to this Agreement.
9.2 Use of Proprietary Information. Each of OPOCRIN and INTERCARDIA
agrees that the Proprietary Information shall only be used in connection with
its obligations under this Agreement, or by OPOCRIN in connection with its
business, licensing, manufacturing and sale of the Licensed Compound or the
Licensed Products in the OPOCRIN Territory, and further agrees to keep all
OPOCRIN Know-How and INTERCARDIA Know-How confidential subject to exceptions
(b), (e), (f) or (g) in Section 9.1 above.
9.3. Publication. During the term of this Agreement, INTERCARDIA and
OPOCRIN each acknowledge the other party's interest in publishing its results
related to the Licensed Compound and Licensed Products to obtain recognition
within the scientific community and to advance the state of scientific
knowledge. Each party also recognizes the mutual interest in obtaining valid
patent protection and in protecting business interests and trade secret
information. Consequently, either party, its employees or consultants wishing to
make a publication shall deliver to the other party a copy of the proposed
written publication or an outline of an oral disclosure at least ten (10)
working days prior to submission for publication or presentation. The
nonpublishing party shall have the right (a) to propose modifications to the
publication for scientific reason, patent reasons, trade secret reasons or
business reasons or (b) to request a reasonable delay in publication or
presentation in order to protect patentable information. If the nonpublishing
party requests a delay, the publishing party shall delay submission or
presentation for a period of thirty (30) working days to enable patent
applications protecting each party's rights in such information to be filed in
accordance with Article X below. Upon expiration of such thirty (30) working
days, the publishing party shall be free to proceed with the publication or
presentation.
30
ARTICLE X
REPRESENTATIONS AND WARRANTIES: PATENTS
10.1 Representation and Warranty of OPOCRIN. OPOCRIN represents and
warrants to INTERCARDIA that as of the date of this Agreement it has the full
right, power and authority to enter into this Agreement, to perform this
Agreement; that it is a duly organized and validly existing corporation 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 organization 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.
10.2 Representation and Warranty of INTERCARDIA. INTERCARDIA represents
and warrants that it is a duly organized and validly existing corporation 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 organization 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.
31
10.3 Limitation of OPOCRIN Liability. EXCEPT AS OTHERWISE EXPRESSLY SET
FORTH IN THIS AGREEMENT, OPOCRIN MAKES NO REPRESENTATIONS AND EXTENDS 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 OPOCRIN KNOW-HOW,
THE COMPOUND, OR THE LICENSED PRODUCTS. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH
IN THIS AGREEMENT OPOCRIN SHALL HAVE NO LIABILITY FOR SPECIAL, PUNITIVE,
INDIRECT OR CONSEQUENTIAL DAMAGES, LOST PROFITS, LOSS OF GOODWILL, OTHER
ECONOMIC LOSS OR IMAGE LOSS (WHETHER IN TORT, CONTRACT OR OTHERWISE) IN
CONNECTION WITH THIS AGREEMENT OR WITH RESPECT TO THE PATENT RIGHTS, OR OPOCRIN
KNOW-HOW OR AS TO THE COMMERCIAL VIABILITY OF THE LICENSED COMPOUND OR THE
LICENSED PRODUCTS.
10.4 Limitation of INTERCARDIA Liability. EXCEPT AS OTHERWISE EXPRESSLY
SET FORTH IN THIS AGREEMENT, INTERCARDIA MAKES NO REPRESENTATIONS AND EXTENDS NO
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AS TO THE
COMMERCIAL VIABILITY OF THE LICENSED PRODUCTS OR INTERCARDIA KNOW-HOW.
INTERCARDIA SHALL HAVE NO LIABILITY FOR SPECIAL, PUNITIVE, INDIRECT OR
CONSEQUENTIAL DAMAGES, LOST PROFITS, LOSS OF GOODWILL, OTHER ECONOMIC LOSS OR
IMAGE LOSS (WHETHER IN TORT, CONTRACT OR OTHERWISE) IN CONNECTION WITH THIS
AGREEMENT OR WITH RESPECT TO THE LICENSED COMPOUND OR LICENSED PRODUCTS OR
INTERCARDIA KNOW-HOW.
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10.5 Filing. Prosecution and Maintenance of Patents. OPOCRIN agrees to
file, prosecute and maintain in INTERCARDIA Territory, or cause such actions to
be taken, at its own cost upon appropriate consultation with INTERCARDIA, the
Patent Rights, OPOCRIN Know-How and all Joint Information and Inventions.
OPOCRIN shall be responsible for the payment of all costs, expenses and fees
incurred in connection with such filings, prosecution and maintenance; provided,
however, that OPOCRIN and INTERCARDIA shall share on an equal basis, such costs,
expenses and fees relating to all Joint Information and Inventions. OPOCRIN may
elect not to file and if so INTERCARDIA shall have the right to file any such
patent application relating to the Patent Rights, OPOCRIN Know-How or Joint
Information and Inventions. In each case, the filing party shall give the
non-filing party an opportunity to review the text of the application before
filing, shall consult with the non-filing party with respect thereto, and shall
supply the non-filing party with a copy of the application as filed, together
with notice of its filing date and serial number. OPOCRIN shall keep INTERCARDIA
advised of the status of the actual and prospective patent filings and upon the
request of INTERCARDIA, provide advance copies of any papers related to the
filing, prosecution and maintenance of such patent filings. OPOCRIN shall have
the sole right, power and authority to request, file or declare or to respond to
any interference, opposition or reexamination relating to the Patent Rights or
OPOCRIN Know-How or Joint Information and Inventions and shall promptly notify
INTERCARDIA of any such interference, opposition or reexamination.
10.6 Option of INTERCARDIA to Prosecute and Maintain Patents. OPOCRIN
shall give notice to INTERCARDIA of any desire to cease prosecution and/or
maintenance of Patent Rights in any country and, in such case, or in the case of
any abandonment as failure to proceed to prosecute or maintain any such rights,
shall permit INTERCARDIA, at its sole discretion, to continue prosecution or
maintenance at its own expense for such country Patent Rights. If INTERCARDIA
elects to continue prosecution or maintenance, OPOCRIN shall execute such
documents and perform such acts at
33
INTERCARDIA's expense as may be reasonably necessary for INTERCARDIA to perform
such prosecution or maintenance.
10.7 Enforcement. INTERCARDIA shall enforce and/or protect the Patent
Rights, and OPOCRIN Know-How licensed to INTERCARDIA under this Agreement
against any third party who infringes the Patent Rights or wrongfully uses the
OPOCRIN Know-How. INTERCARDIA shall have the first right to initiate litigation
in the event of a third party claim of patent infringement pertaining to a
Licensed Product or Licensed Compound.
10.8 Infringement Action. In the event INTERCARDIA institutes an action
at its expense against third party infringers with respect to a Licensed Product
or Licensed Compound or takes appropriate action to defend the Patent Rights or
OPOCRIN Know-How, OPOCRIN hereby agrees to reasonably cooperate with
INTERCARDIA. Any recovery obtained by INTERCARDIA as a result of such proceeding
or other actions, whether obtained by settlement or otherwise, shall be divided
with OPOCRIN receiving its applicable royalty percentage on the balance of the
award and INTERCARDIA retaining all amounts after payment of such royalty
amounts.
10.9 Option to Prosecute Infringement. If within sixty (60) days of
becoming aware of the infringement of the Patent Rights for which INTERCARDIA
retains a license under this Agreement or unauthorized use of the OPOCRIN
Know-How, INTERCARDIA decides not to institute an infringement suit or take
other reasonable action to protect the Patent Rights and the OPOCRIN Know-How,
OPOCRIN shall have the right to institute such suit or take other appropriate
action at its own expense in the name of INTERCARDIA. INTERCARDIA shall
cooperate fully with OPOCRIN in connection with any such actions to protect the
Patent Rights, OPOCRIN Know-How and Licensed Products. Any recovery obtained by
OPOCRIN as a result of such proceeding, by settlement or otherwise, shall be
divided, after deduction of OPOCRIN's expenses, with OPOCRIN receiving its
applicable royalty percentage on the balance of the
34
award and INTERCARDIA receiving all amounts after OPOCRIN's receipt of such
royalty and expense amounts..
10.10 Abandonment. OPOCRIN shall promptly give notice to INTERCARDIA of
the grant, lapse, revocation, surrender, invalidation, interference proceeding,
or abandonment of any Patent Rights licensed to INTERCARDIA for which OPOCRIN is
responsible for the filing, prosecution and maintenance.
10.11 Patent Term Restoration. The parties hereto shall cooperate with
each other in obtaining patent term restoration or supplemental protection
certificates or data exclusivity or their equivalents in the OPOCRIN Territory
and the INTERCARDIA Territory where applicable to Patent Rights. In the event
that elections with respect to obtaining such patent term restoration are to be
made, OPOCRIN shall have the right to make the election based upon the written
recommendation of INTERCARDIA and INTERCARDIA agrees to abide by such election.
10.12 Notices. All notices, inquiries and communications in connection
with this Article X shall be sent in accordance with Section 13.4.
ARTICLE XI
TERM AND TERMINATION
11.1 Term and Expiration. This Agreement shall commence on the
Effective Date and shall terminate fifteen (15) years from the Effective Date.
At the termination of this Agreement, INTERCARDIA shall retain the rights to
Regulatory Approvals, INTERCADIA Know-How, OPOCRIN Know-How and other
intellectual property necessary or required to sell, use or manufacture the
Licensed Compound or Licensed Products.
35
11.2 Termination.
11.2.1 Termination for Cause. This Agreement may be terminated by
notice delivered to either party at any time during the term of this Agreement
as follows:
(a) by either party, if the other party is in breach of its material
obligations hereunder, other than a breach for failure to pay royalties or
advance funds covered in Section 11.2.1(b) below, by causes and reasons within
its control and has not cured such breach within ninety (90) days after written
notice requesting cure of the breach; provided, however, that if the breach is
not capable of being cured within ninety (90) days of such written notice, this
Agreement may not be terminated so long as the breaching party commences and
diligently prosecutes all commercially reasonable actions to cure such breach as
promptly as practicable; or
(b) by OPOCRIN if INTERCARDIA fails to pay OPOCRIN any amounts due and
payable to OPOCRIN defined in this Agreement; provided that OPOCRIN shall give
INTERCARDIA written notice of such overdue payment. If such overdue payments are
not made by INTERCARDIA within twenty (20) days after receipt of such notice,
OPOCRIN shall have the right to institute an action to collect such amounts
without terminating this Agreement; provided, however, that if INTERCARDIA in
good faith disputes any portion of the overdue payment, OPOCRIN shall not be
entitled to terminate this Agreement so long as all non-disputed amounts which
are due have been paid to OPOCRIN, or
(c) by either party, if the other party files or institutes bankruptcy,
reorganization, liquidation or receivership proceedings, or if the other party
assigns a substantial portion of its assets for the benefit of creditors;
provided, however, in the case of any involuntary bankruptcy proceeding such
right to terminate shall only become effective if the party consents to the
involuntary bankruptcy or such proceeding is not dismissed within ninety (90)
days after the filing thereof.
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(d) by INTERCARDIA in its sole discretion, upon thirty (30) days
notice, at any time without further obligation to OPOCRIN. Upon such
termination, ownership of all data and information and related intellectual
property developed by or on the behalf of INTERCARDIA during the term of this
Agreement solely and directly relating to the Licensed Compound shall be
transferred to OPOCRIN at no cost.
(e) by OPOCRIN, if and only if, INTERCARDIA fails to use Reasonable
Commercial Efforts to develop the License Compound, OPOCRIN shall have the right
to terminate this Agreement, and in such event the data and information and
related intellectual property rights developed by or on the behalf of
INTERCARDIA during the term of this Agreement solely and directly relating to
the Licensed Compound shall be transferred to OPOCRIN at no cost. OPOCRIN shall
have no recourse to claim damages, costs, expenses, lost profits or any other
claim in the event OPOCRIN or INTERCARDIA terminate this Agreement. Termination
by INTERCARDIA or OPOCRIN pursuant to this paragraph shall not, however, affect
any payments due and payable, but unpaid prior to such termination. No
termination shall be available to OPOCRIN as a result of INTERCARDIA's decision
as to timing of development in any market or its decision not to enter any
market, nor shall any termination be effective prior to the expiration of six
months written notice to INTERCARDIA of OPOCRIN's intent to terminate and its
written plan of objective and commercially reasonable actions required by
INTERCARDIA to cure any INTERCARDIA breach of its obligation to use Reasonable
Commercial Efforts to develop the Licensed Compound, and only if INTERCARDIA
fails to take reasonable steps to cure such breach. OPOCRIN shall have no rights
to terminate this Agreement under the terms of this section at any time
subsequent to the approval of an NDA in the U.S. or a major EC market.
(f) by OPOCRIN upon thirty (30) days prior written notice to
INTERCARDIA in the event INTERCARDIA challenges the Patent Rights.
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11.2.2 Effect of Termination for Cause on License. In the event
INTERCARDIA terminates this Agreement under Section 11.2.1(c), all rights and
licenses granted under or pursuant to this Agreement by OPOCRIN to INTERCARDIA
are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the
Bankruptcy Code, or other applicable bankruptcy or insolvency rules and
regulations, licenses of rights to "intellectual property" as defined under
Section 101(52) of the Bankruptcy Code. The parties agree that INTERCARDIA, as a
licensee of such rights under this Agreement, shall retain and may fully
exercise all of its rights and elections under the Bankruptcy Code. The parties
further agree that, in the event of the commencement of a bankruptcy proceeding
by or against OPOCRIN under the Bankruptcy Code, INTERCARDIA shall be entitled
to a complete duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments of such intellectual property upon
written request therefore by INTERCARDIA. Such intellectual property and all
embodiments thereof shall be promptly delivered to INTERCARDIA (i) upon any such
commencement of a bankruptcy proceeding upon written request therefore by
INTERCARDIA, unless OPOCRIN elects to continue to perform all of its obligations
under this Agreement or (ii) if not delivered under (i) above, upon the
rejection of this Agreement by or on behalf of OPOCRIN upon written request
therefore by INTERCARDIA.
11.3 Termination Without Cause. INTERCARDIA may terminate this
Agreement without cause at any time after the Effective Date and prior to the
Expiration, as defined in 11.1, without financial or other recourse by OPOCRIN,
other than the obligation to pay any amounts due and payable to OPOCRIN accrued
but unpaid at such time and to provide to OPOCRIN the data developed for
Licensed Compound or Licensed Product.
11.4 Effect of Termination. Expiration or termination of the Agreement
shall not relieve the parties of any obligation accruing prior to such
expiration or termination, and the provisions of Article IX shall survive the
expiration or termination of the Agreement. Any expiration or early termination
of this Agreement shall be without prejudice to the rights of either party
against the other accrued or accruing
38
under this Agreement prior to termination, including the obligation to pay
royalties for Licensed Product sold prior to such termination.
ARTICLE XII
INDEMNITY
12.1 General. For purposes of this Article XII "Indemnified Parties"
refers to INTERCARDIA, its Affiliates and the officers, directors, employees,
and agents of INTERCARDIA and its Affiliates when OPOCRIN is the indemnitor, and
"Indemnified Parties" refers to OPOCRIN, its Affiliates and officers, directors,
employees, and agents of OPOCRIN and its Affiliates when INTERCARDIA is the
indemnitor.
12.1.1 OPOCRIN Indemnity. OPOCRIN, as indemnitor on behalf of itself
and its officers, directors, employees, agents and representatives shall
indemnify and hold harmless the INTERCARDIA Indemnified Parties and each of them
from any and all liability arising out of any suit, action, legal proceeding,
claim or demand of whatever kind or character based upon:
(a) a claim or occurrence arising from any acts, whether of omission or
commission, by said officers, directors, employees, agents or representatives in
connection with any aspect of this Agreement undertaken by OPOCRIN; or
(b) any breach of any representation, warranty or agreement made by
OPOCRIN hereunder; or
(c) the failure by OPOCRIN in performing its obligations under this
Agreement; or
(d) a claim or occurrence in a particular country arising out of or
relating to the Licensed Compound or the Licensed Products, prior to receipt by
INTERCARDIA of Regulatory Approval for such country.
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12.1.2 INTERCARDIA Indemnity. INTERCARDIA, as indemnitor on behalf of
itself and its officers, directors, employees, agents and representatives shall
indemnify and hold harmless the OPOCRIN Indemnified Parties and each of them
from any and all liability arising out of any suit, action, legal proceeding,
claim or demand of whatever kind or character based upon:
(a) a claim or occurrence arising from any acts, whether of omission or
commission, by said officers, directors, employees, agents or representatives in
connection with any aspect of this Agreement undertaken by INTERCARDIA; or
(b) any breach of any representation, warranty or agreement made by
INTERCARDIA hereunder; or
(c) the failure by INTERCARDIA in performing its obligations under this
Agreement; or
(d) a claim or occurrence in a particular country arising out of or
relating to the Licensed Compound or the Licensed Products, subsequent to
receipt by INTERCARDIA of Regulatory Approval for such country.
12.1.3 Negligence or Willful Misconduct. Anything to the contrary in
this Article XII notwithstanding, neither party shall be obligated to indemnify
an Indemnified Party for such Indemnified Party's own acts of negligence or
willful misconduct or for any violation of any warranty, representation or
agreement made by such Indemnified Party hereunder.
12.2 Scope of Indemnification.
12.2.1 Nature of Damages. The agreement to indemnify and hold harmless
from liability set forth herein shall include, subject to the limitation of
liability contained in Sections 10.3 and 10.4, all damages of every kind,
reasonable attorney fees, all costs and expenses which may be levied against and
out of pocket
40
costs incurred by the Indemnified Parties in connection with any suit, action,
legal proceeding, claim or demand.
12.2.2 Survival. Each party acknowledges and hereby agrees that the
obligations set forth in this Article XII shall survive the termination or
expiration of this Agreement until the expiration of any applicable statute of
limitations.
12.2.3 Cooperation of the Parties. The Indemnified Parties will
cooperate with the indemnitor at the indemnitor's expense in the defense of any
suit. Neither party shall be liable for any costs resulting from any settlement
made by a party prior to using its reasonable efforts to obtain the consent of
the other party to such settlement.
12.3 Insurance. INTERCARDIA and OPOCRIN each shall maintain product
liability insurance with respect to development, manufacture and sales of
Licensed Compound and Licensed Product in such amount as INTERCARDIA or OPOCRIN,
respectively, customarily maintains with respect to sales of its other products
similar in nature to Licensed Compound and Licensed Product. If INTERCARDIA or
OPOCRIN obtain product liability insurance from a third party insurance carrier,
the other party shall, if possible, be named as an additional insured on any
such external insurance policy. Each party shall provide the other party
coverage against product liability claims arising in connection with the sale of
the Licensed Compound and Licensed Products as if the other party were an
additional insured under any self-insurance program assuming no retention of
liability for costs, expenses, claims or damages by INTERCARDIA or OPOCRIN. Each
party shall provide the other party with a certificate of insurance for coverage
required hereunder.
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ARTICLE XIII
MISCELLANEOUS
13.1 Force Majeure. Neither party shall be held liable or responsible
to the other party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party including, but not limited to,
fire, floods, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party. The affected party shall notify the
other party of such force majeure circumstances as soon as reasonably practical.
13.2 Assignment. This Agreement may not be assigned or otherwise
transferred, nor, except as expressly provided hereunder, may any right or
obligations hereunder be assigned or transferred, by either party without the
consent of the other party; provided, however, that either party may, without
such consent, assign this Agreement and its rights and obligations hereunder to
an Affiliate or in connection with the transfer or sale of all or substantially
all of its assets related to its business, or in the event of its merger or
consolidation or change in control or similar transaction. Any permitted
assignee shall assume all obligations of its assignor under this Agreement, and
such assignor shall remain jointly responsible for compliance with all of its
obligations under this Agreement for the term hereof.
13.3 Severability. In the event any one or more of the provisions
contained in this Agreement should be held invalid, illegal or unenforceable in
any respect, the validity, legality and enforceability of the remaining
provisions contained herein shall not in any way be affected or impaired
thereby, unless the absence of the invalidated provision(s) adversely affect the
substantive rights of the parties. The parties shall in such an instance use
their best efforts to replace the invalid, illegal or unenforceable provision(s)
42
with valid, legal and enforceable provision(s) which, insofar as practical,
implement the purposes of this Agreement.
13.4 Notices. All notices or other communications which are required
or permitted hereunder shall be in writing and sufficient if delivered
personally, sent by telecopier (and promptly confirmed by personal delivery,
registered or certified mail or overnight courier), sent by
nationally-recognized overnight courier or sent by registered or certified mail,
postage prepaid, return receipt requested, addressed as follows:
if to INTERCARDIA, to:
INTERCARDIA, INC
Post Office Box 14287
3200 East Highway 54
Cape Fear Building, Suite 300
Research Triangle Park, NC 27709-4287
ATTN: President
with a copy to:
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ & ▇▇▇▇▇▇ LLP
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
if to OPOCRIN, to:
OPOCRIN, S.p.A.
▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇
▇▇▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇
▇▇▇▇▇
ATTN: President
or to such other address as the party to whom notice is to be given may have
furnished to the other party in writing in accordance herewith. Any such
communication shall be deemed to have been given when delivered if personally
delivered or sent by telecopier on a business day, on the third business day
after dispatch if sent by internationally-recognized overnight courier and on
the fifth business day following the date of mailing if sent by mail.
43
13.5 Applicable Law. The Agreement shall be governed by and construed
in accordance with the laws of Switzerland without reference to any rules of
conflict of laws.
13.6 Arbitration. Any disputes (other than the failure to make a
payment required under this Agreement of an undisputed amount) arising between
the parties relating to, arising out of or in any way connected with this
Agreement or any term or condition hereof, or the performance by either party of
its obligations hereunder, whether before or after termination of the Agreement,
may be resolved by binding arbitration upon mutual agreement of the parties.
Whenever a party shall decide to institute arbitration proceedings, it shall
give written notice to that effect to the other party. The party giving such
notice shall refrain from instituting the arbitration proceedings for a period
of sixty (60) days following such notice. During such period, the parties shall
make good faith efforts to amicably resolve the dispute without arbitration. Any
arbitration hereunder shall be conducted under the Rules of Arbitration and
Conciliation of the International Chamber of Commerce. Each such arbitration
shall be conducted by a panel of three arbitrators: one arbitrator shall be
appointed by each of INTERCARDIA and OPOCRIN and the third shall be appointed by
the two arbitrators. Any such arbitration shall be held in Geneva, Switzerland
and the arbitration shall be conducted in English. The arbitrators shall have
the authority to direct the parties as to the manner in which the parties shall
resolve the disputed issues, to render a final decision with respect to such
disputed issues, or to grant specific performance with respect to any such
disputed issue. Judgment upon the award so rendered may be entered in any court
having jurisdiction or application may be made to such court for judicial
acceptance of any award and an order of enforcement, as the case may be. Nothing
in this Section 12.6 shall be construed to preclude either party from seeking
provisional remedies, including but not limited to, temporary restraining orders
and preliminary injunctions, from any court of competent jurisdiction, in order
to protect its rights pending arbitration, but such preliminary relief shall not
be sought as a means of avoiding arbitration. In no event shall a demand for
arbitration be made after the date when institution of a legal or equitable
proceeding based on such claim, dispute or other matter in question would
44
be barred by the applicable statute of limitations. The prevailing party in any
legal or arbitration action shall be entitled, in addition to any other rights
and remedies it may have, to reimbursement for its expenses incurred thereby,
including but not limited to court costs and reasonable attorney's fees.
13.7 Entire Agreement. The Agreement contains the entire understanding
of the parties with respect to the subject matter hereof. This Agreement
replaces and supersedes in its entirety the Letter of Intent. All express or
implied agreements and understandings, either oral or written, heretofore made
are expressly merged in and made a part of the Agreement. The Agreement may be
amended, or any term hereof modified, only by a written instrument duly executed
by both parties hereto.
13.8 Headings. The captions to the several Articles and Sections
hereof are not a part of the Agreement, but are merely guides or labels to
assist in locating and reading the several Articles and Sections hereof.
13.9 Independent Contractors. It is expressly agreed that OPOCRIN and
INTERCARDIA shall be independent contractors and that the relationship between
the parties shall not constitute a partnership, joint venture or agency. Neither
OPOCRIN nor INTERCARDIA shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other, without the prior consent of the party to do so.
13.10 Waiver. The waiver by a party of its right either to exercise
any right it has under this Agreement or to enforce any obligation the other
party has under this Agreement shall only be valid and effective if it is in
writing, refers specifically to the Agreement and is signed by the party waiving
such right. Furthermore, such waiver shall not operate as a waiver of such
party's right to exercise such right or enforce such obligation on any future
occasion, unless the waiver is expressly stated to have such effect.
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13.11 Expenses. OPOCRIN and INTERCARDIA shall bear their respective
legal, accounting, and other expenses associated with this Agreement.
13.12 Counterparts. The Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this Agreement effective
as of the Effective Date herein.
OPOCRIN S.p.A. INTERCARDIA, INC.
By:_____________________________ By:_____________________
Name:__________________________ Name:___________________
Title:___________________________ Title:__________________
Date:___________________________ Date: __________________
46