EXHIBIT 10.37


 


CONFIDENTIAL


 


LICENSE  &  SUPPLY


 


AGREEMENT


 


dated as of August 9, 2004


 




between


 


PRONOVA BIOCARE A.S.


 


Postboks 420, Vollsveien 6, NO-1327 Lysaker, Norway


 


(hereinafter “PRONOVA”)


 


and


 


RELIANT PHARMACEUTICALS, INC.


 


110 Allen Road, Liberty Corner, NJ 07938, USA


 


(hereinafter “RELIANT”)


 


collectively referred to as the “Parties”,


 


or in the singular, as the “Party”.


 


 


 

















 


WHEREAS,
PRONOVA owns and/or controls certain intellectual property rights and know-how
with respect to a pharmaceutical product known as Omacor® and has
the manufacturing skills to produce Omacor®;


 


WHEREAS,
RELIANT is a pharmaceutical company with a marketing and sales network in the
Territory and is interested in utilizing this network in order to market and
sell Omacor® in the Territory;


 


WHEREAS,
PRONOVA has the intention to obtain an FDA approval for Omacor® in
the Territory for the indication Hypertriglyceridemia and other indications to
be agreed upon;


 


WHEREAS,
the Parties on the basis of the above, hereby enter into this Agreement
granting RELIANT an exclusive license to Omacor® in the Territory,
as more particularly described herein, and setting forth certain terms and
agreements by which PRONOVA shall supply RELIANT products having as an active
pharmaceutical ingredient high-concentration Omega-3 fatty acids;


 


NOW
THEREFORE, in consideration of the premises and mutual covenants herein
contained, the Parties agree as follows:


 


1.                                      DEFINITIONS


 


In
this Agreement;


 


1.1                                 “Actual Abbott Handover Date” means the date on which all rights
(including the Registration for the Product and Intellectual Property Rights
license) currently held by Abbott according to agreement with PRONOVA December
19th 2003, to be licensed hereunder to RELIANT actually revert to
PRONOVA.


 


1.2                                 “Act” shall mean collectively the United States Federal Food,
Drug, and Cosmetic Act of 1938, including any amendments thereto, and all
regulations and rules promulgated thereunder, and the United States Federal
Controlled Substances Act, including all amendments thereto, and all
regulations, rules, guidelines and procedures promulgated thereunder.


 


1.3                                 “Additional Products” means any pharmaceutical product other than
the Product, which is covered in whole or in part, or is made or used by a
process or method covered in whole or in part by at least one unexpired issued
claim or a pending claim in the Patents in the Territory or by Product
Know-How, in which any such process, product or part thereof is made, used or
sold that (i) contains the API as its sole active ingredient (i.e., a monotherapy product), regardless
of the indication therefor, or (ii) is a Combination Product that has a
Cardiovascular Indication; or (iii) is a Combination Product that has a
Non-Cardiovascular Indication that RELIANT has the right to commercialize in
the Territory pursuant to the terms of this Agreement.


 


1.4                                 “Affiliate” means, when used with reference to a Party, any
person or entity directly or indirectly controlling or controlled by, or under
direct or indirect common control with, such Party. For the purposes of this
definition “control” means the direct or indirect ownership of more than 50% of
the outstanding voting securities of an entity, or, if 


 


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there are no such securities, more than 50% of the voting rights or
equity interest in such entity.


 


1.5                                 “ANDA” means Abbreviated New Drug Application as defined under
the Act.


 


1.6                                 “API” means the K85EE active pharmaceutical ingredient with
Specifications set forth in Schedule 1.6, as more particularly described
in NDA #21-654 for Omacor®.


 


1.7                                 “Base Supply Price” means the price set forth in Section 7.1,
as the same may be adjusted from time to time pursuant to Section 7.4
and/or Section 7.5.


 


1.8                                 “Cardiovascular Indication” means, with respect to any
pharmaceutical product, an indication that has been granted Regulatory Approval
(or, as applicable, for which Regulatory Approval is being sought or is
intended to be sought) for the cure, mitigation, treatment or prevention of any
cardiovascular disease, condition or symptom in humans, including dyslipidemia
and other related metabolic disorders.


 


1.9                                 “cGMP” means current Good Manufacturing Practices applicable to
pharmaceutical products, as defined and implemented under the Act.


 


1.10                           “Combination Product” means a pharmaceutical product containing
the API as an active pharmaceutical ingredient in combination with one or more
other active pharmaceutical ingredients, wherein the Combination Product is
covered in whole or in part, or is made or used by a process or method covered
in whole or in part by at least one unexpired issued claim or a pending claim
in the Patents in the Territory or by Product Know-How, in which any such
process, product or part thereof is made, used or sold.


 


1.11                           “Confidential Information” means all intellectual property and
confidential facts relating to the business and affairs of a Party or any of
its Affiliates, including the terms and conditions of this Agreement, financial
information, business opportunities, information relating to pharmaceutical
products of any nature whatsoever, Technical Information, know-how, and
compilations of information in any form whatsoever; provided, however, that “Confidential Information”
shall not include any information that (a) was already in the public domain at
the time of disclosure; (b) becomes part of the public domain through no action
or omission of the receiving Party after disclosure to the receiving Party; (c)
was already known to the receiving Party, other than under an obligation of
confidentiality to the disclosing party, at the time of the disclosure by the
other Party; (d) was independently discovered or developed by the receiving
Party without the use of Confidential Information belonging to the disclosing
Party, or (e) was disclosed to the receiving Party, other than under an
obligation of confidentiality to which a third party was subject, by a third
party who had no obligation to the disclosing Party not to disclose such
information to others.


 


1.12                           “FDA” means the United States Food and Drug Administration.


 


1.13                           “First Commercial Sale” means the first arm’s length sale of the
Product as Trade Product by RELIANT to an unaffiliated third party in the
Territory.


 


1.14                           “Governmental Authority “ means any nation or government, any
state, regional, local or other political subdivision thereof, any
supranational organization of sovereign states, and any entity, department,
commission, bureau, agency, authority, board, body, court, official or officer,
domestic or foreign, exercising executive, judicial, regulatory or
administrative functions of or pertaining to government.


 


1.16                           “HTG” means Hypertriglyceridemia.


 


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1.17                           “Intellectual Property Rights” means the Patents, the Trademarks,
the Product Know-How and the Technical Information.


 


1.18                           “NDA” means any new drug application pursuant to Section 505 of
the Act submitted to the FDA or any successor application, including, where
applicable, all subsequent submissions, supplements and/or amendments thereto,
now or hereafter filed with respect to any pharmaceutical product, including
the Product.


 


1.19                           “Net Sales” means, for any period, the aggregate amounts invoiced
by RELIANT or its Affiliates for sales of the Product or Additional Product to
un-affiliated third parties, commencing with the First Commercial Sale of the
Product or Additional Product, less the following deductions from such amounts
which are incurred, allowed, accrued or specifically allocated to the Product or
Additional Product: (i) price adjustments or allowances for damaged products,
returns or rejections of Product or Additional Product; (ii) normal and
customary trade, cash and quantity discounts, allowances and credits which
reduce the effective price of the Product or Additional Product (other than
price discounts granted at the time of invoicing which have been already been
included in the gross amount invoiced); (iii) coupons, chargebacks, retroactive
price adjustments and other incentive payments and rebates (or the equivalent
thereof); (iv) any invoiced freight, postage, shipping, insurance, warehousing
and other transportation and storage 
charges related to the shipment of the Product or Additional Product; and
(v) taxes and similar duties, levies and charges collected, charged or
otherwise required to be paid by or on behalf of RELIANT in respect thereof.


 


1.20                           “Non-Cardiovascular Indication” means, with respect to any
pharmaceutical product, an indication other than a Cardiovascular Indication.


 


1.21                           “Other Products” means any pharmaceutical product, other than the
Product or any Additional Product, owned or licensed by or to PRONOVA that
contains the API or an active pharmaceutical ingredient substantially similar
to the API, including any and all dosage forms, formulas, strengths and package
sizes and types thereof, whether or not currently marketed, and whether or not
sold on a prescription or over-the-counter (OTC) basis, including, without
limitation, the pharmaceutical products sold under the Zodin®
trademark outside of the Territory.


 


1.22                           “Patents” means (a) the patents and patent applications in the
Territory owned or controlled by or licensed to PRONOVA set out in Schedule
1.22 and any substitutions, extensions, additions, reissues, reexaminations,
renewals, divisions, continuations, continuations-in-part or supplementary
protection certificates thereof and (b) any future patents and patent
applications in the Territory owned or
controlled by or licensed to PRONOVA that cover, in whole or in part, the use
for a Cardiovascular Indication of any prescription or OTC pharmaceutical
product containing Omega-3 fatty acids as an active ingredient.


 


1.23                           “Product” means the pharmaceutical product containing the API and
certain excipients described in NDA #21-654 for Omacor®, including
any and all dosage forms, formulas, strengths and package sizes and types
thereof, whether or not currently marketed, and whether or not sold on a
prescription or over-the-counter (OTC) basis, which is covered in whole or in
part, or is made or used by a process or method covered in whole or in part, by
at least one unexpired issued claim in the Patents in the Territory or by
Product Know-How, in which any such process, product or part thereof is made,
used or sold.


 


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1.24                           “Product Know-How” means all know-how, show-how, technical and
non-technical information, trade secrets, formulae, techniques, sketches,
drawings, models, inventions, designs, specifications, processes, apparatus,
equipment, databases, research, experimental work, development, pharmacology
and clinical data, software programs and applications, software source
documents, third-party licenses, and any similar type of proprietary
intellectual property right related to the Product or any Additional Product,
either (a) now existing or (b) hereafter created that cover, in whole or in
part, the use for a Cardiovascular Indication of any prescription or OTC
pharmaceutical product containing Omega-3 fatty acids as an active ingredient,
together with all modifications, enhancements and improvements thereto that is owned or licensed (with the
right to sublicense) by PRONOVA.


 


1.25                           “Product Material Adverse Event” shall mean one or more of any of
the following with respect to the Product: (i) a Class I or similar recall
resulting in discontinuance of the marketing of the Product within the
Territory, other than a Class I or similar recall that is not the result of the
design, formulation or manufacture, storage or handling of the API by or on
behalf of any PRONOVA Indemnitee (as defined in Section 16.2); (ii) the
requirement that a “black box” warning be included on the labeling of the
Product; or (iii) the introduction by an unaffiliated third party of a
therapeutically equivalent drug product to the Product (that is not otherwise terminated or being
opposed by the parties pursuant to Section 14), as such therapeutic equivalence shall be determined by the FDA and demonstrated by an “A” code designation (i.e., the product is rated AA, AN, AO, AP,
AT or AB) in the publication “Approved Drug Products with Therapeutic
Equivalence Evaluations, also known as the “Orange Book”) (each, an “Equivalent
Product”).


 


1.26                           “Registrations” means all regulatory approvals, filings, applications
and similar materials applicable to the Product or any Additional Product in
the Territory, including, without limitation, any Drug Identification Numbers (“DINs”),
Investigational New Drug Applications (“INDs”), NDAs, chemistry,
manufacturing and control (“CMC”) data, pharmaceutical development
reports, and any reference materials for API, related substances, degradation
products and intermediates, in each case with all supplements and amendments
thereto, applicable to the Product or any Additional Product in the Territory,
and all documents, correspondence and other materials related thereto issued or
sent by or to any Governmental Authority including, without limitation, the
Registration filing for the Product as more particularly described in NDA #
21-654 for Omacor®.


 


1.27                           “Regulatory Approval” means, with respect to the Product or any
Additional Product, the approval or authorization granted by a Regulatory
Authority for the initial and ongoing commercialization of the Product or any
such Additional Product in the Territory.


 


1.28                           “Regulatory Authority” means the FDA and/or any equivalent,
similar or successor body, whose approval is required by applicable law to
import, test, encapsulate, label, package, store, handle, market, advertise,
promote, sell, offer for sale, distribute and otherwise commercialize the
Product or any Additional Product in the Territory.


 


1.29                           “Regulatory Requirements” shall mean all applicable Regulatory
Approvals, licenses, registrations, GMPs, and authorizations and all other
requirements of any Government Authority in relation to the API, the Product or
any Additional Product, including each 


 


4

















 


of the foregoing which is necessary
for, or otherwise governs, the manufacture, importation, testing,
encapsulating, labeling, packaging, storing, handling, marketing, advertising,
promotion, sale, offer for sale, distribution or other commercialization of the
API, the Product or any Additional Product.


 


1.30                           “Sample Product” means Products supplied to physicians and other
permitted recipients free of charge in accordance with applicable Regulatory
Requirements.


 


1.31                           “Serious or Unexpected Adverse Drug Experience” means any adverse
drug experience occurring at any dose that results in any of the following
outcomes: death, a life-threatening adverse drug experience, inpatient
hospitalization or prolongation of existing hospitalization, a persistent or
significant disability/incapacity, or a congenital anomaly/birth defect. Important
medical events that may not result in death, be life-threatening, or require
hospitalization may be considered a Serious or Unexpected Adverse Drug
Experience when, based upon appropriate medical judgment, they may jeopardize
the patient or subject and may require medical or surgical intervention to
prevent one of the outcomes listed in this definition as more fully defined in
21 C.F.R. (Section 314.80 or Section 600.80, as applicable). An unexpected
adverse drug experience means any drug experience that is not listed in the
current labeling for the drug product. This includes events that may be
symptomatically and pathophysiologically related to an event listed in the
labeling, but differ from the event because of greater severity or specificity.
Unexpected refers to an adverse drug experience that has not previously been
observed (i.e., not included in
the labeling) rather than from the perspective of not being anticipated from
the pharmacological properties of the pharmaceutical product.


 


1.32                           “Specifications” means the specifications and standards for the
API used in the Product and any Additional Products as set forth in Schedule
1.6 attached hereto, as the same may amended from time to time by PRONOVA
as required by any Regulatory Authority (in which event PRONOVA shall provide
RELIANT written notice thereof as soon as possible), or otherwise with the
prior written consent of RELIANT, such consent not to be unreasonably withheld,
delayed or conditioned.


 


1.33                           “Technical Information” means the data and other information
related to the API, the Product or any Additional Product that will be used for
the Registration of the Product or such Additional Product, which is in the
possession of, developed by or on behalf of, or otherwise controlled by or
licensed to PRONOVA, either (a) now existing or (b) hereafter created that
cover, in whole or in part, the use for a Cardiovascular Indication of any
prescription or OTC pharmaceutical product containing Omega-3 fatty acids as an
active ingredient, including, without limitation, all clinical data, adverse
event data, pharmaceutical development reports, and other medical information,
and any such data and (from the time such information is transferred by Abbott
Laboratories) relevant information currently in the possession of Abbott
Laboratories or any of its Affiliates as relates to the Product.


 


1.34                           “Territory” means the United States of America, its territories
and possessions, including Puerto Rico.


 


1.35                           “Trademarks” means the trademark Omacor®, and any
other trademarks, service marks, service names, trade names, Territory-specific
internet domain names, applications or registrations for any of the foregoing,
or extensions, renewals, continuations or re-issues thereof, or amendments or
modifications thereto, brandmarks, brand, trade dress, 


 


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package designs, product inserts,
labels, logos and associated artwork owned by or licensed to PRONOVA with
respect to the Product or any Additional Product or the packaging therefor in
the Territory, as set forth on Schedule 1.35.


 


1.36                           “Trade Product” means any Product that is not Sample Product.


 


1.37                           “USD” means United States dollars.


 


The use of plural shall include the singular
and vice versa.


 


2.                                      GRANT OF
RIGHTS


 


2.1                                 License. Subject to
the terms and conditions of this Agreement, and effective as of the Actual
Abbott Handover Date, PRONOVA hereby grants to RELIANT, and RELIANT hereby
accepts, an exclusive royalty-bearing license under the Intellectual Property
Rights: (a) to use, develop, import, test, encapsulate and package the API in
finished dosage form in the Territory; (b) to use, develop, import, test,
encapsulate, package, market, promote, sell, offer for sale, distribute and
otherwise commercialize the Product and, as applicable, any Additional
Products, in the Territory; and (c) to use the Technical Information to obtain
Regulatory Approval for the Product and, as applicable, any Additional
Products, in the Territory (the “License”). The License does not allow
RELIANT to grant sublicenses; provided,
however, that nothing herein shall limit or otherwise restrict
RELIANT’s right to engage Affiliates or third parties as permitted under Section
2.9 of this Agreement.


 


2.2                                 Development of Additional Products; Adjustment to Base Supply Price. PRONOVA shall inform RELIANT about any development plans of PRONOVA
with respect to any Additional Products (and products with respect to which
RELIANT has a right of first negotiation under Section 10 of this
Agreement). RELIANT shall, subject to the terms and conditions of this
Agreement, have the right, but not the obligation, to develop, at RELIANT’s
expense, and commercialize in the Territory Additional Products, and such
Additional Products shall automatically be included within the scope of the
License under Section 2.1. With respect to any Additional Product that
is a Combination Product, RELIANT’s right to use, market and sell any such
Combination Product shall be subject to an upfront or license fee, and/or other
milestone payments, as shall be agreed to by the Parties based on the models
used in this Agreement; provided, however,
that, in the event that development costs for such Additional Product are fully
funded by RELIANT (including, without limitation, development costs necessary
for approval and commercialization in the Territory), RELIANT shall not be
obligated to any upfront or license fee, or other milestone payments, in
connection therewith; provided, further,
that, in the event that development costs for such Additional Product are
partially funded by RELIANT, any upfront or license fee, or other milestone
payments, in connection therewith shall be proportionately reduced to reflect
RELIANT’s funding contribution to such development costs. Royalty rates for
Combination Products are set out in Schedule 7.2.


 


2.3                                 PRONOVA Right to Prohibit Development of Additional Products. In the event that RELIANT seeks to develop any Additional Products for
commercialization in the Territory, RELIANT shall provide written notice (a “Development
Intention Notice”) to PRONOVA describing the Additional Product to be
developed and RELIANT’s reasons therefor. Within thirty (30) days following
delivery of a Development Intention Notice, 


 


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RELIANT and PRONOVA shall meet to
discuss such proposed development plans and to address any concerns or
questions that PRONOVA may have in respect thereof. Within sixty (60) days
following such meeting, in the event that PRONOVA reasonably determines that
adverse clinical events would be likely to arise from the clinical studies or
development of such Additional Product and that such events would have a
material and detrimental effect on the perception of the safety of Other
Products of PRONOVA outside the Territory, PRONOVA shall provide written notice
(a “Development Objection Notice”) to RELIANT of such determination and
a description of the basis therefor, and RELIANT shall not be entitled to
undertake clinical studies and development of the Additional Product that was
the subject of the Development Intention Notice. Notwithstanding the foregoing,
PRONOVA shall not be entitled to deliver a Development Objection Notice with
respect to: (a) any clinical studies or other development activities required
by the FDA to maintain any Regulatory Approvals; or (b) any proposed Additional
Product that is substantially identical to any other product or potential
product of PRONOVA (i) the development or commercialization of which is
expressly contemplated by this Agreement (i.e.,
other indications for the Product), or (ii) that is, at the time of
the Development Intention Notice, being actively developed or commercialized,
whether directly or indirectly, by PRONOVA or other licensees.


 


2.4                                 Additional Products for Non-Cardiovascular Indications. PRONOVA shall inform RELIANT about any development plans of PRONOVA
with respect to Additional Products for Non-Cardiovascular Indications, and
RELIANT shall have a right of first negotiation to participate in the
development of, and to obtain exclusive commercialization rights for, such
Additional Products in the Territory pursuant to the provisions set out in Section
10. Any Additional Product for a Non-Cardiovascular Indication included
under this Agreement pursuant to the exercise of RELIANT’S right of first
negotiation hereunder shall be deemed an “Additional Product” for the purposes
of this Agreement and the License and subject to Section 2.2 of this
Agreement.


 


2.5                                 Sole Supplier of API; RELIANT Non-Compete. During the term of this Agreement and provided PRONOVA is in
compliance with its supply obligations hereunder, PRONOVA shall be the sole
supplier of RELIANT and its Affiliates of the API for the Product and any
Additional Products. During [***] neither RELIANT nor any of its Affiliates
shall, directly or indirectly, develop, manufacture, market or sell in the
Territory any [***], which is covered in whole or in part, or is made or used
by a process or method covered in whole or in part, by at least one unexpired
issued claim or a pending claim in the Patents in the Territory or by Product
Know-How, in which any such process, product or part there is made, used or
sold, except as provided for in this Agreement. Neither RELIANT nor any of its
Affiliates shall resell or otherwise distribute API in bulk form or in any form
other than as Product or Additional Product.


 


2.6                                 PRONOVA Non-Compete. Except as
provided in Section 2.8(b) below, during [***] neither PRONOVA nor any
of its subsidiaries shall commercialize, license or otherwise supply or provide
to any third party for commercialization in the Territory, and PRONOVA and its
subsidiaries shall use commercially reasonable efforts, consistent with 


 






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7

















 


applicable laws and regulations, to
restrict their licensees, customers and distributors from commercializing,
licensing or otherwise supplying or providing to any third party for
commercialization in the Territory (provided that such obligation to use
commercially reasonable efforts to restrict licensees, customers and
distributors shall not require PRONOVA to commence any legal action to enforce
restrictions unless RELIANT first reasonably demonstrates that the volume of
restricted [***] and/or restricted products imported, sold or otherwise
distributed in the Territory has an aggregate value in excess of $500,000 per
year):


 


(a)                                  any [***] or [***] with a [***]
indication that contains [***], whether alone or in combination with one or
more other active pharmaceutical ingredients;


 


(b)                                 any [***] for use as an active
pharmaceutical ingredient (or [***], in the event that the use of such [***]
requires reference to a PRONOVA Drug Master File), whether alone or in
combination with one or more other active pharmaceutical ingredients or [***],
in a [***] with a [***] indication;


 


(c)                                  any [***]  (whether in finished product form or as an
active pharmaceutical ingredient or [***], either alone or in combination with
one or more active pharmaceutical ingredients or [***]) for use in any [***] or
similar product in which (i) [***] percent ([***]%) in the aggregate, and (ii)
the [***] weight ratio is not within the range of [***] to [***]; or


 


(d)                                 any [***] (whether in finished
product form or as an active pharmaceutical ingredient or [***], either alone
or in combination with one or more active pharmaceutical ingredients or [***])
for use in any [***] product or any [***] or similar product in which (i) [***]
is higher than [***] percent ([***]%) in the aggregate, and (ii)the  [***] is within the range of [***] to [***]; provided, however, that this clause (d)
shall not prohibit PRONOVA from supplying [***] in such [***] with a combined
[***] higher than [***] percent ([***]%) but not higher than [***] percent
([***]%) for use in a [***] or as [***], if third parties are supplying
similarly formulated [***] within the [***] set forth above in this clause (d)
for such purposes in the Territory.


 


PRONOVA acknowledges that the
foregoing restrictions do not prevent PRONOVA from supplying [***] to any third
party for commercialization in the Territory solely as [***] in substantially
the same manner and formulations as PRONOVA currently supplies such third
parties in the Territory as of the date of this Agreement (a list of which
products is attached hereto as Schedule 2.6). In the event that PRONOVA
or any of its subsidiaries desires to
commercialize, license or otherwise supply or provide to any third party for
commercialization in the Territory any [***]  as an active pharmaceutical ingredient for a [***] or [***] for a [***]
that it would otherwise be prohibited from doing so under this Section 2.6,
PRONOVA may request that RELIANT consent to such commercialization, license,
supply or provision, which consent RELIANT agrees shall not be unreasonably
withheld, delayed or conditioned.


 






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with respect to the omitted portions.


 


8

















 


2.7                                 Prohibition on RELIANT Sales Outside Territory. During the term of this Agreement, neither RELIANT nor any of its
subsidiaries shall knowingly (a) solicit for sale, market, promote, distribute,
sell or import the Product, any Additional Product, the API or an active
pharmaceutical ingredient substantially similar to the API outside the
Territory, or (b) supply any API to any third party for ultimate sale and/or
distribution outside the Territory. RELIANT further agrees that it shall use
commercially reasonable efforts, consistent with applicable laws and
regulations, to impose and enforce similar restrictions on its and its
subsidiaries’ licensees, customers and distributors; provided  that
such obligation to use commercially reasonable efforts to enforce restrictions
shall not require RELIANT to commence any legal action to enforce such
restrictions unless PRONOVA first reasonably demonstrates that failure to
adhere to such restrictions are resulting in the sale or importation of volumes
of Product, any Additional Product, the API or an active pharmaceutical
ingredient substantially similar to the API outside the Territory having an
aggregate value in excess of USD 500,000 per year.


 


2.8                                 Prohibition on PRONOVA Sales Inside Territory. During the term of this Agreement, neither PRONOVA nor any of its
subsidiaries shall knowingly (a) solicit for sale, market, promote, distribute,
sell or import any Other Product inside the Territory or (b) supply any API or
an active pharmaceutical ingredient substantially similar to the API to any
third party for ultimate sale and/or distribution in the Territory (other than
with respect to Combination Products for Non-Cardiovascular Indications for
which RELIANT has not exercised its right of first negotiation hereunder). PRONOVA
further agrees that it shall use commercially reasonable efforts, consistent
with applicable laws and regulations, to impose and enforce similar
restrictions on its and its subsidiaries’ licensees, customers and
distributors; provided that such obligation to use commercially
reasonable efforts to enforce restrictions shall not require PRONOVA to
commence any legal action to enforce such restrictions unless RELIANT first
reasonably demonstrates that failure to adhere to such restrictions are
resulting in the sale or importation of volumes of Other Products and/or API or
an active pharmaceutical ingredient substantially similar to the API inside the
Territory having an aggregate value in excess of $500,000 per year.


 


2.9                                 Additional Rights of RELIANT. Notwithstanding
any provision in this Agreement to the contrary: (a) RELIANT may cause or
engage one or more of its Affiliates or third parties to perform any of RELIANT’s
rights or obligations hereunder, including, without limitation, in respect of
the use, development, registration, with the FDA and maintenance of the FDA registration
for, importation, testing, encapsulation, packaging, marketing, promotion,
sale, offer for sale, distribution and commercialization of the Product or any
Additional Products hereunder (e.g., product
packagers, contract sales organizations, advertising agencies, etc.); and (b)
RELIANT shall have the right to assign certain rights (but not delegate
obligations) hereunder as may be necessary in connection with one or more
secured third-party financing arrangements; provided, however,
that the foregoing clauses (a) and (b) do not give RELIANT or its Affiliates
the right to enter into any co-marketing arrangement with any third party with
respect to the Product or any Additional Product or any other sublicensing,
assignment of rights or commercialization arrangement in which RELIANT and/or
its Affiliates (or their respective successors or assigns) do not book 


 


9

















 


all sales of Product and Additional
Products. In
the event that RELIANT exercises any of its rights under this Section 2.9,
RELIANT shall continue to be responsible directly to PRONOVA for the
performance of all of RELIANT’s obligations under this Agreement and compliance
with the applicable terms of hereof. Notwithstanding any provision herein to
the contrary, the Parties agree that RELIANT shall be entitled to use the
License granted under this Agreement in connection with the exercise of its
rights under this Section 2.9.


 


2.10                           No Right of RELIANT to Manufacture. The License granted hereunder does not include the right to
manufacture the API or otherwise sell or distribute API in bulk form or in any
form other than as Product or Additional Product.


 


3.                                      REGISTRATION
AND DISCLOSURE OF INFORMATION


 


3.1                                 Current Registration Status of Product; Acquisition by PRONOVA. PRONOVA hereby represents, warrants and covenants to RELIANT: (a) that
the Registration for the Product has been filed in the name of, and is
currently held by, Abbott Laboratories or one of its subsidiaries or Affiliates
(collectively, “Abbott”); (b) that the Registration for the Product
being prosecuted by Abbott is the only Registration for the Product (regardless
of indication) based on intellectual property rights owned, controlled or
licensed by PRONOVA (and PRONOVA is not currently aware of any other
Registrations in the Territory for the Product, any Additional Product or the
API); (c) that PRONOVA has the unconditional (except for a fee payable by
PRONOVA to Abbott), irrevocable and indefeasible right and option to acquire
all right, title and interest to any and all Registrations for the Product from
Abbott no later than the earlier to occur of (i) forty-five (45) days following
FDA approval of the Registration for the Product for the HTG indication, or
(ii) forty-five (45) days following June 30, 2005 in the event that the FDA has
not approved the Registration for the Product by such date (it being
acknowledged that the foregoing forty-five (45) day time periods include a
thirty (30) day termination right plus an additional seven (7) to fourteen (14)
day period during which Abbott shall assign, transfer and return to PRONOVA the
actual Registration(s) and related data, information and correspondence); provided
that the foregoing time periods set forth in this clause (c) do not
include any delays resulting from any regulation or other requirement requiring
approval or other action by the FDA in order that such transfer of a
Registration be effective; (d) that PRONOVA has provided or caused to be
provided, and will continue to provide or cause to be provided, to RELIANT a
correct and complete copy of any and all Registration(s) for the Product,
including, all data, clinical and CMC data, information and correspondence
included in or related to the Registration or the file for application of the
Registration for the Product (or, as applicable, the reasonable access thereto
for RELIANT); (e) that, except for certain redacted portions, PRONOVA has
provided to RELIANT a true, correct and complete copy of the Abbott Agreement
(as defined in Section 15.1(d)), and such agreement is currently in full
force and effect; (f) that PRONOVA shall not amend, waive or otherwise
modify any provision of or rights or obligations under the Abbott Agreement
without the prior written consent of RELIANT, which shall not be unreasonably
withheld, delayed or conditioned; and (g) that PRONOVA shall fully pay,
perform and discharge its obligations under the Abbott Agreement, when and as
due, and shall fully enforce and protect its rights, benefits and privileges
under the Abbott Agreement. PRONOVA shall acquire the Registration for the
Product from Abbott


 


10

















 


and, subject to the terms of this
Agreement, transfer unencumbered ownership to the Registration(s) (including,
all data, clinical and CMC data, information and correspondence included in or
related to the Registration(s) or the file for application of the
Registration(s)) for the Product to RELIANT, without undue delay after the
Actual Abbott Handover Date. In any event RELIANT must have received the
Registration(s) for the Product no later than sixty (60) days following FDA
approval of the Registration of the Product or September 15, 2005,
whichever comes first (the “Abbott Outside Date”); provided  that
the Abbott Outside Date shall be postponed for any delays resulting from any
regulation or other requirement requiring approval or other action by the FDA
in order that such transfer of a Registration be effective. Prior to the date
RELIANT receives the Registration, RELIANT shall have no obligations under this
Section 3. In the event that PRONOVA shall not have transferred the
Registration for the Product to RELIANT by the Abbott Outside Date, any and all
amounts previously paid by RELIANT to PRONOVA shall be immediately refunded by
PRONOVA to RELIANT.


 


3.2                                 FDA Approval of Product Registration. PRONOVA shall use commercially reasonable efforts to ensure that
Abbott obtains an FDA approval for the Product for the indication HTG in the
Territory as soon as reasonably practicable following the date of this
Agreement. Prior to the date RELIANT receives the Registration, RELIANT shall
have no obligation to contribute to or participate in the filing of any
Registration in order to obtain the FDA approval for the Product.


 


3.3                                 Additional Development Work for Product. In the event the NDA filed for the Product results in an “approvable”
letter or a succeeding equivalent communication from the FDA in the form of a
regulatory decision letter (an “Approvable Letter”), RELIANT shall have
the option to either:


 


(a)                                  notify PRONOVA in writing within
thirty (30) days after the date of RELIANT’s receipt of the Approvable Letter,
that RELIANT will contribute to the continued development of the Product and
pay to PRONOVA the Approvable Letter milestone payment pursuant to Section
4.1 (as set out in Schedule 4.1). In such event, RELIANT will
contribute to and fund all further development of the Product (other than
development costs otherwise funded by Abbott) in order to obtain a final FDA approval
of the Product for the indication HTG; provided, however,
that PRONOVA shall be solely responsible for any expenses with respect to
supply chain or manufacturing issues raised by the FDA; provided,
further, that in the event that RELIANT determines that it no longer
desires to continue to fund such development costs, it may cease such funding
and transfer the Registration for the Product to PRONOVA free of charge, save
for an equitable distribution of any proceeds of any subsequent transaction involving
the Registration for the Product within two years after RELIANT ceased funding,
which shall be agreed between the Parties in good faith to discussions. Upon
final FDA approval RELIANT will pay to PRONOVA the final approval payment
pursuant to Section 4.1 (as set out in Schedule 4.1), which will
be reduced by 50% of all pre-marketing development costs actually incurred
prior to final FDA approval by or on behalf of RELIANT in accordance with this Section
3.3, provided that in no event shall such reduction reduce the final
approval payment below USD 0; or


 


11

















 


(b)                                 notify PRONOVA in writing within
thirty (30) days after the date of RELIANT’s receipt of the Approvable Letter,
that RELIANT will not contribute to the work and expenses necessary to meet the
conditions required to obtain an FDA approval. In such event (or in the event
RELIANT fails to provide a written notice to PRONOVA under Section 3.3(a)
or 3.3(b) within thirty (30) days after the date of RELIANT’s receipt of
the Approvable Letter), the initial up front payment paid by RELIANT pursuant
to Section 4.1 (as set out in Schedule 4.1) will remain with
PRONOVA and this Agreement shall automatically terminate.


 


In the event that the initial effort
by Abbott or PRONOVA to obtain an FDA approval for the NDA for the Product
results in a “not approvable letter” or an equivalent communication from the
FDA (a “Not Approvable Letter”) for the indication HTG, (i) RELIANT’s
option under this Section 3.3 shall become immediately exercisable (and
in the event RELIANT fails to provide a written notice to PRONOVA under Section
3.3(a) or Section 3.3(b) within thirty (30) days after the date of
RELIANT’s receipt of the Not Approvable Letter, RELIANT shall be deemed to have
exercised the option set forth in Section 3.3(b)), (ii) RELIANT shall
not be obligated to make any payments under Section 4.1 otherwise
payable following the issuance of an Approvable Letter or final FDA approval
until such time as an Approvable Letter or final FDA approval is issued, if
ever, and (iii) subject to any applicable expiration or termination provision
of this Agreement, this Agreement shall remain in force as so modified.


 


3.4                                 RELIANT Regulatory Obligations. Following transfer of the Registration for the Product (including all
documentation related thereto) to RELIANT, RELIANT will for the duration of
this Agreement be responsible for the maintenance of the Registration for the
Product, and shall cover all necessary costs associated therewith. RELIANT
shall be responsible for the filing of supplemental or additional Registrations
for the Product and for the Additional Products to be commercialized in the
Territory, and PRONOVA shall provide such assistance as may be reasonably
required. With respect to any supplemental or additional Registrations that may
be filed by RELIANT, PRONOVA may object to any such filing (a) in the event
that there have been significant deviations from the development plan, and (b)
such deviations are demonstrated by PRONOVA to have a material and detrimental
effect on sales of Other Products of PRONOVA outside of the Territory, in which
case PRONOVA shall provide a Development Objection Notice to RELIANT of such
determination and a description of the basis therefor, and RELIANT shall not be
entitled to file such supplemental or additional Registrations. Notwithstanding
the foregoing, PRONOVA shall not be entitled to deliver a Development Objection
Notice with respect to any proposed supplemental or additional Registrations
that cover products or indications that are substantially identical to or
claimed by any other product or potential product of PRONOVA (i) the
development or commercialization of which is expressly contemplated by this
Agreement, or (b) that is then being actively developed or commercialized,
whether directly or indirectly, by PRONOVA or any of its Affiliates or other
licensees. RELIANT shall provide PRONOVA with reasonable advance written notice
of any filing to allow PRONOVA to exercise its rights set forth in the 


 


12

















 


immediately preceding sentence. All
costs associated with such supplemental or additional Registrations shall be
borne by RELIANT.


 


3.5                                 Ownership and Maintenance of Additional Registrations. All supplemental or additional Registrations for new agreed
indications for the Product and for the Additional Products in the Territory
shall be issued in the name of, and owned by, RELIANT. RELIANT will for the
duration of this Agreement be responsible for the maintenance of such
supplemental or additional Registrations, and shall cover all necessary costs
associated therewith.


 


3.6                                 Rights to Clinical Data. PRONOVA
currently has rights to clinical data with respect to Other Products currently
in existence or under development from its, licensees and partners, which
PRONOVA is not prevented from disclosing to RELIANT. Hereafter, PRONOVA shall
use commercially reasonable efforts to obtain rights to clinical data for any
Other Products from its licensees and partners. If PRONOVA obtains rights to
such clinical data that PRONOVA is not prevented from disclosing to RELIANT,
RELIANT will, for regulatory filing or promotional purposes only in the
Territory, receive a fully paid up royalty free license to use and cross
reference the clinical data from planned and ongoing studies related to such
Other Products by PRONOVA and/or its partners. RELIANT shall use commercially
reasonable efforts to obtain rights to clinical data for the Product from its
Affiliates and partners. If RELIANT has rights to such clinical data that
RELIANT is not prevented from disclosing to PRONOVA, RELIANT hereby grants to
PRONOVA a fully paid up royalty free license to use and cross reference
clinical data for the Product from RELIANT’s own and/or its partners’ clinical
studies for regulatory filing and promotional purposes outside the Territory
only. A list of current clinical trials and PRONOVA’s rights to these is set
out in Schedule 3.6.


 


3.7                                 Exchange of Additional Data. RELIANT and
PRONOVA shall, subject to any restrictions in agreements between PRONOVA or
RELIANT, as the case may be,  and third
parties, from time to time upon request, and at least once per year (or more
frequently as may be required by Regulatory Requirements), and without charge,
submit to and exchange with the other Party all other relevant technical and
scientific information and data generated by RELIANT and/or PRONOVA with regard
to the Product and any Additional Product or Other Product. Each Party shall be
entitled to use free of charge such information and data received from the
other Party for regulatory filing and promotional purposes only, subject, in
the case of RELIANT, to the terms of the License, and, in the case of PRONOVA,
to such terms and conditions as may agreed to between the Parties.


 


3.8                                 Changes to Manufacturing Process, Specifications, Etc. PRONOVA shall not make any changes to the Specifications or to any
aspect of its manufacturing or testing process or procedures, API formulation
or similar matters that, under 21 CFR Section 314.70, require prior FDA
approval or a submission to FDA at the time of the change, unless PRONOVA shall
have first provided RELIANT with written notice thereof and provided RELIANT
with such information related thereto as RELIANT shall reasonably request in
order that RELIANT may evaluate and prepare for the regulatory implications of
such change (e.g., additional
stability, clinical studies, etc.), and RELIANT shall have approved such
change, such approval not to be unreasonably withheld, delayed or conditioned. Notwithstanding
anything herein to the contrary, 


 


13

















 


PRONOVA shall provide written notice
to RELIANT of any changes to the Specifications or to any aspect of its manufacturing
or testing process or procedures, API formulation or similar matters
(regardless of whether RELIANT has a consent right under this Section 3.8
in respect thereof) prior to implementing such changes or as soon as
practicable thereafter.


 


3.9                                 Disclosure of PRONOVA Technical Information. Except as otherwise provided in this Agreement and subject to the
provisions of Section 3.10, Technical Information will be disclosed to
RELIANT on a need to know basis at PRONOVA’s reasonable discretion, depending on
product category and RELIANT’s obligations under the Agreement.


 


3.10                           Information Needed to Comply with Regulatory Requirements. Notwithstanding anything in this Agreement to the contrary, PRONOVA
shall provide to RELIANT, on a timely basis, all such information, data and
other information in PRONOVA’S possession as may be required by RELIANT to
obtain and maintain the effectiveness of any Registrations and Regulatory
Approvals, complete any required process validations, and to comply with all
Regulatory Requirements and the requests or requirements of any Regulatory
Authorities, with respect to the Product and any Additional Products.


 


4.                                      UP-FRONT AND
MILESTONE PAYMENTS


 


4.1                                 Up-Front, Approvable and Final Approval Payments. In consideration of the License and other rights granted to RELIANT
under this Agreement, RELIANT shall pay to PRONOVA, in accordance with this
Agreement, payments according to one of the two models set out in Schedule
4.1 attached hereto (the appropriate model to be decided by RELIANT by
written notification to PRONOVA within the time period contemplated by Section
26.14).


 


4.2                                 Additional Milestone Payments. In addition
to any payments made under Section 4.1 above, RELIANT will pay to
PRONOVA additional milestone payments as follows:


 


(a)                                  USD [***] due and payable thirty (30)
days after the date of FDA notification of FDA approval of “IgA nephropathy” as
an additional indication for the Product (provided that RELIANT owns the
Registration for the Product at such time); and


 


(b)                                 USD [***] due and payable thirty (30)
days after the date of FDA notification of FDA approval of a label change for
the Product containing the plaque stabilization data (Southampton Study)
(provided that RELIANT owns the Registration for the Product at such time).


 


RELIANT shall only be responsible for those costs
directly related to the preparation and filing of the supplemental NDAs and
similar documents required to be filed with the applicable Regulatory
Authorities for the Regulatory Approvals related to the matters described in
clauses (a) and (b) above, and RELIANT shall not be responsible for any other
costs and expenses associated therewith, including any costs associated with
clinical studies or data.


 


4.3                                 Withholding. Where any sum due to be paid to
PRONOVA under this Agreement is subject to any withholding or similar tax, the
Parties shall use their commercially 


 






[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 


14

















 


reasonable
efforts to do all such acts and things and to sign all such documents as will
enable them to take advantage of any applicable double taxation agreement or
treaty (the costs thereof to be borne by PRONOVA). In the event there is no
applicable double taxation agreement or treaty, or if an applicable double
taxation agreement or treaty reduces but does not eliminate such withholding or
similar tax, RELIANT shall remit such withholding or similar tax to the
appropriate Governmental Authority, deduct the amount paid from the amount due
PRONOVA and secure and send to PRONOVA official receipts of payment of any such
withholding taxes. No amounts required to be paid by RELIANT hereunder shall be
subject to any gross-up or similar adjustment in the event that RELIANT is
required to withhold or remit any similar taxes in respect thereof.


 


5.                                      SUPPLY OF API
FOR THE PRODUCT AND ADDITIONAL PRODUCTS


 


5.1                                 Manufacture and Supply. Subject to Section
5.12, PRONOVA shall, after FDA approval of the Product for the indication
HTG, manufacture and supply to RELIANT the total of RELIANT’s requirements of
the API for the Product for sale and distribution in the Territory. Similarly, after
FDA approval of any Additional Product, PRONOVA shall supply to RELIANT the
total of RELIANT’s requirements of the API for the Additional Product for sale
and distribution in the Territory. The provisions of this Section 5
shall apply to the supply of API for any Additional Product in the same manner
as they apply to the supply of API for the Product.


 


5.2                                 Forecasts. RELIANT
shall prior to and with effect from the 15th of each month following
the first Regulatory Approval, and thereafter, (M0) give a rolling forecast for
the next consecutive 12-month period. Such forecasts shall be sent to PRONOVA
in writing. M1, M2 and M3 shall be firm orders. M4 and M5 shall non-binding
forecasts, but will be subject to the provisions set forth below. M6 to M12
shall be non-binding forecasts. RELIANT is not entitled to change forecasts for
M1, M2 and M3, and is only entitled to change the consecutive forecasts for M4
and M5 with +/- 15% from the last forecast. An example of the order and
forecast procedure is provided as Schedule 5.2 to this Agreement.


 


5.3                                 Variances. PRONOVA
shall use commercially reasonable efforts to supply RELIANT with the quantities
ordered within 115% of the forecasts, provided that the forecast has been
delivered to PRONOVA in accordance with Section 5.2 or  Section 5.3.


 


5.4                                 Delivery Date. PRONOVA
shall use its commercially reasonable efforts to deliver the API at the dates
specified in RELIANT’s orders; provided, however,
that once an order for a given month becomes a firm order pursuant to Section
5.2, such order may not be changed. RELIANT shall use reasonable efforts to
distribute orders of the Product evenly over a year, or otherwise in agreement
with PRONOVA from time to time.


 


5.5                                 Delivery of Bulk Product. PRONOVA
shall deliver the API to RELIANT in a finished bulk liquid according to the
Specifications ready for encapsulating and final consumer labeling and
packaging as finished Product by or on behalf of RELIANT. PRONOVA shall deliver
the API in proper bulk packaging so as to permit safe transport and storage in
compliance with all Regulatory Requirements.


 


5.6                                 Compliance with cGMP, Regulatory Requirements and Specifications.


 


(a)                                  Compliance. PRONOVA shall manufacture the API
in an FDA-approved facility and supply the API to RELIANT at all times in full
compliance and conformance with the Act, FDA’s cGMP regulations for pharmaceuticals,
the applicable


 


15

















 


Specifications
and any other applicable Regulatory Requirements in effect at the time of
shipment. In addition to the foregoing, PRONOVA, in its own name engaged in the
performance of the actions contemplated hereby, including, without limitation,
the manufacture, sale and supply of API hereunder, hereby represents, warrants
and covenants to RELIANT that all API that is manufactured, supplied and
delivered by PRONOVA under and pursuant to this Agreement: (i) will conform in
all respects to the applicable Specifications; (ii) will be free and clear
from all liens, encumbrances and defects of title (with the possible except of
a purchase money security interest in favor of PRONOVA to secure amounts owned
by RELIANT in respect of such shipment of API); and (iii) will comply with all
of the requirements under the applicable Registration, the Act, Norwegian
Regulatory Requirements for the API production in Norway and US Regulatory
Requirements; and (iv) will not, at the time of such delivery, (A) be
adulterated or misbranded within the meaning of the Act, or (B) be an article
which may not, under the provisions of the Act, be introduced into interstate
commerce for the purpose of incorporation into a pharmaceutical product for
which Regulatory Approval has been granted. RELIANT shall use its commercially
reasonable efforts to inform PRONOVA of any changes to US Regulatory
Requirements that would require any changes to the Specification or other
aspects of the API production (at a cost sharing to be agreed between the
Parties if the modification requirements are substantial).


 


(b)                                 Records. PRONOVA shall maintain during the
term of this Agreement and for a period thereafter consistent with standard
cGMP requirements, all records as are necessary or appropriate to demonstrate
compliance with the Act, cGMP and any other applicable quality control standards
of any Regulatory Authority in the Territory. If PRONOVA fails to comply with
cGMPs in any manner, as demonstrated by an observation of a Regulatory
Authority, PRONOVA shall diligently proceed to remedy such deviation as soon as
practicable. PRONOVA shall provide to RELIANT all information in its possession
or control required to prepare any reports required to be filed by RELIANT
under any Regulatory Requirements, including applicable information and reports
related to the manufacture and production of the API. PRONOVA shall also advise
RELIANT of any occurrences or information known to PRONOVA arising out of
PRONOVA’s manufacturing and production activities that have or could reasonably
be expected to have adverse regulatory compliance and/or reporting consequences
with respect to or concerning the API, the Product or any Additional Product.


 


(c)                                  FDA Inspections. Except as otherwise provided
herein, PRONOVA shall be responsible, at PRONOVA’s sole expense, for handling
and responding to any FDA or other Regulatory Authority inspections with
respect to PRONOVA’s manufacture of the API during the term of this Agreement. PRONOVA
shall provide to RELIANT any information reasonably requested by RELIANT and
all information requested by any Regulatory Authority concerning any inspection
by any Governmental Authority related to the Products. In the event PRONOVA is
provided notice by any Regulatory Authority that it will be inspected by such
Regulatory Authority in connection with the API, PRONOVA shall promptly 


 


16

















 


notify
RELIANT of any observations made during such inspection. Notwithstanding any
provision herein to the contrary, PRONOVA shall provide RELIANT with the
opportunity to comment on any filings, notices or other correspondence with any
Regulatory Authority that relates to or could affect the manufacture or supply
of API hereunder.


 


(d)                                 Notice to RELIANT. In the event PRONOVA, the API or
any facility at which the API or any component thereof is manufactured, packaged,
tested or stored are inspected by any Regulatory Authority, PRONOVA shall
promptly notify RELIANT, to the extent that such inspection affects or could
reasonably be expected to affect the API, the Product, any Additional Product
or the manufacture thereof under this Agreement, of (i) any such inspection
with reasonable advance notice, and (ii) any alleged written violations or
deficiencies relating to the manufacturing facility at which API is
manufactured, packaged, tested or stored, and (iii) the corrective action to be
taken, and shall promptly contest such alleged violations or deficiencies in
good faith or take the required corrective action, each at PRONOVA’s sole
expense. If, based on a specific observation made by any Regulatory Authority following
an audit or inspection, either Party reasonably determines that the API was
manufactured or stored under conditions that materially deviated from cGMPs,
Regulatory Requirements or any applicable law, rule, regulation, guideline or
procedure, including the Act, the Parties shall agree upon the appropriate
action to be taken in conformance with the FDA 483 or the action letter
received from FDA by PRONOVA relating to the API.


 


(e)                                  Facility Audit. RELIANT shall have the right,
either by itself or through independent outside auditors or consultants, not
more than once per year during the term of this Agreement, unless reasonable
cause is shown, to inspect and audit any areas of PRONOVA’s facilities in which
any portion of the manufacturing of the Product or the API is performed for the
examination of production or quality records or to perform cGMP audits, at its
sole expense, on reasonable advance notice, during PRONOVA’s normal business
hours in a manner that does not interfere unreasonably with PRONOVA’s
operations. Any such auditor or consultant shall enter into an agreement with
the Parties on terms in which such independent auditor shall agree to maintain
the confidentiality of the information obtained during the course of such
audit.


 


(f)                                    Acquisition of Raw Materials. PRONOVA shall provide all materials
necessary for the manufacture and supply to RELIANT of API for the Product and
any Additional Products, as part of the Base Supply Price under Section 7.
PRONOVA shall be responsible for vendor quality approval for vendors of
materials, all of which shall comply with the Specifications, the Regulatory
Approvals and all other Regulatory Requirements.


 


(g)                                 Exception Documentation, Certificates
of Analysis and Batch Records. PRONOVA shall provide a certificate of analysis and such other
documents as shall be reasonably requested by RELIANT for any API to be
released hereunder, in a form in accordance with the cGMPs and all other
applicable Regulatory Requirements and the Specifications and as shall be agreed
upon by the Parties. For any batch that initially failed to meet any
Specification, the certificate of 


 


17

















 


analysis
shall document the exception. RELIANT shall be under no obligation to accept
any API for delivery hereunder that shall have an expiry period after delivery
which is less than half the retest period approved by FDA, provided however that if retesting after
the retest period demonstrates that the API is within regulatory requirements
and Specifications, RELIANT shall be obliged to accept delivery.


 


(h)                                 Access to Batch Documentation; Annual
Audit. Full
batch documentation including batch production records, and manufacturing and
analytical procedures for the API for the Products and any Additional Products
shall be available for review by RELIANT in conjunction with the annual audit
or at semi-annual status meetings.


 


(i)                                     Certificate of Compliance. Prior to the first shipment of
API  hereunder and thereafter at least
once per year thereafter, PRONOVA shall provide a certificate of compliance, in
form and substance reasonably satisfactory to RELIANT, certifying compliance
with the Specifications, FDA’s cGMP regulations, the Act, Regulatory Approvals,
Regulatory Requirements and all related processes and procedures contemplated
hereby.


 


(j)                                     Application to Other Parties In
Supply Chain. PRONOVA
shall ensure that the provisions of this Section 5.6 relating to cGMP
compliance and similar matters shall be complied with to the extent relevant by
PRONOVA’s Affiliates and any third parties in the CMC supply chain or otherwise
involved in the manufacture of the API or the supply of any raw materials
therefor.


 


(k)                                  Quality Agreement. Within at least sixty (60) days
following the date of this Agreement, the Parties shall mutually agree upon an
intercompany quality agreement which will appropriately address regulatory,
operational and quality responsibilities (the “Quality Agreement”). The
Quality Agreement will include a key contact list for each Party.


 


5.7                                 Encapsulation by RELIANT. RELIANT, or
its designated partner, shall encapsulate, package, label, test, and otherwise
use API supplied in accordance with this Agreement to manufacture, hold and
distribute the Product and Additional Product in accordance with the Act,
cGMPs, Regulatory Approvals and all other applicable Regulatory Requirements. In
the event RELIANT, the Product (or any Additional Products) or any facility at
which the Product (or any Additional Products) is encapsulated, packaged, paper
labeled, tested or otherwise manufactured or stored are inspected by any
Regulatory authority, RELIANT shall promptly notify PRONOVA, to the extent that
such inspection affects or could reasonably be expected to affect the Product
(or any Additional Product) or the manufacture thereof under this Agreement, of
(i) any such inspection with reasonable advance notice, and (ii) any alleged
written violations or deficiencies relating to the manufacturing facility at
which API is encapsulated, packaged, paper labeled, tested or otherwise
manufactured or stored, and (iii) the corrective action to be taken, and shall
promptly contest such alleged violations or deficiencies in good faith or take
the required corrective action, each at RELIANT’s sole expense. If based on a
specific observation made by any Regulatory Authority following an audit or
inspection, either Party reasonably determines that the Product (or any
Additional Product) was manufactured or the API was stored under conditions
that materially deviated from cGMPs, Regulatory Requirements or any applicable
law, rule, 


 


18

















 


regulation, guideline or procedure,
including the Act, the Parties shall agree upon the appropriate action to be
taken in conformance with the FDA 483 or the action letter received from FDA by
RELIANT relating to the API, or Product or the Additional Product.


 


5.8                                 Inspection of Shipment. RELIANT
shall have a period of fourteen (14) days after the date of its receipt of a
shipment of API to inspect and accept or reject such shipment for
non-conformance with the Specifications based on the outward appearance of such
shipment. RELIANT shall have a period of thirty (30) days (forty-five (45) days
if an outside testing laboratory is used) after the date of its receipt of a
shipment of API to inspect and accept or reject such shipment for any other
non-conformance with the Specifications or based upon a finding by RELIANT of
non-conformance, or due to deviation from the Act, cGMPs or Regulatory
Requirements in the production of the shipment.


 


5.9                                 Rejection of Shipment; Additional Testing. If, following inspection, RELIANT rejects any shipment, it shall
promptly so notify PRONOVA, and the Parties shall thereafter attempt in good
faith to determine whether such API shipment did or did not conform to the
applicable Specifications and shall reasonably cooperate with each other for
such purpose (including, but not limited to, providing the other Party with
reasonable access to all documents, filings and other relevant materials then
in such Party’s possession or reasonably accessible to such Party and RELIANT’s
provision to PRONOVA of samples of such shipment for testing). If either Party
determines that such shipment did not conform to the Specifications, either Party
may, if such Party determines it to be relevant, submit samples of such
shipment to an independent laboratory of nationally recognized standing for
testing. If such independent laboratory determines that the shipment conformed
in all respects to the Specifications, RELIANT shall bear all expenses of
shipping and testing such shipment samples and shall be obligated to accept and
pay for such shipment. If PRONOVA or such independent laboratory confirms that
such shipment did not meet the Specifications in all respects, PRONOVA shall
replace, at no cost to RELIANT, that portion of the shipment that does not
conform to the Specifications, and shall bear all expenses of shipping and
testing the shipment samples, including any costs incurred by RELIANT in returning
such API to PRONOVA or its designee. Except in instances of gross negligence or
intentional misconduct by or on behalf of PRONOVA, RELIANT agrees that, in the
event that PRONOVA replaces all of the non-conforming portion of such shipment
within sixty (60) days of the confirmation by or to PRONOVA that such shipment
did not meet the Specifications and otherwise bears the expenses contemplated
by this Section 5.9, the remedies provided for in this Section 5.9
shall be RELIANT’s sole remedies for the failure of such shipment to conform to
the Specifications. In the event that PRONOVA fails to replace all of the
non-conforming portion of such shipment within sixty (60) days of the
confirmation by or to PRONOVA that such shipment did not meet the Specifications,
such failure shall constitute a Failure to Supply (as defined in Section
5.12(a)) and shall give rise to the rights and obligations of the Parties
under Section 5.12.


 


5.10                           Facility Inspection. If based on
a facility inspection or audit by RELIANT as provided herein, or based on a
specific observation made by any Regulatory Authority following an audit or
inspection, RELIANT determines and notifies PRONOVA that a shipment 


 


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or portion of a shipment was
manufactured under conditions that materially deviated from the Act, cGMPs or
Regulatory Requirements, the Parties shall agree upon the appropriate action to
be taken in conformance with the FDA483 or the action letter received from FDA
by PRONOVA relating to the API, the Product or any Additional Product. If
rejection of API is warranted, PRONOVA shall replace, at no cost to RELIANT,
that portion of the API shipment that was manufactured under conditions
materially deviating from the Act, cGMPs or Regulatory Requirements. Any
non-conforming portion of any shipment shall be disposed of as directed by
PRONOVA, at PRONOVA’s expense. Except in instances of gross negligence or
intentional misconduct by or on behalf of PRONOVA, RELIANT agrees that, in the
event that PRONOVA replaces all of the non-conforming portion of such shipment
within sixty (60) days of the determination and notification to PRONOVA that
such shipment was manufactured under conditions materially deviating from the
Act, cGMPs or Regulatory Requirements, and otherwise bears the expenses
contemplated by this Section 5.10, the remedies provided for in this Section
5.10 shall be RELIANT’s sole remedies for the fact such shipment was
manufactured under conditions materially deviating from the Act, cGMPs or
Regulatory Requirements. In the event that PRONOVA fails to replace all of the
so deviating portion of such shipment within sixty (60) days of the
determination and notification to PRONOVA contemplated by this Section 5.10,
such failure shall constitute a Failure to Supply and shall give rise to the
rights and obligations of the Parties under Section 5.12.


 


5.11                           Sample Retention. PRONOVA, on
behalf of both Parties, shall retain representative samples and associated
documentation from each lot of finished API and manufacturer’s corresponding
lot of key ingredients used in the manufacture of API  for the period required by the applicable
provisions of the Act.


 


5.12                           Failure to Supply.


 


(a)                                  Failure to Supply. Notwithstanding any provision
herein to the contrary, in the event that PRONOVA for any reason (including a
Force Majeure event) shall not have delivered the total amount of API ordered
by RELIANT in accordance with this Section 5 within sixty (60) days
of the date specified in RELIANT’s order (a “Failure to Supply”), then
the provisions of this Section 5.12 shall apply. In no event shall
PRONOVA have any liability under this Agreement for a Failure to Supply
occurring prior to July 1, 2005 or for failure to supply RELIANT with API in
excess of 250,000 kilograms in total during calendar year 2005.


 


(b)                                 Allocation of Available Supply. If PRONOVA for any reason
(including a Force Majeure event) is unable to supply to RELIANT its total
requirements of the API for the Product and any Additional Products ordered in
accordance with this Section 5, PRONOVA shall apportion its
available production capacity among RELIANT and other licensees and
distributors of the API (and, as applicable, other active pharmaceutical
ingredients similar to the API) on a pro rata basis as follows: (i) if such
failure to supply occurs during the first two (2) Commercialization Years (as
defined in Section 6.1), such pro ration shall based on PRONOVA’s actual
sales of the API (and/or active pharmaceutical ingredients similar to the API)
to its licensees and distributors other than RELIANT during the prior twelve
(12) month period and, in the case of RELIANT, RELIANT’s forecasted purchases
of API for the following twelve (12) month period (not to 


 


20

















 


exceed
250,000 kilograms), and (ii) if such failure to supply occurs after the second
Commercialization Year, such pro ration shall based on PRONOVA’s actual sales
of the API (and/or active pharmaceutical ingredients similar to the API) to its
licensees and distributors (including RELIANT) during the prior twelve (12)
month period; provided, however, that in either
case, in determining RELIANT’s pro rated share of API, PRONOVA shall only take
into account sales to licensees or distributors in those territories in which
PRONOVA currently has licensing or supply agreements for the API (or active
pharmaceutical ingredients similar to the API), which territories are listed on
Schedule 5.12(b). In the case of a failure to supply, PRONOVA shall provide
RELIANT with a schedule indicating PRONOVA’s inventory of API and a reasonably
detailed written explanation of the basis for any apportionment of supply among
RELIANT and PRONOVA’s other licensees and distributors (an “Inventory
Shortage Report”). RELIANT shall have the right to cause an independent,
certified public accountant reasonably acceptable to PRONOVA, at reasonable
times and upon reasonable written notice, to examine such records of PRONOVA as
may be necessary for the sole purpose of verifying the calculation and accuracy
of the Inventory Shortage Report. In the event that any such audit reveals any
inaccuracies in the amount of any inventory or with respect to RELIANT’s
allocation thereof, then PRONOVA shall reapportion the inventory in accordance
with this Agreement and, in the event that such inaccuracy is in excess of ten
percent (10%), then PRONOVA shall reimburse RELIANT for the reasonable cost of
such audit.


 


(c)                                  Failure to Supply for Force Majeure. In the event PRONOVA is unable to supply
to RELIANT its total requirements of the API for the Product and any Additional
Products ordered in accordance with this Section 5 as a result of
Force Majeure (a “Force Majeure Failure to Supply”), then PRONOVA shall
use commercially reasonable efforts to ensure deliveries of the API to RELIANT
from third parties and at no increased cost to RELIANT; provided, however, that PRONOVA shall not
be required to pay more than the then applicable Base Supply Price for Trade
Product applicable under Section 7.1 of this Agreement for any such API
procured from a third party. If during the term if this Agreement PRONOVA, for
a period of at least four (4) consecutive months has been unable to supply to
RELIANT as a result of a Force Majeure Failure to Supply (or otherwise obtain
for RELIANT pursuant to this Section 5.12(c)) RELIANT’s total
requirements of the API for the Product and any Additional Products ordered in
accordance with this Section 5, then RELIANT shall be free to
obtain its requirements for API from other manufacturing sources (a “Third
Party Manufacturer”) at its own expense, in which event PRONOVA shall, free
of charge (but subject to reasonable confidentiality undertakings), (i) provide
such reasonable technical assistance and (ii) grant such licenses or other
rights (at no additional cost to RELIANT or any other party) as are necessary
to enable such Third Party Manufacturer to meet RELIANT’s supply requirements
for API without infringing patent rights or engaging in any misappropriation of
know-how owned or controlled by PRONOVA; provided,
however, RELIANT shall (subject to reasonable confidentiality
undertakings) be free to communicate with potential 


 


21

















 


Third Party
Manufacturers and provide them with information in RELIANT’s possession
regarding the API at any time following the occurrence of a failure to supply. As
soon as PRONOVA is again able to deliver all of RELIANT’s requirements of the
API, PRONOVA shall notify RELIANT and RELIANT shall have 120 days to resume
procuring its requirements for the API from PRONOVA and shall discontinue any
and all purchases from Third Party Manufacturers; provided, however, that PRONOVA shall reimburse RELIANT for
any costs associated with such discontinuation up to an amount which shall not
exceed USD one (1) million or, in the event that PRONOVA shall not have
qualified an additional manufacturing site as contemplated in Section 5.13
prior to such failure to supply, USD three (3) million. In such event, the Parties
shall negotiate in good faith the reinstatement of any minimum purchase
requirements under Section 6 of this Agreement, taking into account any
purchases of API by RELIANT from other manufacturing sources. RELIANT’s rights
under this Section 5.12(c) shall be its sole remedy in the event of a
Force Majeure Failure to Supply, except where such failure to supply is the
result of PRONOVA’s gross negligence or intentional misconduct.


 


(d)                                 Failure to Supply for Reasons Other
Than Force Majeure. In the event PRONOVA is unable to supply to RELIANT its total
requirements of the API for the Product and any Additional Products ordered in
accordance with this Section 5 for a reason other than a Force
Majeure (a “Non-Force Majeure Failure to Supply”), then PRONOVA shall
use commercially reasonable efforts to ensure deliveries of the API to RELIANT
from third parties and at no increased cost to RELIANT; provided, however, that to the extent, in
the exercise of such commercially reasonable efforts, PRONOVA is required to
pay more than the then applicable Base Supply Price for Trade Product
applicable under Section 7.1 of this Agreement for any such API
procured from a third party, RELIANT will (in addition to payment of the Base
Supply Price) bear fifty percent (50%) of the incremental cost of such API
above then applicable Base Supply Price for Trade Product applicable under Section
7.1 of this Agreement, so long as PRONOVA’s inability to deliver API is not
due to the gross negligence or intentional misconduct of PRONOVA. If during the
term if this Agreement PRONOVA, for a period of at least four (4) consecutive
months has been unable to supply to RELIANT as a result of a Non-Force Majeure
Failure to Supply (or otherwise obtain for RELIANT pursuant to this Section
5.12(d)), RELIANT’s total requirements of the API for the Product and any
Additional Products ordered in accordance with this Section 5, then
RELIANT shall be free to obtain its requirements for API from a Third Party
Manufacturer, in which event PRONOVA shall bear fifty percent (50%) of the
incremental cost of such API above then applicable Base Supply Price for Trade
Product applicable under Section 7.1 of this Agreement. In addition,
PRONOVA shall, free of charge (but subject to reasonable confidentiality undertakings),
(i) provide such reasonable technical assistance and (ii) grant such licenses
or other rights (at no additional cost to RELIANT or any other party) as are
necessary to enable such Third Party Manufacturer to meet RELIANT’s supply
requirements for API without infringing patent rights or engaging in any
misappropriation of know-how owned 


 


22

















 


or
controlled by PRONOVA; provided, however,
RELIANT shall (subject to reasonable confidentiality undertakings) be free to
communicate with potential Third Party Manufacturers and provide them with
information in RELIANT’s possession regarding the API at any time following the
occurrence of a failure to supply. As soon as PRONOVA is again able to deliver
all of RELIANT’s requirements of the API, PRONOVA shall notify RELIANT and
RELIANT shall have 120 days to resume procuring its requirements for the API
from PRONOVA and shall discontinue any and all purchases from Third Party
Manufacturers; provided, however, that PRONOVA
shall reimburse RELIANT for any costs associated with such discontinuation up
to an amount which shall not exceed USD one (1) million or, in the event that
PRONOVA shall not have qualified an additional manufacturing site as
contemplated in Section 5.13 prior to such failure to supply, USD
three (3) million. In such event, the Parties shall negotiate in good faith the
reinstatement of any minimum purchase requirements under Section 6 of
this Agreement, taking into account any purchases of API by RELIANT from other
manufacturing sources. RELIANT agrees that PRONOVA’s maximum liability to
RELIANT for a Non-Force Majeure Failure to Supply shall be equal to all amounts
paid by or on behalf of RELIANT to PRONOVA in connection with the signing of
this Agreement pursuant to Section 4.1 (as set out in Schedule
4.1) (i.e., the initial up front payment,
excluding any subsequent Approvable Letter or final FDA approval payments paid
pursuant such provisions) and that receipt of payment of such amounts shall be RELIANT’s
sole remedy for a Non-Force Majeure Failure to Supply; provided,
however, that such limitation on liability and remedies shall not
apply in the event that such failure to supply is the result of PRONOVA’s gross
negligence or intentional misconduct, but shall otherwise be subject to the
limitations under Section 16.4.


 


5.13                           Continuity of Supply. The Parties
agree that promptly following the date of this Agreement, they shall meet and
determine appropriate measures to qualify an additional manufacturing site. PRONOVA
agrees to use commercially reasonable efforts to qualify an additional
manufacturing site prior to the later of (a) one (1) year following the final
FDA approval of the Product for the indication HTG or (b) one (1) year
following PRONOVA’s receipt of the Registration(s) from Abbott. The License
restrictions set out in Section 2.1 with respect to PRONOVA shall not
restrict PRONOVA from establishing additional manufacturing sites in Puerto
Rico or other parts of the Territory (and PRONOVA shall provide RELIANT with
reasonable advance written notice thereof).


 


6.                                      MINIMUM
PURCHASE LEVELS


 


6.1                                 Base Minimum Purchase Levels. Provided
that PRONOVA is not in breach of its supply obligations under Section 5,
this Agreement will be subject to RELIANT making at least the following
purchases of API for Trade Product (the “Base Minimum Purchase Levels”)
during the first twelve month period following the First Commercial Sale and
every 12-month period thereafter (each a “Commercialization Year”):


 


•                  1st Commercialization
Year: USD 6,000,000.


•                  2nd
Commercialization Year: USD 19,000,000.


 


23

















 


•                  3rd
Commercialization Year and each subsequent year through 2013: USD 30,000,000.


•                  2014 and beyond: USD
12,000,000.


 


The Minimum Purchase Level may be reached by
RELIANT by purchasing API for Sample Product at the price for Trade Product, or
by paying the difference between actual Trade Product bought during the
respective Commercialization Year and the Minimum Purchase Level in that year.


 


6.2                                 Adjustment to Minimum Purchase Levels. The Parties shall, after the 5th Commercialization Year,
negotiate in good faith to adjust the Base Minimum Purchase Levels as set out
in this Section 6, with effect from the 6th Commercialization Year
until 2014, provided that such adjustment is reasonable taking into account
major developments in the macro-economic environment since the signing of this
Agreement.


 


6.3                                 Effect of Product Material Adverse Event. Following a Product Material Adverse Event, the Parties shall confer
and agree upon reduced Base Minimum Purchase Levels that reflect the effect of
the Product Material Adverse Event and taking into account the effect on Net
Sales of the Product during the one year period following the Product Material
Adverse Event, which reduced levels shall be agreed upon no later than thirty
(30) days following the first anniversary of the date of Product Material
Adverse Event. The revised Base Minimum Purchase Levels shall be retroactively
effective from and after the date of the Product Material Adverse Event; provided, however, that until such time as the Parties agree
to the revised Base Minimum Purchase Levels, RELIANT shall not be obligated to
comply with the Base Minimum Purchase Levels under this Section 6 and
shall not be in breach of this Agreement as a result thereof. Failure to reach
agreement on revised Base Minimum Purchase Levels shall be resolved through
arbitration in accordance with this Agreement. In addition, following a Product
Material Adverse Event, the Parties shall confer and agree upon any other
appropriate revisions to RELIANT’s obligations with respect to the development
and commercialization of the Product pursuant to this Agreement, and RELIANT’s
obligations and PRONOVA’s rights under Sections 5.2, 5.4 and 8
shall be suspended until such time as the Parties shall have reached a mutual
agreement regarding appropriate revisions thereto.


 


7.                                      SUPPLY PRICE
AND ROYALTY


 


7.1                                 Base Supply Price; Payment Mechanism; Audit Right. Subject to adjustment pursuant to Section 7.4 and/or Section
7.5, RELIANT shall pay the following price (the “Base Supply Price”)
per kilogram for the Product for delivery FOB Sandefjord, Norway (Incoterms
2000), freight and tariffs/taxes to be paid by RELIANT:


 


•                              USD [***] per kilogram for Product
used as Sample Product.


•                              USD [***] per kilogram for Product
used as Trade Product.


 






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24





















 


All
Product shall initially be purchased by RELIANT from PRONOVA at the Sample
Product price. Within thirty (30) days after the end of each calendar month
following the First Commercial Sale, RELIANT shall provide PRONOVA with a
written report (a “Trade Product Report”) indicating the amount of
Product that RELIANT has packaged, or caused to be packaged, as Trade Product
and Sample Product during such month and shall remit therewith a true-up
payment equal to the amount of the Product packaged as Trade Product during
such month, multiplied by the difference between the Base Supply Price for
Sample Product and the Base Supply Price for Trade Product applicable at the
time such Product was purchased by RELIANT hereunder. The Trade Product Report
shall be accompanied by such documentation as PRONOVA shall reasonably request
(including, as applicable, documentation from the packager of the Product) to
evidence the amount of Product packaged as Trade Product and as Sample Product
during such month. Not more than once per year,
PRONOVA shall have the right to cause an independent, certified public
accountant reasonably acceptable to RELIANT, at reasonable times and upon
reasonable written notice, to examine such records of RELIANT and/or any of
RELIANT’s third party packager of the Product as may be necessary for the sole
purpose of verifying the calculation and accuracy of the Trade Product Reports,
and the correctness of any payments made pursuant thereto. All results of any
such examination shall be made available to RELIANT and RELIANT may share such
results with any third party packager of the Product. In the event that any
audit reveals inaccuracies in the amount of any payments that were paid by
RELIANT to PRONOVA, then the overpayment or underpayment amount, as the case
may be, shall be paid within thirty (30) days after receipt of the final audit
report. In addition, if the underpayment is in excess of five percent (5%) of
the amount that actually should have been paid by RELIANT to PRONOVA, then
RELIANT shall reimburse PRONOVA for the reasonable cost of such audit and
PRONOVA shall have the right to an additional audit within one calendar year
after such audit.


 


7.2                                 Royalty. In addition
to the Base Supply Price, RELIANT shall pay to PRONOVA for the supply of the
API (including any API supplied by a Third Party Manufacturer under Section
5.12(c) or 5.12(d)) for the Product and each Additional Product as a
contingent supply price in the form of a royalty fee. The royalty fee shall be
as follows: (i) in respect of the license of the Patents hereunder, [***]
percent ([***]%) of the Net Sales of the Product until midnight of the day of
expiration of the last to expire of the Patents; and (ii) in respect of the
license of the Product Know-How hereunder, [***] percent ([***]%) of the Net
Sales of the Product during the term of this Agreement. The royalty fees for
each Additional Product, based on the Net Sales for each such Additional
Product, are set out in Schedule 7.2. The royalty fees for each
Additional Product shall be based [***] in respect of the license of Patents
applicable thereto and [***] in respect of the license of Product Know-How
applicable thereto. The royalty fee for Products and Additional Products shall
be payable to PRONOVA on a semi-annual basis, so that the fee for the first six
(6) months of each Commercialization Year is payable thirty (30) days after the
end of this period, and the fee for the last six (6) 


 






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25

















 


months of each Commercialization Year
is payable thirty (30) days after the end of that period. At the same time as
payments are made, an external auditor agreeable to both parties shall, at
RELIANT’s cost, confirm the Net Sales. PRONOVA shall have the right to appoint
an independent internationally recognized audit firm, reasonably acceptable to
RELIANT, to audit the books of account of RELIANT in order to determine whether
Reliant has properly reported and accounted for any royalty payments due to
PRONOVA pursuant to this Section 7.2. Audits may be performed during
regular business hours, not more than once in any calendar year during the term
and upon reasonable prior notice to RELIANT. The audit fees shall be borne by
PRONOVA unless such auditor determines that the amount actually due PRONOVA, in
the aggregate, exceeds the greater of (a) USD 50,000 and (b) seven and one-half
percent (7.5%) of the amounts paid by RELIANT hereunder, in which case the
audit fees shall be borne by RELIANT, and PRONOVA shall be entitled to perform
audits twice during the next succeeding calendar year.


 


7.3                                 Additional Royalty Following Approval of Post-myocardial Infarction
Indication. If an FDA approval of the
Product for the indication post-myocardial infarction has been obtained so that
the Product can be marketed and sold for this indication in the Territory and
provided that such indication is covered by a valid patent in the Territory
held by Pharmacia Italia S.p.A., RELIANT shall pay an additional royalty fee to
Pharmacia Italia S.p.A (as described on Schedule 7.3), such additional
royalty fee not to exceed [***] percent ([***]%) of net sales set out in Schedule
7.3. The royalty fee shall be payable in accordance with this Agreement but
subject to the conditions set out in Schedule 7.3. PRONOVA (i)
represents and warrants to RELIANT that, as of the date of this Agreement,
PRONOVA is not party to any other agreements, licenses or arrangements pursuant
to which a royalty, license fee or similar payment would be due from RELIANT in
the event that the Product is approved for any other indications other than HTG
and post-myocardial infarction, and (ii) covenants to RELIANT that, during the
term of this Agreement, PRONOVA shall not enter into any other agreements,
licenses or arrangements pursuant to which a royalty, license fee or similar
payment would be due from RELIANT in the event that the Product is approved for
any other indications other than HTG and post-myocardial infarction. In
addition to the foregoing, the Parties shall cooperate with each other
regarding matters related to the patent that Pharmacia Italia S.p.A is seeking
in the Territory referenced in Schedule 1.22.


 


7.4                                 CPI Adjustment to Base Supply Price. The Base Supply Price will be adjusted up or down at the beginning of
every calendar year [***].


 


7.5                                 Additional Adjustment to Base Supply Price. In addition to the adjustment under Section 7.4, the Base
Supply Price will also be adjusted up or down at the beginning of every
calendar year by an amount equal to [***]


 


7.6                                 Payment Terms. With
respect to any delivered Product, RELIANT shall pay the Base Supply Price
within thirty (30) days after receipt of PRONOVA’s invoice in accordance with
this Section 7.


 






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26

















8.                                      MARKETING AND
PROMOTION


 


8.1                                 In General. RELIANT
shall be responsible for the marketing and promotion of the Product in the
Territory and shall bear all costs in this regard unless the Parties otherwise
agreed in advance in writing. Such marketing and promotion shall be in or
directed to the Territory, and shall be in accordance with any and all
applicable laws and regulations. Pursuant to the terms of  Section 2.9, including the limitations
set forth in Section 2.9, RELIANT is free to use its Affiliates and
third parties to fulfill its obligations to encapsulate, label, package,
distribute, market, detail, promote and sell the Product, but shall ensure
their compliance with applicable laws and regulations.


 


8.2                                 Sales Force. RELIANT
shall have a sales force of at least [***] representatives actively detailing
the Product for the first [***] years after the First Commercial Sale.


 


9.                                      IMPROVEMENTS
AND INVENTIONS


 


9.1                                 RELIANT
Improvements. RELIANT shall be the sole owner of any discoveries,
improvements, inventions, and/or proprietary technology arising from the
development of the Product or any Additional Product invented solely by RELIANT
or any of RELIANT’s subsidiaries, sublicensees or agents, including but not
limited to any modifications such as new formulations or dosage forms, whether
patentable or not (collectively, the “RELIANT Improvements”). Except as
may otherwise be agreed to by the Parties or required by other contractual
obligations of RELIANT, PRONOVA  shall have a non-exclusive, world-wide, perpetual, fully paid up,
royalty free right (including free of any other payment) to make use of any
RELIANT Improvement for Other Products, subject in each case to the rights and
obligations of the Parties under this Agreement. In addition, PRONOVA shall
have the right to grant sublicenses to PRONOVA’s Affiliates or to other
licensees to use such RELIANT Improvements for Other Products; provided, however, that before RELIANT initiates any
development programs in which such RELIANT Improvements are conceived or first
reduced to practice, whether directly or through one or more Affiliates or other
sublicensees, RELIANT may discuss with PRONOVA terms and conditions for such
use, and any such terms and conditions agreed by the Parties prior to the
initiation of such development programs shall apply to the grant of any such
licenses or sublicenses to or by PRONOVA as contemplated by this sentence.


 


9.2                                 PRONOVA
Improvements. PRONOVA shall be the sole owner of any discoveries,
improvements, inventions, and/or proprietary technology arising from the
development of the API, the Product or any Additional Product invented solely
by PRONOVA or any of PRONOVA’s subsidiaries, licensees or agents, including but
not limited to any modifications such as new formulations or dosage forms,
whether patentable or not (collectively, the “PRONOVA Improvements”). Except
as may otherwise be agreed to by the Parties or required by other contractual
obligations of PRONOVA, the Intellectual Property Rights shall automatically be
deemed to include any PRONOVA
Improvement relating to the use for a Cardiovascular Indication of any
prescription or OTC pharmaceutical product containing Omega-3 fatty acids as an
active ingredient. In addition, RELIANT shall have the right to grant
sublicenses to RELIANT’s Affiliates to use such PRONOVA Improvements; provided, however, that before PRONOVA initiates any
development programs in which such PRONOVA 


 






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27

















 


Improvements are conceived or first
reduced to practice, whether directly or through one or more Affiliates or
other licensees, PRONOVA may discuss with RELIANT terms and conditions for such
use, and any such terms and conditions agreed by the Parties prior to the
initiation of such development programs shall apply to the grant of any such
licenses or sublicenses to or by RELIANT as contemplated by this sentence.


 


9.3                                 Joint Improvements. Any discoveries, improvements,
inventions, and/or proprietary technology arising from the development of the
API, the Product, any Additional Product or Other Product invented jointly by
RELIANT, any of RELIANT’s subsidiaries, sublicensees or agents, and PRONOVA or
any of PRONOVA’s subsidiaries, licensees or agents, including but not limited
to any modifications such as new formulations or dosage forms, whether
patentable or not (collectively, the “Joint Improvements” and, together
with RELIANT Improvements and PRONOVA Improvements, referred to herein as the “Improvements”)
shall be jointly owned by RELIANT and PRONOVA and each Party shall have the
right to use and exploit such Joint Improvements without the other Party’s
consent or any duty to account to the other Party for such use or exploitation.
With regard to Joint Improvements, each Party may publish information regarding
technical developments and/or research findings made jointly by both of the
Parties. With respect to such publications, each Party agrees to submit a copy
of any proposed publication to the other Party at least thirty (30) days prior
to submission for publication in order to allow the other Party to determine
whether any subject matter to be published warrants patent protection. In such
case, the other Party will identify such subject matter requiring protection
and notify the publishing Party thereof. The publishing Party hereby agrees to
delay publication of such subject matter for a period of time mutually
agreeable to the parties (but in no case for less than thirty (30) days after
any notification of the other Party’s desire for patent protection) in order to
permit the Parties, whether solely or jointly, to file U.S. and/or foreign
patent applications prior to the publication date that would prevent the Parties
from obtaining valid patent rights in the relevant subject matter.


 


9.4                                 Notice. During the term of this
Agreement, each Party shall promptly inform the other Party in writing of any
Improvement developed by or on behalf of such Party or any of such Party’s
Affiliates, permitted licensees or agents relating to the Product or any
Additional Product, whether patentable or not.


 


9.5                                 Patent
Protection. Each of Party may, in its own name and at its own
expense and in its sole discretion, obtain, maintain and/or extend any patents
or other proprietary rights in connection with such Party’s respective
Improvements and shall do so jointly (or in such other manner as they may
agree) with respect to Joint Improvements.


 


9.6                                 Ability to File Patent Applications. In the event
either Party (or, as applicable, such Party’ s Affiliate, permitted licensee or
agent) decides not to file patent applications regarding such Party’s
Improvements within 120 days after the written request of the other Party to do
so, then such other Party shall be entitled to file such patent application in
its own name and at its own expense, and the non-filing Party shall, upon
request of the filing Party, and against reimbursement of out-of-pocket
expenses, cooperate (or, as applicable, cause such non-filing Party’ s
Affiliate, permitted licensee or agent to cooperate), in good faith with the
filing Party in making such filing.


 


9.7                                 Marking. RELIANT
shall mark all Products and Additional Products made, sold or imported in the
Territory in accordance with 35 U.S.C. 287(a).


 


28

















 


10.                               RIGHT OF
NEGOTIATION FOR CERTAIN ADDITIONAL PRODUCTS


 


10.1                           Right of First Negotiation. During the term of this Agreement,
PRONOVA shall not develop, promote, market, sell, offer to sell or otherwise
commercialize in the Territory any Additional 
Product for a Non-Cardiovascular Indication (for the purposes of this Section
10, each such Additional Product, a “ROFN Product”) (it being
agreed that, in the event such ROFN Product is a
Combination Product, for the purposes of this Section 10 the term “ROFN
Product” shall include any additional Combination Products incorporating
substantially the same active pharmaceutical ingredients arising from the same
development effort as the original ROFN Product), unless PRONOVA shall have first offered in a written notice (the “Offer Notice”) to RELIANT
the right to participate in the development of, and to obtain exclusive
commercialization rights for, such ROFN Product in the Territory, specifying the terms and conditions thereof, which terms and
conditions may include a requirement that RELIANT commit to a minimum purchase
obligation of the ROFN Product. RELIANT shall have sixty (60) days (the “Offer
Period”) from the date of its receipt of the Offer Notice to accept the
offer to commercialize the ROFN Product in the Territory upon such terms and
conditions contained in the Offer Notice. In the event that RELIANT shall fail
to respond in writing accepting the terms and conditions of the Offer Notice
prior to the expiration of the Offer Period, RELIANT shall be deemed to have
rejected the offer. During the Offer Period, unless RELIANT rejects the offer
contained in the Offer Notice in writing PRONOVA shall not offer to, solicit
or accept offers for, negotiate or otherwise discuss such ROFN Product
opportunity with any other person or entity for the purpose of developing and
commercializing such ROFN Product in the Territory.


 


10.2                           Right of PRONOVA to Offer to Third Party. In the event RELIANT does not exercise its right of first negotiation
under Section 10.1 prior to the expiration of the Offer Period, PRONOVA
shall be free to offer to any third party, the right to participate in the
development and commercialization of the ROFN Product in the Territory provided
that the third party accepts terms and conditions, which taken as a whole are
as favorable or more favorable to PRONOVA than those set forth in the Offer
Notice.


 


10.3                           Time Limit. If PRONOVA
shall not have entered into a definitive agreement with such third party within
eighteen (18) months following the end of the Offer Period, then any
commercialization of the ROFN Product in the Territory shall again become
subject to the provisions of Section 10.1 and Section 10.2, and
RELIANT’s rights thereunder.


 


10.4                           Independent Rights. The Parties acknowledge and agree
that RELIANT’s rights as set forth in this Section 10 are independent
rights which RELIANT may exercise separately, and for which the obligations set
forth in this Section 10 shall apply separately, for each ROFN Product.


 


11.                               RESEARCH AND
DEVELOPMENT


 


11.1                           Co-Operation Regarding Clinical Testing Programs. PRONOVA has the intention to develop and perform programs for clinical
testing of the Product in co-operation with its licensees. If PRONOVA wishes to
develop and perform such programs with RELIANT, the Parties shall agree upon
the terms and conditions for such co-operation including sharing of costs.


 


11.2                           Clinical Studies Regarding Product. Except as required by applicable Regulatory Requirements or as may be
necessary to maintain the Registration for the Product or Phase IV clinical
studies with respect to the Product in respect of any indication 


 


29

















 


covered by the FDA-approved label for
the Product, any right of RELIANT to initiate any clinical or pre-clinical
studies relating to the Product shall be subject to the Development Intention
Notice and Development Objection Notice procedures set forth under Section 2.3.


 


11.3                           FDA-Required Clinical Trials. If the
Regulatory Authorities in the Territory require post marketing clinical trials
after the FDA approval of the Product for the indication HTG, RELIANT shall be
responsible for performance and cost; provided, however,
that in the event that RELIANT determines that it no longer desires to continue
to fund such development costs, it may cease such funding with reasonable
notice to PRONOVA beforehand so that PRONOVA may arrange funding such that such
studies are not interrupted or otherwise compromised and transfer the
Registration for the Product to PRONOVA free of charge; provided,
however, that in the event that PRONOVA sells or licenses the
Registration to any third party, otherwise receives compensation from any third
party in respect of the Registration, or acquires rights with respect to the
foregoing,  during the two (2) year
period following the date on which the Registration is retransferred to PRONOVA
hereunder, PRONOVA shall pay [***] percent ([***]%) of the net amount of such
proceeds (reduced by PRONOVA’s transaction costs) to RELIANT, such amounts to
be paid within thirty (30) days after receipt by PRONOVA.


 


11.4                           Right of First Negotiation Regarding Development
Opportunities. In addition to
any other rights or restrictions set forth in this Agreement, PRONOVA agrees
that during the term of this Agreement, PRONOVA shall not initiate, conduct,
assist with, partner with any third party for or otherwise engage in any
clinical development with respect to any prescription or OTC pharmaceutical
product that contains Omega-3 fatty acids as an active ingredient and that is
covered by patent rights owned or controlled by PRONOVA  (other than through any license granted by
the third party in connection with such clinical development), either alone or
in combination with one or more active ingredients, that PRONOVA intends,
directly or indirectly, to commercialize in the Territory (each such
prescription or OTC pharmaceutical product, together with additional products
arising from the same development effort, a “Development Opportunity”),
unless PRONOVA shall have first offered in a written notice (the “Development
Opportunity Offer Notice”) to RELIANT the right to partner with PRONOVA
with respect to such Development Opportunity or otherwise acquire rights in the
Territory for any products, processes or other intellectual property rights
resulting from such Development Opportunity, specifying the terms and
conditions thereof. RELIANT shall have sixty (60) days (the “Development
Opportunity Offer Period”) from the date of its receipt of the Development
Opportunity Offer Notice to accept the offer to partner with PRONOVA for, or
otherwise acquire rights in respect of, such Development Opportunity, upon such
terms and conditions contained in the Development Opportunity Offer Notice. In
the event that RELIANT shall fail to respond in writing accepting the terms and
conditions of the Development Opportunity Offer Notice prior to the expiration
of the Development Opportunity Offer Period, RELIANT shall be deemed to have
rejected the offer. During the
Development


 






[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 


30














 


Opportunity Offer Period, unless
RELIANT rejects the offer contained in the Development Opportunity Offer Notice
in writing PRONOVA
shall not offer to, solicit or accept offers for, negotiate or otherwise
discuss such Development Opportunity with any other person or entity.


 


11.5                           Right of PRONOVA to Offer to Third Party. In the event RELIANT does not exercise its right of first negotiation
under Section 11.4 prior to the expiration of the Development
Opportunity Offer Period, PRONOVA shall be free to offer to any third party the
right to partner with PRONOVA with respect to such Development Opportunity or
otherwise acquire rights in the Territory for any products, processes or other
intellectual property rights resulting from such Development Opportunity,  provided that the third party accepts terms and conditions, which taken
as a whole are as favorable or more favorable to PRONOVA than those set forth
in the Development Opportunity Offer Notice and subject in all cases to the
terms, conditions and restrictions under this Agreement (including, without
limitation, the provisions of Section 2.6 hereof).


 


11.6                           Time Limit. If PRONOVA
shall not have entered into a definitive agreement with such third party within
eighteen (18) months following the end of the Development Opportunity Offer
Period, then such Development Opportunity shall again become subject to the
provisions of Section 11.4 and Section 11.5, and RELIANT’s rights
thereunder.


 


11.7                           Independent Rights. The Parties acknowledge and agree
that RELIANT’s rights as set forth in Sections 11.4, 11.5 and 11.6
are independent rights which RELIANT may exercise separately, and for which the
obligations set forth in such sections shall apply separately, for each Development Opportunity.


 


12.                               TRADEMARK


 


12.1                           Product Trademark. RELIANT
shall encapsulate, package, distribute, market and sell the Product in the
Territory under the Omacor® Trademark or, subject to PRONOVA’s
consent, not to be unreasonably withheld, delayed or conditioned, any other
trademark RELIANT may select. The use of the Omacor® Trademark in
connection with RELIANT’s encapsulation and packaging of the Product shall be
approved by PRONOVA in writing in advance, such approval not to be unreasonably
withheld, delayed or conditioned. RELIANT shall only use the Trademark in
accordance with the specifications set forth in Schedule 1.35. The
Parties shall discuss trademarks to be used for any Additional Products, but
RELIANT shall be under no obligation to use any of PRONOVA’s Trademarks for any
Additional Products developed by RELIANT. Other than the Trademarks, any other
trademark used by RELIANT for the Product or any Additional Product shall, as
between RELIANT and PRONOVA, be owned solely by RELIANT.


 


12.2                           Use of Product Trademark; RELIANT Trademarks. The Omacor® Trademark is registered in the name of PRONOVA
and shall be exclusively licensed to RELIANT for use on the Product and the
Additional Products in the Territory (it being agreed that no other party,
including PRONOVA, shall have the right to use the Omacor® Trademark
in the Territory for any other product or purpose during the term of this
Agreement). In addition, the Parties shall provide a mechanism for internet
users of the omacor.com website
who are located in the Territory to be routed to internet pages controlled by
RELIANT for the purpose of marketing the Product and Additional 


 


31

















 


Products in the Territory. RELIANT
shall comply with any requirements established by PRONOVA concerning the style,
design, display and use of the Trademarks; to correctly use the trademark
symbol TM or registration symbol ®  with
every use of the mark and to use the registration symbol ®  upon receiving notice of registration of the
mark from PRONOVA. The Omacor® Trademark shall not be used by
RELIANT for any other product marketed or sold or any purpose whatsoever by
RELIANT, whether inside or outside of the Territory. Each of PRONOVA and
RELIANT agrees not to produce, license, sell or distribute in the Territory, at
any time, during the term of this Agreement, directly or indirectly, any other
product whose trademark, trade name or other designation is confusingly similar
to the Omacor® Trademark. Notwithstanding the foregoing, the Parties
agree that RELIANT may use any of the trademarks identified on Schedule 12.2
(the “RELIANT Trademarks”) in connection with the commercialization of
other pharmaceutical products and that PRONOVA will not oppose RELIANT’s use of
any of such trademarks or otherwise claim such trademarks are confusingly
similar to the Omacor® Trademark. As applicable, PRONOVA shall
comply with the foregoing provisions in respect of any RELIANT Trademarks used
for the Product or any Additional Product.


 


12.3                           PRONOVA Ownership. RELIANT
hereby agrees to and recognizes PRONOVA’s exclusive ownership or license rights
of the Trademarks and the renown of the Trademarks. RELIANT agrees not to take
any action inconsistent with such ownership and further agrees to take any
action, at PRONOVA’s expense, which PRONOVA reasonably deems necessary to
establish and preserve PRONOVA’s exclusive rights in and to the Trademarks in
the Territory including cooperating in the registration of the Trademarks on
the trademark registry or other appropriate registration procedure in the
Territory.


 


12.4                           RELIANT Ownership. PRONOVA
hereby agrees to and recognizes RELIANT’s exclusive ownership or license rights
of the RELIANT Trademarks and the renown of the RELIANT Trademarks. PRONOVA
agrees not to take any action inconsistent with such ownership.


 


12.5                           Maintenance of Trademarks. PRONOVA
shall pay all fees and taxes, and shall use commercially reasonable effort to
satisfy all requirements of Governmental Authorities (with appropriate
assistance from RELIANT, as described herein below), for keeping the Trademarks
in full force and effect in the Territory.


 


12.6                           Notice of Infringement. In the
event that either Party becomes aware of any actual or threatened infringement
of the Trademarks or any other trademarks used in respect of the Product or any
Additional Product, that Party shall forthwith inform the other Party in
writing of all details available concerning the said infringement.


 


12.7                           Infringement Action. It is
vested in PRONOVA’s own discretion to decide whether an infringement of the
Trademarks actually does occur and how, if appropriate, to respond. The costs
of such responses shall be borne by PRONOVA and PRONOVA shall retain all
recoveries obtained through such responses. RELIANT shall in all such responses
assist PRONOVA to all reasonable extents free of charge, other than RELIANT’s
out of pocket expenses. If PRONOVA decides not to institute litigation in
respect of a possible infringement of any Trademarks, RELIANT shall be entitled
to institute appropriate legal action as further described in Section 14,
and PRONOVA shall in all 


 


32

















 


such actions assist RELIANT to all
reasonable extents free of charge, other than PRONOVA’s out of pocket expenses.


 


12.8                           No Confusion. RELIANT shall
not adopt, use, or register any acronym, trademark, trade names, service mark
or other marketing name that is confusingly similar to the Trademarks or the
PRONOVA name, and shall not use the Trademarks or the PRONOVA name other than
in connection with the packaging, labeling and commercialization of the Product
and the Additional Products pursuant to this Agreement. PRONOVA shall not
adopt, use, or register any acronym, trademark, trade names, service mark or
other marketing name that is confusingly similar to RELIANT Trademarks or the
RELIANT name, and shall not use the RELIANT Trademarks or the RELIANT name
other than as may be agreed to by RELIANT pursuant to this Agreement.


 


12.9                           Quality Control. PRONOVA
shall have the right to monitor and observe RELIANT’s encapsulation, packaging,
marketing, selling and distribution of Products and Additional Products for the
purpose of protecting and maintaining the standards of quality established by
PRONOVA for products sold under the Trademarks. RELIANT shall permit PRONOVA’s
authorized personnel to enter RELIANT’s premises at all reasonable times, with
reasonable advance notice, to inspect RELIANT’s encapsulation, packaging,
marketing, selling and distribution facilities and operations, and to inspect
and test all Products and Additional Products produced for sale under the
Trademarks. RELIANT shall, upon request from PRONOVA from time to time at
PRONOVA’s discretion, without undue delay send samples of advertising and
promotional materials, as well as goods and promotional and advertising
materials bearing or sold under the Trademarks, and any other documents which
may permit PRONOVA to determine whether the Product or Additional Product and
Trademarks used meet the standards, specifications and directions approved by
PRONOVA. If PRONOVA at any time finds that any of such Products being sold
under the Trademarks are not being encapsulated, packaged, marketed, sold or
distributed in accordance with standards of quality acceptable to PRONOVA or
have been packaged in a misleading or deceptive manner, or otherwise have been
encapsulated, packaged, marketed, sold or distributed in a manner in violation
of Section 12.1 of this Agreement, PRONOVA may notify RELIANT in writing
of such deficiencies, and RELIANT shall use its commercially reasonable efforts
to correct such deficiencies as soon as practicable thereafter. With respect to
third parties performing any activities in respect of the Product or any
Additional Product hereunder, RELIANT shall obtain for the benefit of PRONOVA
inspection opportunities consistent with the foregoing.


 


13.                               PROSECUTION
OF PATENTS AND TRADEMARKS; INFRINGEMENT


 


13.1                           Patent and Trademark Prosecution. PRONOVA undertakes during the term of this Agreement to use commercially reasonable efforts to obtain, maintain and defend the Patents and the
Trademarks entirely at PRONOVA’s expense. PRONOVA shall control the
preparation, prosecution and maintenance of the Patents and the Trademark. Neither
PRONOVA
nor any of its Affiliates shall abandon any of the Patents or Trademarks,
without first notifying RELIANT in writing of such intended abandonment, and
providing RELIANT the opportunity to acquire such Patent or Trademark.


 


33

















 


13.2                           Notification. If either Party
shall learn of (i) any claim or assertion that the manufacture, use, sale,
labeling, packaging, promotion, distribution or other commercialization of the
Product or any Additional Product, or the use of the Intellectual Property
Rights related to the Product or any Additional Product, infringes,
misappropriates or otherwise violates the intellectual property rights of any
third party, or (ii) the actual or threatened infringement,
misappropriation or other violation by any third party of the Intellectual
Property Rights or other intellectual or industrial property rights of either
Party or any of its Affiliates related to the Product or any Additional
Product, then the Party becoming so informed shall as soon as reasonably
practicable, notify the other Party of such claim or assertion, or actual or
threatened infringement, misappropriation or other violation. The Parties agree
to confer in good faith regarding such potential infringement risk and to
explore reasonable alternatives for avoiding such risk and to provide such
information to each other as either Party may reasonably request.


 


13.3                           Infringement of Third Party Intellectual Property Rights. In the event a claim of infringement of a third party’s intellectual
property rights arising from the manufacture of the API, the importation of the
API into the Territory, or the use or sale of the API in the Product or any
Additional Product with a Cardiovascular Indication, is brought against either
Party, PRONOVA shall defend such action at its own cost and expense in
accordance with Section 13.4 and take either or both of the following
actions simultaneously or sequentially:


 


(a)                                  defend the claim and indemnify and
hold harmless RELIANT, its Affiliates, 
directors, officers, employees, representatives, consultants and agents
(the “RELIANT Infringement Indemnitees”) as set forth in Section 13.4
below; and/or


 


(b)                                 obtain for itself and the benefit of
RELIANT the right, through license or otherwise, to utilize the technology upon
which the claim of infringement was based. Such rights obtained by PRONOVA from
a third party under this Section 13.3(b) shall be licensed or
sublicensed to RELIANT as part of the License hereunder.


 


In connection with the foregoing, PRONOVA, at its option and expense,
may dispose of such claim or may conduct the defense of such suit in its own
discretion; provided, however,
that PRONOVA
shall not settle any such claim, suit or action if such settlement would impose
on RELIANT the obligation to pay any damages or otherwise adversely affect
RELIANT’s rights and obligations under the this Agreement, including, without
limitation, requiring RELIANT to transfer any rights in or to the Patents or
Trademarks, or become subject to an injunction, and so long as such settlement
does not conflict with this Agreement. RELIANT will cooperate with PRONOVA in
the defense and settlement of any such claim.


 


13.4                           Additional Provisions Regarding Infringement of Third Party Intellectual
Property Rights. If PRONOVA
cannot obtain the rights as set forth in Section 13.3 on commercially
reasonable terms, PRONOVA and RELIANT shall meet to discuss appropriate
strategies and, as necessary, modifications to this Agreement as a result of
such third party claim and PRONOVA shall provide RELIANT with reasonable
opportunity to participate in any actions or other matters related to such
third party 


 


34

















 


claim. In the event that,
notwithstanding the foregoing, the Parties are unable to reach a mutually
satisfactory solution within one hundred twenty (120) days following their
initial meeting, either Party may terminate this Agreement and the License
granted to RELIANT hereunder in which event PRONOVA shall refund to RELIANT an
amount equal to the aggregate of all payments made by RELIANT to PRONOVA
pursuant to Sections 4.1 and 4.2 (which amount shall be reduced
by twenty percent (20%) on each anniversary of the date of first commercial
sale of the Product or, if earlier, the first Additional Product – i.e., no refund will be available
following the fifth (5th) anniversary).


 


13.5                           Infringement Indemnification. Notwithstanding
any other provisions of this Agreement, PRONOVA will defend, indemnify and hold
harmless RELIANT Infringement Indemnitees, from and against any and all Losses
(as defined in Section 16.1) suffered or incurred by RELIANT
Infringement Indemnitees resulting from any claims by any third party that
RELIANT’s or any RELIANT Infringement Indemnitee’s exercise of the rights
granted hereunder as a result of or arising from the manufacture of the API,
the importation of the API into the Territory, or the use or sale of the API in
the Product or any Additional Product with a Cardiovascular Indication,
infringes or violates any license, patent, copyright, trademark or other
intellectual property right of that third party; provided, however, that PRONOVA shall have no obligation to
indemnify any RELIANT Infringement Indemnitee pursuant to this Section 13.5
to the extent such claim arises from violation of law, use of trademarks other
than the Trademarks or its negligent or intentionally wrongful conduct by any
RELIANT Infringement Indemnitee, or from the presence or use in a Combination
Product of an active or inactive ingredient other than API, it being expressly
understood that RELIANT’s exploitation of the license and rights granted
hereunder in accordance with the terms of this Agreement shall not be deemed a
violation of law or intentional or negligent as pertaining to violation of
another party’s intellectual property rights.


 


14.                               THIRD PARTY
INFRINGEMENT


 


14.1                           Notification. Each Party
will notify the other Party if it becomes aware of the activities of any third
party in the Territory that are believed to infringe any of the Intellectual
Property Rights and shall
supply the other Party with any evidence available to it pertaining to the
infringement. The Parties shall consult as to a potential
litigation strategy or strategies against the alleged infringer and shall use
commercially reasonable efforts to terminate such alleged infringement without
litigation.


 


14.2                           Action by
PRONOVA. If the efforts of the Parties are not successful in
abating the alleged infringement, then PRONOVA shall have the right, but not
the obligation, to bring an appropriate suit or action against such
infringement, at its own expense. RELIANT shall cooperate in any such
infringement action and agrees to execute all documents and perform such other
acts as may be reasonably requested by PRONOVA (including but not limited to
consent to be joined as a nominal party plaintiff in such action), at PRONOVA’s
expense. Neither PRONOVA nor any of its Affiliates shall enter into any
settlement, consent or other resolution of any such action or suit that would
reasonably be expected to adversely affect RELIANT’s rights under this
Agreement or the commercialization of the Product or any Additional Product by
RELIANT in the Territory, without RELIANT’s prior written consent, such consent
not to be unreasonably withheld. In addition
to the foregoing, if RELIANT so desires, it 


 


35

















 


may join such action at its own
expense, and PRONOVA shall not oppose any attempt by RELIANT to join, or
otherwise intervene in such action; provided, however,
that, notwithstanding any provision herein to the contrary, RELIANT shall not
be precluded from seeking, in its own independent cause of action, the recovery
of damages resulting from its own lost sales, price erosion or similar damages
suffered or incurred by RELIANT, in each case outside the scope of this
Agreement.


 


14.3                           Action by RELIANT. In the
event PRONOVA and/or any of its Affiliates are unable to or elect not to
commence an action against the third party responsible for the alleged
infringement or misappropriation within one hundred twenty (120) days
of the date on which PRONOVA becomes aware of such infringement (or, if
reasonably possible, such shorter period as may be required to permit RELIANT
to sufficiently pursue such action following such inability or election), then
RELIANT may, but shall not be required to, prosecute the alleged infringement
or threatened infringement. PRONOVA agrees to cooperate in any such
infringement action and agrees to execute, or cause to be executed, all
documents and perform such other acts as may be reasonably requested by RELIANT
(including but not limited to consent to be joined as a nominal party plaintiff
in such action), at RELIANT’s expense. RELIANT shall not enter into any
settlement, consent or other resolution of any such action or suit without
PRONOVA’s prior written consent, such consent not to be unreasonably withheld,
delayed or conditioned.


 


14.4                           Allocation of Recovered Amounts. Any amount recovered in any action or suit
against a third party infringer, from settlement or otherwise, shall be
allocated between the Parties in the following manner:


 


(a)                                  first, the Party bringing the action shall be reimbursed from such
recovered amount for that Party’s actual costs in bringing, pursuing and
resolving the action, including but not limited to attorney’s and other
professional fees and expenses and the other Party shall be reimbursed from
such recovered amount for that other Party’s actual costs in cooperating in the
action at the request of the Party bringing the action, provided that if the
recovered amount is less than the total respective actual costs, then the
Parties shall split such recovered amount in the same proportion as their
respective actual costs;


 


(b)                                 next, to the extent that the amount recovered
relates to infringement outside the Territory, such amount shall be PRONOVA’s;
and


 


(c)                                  thereafter, to the extent that the amount
recovered relates to infringement within the Territory, the Parties shall allocate such proceeds in proportion to the relative harm
suffered by the Parties.


 


15.                               REPRESENTATIONS,
WARRANTIES AND COVENANTS


 


15.1                           Mutual Representations and Warranties. Each Party represents and warrants
to the other Party that:


 


(a)                                  Organization. Such Party is (i) a corporation duly organized,
validly existing and in good standing under the laws of the state or country of
its incorporation, and (ii) has all necessary corporate power and corporate
authority to own its properties and to conduct its business, as currently
conducted.


 


(b)                                 Authorization.
Such Party has the full corporate right, power and authority to execute,
deliver and perform this Agreement and to consummate the transactions
contemplated hereby and the execution, delivery and performance of this 


 


36

















 


Agreement, and the consummation of the transactions
contemplated hereby have been duly authorized by all necessary corporate action
on the part of such Party.


 


(c)                                  Enforceability.
This Agreement has been duly executed and delivered by an authorized officer of
such Party, and is a legal, valid and binding obligation of such Party
enforceable against it in accordance with its terms, except as enforcement may
be limited by
bankruptcy, reorganization, insolvency and other similar laws affecting the
enforcement of creditors’ rights in general and general principles of equity
(regardless of whether considered in a proceeding in equity or an action at
law).


 


(d)                                 No Violation. The execution, delivery and
performance of this Agreement by such Party is not prohibited or limited by, and
will not result in the breach of or a default under, the charter or governance
documents of such Party; any contract, agreement or instrument binding on such
Party or any of its Affiliates (including, without limitation, with
respect to PRONOVA, that certain Amended and Restated License & Supply Agreement between
Abbott and PRONOVA dated 19 December 2003, as amended to date  (the “Abbott Agreement”)), and any
related agreements, any rights of third parties or any applicable order, law,
writ, injunction or decree of any court or Governmental Authority applicable to
such Party or its Affiliates.


 


(e)                                  No Consents. No notice to, filing with,
authorization of, exemption by, or consent of, any person or entity, including
any Governmental Authority, is required for such Party to enter into this
Agreement or consummate the transactions contemplated hereby.


 


15.2                           Additional Representations,
Warranties and Covenants of PRONOVA. PRONOVA represents and warrants to RELIANT that as
of the date of this Agreement:


 


(a)                                  Ownership of Intellectual Property Rights and Right to
License. PRONOVA
is the true and valid owner or licensee of the Intellectual Property Rights
and, except as set forth on Schedule 15.2(a), has the right to, and
will, grant the rights and licenses to RELIANT under this Agreement, free and
clear of any liens, security interests, licenses, obligations, transfer
agreements, enforceable claims, royalties or encumbrances. The Patents listed
on Schedule 1.22 constitute all of PRONOVA’s patent rights, and the Trademarks
listed on Schedule 1.35 constitute all of PRONOVA’s trademark rights, in
each case either issued or pending, with respect to the API or the Product in
the Territory. EXCEPT AS STATED HEREIN, PRONOVA MAKES NO REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE INTELLECTUAL PROPERTY
RIGHTS OF THE PRODUCT; BY WAY OF EXAMPLE BUT NOT OF LIMITATION, PRONOVA MAKES
NO REPRESENTATIONS OR WARRANTIES OF COMMERCIAL UTILITY, OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF THIRD PARTY PATENT OR
OTHER INTELLECTUAL PROPERTY RIGHTS BY THE PRACTICE OF THE INTELLECTUAL PROPERTY
RIGHTS OR THE MANUFACTURE, USE, SALE OR OFFER FOR SALE OF API, PRODUCT OR
ADDITIONAL PRODUCT (IT BEING AGREED THAT NOTHING IN THE FOREGOING DISCLAIMER
SHALL LIMIT OR OTHERWISE RESTRICT RELIANT’S INDEMNITY RIGHTS UNDER THIS 


 


37

















 


AGREEMENT, INCLUDING, WITHOUT LIMITATION, SECTION 13.4 HEREOF).


 


(b)                                 Product Registration. PRONOVA has the unconditional (except
for a fee payable by PRONOVA to Abbott), irrevocable and indefeasible right and
option to acquire all right, title and interest to any and all Registrations
for the Product from Abbott as set forth in Section 3.1(c), and will
have such right until such time as PRONOVA acquires the same from Abbott. PRONOVA
shall transfer to RELIANT good and valid legal and beneficial title to the
Registration for the Product, free and clear of any liens, security interests,
licenses, obligations, transfer agreements, claims, royalties or encumbrances
(other than this Agreement). The only pending Registrations in respect of the
Product held by PRONOVA or Abbott with respect to the Territory is NDA # 21-654
for Omacor®. There are no proceedings pending or, to PRONOVA’s
knowledge, threatened, or circumstances in existence which could result in the
revocation, cancellation, material delay or suspension of any of the
Registrations for the Product, whether while pending or following approval.


 


(c)                                  No Debarment. PRONOVA has not been debarred and
PRONOVA has not and will not use in any capacity in connection with the
performance of its obligations under this Agreement the services of any
individual, person or entity known by PRONOVA to be debarred by the FDA under
the provisions of the Generic Drug Enforcement Act of 1992, as amended, or any
other applicable laws, orders, rules or regulations.


 


(d)                                 Facility. No inspection by the FDA of the
PRONOVA facilities used to make, package or store the API or the Product has
resulted in the issuance of any Establishment and Inspection Report or similar
report that contains any material adverse findings specific to the API or the
Product (other than findings and actions duly conveyed to RELIANT in writing
prior to the date hereof).


 


(e)                                  Validity; No Infringement. To the knowledge of PRONOVA, the
Intellectual Property Rights are valid. With the exception of Pharmacia’s
pending patent application, to PRONOVA’s knowledge, there are no circumstances
in existence such that the manufacture, import/export, registration, sale,
offer for sale, promotion or marketing of the Product in Territory or the use
of the Intellectual Property Rights within the Territory infringes or will
infringe any patent, trademark, trade name, copyright or legally protectable
right of any third party. The Parties acknowledge that PRONOVA has not
undertaken, and shall not be required to undertake, any independent
investigation as to the matters covered by this representation.


 


(f)                                    Litigation. There is no litigation, arbitration
proceeding, governmental investigation, action or claim of any kind, pending
or, to the knowledge of PRONOVA, threatened, by or against PRONOVA or its
licensees relating to the Intellectual Property Rights, the Product or the API
or an active pharmaceutical ingredient substantially similar to the API, or
that would in any way impede, impair, restrict or interfere with the license
granted RELIANT hereunder or the ability of either Party to exercise its rights
or perform its obligations hereunder.


 


(g)                                 No Competing or Adverse Claims. Except for the license rights of
Abbott as of the date hereof under those provisions of the Abbott Agreement
provided to 


 


38

















 


RELIANT,
there are no competing or adverse claims pending or to the knowledge of PRONOVA
threatened with respect to ownership of the Intellectual Property Rights.


 


(h)                                 No Default. PRONOVA is not in breach or default
nor has it received notice of breach or default of any obligations to third
parties relating to the Intellectual Property Rights.


 


(i)                                     Product Liability.
There are no pending or, to PRONOVA’s knowledge, threatened product
liability, warranty or other similar claims by any person (whether based in
contract or in tort and whether relating to personal injury, including death,
property damage or economic loss) arising from the marketing, sale or use of
the Product or any other pharmaceutical product containing the API or an active pharmaceutical
ingredient substantially similar to the API.


 


(j)                                     Clinical Development and
Registration. To PRONOVA’s knowledge, the
development, including clinical and scientific development, and registration in
the Territory of the Product was conducted substantially in accordance with
Regulatory Requirements, and other laws and regulations in effect and
applicable at the time of such development.


 


16.                               INDEMNITIES
AND LIMITATION OF LIABILITY


 


16.1                           Indemnification by PRONOVA. PRONOVA
shall defend the claim and indemnify and hold harmless RELIANT, its Affiliates,
directors, officers, employees, representatives, consultants and agents (the “RELIANT
Indemnitees”) from and against any and all liabilities, damages, losses,
costs and expenses (including the reasonable fees of attorneys and other
professionals) (collectively, “Losses”) for claims arising out of or
resulting from any lawsuit, action, claim, demand or proceeding asserted
against a RELIANT Indemnitee by any third party (other than a RELIANT
Indemnitee) as a result of:


 


(a)                                  any
negligent act or omission or intentional misconduct on the part of any PRONOVA Indemnitee
relating to or in
connection with the activities contemplated under this Agreement;


 


(b)                                 any breach of any representation,
warranty, obligation or covenant of PRONOVA contained in this Agreement;


 


(c)                                  the design, formulation or
manufacture, storage or handling of the API by or on behalf of any PRONOVA
Indemnitee;


 


(d)                                 the commercialization or use of the
API, an active pharmaceutical ingredient substantially similar to the API or
any Other Products outside the Territory by or on behalf of any PRONOVA
Indemnitee; or


 


(e)                                  any claim asserted by or on behalf of
Abbott related to the Abbott Agreement;


 


provided, however, that PRONOVA shall have no obligation to indemnify any RELIANT
Indemnitee pursuant to this Section 16.1 to the extent that RELIANT
is obligated to indemnify and hold harmless the PRONOVA Indemnitees for such
Losses pursuant to Section 16.2 or to the extent that such Loss is the
direct result of the gross negligence or intentional misconduct of any RELIANT
Indemnitee.


 


16.2                           Indemnification by RELIANT. RELIANT
shall defend the claim and indemnify and hold harmless PRONOVA, its Affiliates,
licensees, directors, officers, employees, 


 


39

















 


representatives, consultants and
agents (the “PRONOVA Indemnitees”) from and against any and all Losses
for claims arising out of or resulting from any lawsuit, action, claim, demand
or proceeding asserted against a PRONOVA Indemnitee by any third party (other
than a PRONOVA Indemnitee) as a result of:


 


(a)                                  any
negligent act or omission or intentional misconduct on the part of any RELIANT Indemnitee
relating to or in
connection with the activities contemplated under this Agreement;


 


(b)                                 any breach of any representation,
warranty, obligation or covenant of RELIANT contained in this Agreement;


 


(c)                                  the design, formulation, manufacture,
encapsulation, packaging, labeling, testing, storage, handling, distribution,
marketing, advertising, promotion, sale, commercialization or use of the
Product or any Additional Products by any RELIANT Indemnitee;


 


provided, however, that RELIANT shall have no obligation to indemnify any PRONOVA
Indemnitee pursuant to this Section 16.2 to the extent that PRONOVA
is obligated to indemnify and hold harmless the RELIANT Indemnitees for such
Losses pursuant to Section 16.1 or to the extent that such Loss is the
direct result of the gross negligence or intentional misconduct of any PRONOVA
Indemnitee.


 


16.3                           Notice of Claims. The
indemnified party shall promptly notify the indemnifying party in writing of
all matters which may give rise to the right to indemnification hereunder; provided, however, that failure to timely
give the notice provided in this Section 16.3 shall not be a
defense to the liability of the indemnifying party for such claim, but the
indemnifying party may recover any actual damages arising from the indemnified
party’s failure to give such timely notice. The indemnified party shall not
admit any liability with respect to, or settle, compromise or discharge any
such matter covered by this Section 16 without the indemnifying party’s
prior written consent (which shall not be unreasonably withheld). The
indemnifying party shall have the right, with the consent of the indemnified
party (which shall not be unreasonably withheld), to settle all indemnifiable
matters related to claims by third parties which are susceptible to being
settled. In connection with any claim giving rise to indemnity hereunder, the
indemnifying party at its sole cost and expense may, upon written notice to the
indemnified party received by the indemnified party within ten (10) calendar
days after the indemnifying party’s receipt of notice of such claim, assume the
defense of any such claim or legal proceeding. If the indemnifying party
assumes the defense of any such claim or legal proceeding, the indemnifying
party shall select counsel reasonably acceptable to the indemnified party to
conduct the defense of such claims or legal proceedings and, at the
indemnifying party’s sole cost and expense (which costs and expenses shall not
be applied against any indemnity limitation herein), shall take all steps
necessary in the defense or settlement thereof. The indemnified party shall be
entitled to participate in (but not control) the defense of any such action,
with its own counsel and at its own expense, and shall be entitled to any and
all information and documentation relating thereto. If the indemnifying party
does not assume (or continue to diligently and competently prosecute) the
defense of any such claim or litigation resulting therefrom in accordance with
the terms hereof, the indemnified party may, at 


 


40

















 


the indemnifying party’s expense,
defend against such claim or litigation in such manner as it may deem
appropriate, including, but not limited to, settling such claim or litigation,
after giving notice of the same to the indemnifying party, on such terms as the
indemnified party may deem appropriate. The indemnified party will cooperate
reasonably with the indemnifying party in its efforts to conduct or resolve
such matters, including by making available to the indemnifying party relevant
documents and witnesses. The indemnified party and the indemnifying party shall
keep each other informed of all settlement negotiations with third parties and
of the progress of any litigation with third parties. The indemnified party and
the indemnifying party shall permit each other reasonable access to books and
records and shall otherwise cooperate with all reasonable requests of each
other in connection with any indemnifiable matter resulting from a claim by a
third person.


 


16.4                           LIMITATION OF DAMAGES. NEITHER
PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR LOST PROFITS, LOSS OR INTERRUPTION
OF BUSINESS, OR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, MULTIPLE OR
CONSEQUENTIAL DAMAGES OF ANY KIND, WHETHER ARISING OUT OF WARRANTY, CONTRACT,
TORT OR OTHERWISE; PROVIDED, HOWEVER,
THAT THE FOREGOING LIMITATION SHALL NOT APPLY TO ANY AMOUNTS ACTUALLY PAID BY
ANY PARTY IN RESPECT OF ANY THIRD PARTY CLAIM RELATED TO THE PRODUCT OR THIS
AGREEMENT OR AS RESULT OF ANY GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT
(INCLUDING AN INTENTIONAL BREACH OF THIS AGREEMENT) BY SUCH PARTY.


 


16.5                           Disclaimer. Nothing in
this Agreement shall be construed as a representation or warranty by PRONOVA as
to the financial results to be attained by use of the Intellectual Property
Rights.


 


16.6                           Survival. This Section
16 (except for the limitation of damages set forth in Section 16.4,
which shall survive in perpetuity) shall survive the expiration or any
termination of this Agreement for a period of three (3) years.


 


16.7                           Indemnification Not Sole Remedy. Each Party hereby acknowledges that the indemnification provided for
under this Section 16 shall in no manner limit, restrict or prohibit
(unless liability is otherwise expressly limited by the terms of this
Agreement) either Party from seeking any recovery or remedy provided at law or
in equity from the other Party in connection with any breach or default by such
other Party of any representation, warranty or covenant hereunder.


 


17.                               INSURANCE


 


17.1                           Insurance. Each Party
will have in force prior to the First Commercial Sale and shall maintain in
good standing throughout the term of this Agreement and for a period of two (2)
years thereafter, liability insurance policies in respect of, in the case of
PRONOVA, the API, and, in the case of RELIANT, the Product or any Additional
Product, in each case with an insurer or insurers licensed to do business in
the Territory in an amount not less than USD 2.0 million per occurrence.


 


17.2                           Proof of Insurance. Each Party
shall provide proof of such insurance to the other Party within thirty
(30) days prior to the First Commercial Sale and thereafter within thirty
(30) days of request of proof of such insurance.


 


41

















 


18.                               REGULATORY
MATTERS


 


18.1                           Adverse Event Reporting. PRONOVA and
RELIANT shall report to the other any information obtained or received from any
source concerning any adverse drug experience in connection with the use of the
Product, any Additional Product, the API, any active pharmaceutical ingredient
substantially similar to the API, or any Other Product, including the incidence
or severity thereof, including, but not limited to events associated with
non-clinical studies, clinical uses, post-Registration studies, investigations
or tests, reports in scientific literature or unpublished papers, or notices
from regulatory authorities, whether or not determined to be attributable to
the Product, any Additional Product, the API, any active pharmaceutical
ingredient substantially similar to the API, or any Other Product. Reports of
routine adverse drug experiences of the type defined in Section 314.80 (or Section 600.80, as applicable) of Title 21
of the U.S. Code of Federal Regulations shall be exchanged by each Party on a
calendar quarter basis. Reports of Serious Adverse Drug Experiences and
unexpected adverse drug experiences or information that would require an IND
safety report as described in 21 CFR 312.32 shall be made available to the
other Party as soon as practicable but in no event more four (4) days after a
Party becomes aware of same. Upon receipt of any such information concerning
any Serious Adverse Drug Experience or unexpected adverse drug experience or
information that would require an IND safety report as described in 21 CFR
312.32 by either PRONOVA or RELIANT, the Parties shall promptly consult each
other and use commercially reasonable efforts to arrive at a mutually
acceptable procedure for taking such possible actions as appropriate or
required under the circumstances. If either Party has information that would
require the filing of a 3-day Field Alert report under 21 CFR Section 314.81,
that Party shall immediately notify the other Party. RELIANT shall make the
required report or submission to the FDA or take any other action that the
Parties deem to be appropriate or required by applicable law and provide a copy
to PRONOVA.


 


18.2                           Recall; Withdrawal. PRONOVA and
RELIANT will each maintain or cause to be maintained such traceability records
as are necessary to permit a recall, withdrawal or field correction of the
Product (each, a “Recall”). Each Party will give telephonic notice (to
be confirmed in writing) to the other within twenty-four (24) hours of the
receipt of any information which indicates a Recall may be necessary. The
decision to conduct and the right to control a Recall will be solely that of
RELIANT, after appropriate consultation with PRONOVA. Each Party will cooperate
fully with the other in connection with any Recall efforts. If any Recall is
the result of the design, formulation or manufacture, storage or handling of
the API by or on behalf of any PRONOVA Indemnitee (as defined in Section
16.2), PRONOVA will bear the cost of the Recall and replace API contained
in recalled Product with conforming API at no additional charge hereunder and
will reimburse RELIANT for all of RELIANT’s reasonable direct costs and expenses
actually incurred by RELIANT in connection with the Recall including, but not
limited to, direct costs of retrieving Product or Additional Products already
delivered to customers and direct costs and expenses RELIANT is required to pay
for notification, shipping and handling charges; provided, however, that for each such Recall (a) RELIANT
will in good faith consult with PRONOVA and, to the extent commercially
reasonable, implement PRONOVA’s recommendations on how best to conduct the
Recall including, without limitation, the notification and retrieval of Product
or Additional Product, and (b) prior to any reimbursement 


 


42

















 


hereunder, RELIANT will provide
PRONOVA with detailed supporting documentation of all costs and expenses for
which reimbursement is being sought. If a Recall of Product or any Additional
Product distributed is due to any act or omission of RELIANT, RELIANT will
remain responsible for the costs of such Recall and will reimburse PRONOVA for
all of the reasonable direct costs and expenses described above actually
incurred by PRONOVA (if any) in connection with such Recall including, but not
limited to, administration of the recall and such other reasonable direct costs
as may be reasonably related to the Recall.


 


19.                               TERM


 


19.1                           Term. This Agreement is entered
into as of the date of signing and, unless earlier terminated pursuant to Section
20, shall continue in full force and effect until the longer of (a) 15
years after the date of the First Commercial Sale of the Product in the
Territory, (b) the commercial introduction of an Equivalent Product (as such
term is defined in Section 1.25, above) to the Product in the Territory,
or (c) the expiration of the last to expire of the Patents.


 


20.                               TERMINATION


 


20.1                           PRONOVA Right to Terminate. This
Agreement may be terminated with immediate effect by PRONOVA if:


 


(a)                                  the final FDA approval of the Product
(or another pharmaceutical product containing Omega-3 fatty acids supplied by
PRONOVA as an active ingredient) has not been obtained by January 1, 2007 in
the event that RELIANT has not exercised its commercially reasonable efforts to
obtain such FDA approval prior to such time (in such event any payments made by
RELIANT to PRONOVA under Section 4 shall remain with PRONOVA, and any
outstanding amounts payable at the time of termination shall be paid without
further notice);


 


(b)                                 the final FDA approval of the Product
(or another pharmaceutical product containing Omega-3 fatty acids supplied by
PRONOVA as an active ingredient) has not been obtained by January 1, 2009,
regardless whether or not RELIANT has exercised such commercially reasonable
efforts (in such event any payments made by RELIANT to PRONOVA under Section
4 shall remain with PRONOVA, and any outstanding amounts payable at the
time of termination shall be paid without further notice);


 


(c)                                  RELIANT shall not have commenced
clinical studies for the Product (or another pharmaceutical product containing
Omega-3 fatty acids supplied by PRONOVA as an active ingredient) within the
later to occur of: (i) six (6) months following RELIANT’s receipt of written
notification from the FDA (or copy thereof) requiring such studies as a
pre-condition to Regulatory Approval of the Product for the HTG indication (or
such other product); and (ii) three (3) months following the transfer of the
Registration for the Product or such other product to RELIANT (or the granting
to RELIANT of the right to reference such Registration); or


 


(d)                                 following FDA approval, the First Commercial
Sale in the Territory has not taken place within six (6) months after RELIANT’s
receipt (FOB, Sandefjord, Norway) of API in accordance with the provisions of Section
5 of this Agreement (or another pharmaceutical product containing Omega-3
fatty acids supplied by 


 


43

















 


PRONOVA
as an active ingredient) and such delay is not primarily caused by PRONOVA.


 


20.2                           RELIANT Right to Terminate. This
Agreement may be terminated with immediate effect by RELIANT if:


 


(a)                                  in the event that RELIANT shall not
have received the Registration for the Product on or prior to the Abbott
Outside Date;


 


(b)                                 the final FDA approval of the Product
for the indication HTG, despite RELIANT diligently attempting to obtain such
approval in accordance with this Agreement, has not been obtained by 1 January
2009; or


 


(c)                                  in the event that a Failure to Supply
shall have occurred and continued for more than six (6) consecutive months
following the expiration of the four (4) month period referred in Section
5.12(c) or 5.12(d) and the Parties shall not have been able to find
alternative sources of supply to meet RELIANT’s requirements of API during such
period.


 


20.3                           Mutual Termination Rights. This
Agreement may be terminated with immediate effect upon the mutual agreement of
the Parties or by either Party if:


 


(a)                                  The other Party commits a material
breach of this Agreement that is unremedied later than ninety (90) days after
written notice of such material breach has been sent to the breaching Party  specifying  the breach in reasonable detail, in which
event the termination shall be effective ninety (90) days after receipt of the
written notice, unless the breaching Party cures the breach within that ninety
(90) day notice period, or, if such breach is incapable of cure within such
ninety (90)  day period, the breaching
Party has commenced good faith efforts to cure such breach within such ninety
(90) day period and cures such breach within six (6) months after the receipt
of the notice of material breach; or


 


(b)                                 the other Party enters into a
bankruptcy event, meaning the other Party (i) shall voluntarily file in any
court pursuant to any statute of any Governmental Authority in any country a
petition in bankruptcy or insolvency or for reorganization or for the
appointment of a receiver or trustee of such Party or of its assets; (ii) shall
be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed within sixty (60) days after
the filing thereof; (iii) shall be a Party to any dissolution or liquidation;
or (iv) shall make a general assignment for the benefit of its creditors.


 


20.4                           Additional PRONOVA Termination Right.


 


(a)                                  In addition to any other rights or
obligations of the Parties hereunder, in the event that PRONOVA in good faith
reasonably determines that the API is dangerous and poses a serious health risk
to its users (an “Adverse Safety Determination”), then PRONOVA shall
provide written notice to RELIANT thereof, together with such data, documents
and other information upon which PRONOVA has made such determination. In the
event that RELIANT disputes PRONOVA’s Adverse Safety Determination, RELIANT
may, at its expense, engage a third party to review the Adverse Safety Determination
(including any data, documents and other information relied upon by PRONOVA in
connection therewith) and PRONOVA shall fully cooperate with such third party’s
review. PRONOVA agrees to review and consider in good faith any findings of
such third party reviewer in connection with such Adverse Safety Determination.


 


44

















 


(b)                                 Following delivery of an Adverse
Safety Determination, the Parties shall meet to discuss the safety concerns and
shall negotiate in good faith to reach a mutually agreeable solution. If the
Parties are unable to reach a mutually agreeable solution within sixty (60)
days following the delivery of the Adverse Safety Determination, then PRONOVA
shall be entitled to terminate this Agreement, in which event, notwithstanding
any other provisions in this Agreement to the contrary: (i) RELIANT shall be
entitled to retain the Registrations for the Product or any Additional Product;
(ii) the License granted hereunder shall continue in full force and effect on a
perpetual, royalty-free basis to allow continued commercialization of the
Product or any Additional Product in the Territory; (iii) RELIANT shall
have the option, but not the obligation, to continue commercialization of the
Product in the Territory under the Omacor® Trademark, in which event
PRONOVA shall assign to RELIANT all of its right, title and interest to the
Omacor® Trademark in the Territory; (iv) PRONOVA shall, free of
charge (but subject to reasonable confidentiality undertakings), (A) provide
such reasonable technical assistance and (B) grant such licenses or other
rights (at no additional cost to RELIANT or any other party) as are necessary
to enable a Third Party Manufacturer to meet RELIANT’s supply requirements for
API for the purposes of commercializing the Product and any Additional Product
in the Territory pursuant to the License, without infringing patent rights or
engaging in any misappropriation of know-how owned or controlled by PRONOVA;
and (v) PRONOVA shall refund to RELIANT an amount equal to the aggregate of all
payments made by RELIANT to PRONOVA pursuant to Sections 4.1 and 4.2
(which amount shall be reduced by twenty percent (20%) on each anniversary of
the date of first commercial sale of the Product or, if earlier, the first
Additional Product – i.e., no
refund will be available following the fifth (5th) anniversary).


 


21.                               EFFECTS OF
TERMINATION


 


21.1                           Return of Product Inventory. If this
Agreement is terminated in accordance with Section 20 (except for a
termination by PRONOVA in accordance with Section 20.3), RELIANT shall
have the right, at its option, either (a) to sell the Product from its then
existing inventory for a period of not more than six (6) months from the
effective date of termination, and only on the same terms in the market (price,
etc.) as were applicable prior to the termination of this Agreement, or (b) to
sell the Product back to PRONOVA at the price paid for such Product.


 


21.2                           Return of Rights to PRONOVA. Upon
termination of this Agreement in accordance with Section 20 (other than Section
20.4), but not in the event of expiration of this Agreement in accordance
with Section 19, RELIANT shall take such actions as may be necessary to
promptly assign to PRONOVA, or a third party designated by PRONOVA, any and all
rights and Registrations with respect to the Product that may be in the name of
RELIANT or any of its Affiliates or sublicensees, including but not limited to
any NDA, ANDA and/or any other registrations with the FDA or other Governmental
Authority.


 


21.3                           Trademarks. Upon
termination of this Agreement in accordance with Section 20 (other than Section
20.4), but not in the event of expiration of this Agreement in accordance
with Section 19, RELIANT shall immediately cease using the Trademarks,
except to the extent it is necessary in order to sell RELIANT’S existing
inventory according to 


 


45

















 


Section 21.1 above. Furthermore, RELIANT shall not upon such a termination do
anything in the Territory that would deteriorate the value of the Trademarks or
the Product or Additional Product. Upon such a termination, RELIANT shall
immediately and for no additional consideration transfer to PRONOVA any
ownership rights in or to the Trademarks that RELIANT has acquired in any
manner (including without limitation by registration or by operation of law).


 


21.4                           Return of Technical Information. Upon termination of this Agreement in accordance with Section 20
(other than Section 20.4), but not in the event of expiration of this
Agreement in accordance with Section 19, RELIANT shall return to PRONOVA
at PRONOVA’s expense all designs, drawings, specifications, material and other
information (including the Technical Information) received from PRONOVA
comprising and/or relating to the Product and/or PRONOVA.


 


21.5                           Sharing of Proceeds Following Certain Terminations. In addition to any other rights RELIANT may have hereunder, in the
event that this Agreement is terminated by PRONOVA pursuant to Section
20.1(b) (in the event that RELIANT has exercised its commercially
reasonable efforts to obtain such FDA approval prior to such termination) or by
RELIANT pursuant to Sections 20.2(a), 20.2(b), 20.2(c), 20.3(a)
or 20.3(b), then in the event that PRONOVA sells or licenses the
Registration, Trademark or any other rights of the type returned to PRONOVA by
RELIANT under Sections 21.2, 21.3 or 21.4 (collectively,
the “Returned Rights”), to any third party for commercialization or
exploitation in the Territory, or otherwise receives compensation from any
third party in respect thereof, PRONOVA shall pay to RELIANT pay fifty percent
(50%) of the value it receives for such Returned Rights (reduced by PRONOVA’s
transaction costs, and excluding any reasonable bona fide royalties, transfer/supply
payments or R&D payments paid to PRONOVA that are substantially consistent
with PRONOVA’s arrangement with its other licensees, customers and
distributors), such amounts to be paid within thirty (30) days after receipt by
PRONOVA.


 


21.6                           Survival. Notwithstanding
any provision herein to the contrary, the following provisions shall survive
any termination of this Agreement: Section 1 (to the extent necessary to
provide definitions for any surviving provisions of this Agreement); Section
5.6(b); Section 5.11, Section 9, Section 12 (to the
extent RELIANT has the right to continue use of any Trademarks following
expiration), Section 16 (for the period provided in Section 16.6),
Section 17 (for the period provided in Section 17.1), Section
18.2 (first sentence only), this Section 21, Section 22 (to
the extent provided in Section 22.4), Section 25.2, and Section 26.


 


22.                               CONFIDENTIALITY;
PUBLICATIONS; PUBLIC ANNOUNCEMENTS


 


22.1                           PRONOVA’s Information.   Except as provided in Section 22.3
or elsewhere in this Agreement, all Confidential Information provided by
PRONOVA to RELIANT, whether in writing, orally or through access to such Party’s
premises, and concerning this Agreement, shall be maintained in strict
confidence by RELIANT. Such information shall remain the property of PRONOVA,
and RELIANT shall not use the same for or on behalf of any person or entity
other than PRONOVA or make use of any such information except as permitted by
this Agreement without the express prior written approval of PRONOVA.


 


22.2                           RELIANT’s Information.   Except as provided in Section 22.3 or
elsewhere in this Agreement, all Confidential Information provided by RELIANT
to PRONOVA, 


 


46

















 


whether in writing, orally or through
access to such Party’s premises, and concerning this Agreement, shall be
maintained in strict confidence by PRONOVA. Such information shall remain the
property of RELIANT, and PRONOVA shall not make use of any such information
except as permitted by this Agreement without the express prior written
approval of RELIANT.


 


22.3                           Exceptions. The
covenants of the receiving Party contained in Section 22.1 and Section 22.2
shall not apply to Confidential Information that the receiving Party can
reasonably demonstrate by competent proof that such information: (a) is
required to be disclosed by law or a court or other Governmental Authority
pursuant to (i) regulatory filings; (ii) prosecuting or defending
litigation; (iii) complying with applicable law and the orders or decisions of
any Governmental Authority having jurisdiction; (iv) conducting pre-clinical or
clinical trials of Product; or (b) is disclosed to Affiliates who agree to be
bound by similar terms of confidentiality. Notwithstanding any provision herein
to the contrary, nothing herein shall prevent or prohibit any disclosure of any
information (including Confidential Information) concerning this Agreement (i)
required under applicable securities laws and the rules and regulations of any
stock exchange or market system on which any Party’s securities are or may be
traded, (ii) by either Party in connection with an Approved Transaction (as
defined below), where prospective parties or the other party or parties to such
Approved Transaction have entered into confidentiality agreements with the
Party concerning such Confidential Information, (iii) to its financial advisors
or legal advisors who have agreed to the limitations on disclosure contained
herein and/or (iv) to investment bankers and/or financing sources in connection
with bona fide financing transactions involving either Party or an Affiliate.
For the purposes of this Agreement, each of the following shall constitute an “Approved
Transaction”: (i) the issuance by either Party of securities in connection
with any financing transaction or public offering, and/or (ii) a merger,
consolidation or other similar transaction involving either Party (i.e., wherein all or substantially all of
that Party’s equity interests or assets are acquired by another entity). If a
Party is required or permitted to make a disclosure of the other Party’s
Confidential Information pursuant to this Section 22.3 it shall provide
prior notice of such intended disclosure to such other Party if practicable
under the circumstances and shall disclose only such Confidential Information
of such other Party as such Party reasonably determines is required to be
disclosed.


 


22.4                           Survival. Sections
22.1, 22.2, 22.3 and 22.4 shall survive termination of
this Agreement for a period of seven (7) years.


 


22.5                           Public Announcements. Except as
otherwise required by applicable law or regulation (or reasonably determined by
either Party upon advice of legal counsel to be required by applicable law or
regulation), neither Party shall make any publicity releases, interviews or
other dissemination of Confidential Information concerning the Product (the
purpose of which is not advertisement or promotion), this Agreement or its
terms, or either Party’s performance hereunder, to communication media,
financial analysts or others without the prior written approval of the other
Party, which approval shall not be unreasonably withheld, conditioned or
delayed. Either Party may, upon written notice to the other, make any
disclosure in filings with Governmental Authorities as required by law or
applicable court or other order; provided,
however, that the other Party shall have the opportunity to review
and comment on such disclosures and filings.


 


47

















 


23.                               ASSIGNMENT
AND CHANGE OF CONTROL


 


23.1                           Assignment. Neither
Party may assign or transfer this Agreement or any rights or obligations
hereunder without the prior written consent of the other, not to be
unreasonably withheld, except that either Party may make such an assignment
without the other Party’s consent to its Affiliates or to a successor to
substantially all of the pharmaceutical assets or business of such Party,
whether in a merger, sale of stock, sale of assets or other transaction. Any
attempted assignment or transfer of this Agreement or rights or obligations
hereunder that is not in compliance with this Section 23.1 shall be
void.


 


23.2                           Change of Control. The rights
granted RELIANT in this Agreement will remain with RELIANT in case of a change
of control or ownership in either RELIANT or PRONOVA.


 


24.                               FORCE MAJEURE


 


24.1                           Force Majeure Defined. Except as
otherwise specifically provided herein, the obligations of either Party under
this Agreement shall be suspended during the time the Party is prevented or
hindered from complying herewith in whole or in part by reason(s) of Force
Majeure. “Force Majeure” means an occurrence outside the Party’s
reasonable control which that Party cannot reasonably be expected to avoid or
overcome, including, without in any way limiting the generality of the
foregoing, war, terrorism, force of arms, riots, civil disorder, fire, flood,
explosion, strike, lockouts or actions of regulatory authorities/changes in
applicable Regulatory Requirements (other than those specifically related or
applicable to such Party or any act or omission by or on behalf of such Party).


 


24.2                           Notification. The Party
so affected shall promptly notify the other Party of the existence of Force
Majeure in writing and provide full particulars of the cause or event and the
date of first occurrence thereof, the expected duration of Force Majeure, and
its estimated effect on the Party’s ability to perform its obligations under
this Agreement. The Party so affected shall also keep the other Party informed
of any further developments following the initial notice. The Party so affected
shall use its commercially reasonable efforts to remove the cause of
non-performance, and both Parties shall resume performance hereunder with the
utmost dispatch when such cause is removed, unless this Agreement has
previously been terminated.


 


24.3                           Termination. If the
Force Majeure continues for more than six (6) months, the Party not invoking
Force Majeure shall be entitled to terminate this Agreement with immediate
effect.


 


25.                               TERMS OF
PAYMENT


 


25.1                           Payments in US Dollars. All
payments to be made under this Agreement shall be made in USD by wire transfer
to an account designated by the creditor in writing from time to time.


 


25.2                           Interest on Late Payments. A payment
shall be deemed paid as of the day on which it is received in the account of
the creditor. Amounts that are not paid when due shall accrue interest at a
rate of 10% p.a., from due date until paid, (compounded as of the first day of
each calendar month). PRONOVA, or as the case may be, RELIANT, may treat
payments unpaid by the other Party for more than one month as a material breach
of this Agreement notwithstanding the payments of interest. In addition, the
late-paying Party shall reimburse the other Party for all costs and expenses,
including without 


 


48

















 


limitation reasonable attorney’s fees
and legal expenses, incurred in the collection of late payments.


 


25.3                           Factoring. Subject to
timely notice to RELIANT, PRONOVA may assign its claims for payment as part of
a factoring agreement.


 


26.                               MISCELLANEOUS


 


26.1                           Entire Agreement. This
Agreement contains the entire agreement and understanding between the Parties
hereto with respect to the subject matter hereof and supersedes all prior
agreements and understandings, whether written or oral, relating to such
subject matter.


 


26.2                           Amendment and Waiver. This
Agreement may be amended only by a writing that specifically states that such
is an amendment, specifically states its purpose and that is signed by both
Parties. No course of dealing between the Parties or failure by either Party to
exercise any right or remedy hereunder shall constitute an amendment to this
Agreement or a waiver of any other right or remedy or the later exercise of any
right or remedy.


 


26.3                           Subsidiaries; Successors and Assigns. The use of the terms “PRONOVA” and “RELIANT” shall be deemed to
include their respective majority and wholly owned subsidiaries, whether now or
hereafter in existence. The provisions of this Agreement shall be binding upon
and inure to the benefit of the Parties hereto and their respective successors
and permitted assigns.


 


26.4                           Nature of Agreement. In
performing this Agreement, each Party shall act independently and this
Agreement shall not be construed as creating any partnership, joint venture or
incorporated business entity. Neither Party shall have any authority to incur
any liability or obligation whatsoever on behalf of the other Party.


 


26.5                           Notices. All notices
in connection with or pursuant to this Agreement shall be in writing and in the
English language and shall be served by registered airmail or facsimile on the
Parties at the address stated at the front page of this agreement or to any
other address notified by one Party to the other in writing for such purpose.


 


26.6                           Severability. Each Party intends not to violate
any public policy, statutory or common law, rule, regulation, treaty or
decision of any Governmental Authority. If any term or provision of this
Agreement is held to be invalid, illegal or unenforceable by a court or other
Governmental Authority of competent jurisdiction, such invalidity, illegality
or unenforceability shall not affect any other term or provision of this
Agreement, which shall remain in full force and effect and the Parties shall
replace such term or provision with a new term or provision permitted by law
and having an economic and contractual effect as close as possible to the
invalid, illegal or unenforceable term or provision. The holding of a term or
provision to be invalid, illegal or unenforceable in a jurisdiction shall not
have any effect on the application of the term or provision in any other
jurisdiction.


 


26.7                           Further Documents. Each Party
hereto agrees to execute such further documents and take such further steps as
the other Party reasonably determines may be necessary or desirable to
effectuate the purposes of this Agreement.


 


26.8                           Construction. The
language in all parts of this Agreement shall be construed, in all cases,
according to its fair meaning. Each Party and its counsel have reviewed and
revised this Agreement and that any rule of construction to the effect that any
ambiguities are to be resolved against the drafting Party shall not be employed
in the 


 


49

















 


interpretation of this Agreement. The
words “hereof,” “herein,” “hereto” and “hereunder” and words of similar import,
when used in this Agreement, shall refer to this Agreement as a whole and not
to any particular provision of this Agreement. The terms defined in the
singular shall have a comparable meaning when used in the plural, and vice
versa. Whenever used herein, the words “include,” “includes” and “including”
shall mean “include, without limitation,” “includes, without limitation” and “including,
without limitation,” respectively. The masculine, feminine or neuter gender and
the singular or plural number shall each be deemed to include the others
whenever the context so indicates. With respect to any particular action or
agreement, the use of the words “shall” or “will” herein shall also mean a
Party “shall cause” the particular action to be performed.


 


26.9                           Governing Law. This
Agreement shall be governed by the laws of the State of New York, United States
of America, notwithstanding the provisions governing conflict of laws under
such New York law to the contrary and without giving effect to the United
Nations Convention on Contracts for the International Sale of Goods.


 


26.10                     Dispute Resolution. Except as
otherwise provided in Section 7.1, Section 7.2 and Section 7.3/Schedule
7.3, all disputes hereunder shall be resolved using binding arbitration
under the commercial arbitration rules of the American Arbitration Association.
Any such arbitration shall be held in New York, New York. Any dispute, controversy
or claim arising under or relating to this Agreement shall be finally settled
exclusively by arbitration under the International Arbitration Rules of the
American Arbitration Association (the “Rules”) provided however that
nothing herein shall prevent or prohibit any Party from seeking
injunctive/equitable relief in any court within appropriate jurisdiction. Unless
otherwise agreed in writing, any arbitration shall be conducted in the English
language and shall be held in New York City, New York, and heard by a
panel of three (3) arbitrators. Each party shall nominate one arbitrator. The
third arbitrator, who will be chairman of the arbitral tribunal, shall be
appointed in accordance with the Rules. The decision and award of the arbitral
tribunal shall be final and binding and may be entered in any court of
competent jurisdiction, for which purpose, and for all other purposes under
this Agreement, each party hereto submits to the jurisdiction and venue of the
U.S. District Court for the Southern District of New York. The costs of any
such arbitration shall be borne equally by the Parties or paid by the
non-prevailing Party, subject to the arbitrators’ discretional decision.
PRONOVA agrees that in the event RELIANT institutes an appropriate action seeking
injunctive/equitable relief for specific performance under this Agreement,
RELIANT shall not be required to provide PRONOVA with service of process of a
complaint and summons under the procedures set forth in the Convention on the
Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial
Matters (the “Hague Convention”), or via any Norwegian judicial process
or system. Under such circumstances, RELIANT need only provide PRONOVA with two
copies of a true, correct and lawfully issued summons and complaint, via
Federal Express (priority delivery).


 


26.11                     Agent for Service of Process. Promptly
following its execution hereof (but in no event later than the expiration of
the period contemplated by Section 26.14), PRONOVA shall appoint an agent
located in the United States of America for service of process in 


 


50

















 


respect of all matters arising
hereunder and shall provide RELIANT with evidence of such appointment and the
agent’s acceptance thereof.


 


26.12                     Foreign Corrupt Practices Act. PRONOVA and
RELIANT each agrees that it shall comply with the requirements of the U.S. Foreign Corrupt Practices Act or any
successor Law or Law to similar effect (the “Foreign Corrupt Practice Act”)
and shall refrain from any payments to third parties or any other acts or
omissions which would cause PRONOVA or RELIANT to violate the Foreign Corrupt
Practice Act.


 


26.13                     English Language. The English language version of this
Agreement shall govern over any translation of this Agreement made by any
person for any reason. Any information, reports, proposed publications or any
other communication or notice relating to this Agreement to be exchanged or
provided by the Parties shall be provided in English. The resolution of any
disputes arising out of or relating to any provision of this Agreement shall be
conducted and concluded in English.


 


26.14                     Board Approval Condition. The Parties acknowledge that this
Agreement remains subject to approval by the Board of Directors of each Party
and agree that their respective Boards of Directors shall convene promptly
following the date hereof to consider and vote upon this Agreement. In the
event that the Board of Directors of either Party does not approve this
Agreement, such Party may deliver a written termination notice to the other
Party no later than 9:00 p.m., U.S. Eastern time, on the tenth (10th)
business day following the date of this Agreement, in which event this
Agreement shall be deemed null and void ab
initio and neither Party shall have any rights, obligations, or
liabilities in respect hereof. In the event that neither Party delivers a
termination notice pursuant to this Section 26.14 prior to such time,
then this Agreement shall be deemed in full force and effect as of and
following the date first above written.


 


26.15                     Counterparts. This Agreement may be executed in
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.


 


Signature page follows.


 


51














 


IN WITNESS HEREOF, each of the Parties has caused this Agreement to be
executed by its duly authorized representative on and as of the date first
written above.


 


	
  PRONOVA BIOCARE A.S.

  	
  RELIANT PHARMACEUTICALS, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:
  :

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Typed
  or printed name:

  	
  Type
  or printed name:

  
	
   

  	
   

  
	
   

  	
   

  
	
  Title:

  	
  Title:

  
						



 


52

















 


List of Schedules


 


	
  Schedule 1.6

  	
   

  	
  API
  specifications

  
	
   

  	
   

  	
   

  
	
  Schedule 1.22

  	
   

  	
  Patents

  
	
   

  	
   

  	
   

  
	
  Schedule 1.35

  	
   

  	
  Trademarks/Trademark
  Specifications

  
	
   

  	
   

  	
   

  
	
  Schedule 2.6

  	
   

  	
  Other
  Omega-3 Products being sold into Territory by PRONOVA

  
	
   

  	
   

  	
   

  
	
  Schedule 3.6

  	
   

  	
  PRONOVA
  Rights to Clinical Data

  
	
   

  	
   

  	
   

  
	
  Schedule 4.1

  	
   

  	
  Payment
  Models

  
	
   

  	
   

  	
   

  
	
  Schedule 5.2

  	
   

  	
  Order
  and Forecast Procedure

  
	
   

  	
   

  	
   

  
	
  Schedule 5.12(b)

  	
   

  	
  Territories in which PRONOVA Currently has Licensing or Supply Agreements for API (or
  Active Pharmaceutical Ingredients Similar to API)

  
	
   

  	
   

  	
   

  
	
  Schedule 7.2

  	
   

  	
  Combination
  Product Royalty Rates

  
	
   

  	
   

  	
   

  
	
  Schedule 7.3

  	
   

  	
  Pharmacia
  Patent Royalty

  
	
   

  	
   

  	
   

  
	
  Schedule 12.2

  	
   

  	
  Reliant
  Trademarks

  
	
   

  	
   

  	
   

  
	
  Schedule 15.2(a)

  	
   

  	
  Exception
  to Ownership of Intellectual Property Rights, Right to License Representation

  



 


 

















 


Schedule 1.6


 


API specifications


 


SPECIFICATION


	
  Product:

  [***]

  	
   

  	
  Specification no.:

  [***]

  	
   

  	
  Previous specification
  no.:

  [***]

  	
   

  	
   

  
	
  This edition approved:

  [***]

  	
   

  	
  Previous edition
  approved:

  [***]

  	
   

  	
  First edition approved:

  [***]

  	
   

  	
  Shelf life/retest
  period:

  [***]

  
	
  Prepared by:

  Kathrine Alfheim

  	
   

  	
  Verified by:

  Wenche Gordon

  	
   

  	
  Authorized by:

  Hilde Merete Næss

  	
   

  	
   

  



 


	
  Test

  	
   

  	
  Min. value

  	
   

  	
  Max. value

  	
   

  	
  Unit

  	
   

  	
  Method

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
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Shelf life is guaranteed if product is stored in
unopened original closed containers, protected from heat and light.






[***]: 
Certain information on this page has been omitted and filed separately
with the Commission.  Confidential
treatment has been requested with respect to the omitted portions.


 


 

















                


Schedule 1.22


 


Patents


 


A. Existing patents


 


1.               US Patent number
5,502,077


 


2.               US Patent number
5,656,667


 


3.               US Patent number
5,698,594


 


B. Patent applications


 


4.               U.S. Patent
Application No. 10/451,623 (Pharmacia Post MI)


 


5.               WIPO patent
application number WO 03/092673 A1 (Southampton Plaque stabilization)


 


6.               Possible patent
application submittal (IgA Nephropathy) by PRONOVA based substantially on the
abstract attached hereto as Attachment 1.22-A.


 

















 


Attachment 1.22-A


 


Title: Omega-3 Fatty Acids
(O3FA) for Patients with Iga Nephropathy Efficiency is Dose-dependent Report
from the North American IgA Nephropathy Trial.


 


Ronald J. Hogge, M.D.*(1), Lisa Fitzgibbons, PhD(1),
Jeannette Lee, PhD(2), James V. Douadio, M.D.(3), Bruce A. Julian, M.D.(2) and
Bruce J. Holub, PhD(4),(1) Medical City Hospital, Dallas, Texas, United States;(2)
University of Albama, Birmingham, Albama, United States;(3) Mayo Clinte,
Rochester, Minnesota, Unites States and(4) University of Gueiph, Guelph,
Ontatio, Canada.


 


In the placebo-controlled North American IgAN Trial,
we were unable to show benefit of a two year course of O3FA
ercosapent/doconexent eicosapentanoic acid [EPA] 1.88g. docosahexanoic acid
[DHA] 1.48g) using on pt outcome, but there was wide warriation in the
phospholipid (PL) O3/O6 and EPA/arachidonic acid (AA) levels. The purpose of
this study was to determine the cause for this variabilityand to evaluate if
the PL O3/O6 and EPA/AA levels affected the outcome of the pts. PLFA levels
were measured after 21 months in 23 pts who received O3FA taged 7-10 years and
weighing 25-25 kg. and in 11 placebo pts. A Clinical Outcome Score (COS) ranging
from -10 to +10 was determined for each pt based on the mean values of
estimated GFR and urine protein/creatinnie ratios (UP/C) after 18 and 24 months
versus baseline. The dosage of O3FA given to each pt was calculated as g/kg BWt
and g/m BSA. Adherence to therapy (Adh-Rx) was based on pill counts.
Correlations were determined between the variables of interest and expressed as
Spearman’s rho (rho). The PL O3/O6 ratios ranged from 0.17 to 0.58 (mean 0.34)
and the EPA/AA ratios ranged from 0.06 to 0.91 (0.42 ) in the 23 pts. versus
0.06-0.13 and 0.03-0.09 in the placebo pts. There was no relationship between
the O3/O6 and EPA/AA ratios and Adh-RX (rho=0.09, rho=0.20. The PL O3/O6 and
EPA/AA ratios were closely correlated with BW (rho=0.68 and 0.80 p=0.0001 and
g/m(2) rho=0.69 and 0.82 p=0.0001). As expected the PL EPA/AA and DHA/AA were
closely correlated rho=0.85 p=0.0001. The COS correlated with O3/O6 rho=0.53
p=0.009 EPA/AA rho=0.50 p=0.0003 dose in g/kg rho=0.55 p=0.006 and dose/m(2)
BSA rho=0.54 p=0.008,. but out Adh-RX (rho=0.21). These data suggest that the
efficacy of O3FA Rs for JgAN pts is dose-dependent and that therapy with
EPA+DHA is of benefit if dosing is done according to body size and/or EPA/AA
levels.


 

















 


Schedule 1.35

Trademarks/Trademark Specifications


 


 


 






 










 


	
  

  	
  Branding

  Guidelines

  OMACOR®

  icosapent/doconexent

   

  



 













 


	
  

  	
  Table of
  Contents

  icosapent/doconexent

  ®

  Apo B–100

  Apo E

  Apo C

  VLDL–Triglycerides

  VLDL

  remnant

  LDL

  Other sites

  Liver

  Inhibition of

  VLDL–

  Triglyceride

  synthesis

  Branding
  Omacor®

  Logotype

  Symbol

  Colour
  Environment

  Logo Cluster

  Graphic Styling

   

  



 













 


	
  

  	
  Branding
  Omacor® In order to build a pharmaceutical brand in today’s crowded and
  competitive marketplace, it is essential that all materials maintain a
  strong, distinctive and consistent visual image. Each of the product’s
  branding components should therefore be used consistently and repeatedly
  wherever and whenever the product is promoted in its markets around the
  world. The benefit to individual marketing companies is that strong product
  branding produces a more distinct and powerful image for a product. In turn,
  this complements the other elements of the marketing mix, to build a brand
  that is stronger, more durable, and therefore more successful. These
  guidelines are provided to help you to build Omacor® as a pharmaceutical
  brand that will differentiate itself in the current market and continue to be
  distinctive and relevant as the market evolves. The four key “global
  branding” components for Omacor® have been developed to endure over time,
  regardless of changes in advertising “fashions”. They are: Distinctive
  Logotype (i.e., the typestyle of the brand name) Unique and Relevant Symbol
  Distinctive Brand Colour Environment Consistent Visual Styling (typefaces,
  design, photography and artwork) 

  icosapent/doconexent

  



 













 


	
  

  	
  The Omacor®
  Logotype + Generic name The representation of the brand name, or ‘logotype’,
  is the most important of all branding elements. Omacor® is produced by a
  unique process, making it a unique drug, that therefore deserves a unique and
  distinctive logotype.

   

  icosapent/doconexent

   

  The consistent
  use of the generic name together with the logotype is essential to the
  pharmaceutical image of Omacor®. The generic name for Omacor® is
  icosapent/doconexent. The logotype should always be used together with the
  generic name. It is recommended also to use the symbol wherever possible. The
  symbol to employ when used with the logotype is the boxed form which can be
  seen throughout this binder in the logo/symbol configuration. A description
  of the symbol is given in ‘The Omacor Symbol’ section. Use the Omacor
  logotype with the ® symbol in all countries where the trademark has been
  registered, and the TM symbol in all other countries.

  



 













 


	
  

  	
  The Omacor®
  Symbol

  The Omacor®
  symbol has a blood

  vessel as its
  inspiration; it also

  reflects the
  ‘O’ of Omacor®. The

  symbol has been
  rendered with a

  ‘segmented’
  effect, to allude to the

  multi-factorial
  nature of the disease

  area, and to
  the multi-stage

  PUFA-XPC
  purification process.

  This
  segmentation effect also

  allows the
  central counterspace to

  be developed
  into a heart shape.

  The Omacor®
  symbol may be

  used as a
  graphic device (as can

  be seen
  throughout these

  guidelines),
  with the following

  recommendations:

   

  In whole or in
  part, the

  surrounding box
  omitted. In

  this form it
  should be noted

  that the
  segment which passes

  through the box
  appears

  intact and not
  divided by the

  box rule.

  The individual
  segments may

  be used
  graphically or

  photographically.

  The symbol
  should only be

  used in the
  boxed form when

  in the
  logo/symbol configuration.

  The boxed form
  highlights the

  symbol. This
  not only separates

  the symbol from
  the logotype

  as a distinct
  visual element but

  creates
  integrity to the logo/

  symbol unit by
  being the

  same height as
  the OMACOR

  lettering.

   

  icosapent/doconexent

   

  



 













 


	
  

  	
  The Omacor®
  Logo/Symbol

  When
  reproducing the Omacor®

  logotype and
  symbol together – the

  logo/symbol –
  it is essential that the

  various elements
  are kept in the

  correct
  proportions and relative

  positions,
  together with consistent

  application of
  branding colours

  (see Colour
  Environment).

   

  icosapent/doconexent

   

  Colour and
  black and white

  reproducible
  art, for both the larger

  and smaller
  versions of the

  logo/symbol,
  are included at the

  back of this
  binder.

   

  



 













 


	
  

  	
  The Omacor®
  Colour Environment

  It is important
  that, whenever

  possible, the
  Omacor® logotype and

  symbol be
  reproduced in full colour.

  Please see the
  colour keys on this

  page for
  information required to

  reproduce these
  colours with the

  Pantone
  Matching System (PMS)

  colour system,
  four-colour process,

  and with an
  Apple Macintosh

  computer.

  The branding
  colours selected for

  Omacor® are:
  PMS 2587C,

  PMS 326C, and
  PMS 293C.

  When budget
  considerations

  require black
  and white

  reproduction,
  please refer to the

  reproducible
  art sheets at the back

  of this binder.

   

  PMS 2587C

  Four-colour
  process

  C 72% M 79% Y
  0% K 0%

  Apple Macintosh

  R 54.1% G 12.5%
  B 85.9%

  Hue 76.1%
  Saturation 85.4%

  Brightness
  85.9%.

  PMS 326C

  Four-colour
  process

  C 94% M 0% Y
  43% K 0%

  Apple Macintosh

  R 42.0% G 72.5%
  B 63.1%

  Hue 44.9%
  Saturation 42.2%

  Brightness
  72.5%

  PMS 293C

  Four-colour
  process

  C 100% M 56% Y
  0% K 0%

  Apple Macintosh

  R 0% G 0% B
  70.6%

  Hue 66.7%
  Saturation 100%

  Brightness 70.6%

   

  Please note,
  the colour reproduction in

  these prints is
  not exact.

   

  icosapent/doconexent

   

   

  



 













 


	
  

  	
  The Omacor®
  Logo Cluster

   

  The Omacor®
  “logo cluster” is

  created by the
  combination of the

  following
  elements:

   

  Eyebrow

  Logotype

  Symbol

  Generic name

   

  Biosynthesised

  icosapent/doconexent

   

  These elements
  are described and

  discussed on
  the following page.

  The Omacor®
  logo cluster should

  be used,
  whenever possible and

  wherever
  appropriate, in

  promotional and
  educational

  materials.

  Reproducible
  art sheets for the

  Omacor® logo
  cluster are included

  at the back of
  this binder.

   

  



 













 


	
  

  	
  Eyebrow

  The eyebrow
  sits above the brand name.

  It may be
  reproduced in either black or

  in reversed-out
  white type.

  Generic Name

  The generic
  name,

  icosapent/doconexent,
  is positioned

  flush left. The
  recommended size is

  indicated but,
  of course, is subject to

  national
  regulatory control.

  It should
  appear in black, or in

  reversed-out
  white type.

   

  Biosynthesised

  icosapent/doconexent

   

  



 













 


	
  

  	
  The Omacor®
  Background

  The Omacor®
  background has

  been developed
  to further enhance

  the page
  layouts, and to emphasise

  typographic
  points. This

  background is a
  series of horizontal

  bands
  orchestrated down a blue

  vignette.

   

  55%

   

  As can be seen
  throughout these

  guidelines the
  Omacor® logo cluster

  should always remain
  on

  a white
  background.

   

  70%

   

  It is possible
  to create this

  background. The
  colour to use is

  PMS 293C. The
  percentages of

  PMS 293C are
  shown on this page.

   

  55%

   

  It is advisable
  to discuss this

  background with
  your local

  Art Studio.

   

  70%

  25%

  25%

  25%

  0%

   

  icosapent/doconexent

   

  



 













 


	
  

  	
  Omacor® Colour
  Priorities

  If reproduction
  considerations,

  or budgetary
  constraints, do not

  allow use of
  4-colour reproduction,

  the colour
  directions to use are

  shown below.

  The PMS colours
  chosen being

  those described
  previously.

   

  icosapent/doconexent

  3-colour
  reproduction

  PMS 2587 PMS
  326 PMS 293

   

  icosapent/doconexent

  1-colour
  reproduction

  PMS 2587

   

  icosapent/doconexent

  Black and white
  reproduction

   

  icosapent/doconexent

  For
  reproduction on a dark background

   

   

  



 













 


	
  

  	
  PMS 2587C

   

  PMS2587 PMS2587
  PMS2587 PMS2587 PMS2587 PMS2587 PMS2587 PMS2587

  PMS2587 PMS2587
  PMS2587 PMS2587 PMS2587 PMS2587 PMS2587 PMS2587

  PMS2587 PMS2587
  PMS2587 PMS2587 PMS2587 PMS2587 PMS2587 PMS2587

  PMS2587 PMS2587
  PMS2587 PMS2587 PMS2587 PMS2587 PMS2587 PMS2587

  PMS2587 PMS2587
  PMS2587 PMS2587 PMS2587 PMS2587 PMS2587 PMS2587

  PMS2587 PMS2587
  PMS2587 PMS2587 PMS2587 PMS2587 PMS2587 PMS2587

  PMS2587 PMS2587
  PMS2587 PMS2587 PMS2587 PMS2587 PMS2587 PMS2587

  PMS2587 PMS2587
  PMS2587 PMS2587 PMS2587 PMS2587 PMS2587 PMS2587

   

  



 













 


	
  

  	
  PMS 326C

   

  PMS326 PMS326
  PMS326 PMS326 PMS326 PMS326 PMS326 PMS326

  PMS326 PMS326
  PMS326 PMS326 PMS326 PMS326 PMS326 PMS326

  PMS326 PMS326
  PMS326 PMS326 PMS326 PMS326 PMS326 PMS326

  PMS326 PMS326
  PMS326 PMS326 PMS326 PMS326 PMS326 PMS326

  PMS326 PMS326 PMS326
  PMS326 PMS326 PMS326 PMS326 PMS326

  PMS326 PMS326
  PMS326 PMS326 PMS326 PMS326 PMS326 PMS326

  PMS326 PMS326
  PMS326 PMS326 PMS326 PMS326 PMS326 PMS326

  PMS326 PMS326
  PMS326 PMS326 PMS326 PMS326 PMS326 PMS326

   

  



 













 


	
  

  	
  PMS 293C

   

  PMS293 PMS293
  PMS293 PMS293 PMS293 PMS293 PMS293 PMS293

  PMS293 PMS293
  PMS293 PMS293 PMS293 PMS293 PMS293 PMS293

  PMS293 PMS293
  PMS293 PMS293 PMS293 PMS293 PMS293 PMS293

  PMS293 PMS293
  PMS293 PMS293 PMS293 PMS293 PMS293 PMS293

  PMS293 PMS293
  PMS293 PMS293 PMS293 PMS293 PMS293 PMS293

  PMS293 PMS293
  PMS293 PMS293 PMS293 PMS293 PMS293 PMS293

  PMS293 PMS293
  PMS293 PMS293 PMS293 PMS293 PMS293 PMS293

  PMS293 PMS293
  PMS293 PMS293 PMS293 PMS293 PMS293 PMS293

   

  



 













 


	
  

  	
  Omacor®
  Reproducible Art

   

  icosapent/doconexent

   

  icosapent/doconexent

   

  icosapent/doconexent

   

  icosapent/doconexent

   

  icosapent/doconexent

  icosapent/doconexent

   

  icosapent/doconexent                                                icosapent/doconexent

   

  



 













 


	
  

  	
  OmacorTM
  Reproducible Art

   

  icosapent/doconexent

   

  icosapent/doconexent

   

  icosapent/doconexent

   

  icosapent/doconexent

   

  icosapent/doconexent                                                icosapent/doconexent

   

  icosapent/doconexent                                                icosapent/doconexent

   

  



 













 


	
  

  	
  The Omacor®
  Typeface

   

  A distinctive
  typeface has been

  created, based
  on the logotype,

  for Omacor.

  The typeface
  should be used

  selectively, so
  that its impact is

  not diluted. It
  may be used for

  short headlines
  or journal titles.

  Greek
  characters have been

  designed in
  harmony with the

  Latin typeface.

   

  abcdefghijkl

  mnopqrstuv

  wxyz

  1234567890

  ABCDEFGHIJK

  LMNOPQRRST

  UVWXYZ

  

  

  

  icosapent/doconexent

   

  



 










 


Schedule 2.6


 


Other Omega-3 Products being sold
into Territory by PRONOVA


 


	
  Product

  	
   

  	
   

  	
   

  	
  EPA+DHA

  	
   

  	
  EPA/DHA Ratio

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Min

  	
   

  	
  Max

  	
   

  	
  Min

  	
   

  	
  Max

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 






[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested with
respect to the omitted portions.


 

















 


Schedule 3.6


 


PRONOVA Rights to Clinical Data - Clinical
trials with OMACOR®


 


	
  1.

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 






[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 

















 


Schedule 4.1


 


Payment Models


 


Model 1:


 


USD [***] due and payable thirty (30) days after the signing of this Agreement; plus


 


•                  USD [***] due and payable after the date of FDA notification if the initial NDA
results in a final FDA approval of the Product for the indication HTG upon the
later of (i) thirty (30) days after such notification, and (ii) the transfer of
the Registration for the Product to RELIANT; or


 


•                  USD [***] due and payable thirty (30) days after the date of FDA notification if
the initial NDA results in an Approvable Letter (unless RELIANT shall not have
provided a notice to PRONOVA under Section 3.3(a)), plus USD [***] due and payable upon
the later of (i) thirty (30) days after the date of FDA notification of final
FDA approval of the Product for the indication HTG, and (ii) the transfer of
the Registration for the Product to RELIANT.


 


Model 2:


 


USD [***] due and payable thirty (30) days after signing of this Agreement; plus


 


•                  USD [***] due and payable after the date of FDA notification if the initial NDA
results in a final FDA approval of the Product for the indication HTG upon the
later of (i) thirty (30) days after such notification, and (ii) the transfer of
the Registration for the Product to RELIANT; or


 


•                  USD [***] due and payable thirty (30) days after the date of FDA notification if
the initial NDA results in an Approvable Letter from FDA (unless RELIANT shall
not have provided a notice to PRONOVA under Section 3.3(a)), plus USD [***] due and payable upon
the later of (i) thirty (30) days after the date of FDA notification of final
FDA approval of the Product for the indication HTG, and (ii) the transfer of
the Registration for the Product to RELIANT.


 


RELIANT’s obligation to make any of the foregoing “final
FDA approval” payments shall be conditioned upon RELIANT’s having received
access to validated API to create finished encapsulated Product for sale in the
Territory.


 






[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 

















 


Schedule 5.2


 


Forecasting, Ordering and Delivery procedures (examples)


 


	
   

  	
   

  	
  January

  	
   

  	
  February

  	
   

  	
  March

  	
   

  	
  April

  	
   

  	
  May

  	
   

  	
  June

  	
   

  	
  July

  	
   

  	
  August

  	
   

  	
  September

  	
   

  	
  October

  	
   

  	
  November

  	
   

  	
  December

  	
   

  	
  January

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  M0

  	
   

  	
  M1

  	
   

  	
  M2

  	
   

  	
  M3

  	
   

  	
  M4

  	
   

  	
  M5

  	
   

  	
  M6

  	
   

  	
  M7

  	
   

  	
  M8

  	
   

  	
  M9

  	
   

  	
  M10

  	
   

  	
  M11

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Example for procedure January

  	
   

  	
  Order/Fore-cast to be received by 15th

  	
   

  	
  Firm Order (already placed)

  	
   

  	
  Firm Order (already placed)

  	
   

  	
  New Firm Order

  	
   

  	
  Binding forecast (last month +/- 15%)

  	
   

  	
  Binding forecast (last month +/- 15%)

  	
   

  	
  Forecast

  	
   

  	
  Forecast

  	
   

  	
  Forecast

  	
   

  	
  Forecast

  	
   

  	
  Forecast

  	
   

  	
  Forecast

  	
   

  	
   

  
	
   

  	
   

  	
  

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  M0

  	
   

  	
  M1

  	
   

  	
  M2

  	
   

  	
  M3

  	
   

  	
  M4

  	
   

  	
  M5

  	
   

  	
  M6

  	
   

  	
  M7

  	
   

  	
  M8

  	
   

  	
  M9

  	
   

  	
  M10

  	
   

  	
  M11

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Example for next month, February

  	
   

  	
  Order/Fore-cast to be received by 15th

  	
   

  	
  Firm Order (already placed)

  	
   

  	
  Firm Order (already placed)

  	
   

  	
  New Firm Order

  	
   

  	
  Binding forecast (last month +/- 15%)

  	
   

  	
  Binding forecast (last month +/- 15%)

  	
   

  	
  Updated Forecast

  	
   

  	
  Updated Forecast

  	
   

  	
  Updated Forecast

  	
   

  	
  Updated Forecast

  	
   

  	
  Updated Forecast

  	
   

  	
  New Forecast

  
	
   

  	
   

  	
   

  	
   

  	
  

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Latest
  Delivery of Firm Order for May

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


 

















 


Schedule 5.12(b) 


 


Territories in which PRONOVA
Currently has Licensing
or Supply Agreements for API (or Active Pharmaceutical Ingredients Similar to
API)


 


Europe & “former Soviet Union”


 


Germany


 


Austria


 


United Kingdom


 


Ireland


 


Belgium


 


Netherlands


 


Luxembourg


 


Switzerland


 


Greece


 


Spain


 


Portugal


 


France


 


Italy


 


S.
Marino


 


Vatican
City


 


Norway


 


Sweden


 


Finland


 


Denmark


 


Iceland


 

















 


Estonia


 


Latvia


 


Lithuania


 


Poland


 


Czech Republic


 


Slovakia


 


Hungary


 


Romania


 


Bulgaria


 


Slovenia


 


Croatia


 


Bosnia-Herzegovina


 


Yugoslavia


 


Macedonia


 


Moldova


 


Albania


 


Malta


 


Cyprus


 


Turkey


 


Israel

Belarus


 


Ukraine


 


Russia


 


Georgia


 


Armenia


 


Kazakhstan


 

















 


Azerbaijan


 


Kyrgyzstan


 


Tajikistan


 


Uzbekistan


 


Turkmenistan


 


Middle East


 


Jordan


 


Lebanon


 


Syria


 


Saudi-Arabia


 


Yemen


 


Oman


 


United Arab Emirates


 


Qatar


 


Bahrain


 


Kuwait


 


Asia


 


Thailand


 


Myanmar


 


Malaysia


 


Philippines


 


Singapore


 


Vietnam


 

















 


Indonesia


 


Brunei


 


Sri Lanka


 


Laos


 


Cambodia


 


South Korea


 


Taiwan


 


Australia


 


North America


 


Canada


 


Africa


 


Algeria


 


Morocco


 


Tunisia


 


Benin


 


Burkina


 


Burundi


 


Camerun


 


Congo


 


Ivory Coast


 


Gabon


 


Guinea


 


Madagaskar


 

















 


Mali


 


Mauritania


 


Niger


 


Central African Republic


 


Djibouti


 


Rwanda


 


Senegal


 


Tchad


 


Togo


 


Congo (former Zaire)


 


South-Africa


 


Central & South America


 


Argentina


 


Bolivia


 


Brazil


 


Chile


 


Colombia


 


Costa Rica


 


Dominican Republic


 


Equador


 


El Salvador


 


Guatemala


 


Honduras


 


Mexico


 

















 


Nicaragua


 


Panama


 


Paraguay


 


Peru


 


Uruguay


 


Venezuela


 

















 


Schedule 7.2


 


Combination Product Royalty
Rates 


 


Note:      The following royalty rates are in lieu of any other royalties
under Section 7.2 in respect of the Combination Products described
below


 


1.             In the event
Reliant commercializes Combination Products, the royalty rate due on the Net
Sales of each such Combination Product will depend on whether such Combination
Product is commercialized in a [***] dosage form, or in [***] dosage forms, as
required by the FDA in the labeling of each such Combination Product.


 


2.             In the event
Reliant commercializes a Combination Product with only a [***] dosage form,
Reliant will pay a royalty rate on the Net Sales of such Combination Product
based on (i) [***] and (ii) [***].  The
royalty due on the Net Sales of each such Combination Product will be equal to
the product of (i) [***] and the [***] and (ii) the appropriate [***] below:


 




	
  API contained in the recommended daily
  dosage of the Combination Product

  	
   

  	
  Royalty rate

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
  %

  
	
  [***]

  	
   

  	
  [***]

  	
  %

  
	
  [***]

  	
   

  	
  [***]

  	
  %

  
	
  [***]

  	
   

  	
  [***]

  	
  %

  






 


3.             In the event that
FDA requires that Reliant commercializes a Combination Product with multiple
daily dosage forms, Reliant will pay a royalty rate on the Net Sales of such
Combination Product based on (i) [***] and (ii) [***].  The royalty due on the Net Sales of each such
Combination Product will be equal to the product of (i) [***] and the [***];
and (ii) the [***]:


 




	
  API contained in the highest daily dosage
  of the Combination Product

  	
   

  	
  Royalty rate

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
  %

  
	
  [***]

  	
   

  	
  [***]

  	
  %

  
	
  [***]

  	
   

  	
  [***]

  	
  %

  
	
  [***]

  	
   

  	
  [***]

  	
  %

  






 


4.                                       In the event Reliant launches a Combination Product containing a
fractional amount of API, the royalty rate for such Combination Product will be
based on a [***].  Further, in the event
Reliant launches multiple Combination Products, the royalty of Net Sales for
each such Combination Product will be calculated independently.


 


 






[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 

















 


Schedule 7.3


 


Pharmacia Patent Royalty


 


The
royalty fee under Section 7.3 shall be payable subject to the following
conditions:


 


1.               The royalty fee shall be [***] percent ([***]%) of the Net
Sales (as defined below) for as long as PRONOVA’s patent GB 8819110 or any
counterpart thereof, validly exists in the Territory. If PRONOVA’s patent GB
8819110 or any counterpart thereof, does not exist in the Territory or, after
the expiration of such patent, the royalty fee shall be increased to [***]% ([***] percent) of the
Net Sales (as defined below).


 


2.               The royalty fee shall be
payable to Pharmacia Italia S.p.A., Via Robert Koch 1.2, Milan, Italy.


 


3.               The royalty fee shall be
payable, on a back-to-back basis, for as long as and to the extent PRONOVA is
contractually bound to pay a royalty fee to Pharmacia Italia S.p.A. or its
successors in relation to the sale of the Product in the Territory.


 


4.               The royalty shall be
denominated in Euro. Monetary conversion into Euro from USD shall be made at
the official exchange rate of the European Central Bank quoted on Reuter’s page
ECB37 two business days prior to the last business day of the calendar year for
which the royalties have accrued.


 


5.               RELIANT shall present a
report, certified by its auditor, to PRONOVA containing the relevant
calculations and documentation regarding the Net Sales (as defined below) of
the Product during the year in question. Such report shall be presented to
PRONOVA within 90 days after the end of the applicable calendar year. PRONOVA
shall be entitled to, at its own expense, appoint an independent auditor to
control the content of such report, and RELIANT shall provide such auditor with
reasonable access to RELIANT’s offices and the relevant records, files and
accounts, and such auditor shall have the right to examine any other records
reasonably necessary to determine the accuracy of the calculations provided by
RELIANT. The auditor shall inform both Parties of the outcome of his control
and state his reasons should he find that his conclusion varies from the
figures stated in RELIANT’s report. The auditor shall otherwise work under a
confidentiality obligation and shall not reveal further numbers or data to
PRONOVA.


 


6.               The royalty set forth above
shall be calculated on an annual basis and shall be invoiced on the basis of
the royalty report referred to above. RELIANT shall pay such royalty within 30
days from the invoice date. Amounts that are not paid when due shall bear
interest using the Interest Rate (as defined below) from the due date until
payment actually occurs.


 






[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 

















 


7.               In this Schedule 7.3,
Net Sales shall mean the gross invoice value of the Product sold by RELIANT and
distributors on any indication in the Territory, net of returns and credits for
rejected goods, and less (a) cash and trade discounts and rebates; (b)
allowances and adjustments actually credited to customers for spoiled, damaged,
outdated or returned Products and (c) value-added, excise or similar taxes,
transportation or handling charges and insurance premiums, which items are
included in the gross invoice value as separate items. Notwithstanding the
foregoing, Products sold by RELIANT or its permitted sublicensees or
distributors to a third party for use in clinical studies or for equivalent
purposes shall be excluded. For the avoidance of doubt, net sales shall exclude
all sales made by RELIANT to RELIANT’s distributors.


 


8.               In this Schedule 7.3,
Interest Rate shall mean, in relation to any given calendar month, the rate per
annum quoted at or about 12:00 noon CET two business days prior to the first
business day during such calendar month for one months deposits in Euro offered
by leading European banks (EURIBOR) as published on Reuter’s page EURIBOR01, or
if such rate is not available, a substitute rate being the rate offered for
deposits in Euro by Deutsche Bank (or failing such determination Barclays
Bank), plus a margin of 2%.


 

















 


Schedule 12.2


 


Reliant Trademarks


 


 Reliant


 


 DynaCirc


 


 DynaCirc CR


 


 Axid


 


 InnoPran XL


 


 Rythmol*


 


 Rythmol SR*


 


 Luxacor


 


 Luxor


 


 RelCor


 

















 


 Antara


 


 Lescol**


 


 Lescol XL**


 






*
Rythmol is a registered trademark of Gerd Petrik


 


**
Lescol is a registered trademark of Novartis Pharmaceutical Corporation;


 

















 


Schedule 15.2(a)


 


Exception to Ownership of
Intellectual Property Rights, Right to License Representation


 


1.
The first sentence of Section 15.2(a) is hereby qualified to except royalties
and other financial obligations payable by RELIANT to PRONOVA pursuant to the
terms of this Agreement.


 


2.
Under Norwegian law, employee inventors may have certain rights to economic
compensation with respect to patents obtained by their employers through
efforts made by such employee inventors in the course of their employment. The
first sentence of Section 15.2(a) is hereby qualified accordingly; provided
that PRONOVA acknowledges that any such economic compensation payable to
PRONOVA employees in respect of the Patents is solely an obligation of PRONOVA.


 


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