Exhibit 10.1

NOTE: CERTAIN CONFIDENTIAL INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT AND
REPLACED BY “[*]”. A COMPLETE COPY OF THIS DOCUMENT INCLUDING THE CONFIDENTIAL
INFORMATION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (the “Agreement”) is made and entered into as of July 2,
2007 (the “Effective Date”), by and between NPS ALLELIX CORP. (“NPS”), with a
business address of MaRS Centre, 101 College Street, South Tower, Suite 800,
Toronto, ON MSG 1L8 Canada, and Nycomed Danmark ApS (“Nycomed”), company
registration number CVR 16406899, located at Langebjerg 1, 4000 Roskilde,
Denmark. NPS and Nycomed are referred to in this Agreement individually as a
“Party” and collectively as “Parties.”

WHEREAS, NPS and Nycomed on April 20, 2004 entered into that certain
Distribution and License Agreement (as amended on July 1, 2004 and on June 5,
2007, “Distribution Agreement”) and on February 24, 2005 entered into that
certain Supply Agreement (as amended on July 29, 2005, “Supply Agreement”);

WHEREAS, the Parties desire to enter into this Agreement to provide for the
assumption by Nycomed of obligations relating to the supply of Product and the
release of NPS from such supply obligations, in exchange for Nycomed receiving
the right to market the Product in additional countries as set forth herein; and

WHEREAS, the Parties desire to have performance under the Distribution Agreement
excused during the term of this Agreement as set forth herein.

NOW THEREFORE, in consideration of the mutual covenants and conditions herein
contained, and intending to be legally bound hereby, the parties mutually agree
as follows:

 

1. DEFINITIONS

1.1 “Actual True Cost of Goods” means with respect to the Product, the costs
actually incurred by NPS, in accordance with generally accepted accounting
principles, for supply and manufacture of Drug Substance, Product or Devices, as
the case may be, including costs for testing and release of such items.

1.2 “Affiliate” means a corporation or other business entity which, directly or
indirectly, through one or more intermediaries, controls, is controlled by or is
under common control with a Party. For purposes of this definition only,
“control” and, with corresponding meanings, the terms “controlled by” and “under
common control with” means (a) the possession, directly or indirectly, of the
power to direct the management or policies of a legal entity, whether through
the ownership of voting securities or by contract relating to voting rights or
corporate governance, or (b) the ownership, directly or indirectly, of more than
50% of the voting

 

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securities or other ownership interest of a legal entity; provided, however,
that if local law restricts foreign ownership, control will be established by
direct or indirect ownership of the maximum ownership percentage that may, under
such local law, be owned by foreign interests.

1.3 “Approvals” means any approvals of any national or local regulatory agency,
department, bureau or other governmental entity, necessary for the manufacture,
use, storage, importation, export, transport, distribution or sale of a Product
or Device except for the Marketing Authorization.

1.4 “Control” or “Controlled by” means, with respect to a Party, any Patent,
Know-How, other intellectual property right, or Marketing Authorization,
(a) that such Party owns or has a license to use such Patent, Know-How,
intellectual property right or Marketing Authorization, and (b) has the ability
to grant the other Party access, a license or a sublicense (as applicable) or
right to use such Patent, Know-How, or intellectual property right, or the right
to reference such Marketing Authorization during the Term without violating the
rights of any Third Party and without obligation to make any payments to a Third
Party as a result of such grant of access, license or sublicense, or right of
reference, or the exercise thereof by the other Party. For purposes of
information that a Party is obligated to transfer under this Agreement,
“Control” or “Controlled by” means such information that is reasonably available
to such Party.

1.5 “Device” means the drug delivery device described in Schedule 1.5 hereto and
any future Improvements hereof.

1.6 “Drug Master File” or “DMF” shall mean a submission to the FDA or other
regulatory agency used to provide confidential detailed information about
facilities, processes, or articles used in the manufacturing, processing,
packaging, and storing of human drugs, as more particularly described in United
States Code of Federal Regulations, 21 CFR 314-420.

1.7 “Drug Substance” means shall mean the parathyroid hormone drug substance to
be used for the Product.

1.8 “EU” means the member states from time to time of the European Union.

1.9 “Future Partner” means a Third Party to whom NPS grants rights to
commercialize or distribute the Product in the US.

1.10 “Improvement” means any invention, discovery, derivative or Know-How,
whether or not patentable, relating to the Product, the Device or Drug Substance
(including in other formulations and indications). Any general patent or patent
application which relates both to the Product, Device or Drug Substance as well
as to other active substances shall be included in the definition of
Improvement.

1.11 “Know-How” means information, results and data of any type whatsoever, in
any tangible or intangible form whatsoever, including without limitation,
Technical Information, databases, practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill, experience,
test data including pharmacological, medicinal chemistry, biological, chemical,
biochemical, toxicological and clinical test data, analytical and quality
control data, stability data, studies and procedures, and manufacturing process
and development information, results and data relating to the Product, Device or
Drug Substance.

 

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1.12 “Licensed Technology” means the NPS Know-How, NPS Patents, and any
Improvements relating to the Product, Device or Drug Substance.

1.13 “MAA” means a Marketing Authorization application submitted to the
appropriate regulatory body in a country of the Territory for the purposes of
obtaining Approval for the marketing of a pharmaceutical product in such
country.

1.14 “Marketing Authorization” means any approvals (including, but not limited
to, price and reimbursement approvals) and any master files, DMFs, establishment
licenses, registrations or authorizations (including the approval of an MAA)
issued under Directive 2001/83/EC or local legislation deriving thereof (as
amended by Directive 2004/27) or local legislation deriving thereof, Council
Regulation 2309/93 and any amendments or replacements hereof or any national
equivalents (whether inside or outside the Territory) in relation to the Product
and any CE Marking or approval by local authorities of the Device.

1.15 “Master Cell Bank” means NPS’ master cell bank containing the host cell
(with the plasmid incorporated therein) for fermentation of the recombinant
parathyroid hormone. The Master Cell Bank is used to generate the Working Cell
Bank.

1.16 “Net Sales” means the gross amount invoiced by Nycomed or its Affiliates or
sublicensees for sale or other commercial disposition of a Product to a Third
Party in the Original Territory, as described in Section 7.3, less the following
deductions:

(a) Discounts and allowances allowed and taken for returns or rejections
(provided such amounts have been formally designated as such in accordance with
the internal accounting procedures, consistently applied, of Nycomed and its
Affiliates), and wholesaler charge backs allowed and taken in amounts normal and
customary in the trade;

(b) Import, export, excise, sales or use taxes, value added taxes, and other
taxes, tariffs or duties levied, absorbed or directly imposed and properly
allocable to particular sales of Products to the extent such items are included
in the gross amount invoiced (in any event excluding taxes on the income of
Nycomed and its Affiliates);

(c) Freight, postage, shipping, insurance, and packaging costs and other
outbound transportation charges prepaid or allowed to the extent included as
part of the invoiced amount;

(d) Amounts allowed or credited for retroactive price reductions or rebates;

(e) The amounts of trade and cash discounts actually allowed on account of the
purchase of Products;

(f) Allowances, adjustments, reimbursements, discounts and rebates made with
respect to sales paid for by Third Parties, including, but not limited to,
rebates given to health care organizations or other Third Parties who bought or
paid for a Product; and

 

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(g) Any amounts actually written off or specifically identified as
uncollectible, in accordance with consistently applied accounting policies of
Nycomed and except to the extent Nycomed recovers payment of any such written
off amounts; provided however, that no such deduction shall be made for the
Actual True Cost of Goods of such Product.

(h) Notwithstanding the foregoing, if: (i) a Product is sold together with other
goods, whether with a separate price for such Product (unless such separate
price is the same as the price for such Product when not sold together with
other goods) or without a separate price for such Product, (ii) the
consideration exchanged for a Product includes any non-cash consideration, or
(iii) a Product is transferred for purposes of resale, in any manner other than
as an invoiced sale, then, in each case the Net Sales applicable to the quantity
of such Product included in any such transaction will be deemed to be the
average Net Sales for such quantity of such Product for all transactions of such
Product (other than those described in the preceding Sections (i)-(iii),
inclusive) made in the relevant country during the last full calendar quarter
prior to such transaction (or, if the Product was not commercially available
during the last full calendar quarter preceding such transaction, during the
current quarter).

(i) In the event that Products are sold or otherwise disposed of to a Third
Party other than on arm’s length terms and are subsequently sold or otherwise
disposed of by such Third Party on arm’s length terms, then Net Sales will be
calculated based upon the first such arm’s length sale or disposition. “Net
Sales” excludes (a) the transfer of reasonable and customary quantities of free
samples of Product to physicians for professional use, other than for subsequent
resale, (b) the transfer of Product as clinical trial materials, other than for
subsequent resale, and (c) the transfer of Product to any regulatory agency in a
country in the Territory for use by such agency in connection with securing
Marketing Authorization for such Product in such country.

(j) In the event that Product is sold through sublicensees, distributors etc.
appointed by Nycomed any costs, margins etc. payable by Nycomed to any such
sublicensee, distributor etc. shall be borne solely and entirely by Nycomed and
no such amount(s) shall be deducted when determining Net sales pursuant to this
definition.

1.17 “New Territory” means all countries of the Territory which are not the
Original Territory.

1.18 “NPS Know-How” means (a) any non-public or confidential sections of any MAA
relating to any Product, and (b) any other non-public or confidential Know-How
Controlled by NPS during the Term that is necessary or useful for the
performance of pre-clinical or clinical development, for the filing of Marketing
Authorizations in the Territory, or the commercialization, marketing or
manufacture of a Product.

1.19 “NPS Patents” means the Patents listed in Schedule 1.19, as well as any
Patents that NPS and its Affiliates own, have under license, have a right to
acquire or Control, that are necessary or useful for, or otherwise, related to
the exercise of the licenses granted in Section 2, such Patents to be added to
Schedule 1.19 by NPS from time-to-time, with Nycomed’s approval.

 

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1.20 “Original Territory” means all the countries of the EU, European countries
outside EU, the Commonwealth of Independent States (formerly the USSR) and
Turkey.

1.21 “Patent” means patents, letters patent, applications for patents,
provisional applications for patents, and any patents issuing therefrom
(including any divisions, continuations, continued prosecution applications and
continuations-in-part thereof), reexamination certificates, reissue patents,
patent extensions, patent term restorations, supplementary protection
certificates issued under directive Council Regulation 1768/92 and any
amendments and replacements hereof and any equivalents, substitutions,
confirmations, registrations, revalidations, additions, continuations in part
and divisions thereof.

1.22 “Product” means any pharmaceutical formulation dosing and administration
form of the Drug Substance recombinant human parathyroid hormone 1-84, as
currently set out in EMEA/H/C/659 as well as any Improvements thereto.

1.23 “Product Trademarks” means any trademarks, trade dress, logos, slogans, and
designs, whether or not registered in the Territory, used to identify or promote
a Product in the Territory including the trademarks listed in Schedule 2.2.

1.24 “Technical Information” means all information in physical form be it
written, electromagnetic or photographic in relation to the Product, Drug
Substance or Device including, without limiting the generality of the foregoing,
results of pre-clinical studies and clinical trials, formulae, raw-data from
product development, data, drawings and designs, toxicological, pharmacological,
analytical and quality control data and testing data Controlled by NPS or
Nycomed or their Affiliates and of which such entity is free to dispose, which
is necessary or useful to the manufacture, development or other exploitation of
Drug Substance, Products and Devices in accordance with this Agreement.
Technical Information as defined in this Agreement shall be considered
“Know-how” and include information relating to Master Cell Bank and Working Cell
Bank as well as all research and development related information on the
pharmaceutical technical aspects concerning the formulation and manufacturing of
the Product and the Drug Substance.

1.25 “Term” means the period from Effective Date and until the earlier of
termination or expiry as set out in Section 16.

1.26 “Territory” means all the countries of the world, except for US, Japan and
Israel.

1.27 “Third Party” means any individual or entity other than NPS, Nycomed and
their respective Affiliates including, but not limited to any national or local
governments, hospitals, drug wholesalers, pharmacies and other third party
customers.

1.28 “Working Cell Bank” means NPS’ working cell banks containing the host cell
(with the plasmid incorporated therein) for fermentation of the recombinant
parathyroid hormone. The Working Cell Bank is generated from the Master Cell
Bank.

 

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2. LICENSE GRANT

2.1 Licensed Technology. NPS hereby grants to Nycomed the exclusive right and
license, with a right to sublicense, under the Licensed Technology to market,
use, import, export, distribute and sell the Product and Devices in the
Territory in accordance with the terms of this Agreement; provided, however,
that with respect to any sublicense relating to the Original Territory, such
sublicense shall require NPS’ prior written consent, such consent not to be
unreasonably withheld.

2.2 Trademarks. NPS hereby sells, assigns and transfers to Nycomed the entire
right, title and interest in and to the PREOTACT trademarks in the Territory as
identified on Schedule 2.2, together with the trademark registrations and
trademark applications identified on Schedule 2.2 and any accompanying goodwill
pertaining thereto, together with all claims, demands and causes of action for
the past infringement of any or all of the trademarks or for unfair competition
in business in connection therewith, the same to be held and enjoyed by Nycomed,
its successors, assigns or other legal representatives as fully and entirely as
the same would or could have been held and enjoyed by NPS had this assignment
not been made. NPS hereby grants to Nycomed an exclusive and royalty free
license to use the Product Trademarks other than the PREOTACT trademarks in the
Territory under the terms of this Agreement in connection with marketing, sale,
use, import and distribution, and/or sublicensing with NPS’ prior consent, which
shall not be unreasonably withheld, of the Product and Device. Product
Trademarks shall be solely for display, advertising, labeling and packaging
purposes in connection with marketing, selling and distributing Product and
Devices in accordance with this Agreement. Nycomed shall not at any time do or
permit any act to be done which may in any way impair the rights of NPS in
Product Trademarks.

2.3 Limitation Relating to Canada and Mexico. Notwithstanding Sections 2.1 and
2.2, the license granted hereunder with respect to Canada and Mexico shall be
limited as set out in Section 8.

2.4 Manufacture. NPS hereby grants to Nycomed the non-exclusive royalty-free
right under the Licensed Technology to develop, have developed, manufacture and
have manufactured Product, Drug Substance and the Devices for its own use, or
use of its sublicensees or for supply of Products, Drug Substance or Devices to
NPS and any Future Partner in the Territory.

2.5 Technical Information. NPS further grants to Nycomed the exclusive
royalty-free right and license, with a right to sublicense (in respect of rights
relating to the Original Territory with NPS’ prior written consent which shall
not be unreasonably withheld), to use the Technical Information of NPS to
develop Product, Drug Substance or Device and to submit for approval for or
amendment of Marketing Authorization for the Product. The license granted
pursuant to this Section 2.5 does not impose on NPS an obligation to actually
engage in or support any application for a Marketing Authorization in the
Territory.

2.6 Nycomed Grant to NPS. Nycomed grants to NPS the exclusive royalty-free right
and license, with a right to sublicense or subcontract distribution to a partner
with Nycomed’s prior written consent on terms to be reasonably negotiated, to
use the Technical Information of Nycomed to development Product, Drug Substance
or Device and to submit for approval for or amendment of Marketing Authorization
for the Product. The license granted pursuant to this Section 2.6 does not
impose on Nycomed an obligation to actively engage in or support any application
for a Marketing Authorization outside the Territory. In addition, Nycomed hereby
grants to NPS the exclusive right and license, with a right to sublicense or

 

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subcontract distribution to a partner with Nycomed’s prior written consent on
terms to be reasonably negotiated, under Nycomed’s Improvements to develop,
make, have made, use, import, sell and have sold the Product and Devices outside
the Territory. The licenses granted under this Section 2.6 shall not limit
Nycomed’s rights under Section 2.7 to enter into negotiations with, or grant
rights to, a Future Partner.

2.7 Improvements. Nycomed undertakes upon request by a Future Partner to discuss
in good faith exploitation of Improvements outside the Territory with any Future
Partner. NPS undertakes to use reasonable efforts to insert in any agreement
with a Future Partner an equivalent obligation on a Future Partner to discuss in
good faith exploitation of Improvements conceived by the Future Partner inside
the Territory.

2.8 Clinical Study Data. NPS hereby grants to Nycomed the exclusive rights in
the Territory, to the extent of NPS’ rights, to exploit all data emerging from
the clinical study entitled “The Effects of PTH on the Skeleton in
Hypoparathyroidism.”

2.9 Right of Negotiation. NPS grants to Nycomed the right of negotiation with
respect to any of NPS’ pipeline products and or new products, which NPS is
offering in a competitive process for license or sale to non-Affiliates in the
Territory. Nycomed shall be provided with the same data, documentation, and
other information simultaneously as such information is being submitted to any
Third Party relating to the right of negotiation in the previous sentence.

2.10 Territorial Restriction. NPS shall ensure, to the extent permitted by
applicable law, that its other licensees who distribute the Product outside the
Territory will not actively sell the Product in the Territory. Nycomed shall
ensure, to the extent permitted by applicable law, that it and its licensees who
distribute the Product in the Territory will not actively sell the Product
outside of the Territory.

2.11 Distribution Agreement. On the Effective Date, the Parties’ performance and
all obligations under the Distribution Agreement shall be excused in all
respects until midnight on September 1, 2007, at which time such performance and
obligations shall be reinstated in full as of such time (including, without
limitation, that NPS shall supply Product at the prices set out in the relevant
provisions of the Distribution Agreement and the Supply Agreement); provided,
however, that (i) the provisions of Section 19.7.2 of the Distribution Agreement
shall not be reinstated but shall be immediately terminated and deemed null and
void in all respects; and (ii) upon the earlier delivery of the Release
Certificate as set forth in Section 6.8, the Distribution Agreement shall be
immediately terminated and deemed null and void in all respects upon the date of
such delivery. Notwithstanding the foregoing, until the Supply Agreement is
terminated as set forth in Section 6.8 the sections and definitions contained in
the Distribution Agreement incorporated by reference into the Supply Agreement
shall continue to be so incorporated in the Supply Agreement. In the event that
the Release Certificate is not delivered as set forth in Section 6.8, subject to
Section 16.8, this Agreement shall be immediately terminated and deemed null and
void in all respects (provided, however, that any amounts due and payable
hereunder but not paid as of such termination date shall be due and payable in
accordance with the terms of this Agreement). In the event that the Release
Certificate is not delivered as set forth in Section 6.8, except as expressly
contemplated in the provisions specified in Section 16.8, each of the Parties
shall use reasonable efforts to put the other Party in the position it was in
before entering into this Agreement, including, without limitation, the return
of the information of relevant Third Parties, the return of Technical
Information and the return of any registered rights relating exclusively to the
New Territory (except for Brazil, which rights shall not be returned).

 

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3. DEVELOPMENT

3.1 Development. Nycomed shall have the right to develop the Product, Drug
Substance and the Device including the development hereof for new administration
forms and indications. Nycomed shall inform NPS or a Future Partner designated
by NPS about its ongoing development projects on a quarterly basis. NPS or such
Future Partner shall treat any such information as confidential in accordance
with Section 13. Subject to Section 2.7, Nycomed shall have exclusive ownership
to all Improvements conceived solely by Nycomed.

 

4. COMMERCIALIZATION

4.1 Commercialization. Nycomed will be solely responsible for the
commercialization of the Product in the Territory at Nycomed’s expense. Nycomed
shall have the right to commercialize through sublicensees. Nycomed shall
launch, market and sell the Product in the countries of the Territory in which
Nycomed at its sole discretion finds the marketing financially feasible. If
Nycomed determines that launching the Product in a country in the Original
Territory, Canada or Mexico would not be commercially viable or would
substantially limit the commercial potential of the Product in other countries
of the Territory, then Nycomed will provide NPS with written notice of such
determination and with copies of or access to all evidence considered by Nycomed
in making such determination. Such evidence will be updated annually on request
by NPS for as long as Nycomed does not launch Product in any country of the
Original Territory, Canada or Mexico. In relation to the New Territory, other
than Canada or Mexico, Nycomed shall have no reporting obligations.

4.2 Marketing Plan. Nycomed will commercialize the Product in the Territory
pursuant to an annually updated marketing plan (“Marketing Plan”). Nycomed will
prepare the Marketing Plan according to Nycomed’s marketing planning process and
will include at a minimum in each Marketing Plan, medical education and
communication, publications, congress and symposia, patient education, life
cycle management, brand strategy, pan-EU brand positioning, key messages, Phase
IV program, public relations, sales and distribution strategies. Each Marketing
Plan will identify commercial milestones and describe the Product’s positioning
and specify the target physician and patient populations and distribution
channels to which Nycomed will devote its promotional efforts, the personnel and
other resources by or on behalf of Nycomed as well as market and sales forecasts
for the Product in the Territory.

4.3 Review and Comment on Marketing Plan. Nycomed will submit the final draft of
the initial and updated Marketing Plan to NPS for review and comment. NPS will
have twenty (20) business days to provide comments on such draft to Nycomed, and
Nycomed will reasonably consider and address such comments prior to finalization
and implementation of such plan. NPS shall review the Marketing Plan with a view
to optimize the value of the Product and maintain brand consistency for the
Product in the Territory that is not in conflict with NPS’ global
commercialization strategy.

 

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4.4 Launch Diligence Obligations. Subject to Section 4.1, Nycomed undertakes to
launch the Product through its own sales and marketing organization in Germany,
UK, France, Italy, Spain, Greece, Austria, Switzerland, Belgium, Netherlands,
Sweden, Norway, Denmark, Finland, Estonia, Latvia, Lithuania, Poland and the
Commonwealth of Independent States (formerly the USSR) and to maintain the
necessary personnel to perform sales and marketing activities towards relevant
target groups of hospital and office based specialists. Furthermore, Nycomed
will launch the Product in each country in the Original Territory as soon as
reasonably possible after receipt of Marketing Authorization, pricing and
reimbursement approval, for the Product and Device in such country, but in no
event later than four (4) months after such receipt; provided, however, that
such 4-month period will be tolled during such time as commercial supply of such
Product is not available to Nycomed other than as a result of any act or
omission by Nycomed. Schedule 4.4 contains a description of Nycomed’s initial
sales and marketing personnel commitment to the Original Territory during the
first five years from launch. Such allocation shall be fully in place twelve
(12) months from launch and shall not be decreased by more than thirty-five
percent (35%) in a country or more than twenty-five percent (25%) in the
aggregate in the Original Territory without prior consultation and approval by
NPS. Should Nycomed, to an unreasonable extent, delay or postpone the launch of
the Product in any of the markets as set forth in this Section 4.4 for reasons
within Nycomed’s or Nycomed’s sublicensees control (or any other markets in the
Original Territory), NPS or its sublicensee shall be entitled but not obliged to
“march-in” to ensure the launch of the Product in any such country, and
Nycomed’s rights with respect to any such countries may be terminated.

4.5 General Diligence Obligations. Nycomed will use commercially reasonable
efforts to perform the activities set forth under each Marketing Plan. Nycomed
will promote, market, sell and distribute the Product in the Territory by
applying efforts and resources as reasonably required to capture the commercial
potential of the Product throughout the Original Territory and at least equal to
the efforts and resources normally used by a similarly situated pharmaceutical
company for a product owned by it which has a similar market potential and is at
a similar stage in its product life cycle as the Product. All efforts of
Nycomed’s Affiliates, sublicensees or distributors will be considered efforts of
Nycomed for the purpose of determining Nycomed’s compliance with its obligations
under this Section 4.5.

4.6 Nycomed Diligence Concerning Shipment of Product Outside the Territory.
Nycomed may not deliver or tender (or cause to be delivered or tendered) any
Product outside of the Territory. If Nycomed receives any order from a
prospective purchaser located outside the Territory, Nycomed shall immediately
refer that order to NPS. Nycomed shall not accept any such orders.
Notwithstanding anything in this Section 4.6 to the contrary, if Nycomed
receives an unsolicited order for Product from a prospective purchaser located
outside the Territory, and such purchaser is committed to resell the Product
back into the New Territory and not the Original Territory (as evidenced by a
written agreement by such purchaser), then Nycomed may accept such order;
provided, however, that if any such Product is sold back into the Original
Territory and Nycomed knew or had reason to know such fact when selling such
Product to such purchaser, then such sale shall be included in Net Sales for
purposes of Section 7.5. In addition, with respect to sales invoiced in the New
Territory but that were re-sold or imported for resale into the Original
Territory, see Section 7.3.

4.7 Right of Reference. Subject to the terms and conditions set forth in this
Agreement, (i) NPS hereby grants to Nycomed a fully paid, exclusive right and
license to reference any Marketing Authorizations Controlled by NPS for Product
outside the Territory for

 

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the purpose of obtaining Marketing Authorization of the Product in one or more
countries in the Territory and (ii) Nycomed hereby grants to NPS and its
sublicensees a fully paid, exclusive right and license to reference any
Marketing Authorizations Controlled by Nycomed for Product inside the Territory
for the purpose of obtaining Marketing Authorization of the Product in one or
more countries outside the Territory. The license granted pursuant to this
Section 4.7 does not impose on any of the Parties an obligation to actively
engage in or support any application for a Marketing Authorization in the
territory of that other Party.

 

5. MARKETING AUTHORIZATION

5.1 Filing of Marketing Authorizations. Subject to Section 4.4, Nycomed shall
have the right to, and shall at its sole discretion file the MAAs in order to
obtain Marketing Authorizations or to have amended the existing MAA in any
country of the Territory.

5.2 Ownership and Maintenance of Marketing Authorizations. Nycomed shall be the
Marketing Authorization holder and owner in respect of all Products in each part
of the Territory and shall assume all responsibilities towards the regulatory
authorities. Nycomed shall maintain the Marketing Authorizations at its costs in
the Territory for the Term. NPS will, throughout the Term, at its own costs,
provide technical and scientific support to the extent such support is
reasonably possible to NPS, taking into consideration its operations at the time
of Nycomed’s request or to the extent the request relates to data available to
NPS but not to Nycomed.

5.3 Meetings and Correspondence. The provisions of this Section shall not apply
to adverse events reporting, which shall be governed by Section 5.4. To the
extent either Party receives any written or oral communications relating to a
Product from any regulatory authority in the Territory, such Party will promptly
inform the other Party and the Future Partner, if any, thereof (including by
providing a copy of any written communication or a written account of any oral
communication), but in no event later than five (5) business days after receipt
of such communication. Each Party will promptly notify the other Party and the
Future Partner, if any, and provide such other Party and Future Partner, if any,
with a copy, of any correspondence or other reports or complaints submitted to
or received by the first Party from any regulatory authority in the Territory or
from any other Third Party claiming that any Product promotional materials are
inconsistent with a Product’s labeling or are otherwise in violation of
applicable law or regulation. Each Party will provide the other Party and the
Future Partner, if any, with a copy of any documents or reports filed with or
received from any regulatory authority in the Territory with respect to a
Product. In addition, NPS shall require that the Future Partner, if any, provide
Nycomed with a copy of any documents or reports filed with or received from any
regulatory authority in the U.S. with respect to a Product.

5.4 Adverse Events Reporting. Nycomed will provide NPS and the Future Partner,
if any, with prompt written notice of any serious adverse drug event or reaction
reports received by Nycomed with respect to Products in the Territory, including
copies of any such written reports where available. NPS will provide Nycomed
with prompt written notice of any serious adverse drug event or reaction reports
received by NPS with respect to Products in any jurisdiction outside the
Territory where NPS is, at such time, developing or marketing Products,
including copies of any such written reports where available. NPS Shall require
that the Future Partner, if any, provide Nycomed with prompt written notice of
any serious adverse drug event

 

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or reaction reports received by the Future Partner with respect to Products in
any jurisdiction outside the Territory where the Future Partner is, at such
time, developing or marketing Products, including copies of any such written
reports where available. Nycomed will be responsible for complying with adverse
drug event reporting requirements in the Territory with respect to Products and
will copy NPS on all correspondence with regulatory authorities in the Territory
regarding the same. NPS will be responsible for complying with adverse drug
event reporting requirements in jurisdictions outside the Territory where NPS
is, at such time, developing or marketing Products and will copy Nycomed on all
correspondence between NPS and the regulatory authorities in such jurisdictions
regarding serious adverse drug events or reactions. NPS will have the right to
redact such correspondence to remove information proprietary to NPS as
applicable.

 

6. TRANSFER OF MANUFACTURE AND SUPPLY

6.1 License of Know-How. NPS and Nycomed agree to license the Know-How as set
out in this Section 6.1 on a non-exclusive basis (it being understood that this
Section 6.1 shall not limit any exclusive licenses granted pursuant to
Section 2). The common aim of this Section 6 shall be to enable Nycomed to take
over responsibilities relating to the manufacture of the Product, Drug Substance
and Device and to develop and improve the Product, Drug Substance and Device and
the manufacturing process. Both Parties undertake to use commercially reasonable
efforts to achieve that overall purpose when executing this Section 6.

6.2 Assumption of Manufacture. Subject to Section 6.8, Nycomed shall use
reasonable efforts to ensure supply of Products through itself or Third Parties,
including, without limitation, the negotiation of supply and manufacturing
obligations and amendment of Marketing Authorizations to permit such changed
supply chain.

6.3 Contributions of NPS. NPS shall make available to Nycomed all of the
Technical Information (including any manufacturing information) in its Control
in the form reasonably available to NPS according to the lists and timeplans set
out in Schedules 6.3(a) and 6.3(b). To the extent practicable, NPS shall
accommodate Nycomed on any reasonable request to convert such Technical
Information into another form that is required or requested by a Regulatory
Authority. NPS shall use reasonable efforts to perform and undertake the
activities listed in Schedules 6.3(a) and 6.3(b) of the Agreement. NPS hereby
expressly grants to Nycomed all rights to conclude the undertaking set out in
Section 6, including without limiting the entering into of agreements with Third
Party suppliers and approaching the authorities for amendment of Marketing
Authorizations and Approvals. Any Technical Information not contemplated by
Schedules 6.3(a) and 6.3(b) and that has not already been provided by NPS to
Nycomed shall be made available to Nycomed upon Nycomed’s reasonable request to
the extent reasonably available to NPS. NPS shall continue current efforts
through [*] to undertake the actions and to resolve current problems relating to
the supply chain of Products described in Schedules 6.3(a) and 6.3(b).

6.4 Subsequent Technical Information. Any Technical Information which comes
under the Control of NPS or its Affiliates after the transfer according to
Section 6.3 and during the Term shall be submitted to Nycomed as soon as
reasonably practicable after it becomes available to NPS. NPS shall use
reasonable efforts to not, and use reasonable efforts to cause its Affiliates to
not, enter into any agreement with any entity which prevents Technical

 

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Information obtained as a result of such agreement being made available to
Nycomed. Any Technical Information which comes under the Control of Nycomed or
its Affiliates after the transfer according to Section 6.3 and during the Term
shall be submitted to NPS as soon as reasonably practicable after it becomes
available to Nycomed. Nycomed shall use reasonable efforts to not, and use
reasonable efforts to cause its Affiliates to not, enter into any agreement with
any entity which prevents Technical Information obtained as a result of such
agreement being made available to NPS.

6.5 Nycomed Technical Information. Any Technical Information which is developed
or acquired by Nycomed or its Affiliates or its sublicensees during the term of
this Agreement shall be the property of Nycomed. Any Technical Information which
is developed or acquired by NPS or its Affiliates or its sublicensees during the
term of this Agreement shall be the property of NPS. To the extent that the
Technical Information is an Improvement Sections 2.7 and 3.1 shall apply.

6.6 Master Cell Bank and Working Cell Bank. NPS is currently a party to a
certain Laboratory Services and Confidentiality Agreement, dated as of [*], by
and between NPS and [*], under which [*] performs certain contract research
duties for NPS. As promptly as practicable after the Effective Date, NPS shall
transfer to [*] or ATCC Patent Depository, which is in the business of
maintaining legal compliant storage of materials for patent purposes (“ATCC”),
or another Third Party appointed by NPS and approved by Nycomed, such approval
not to be unreasonably withheld or delayed, the Master Cell Bank and Working
Cell Bank and the technology related thereto under a trust agreement allowing
royalty free access to Nycomed, NPS and the Future Partner in such a manner as
to prevent either party from depleting these materials such that harm is caused
to the other party. As part of such trust agreement, a mechanism for storage
fees, withdrawals and manufacture of additional Working Cell Banks will be
defined. Nycomed and NPS (or their respective assignee or sublicense) shall each
cover fifty percent (50%) of the total costs and expenses of the activities
required to maintain such trust. Until the trust agreement is in place, NPS
shall deliver to Nycomed Master Cell Banks or Working Cell Banks or Drug
Substance as needed by Nycomed for purposes of performing its obligations
hereunder.

6.7 Parent Strain [*]. As promptly as practicable after the Effective Date, NPS
shall transfer to [*] or ATCC or another a Third Party appointed by NPS and
approved by Nycomed, such approval not to be unreasonably withheld or delayed,
the parent strain [*] of the Master Cell Bank and the technology related thereto
under a trust agreement allowing royalty free access to both Nycomed and the
Future Partner in such a manner as to prevent either Party from depleting these
materials such that harm is caused to the other Party. As part of such trust
agreement, a mechanism for storage fees, withdrawals and manufacture of
additional Master Cell Banks will be defined. Nycomed shall cover its portion of
the activities required to maintain such trust.

6.8 Release from Manufacturing Obligations. Nycomed shall have the option, in
its sole discretion, to assume the supply obligations relating to the Products
as set forth in this Section 6.8. Nycomed shall so elect to release NPS from the
supply obligations relating to the Products by executing and delivering to NPS
the Release Certificate substantially in the form set out in Schedule 6.8 no
later than midnight on September 1, 2007. Upon delivery of the executed Release
Certificate by midnight on September 1, 2007, the grant of rights to the New
Territories shall become permanent. In the event Nycomed delivers the executed
Release Certificate as set forth above, the Distribution Agreement shall be
terminated in accordance with

 

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Section 2.11 and the Supply Agreement shall be terminated no later than [*] and
NPS shall be released of its supply obligations under the Distribution Agreement
and Supply Agreement following such termination of the Supply Agreement except
as specifically provided for in this Agreement. In that event, Nycomed shall
purchase the Products at a rate corresponding to [*]. To the extent that the
activities due to be performed by NPS on or before September 1, 2007 in Schedule
6.3(a) have not been fulfilled in all material respects by September 1, 2007,
Nycomed’s right and obligation to execute and deliver the Release Certificate
shall be postponed until such activities have been fulfilled in all material
respects and all references to September 1, 2007 in Section 2.11 shall be deemed
to refer to the date at which such postponement ends.

6.9 Information of Third Parties. Subject to Section 6.13, no later than seven
(7) days from Effective Date NPS shall inform relevant Third Parties (including
Vetter, Ypsomed and Boehringer Ingelheim) that Nycomed is intended to take over
manufacturing responsibilities in relation to the Product, Drug Substance and
Device for the Territory and shall permit each such relevant Third Party to have
direct contact with Nycomed and disclose confidential information to Nycomed.

6.10 Accessibility of Employees. NPS shall use commercially reasonable efforts
to ensure that the persons set out in Schedule 6.10 shall be at Nycomed’s
reasonable disposal in the period of time from Effective Date until [*] and that
the same persons shall at reasonable notice be at Nycomed’s reasonable disposal
from [*] until [*].

6.11 No Adverse Third Party Agreements. NPS shall ensure that no contractual
agreements entered into by or on behalf of NPS shall prevent Nycomed from
entering into agreements with Third Parties relating to the supply of Products,
Drug Substance or Devices. Nycomed shall ensure that no contractual agreements
entered into by or on behalf of Nycomed shall prevent NPS or the Future Partner
from entering into agreements with Third Parties relating to the supply of
Products, Drug Substance or Devices.

6.12 Stock. Nycomed shall be obligated to purchase the Drug Substance inventory
stock owned by NPS and set forth on Schedule 6.12. The prices for Drug Substance
shall be as set out in Schedule 6.12.

The supply terms of the Supply Agreement shall apply to such purchase of
inventory stock with the following modification:

Some batches are marked “In test” or “Passed, awaiting validation of test
methods” on Schedule 6.12. To decide whether the listed batches comply with the
product warranty, these batches are undergoing further analytical testing,
investigation and evaluation. The methods of testing and the results are
currently being discussed and evaluated by the Parties and the Third Party
supplier Vetter GmbH. Nycomed shall purchase only batches which are declared by
the quality assurance departments of each of Nycomed, NPS and Vetter GmbH to be
in compliance with the product warranty in Section 6 of the Supply Agreement
based on an evaluation made in good faith, and have a remaining shelf life of at
least 18 months. In connection with such evaluation, Nycomed shall provide to
Vetter GmbH any information in its Control which Vetter GmbH reasonably needs in
order to so evaluate.

6.13 Third Party Manufacturers. Nycomed shall not enter into any agreement with
any Third Party in exercise of the license granted to Nycomed pursuant to
Section 2.4 without prior notification to and consultation with NPS and without
providing NPS

 

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reasonable opportunity to be present and participate in any discussions or
negotiations with any such Third Party. Until September 1, 2007, any such
agreement with any Third Party that is then a supplier to NPS shall be
negotiated in coordination between Nycomed and NPS with a view toward achieving
contractual cost and other performance benefits for both Nycomed and NPS.
Nycomed shall use reasonable efforts to ensure that any such agreement with any
Third Party shall not adversely affect NPS during the term thereof or in the
event of termination of this Agreement in accordance with Section 2.11.
Notwithstanding the foregoing, Nycomed has no obligation to provide for the
supply of Products, Drug Substance or Devices to the U.S. in such negotiations
with Third Parties.

6.14 Third Party Credits. In the event that Nycomed enters into any contractual
relationship with a Third Party manufacturer and/or supplier with which NPS had
a pre-existing manufacturing relationship (including, but not limited to,
Vetter, Ypsomed and Boehringer Ingelheim), Nycomed shall reimburse NPS for any
credits which NPS had with respect to such Third Party manufacturer and/or
supplier to the extent that Nycomed uses or otherwise receives the benefit from
such credits. For purposes of clarity, the reimbursements and credits referenced
in this Section 6.14 shall not impact Net Sales under this Agreement.

 

7. COMPENSATION

7.1 Compensation Generally. As compensation for NPS’ obligations hereunder,
Nycomed agrees to pay NPS the remuneration set forth in this Section 7.

7.2 Fees. Nycomed agrees to pay to NPS the following fees (in addition to the
royalties payable under Section 7.5):

(a) € [*] upon receipt of approval for reimbursement in France;

(b) € [*] upon reaching cumulative Net Sales of € [*] of Product in the Original
Territory; and

(c) € [*] when the aggregated Net Sales of Product in the Original Territory for
a calendar year first reach € [*].

The above payments are due and payable no later than 30 days from the date of
the event triggering the payment of the applicable fee described above.

7.3 Net Sales. Net Sales shall only be counted from sales invoiced in the
Original Territory. Sales invoiced in the New Territory shall not be counted
when calculating the Net Sales. However, in the event that a Product or Device
that was sold in the New Territory was re-sold or imported for resale into a
country of the Original Territory, and Nycomed knew or had reason to know that
it would be re-sold in the Original Territory when selling that Product or
Device, then the revenue from such sale by Nycomed in the New Territory shall be
deemed to be Net Sales subject to the royalty provisions of this Agreement. In
addition, with respect to sales invoiced outside the Territory but then sold
back into the Original Territory, see Section 4.6.

7.4 Payments for Sale of Product Outside the Territory. In the event that
Product sold by a Party is discovered in the territory of the other Party then
the non-selling Party shall be entitled to recover from the exporting Party the
gross profits earned by the exporting Party on the sale of such Product.

 

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7.5 Royalty. Nycomed shall make the following payments to NPS based on Net Sales
of Products in the Original Territory (calculated as described in Section 7.3
above):

(a) [*] of Net Sales for that portion of Net Sales of Product in such calendar
year that is less than € [*];

(b) [*] of Net Sales for that portion of Net Sales of Product in such calendar
year that equals or exceeds € [*] but is less than or equals € [*]; and

(c) [*] of Net Sales for that portion of Net Sales of Product in such calendar
year that exceeds € [*].

7.6 Royalty Payments. Nycomed will provide NPS within twenty (20) business days
after the end of each calendar quarter, with a report stating the volume of
Product sold in each country of the Original Territory, invoiced sales and Net
Sales and the amount of royalties due on such Net Sales. Within forty-five
(45) days after the end of each calendar quarter, Nycomed will transfer, by
wire, the amount of royalties due to NPS to such bank account as NPS may
indicate from time to time or as NPS may otherwise direct in writing. Payment of
all royalties hereunder will be made in USD.

7.7 Withholding Taxes. Nycomed and NPS have determined that Nycomed does not
have an obligation to withhold taxes on payments from Nycomed to NPS hereunder.
Nevertheless, in the event a tax authority in the Territory concludes that
Nycomed is, by law or income tax treaty, required to withhold such taxes, and
after Nycomed has exhausted all remedies reasonably available to avoid such
withholding obligation, then Nycomed may withhold such taxes and pay over such
withheld amounts to the applicable tax authority. Nycomed shall furnish NPS with
proof of such payments. Any such tax required to be paid or withheld shall be an
expense borne by NPS. Nycomed shall promptly provide NPS with a certificate or
other documentary evidence to enable NPS to support a claim for a refund or
foreign tax credit with respect to any such tax so withheld or deducted by
Nycomed. At NPS’ request, Nycomed shall reasonably cooperate to support any
claim by NPS for such a refund or credit.

7.8 Audit Rights; Adjustments.

7.8.1 Nycomed will permit an independent certified public accountant designated
by NPS or a Third Party recipient of royalties under this Agreement and
reasonably acceptable to Nycomed (the “Auditor”), to have access to Nycomed’s
records and books during regular business hours for the sole purpose of
determining the accuracy of the amounts reported and actually paid or otherwise
payable to NPS under the terms of this Agreement (the “Audit”). Any Audit will
cover a period not to exceed three (3) years immediately preceding such audit.
NPS will bear all costs and expenses in connection with the Audit; provided,
however, that if any Audit reveals an understatement of Net Sales greater than
five percent (5%) of the stated amount, then Nycomed will bear all costs and
expenses in connection with such Audit. Any Audit will be performed, upon at
least thirty (30) calendar days’ prior written notice, during regular business
hours, and not more than once in each calendar year during the term of this
Agreement and during any calendar year in the three (3) year period following
expiration or termination of this Agreement.

 

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7.8.2 The Auditor will execute a written confidentiality agreement with Nycomed
and will disclose to NPS only the amount and accuracy of payments reported and
actually paid or otherwise payable under this Agreement. The Auditor will send a
copy of the report to Nycomed at the same time it is sent to NPS. The report
sent to Nycomed will also include the methodology and calculations used to
determine the results.

7.8.3 If the Audit results in a determination that Net Sales have been
overstated, then NPS will repay the amount of any resulting overpayment to
Nycomed within thirty (30) days after receipt of the Auditor’s report.

7.8.4 If the Audit results in a determination that Net Sales have been
understated, then any resulting underpayment will be paid to NPS within thirty
(30) days after receipt of the Auditor’s report.

7.9 Interest on Late Payments. Any payment not received within the period set
forth in Sections 7.2, 7.5, 7.8.3 and 7.8.4 above, shall accrue interest at the
rate of 18% per annum until paid in full.

7.10 No Right to Set-off. Neither Party shall have any right to set-off, deduct,
counterclaim or offset against amounts owed by it to the other Party.

 

8. INTERIM TERRITORY

8.1 Canada and Mexico. After Marketing Authorization for the Product in the U.S.
has been granted, Nycomed shall upon NPS’ request assign any Marketing
Authorization and Approvals, if any, for the Product in Canada and Mexico to NPS
or the Future Partner.

8.2 Amendment of Territory. Following such assignment, this Agreement shall
automatically be amended so that “Territory” shall no longer include Canada and
Mexico.

8.3 Supply. After assigning Marketing Authorizations and Approvals, Nycomed will
upon request from NPS or the Future Partner supply NPS or the Future Partner
with the Product and Device for use in Mexico and/or Canada for a period not
exceeding [*] from the grant of the Marketing Authorization in the US.

8.4 Supply Terms. The terms for supply of Products and Devices to NPS or the
Future Partner shall be negotiated in good faith with NPS or the Future Partner,
as applicable, and be on terms customary to the industry. Nycomed will supply
Product and Device to NPS or the Future Partner corresponding to the
specifications for the Product in the Territory. Nycomed explicitly undertakes
that it will not provide Product corresponding to requirements of the US or
Japan market. Nycomed shall not give warranties relating to intellectual
property rights. The supply price shall be negotiated in good faith and at least
correspond to [*].

8.5 Nycomed Acting as Sales Force for Future Partner. In the event that there is
a Future Partner, NPS shall ensure that the Future Partner contractually accepts
the obligation to use Nycomed’s sales organization(s) in Canada and Mexico for a
period of not less than [*] from grant of the Marketing Authorization in the US
on terms to be negotiated in good faith and at contract sales organization rates
customary to the industry.

 

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8.6 Cooperation. Nycomed undertakes to discuss in good faith development and
marketing strategy with NPS or a Future Partner in order to optimize the global
value of the Product. This includes good faith discussion of granting mutual
license rights to any Improvements of the Product. Nycomed undertakes to
co-ordinate any actions relating to regulatory or intellectual property rights
in a way that will not materially impair the rights of NPS or the Future Partner
and will optimize Net Sales in the Original Territory. NPS undertakes to
contractually impose equivalent undertakings towards Nycomed on NPS or a Future
Partner.

 

9. INTELLECTUAL PROPERTY

9.1 Ownership of Intellectual Property. NPS shall retain all of its rights,
title and interest in and to Licensed Technology, subject to the licenses
granted in this Agreement. Other than as provided above, Nycomed has no right,
title or interest in any Licensed Technology relating to the Product and Devices
and shall not sell, distribute, market, use, import or export the Product and
Devices otherwise than in accordance with the terms of this Agreement.

9.2 Patent and Trademark Registration. Nycomed shall have the right to be
registered with all applicable patent or trademark departments of the Territory
in relation to the NPS Patents and Product Trademarks as the exclusive licensee
empowered to act in relation hereto as common representative for both Parties.
NPS shall execute and deliver all documents reasonably requested by Nycomed in
completion of the above mentioned registration process and enabling Nycomed to
undertake the acts set out in subsection 9.3.

9.3 Prosecution and Maintenance of NPS Patents. Nycomed shall at its own costs
be responsible for patent prosecution, filing and maintenance of NPS Patents in
the Original Territory, including, without limitation, prosecution, renewal, the
filing of supplementary protection certificates and other fees necessary to
maintain the NPS Patents in full force and effect until the earlier of their
expiration or the termination or expiration of this Agreement. Nycomed’s efforts
under this Section 9 shall be subject to Nycomed’s decision to launch in the
applicable country as set out in Section 4.1.

To enable Nycomed to prosecute, file, maintain and defend the NPS Patents in the
Territory, on the request of Nycomed, NPS shall grant to Nycomed all necessary
rights, in Nycomed’s sole discretion (provided such rights do not include any
ownership interest in the NPS Patents), to enable Nycomed to direct any outside
patent or legal counsel (in the following “Nycomed IP law firms”). Nycomed shall
have the sole and exclusive right to handle all matters related to patent
prosecution, filing, maintenance and defense of NPS Patents in the Territory
with the Nycomed IP law firms. Nycomed or the Nycomed IP law firms will inform
NPS on a regular basis as outlined in Section 9.4. below.

In relation to the Original Territory, NPS shall provide reasonable technical
support for Nycomed’s activities, including but not limited to providing access
to NPS inventors, key experts and consultants, establishing and providing
declarations of the NPS inventors, key experts and consultants and to providing
experimental data available at NPS to support the patent prosecution, filing,
maintenance and defense of NPS Patents in the Territory. Nycomed’s
responsibilities shall include, in Nycomed’s sole discretion, oppositions and
appeals against third party IP rights with the applicable patent authorities.

 

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In the event Nycomed intends to allow any NPS Patent in the Territory to lapse
or become abandoned, as soon as reasonably practical after Nycomed’s decision to
allow such NPS Patent to lapse or become abandoned, then NPS may, but shall not
be required to, assume further responsibility for the prosecution, maintenance,
and defense of such Nycomed Patents. In such event, NPS or its designee shall
act in NPS’ name and at NPS’ or its designee’s expense. Nycomed shall cooperate
with NPS or its designee as reasonably requested at NPS’ or its designee’s
expense. Notwithstanding the foregoing, it is expressly understood and agreed
that Nycomed may not allow any NPS Patent to lapse or become abandoned that
would be necessary and/or advantageous for NPS to fulfill its obligations under
the Agreement with regard to the Original Territory.

9.4 Periodic Information. The Parties shall on a regular basis or upon
reasonable request and in no event less than on a quarterly basis inform each
other of any changes or updates relating to the Licensed Technology.

9.5 Use, Prosecution and Maintenance of Product Trademarks.

9.5.1 Use of Product Trademarks. Nycomed shall use the Product trademark
PREOTACT® where possible. To the extent that PREOTACT® can not be used for
commercial, regulatory or other reasons, Nycomed shall have the right to use
Product Trademarks other than PREOTACT® including PREOS® for use on or in
connection with the Product and Device, subject to NPS’ prior approval not to be
unreasonably withheld. In the event Nycomed uses the PREOS® trademark for use on
or in connection with the Product and Device, all goods sold by Nycomed under
the PREOS® trademark and all related advertising, promotional and other related
uses of the PREOS® trademark by Nycomed shall conform to all standards that may
be set from time to time by NPS and shall otherwise be of a high standard in the
respective trade and of such style, appearance and quality as to be adequate and
suited to their exploitation to the best advantage and to the protection and
enhancement of the PREOS® trademarks and the good will pertaining thereto.
Nycomed agrees to cooperate with NPS in facilitating NPS’ control of such nature
and quality, to permit reasonable inspection of Nycomed’s operation, and to
supply NPS with specimens of all uses of the PREOS® trademark upon request.

9.5.2 Prosecution, Maintenance and Ownership of Product Trademarks. Nycomed
shall be responsible for filing, prosecution, maintenance and defense of all
registrations of the Product Trademarks and will be responsible for the payment
of any costs relating to filing, prosecution, maintenance and defense of the
Product Trademarks in the Territory. Except as provided in Section 2.2, NPS will
be the sole owner of the Product Trademarks.

9.6 Third Party Patent Infringement.

9.6.1 Potential Infringement. In the event either Nycomed or NPS learns of any
Third Party Patents which may cover the distribution, marketing or sale of
Product or Device in the Territory, as carried out by NPS in accordance with its
rights under this Agreement, such Party will notify the other. The Parties agree
to confer in good faith regarding such potential infringement risk and to
explore reasonable alternatives for avoiding such risk.

9.6.2 Defense by Nycomed. If a Third Party files a claim, suit or action against
Nycomed claiming that a Patent or other intellectual property right owned by
such Third Party is infringed or misappropriated by the distribution, marketing
or sale or even manufacture,

 

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as the case may be, of Product or Device in the Territory, and such claim, suit
or action arises out of Nycomed’s permissible exercise of its rights under this
Agreement, the Parties shall confer in good faith regarding such alleged
infringement or misappropriation. Nycomed shall at its discretion, and at its
own costs defend any such claims, suits or actions. NPS will assist in the
defense of any such claim, suit or action as reasonably requested by Nycomed.
Nycomed shall not settle any such claim, suit or action if such settlement would
impose on NPS the obligation to pay any damages (including royalties under a
license) without the prior express written consent of NPS, which shall not be
unreasonably withheld or delayed. If Nycomed chooses not to defend any such
claim, suit or action, it shall promptly notify NPS of such decision and NPS
may, but shall not be required to, assume such defense in it its own name at its
own cost and expense. In such an event, Nycomed shall cooperate with NPS as
reasonably requested at NPS’ request.

9.7 Infringement of Licensed Technology.

9.7.1 Notice of Infringement. In the event Nycomed or NPS becomes aware of any
actual or threatened infringement or misappropriation of any Licensed
Technology, the Party first having knowledge of such infringement shall promptly
notify the other, and the Parties shall thereupon consult together as to the
action to be taken.

9.7.2 Prosecution by Nycomed. Nycomed may, but shall not be obligated to
commence an infringement action against any person or entity infringing,
including infringement or misappropriating the Licensed Technology directly or
contributorily. NPS shall cooperate with Nycomed as reasonably requested. The
costs of such enforcement shall be shared equally on a country-by-country basis.
Any and all amounts recovered with respect to such an action shall be applied
first to reimburse the Parties for their out-of-pocket expenses (including
reasonable attorneys’ fees) in prosecuting such infringement or
misappropriation. The remainder shall be deemed Net Sales under this Agreement
and be treated accordingly.

9.7.3 Prosecution by NPS. In the event Nycomed is unable to or elects not to
commence action against the person or entity responsible for the alleged
infringement or misappropriation within ninety (90) days of the date of
Nycomed’s becoming aware of such infringement, then NPS may, but shall not be
required to, prosecute the alleged infringement or threatened infringement. In
such event, NPS shall act in its own name and at its own expense. Nycomed shall
cooperate with NPS as reasonably requested including being named as a Party if
necessary, at NPS’ expense. If Nycomed so desires, it may actively participate
in such action at a later date, at its own expense. Any amounts recovered with
respect to such an action shall be applied first to reimburse the Parties for
their out-of-pocket expenses (including reasonable attorneys’ fees in the
prosecution of such infringement). The remainder shall be deemed Net Sales under
this Agreement and be treated accordingly.

9.7.4 Enforcing Party. If a Party elects not to bear an equal share of the costs
of such an action, such party may opt out of such costs by providing the other
Party with adequate notice, which shall be given before initiation of the trial,
of its intention not to participate in the costs of the enforcement action. In
such event, the Party opting out of the enforcement costs will continue to
cooperate with the enforcing Party at the enforcing Party’s expense, and the
enforcing Party will retain the full amount of any damage awards resulting from
such enforcement action.

9.7.5 Current Opposition Claim. NPS currently is a party to an opposition appeal
no. [*] concerning the patent [*] before the Board of Appeal of the European
Patent

 

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Office. NPS shall provide Nycomed with a copy of all correspondence with the
Board of Appeal of the European Patent Office and with the counterparty in
relation to the appeal and shall consult with Nycomed and duly consider any
feedback in relation to all activities concerning the proceedings. NPS hereby
authorizes Nycomed to approach the counterparty directly in order to settle the
appeal case. NPS shall consent to the settlement and if so requested by Nycomed
withdraw the claim, provided, however, that NPS shall not be required to give
such consent and withdraw the claim to the extent it would be detrimental to
NPS’ rights.

9.8 Third Party Trademark Infringement.

9.8.1 Prosecution by Nycomed. Nycomed shall be primarily responsible for any
legal proceedings against any infringement of Product Trademarks. NPS shall
cooperate with Nycomed as reasonably requested. The costs of such proceedings
shall be borne by Nycomed. Any and all amounts recovered with respect to such
action shall be applied first to reimburse Nycomed for such costs of such
proceedings (including reasonable attorneys’ fees). The remainder shall be
deemed Net Sales under this Agreement and be treated accordingly. In the event
Nycomed shall not be willing to take legal proceedings against any infringer,
NPS may take such proceedings at its own cost, and in such case any damages
recovered shall belong solely to NPS.

9.8.2 Infringement by Nycomed. Nycomed shall indemnify and hold NPS harmless
from any claims and liability from a Third Party arising out of Nycomed’s
infringement of a Third Party’s trademark rights in the Territory by exercising
its rights to the Product Trademarks under this Agreement.

9.8.3 Withdrawal Due to Alleged Infringement. In the event Nycomed receives
notice from a Third Party alleging that the manufacture, use or sale of the
Product in the Territory infringes such Third Party’s intellectual property
rights in the New Territory, Nycomed shall provide NPS with written notice
thereof and the Parties shall consult with each other in good faith regarding
such allegation. Nycomed shall consider NPS’ suggestions and comments regarding
such alleged infringement; provided, however, that Nycomed shall have the right
after such consultation with NPS, at its own discretion, to withdraw the Product
from the market of such country in the New Territory and keep it off the market
in such country in the New Territory until the issue is resolved through
acknowledgment of non-infringement by the Third Party or through court ruling in
the relevant territory. Such withdrawal shall not constitute a breach of any of
Nycomed’s obligations set out in this Agreement.

 

10. REPRESENTATIONS AND WARRANTIES

10.1 Mutual Representations and Warranties. Each of the Parties hereby
represents and warrants to the other Party as of the date hereof that:

10.1.1 such Party is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it is incorporated;

10.1.2 this Agreement is a legal and valid obligation binding upon such Party
and enforceable against such Party in accordance with its terms;

 

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10.1.3 the execution, delivery and performance of this Agreement by such Party
does not conflict with any agreement, instrument or understanding, oral or
written, to which it is a Party or by which it is bound;

10.1.4 the execution, delivery and performance of this Agreement by such Party
does not violate any law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over such Party;

10.1.5 it has the full power and authority to enter into this Agreement and to
carry out the obligations contemplated hereby;

10.1.6 such Party has not, and during the Term will not, grant any right to any
Third Party relating to its respective Patents and Know-How which would conflict
with the rights granted or obligated to be granted;

10.1.7 to the best of such Party’s knowledge, it has not engaged, nor will it
engage, services of employees, officers, subcontractors or consultants to
perform development on the Product or the Device, that i) have been debarred or
convicted of a crime for which an entity or person could be debarred under 21
U.S.C. Section 335a, or ii) is under indictment for a crime for which an entity
or person could be debarred under 21 U.S.C. Section 335a; and

10.1.8 such Party has taken all necessary corporate action on its part to
authorize the execution and delivery of this Agreement.

10.2 Distribution Agreement Representations and Warranties. NPS hereby
represents and warrants to Nycomed as of the date hereof that each of the
representations and warranties that NPS made in Section 9.2 of the Distribution
Agreement were true and accurate as of the date such representations and
warranties were made thereunder.

10.3 Territory. Except as previously disclosed to Nycomed, NPS is not aware of
any facts that would cause the sale or manufacture of the Product (in its
current form as of the Effective Date) in the Territory to infringe any Patents
of any Third Party, it being understood that NPS has not made any independent
investigation with respect thereto.

 

11. LIMITATION OF WARRANTY

EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT NEITHER PARTY MAKES ANY WARRANTY OR
REPRESENTATION, AND EACH PARTY EXPRESSLY DISCLAIMS TO THE FULLEST EXTENT
PERMITTED BY APPLICABLE LAW, ALL IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED
TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

12. INDEMNIFICATION

12.1 Indemnification by Nycomed. Nycomed shall indemnify, defend and hold
harmless NPS and its directors, officers, employees, agents and Affiliates from
and against

 

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any liabilities, damages, fees, costs or expenses, including reasonable
attorneys’ fees (collectively, “Losses”), which arise out of, relate to or
result from the breach by Nycomed of any of its representations, warranties or
obligations contained within this Agreement. Notwithstanding the foregoing,
Nycomed shall not indemnify NPS for any Losses to the extent that Nycomed is
entitled to seek indemnification from NPS for such Losses under Section 12.2 of
this Agreement.

12.2 Indemnification by NPS. NPS shall indemnify, defend and hold harmless
Nycomed and its directors, officers, employees, agents, Affiliates and
sublicensees from and against any Losses which arise out of, relate to or result
from: (a) the breach by NPS of any of its representations, warranties or
obligations contained within this Agreement; or (b) any claim, lawsuit or other
action by a Third Party arising from or relating to the Product or any use
thereof, including but not limited to any claim or obligation, whether pursuant
to a settlement or not, to pay royalties, which term shall be broadly defined to
include any payments made in connection with any license required during the
Term of this Agreement from a Third Party, to a Third Party in order for Nycomed
to enjoy the rights and fulfill its obligations under this Agreement in the
Original Territory. Notwithstanding the foregoing, NPS will not indemnify
Nycomed for: (i) in relation to product liability claims, for claims caused
through the Product or Device not corresponding to its specifications to the
extent such Product or Device was supplied to Nycomed from a third party
supplier acting under a supply agreement with Nycomed; or (ii) any Losses to the
extent that NPS is entitled to seek indemnification from Nycomed for such Losses
under Section 12.1 of this Agreement.

12.3 Indemnification Procedures. Sections 12.4, 12.5 and 12.6 shall not apply to
disputes concerning a potential Patent infringement, which shall exclusively be
governed by Sections 9.3, 9.6 and 9.7. A Party that intends to claim
indemnification under Section 12.1 or 12.2 of this Agreement (the “Indemnitee”)
will promptly notify the other Party (the “Indemnitor”) in writing of any claim,
lawsuit or other action in respect of which the Indemnitee or any of its
directors, officers, employees, and/or Affiliates intend to claim such
indemnification within a reasonable period of time after the assertion of such
claim; provided, however, that the failure to provide written notice of such
claim within a reasonable period of time will not relieve the Indemnitor of any
of its obligations hereunder, except to the extent that the Indemnitor is
prejudiced by such failure to provide prompt notice. The Indemnitor will have
the right to assume the complete control of the defense, compromise or
settlement of any such claim with the prior written consent of such Indemnitee,
such consent not to be unreasonably withheld; provided, however, that Indemnitee
will have the right to withhold such consent in its sole discretion if such
defense, compromise or settlement includes any admission of wrongdoing on the
part of Indemnitee, or limits the scope of any claims in or enforceability of
any Patents owned by or licensed to the Indemnitee. The Indemnitor may at its
own expense, employ legal counsel to defend the claim at issue. At any time
after Indemnitor has assumed defense of a claim, the Indemnitor may exercise, on
behalf of the Indemnitee, any rights which may mitigate the extent or amount of
such claim; provided, however, the Indemnitee:

12.3.1 may, in its sole discretion and at its own expense, employ legal counsel
to represent it (in addition to the legal counsel employed by the Indemnitor) in
any such matter, and in such event legal counsel selected by the Indemnitee will
be required to confer and cooperate with such counsel of the Indemnitor in such
defense, compromise or settlement for the purpose of informing and sharing
information with the Indemnitor;

 

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12.3.2 will, at its own expense, make available to Indemnitor those employees,
officers and directors of Indemnitee whose assistance, testimony or presence is
necessary, useful or appropriate, to assist the Indemnitor in evaluating and in
defending any such claim; provided, however, that any such access will be
conducted in such a manner as not to interfere unreasonably with the operations
of the businesses of Indemnitee; and

12.3.3 will otherwise fully cooperate with the Indemnitor and its legal counsel
in the investigation and defense of such claim. The rights and remedies provided
pursuant to this Section 12 are the sole and exclusive remedies of the Parties
hereto with respect to Losses.

EXCEPT FOR THE OBLIGATIONS TO INDEMNIFY DESCRIBED IN SECTION 12 ABOVE, NEITHER
PARTY WILL BE LIABLE TO THE OTHER PARTY FOR INCIDENTAL, SPECIAL, CONSEQUENTIAL
OR PUNITIVE DAMAGES, INCLUDING, BUT NOT LIMITED TO, ANY CLAIM FOR DAMAGES BASED
UPON LOST PROFITS,

 

13. CONFIDENTIALITY

13.1 Confidential Information. Any information or materials communicated by one
Party to the other Party pursuant to this Agreement or the Distribution
Agreement or the Confidential Disclosure Agreement between the Parties dated
February 11, 2004 will be deemed “Confidential Information” of the disclosing
Party if marked “confidential” or with a similar legend, or if disclosed orally
or visually, if identified as being confidential at the time of such oral or
visual disclosure or which information or materials would, due to the nature
thereof or the circumstances surrounding disclosure, appear to a reasonable
person to be confidential or proprietary. Notwithstanding the preceding
sentence, “Confidential Information” will not be deemed to include information
that the receiving Party can demonstrate, by competent written proof:

(a) at the time of disclosure is published or is publicly known or otherwise in
the public domain, other than through any breach by the receiving Party;

(b) was already known to the receiving Party, other than under an obligation of
confidentiality or non-use, prior to the time of disclosure;

(c) is disclosed to the receiving Party in good faith, without an obligation of
confidentiality, by a Third Party, whom the receiving Party has no reason to
believe is under any obligation of confidence with respect to such information;
or

(d) is independently developed by the receiving Party without use of or
reference to the disclosing Party’s Confidential Information.

13.2 Treatment of Confidential Information. The Parties agree that during the
term of this Agreement and for seven (7) years after its expiration or
termination for any reason whatsoever, a Party receiving Confidential
Information of the other Party will: (a) treat any such Confidential Information
disclosed to it by the other Party as strictly confidential; (b) except as
necessary in the performance of this Agreement, not disclose such Confidential

 

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Information to Third Parties without the prior written consent of the other
Party, other than to its Affiliates, sublicensees, collaborators or any
consultants, provided that such disclosure be subject to confidentiality
obligations comparable to those contained in this Agreement; (c) not use such
Confidential Information for purposes other than those authorized expressly
herein; and (d) use reasonable efforts to prevent inadvertent disclosure of such
Confidential Information.

13.3 Access. Access to Confidential Information will be limited to those
employees or consultants of the Party receiving such information or of such
Party’s Affiliates who reasonably require such information in order to carry out
activities authorized pursuant to this Agreement. Such employees or consultants
will be advised of the confidential nature of the Confidential Information and
the related confidentiality undertaking.

13.4 Permitted Disclosures. Notwithstanding any other provision in this
Agreement, a receiving Party may disclose Confidential Information of the
disclosing Party to the extent such disclosure is required by law or court
order, provided that the receiving Party gives the disclosing Party prompt
written notice of the requirement to disclose and reasonably cooperates with the
disclosing Party to seek a protective order or other restrictions on the
disclosure of such Confidential Information of the disclosing Party. Any such
required disclosure will be limited only to that Confidential Information that
is required to be disclosed and such disclosed Confidential Information will
remain Confidential Information hereunder despite the required disclosure.
Notwithstanding any other provision in this Agreement, either Party may disclose
this Agreement (and prior to signing the draft versions hereof) and any and all
Schedules and other Attachments hereto and financial calculations to be derived
from this Agreement to existing or potential investors or potential buyers of
the Parties hereto whom are subject to Confidentiality Agreements with terms
similar to those contained herein.

13.5 Return of Confidential Information. Upon termination (and not expiration)
of this Agreement, each Party hereto and its Affiliates will return all
Confidential Information of the other Party in its possession to the other
Party; provided, however, that each Party may retain:

(a) a single archival copy of the Confidential Information of the other Party
solely for the purpose of determining the extent of disclosure of Confidential
Information hereunder and assuring compliance with the surviving provisions of
this Agreement;

(b) any portion of the Confidential Information of the other Party which is
contained in laboratory notebooks; and

(c) any portion of the Confidential Information of the other Party that a Party
is required by mandatory applicable law to retain.

13.6 Confidentiality of the Agreement Terms. Neither Party will disclose the
terms of this Agreement to any Third Party without the prior written consent of
the other Party; provided, however, that either Party may disclose the terms of
this Agreement to actual or prospective investors and corporate partners
(including sublicensees), to a Party’s accountants, attorneys and other
professional advisors, and as required by applicable laws and regulations of the
U.S. Securities and Exchange Commission and any stock exchange on which a
Party’s stock or other instruments are or may be traded.

 

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14. ASSIGNMENT

14.1 Affiliates. The Parties recognize that each Party may perform some or all
of its obligations under this Agreement through Affiliates, provided, however,
that each Party will remain responsible for the performance by its Affiliates
and will cause its Affiliates to comply with the provisions of this Agreement in
connection with such performance and any act or omission committed by an
Affiliate shall be deemed to have been conducted by the Party itself. Each Party
hereby expressly waives any requirement that the other Party exhaust any right,
power or remedy, or proceeds against an Affiliate, for any obligation or
performance hereunder prior to proceeding directly against such Party.

14.2 Assignment. Neither Party will assign its rights or obligations under this
Agreement to any Third Party without the prior written consent of the other
Party; except that either Party may assign such rights and obligations to an
Affiliate of the respective Party or to the surviving entity pursuant to a
merger, acquisition or consolidation, or to a Third Party acquiring all or
substantially all assets of a Party. All permitted assignments by either Party
of any of its rights under this Agreement will be subject to all of the terms
and conditions of this Agreement. All successors, permitted assignees of either
Party will be subject to, and will be bound by, all the terms and conditions of
this Agreement. Any purported assignment not permitted under the terms of this
Agreement will be null, void, and of no effect.

14.3 Consent. Notwithstanding the foregoing, the Parties acknowledge that they
entered into that certain Consent to Assignment, dated as of June 8, 2007 (the
“Assignment Consent”), whereby Nycomed agreed that NPS may assign to one or more
Third Parties its rights and obligations to receive royalties under Section 15.2
of the Distribution Agreement on Net Sales made on or after April 1, 2007, as
well as all related rights incident thereto, including certain enumerated other
sections of the Distribution Agreement. Furthermore, the Parties acknowledge
that this License Agreement is replacing the Distribution Agreement and
therefore, such consent to assignment shall apply to the assignment of such
corresponding rights in this Agreement, and such Parties agree that such
corresponding sections in this Agreement shall include Sections 7.4, 7.5, 7.6,
7.8, 7.9, 9.4, 9.6.1, 9.6.2, 9.7.1, 9.7.2, 9.7.3, 9.8.1 and 9.8.3; provided,
however, that in the event that this Agreement is terminated pursuant to
Section 2.11, the Assignment Consent shall revert back to its original form as
of June 8, 2007 and shall reference the sections of the Distribution Agreement
as in effect at that time. Nycomed hereby consents to NPS’ granting a security
interest in all or any of the Licensed Technology and in this Agreement to any
Third Party, subject to the licenses granted under this Agreement.

 

15. JOINT PUBLICITY

15.1 Public Disclosures. If either Party wishes to make significant public
disclosure exclusive of correspondence and written communication in the ordinary
course of business, concerning this Agreement or the relationship established
hereunder and such disclosure mentions the other Party by name or description,
such other Party shall be provided in advance with a copy of the disclosure and
shall have five (5) business days within which to approve or disapprove of such
use of its name or description (including the mentioning of the name of the
Product and/or reference to a description of the terms of this Agreement or to
any of the exhibits to this Agreement that are incorporated by reference
hereto). Neither party shall unreasonably withhold such approval. Failure to
respond within said time shall be deemed to

 

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constitute an approval. Absent approval, no public disclosure shall use the name
of or otherwise describe such Party except to the extent as may be required by
law in the reasonable judgment of the respective Party’s counsel, or to the
extent that the description of the other Party is limited to public information
about the availability of the Product.

15.2 Scientific Publications. At least thirty (30) days prior to submission of
any material related to the research or development activities hereunder for
publication or presentation to Third Parties, the submitting Party shall provide
to the other Party a draft of such material for its review and comment. The
receiving Party shall provide any comments to the submitting Party within
fifteen (15) days of receipt of such materials. No publication or presentation
with respect to the research or development activities hereunder shall be made
unless and until the other Party’s comments on the proposed publication or
presentation have been addressed and changes have been agreed upon and any
information determined by the other Party to be its Confidential Information has
been removed. If requested in writing by the other Party, the submitting Party
shall withhold material from submission for publication or presentation for the
time reasonably required for the filing and until expiry of the priority year
relating a patent application or the taking of such measures to establish and
preserve proprietary rights in the information in the material being submitted
for publication or presentation.

 

16. TERM, TERMINATION AND CONCEQUENCES OF TERMINATION

16.1 Term of the Agreement. This Agreement shall commence on the Effective Date
and, unless terminated earlier pursuant to this Section 16, remain in force on a
country by country basis for the longer of fifteen (15) years from the first
commercial sale of the Product in the respective country and the expiration date
in such country of the last to expire of any issued NPS Patent. The Agreement on
a country basis shall cease upon such expiry date(s) (the “Term”).

16.2 Termination for Commercial Reasons. In the event that Licensee can
demonstrate that Licensee, as a result of circumstances in one or more markets
in the Original Territory, including competition, is not making a reasonable
profit and that Licensee, in its reasonable opinion, has no prospects of making
a reasonable profit during the remainder of the Term, the Parties shall meet and
renegotiate the key commercial terms of this Agreement. Should the Parties not
be able to reach agreement on such new terms within six (6) weeks, the matter
shall be referred to the Chief Executive Officers of the Parties. Should the
Chief Executive Officers not be able to reach agreement within two (2) weeks,
Licensee shall be entitled to terminate the Agreement giving NPS six (6) months
written notice

16.3 Termination for Material Breach. In the event of a material breach of this
Agreement by either Party, which is not cured within sixty (60) days following
receipt of written notice of such breach from the non-breaching Party, the
non-breaching Party will have the right to terminate this Agreement by written
notification to the other Party, effective immediately upon receipt.

16.4 Termination for Bankruptcy. Either Party may immediately terminate this
Agreement upon the occurrence of either of the following: (a) the entry of a
decree or order for relief by a court having jurisdiction over the other Party
in an involuntary case under any applicable national, federal, provincial or
state insolvency or other similar law, and the

 

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continuance of any such decree or order unstayed and in effect for a period of
sixty (60) consecutive days; or (b) the filing by the other Party of a petition
for relief under any applicable national, federal, or state insolvency or other
similar law. All rights and licenses granted under or pursuant to this
Agreement, including amendments hereto, by each Party to the other Party are,
for all purposes of II U.S.c. Section 365(n), licenses of rights to intellectual
property as defined in Title II.

16.5 General. No termination of this Agreement will relieve any Party hereto
from any liability which, at the time of such termination, has already accrued
to the other Party or which is attributable to a period prior to such
termination, nor preclude either Party from pursuing any rights and remedies it
may have under this Agreement or at law or in equity which have accrued or are
based upon any event occurring prior to such termination.

16.6 Effects of Termination for Commercial Reasons. In the event of termination
by Nycomed of the entire Agreement under Section 16.2, Nycomed shall forthwith
as at the effective date of termination:

(a) deliver to NPS the dossier, all product data and any other documents,
materials, data or information within its possession or control containing or
evidencing any Licensed Technology of NPS and all Confidential Information of
NPS;

(b) cease all exploitation and marketing of Product and Device provided always
that Nycomed shall be entitled to continue to sell Product and Device for a
period of six calendar months thereafter in order to fulfill existing orders
only (subject always to the payment terms under this Agreement) and provided
that Nycomed shall not sell such stock in a manner detrimental to the market for
Product in the Territory;

(c) give or procure for NPS access to all data filed in connection with the
Marketing Authorizations for the Product in the Territory;

(d) allow NPS to cross-reference any MA relating to the Product with each
relevant Regulatory Authority, for the purpose of transferring the MAs for the
Product in the Territory to NPS or as it may nominate at NPS’ cost;

(e) subject to Nycomed’s right to sell its stock of Product pursuant to
Section 16.6.2, transfer the adverse event data base for the Product relating to
the Territory to NPS;

(f) Nycomed acknowledges that in the event of such termination it shall not be
entitled to any reimbursement or repayment of any sums paid to NPS under the
terms of this Agreement prior to the effective date of termination; and

(g) Sell, assign and transfer to NPS the entire right, title and interest in and
to the PREOTACT trademarks in the Territory and related items that were
transferred by NPS to Nycomed pursuant to Section 2.2.

16.7 Licenses Upon Expiration. Upon expiration of this Agreement pursuant to
Section 16.1 of this Agreement with respect to a country in the Territory,
Nycomed will have a non-exclusive, fully paid, perpetual, royalty-free right and
license under the Licensed Technology to develop, have developed, make, have
made, use, offer to sell, sell, and import Product and Device in the Territory.

 

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16.8 Survival. In the event of expiration or termination of this Agreement
pursuant to this Agreement, the following sections will survive, together with
the definitions of any defined terms used therein: Sections 2.11, 4.7, 5.4, 11,
12, 13, 14.3, 15, 16, 18, 20, 21, 22, 23, 24 and 25. All other provisions,
including all rights and obligations thereunder, will terminate and be of no
further force and effect.

 

17. FORCE MAJEURE

17.1 Force Majeure. No Party (the “Affected Party”) shall be considered to be in
breach of any of its obligations under this Agreement where failure to perform
or delay in performing any obligation is due, wholly or in material part,
directly or indirectly, to the occurrence of any act of God, act of public
enemy, act of a governmental body or agency, foreign or domestic, sabotage,
riot, fire, flood, typhoon, explosion or other catastrophe, epidemic or
quarantine restriction, accident, freight embargo, or because of any other
similar event (a “Force Majeure Event”), for the period of time occasioned by
any such occurrence, so long as the event is beyond the reasonable control of,
does not result from the fault of, and cannot be overcome by the exercise of
reasonable due diligence by the Affected Party, and provided that:

(a) the Affected Party forthwith gives the other Party written notice of the
Force Majeure Event, which notice shall include an estimate of the duration and
the likely impact of the Force Majeure Event;

(b) the suspension or delay of performance shall be of no greater scope and of
no longer duration than is reasonably required by the Force Majeure Event;

(c) the Affected Party will use its reasonable best efforts to correct, cure or
overcome the Force Majeure Event; and

(d) then the Affected Party will for a period of up to three (3) months be
excused from the obligations or conditions as a result of the Force Majeure
Event to the extent and for the time so affected and provided that if a Force
Majeure Event continues thereafter, the other Party (who is not the Affected
Party) shall be entitled to terminate this Agreement upon ten (10) business days
written notice to the Affected Party.

 

18. LAW AND VENUE

18.1 Governing Law. This Agreement will be governed by, and construed and
interpreted in accordance with the laws of New York without giving effect to any
choice of law rule that would cause the application of the laws of any
jurisdiction other than the laws of New York to the rights and obligations of
the Parties.

18.2 Construction. Unless used in combination with the word “either,” the word
“or” is used throughout this Agreement in the inclusive sense (and/or). The
captions of this Agreement are for convenience of reference only and in no way
define, describe, extend or limit

 

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the scope or intent of this Agreement or the intent of any provision contained
in this Agreement. The term “including” as used herein will mean including,
without limiting the generality of any description preceding such term. No rule
of strict construction will be applied against either Party hereto. Unless
expressly provided herein to the contrary, all time limits, notice periods,
deadlines or the like described herein will be governed by the follow
parameters: (i) for all time periods that are five (5) days in length or less,
such periods will be deemed to be business days, and (ii) for all time periods
greater than five (5) days in length will be deemed to be calendar days.

18.3 Disputes. The Parties will try to settle their differences amicably between
themselves with respect to any provision of this Agreement or the performance or
alleged non-performance of a Party with respect to any of its obligations under
this Agreement (“Dispute”). In the event of any controversy or claim arising out
of or relating to this Agreement, the complaining Party shall notify the other
Party in writing of such Dispute. If the Parties are unable to resolve the
Dispute within twenty (20) days of receipt of the written notice by the other
Party, such Dispute will be referred to the Chief Executive Officers of each of
the Parties (or their respective designees) who will meet or hold a phone
conference within fifteen (15) days and use their good faith efforts to have the
Dispute resolved within fifteen (15) days after such meeting.

18.4 Arbitration. Any dispute that is not resolved amicably in accordance with
the above, whether before or after termination of this Agreement, will be
resolved by arbitration pursuant to the London Court of International
Arbitration (LCIA) Rules, which Rules are deemed to be incorporated by reference
into this clause. The number of arbitrators shall be three. Each Party shall
appoint one arbitrator and the two arbitrators appointed by the Parties shall
then agree on the appointment of the third. The place of arbitration shall be
Geneva, Switzerland. The language to be used in the arbitral proceedings shall
be English.

 

19. AMENDMENTS

The Parties hereto may amend, modify or alter any of the provisions of this
Agreement, but such amendment, modification or alteration will be valid and
binding on either Party only if made by a written instrument that explicitly
refers to this Agreement and that is signed by a duly authorized representative
of each Party.

 

20. ENTIRE AGREEMENT

This Agreement, together with the schedules and exhibits hereto, and the
Distribution Agreement (in the form attached as Exhibit 20(a)) and Supply
Agreement (in the form attached as Exhibit 20(b)), comprise the entire
understanding of the Parties with respect to the subject matter hereof.

 

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21. THE PARTIES LEGAL RELATIONSHIP.

The Parties hereto are independent contractors. Nothing contained herein will
constitute either Party the agent of the other Party for any purpose whatsoever,
or constitute the Parties as partners or joint venturers. Employees of each
Party remain employees of said Party and will be considered at no time agents of
or owing a fiduciary duty to the other Party. Neither Party hereto will have any
implied right or authority to assume or create any obligations on behalf of, or
in the name of, the other Party or to bind the other Party to any other
contract, agreement or undertaking with any Third Party.

 

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22. SEVERABILITY

In the event that any provision in this Agreement is held to be unlawful or
invalid in any jurisdiction, the meaning of such provision will be construed to
the greatest extent possible so as relevant to render it enforceable. If no such
construction can render such provision enforceable, it will be severed. The
remainder of this Agreement will remain in full force and effect, and the
Parties will negotiate in good faith a reasonable substitute provision that is
valid and enforceable in such jurisdiction. If the Parties are unable to agree
on a substitute provision, and if the unlawful or invalid provision was an
essential element of this Agreement without which one of the Parties would not
have entered into this Agreement, as evidenced by this Agreement as a whole,
then such Party may terminate this Agreement by written notice to the other
Party effective upon receipt, and the Parties, in such case, shall agree on
terms that will, to the extent practicably possible, put each Party in the
position it would have been had the Agreement not been entered into.

 

23. WAIVER

The failure of either Party to enforce any provision of this Agreement at any
time will not be construed as a present or future waiver of such or any other
provision of this Agreement. The express waiver by either Party of any provision
or requirement hereunder will not operate as a future waiver of such or any
other provision or requirement and will be effective only if set forth in a
written instrument signed by a duly authorized representative of the Party
waiving such provision or requirement.

 

24. HEADINGS

The headings in this Agreement are for convenience only and shall not be applied
when interpreting the content of this Agreement.

 

25. MISCELLANEOUS

25.1 Notice. All notices hereunder must be given in writing and will be deemed
given if delivered personally or by facsimile transmission (receipt confirmed),
mailed by registered or certified mail (return receipt requested) with postage
prepaid, or sent by express courier service (FedEx or other reputable,
internationally recognized courier service), to the Parties at the following
addresses (or at such other address for a Party as will be specified by like
notice; provided that notices of a change of address will be effective only upon
receipt thereof).

 

If to NPS:

   NPS Allelix Corp.    MaRS Centre    101 College Street, South Tower    Suite
800    Toronto, ON MSG 1L8    Canada    Attention: General Counsel    Facsimile:
(973) 316-6463

 

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With copies to:

   NPS Pharmaceuticals, Inc    Morris Corporate Center 1    4th Floor, Building
B    300 Interpace Parkway    Parsippany, New Jersey 07054    United States of
America    Attention: Vice President, Corporate Development    Facsimile:
(973) 316-6463

and:

   NPS Pharmaceuticals, Inc    Morris Corporate Center 1    4th Floor, Building
B    300 Interpace Parkway    Parsippany, New Jersey 07054    United States of
America    Attention: General Counsel    Facsimile: (973) 316-6463

If to Nycomed:

   Nycomed Danmark ApS Langebjerg I    DK-4000 Roskilde Denmark    Attention:
Managing Director    Facsimile: +4546756968 With a copy to:    Nycomed Group   
c/o Nycomed Germany Holding GmbH    Byk-Gulden-Str. 2    78467 Konstanz   
Germany    Attention: General Counsel    Facsimile: +497531842982

25.2 Counterparts. This Agreement may be executed by the Parties in one or more
identical counterparts, all of which together will constitute this Agreement. If
this Agreement is executed in counterparts, no signatory hereto will be bound
until both Parties have duly executed a counterpart of this Agreement.

 

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The Parties have caused this Agreement to be executed as of the Effective Date
by signature of their duly authorized representatives.

 

NPS ALLELIX CORP. By:     Title:    

 

NYCOMED DANMARK APS By:     Title:     By:     Title:    

[Signature Page to License Agreement]

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SCHEDULE 1.5

DEVICE

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SCHEDULE 1.19

NPS PATENTS

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SCHEDULE 2.2

PRODUCT TRADEMARKS

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SCHEDULE 6.3

TRANSFER PROTOCOL

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SCHEDULE 6.8

RELEASE CERTIFICATE

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SCHEDULE 6.10

EMPLOYEES

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SCHEDULE 6.12

INVENTORY STOCK FOR SALE

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EXHIBIT 20(a)

DISTRIBUTION AGREEMENT

A copy of the Distribution Agreement has been attached to our Form 10-Q for the
quarter-ended June 30, 2004.

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EXHIBIT 20(b)

SUPPLY AGREEMENT

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