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Exhibit
10.1
NOTE: C ERTAIN C
ONFIDENTIAL I NFORMATION
HAS BEEN OMITTED
FROM THIS DOCUMENT
AND REPLACED BY
“[*]”. A COMPLETE COPY
OF THIS DOCUMENT
INCLUDING THE C
ONFIDENTIAL I NFORMATION
HAS BEEN FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION .
L ICENSE A
GREEMENT
T HIS L
ICENSE A GREEMENT (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:
1.1 “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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2.1 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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3.1
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.
4.1
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
10
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
11
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
12
Section 2.11 and the Supply
Agreement shall be ter
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