Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. AMENDED AND RESTATED LICENSE AGREEMENT
Exhibit 10.1 Amended and Restated License
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Securities and Exchange Commission. Asterisks denote omissions.
AMENDED AND RESTATED LICENSE AGREEMENT
This Amended and Restated License Agreement (the “Agreement”) is made and entered into
effective as of November 10, 2010 (the “Effective Date”) by and between Clavis Pharma ASA,
a Norwegian company (“Licensor”), and Clovis Oncology, Inc., a Delaware corporation
(“Licensee”). Licensor and Licensee are sometimes referred to herein individually as a
“Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Licensor and Licensee entered into that certain License Agreement, dated November 23,
2009, between the Parties (the “Existing Agreement”) whereby Licensor granted licenses
under certain of its rights in Xxxxx Xxxxxxx, Xxxxxxx xxx Xxxxx Xxxxxxx and Europe to Licensee with
respect to certain oral and intravenous formulations of CP-4126, a lipid vector technology
derivative of gemcitabine; and
WHEREAS, Licensee now desires to obtain a license to Develop and Commercialize (each as
defined below) the above-mentioned pharmaceutical compound in the Asia/ROW Territory (as defined
below) in addition to the above-mentioned territories, and Licensor desires to so extend the
territorial scope of Licensee’s licenses under the Existing Agreement, and the Parties desire to
amend and restate the Existing Agreement in connection therewith with the mutual understanding that
the rights and obligations set forth herein with respect to the Asia/ROW Territory shall be deemed
to apply only as of the Effective Date, as set forth herein.
NOW, THEREFORE, in consideration of the foregoing premises, the mutual promises and covenants
of the Parties contained herein and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do
hereby agree to amend and restate the Existing Agreement in its entirety to read as follows, and do
hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Defined Terms. Unless otherwise specifically provided herein, the following terms
shall have the following meanings:
1.1.1 “Adverse Event Experience” shall have the meaning set forth in Section 9.2.
1.1.2 “Affiliate” shall mean, with respect to a Party, any Person that, directly or
indirectly, through one or more intermediaries, controls, is controlled by or is under common
control with such Party. For purposes of this definition, “control” and, with correlative
meanings, the terms “controlled by” and “under common control with” shall mean (a) the possession,
directly or indirectly, of the power to direct the management or policies of a business entity,
whether through the ownership of voting securities, by contract relating to voting rights or
corporate governance, or otherwise, or (b) the ownership, directly or indirectly, of at least fifty
percent (50%) of the voting securities or other ownership interest of a business entity (or, with
respect to a limited partnership or other similar entity, its general partner or controlling
entity).
1.1.3 “Agreement” shall have the meaning set forth in the preamble to this Agreement.
1.1.4 “Americas/Europe Territory” means Xxxxx Xxxxxxx, Xxxxxxx xxx Xxxxx Xxxxxxx and
Europe.
1.1.5 “Americas/Europe Development Plan” shall have the meaning set forth in Section
3.2.1.
1.1.6 “Americas/Europe Commercialization Plan” shall have the meaning set forth in
Section 4.9.1.
1.1.7 “ANDA” shall mean an Abbreviated New Drug Application under the U.S. Drug Price
Competition and Patent Term Restoration Act of 1984.
1.1.8 “Applicable Law” shall mean applicable laws, rules and regulations, including
any rules, regulations, guidelines or other requirements (including good laboratory practices, good
clinical practices, good manufacturing practices and good distribution practices) of the Regulatory
Authorities, that may be in effect from time to time.
1.1.9 “Arbitration Matter” shall have the meaning set forth in Section 15.7.2.
1.1.10 “Arbitration Rules” shall have the meaning set forth in Section 15.7.2.
1.1.11 “Asia/ROW Territory” shall mean the entire world other than the Americas/Europe
Territory.
1.1.12 “Asia/ROW Development Plan” shall have the meaning set forth in Section 3.2.1.
1.1.13 “Average Full Royalty Rate” shall have the meaning set forth in Section 7.5(b).
1.1.14 “Breaching Party” shall have the meaning set forth in Section 14.2.
1.1.15 “Business Day” shall mean a day other than a Saturday or Sunday on which
banking institutions in New York, New York and Oslo, Norway are open for business.
1.1.16 “Calendar Year” shall mean each successive period of twelve (12) calendar
months commencing on January 1 and ending on December 31.
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1.1.17 “Clinical Data” shall mean all information with respect to the Licensed
Products and the Licensed Compound made, collected or otherwise generated in the performance of or
in connection with Clinical Studies or Post Approval Studies for the Licensed Product, including
any investigator’s brochure, data, case report forms, reports and results with respect thereto.
1.1.18 “Clinical Studies” shall mean any Phase I Study, Phase II Study, Phase III
Study and such other tests and studies in patients that are required by Applicable Law, or
otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals,
but excluding Post Approval Studies.
1.1.19 “Co-Promote” shall mean to promote jointly the Licensed Products in Europe
through Licensor and Licensee and their respective sales forces under the Product Trademarks.
1.1.20 “Co-Promotion Exercise Date” shall mean the date upon which Licensor elects to
exercise the Licensor Co-Promotion Option.
1.1.21 “Co-Promotion Expiration Date” shall have the meaning set forth in Section
5.1.1.
1.1.22 “Co-Promotion Period” shall mean the period commencing on the Co-Promotion
Exercise Date and ending on the earlier of (a) the effective date of the Licensor Opt-out Right or
(b) the termination of this Agreement in accordance with its terms.
1.1.23 “Commercialization” shall mean any and all activities (whether before or after
Regulatory Approval) directed to the marketing, Detailing and promotion of the Licensed Products
and shall include pre launch and post-launch marketing, promoting, Detailing, marketing research,
distributing, offering to commercially sell and commercially selling the Licensed Products,
importing, exporting or transporting the Licensed Products for commercial sale and regulatory
affairs with respect to the foregoing, but shall not include Post Approval Studies or
Manufacturing. When used as a verb, “Commercializing” means to engage in Commercialization and
“Commercialize” and “Commercialized” shall have corresponding meanings.
1.1.24 “Commercialization Costs” shall mean the direct out of pocket costs (other than
Development Costs) that are recorded as an expense in accordance with GAAP and incurred during the
Co-Promotion Period by or on behalf of a Party or any of its Affiliates substantially in accordance
with the Americas/Europe Commercialization Plan (and the budget contained therein) to the extent
incurred in performing tasks that are specifically identified in the Americas/Europe
Commercialization Plan for Europe or reasonably allocable to the Commercialization of a Licensed
Product in Europe. Commercialization Costs shall include only the following costs, in each case
solely with respect to Europe:
(a) Manufacturing Costs of Licensed Products sold in Europe plus any inventory losses incurred
(except to the extent caused by the gross negligence or willful misconduct of a Party),
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(b) marketing expenses specifically attributable to a Licensed Product, including costs
incurred in connection with the preparation of a commercial launch, market research, Post Approval
Studies, costs associated with marketing personnel (including compensation, benefits, travel,
supervision, and training) advertising, advertising agencies, producing Licensed Product
Promotional Materials, sponsoring seminars and symposia (including continuing medical education
programs), reimbursement and other patient support services, allocated based upon the proportion of
such expenses directly attributable to such Licensed Product or the activities of the Parties in
connection with the conduct of the Americas/Europe Commercialization Plan specifically with respect
to Europe,
(c) costs specifically identifiable to the sales force and, to the extent the Parties agree to
use Third Party contract sales organizations, the cost of such CSO sales representatives, and
medical science liaison (“MSL”) activities of Licensed Products in Europe, including the
managed care market, including costs associated with sales and MSL representatives, including
compensation, benefits, travel, supervision and training, and sales meetings, consultants, call
reporting and other monitoring/tracking costs, district, regional and national sales management,
but excluding hiring and termination costs associated with either Party’s sales personnel
(including recruiting, relocation, severance and other similar costs); all such costs for personnel
who are not 100% dedicated to the Licensed Product shall be allocable by the relative position of
the products detailed,
(d) to the extent not included in the Manufacturing Costs of a Licensed Product, license fees,
milestone payments and other amounts required to be paid to Third Parties in consideration for
rights required to conduct activities under the Americas/Europe Commercialization Plan solely with
respect to Europe as agreed to pursuant to this Agreement, allocated based on the proportion of
such costs directly attributable to such Licensed Product,
(e) notwithstanding Sections 8.2 and 8.3, costs associated with prosecution, maintenance and
enforcement of Patents and Product Trademarks in Europe pursuant to Sections 8.2 and 8.3 covering
any Licensed Product and defense of Third Party intellectual property claims in Europe pursuant to
Section 8.4.3 incurred after the Regulatory Approval of such Licensed Product,
(f) product liability insurance premiums and, except to the extent required to be indemnified
by a Party under Sections 13.1(a) or (b) or 13.2(a) or (b), product liability claims, market
withdrawals, field adjustments or recalls in respect of Licensed Products sold in Europe,
(g) post-Regulatory Approval regulatory expenses directly related to the Licensed Product,
including costs to maintain such Regulatory Approval (including user fees paid after Regulatory
Approval), medical and safety activities (including, if required, the design, testing and ongoing
implementation of a risk management program for a Licensed Product) and adverse event reporting,
(h) to the extent previously included in Net Sales, bad debt expense associated with accounts
receivable deemed to be uncollectible, only after using reasonable efforts to pursue and collect
such amounts, and
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(i) such other costs that the Parties agree shall be required for the Commercialization of the
Licensed Products in Europe.
1.1.25 “Commercialization Plan” shall have the meaning set forth in Section 4.9.1.
1.1.26 “Commercially Reasonable Efforts” shall mean, with respect to the Development
or Commercialization of a Licensed Product, as the case may be, efforts and resources commonly used
in the research-based pharmaceutical industry by companies similarly situated to the applicable
Party, but in the case of Licensee, in no event less than those efforts and resources commonly used
by specialty oncology companies, for an internally-developed product of similar commercial
potential at a similar stage in its lifecycle. Commercially Reasonable Efforts shall be determined
on a market-by-market basis for each Licensed Product without regard to the particular
circumstances of a Party, including any other product opportunities of such Party and, with respect
to Licensee, without regard to any payments owed to Licensor under ARTICLE 5 and ARTICLE 7. When
used as an adjective, “Commercially Reasonable” shall mean using Commercially Reasonable
Efforts.
1.1.27 “Committee” shall have the meaning set forth in Section 6.2.
1.1.28 “Competing Product” shall have the meaning set forth in Section 4.2.
1.1.29 “Complaining Party” shall have the meaning set forth in Section 14.2.
1.1.30 “Complaints” shall have the meaning set forth in Section 9.1.
1.1.31 “Confidential Information” shall have the meaning set forth in Section 11.1.
1.1.32 “Control” shall mean, with respect to any item of Information, Drug Master
File, Regulatory Documentation, Patent or Intellectual Property Right, possession of the right,
whether directly or indirectly, and whether by ownership, license or otherwise (other than by
operation of the assignments, license and other grants in ARTICLE 2 and Sections 8.1.2, 8.1.3 and
8.1.4 of this Agreement), to assign or grant a license, sublicense or other right to or under, such
Information, Drug Master File, Regulatory Documentation, Patent or Intellectual Property Right as
provided for herein without violating the terms of any agreement or other arrangement with any
Third Party.
1.1.33 “Corporate Names” shall mean (a) in the case of Licensor, the Trademark “Clavis
Pharma ASA” and the Licensor corporate logo or such other names and logos as Licensor may designate
in writing from time to time and (b) in the case of Licensee, the Trademark “Clovis Oncology, Inc.”
and the Licensee corporate logo or such other names and logos as Licensee may designate in writing
from time to time, in each case ((a) and (b)) together with any variations and derivatives thereof.
1.1.34 “CP-4126” means the chemical compound named 5’-gemcitabine elaidic acid ester,
which is also named 5’-O-(trans-9’’-octadecenoyl)-1- b -D-
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2’deoxy2’,2’difluorocytidine (CAS registry number 210820-30-4). CP-4126 has also been named
by Licensee as “CO-101”.
1.1.35 “Detail” shall mean an interactive face-to-face contact of a sales
representative, who is fully equipped with, and knowledgeable of, applicable Promotional Materials
and Product Labeling for the Licensed Product, with a physician or other medical professional
licensed to prescribe drugs or other healthcare professional that has a significant impact or
influence on prescribing decisions, in which relevant characteristics of a Licensed Product are
described by the sales representative in a fair and balanced manner consistent with the
requirements of this Agreement and Applicable Law, and in a manner that is customary in the
industry for the purpose of promoting a prescription pharmaceutical product. When used as a verb,
“Detail” means to engage in a Detail.
1.1.36 “Development” shall mean all activities related to research, preclinical and
other non-clinical testing, test method development and stability testing, toxicology, formulation,
process development, manufacturing scale-up, qualification and validation, quality
assurance/quality control related to the foregoing manufacturing activities, Clinical Studies and
Post Approval Studies, including manufacturing in support thereof, statistical analysis and report
writing, the preparation and submission of Drug Approval Applications, regulatory affairs with
respect to the foregoing and all other activities otherwise requested or required by a Regulatory
Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When
used as a verb, “Develop” shall mean to engage in Development.
1.1.37 “Development Budget” shall have the meaning set forth in Section 5.1.3(b).
1.1.38 “Development Costs” shall mean the costs recorded as an expense in accordance
with GAAP, by or on behalf of a Party or any of its Affiliates on or after the Original Execution
Date pursuant to this Agreement in performing the tasks that are specifically identified in, or
reasonably allocable to, the Development Budget and the Americas/Europe Development Plan
specifically with respect to Europe or the United States. Subject to the foregoing, Development
Costs shall include such costs incurred in connection with only the following activities, but
excluding in each case any costs incurred solely with respect to obtaining Regulatory Approvals in
jurisdictions other than Europe or the United States:
(a) non-clinical activities such as toxicology and formulation development, test method
development, excluding the development and testing of a hENT1 Biomarker Assay;
(b) Clinical Studies and Post Approval Studies for a Licensed Product, including (a) the
preparation for and conduct of clinical trials, including quality assurance and quality control;
(b) data collection and analysis and report writing; (c) clinical laboratory work; and (d)
regulatory activities in connection with such studies, including adverse event recordation and
reporting;
(c) the direct costs for time recorded by a Party’s personnel in performing Development
activities, which shall be charged at the FTE Rate;
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(d) the preparation of a regulatory dossier reasonably necessary to obtain Initial Regulatory
Approval for a Licensed Product in the United States and Europe;
(e) Manufacturing Costs for (i) a Licensed Product for use in Clinical Studies, Post Approval
Studies or other Development activities for such Licensed Product, (ii) the manufacture, purchase
or packaging of comparators or placebo for use in Clinical Studies or Post Approval Studies for a
Licensed Product (with the manufacturing costs for comparators or placebo to be determined in the
same manner as Manufacturing Costs are determined for any Licensed Product) and (iii) costs and
expenses of disposal of drugs and other supplies used in such Clinical Studies, Post Approval
Studies or other Development activities;
(f) Clinical trial insurance and Losses incurred in connection with Third Party Claims
described in Section 13.3 to the extent such Losses are to be included in Development Costs
pursuant to Section 13.3; and
(g) Costs for the development of the Manufacturing Process for a Licensed Product, scale-up,
stability testing, quality assurance, quality control development, Manufacturing Process
validation, including validation batches (other than those that are commercially saleable upon
Regulatory Approval), manufacturing improvements and qualification and validation of Third Party
contract manufacturers.
For the avoidance of doubt and notwithstanding the foregoing, Development Costs shall not
include (i) any intercompany payments or charges of a Party or its Affiliates (or between such
Affiliates); (ii) filing fees in connection with the filing of applications for Regulatory
Approvals for a jurisdiction outside of Europe; and (iii) any costs in respect of any Clinical
Study or Post Approval Study required only by Regulatory Authorities outside of Europe.
1.1.39 “Development Plans” shall mean the plans for the Development of the Licensed
Products in the Licensee Territory, including the Americas/Europe Development Plan and the Asia/ROW
Development Plan, as prepared and amended from time to time in accordance with Section 3.2.1.
1.1.40 “Dispute” shall have the meaning set forth in Section 15.7.
1.1.41 “Distributor” shall mean a Person, other than a Sublicensee or an Affiliate, in
one or more countries in the Licensee Territory that (a) purchases a Licensed Product in finished
form, packaged and labeled from the Licensee, its Affiliate or Sublicensee for such country(ies),
(b) assumes responsibility from the Licensee for all or a portion of the Commercialization of a
Licensed Product in such country(ies) and (c) sells Licensed Product in such country(ies).
1.1.42 “Drug Approval Application” shall mean a New Drug Application (an
“NDA”) as defined in the FFDCA and the regulations promulgated thereunder, or any
corresponding application in countries outside of the United States, including, with respect to
Europe, a Marketing Authorization Application (a “MAA”) filed with the EMEA pursuant to the
centralized approval procedure or with the applicable Regulatory Authority of a country in Europe
with respect to the mutual recognition or any other national approval procedure.
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1.1.43 “Drug Master File” shall mean any drug master files filed with the FDA with
respect to the Licensed Products and any equivalent filing in other countries or regulatory
jurisdictions, e.g. an Active Substance Master File (ASMF) filed with the EMEA.
1.1.44 “Effective Date” shall mean the effective date of this Agreement as set forth
in the preamble to this Agreement.
1.1.45 “EMEA” shall mean the European Medicines Agency and any successor agency
thereto.
1.1.46 “Europe” shall mean (a) France, Germany, Italy, Spain and the United Kingdom of
Great Britain and Northern Ireland (the “EU5 Countries”), (b) Austria, Belgium, Denmark,
Finland, Greece, Ireland, Luxembourg, The Netherlands, Portugal, and Sweden (together with the
EU5 Countries, such countries are the “EU15 Countries”), and (c) Bulgaria, Czech Republic,
Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, Slovenia, and that certain
portion of Cyprus included in such organization (collectively with the EU15 Countries, the
“European Union”) and Iceland, Xxxxxxxxxxxx, Norway, Switzerland and Turkey.
1.1.47 “Executives” shall have the meaning set forth in Section 6.2.4.
1.1.48 “Existing Agreement” shall have the meaning set forth in the preamble to this
Agreement.
1.1.49 “Expert” shall have the meaning set forth in Section 15.7.2(b)(i).
1.1.50 “Exploit” shall mean to make, have made, import, use, sell or offer for sale,
including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or
keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market
or have sold or otherwise dispose of.
1.1.51 “Exploitation” shall mean the act of Exploiting a product or process.
1.1.52 “FDA” shall mean the United States Food and Drug Administration and any
successor agency thereto.
1.1.53 “FFDCA” shall mean the United States Federal Food, Drug, and Cosmetic Act, as
amended from time to time.
1.1.54 “Field” shall mean any and all Indications for human use.
1.1.55 “FTE” shall mean, the full time equivalent of a person year of an employee
performing work directly related to the Development of a Licensed Product.
1.1.56 “FTE Rate” means the rates set forth in Exhibit 1.1.56 per FTE for work
directly related to the Development of a Licensed Product that is performed pursuant to Article 3;
the FTE Rate includes all salary, employee benefits and social costs.
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1.1.57 “Fully Allocated Costs” shall mean the costs described in Exhibit 1.1.96.
1.1.58 “GAAP” shall mean, in the case of Licensee, United States generally accepted
accounting principles and, in the case of Licensor, International Financial Reporting Standards, in
each case, consistently applied.
1.1.59 “Generic Competition” shall have the meaning set forth in Section 7.4.
1.1.60 “hENT1 Biomarker Assay” shall mean an assay that will detect the presence and
proportion of human equilibrative nucleoside transporter one (hENT1) receptors in the tumor tissue,
circulating tumor cells or other relevant site of a patient.
1.1.61 “Improvement” shall mean any modification, variation or revision to a compound
(including any analog or derivative of CP-4126), product or technology or any discovery,
technology, device or process or formulation related to such compound, product or technology,
whether or not patented or patentable, including any enhancement in the efficiency, operation,
manufacture (including any manufacturing process), ingredients, preparation, presentation,
formulation, means of delivery, packaging or dosage of such compound, product or technology, any
discovery or development of any new or expanded Indications for such compound, product or
technology or any discovery or development that improves the stability, safety or efficacy of such
compound, product or technology.
1.1.62 “including” or any variation thereof means “including without limitation” and
shall not be construed to limit any general statement that it follows to the specific items or
matters immediately following it.
1.1.63 “Indemnification Claim Notice” shall have the meaning set forth in Section
13.5.
1.1.64 “IND” shall mean an investigational new drug application filed with the FDA for
authorization to commence Clinical Studies or Post Approval Studies and its equivalent in other
countries or regulatory jurisdictions.
1.1.65 “Indemnified Party” shall have the meaning set forth in Section 13.5.
1.1.66 “Indication” for a Licensed Product shall mean the use of such Licensed Product
for treating a particular disease or medical condition.
1.1.67 “Information” shall mean all technical, scientific and other know-how and
information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae,
instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs,
drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and
other material, including: biological, chemical, pharmacological, toxicological, pharmaceutical,
physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and
information, including study designs and protocols; assays and biological methodology; (whether or
not confidential, proprietary, patented or patentable) in written, electronic or any other form now
known or hereafter developed, but excluding the Regulatory Documentation and the Drug Master File.
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1.1.68 “Initial Regulatory Approval” of a Licensed Product for an Indication means (a)
with respect to the United States, the approval by FDA (whether through means of an NDA, subpart E,
or subpart H filing or otherwise); or (b) with respect to a country in a regulatory jurisdiction in
the Licensee Territory outside the United States, the approval by the applicable Regulatory
Authorities, of the Drug Approval Application with respect to a Licensed Product for an Indication
in the applicable regulatory jurisdiction (including, in Europe, the approval by the European
Commission of an MAA filed pursuant to the centralized approval procedure.
1.1.69 “Intellectual Property Rights” shall mean Trademarks, service marks, trade
names, registered designs, design rights, copyrights (including rights in computer software),
database rights, trade secrets and any rights or property similar to any of the foregoing (other
than Patents) in any part of the world whether registered or not registered together with the right
to apply for the registration of any such rights.
1.1.70 “Invoiced Sales” shall have the meaning set forth in Section 1.1.100.
1.1.71 “Joint Improvement” shall mean any Improvement jointly conceived by or on
behalf of Licensor or its Affiliates, on the one hand, and Licensee or its Affiliates or
Sublicensees, on the other hand.
1.1.72 “Joint Intellectual Property Rights” shall have the meaning set forth in
Section 8.1.5.
1.1.73 “Joint Know-How” shall have the meaning set forth in Section 8.1.5.
1.1.74 “Joint Patents” shall have the meaning set forth in Section 8.1.5.
1.1.75 “Joint Steering Committee” or “JSC” shall have the meaning set forth in
Section 6.1.1.
1.1.76 “Know-How” shall mean the Licensor Know-How, the Licensee Know-How and the
Joint Know-How.
1.1.77 “Knowledge” shall mean the actual knowledge or good faith understanding of the
vice presidents, senior vice presidents, president or chief executive officer of a Party of the
facts and information then in their possession without any duty to conduct any investigation with
respect to such facts and information and “Knowingly” shall mean, with respect to any
action, to take such action with Knowledge.
1.1.78 “Licensed Compound” shall mean CP-4126 and any analog or derivative of CP-4126
developed by Licensor.
1.1.79 “Licensed Product” shall mean any oral and intravenous formulations of the
Licensed Compound existing as of the Original Execution Date, and any formulations developed
thereafter by or for Licensor or Licensee, and any other any form, mode of administration or dosage
of a pharmaceutical composition or preparation that contains the Licensed Compound as an active
ingredient, including any Improvements thereto.
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1.1.80 “Licensee” shall have the meaning set forth in the preamble to this Agreement.
1.1.81 “Licensee Activities” shall have the meaning set forth in Section 3.2.2.
1.1.82 “Licensee Improvement” shall mean any Improvement conceived or used by or on
behalf of Licensee or its Affiliates in connection with the Development of a Licensed Product under
this Agreement (including development of a hENT1 Biomarker Assay), but excluding any Joint
Improvement.
1.1.83 “Licensee Know-How” shall mean all Information, including any Licensee
Improvements and Clinical Data, that is Controlled as of the Original Execution Date or during the
term of this Agreement by Licensee or any of its Affiliates or Sublicensees that is not generally
known and (a) is developed or acquired by or licensed to Licensee or any of its Affiliates or
Sublicensees under or in connection with this Agreement or otherwise used by or on behalf of
Licensee or any of its Affiliates or Sublicensees in the Exploitation of a Licensed Product or (b)
is necessary for the Exploitation of a Licensed Product, but excluding any Information to the
extent covered or claimed by published Licensee Patents, published Joint Patents and any Joint
Know-How.
1.1.84 “Licensee Patents” shall mean all Patents Controlled by Licensee and any of its
Affiliates or Sublicensees that are necessary (or with respect to Patent applications, would be
necessary if such Patent applications were to issue as Patents) for the Exploitation of a Licensed
Product, the Licensed Compound or any Licensee Improvement thereto, including those that claim or
cover any Licensed Product, Licensee Know-How, any Licensee Improvement thereto or the Exploitation
of any of the foregoing, but excluding any Joint Patents.
1.1.85 “Licensee Territory” means the Americas/Europe Territory and the Asia/ROW
Territory.
1.1.86 “Licensor” shall have the meaning set forth in the preamble to this Agreement.
1.1.87 “Licensor Co-Promotion Option” shall have the meaning set forth in Section
5.1.1.
1.1.88 “Licensor Improvement” shall mean any Improvement conceived or used by or on
behalf of Licensor or its Affiliates in connection with the Development of a Licensed Product under
this Agreement (including development of a hENT1 Biomarker Assay) but excluding any Joint
Improvement.
1.1.89 “Licensor Know-How” shall mean all Information, including any Licensor
Improvements and Clinical Data, that is Controlled by Licensor or its Affiliates as of the Original
Execution Date or during the term of this Agreement that is not generally known and (a) is
developed or acquired by or licensed to Licensor or any of its Affiliates under or in connection
with this Agreement or otherwise used by or on behalf of Licensor or any of its Affiliates in the
Development or Commercialization of a Licensed Product or (b) is necessary for the Development or
Commercialization of a Licensed Product, but excluding any Information to the
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extent covered or claimed by published Licensor Patents, published Joint Patents and any Joint
Know-How.
1.1.90 “Licensor Opt-out Right” has the meaning set forth in Section 5.8.
1.1.91 “Licensor Patents” shall mean all of the Patents that Licensor and its
Affiliates Control as of the Original Execution Date or during the term of this Agreement that are
necessary (or, with respect to Patent applications, would be necessary if such Patent applications
were to issue as Patents) for the Development or Commercialization of a Licensed Product or any
Improvement thereto, including those that claim or cover the Licensed Compound, a Licensed Product
or the Development or Commercialization thereof, but excluding any Joint Patents. For the
avoidance of doubt, the Licensor Patents include, as of the Original Execution Date and as of the
Effective Date, the Patents set forth on Exhibit 1.1.91.
1.1.92 [Intentionally left blank].
1.1.93 “Losses” shall have the meaning set forth in Section 13.1.
1.1.94 “MAA” shall have the meaning set forth in Section 1.1.42.
1.1.95 “Manufacture” and “Manufacturing” shall mean all activities related to
the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and
holding of a Licensed Product or any intermediate thereof, including process development, process
qualification and validation, scale up, pre-clinical, clinical and commercial manufacture and
analytic development, product characterization, stability testing, quality assurance and quality
control.
1.1.96 “Manufacturing Cost” shall mean the cost to Manufacture a Licensed Product as
defined in Exhibit 1.1.96.
1.1.97 “Manufacturing Process” shall mean any process or step thereof that is
necessary or useful for Manufacturing a Licensed Product or any intermediate thereof.
1.1.98 “Markings” shall have the meaning set forth in Section 4.3.2.
1.1.99 “NDA” shall have the meaning set forth in Section 1.1.42.
1.1.100 “Net Sales” shall mean, for any period: (a) the gross amount invoiced by
Licensee and its Affiliates or Sublicensees for the sale of a Licensed Product in an arm’s length
transaction exclusively for money (the “Invoiced Sales”), after deduction of allowances for
normal trade, cash and other quantity discounts, government or commercial rebates, wholesaler fees,
chargebacks and any credits actually given by Licensee for returned or defective products, all as
determined in accordance with GAAP, and excluding or making proper deductions for any costs of
packing, insurance, freight and VAT or other sales-related tax and, in the case of export orders,
any import duties or similar applicable governmental levies or export insurance costs expressly
subject in all cases to the same being separately charged on customer invoices or (b) in any sale
or other disposal of a Licensed Product otherwise than in an arm’s length transaction exclusively
for money, the fair market value (if higher) in the relevant country of disposal.
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Licensee’s or any of its Affiliate’s or Sublicensee’s transfer of Licensed Product to
Licensee, an Affiliate or Sublicensee shall not result in any Net Sales, unless a Licensed Product
is consumed by such Affiliate or Sublicensee in the course of its commercial activities. Sales to
Distributors shall be treated identically to any other sales to Third Parties.
1.1.101 “Notice Period” shall have the meaning set forth in Section 14.2.
1.1.102 “Option Exercise Intent Notice” shall have the meaning set forth in Section
5.1.3.
1.1.103 “Original Execution Date” means November 23, 2009.
1.1.104 “Party” and “Parties” shall have the meaning set forth in the preamble
to this Agreement.
1.1.105 “Patent Challenge” shall have the meaning set forth in Section 14.6.
1.1.106 “Patents” shall mean (a) all national, regional and international patents and
patent applications, including provisional patent applications, (b) all patent applications filed
either from such patents, patent applications or provisional applications or from an application
claiming priority from either of these, including divisionals, continuations,
continuations-in-part, provisionals, converted provisionals and continued prosecution applications,
(c) any and all patents that have issued or in the future issue from the foregoing patent
applications ((a) and (b)), including utility models, xxxxx patents and design patents and
certificates of invention, (d) any and all extensions or restorations by existing or future
extension or restoration mechanisms, including revalidations, reissues, re-examinations and
extensions (including any supplementary protection certificates and the like) of the foregoing
patents or patent applications ((a), (b) and (c)) and (e) any similar rights, including so-called
pipeline protection or any importation, revalidation, confirmation or introduction patent or
registration patent or patent of additions to any of such foregoing patent applications and
patents.
1.1.107 “Payments” shall have the meaning set forth in Section 7.9.1.
1.1.108 “Person” shall mean an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability company, business trust,
joint stock company, trust, unincorporated association, joint venture or other similar entity or
organization, including a government or political subdivision, department or agency of a
government.
1.1.109 “Pharmacovigilance Agreement” shall have the meaning set forth in Section 9.3.
1.1.110 “Phase I Study” shall mean a human clinical trial of a Licensed Product, the
principal purpose of which is a preliminary determination of safety in healthy individuals or
patients or similar clinical study prescribed by the Regulatory Authorities, including the trials
referred to in 21 C.F.R. §312.21(a), as amended.
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1.1.111 “Phase II Study” shall mean a human clinical trial of a Licensed Product, the
principal purpose of which is a determination of safety and efficacy in the target patient
population or a similar clinical study prescribed by the Regulatory Authorities, from time to time,
pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b),
as amended.
1.1.112 “Phase III Study” shall mean a human clinical trial of a Licensed Product on a
sufficient number of subjects that is designated to establish that a pharmaceutical product is safe
and efficacious for its intended use and to determine warnings, precautions and adverse reactions
that are associated with such pharmaceutical product in the dosage range to be prescribed, which
trial is intended to support marketing approval of a Licensed Product, including all tests and
studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise.
1.1.113 “Pre-tax Net Profit” shall mean, with respect to sales of Licensed Products in
Europe, the (a) Net Sales and the fair market value of any other consideration (whether in cash,
payment in kind, exchange or other form) actually received by a Party or its Affiliates from Third
Parties with respect to transactions involving the Development or Commercialization of a Licensed
Product or Exploitation of Licensor or Licensee Patents or Know-How or Joint Intellectual Property
Rights in Europe, including upfront and milestone payments by Sublicensees and Distributors and any
payments recovered from the enforcement of Patents pursuant to Section 8.3, less (b) the
Commercialization Costs related to such sales. The Parties acknowledge that the defined term
Pre-tax Net Profit may, in any given accounting period, actually consist of a financial loss.
1.1.114 “Post Approval Study” shall mean any human clinical study or other test or
study with respect to a product for an Indication that (a) is conducted solely in support of
pricing or reimbursement for such product in a country or (b) is not required to obtain or maintain
Regulatory Approval for such product for such Indication (for clarity, any human clinical study
that is intended to expand the Product Labeling for such product shall be a Clinical Study).
Subject to the foregoing, Post Approval Studies may include epidemiological studies, modeling and
pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored studies and
health economics studies.
1.1.115 “Product Labeling” shall mean (a) the Regulatory Authority approved full
prescribing information for a Licensed Product for that country, including any required patient
information; and (b) all labels and other written, printed or graphic matter upon a container,
wrapper or any package insert utilized with or for such Licensed Product.
1.1.116 “Product Trademarks” shall mean the Trademark(s) for the Licensed Products
Controlled by Licensor during the term of this Agreement and used or intended for use in connection
with the Commercialization of the Licensed Products.
1.1.117 “Promotional Materials” shall mean all sales representative training materials
with respect to the Licensed Products and all written, printed, graphic, electronic, audio or video
matter, including journal advertisements, sales visual aids, direct mail, medical
information/education monographs, direct-to-consumer advertising, Internet postings, broadcast
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advertisements and sales reminder aids (e.g., scratch pads, pens and other such items)
intended for use or used by a Party, its Affiliates or, with respect to Licensee, its Sublicensees
or Distributors, in connection with any promotion of the Licensed Products, except Product Labeling
for the Licensed Products.
1.1.118 “Regulatory Approval” shall mean, with respect to a country, any and all
approvals (including Drug Approval Applications), licenses, registrations or authorizations of any
Regulatory Authority necessary to commercially distribute, sell or market a Licensed Product in
such country, including, where applicable, (a) pricing or reimbursement approval in such country,
(b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing
approval or authorization related thereto), (c) labeling approval, (d) technical, medical and
scientific licenses, and (e) orphan drug designations.
1.1.119 “Regulatory Authority” shall mean any applicable supra-national, federal,
national, regional, state, provincial, local or other regulatory agencies, departments, bureaus,
commissions, councils or other government entities, including self-regulatory organizations,
regulating or otherwise exercising authority with respect to the Exploitation of a Licensed
Product.
1.1.120 “Regulatory Documentation” shall mean all applications, registrations,
licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence
submitted to or received from Regulatory Authorities (including minutes and official contact
reports relating to any communications with any Regulatory Authority) and all supporting documents
and all clinical studies and tests, relating to the Licensed Products and all data contained in any
of the foregoing, including all INDs, Drug Approval Applications, regulatory drug lists,
advertising and promotion documents, Clinical Data, adverse event files and complaint files (but
excluding any Drug Master File).
1.1.121 “Regulatory Exclusivity Period” shall mean any period of data, market or other
regulatory exclusivity, including any such periods listed in the FDA’s Orange Book or periods under
national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83, as amended, and all
international equivalents.
1.1.122 “Royalty Rate Floor” shall have the meaning set forth in Section 7.2.4.
1.1.123 “Royalty Term” shall have the meaning set forth in Section 7.3.
1.1.124 “Sublicensee” shall mean a Person, other than an Affiliate, that is (a)
granted a sublicense by Licensee under the grant in Section 2.1 as provided in Section 2.3 or (b)
in the case of the United States, any EU15 Country or Japan, otherwise granted rights to market,
promote and sell a Licensed Product and has the primary responsibility for the marketing and
promotion of such Licensed Product in its distribution territory and has the right to record sales
of such Licensed Product for its account.
1.1.125 “Third Party” shall mean any Person other than Licensor, Licensee and their
respective Affiliates.
1.1.126 “Third Party Claims” shall have the meaning set forth in Section 13.1.
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1.1.127 “Third Party Payments” shall have the meaning set forth in Section 8.4.1(a).
1.1.128 “Trademark” shall include any word, name, symbol, color, designation or device
or any combination thereof, including any trademark, trade dress, brand xxxx, service xxxx, trade
name, brand name, logo or business symbol, whether or not registered.
1.1.129 “United States” or “U.S.” shall mean the United States of America,
including its territories and possessions, the District of Columbia and Puerto Rico.
1.1.130 “VAT” shall have the meaning set forth in Section 7.9.2.
ARTICLE 2
GRANT OF RIGHTS
2.1 Grants to Licensee. Subject to the terms and conditions of this Agreement,
Licensor hereby grants to Licensee:
2.1.1 an exclusive (including with regard to Licensor and its Affiliates), royalty-bearing
license, with the right to grant sublicenses in accordance with Section 2.3, under the Licensor
Patents and the Licensor Know-How to Develop, to obtain, maintain and hold Regulatory Approvals
for, and to Commercialize the Licensed Products in the Field in the Licensee Territory;
2.1.2 a non-exclusive royalty-free license, with the right to grant sublicenses in accordance
with Section 2.3, under the Joint Patents (to the extent Controlled by Licensor) and the Joint
Know-How (to the extent Controlled by Licensor) or any other Intellectual Property Rights
Controlled by Licensor that relate to the Licensed Compound or the Licensed Products to Develop, to
obtain, maintain and hold Regulatory Approvals for, and to Commercialize the Licensed Products in
the Field in the Licensee Territory;
2.1.3 a royalty-bearing license, exclusive in the Licensee Territory, with the right to grant
sublicenses in accordance with Section 2.3, to use the Product Trademarks as necessary to exercise
its rights under the grants in Sections 2.1.1 and 2.1.2;
2.1.4 an exclusive royalty-bearing license and right of reference in the Licensee Territory,
with the right to grant further sublicenses and rights of reference to Sublicensees in accordance
with Section 2.3, under Licensor’s right, title and interest in and to any Clinical Data,
Regulatory Approvals, Drug Master File and all Regulatory Documentation that Licensor may Control
with respect to the Licensed Compound or the Licensed Products as necessary to exercise Licensee’s
rights under the grants in Sections 2.1;
2.1.5 to the extent necessary to exercise Licensee’s rights under the grants in Section 2.1,
Licensor hereby grants, and shall ensure that its Affiliates and Sublicensees grant, to Licensee
and its Sublicensees a “right of reference or use” (as that term is defined in 21 C.F.R. §314.3(b),
as amended from time to time), and any non-United States equivalents (including Article 10c of
Directive 2001/83/EC, as amended), to any and all data contained or referenced in
- 16 -
any Regulatory Approvals and other Regulatory Documentation relating to all Licensed Products,
including all reports, correspondence and conversation logs, and Licensor shall provide appropriate
notification of Licensee’s access and reference rights to the Regulatory Authorities, including an
informed consent letter under Article 10c of Directive 2001/83/EC as amended;
2.1.6 subject to Section 4.10, a non-exclusive license, with the right to grant sublicenses in
accordance with Section 2.3, under the Licensor Patents, the Licensor Know-How, the Joint Patents
(to the extent Controlled by Licensor) and the Joint Know-How (to the extent Controlled by
Licensor) to Manufacture or, subject to Section 2.3 hereof, to have Manufactured the Licensed
Compound and the Licensed Products anywhere in the world for sale in the Licensee Territory; and
2.1.7 a non-exclusive license, with the right to grant sublicenses in accordance with Section
2.3, under the Licensor Patents, the Licensor Know-How, the Joint Patents (to the extent Controlled
by Licensor) and the Joint Know-How (to the extent Controlled by Licensor) to Develop the Licensed
Compound and the Licensed Products anywhere in the world for sale in the Licensee Territory.
Licensee acknowledges that (a) the Licensor Know-How is secret and substantial and that
without Licensor Know-How Licensee would not be able to obtain and maintain Regulatory Approvals,
(b) such Regulatory Approvals will allow Licensee to obtain and maintain Regulatory Exclusivity
Periods with respect to the Licensed Product, (c) access to Licensor Know-How and the license to
the Product Trademarks will provide Licensee with a competitive advantage in the marketplace beyond
the exclusivity afforded by the Licensor Patents and the Regulatory Exclusivity Period and (d) the
milestone payments and royalties set forth in Sections 7.1, 7.2 and 5.4 are, in part, intended to
compensate Licensor for such exclusivity and such competitive advantage.
2.2 Retention of Rights. Notwithstanding anything to the contrary in this Agreement,
Licensor retains all right, title and interest in and to the Licensor Patents, the Licensor
Know-How, the Joint Patents (to the extent Controlled by Licensor) and the Joint Know-How (to the
extent Controlled by Licensor), and the Product Trademarks as may be necessary or useful (a) to
exercise its rights and perform its obligations in connection with the co-promotion of the sale of
the Licensed Products in Europe pursuant to Article 5; and (b) to use and Exploit the Product
Trademarks for any and all purposes, subject only Licensor’s obligations expressly set forth
hereunder with respect thereto. Except as expressly provided herein, Licensor grants no other
right or license, including any rights or licenses to the Licensor Patents, the Licensor Know-How,
the Product Trademarks, the Licensor Corporate Name, the Licensed Compound, any other Patent or
Intellectual Property Rights or any Improvements to any of the foregoing not otherwise expressly
granted herein.
2.3 Sublicenses. The rights and licenses granted to Licensee under Section 2.1 shall
include the right to grant sublicenses (or further rights of reference to Sublicensees) in the
Field in the Licensee Territory; provided, however, that: (a) Licensee may grant sublicenses or
otherwise appoint a Sublicensee in the United States, or the EU5 Countries only with the prior
written consent of Licensor, which will not be unreasonably withheld and as to which there will be
no additional consideration shall be payable to Licensor; (b) Licensee undertakes to be
- 17 -
primarily liable for all obligations hereunder in respect of such sublicensed rights and shall
use all Commercially Reasonable Efforts to procure the performance by any Sublicensee of the terms
of each such sublicense and (c) any Sublicensee shall comply with the applicable terms and
conditions of this Agreement. The grant of any such sublicense shall not relieve the Licensee of
its obligations under this Agreement, except to the extent they are satisfactorily performed by a
Sublicensee. Any such permitted sublicenses shall be consistent with and subject to the terms and
conditions of this Agreement. A copy of any sublicense agreement executed by Licensee (with
financial terms redacted) shall be provided to the Licensor within fourteen (14) days of its
execution.
2.4 Use of Trademarks.
2.4.1 Subject to Sections 2.1.3 and 8.2.2 with respect to the Licensee Territory, Licensor
shall have the sole right to own and use the Product Trademarks with respect to the Exploitation of
the Licensed Products on a worldwide basis. Licensee shall not, and shall not permit its
Sublicensees, Distributors or Affiliates to use in their respective businesses, any Trademark that
is confusingly similar to, misleading or deceptive with respect to or that dilutes any (or any
part) of the Product Trademarks. Licensee shall, and shall cause its Sublicensees, Distributors
and Affiliates to, conform to the customary industry standards for the protection of Trademarks for
pharmaceutical products and guidelines of Licensor (as provided in writing by Licensor) with
respect to manner of use of the Product Trademarks. Licensee shall, and shall cause its
Affiliates, Sublicensees and Distributors to, use Commercially Reasonable Efforts not to do any act
which endangers, destroys or similarly affects, in any material respect, the value of the goodwill
pertaining to the Product Trademarks. Licensee shall not, and shall not permit its Sublicensees,
Distributors or Affiliates to, attack, dispute or contest the validity of or ownership of such
Product Trademark anywhere in the world or any registrations issued or issuing with respect
thereto. Licensee acknowledges and agrees that no ownership rights are vested or created in such
Product Trademark anywhere in the Licensee Territory by the licenses and other rights granted in
Section 2.1 and Section 8.2.2 and that all use of such Product Trademark by Licensee, its
Sublicensees, Distributors and Affiliates, including any goodwill generated in connection
therewith, inures to the benefit of Licensor, and Licensor may call for a confirmatory assignment
thereof.
2.5 [Intentionally left blank].
2.6 Subcontracting. Any delegation or subcontracting by either Party shall be subject
to agreements containing provisions as materially protective of the other Party’s rights, including
with respect to access to data, ownership and licenses of intellectual property rights and
protection of confidential information, as set forth in this Agreement.
ARTICLE 3
DEVELOPMENT AND REGULATORY
3.1 Development of the Licensed Products.
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3.1.1 Diligence. Licensee shall have the right and shall use Commercially Reasonable
Efforts to, at its sole expense (except as otherwise herein expressly provided), Develop the
Licensed Products, obtain Regulatory Approval for the Licensed Products, and Commercialize the
Licensed Products in the U.S., Europe, China, Japan and in each other country within the Licensee
Territory where performing such Development and seeking such Regulatory Approval would be
Commercially Reasonable.
3.1.2 Compliance. Licensee shall perform or cause to be performed, any and all of its
Development obligations under this Agreement in good scientific manner, and in compliance with all
Applicable Law, and shall endeavor to achieve the objectives of the Development Plans diligently
and efficiently by allocating sufficient time, effort, equipment and skilled personnel to complete
such Development activities successfully and promptly.
3.2 Development Plans and Implementation.
3.2.1 Development Plans. As of the Original Execution Date, Licensee has provided
Licensor with the initial development plan outline for the Americas/Europe Territory set forth in
Exhibit 3.2.1 (the “Initial Americas/Europe Development Plan”). As of the Effective Date,
Licensee has provided Licensor with the initial development plan outline for the Asia/ROW Territory
set forth in Exhibit 3.2.1A (the “Initial Asia/ROW Development Plan”). As Licensee further
refines such development plans, including identifying timelines, work plan activities, CROs, trial
sites, investigators, protocols, quality controls, manufacturing procedures and other details as
are customarily included in development plans for oncology products at a similar stage of
development, for each of the Americas/Europe Territory (the “Americas/Europe Development
Plan”) and the Asia/ROW Territory (the “Asia/ROW Development Plan”) (such plans
collectively, its “Development Plans”), it shall furnish copies of such Development Plans
to Licensor through the JSC. Subject to such changes as may be required to meet the requirements
of any Regulatory Authority or which arise from clinical or scientific developments, each
Development Plan shall be consistent with the Initial Americas/Europe Development Plan or the
Initial Asia/ROW Development Plan, as applicable, in all material respects. Licensee shall revise
the Development Plans, from time to time to reflect material changes to such Development Plans, for
review and approval by the JSC. Licensee shall prepare and propose amendments to the Development
Plans that may be necessary or desirable to efficiently and expeditiously complete the Development
activities, including Clinical Studies and Post Approval Studies, and to efficiently and
expeditiously obtain and maintain Regulatory Approvals and successfully Commercialize the Licensed
Products in the Licensee Territory. The JSC shall review each Development Plan and each proposed
amendment, and Licensee shall consider in good faith any comments provided by Licensor.
3.2.2 Licensee Responsibility. Licensee shall have responsibility for the day-to-day
implementation of the Development activity included in the Development Plans with respect to any
Clinical Studies, Post Approval Studies and other Development activities for the Licensed Products
that are conducted in support of Regulatory Approvals for the Licensed Products or
Commercialization of the Licensed Products in the Licensee Territory (collectively, the
“Licensee Activities”).
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3.2.3 Licensor Responsibility. Licensor shall cooperate with the Licensee to enable
Licensee to take over such Clinical Studies and Post Approval Studies and shall perform such
activities with respect thereto, at Licensee’s cost (except as otherwise provided in Section 3.3),
as are reasonably requested of it by Licensee and in the Development Plans under the direction of
the Licensee and subject to the Development Plans and, with respect to the Americas/Europe
Territory, the Development Budget. As reasonably requested from time to time by Licensee, Licensor
shall provide personnel to support the Development of the Licensed Products in Europe.
3.3 Development Costs.
3.3.1 Pre-Clinical Studies. Licensor agrees to complete, and bear the full cost of,
the pre-clinical studies specified on Exhibit 3.3.1 in support of Developing the Licensed Products
in the Americas/Europe Territory. Licensor shall use its Commercially Reasonable Efforts to
complete such studies prior to the first filing of the NDA or MAA as set forth in the Initial
Americas/Europe Development Plan. The costs of any other pre-clinical studies performed by
Licensor in connection with obtaining Regulatory Approvals in the Americas/Europe Territory shall
be borne equally by Licensor and Licensee.
3.3.2 Funding by Licensor for Certain Development Activities to be Conducted in 2011.
Licensor shall reimburse Licensee up to Three Million U.S. Dollars ($3,000,000) for costs incurred
by Licensee to Third Parties between the Effective Date and December 31, 2011 in the course of
performing the Development activities set forth in Exhibit 3.3.2. Such costs shall be determined
and the payments made in the manner set forth in Exhibit 3.3.2.
3.3.3 Costs of Development in the Asia/ROW Territory. Except as set forth in Section
3.3.2, Licensee shall be solely responsible for, and pay, all costs for all Development activities
conducted in connection with obtaining Regulatory Approvals in the Asia/ROW Territory. For the
avoidance of doubt, such costs shall not be included in Development Costs.
3.3.4 Development Cost Reports. Within 45 days after each of June 30 and December 31,
Licensee shall provide a statement disclosing in reasonable detail the Development Costs incurred
in the six months prior to such dates.
3.4 Regulatory Matters.
3.4.1 Regulatory Responsibilities With Respect to Licensee Territory; Preparation of
Regulatory Submissions.
(a) Licensee shall be responsible for all regulatory submissions with respect to Regulatory
Approvals, including Drug Approval Applications, for the Licensed Products in the Licensee
Territory and Licensee Activities in those countries where such activities are conducted, and
ownership of Regulatory Approvals and related submissions within the Licensee Territory relating to
the Licensed Products shall be governed by Section 8.1.3.
(b) As of the Original Execution Date, Licensor is conducting three Clinical Studies for the
Licensed Products that are described in Exhibit 3.4.1. Licensor shall continue to perform the two
Phase I Studies formulation of the Licensed Product. Each Party
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shall use reasonable efforts to transfer sponsorship and ongoing responsibility (including
Licensee obtaining an IND in its name) for the ongoing Phase II Study for the IV formulation of the
Licensed Products to Licensee as soon as reasonably practical so that Licensee may be the sponsor
of such Phase II Study for the dosing of the first patient under the amended protocol contemplated
under the Initial Americas/Europe Development Plan. Substantially simultaneously with the transfer
of the sponsorship of the Phase II Study for the IV formulation of the Licensed Product, Licensor
shall transfer to Licensee the orphan drug designation previously obtained by the Licensor for the
Licensed Product from the EMEA. Licensor shall also assign to Licensee those clinical investigator
agreements related to the Phase II Study for the IV formulation of the Licensed Product. All
Development Costs incurred by Licensor after the Original Execution Date in the conduct of such
Clinical Studies shall be reimbursed by Licensee within 30 days after invoices submitted by
Licensor monthly.
3.4.2 Clinical and Non-Clinical Data.
(a) Each Party shall periodically provide updates to the other Party regarding clinical and
non-clinical data, and other results and analyses with respect to any Development activities with
respect to the Licensed Products, reasonably promptly after such data, results and analyses become
available. All such data transfers and exchanges shall be subject to the confidentiality
obligations of the Parties contained in ARTICLE 11.
(b) Each Party shall support the other, as may be reasonably necessary, in obtaining
Regulatory Approvals for the Licensed Products, including providing necessary documents or other
materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance
with the terms and conditions of this Agreement and the Development Plans.
3.4.3 Communications with Regulatory Authorities.
(a) Licensee Territory.
(i) In General. Licensee shall be solely responsible for any communications
with the Regulatory Authorities occurring or required in connection with performing its
responsibilities set forth in Section 3.4.1 and shall designate a representative to serve as
the designated regulatory representative with respect to such communications.
(ii) Major Communications. Licensee will keep Licensor informed of any other
significant interface or communication with the FDA or other Regulatory Authority which
might affect efforts to obtain Regulatory Approval for the Licensed Products.
(iii) Regulatory Contacts. During the Co-Promotion Period, Licensee shall
provide Licensor with prior notice of all meetings and teleconferences with representatives
of Regulatory Authorities regarding any Licensed Product intended for sale in Europe.
Licensor shall have the right to have representatives present as observers at all such
meetings and teleconferences, to the extent not prohibited by such Regulatory Authority.
During the Co-Promotion Period, Licensee shall use reasonable
- 21 -
efforts to provide Licensor with a reasonable opportunity to review and comment upon
submissions to, and correspondence with, any Regulatory Authority in Europe, and Licensee
shall consider in good faith all comments provided by Licensor in a timely manner. Without
limiting the foregoing, during the Co-Promotion Period, Licensee shall use reasonable
efforts to confirm in writing to Licensor all communications with a Regulatory Authority
with respect to a Regulatory Approval (including filings therefor) and to provide to
Licensor copies of all documents sent to or received from such Regulatory Authority
regarding such Regulatory Approvals.
(b) Adverse Event Experiences. Without limitation to anything contained in this
Section 3.4.3, each Party shall provide to the other Party documentation concerning Adverse Event
Experiences required to be reported to a Regulatory Authority pursuant to Applicable Law in
accordance with ARTICLE 9.
3.4.4 Pricing and Reimbursement Approvals. Licensee shall have sole authority over
and be responsible for all pricing and reimbursement approval proceedings relating to the Licensed
Products in the Licensee Territory. Licensee shall provide Licensor with reasonable advance notice
of all such meetings and advance copies of all related documents (including documents to be
submitted in connection with pricing and reimbursement approvals) and other relevant information
relating to such meetings and shall consider in good faith all comments provided by Licensor.
During the Co-Promotion Period, Licensor shall consult with Licensee concerning all such pricing
and reimbursement approvals and consider in good faith all comments provided by Licensor.
3.4.5 Regulatory Records. Licensee and Licensor each shall maintain, or cause to be
maintained, records of its respective Development activities with respect to the Licensed Products
in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes,
which shall be complete and accurate and shall fully and properly reflect all work done and results
achieved in the performance of its respective Development activities, and which shall be retained
by such Party for at least three (3) years after the termination of this Agreement, or for such
longer period as may be required by Applicable Law. All records should be retained in a secure
area reasonably protected from fire, theft and destruction. Each Party shall have the right,
during normal business hours and upon reasonable notice, to inspect and copy any such records,
except to the extent that a Party reasonably determines that such records contain Confidential
Information that is not licensed to the other Party, or to which the other Party does not otherwise
have a right hereunder. Licensee shall provide Licensor with such additional information regarding
the Licensee Activities as Licensor may reasonably request from time to time.
3.4.6 [Intentionally left blank].
3.5 hENT1 Biomarker. Licensee and Licensor shall Develop a hENT1 Biomarker Assay in
accordance with a joint development plan that the Parties shall establish within 60 days after the
Original Execution Date. If the Parties succeed in Developing a hENT1 Biomarker Assay and
notwithstanding any termination of this Agreement, Licensee agrees to grant to Licensor an
exclusive royalty-free license to use such hENT1 Biomarker Assay anywhere in the world in
connection with any other product developed by Licensor with respect to which the hENT1
- 22 -
Biomarker Assay would be necessary or useful. The Parties shall keep one another informed of
their respective efforts to Develop a hENT1 Biomarker Assay and, to the extent reasonably
practical, will seek to coordinate such efforts through dialogue in the JSC. With respect to
Development of a hENT1 Biomarker Assay, each Party shall pay its internal costs and Licensee shall
pay all costs payable to Third Parties. Licensor is now contemplating entering into an agreement
with a Third Party under terms previously disclosed to Licensee for the license of certain rights
to a hybridoma expressing an antibody for use in an hENT1 Biomarker Assay. If Licensor enters into
such agreement, it shall contain provisions permitting the sublicense of rights to Licensee to the
extent required to Develop and Commercialize an hENT1 Biomarker Assay as provided in this Section
3.5. Each Party shall have the same regulatory obligations concerning the hENT1 Biomarker Assay as
it does under this ARTICLE 3 for Licensed Products. If Licensor succeeds in independently
Developing a hENT1 Biomarker Assay, Licensor shall grant to Licensee an exclusive license to use
such hENT1 Biomarker Assay in the Licensee Territory in connection with the Licensed Products,
subject to Licensee bearing 100% of whatever Third Party royalties and payments are applicable to
the use or sale of such Assay in the Licensee Territory.
3.6 [Intentionally left blank].
ARTICLE 4
COMMERCIALIZATION
4.1 Commercialization of the Licensed Product.
4.1.1 In General. Except as otherwise provided in Article 5 following the
Co-Promotion Exercise Date, Licensee shall have the sole right to Commercialize the Licensed
Products in the Licensee Territory at its sole expense in accordance with the Commercialization
Plans and shall do so in compliance with this Agreement and all Applicable Law.
4.1.2 Commercialization Obligations. Licensee shall use Commercially Reasonable
Efforts to Commercialize the Licensed Products in the U.S., Europe, China, Japan, and in each other
country within the Licensee Territory where Commercializing the Licensed Products would be
Commercially Reasonable.
4.1.3 Product Trademarks. Except with respect to the Corporate Names as provided in
Section 4.3.2, Licensee and its Affiliates, Sublicensees and Distributors shall Commercialize the
Licensed Products solely under the Product Trademarks.
4.2 Non-Compete. During the term of this Agreement, neither Party nor its Affiliates
shall Develop, market, detail, promote or otherwise Commercialize anywhere in the world any
pharmaceutical product (other than the Licensed Products) containing gemcitabine or any other
prodrugs of dFdCTP and/or dFdCDP (a “Competing Product”). Notwithstanding the foregoing, if
either Party is acquired by a Third Party, or merged with or into a Third Party in a transaction in
which the shareholders of the Party immediately prior to such transaction own less than 50% of the
voting rights of such Party or of the resulting entity immediately after such transaction, then
such Party and its Affiliates may continue to Develop, market, detail, promote or otherwise
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Commercialize in the Licensee Territory any Competing Product that was being Developed or
Commercialized by such a Third Party (or any of its Affiliates) prior to the date of such
transaction.
4.3 Promotional Materials and Activities.
4.3.1 In General. Licensee shall be responsible for preparing all Promotional
Materials used to support the Commercialization of the Licensed Products in the Licensee Territory.
4.3.2 Markings. All Promotional Materials, packaging and Product Labeling for the
Licensed Products used by Licensee, its Affiliates, Sublicensees or Distributors in connection with
the Licensed Products in any country in the Licensee Territory shall contain (i) the Product
Trademarks, (ii) the Corporate Name of Licensee and (iii) if required by Applicable Law, the logo
and corporate name of the manufacturer (collectively, the “Markings”). During the
Co-Promotion Period and to the extent permitted by Applicable Law, all Promotional Materials,
packaging and Product Labeling for the Licensed Products used by Licensee, its Affiliates,
Sublicensees or Distributors in connection with the Licensed Products in any country in Europe
shall also contain the logo and Corporate Name of each Party with equal prominence.
4.4 Statements and Compliance with Applicable Law.
4.4.1 Public Statements Regarding Licensed Products. Licensee shall be responsible
for disseminating accurate information regarding the Licensed Products based on Product Labeling
and Promotional Materials for the Licensed Products (and for causing its Affiliates, Sublicensees
and Distributors to so disseminate such accurate information). In exercising its rights pursuant
to this ARTICLE 4, Licensee shall seek to prevent claims or representations in respect of the
Licensed Products or the characteristics of the Licensed Products (e.g., safety or efficacy) being
made by or on behalf of it or its Affiliates, Sublicensees or Distributors (by members of its or
their sales force or otherwise) that do not represent an accurate or fairly balanced summary or
explanation of the Product Labeling for the Licensed Products in the country in question.
4.4.2 Sales Force Compliance. Licensee shall use Commercially Reasonable Efforts to
train and monitor its sales representatives so that such sales representatives: (i) use only
Promotional Materials (without any addition, deletion or other modification) for the promotion of
the Licensed Products in the Licensee Territory, (ii) limit claims of efficacy and safety for the
Licensed Products to those that are consistent with Applicable Law and with approved (by the
appropriate Regulatory Authority) promotional claims in Product Labeling and Promotional Materials
for the Licensed Products, and not add, delete or otherwise modify claims of efficacy and safety in
the promotion of the Licensed Products in any respect from those claims of efficacy and safety that
are contained in such approved Product Labeling and Promotional Materials and (iii) Commercialize
the Licensed Products in accordance in all material respects with Applicable Law and applicable
codes for the promotion of pharmaceutical products, including marketing, promotion and distribution
of medicinal products.
- 24 -
4.4.3 Medical and Other Inquiries. The Licensee shall be responsible for responding
to all medical questions or inquiries from customers or others in the Licensee Territory relating
to the Licensed Products sold in Licensee Territory. The Licensee shall keep such records and make
such reports as are reasonably necessary to document such communications in compliance with all
Applicable Law.
4.4.4 Compliance with Laws. Licensee shall comply with all Applicable Law with
respect to the Commercialization of the Licensed Products. Neither Party shall be required to
undertake any activity relating to the Commercialization of the Licensed Products that it believes,
in good faith, may violate Applicable Law. Licensee shall in all material respects conform its
practices and procedures relating to educating the medical community in the Licensee Territory with
respect to the Licensed Products to any applicable industry association regulations, policies and
guidelines, as the same may be amended from time to time and shall comply with Applicable Law with
respect thereto.
4.5 Use of Distributors. Licensee shall have the right to use Distributors to
Commercialize the Licensed Products in any country in the Licensee Territory in which Licensee
deems it Commercially Reasonable to do so; provided, that (a) no Distributors shall be appointed
for Europe prior to the filing of the MAA and (b) during the Co-Promotion Period, Licensee shall
have obtained Licensor’s prior written consent prior to the appointment of any Distributor in
Europe.
4.6 Sales and Distribution in Licensee Territory. Licensee shall be solely
responsible for invoicing and booking sales, establishing all terms of sale (including pricing and
discounts) and warehousing and distributing the Licensed Products in the Licensee Territory and
shall perform all related services, in each case in a manner consistent with the terms and
conditions of this Agreement and the Commercialization Plans. Licensee shall also be solely
responsible for handling all returns, recalls or withdrawals in accordance with ARTICLE 10, order
processing, invoicing and collection, distribution and inventory and receivables in the Licensee
Territory.
4.7 [Intentionally left blank].
4.8 [Intentionally left blank].
4.9 Commercialization Plans and Implementation.
4.9.1 Commercialization Plan. The Commercialization of the Licensed Products shall be
conducted pursuant to an annual plan and budget to be prepared by Licensee with respect to the
Americas/Europe Territory (the “Americas/Europe Commercialization Plan”) and the Asia/ROW
Territory (the “Asia/ROW Commercialization Plan”) (the Americas/Europe Commercialization
Plan and the Asia/ROW Commercialization Plan, collectively the “Commercialization Plans”),
which plans and budgets shall be consistent with Licensee’s obligations set forth in Section 4.1.
The Commercialization Plans shall include, when and as formulated by Licensee: with respect to the
Americas/Europe Territory or the Asia/ROW Territory, as applicable, (i) general strategies for the
promoting, Detailing, marketing, sales and distribution of the Licensed Products in each applicable
countries, including the identification of any Third Parties engaged or to be engaged in connection
with such activities and the
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arrangements with them that have been or are proposed to be agreed upon (including policies
and procedures for adjustments, rebates, bundling and the like), (ii) estimated launch date, market
and sales forecasts, in numbers of patients and local currency, and competitive analysis for the
Licensed Products for the Licensee Territory and for each country within the Licensee Territory,
(iii) product positioning and promotional plans (including examples of planned Promotional
Materials), (iv) Phase IV clinical trial support, if applicable, (v) managed care contracting
strategy, (vi) conduct of Licensed Product-specific training programs for sales representatives,
(viii) a detailed manufacturing plan, (ix) pre-launch commercialization activities and the expected
date of launch, (x) sales force size and allocation throughout the Licensee Territory and, during
the Co-Promotion Period, (xi) a detailed budget for the Commercialization Costs to be incurred in
connection with performing such Americas/Europe Commercialization Plan and (xii) an allocation of
specific responsibilities of each of the Parties with respect to Commercialization objectives,
including a specification of target market segments and Detailing requirements and strategy to be
achieved during the calendar year to which the Commercialization Plans relate. The Parties agree
that any forecasts provided by Licensee as part of the Commercialization Plans shall be regarded as
Licensee’s good faith estimates based upon conditions then existing and shall not be binding upon
Licensee. The first such Commercialization Plans shall be prepared by Licensee and furnished to
Licensor through the JSC by no later than twelve months before the anticipated launch of the first
Licensed Product in each of the Americas/Europe Territory and Asia/ROW Territory, respectively, and
shall thereafter be updated annually, with delivery of draft Commercialization Plans to Licensor by
no later than November 1 of each successive Calendar Year and delivery of the final
Commercialization Plans following the approval of such Commercialization Plans by the board of
directors of Licensee.
4.9.2 Ongoing Disclosure Regarding Commercialization. Licensee will keep Licensor
informed about Licensee’s efforts to Commercialize the Licensed Products, including summaries of
Licensee’s (and its Affiliates’ and Sublicensees’) major marketing activities, progress towards
meeting the goals and milestones in the Commercialization Plans, significant developments in the
commercialization of the Licensed Products, any reasons for any deviations or variances (either in
time or in sales or other numerical figures) in meeting sales projections, milestones or timelines
in the Commercialization Plans, any proposed changes in the Commercialization Plans, and
representative samples of Promotional Materials. Such disclosures will be made through the members
of the JSC in a written report provided to Licensor at least once every six months while Licensed
Products are being sold anywhere in the Licensee Territory.
4.10 Manufacture of Licensed Product.
4.10.1 Existing Material. Promptly following the Original Execution Date, Licensor
shall make available to Licensee all existing clinical inventory of the Licensed Products meeting
criteria determined by Licensee and furnished to Licensor. Licensee shall pay 50% of the
Manufacturing Costs for all such material that was released prior to the Original Execution Date
and 100% of the Manufacturing Costs of any such material that is released thereafter. Thereafter,
Licensee shall, with the assistance of Licensor, arrange the Manufacture of additional clinical
material to support Phase II Studies if the existing, transferred inventories are determined by
Licensee to be inadequate to complete the Phase II Studies. Licensor shall maintain and
- 26 -
complete ongoing stability studies of the Licensed Products and keep Licensee reasonably
informed with regard to the results from those studies; provided, that Licensee shall pay all
Development Costs incurred in performing such studies after the Original Execution Date.
4.10.2 Scaled Up Manufacturing. Licensor and Licensee shall discuss and agree on the
optimal strategy for Manufacturing development and scale-up, and for the further Manufacture of the
GMP materials for Phase III Studies and commercial supply of the Licensed Product. In particular,
Licensee shall be responsible for leading process development activities and the Manufacture of GMP
materials for Phase III Studies and commercial supply, and shall reimburse Licensor for its
documented internal costs on an FTE Rate basis and its Third Party costs to assist with the
foregoing activities.
ARTICLE 5
LICENSOR CO-PROMOTION OPTION
5.1 General.
5.1.1 Licensor Co-Promotion Option. Licensor shall have the right (but not the
obligation) to, by giving notice to Licensee at any time prior to the later of (x) three months
after the date on which Licensee notified Licensor under Section 5.1.2 of the expected date of the
filing in Europe of the first MAA for a Licensed Product or (y) the first MAA for a Licensed
Product is filed in Europe (such date, the “Co-Promotion Expiration Date”), to elect to
share in the Commercialization activities of the Licensed Products in Europe with Licensee under
the terms of this Agreement in lieu of receiving royalties from Licensee in respect of Europe under
ARTICLE 7 (the “Licensor Co-Promotion Option”). Licensor shall notify Licensee in writing
of its decision, in its sole discretion, to elect to exercise the Licensor Co-Promotion Option in
Europe.
5.1.2 Notices of Anticipated Option Dates. Promptly following the availability of (a)
top-line results from the first Phase II Study of a Licensed Product and (b) top-line results from
the first Phase III Study of a Licensed Product, Licensee shall notify Licensor and shall provide
all then available data, results and reports of such studies, and Licensor shall also provide
Licensor three months’ prior written notice of the date it expects to file the first MAA for a
Licensed Product.
5.1.3 Statement of Initial Development Costs and Other Information. If Licensor, in
good faith, believes that, subject to the procedures described below, it is more than likely to
exercise Licensor Co-Promotion Option, it shall send a notice to Licensee indicating its intent to
so exercise its rights (the “Option Exercise Intent Notice”). Such Option Exercise Intent
Notice shall include an anticipated Co-Promotion Exercise Date. Within ten (10) Business Days
following the date of the Option Exercise Intent Notice, Licensee shall deliver to Licensor:
(a) a statement, prepared in accordance with GAAP and consistent with the information
regarding Development efforts previously furnished to Licensor through the JSC, setting
forth in reasonable detail the aggregate Development Costs that have been incurred by it
from the Original Execution Date through the anticipated Co-
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Promotion Exercise Date. Unless such aggregate amount is disputed by Licensor within
ten (10) days of its delivery, the aggregate figure reflected in Licensee’s statement shall
be definitive for purposes of ARTICLE 5. If the Licensor disputes such statement, then such
Dispute shall be resolved in accordance with Section 15.7.2(b).
(b) Projection of Development Costs for the next 3 Calendar Years (the “Development
Budget”);
(c) Americas/Europe Commercialization Plan and Projection of Commercialization Costs in
Europe for the next 3 Calendar Years;
(d) Such other material results, development protocols, market potential projections
and other information possessed by Licensee (and that was not previously provided to
Licensor) that in Licensee’s reasonable judgment would be material for making Licensor’s
decision to exercise the Licensor Co-Promotion Option.
5.1.4 Within twenty (20) Business Days following the later of the date of delivery of
Licensee’s statement of the Initial Development Costs, or the resolution of any Dispute with
respect to such statement, and the other information described in Section 5.1.3, Licensor shall
deliver either a notice of its exercise of the Licensor Co-Promotion Option, or a notice that it
has decided not to so exercise such Licensor Co-Promotion Option at such time (without prejudice to
its right to so exercise the Licensor Co-Promotion Option at another time prior to the Co-Promotion
Expiration Date.)
5.1.5 It shall be Licensor’s responsibility to allow for sufficient time following the
delivery of an Option Exercise Intent Notice for Licensor to exercise the Licensor Co-Promotion
Option prior to the specified dates set forth in Section 5.2 below and prior to the Co-Promotion
Expiration Date.
5.2 Development Costs Upon Exercise of Licensor Co-Promotion Option.
5.2.1 Initial Development Costs. Upon the exercise by Licensor of the Licensor
Co-Promotion Option provided for in Section 5.1.1 and within sixty (60) Business Days following the
Co-Promotion Exercise Date, Licensor shall make one of the two following payments to Licensee,
dependent upon the timing of the Co-Promotion Exercise Date:
(a) if the Co-Promotion Exercise Date occurs following the date of the provision to Licensor
by Licensee of top-line results from the first Phase II Study of a Licensed Product but prior to
the provision to Licensor by Licensee of top-line results from the first Phase III Study of a
Licensed Product, Licensor shall make a payment to Licensee in the amount of Thirty-Five Percent
(35%) of Development Costs incurred from the Original Execution Date through the Co-Promotion
Exercise Date; or
(b) if the Co-Promotion Exercise Date occurs following the date of the provision to Licensor
by Licensee of top-line results from the first Phase III Study of a Licensed Product, Licensor
shall make a payment to Licensee in the amount of Forty Percent (40%) of Development Costs incurred
from the Original Execution Date through the Co-Promotion Exercise Date.
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If Licensor does not make such payment within such time period, the Licensor Co-Promotion
Option shall not be effective and Licensor shall no longer have the right to exercise the Licensor
Co-Promotion Option.
5.2.2 Responsibility for Development Costs following Co-Promotion Exercise Date.
During the Co-Promotion Period, the Parties shall share all Development Costs in the following
proportions: Licensor shall bear Twenty-Five Percent (25%) of all Development Costs and Licensee
shall bear Seventy Five Percent (75%) of all Development Costs; provided, that (a) each Party shall
pay 50% of all filing fees in connection with the filing of applications for Regulatory Approvals
for a jurisdiction in Europe and 50% of any Development Costs incurred to conduct a Clinical Study
required only by the EMEA; and (b) Licensee shall bear 100% of all Development Costs (x) incurred
in the first 12 months following the Co-Promotion Exercise Date exceeding 110% of the amount for
such time period set forth in the Development Budget provided under Section 5.1.3 and (y) incurred
in the following 24 months exceeding 115% of the amount for such time period set forth in the
Development Budget provided under Section 5.1.3 (excluding, in each such case (x) or (y),
Development Costs incurred to perform any new Clinical Study that is required by a Regulatory
Authority and was not identified in the Americas/Europe Development Plan at the time of the
Co-Promotion Exercise Date).
5.3 Milestone Payments Upon Exercise of Licensor Co-Promotion Option. If the Licensor
elects to exercise the Licensor Co-Promotion Option, then (a) the milestone payments set forth in
Sections 7.1.2(c), 7.1.2(e), 7.1.2(g) and 7.1.2(i) shall be reduced by 33.3% and (b) the milestone
payments set forth in Section 7.1.3 shall each be reduced by 40%.
5.4 Profit Sharing in Lieu of Royalties. If Licensor elects to exercise the Licensor
Co-Promotion Option, then during the Co-Promotion Period Licensor shall not be entitled to any
royalty payments pursuant to Section 7.2 with respect to Net Sales of the Licensed Product in
Europe recorded from and after the Co-Promotion Exercise Date. In lieu of such royalties, during
the Co-Promotion Period Licensor and Licensee shall divide the Pre-tax Net Profit from Net Sales of
Licensed Products in Europe on a fifty/fifty basis.
5.5 Americas/Europe Commercialization Plan after Exercise of Co-Promotion Option.
During the Co-Promotion Period, while Licensee shall maintain overall authority for the
Commercialization of the Licensed Products in Europe, the Americas/Europe Commercialization Plan
shall include mutually agreed upon obligations on the part of Licensor to provide specified levels
of personnel and resources in specific countries within Europe to assist Licensee in the
Commercialization of the Licensed Products, as well as coordination of promotional materials used
by each Party. In any event, during the Co-Promotion Period Licensor shall have the right, on a
Licensed Product-by-Licensed Product basis, to provide up to 50% of the Details in each of the EU5
Countries, Denmark, Norway and Sweden, and a lesser percentage of Details in other European
countries; provided, that, on the Co-Promotion Exercise Date, Licensor has established, or is then
planning in connection with another product at a similar stage of development to establish, prior
to launch of the first Licensed Product in any such country, an organization having a sufficient
number of sales representatives to conduct such Detailing activities.
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5.6 Amendment to Agreement. Promptly following the Co-Promotion Exercise Date, the
Parties will negotiate in good faith an amendment to this Agreement to provide additional detail
regarding the supervision and implementation of the co-promotion activities contemplated by Section
5.5, periodic reporting of Pre-tax Net Profits and the calculations therefor (including monthly
reporting of estimated Pre-tax Net Profits and quarterly payment reconciling amounts), payment and
credit mechanisms to implement Section 5.4, procedures for the defense of Third Party claims that
are subject to shared costs under Section 13.4, procedures to assure that the Detailing assigned to
each Party within the parameters established by Section 5.5 shall be allocated in an equitable and
proportional manner among targeted prescribers (taking into account specialty, expected prescribing
level, geography and other relevant factors), management provisions relating to Licensor sales or
medical marketing representatives and the coordination of their efforts by Licensee’s marketing
management, and other provisions typically found in co-promotion agreements between parties in the
pharmaceutical industry. If the Parties fail to reach such an agreement within forty-five (45)
days after the Co-Promotion Exercise Date, any Dispute in connection therewith shall be resolved in
accordance with Section 15.7.2(b).
5.7 Accounting Procedures. For purposes of determining Development Costs and
Commercialization Costs, any expense allocated by either Party to a particular category under
Development Costs and Commercialization Costs for the Licensed Products shall not also be allocated
to another category under Development Costs and Commercialization Costs for the
Licensed Products. Each Party shall determine Development Costs and Commercialization Costs
with respect to the Licensed Products using its standard accounting procedures in accordance with
GAAP, consistently applied, to the maximum extent practical as if the Licensed Products were
solely-owned products of the Party (provided that the application of such procedures results, on
balance, in outcomes that are fair and equitable to both Parties taking into consideration the
interests of both Parties as reflected in this Agreement). Each Party shall have the right to
audit the other Party’s records to confirm the accuracy of the other Party’s costs and reports as
provided in Section 7.12. If the Parties fail to agree on the accuracy of such costs and reports,
such Dispute shall be resolved in accordance with Section 15.7.2(b).
5.8 Licensor Right to Opt-Out. Licensor shall have the right to opt-out of its rights
under this ARTICLE 5 to Co-Promote the Licensed Products in Europe upon six (6) months prior
written notice to Licensee (the “Licensor Opt-out Right”).
5.8.1 Conversion to Royalty. Following the effective date of the Licensor Opt-out
Right, Licensor shall no longer share in the Pre-tax Net Profit as provided in Section 5.4 and
Licensee shall instead (a) pay 100% of the amount of all milestone payments set forth in Sections
7.1.2 and 7.1.3 accruing thereafter and (b) in addition to royalties payable under Section 7.2.1,
pay an additional royalty on Net Sales in Europe as provided in Section 7.2.3.
ARTICLE 6
JOINT STEERING COMMITTEE
6.1 Joint Steering Committee (JSC).
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6.1.1 Formation and Purpose. For the purpose of establishing a thorough and effective
co-operation and communication between them during the term of this Agreement, within thirty (30)
days after the Original Execution Date the Parties shall establish a “Joint Steering
Committee” or “JSC” in accordance with this Section 6.1 to exchange information
relating to the Development and the Commercialization of the Licensed Products, as further
described in this Section 6.1 or otherwise set forth in this Agreement, and, among other things, to
facilitate the flow of information with respect to Development activities being conducted for the
Licensed Products and Clinical Studies and Post Approval Studies for the Licensed Products
conducted under the Development Plans. Each Party shall designate its initial members of the JSC
within thirty (30) days after the Original Execution Date by written notice to the other Party.
6.1.2 Specific Responsibilities of the JSC. At its meetings, the JSC shall,
consistent with the terms and conditions of this Agreement,
(a) review the Development Plans and, during the Co-Promotion Period, approve the
Americas/Europe Development Plan for the United States and Europe and the Development Budget
(including all amendments),
(b) monitor the Licensee’s progress toward the objectives and timelines set forth in the
Development Plans and the Commercialization Plans and, during the Co-Promotion Period, the progress
of both Parties towards those objectives with respect to the Americas/Europe Development Plan and
the Americas/Europe Commercialization Plan,
(c) review the Commercialization Plans and, during the Co-Promotion Period, approve the
Americas/Europe Commercialization Plan for Europe,
(d) undertake and/or approve such other matters as are specifically provided for the JSC under
this Agreement, and
(e) serve as a forum for communication between the Parties and to resolve issues as mutually
agreed.
The JSC shall create, when advisable, subcommittees such as, for example, a joint development
committee and/or a joint manufacturing committee, comprised of representatives of each Party having
qualifications and experience relevant to a productive dialogue on the subject matter of each such
subcommittee. All such subcommittees shall report to the JSC.
6.2 General Provisions. The following general provisions shall govern the conduct of
the JSC and such other subcommittees as the JSC may establish from time to time under this
Agreement (each, a “Committee”) except as otherwise expressly provided elsewhere in this
Agreement or as agreed to by the Parties in writing:
6.2.1 Membership. Each Committee shall be comprised of an equal number of
representatives from each of Licensor and Licensee, selected by such Party. The minimum number of
such representatives on each Committee shall be two (2) for each of Licensor and Licensee, which
may be increased to such other number as the Parties may agree. Each of Licensee and Licensor may
replace its respective Committee representatives at any time, with prior written notice to the
other Party. In addition, each Party may, at its discretion, invite
- 31 -
employees, and, with the
consent of the other Party, consultants or scientific advisors, to attend meetings of each
Committee as non-voting observers. Licensee shall designate one of its representatives to serve as
chairperson each Committee which designation Licensee may change from time to time by written
notice to Licensor.
6.2.2 Meetings and Minutes. Each Committee shall meet quarterly, or as otherwise
agreed to by the Parties, with the location of such meetings designated by Licensee, provided that
each Committee may meet by teleconference if in-person meetings are not feasible. The chairperson
of each Committee shall be responsible for calling meetings. Each Party shall bear its own
personnel, travel and lodging expenses relating to Committee meetings. No costs incurred by either
Party in attending such meetings shall be included within Commercialization Costs or Development
Costs.
6.2.3 Procedural Rules. The Committee shall have the right to adopt such standing
rules as shall be necessary for its work to the extent that such rules are not inconsistent with
this Agreement. A quorum of the Committee shall exist whenever there is present at a meeting at
least one representative appointed by each Party. Members of the Committee may attend a meeting
either in person or by telephone, video conference or similar means in which each participant can
hear what is said by, and be heard by, the other participants. Representation by proxy shall be
allowed. With respect to those actions which require the approval of the JSC pursuant to the
express terms of this Agreement, the Committee shall take action by consensus of the members
present at a meeting at which a quorum exists, with each Party having a single vote
irrespective of the number of representatives of such Party in attendance or by a written
resolution signed by a representative of each of the members of the Committee. Employees or
consultants of either Party that are not members of the Committee may attend any meeting of the
Committee; provided, however, that such attendees (a) shall not vote or otherwise participate in
the decision-making process of the Committee and (b) are bound by obligations of confidentiality
and non-disclosure equivalent to those set forth in ARTICLE 11.
6.2.4 Decisions of the JSC. The JSC may make decisions with respect to any subject
matter that is subject to the JSC’s decision-making authority and functions as set forth in Section
6.1.2. All decisions of the JSC shall be made by unanimous vote or written consent, with each Party
each having, collectively, among its respective members, one vote in all decisions. Each Party
shall have obtained all necessary board of directors and other internal approvals before attending
meetings of the JSC regarding all subjects identified in an agenda for a meeting and before casting
its vote on any issue. As to subjects not so identified in advance agendas, the JSC shall, if
necessary, defer decision making for a period of no more than ten (10) Business Days to permit such
authorizations to be obtained. The JSC shall use reasonable efforts to resolve the matters within
its roles and functions or otherwise referred to it. If the JSC cannot reach consensus on a matter
within ten Business Days after such matter has been brought to the JSC’s attention, then such
matter shall be handled in the manner set forth below:
(a) any dispute that cannot be resolved by the JSC shall be referred to the Chief Executive
Officer of each Party for resolution (the “Executives”). If the Executives are unable to
resolve a dispute pursuant to this Section 6.2.4(a) within ten Business Days, the Licensee
Executive shall have final decision-making authority on all matters appropriately
- 32 -
referred to the
Parties’ Executives and shall make such decisions in good faith after considering the interests of
both Parties.
(b) Notwithstanding subsection (a) above, all decisions on the following matters shall require
the consent of both Parties:
(i) during the Co-Promotion Period, matters requiring a material change in any
Development or Commercialization activities of Licensor with respect to the United States or
Europe;
(ii) any decisions that would result in a breach, violation or modification of the
terms of this Agreement;
(iii) during the Co-Promotion Period after the third anniversary of the Co-Promotion
Exercise Date, (A) any change to the Americas/Europe Development Plan that is likely to
increase Development Costs by more than 10% of the then current budget for the then current
Calendar Year or by more than 15% of the then current budgets for either of the two years
following the then current Calendar Year, or (B) approval of a Development Budget that would
result in Development Costs exceeding in any Calendar Year the most recently approved
Development Budget by more than 10%;
(iv) during the Co-Promotion Period, (A) any change to the Americas/Europe
Commercialization Plan for Europe that is likely to increase the
Commercialization Costs by more than 10% of the then current budget for the then
current Calendar Year or (B) approval of budget of the Americas/Europe Commercialization
Plan for Europe that would result in Commercialization Costs exceeding in any Calendar Year
the most recently approved budget for such Commercialization Costs by more than 10%; and
provided, as to each of cases (iii) and (iv) above, Licensee may proceed without mutual
approval if it agrees to fund all resulting Development Costs and Commercialization Costs
that exceed such budgeted amounts and their respective percentage collars, in which case
Licensee shall have the right to (x) include all such excess Commercialization Costs in the
calculation of Pre-tax Net Profits for the year in which such amounts are expended and (y)
deduct 25% of all such excess Development Costs from Licensor’s share of Pre-tax Net Profits
for the year in which such amounts are expended.
6.2.5 Limitations on Authority. Each Party shall retain the rights, powers and
discretion granted to it under this Agreement and no such rights, powers, or discretion shall be
delegated to or vested in the Committee unless such delegation or vesting of rights is expressly
provided for in this Agreement or the Parties expressly so agree in writing. The Committees shall
not have the power to amend, modify or waive compliance with this Agreement, which may only be
amended or modified as provided in Section 15.9 or compliance with which may only be waived as
provided in Section 15.12.
6.2.6 Interactions Between the JSC and Internal Teams. The Parties recognize that
each Party possesses an internal structure (including various committees, teams and review boards)
that will be involved in administering such Party’s activities under this Agreement. The
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JSC shall
establish procedures to facilitate communications between such JSC and the relevant internal
committee, team or board of each of the Parties in order to maximize the efficiency of the JSC and
the performance of the Parties of their obligations under this Agreement, including by requiring
appropriate members of such JSC to be available at reasonable times and places and upon reasonable
prior notice for making appropriate oral reports to, and responding to reasonable inquiries from,
the relevant internal committee, team or board.
ARTICLE 7
CONSIDERATION
7.1 Payments to Licensor. In partial consideration of the licenses and other rights
granted herein, Licensee has made and shall make the following payments to Licensor:
7.1.1 Signature Fee. On the Original Execution Date, Licensee made a non-refundable,
non-creditable payment of Fifteen Million U.S. Dollars ($15,000,000) of which (a) $5,000,000 was
allocable to reimbursement of costs to be incurred by Licensor in performing the pre-clinical
studies referred to in Section 3.3.1 and (b) the balance compensated Licensor partially for all
costs incurred to research and develop the Licensed Product prior to the Original Execution Date.
7.1.2 Development and Regulatory Milestone Payments for the Americas/Europe Territory.
Subject to Section 5.3, Licensee shall make each of the milestone payments provided below within
ten (10) days following the achievement of the corresponding milestone event:
Development and Regulatory Milestones & Payments
| Milestone | Associated Payment | |||
(a)
|
Upon the earlier of (i) dosing of the first subject enrolled in a Phase III Study; and (ii) first acceptance for filing by the FDA or EMEA of an NDA or MAA for a Licensed Product for an Indication in the Field; provided, that if, on the date of such filing, Licensee is taking action to commence the first Phase III Study of a Licensed Product, the event described in this clause (ii) shall be the earlier of (A) the dosing of the first subject enrolled in a Phase III Study or (B) 9 months from the date of such filing | [***] | ||
(b)
|
Upon the first acceptance for filing by the FDA of an NDA for a Licensed Product for an Indication in the Field | [ ***] in addition to any amount then payable under milestone (a)(ii) | ||
(c)
|
Upon the first acceptance for filing by the EMEA of an MAA for a Licensed Product for an Indication in the Field | [ ***], in addition to any amount then payable under milestone (a)(ii) | ||
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Development and Regulatory Milestones & Payments
| Milestone | Associated Payment | |||
(d)
|
Upon the first NDA approval of a Licensed Product in the United States for an Indication in the Field | [ ***] | ||
(e)
|
Upon the first MAA approval of a Licensed Product in the European Union for an Indication in the Field | [ ***] | ||
(f)
|
Upon a subsequent NDA approval of a Licensed Product in a second tumor type or any Indication outside of oncology in the United States or of a different formulation of a Licensed Compound for a previously approved Indication | [***] | ||
(g)
|
Upon a subsequent MAA approval of a Licensed Product in a second tumor type or any Indication outside of oncology in the European Union or of a different formulation of a Licensed Compound for a previously approved Indication | [***] | ||
(h)
|
Upon a subsequent NDA approval of a Licensed Product in a third tumor type or any Indication outside of Oncology that was not the previously approved in the United States for such Licensed Product in the United States or of a different formulation of a Licensed Compound for a previously approved Indication | [ ***] | ||
(i)
|
Upon a subsequent MAA approval of a Licensed Product in a third tumor type or any Indication outside of oncology that was not the previously approved in the European Union for such Licensed Product in Europe or of a different formulation of a Licensed Compound for a previously approved Indication | [ ***] | ||
7.1.3 Sales Milestone Payments for the Americas/Europe Territory. Subject to Section
5.3, Licensee shall make each of the milestone payments provided below upon the first achievement
of the corresponding milestone event, with such payment to be made within sixty (60) days following
the completion of the applicable quarter in which such level of sales is first achieved:
Sales Milestones & Payments
| Milestone | Associated Payment | |||
(a)
|
*** U.S. Dollars ($***) in aggregate Net Sales of Licensed Products in the Americas/Europe Territory during any four consecutive calendar quarters | [ ***] | ||
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| Milestone | Associated Payment | |||
(b)
|
*** U.S. Dollars ($***) in aggregate Net Sales of Licensed Products in the Americas/Europe Territory during any four consecutive calendar quarters | [ ***] | ||
(c)
|
*** U.S. Dollars ($***) in aggregate Net Sales of Licensed Products in the Americas/Europe Territory during any four consecutive calendar quarters | [ ***] | ||
(d)
|
*** U.S. Dollars ($***) in aggregate Net Sales of Licensed Products in the Americas/Europe Territory during any four consecutive calendar quarters | [ ***] | ||
(e)
|
*** U.S. Dollars ($***) in aggregate Net Sales of Licensed Products in the Americas/Europe Territory during any four consecutive calendar quarters | [ ***] | ||
7.1.4 Distributor Revenues. Licensee shall also pay Licensor ***% of all upfront and
milestone payments paid to Licensee or its Affiliates by any Distributor.
7.1.5 Fee for Expansion of Licensee Territory to include the Asia/ROW Territory.
Licensee shall make a non-refundable, non-creditable payment of Ten Million U.S. Dollars
($10,000,000) on the Effective Date.
7.1.6 Development and Regulatory Milestones Payments for Asia/ROW Territory. Subject
to Sections 7.1.8 (a) and (d), Licensee shall make each of the milestone payments provided below
within ten (10) days following the achievement of the corresponding milestone event:
Development and Regulatory Milestones & Payments for Asia/ROW Territory
| Milestone | Associated Payment | |||
(a)
|
Upon the first acceptance by applicable Regulatory Authorities in Japan or China for filing of a Drug Approval Application for a Licensed Product for an Indication in the Field | [ ***] | ||
(b)
|
Upon first approval by applicable Regulatory Authorities in Japan or China of a Drug Approval Application for a Licensed Product for an Indication in the Field | [ ***] | ||
(c)
|
Upon a subsequent approval by applicable Regulatory Authorities in Japan or China of a Drug Approval Application for a Licensed Product in a second tumor type or any Indication outside of oncology or of a different formulation of a Licensed Compound for a previously approved Indication in such country | [ ***] | ||
- 36 -
7.1.7 Sales Milestone Payments for the Asia/ROW Territory. Subject to Sections 7.1.8
(a), (b) and (d), Licensee shall make each of the milestone payments provided below upon the first
achievement of the corresponding milestone event, with such payment to be made within sixty (60)
days following the completion of the applicable quarter in which such level of sales is first
achieved:
Sales Milestones & Payments
| Milestone | Associated Payment | |||
(a)
|
*** U.S. Dollars ($***) in aggregate Net Sales of Licensed Products in the Asia/ROW Territory during any four consecutive calendar quarters | [ ***] | ||
(b)
|
*** U.S. Dollars ($***) in aggregate Net Sales of Licensed Products in the Asia/ROW Territory during any four consecutive calendar quarters | [ ***] | ||
(b)
|
*** U.S. Dollars ($***) in aggregate Net Sales of Licensed Products in the Asia/ROW Territory during any four consecutive calendar quarters | [ ***] | ||
(c)
|
*** U.S. Dollars ($***) in aggregate Net Sales of Licensed Products in the Asia/ROW Territory during any four consecutive calendar quarters | [ ***] | ||
7.1.8 Milestone Payment Terms. For clarification:
(a) each milestone payment described in Section 7.1.2, 7.1.3, 7.1.6 or 7.1.7 shall be payable
only once irrespective of the number of times the milestone events set forth such sections shall
have been achieved;
(b) sales milestones shall be measured over a period of four consecutive quarters and not on a
cumulative basis from the inception of sales; if more than one sales milestone is achieved in any
four consecutive calendar quarters, both milestone payments are payable; if one or more sales
milestones are achieved during any four consecutive calendar quarters, none of the sales in any
such quarter may be counted again in determining whether the next sales milestone is achieved;
(c) sales of Licensed Product on a named patient basis or under a compassionate use program
prior to approval of an MAA in Europe shall be excluded from the determination of sales milestones,
unless such sales by themselves achieve any sales milestone prior to approval of an MAA in Europe;
and
- 37 -
(d) Licensee shall notify Licensor promptly of any determination, filing or approval that
would trigger a payment by Licensee to Licensor under Section 7.1.2, 7.1.3, 7.1.6 or 7.1.7 and the
amount of the payment required and shall pay such amount as provided herein.
7.2 Royalties.
7.2.1 Subject to Sections 7.3, 7.4 and 8.4, for sales of Licensed Products in the Licensee
Territory, Licensee shall pay Licensor royalties based on the following table, with each royalty
percentage being applicable to the portion of the annual Net Sales of the Licensed Products falling
within the relevant band of the Net Sales for a Calendar Year:
| Total annual Net Sales of | ||
| Licensed Products in Licensee | ||
| Territory | Applicable royalty rate | |
Less than US$***
|
***% | |
US$*** and greater
|
*** |
For purposes of the foregoing, it is understood that annual Net Sales shall be calculated on a
Calendar Year basis. For example, if in a Calendar Year, Net Sales of US$*** of Licensed Products
were realized by Licensee, the royalty payable would be US$ *** ( ***% of the first US$*** and
***% of the next US$***).
7.2.2 The ***% royalty rate described above shall apply only as long as the Manufacturing
Costs (for the units comprising the applicable Net Sales and expressed as a percentage of Net
Sales) are less than or equal to ***% of the Net Sales of the Licensed Product. If the
Manufacturing Costs exceed such level in any quarter, the royalty rate for such quarter shall be
reduced sufficiently to reflect an equal sharing by both Parties of the amount by which such
Manufacturing Costs exceed ***% of Net Sales; provided, that the royalty rate shall not be less
than ***% on annual Net Sales up to and including US$***
7.2.3 Following the effective date of a Licensor Opt-out Right pursuant to Section 5.8,
Licensee shall pay an additional royalty equal to 5% of the Net Sales in Europe; provided, that,
such additional royalty obligation shall terminate when the aggregate amount of such additional
royalties paid equals 125% of the amount of Development Costs paid by Licensor under Section 5.2.
Notwithstanding anything to the contrary in this Agreement, such additional royalty shall not be
subject to any deductions or credits under Section 8.4.
7.2.4 Notwithstanding the foregoing or any other provision of this Agreement (including any
deductions or credits under Article 8), in no event shall the royalty rate on Net Sales be at a
rate less than [ ***] ([ ***]%) (“Royalty Rate Floor”).
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7.3 Royalty Term. Licensee’s obligations to pay royalties under this ARTICLE 7 shall
terminate, on a country-by-country basis, at such time as Licensee or any Sublicensee is no longer
selling Licensed Products in such country (the “Royalty Term”).
7.4 Royalty Adjustment for Generic Competition. In the event that there is Generic
Competition (as defined below) with respect to a Licensed Product in any country in the Licensee
Territory, the royalty payable by Licensee on Net Sales of Licensed Products in such
country only shall be reduced to the Royalty Rate Floor following the first occurrence of
Generic Competition in such country and for as long as Generic Competition prevails in such
country. In this Section, “Generic Competition” means the commercial sale in any country
in the Licensee Territory of a product that contains the Licensed Compound in a formulation
equivalent to that of a Licensed Product pursuant to an approved ANDA or its equivalent filing in a
jurisdiction outside of the United States.
7.5 Methodology for Royalty Offsets. For purposes of any royalty offsets under Section
8.4:
(a) Royalties in each quarter shall be calculated using the weighted average royalty rate on
the cumulative year-to-date aggregate Net Sales in the Licensee Territory;
(b) Such weighted average royalty rate (the “Average Full Royalty Rate") will be
applied to the cumulative year-to-date Net Sales in any country in which none of the reductions,
deductions or credits referred to Section 8.4 apply; and
(c) In respect of all other countries, the Average Full Royalty Rate will then be adjusted for
each country after taking into account the applicable reductions, deductions or credits referred to
in Section 8.4. Such adjusted Average Full Royalty Rate will then be applied to the cumulative
year-to-date Net Sales in such countries.
7.6 Royalty Payments. Royalties shall be payable on a quarterly basis, within sixty
(60) days after the end of each calendar quarter of each Calendar Year, based upon the Net Sales
during such quarter. Royalties shall be calculated in accordance with GAAP and with the terms of
this ARTICLE 7. Only one royalty payment shall be due on Net Sales even though the sale or use of
a Licensed Product may be covered by more than one Patent or Know-How in a country.
7.7 Royalty Statements. Each royalty payment hereunder shall be accompanied by a
statement showing, on a country-by-country and Licensed Product-by-Licensed Product basis, at a
minimum (a) Invoiced Sales and Net Sales for the Licensee Territory, (b) a detailed breakdown of
any deductions from the Invoiced Sales that were taken to calculate Net Sales, (c) the currency
exchange rates used in determining such Invoiced Sales and Net Sales, and (d) the amount of
royalties due on such Net Sales. Licensee shall also provide a statement of its estimated Net
Sales within ten days after the end of each month.
7.8 Mode of Payment. All payments to Licensor or Licensee under this Agreement shall
be made by deposit of United States dollars in the requisite amount to such bank account as the
receiving Party may from time to time designate by notice to the paying Party. With respect to
sales outside the United States, payments shall be calculated based on currency exchange rates
- 39 -
for
the calendar quarter for which remittance is made for royalties. For each month and each currency,
such exchange rate shall equal the arithmetic average of the daily exchange rates (obtained as
described below) during such calendar quarter; each daily exchange rate shall be obtained from
xxx.XXXXX.xxx or, if not so available, as otherwise agreed by the Parties. Notwithstanding the
foregoing, for purposes of calculating the Net Sales thresholds set forth in Sections 7.1.3,
7.1.7 and 7.2, the aggregate Net Sales with respect to each calendar quarter within
a Calendar Year shall be calculated based on the currency exchange rates for the calendar
quarter in which such Net Sales occurred, in a manner consistent with the exchange rate procedures
set forth in the immediately preceding sentence.
7.9 Taxes.
7.9.1 General. The royalties, milestone payments and other amounts payable by
Licensee to Licensor pursuant to this Agreement (“Payments”) shall not be reduced on
account of any taxes unless required by Applicable Law. Licensor alone shall be responsible for
paying any and all taxes (other than withholding taxes required by Applicable Law to be paid by
Licensee) levied on account of, or measured in whole or in part by reference to, any Payments it
receives. Licensee shall deduct or withhold from the Payments any taxes that it is required by
Applicable Law to deduct or withhold. Notwithstanding the foregoing, if Licensor is entitled under
any applicable tax treaty to a reduction of rate of, or the elimination of, applicable withholding
tax, it may deliver to Licensee or the appropriate governmental authority (with the assistance of
Licensee to the extent that this is reasonably required and is expressly requested in writing) the
prescribed forms necessary to reduce the applicable rate of withholding or to relieve Licensee of
its obligation to withhold tax, and Licensee shall apply the reduced rate of withholding, or
dispense with withholding, as the case may be, provided that Licensee has received evidence, in a
form reasonably satisfactory to Licensee, of Licensor’s delivery of all applicable forms (and, if
necessary, its receipt of appropriate governmental authorization) at least fifteen (15) days prior
to the time that the Payments are due. If, in accordance with the foregoing, Licensee withholds
any amount, it shall pay to Licensor the balance when due, make timely payment to the proper taxing
authority of the withheld amount and send to Licensor proof of such payment within sixty (60) days
following that payment. The rights and obligations set forth in this Section 7.9.1 shall apply
mutatis mutandis with respect to any amounts payable by Licensor to Licensee pursuant to Section
3.3.2.
7.9.2 Value Added Tax. Notwithstanding anything contained in Section 7.9.1, this
Section 7.9.2 shall apply with respect to value added tax (“VAT”). All Payments are
exclusive of VAT. If any VAT is chargeable in respect of any Payments, Licensee shall pay VAT at
the applicable rate in respect of any such Payments following the receipt of a VAT invoice in the
appropriate form issued by Licensor in respect of those Payments, such VAT to be payable on the
later of the due date of the payment of the Payments to which such VAT relates and sixty (60) days
after the receipt by Licensee of the applicable invoice relating to that VAT payment.
7.10 Interest on Late Payment. If any payment due to either Party under this
Agreement is overdue (and is not subject to a good faith dispute), then such paying Party shall pay
interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a
daily basis) of the lesser of two percent (2%) above the prime rate as reported in The Wall
- 40 -
Street
Journal, Eastern Edition, and the maximum rate permitted by Applicable Law, such interest to run
from the date upon which payment of such sum became due until payment thereof in full together with
such interest.
7.11 Financial Records. Licensee shall, and shall cause its Affiliates and
Sublicensees to, keep reasonably complete and accurate books and records pertaining to the
Commercialization,
sale, delivery and use of Licensed Products, including books and records of the Invoiced Sales
(including any deductions therefrom) and Net Sales of Licensed Products, in sufficient detail to
calculate the royalties payable under this Agreement. Both Parties shall, and shall cause their
respective Affiliates and, with respect to Licensee, its Sublicensees to, keep reasonably complete
and accurate books and records pertaining to Development Costs and Commercialization Costs and the
costs described in Section 3.3.2 in connection with the Development activities set forth in Exhibit
3.3.2. Such books and records shall be retained by both Parties and their Affiliates and with
respect to Licensee and its Sublicensees until the later of (a) three (3) years after the end of
the period to which such books and records pertain and (b) the expiration of the applicable tax
statute of limitations (or any extensions thereof), or for such longer period as may be required by
Applicable Law.
7.12 Audit. At the request of either Party, the other Party shall, and shall cause
its Affiliates and, with respect to Licensee, its Sublicensees, to, permit the requesting Party and
its representatives, at reasonable times and upon reasonable notice, to examine the books and
records maintained pursuant to Section 7.11. Such examinations may not (a) be conducted for any
Calendar Year more than three (3) years after the end of such year, (b) be conducted more than once
in any twelve (12) month period or (c) be repeated for any Calendar Year. Except as provided
below, the cost of this examination shall be borne by the Party that requested the examination,
unless the audit reveals a variance of more than five percent (5%) from the reported amounts, in
which case the audited Party shall bear the cost of the audit. Unless disputed pursuant to Section
7.13 below, if such audit concludes that additional payments were owed or that excess payments were
made during such period, the paying Party shall pay the additional royalties or the receiving Party
shall reimburse such excess payments, with interest from the date originally due as provided in
Section 7.10, within sixty (60) days after the date on which a written report of such audit is
delivered to the Parties.
7.13 Audit Dispute. In the event of a Dispute regarding such books and records,
including the amount of royalties owed to Licensor under this ARTICLE 7 or the calculation or
allocation of Development Costs and Commercialization Costs pursuant to ARTICLE 5, Licensor and
Licensee shall work in good faith to resolve the disagreement. If the Parties are unable to reach
a mutually acceptable resolution of any such Dispute within thirty (30) days, such Dispute shall be
resolved in accordance with Section 15.7.2(b).
7.14 Confidentiality. The receiving Party shall treat all information subject to
review under this ARTICLE 7 in accordance with the confidentiality provisions of ARTICLE 11 and the
Parties shall cause any auditor or arbitrator to enter into a reasonably acceptable confidentiality
agreement with the audited Party obligating such firm to retain all such financial information in
confidence pursuant to such confidentiality agreement.
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ARTICLE 8
INTELLECTUAL PROPERTY
8.1 Ownership of Intellectual Property.
8.1.1 Ownership of Technology. Subject to Sections 8.1.2, 8.1.3, 8.1.4, 8.1.5 and
8.1.6 and the licenses and rights of reference granted under Section 2.1, as between the Parties,
each Party shall own and retain all right, title and interest in and to any and all: (a)
Information that is conceived, discovered, developed or otherwise made, as necessary to establish
authorship, inventorship or ownership under applicable United States law, by or on behalf of such
Party under or in connection with this Agreement (or its Affiliates or its licensees or
Sublicensees), whether or not patented or patentable, and any and all Patents and Intellectual
Property Rights with respect thereto, except to the extent that any such Information, or any
Patents or Intellectual Property Rights with respect thereto, is Joint Know-How or Joint Patents,
and (b) other Information or other inventions and Patents and Intellectual Property Rights that are
owned or otherwise Controlled (other than pursuant to the license grants set forth in Section 2.1),
by such Party, its Affiliates or its licensees or Sublicensees. In the event that Licensor makes
any Improvement relating to the Licensed Compound or the Licensed Products including a different
formulation of a Licensed Product, Licensor shall have the right, title and interest in the
Improvement and any Patent covering the Improvement, subject to the licenses granted herein.
8.1.2 Ownership of Product Trademarks, Licensor Patents and Licensor Know-How. Subject
to the licenses and rights of reference granted under Section 2.1, as between the Parties, Licensor
shall own and retain all right, title and interest in and to all Product Trademarks, Licensor
Patents and Licensor Know-How.
8.1.3 Ownership of Regulatory Documentation and the Drug Master File. Except for the
IND under which Licensor shall continue to conduct the Phase I Study of the oral formulation of the
Licensed Product, as between the Parties, Licensee shall own all right, title and interest in and
to all Regulatory Approvals and, to the extent they contain Licensee Know-How, the Drug Master
Files with respect to the Licensed Products in the Licensee Territory and the Regulatory
Documentation (other than Clinical Data as to which Section 8.1.4 shall apply) with respect
thereto. Subject to the right of reference granted to Licensee under Section 2.1.4, Licensor shall
own and retain all right, title and interest in and to all other Regulatory Approvals, and all
other Regulatory Documentation with respect to the Licensed Compound or the Licensed Product.
8.1.4 Clinical Data. Licensee shall own and retain all right, title and interest in
and to all Clinical Data generated by or on behalf of Licensee. Subject to the right of reference
granted to Licensee under Section 2.1, Licensor shall own and retain all right, title and interest
in and to all other Clinical Data.
8.1.5 Ownership of Improvements, Joint Patents and Joint Know-How. Except as
expressly set forth in Section 8.1.3 and 8.1.4, as between the Parties, the Parties shall each own
an equal, undivided interest in any and all (a) Information and Improvements that are
- 42 -
conceived,
discovered, developed or otherwise made, as necessary to establish authorship, inventorship or
ownership under applicable United States law, jointly by or on behalf of Licensor (or its
Affiliates), on the one hand, and Licensee (or its Affiliates or its Sublicensees), on the other
hand, in connection with the work conducted under or in connection with this Agreement, whether or
not patented or patentable (to the extent such Information or Improvements are not generally known
and not covered or claimed by Joint Patents, the “Joint Know-How”) and (b)
Patents and Intellectual Property Rights with respect to such Information and Improvements
(the “Joint Patents”). Together, such Information, Improvements, Patents and Intellectual
Property Rights as described in clause (a) and clause (b) of this Section 8.1.5 shall be referred
to herein as the “Joint Intellectual Property Rights”. Notwithstanding the foregoing, the
intravenous formulation of the Licensed Product that the Parties conceive or reduce to practice and
claim in the provisional patent application filed on the 20th of November 2009 which is entitled,
“Parenteral Formulations of Gemcitabine Derivatives” shall be solely owned by Licensor, regardless
of any inventive contribution by Licensee and its employees and other representatives. Each Party
shall promptly disclose to the other Party in writing, and shall cause its Affiliates, licensees
and Sublicensees to so disclose, the development, making, conception or reduction to practice of
any Joint Know-How or Joint Patents. Each Party shall have the right to Exploit the Joint
Intellectual Property Rights outside the scope of this Agreement in any manner that is not
inconsistent with the rights and obligations of the Parties under this Agreement in its sole
discretion, in each case, without the consent of, or an accounting to, the other Party, and
provided, that neither Party shall assign its rights in any Joint Intellectual Property Rights
without the other Party’s prior written consent, such consent not to be unreasonably withheld or
delayed.
8.1.6 Ownership of Corporate Names. As between the Parties, each Party shall retain
all right, title and interest in and to its Corporate Names and agrees that it shall not attack,
dispute or contest the validity of or ownership of such other Party’s Corporate Names or any
registrations issued or issuing with respect thereto.
- 43 -
8.2 Maintenance and Prosecution of Patents and Trademarks.
8.2.1 Licensor. Subject to Section 8.2.4, Licensor, through patent attorneys or
agents of its choice, shall be responsible for obtaining, prosecuting and maintaining all Licensor
Patents and Joint Patents (in the name of both Parties) other than those referred to in Section
8.2.2 below. Reasonable and verifiable expenses incurred by Licensor in the preparation,
registration, filing, prosecution and maintenance (as applicable) of such Licensor Patents or Joint
Patents shall be borne by Licensee. Licensor shall not abandon or cease the prosecution of any
such application for such Licensor Patent or Joint Patent or permit any Patent issuing therefrom to
lapse without first notifying Licensee and permitting Licensee to continue the prosecution of such
applications or registrations or pay any required fees in the name of Licensor, at Licensee’s
expense and through patent attorneys of its choice. Licensee shall not become an assignee of any
Patent or application for Patent as a result of its continuing the prosecution or registration of
an application for Patent or Trademark or paying any fees according to this Section 8.2.1. The
Party responsible for prosecuting a Patent under this Section 8.2 shall also have the
responsibility, at its costs, for all oppositions and interference proceedings in respect of such
Patent.
8.2.2 Licensee. Licensee shall be responsible for obtaining, prosecuting and
maintaining throughout the Licensee Territory, Licensor Patents (in the name of Licensor) and Joint
Patents (in the name of both Parties) that claim only the Licensed Product. In this regard,
Licensee shall have the first right to (a) file, prosecute and maintain Patent applications to seek
such Patent rights for the Licensed Compound and the Licensed Products and any patentable Know-How
in the Licensee Territory and (b) control the selection, development, registration,
prosecution and maintenance of the Product Trademarks (in the name of Licensor) in the
Licensee Territory. Any expenses incurred by Licensee in the preparation, selection, development,
registration, filing, prosecution and maintenance (as applicable) of such Patents and Product
Trademarks in the Licensee Territory shall be borne by Licensee. With respect to any such Licensor
Patent or Joint Patent or Product Trademark, Licensee shall not abandon or cease the prosecution of
any such application for a Patent or Product Trademark (or preparation thereof) or permit any
Patent or Product Trademark issuing therefrom to lapse without first notifying Licensor and
permitting Licensor to continue the preparation, filing, prosecution and maintenance of such
applications or pay any required fees in the name of Licensee, at Licensor’s expense and through
patent attorneys or agents of its choice. Licensee shall be solely responsible, at its costs, for
prosecuting and maintaining all Licensee Patents worldwide.
8.2.3 Cooperation. Each Party shall assist and cooperate with the other Party as such
other Party may reasonably request from time to time in connection with its activities set forth in
Section 8.2.1 and 8.2.2. Each Party shall (a) keep the other Party currently informed of the
status of and all steps to be taken in the preparation and prosecution of all applications filed by
it according to this Section 8.2, (b) furnish the other Party with copies of such applications for
Patents, amendments thereto and other related material correspondence to and from patent offices,
and (c) to the extent reasonably practicable, permit the other Party an opportunity to offer its
comments thereon and give such comments good faith consideration before making a submission to a
patent office which could materially affect the scope or validity of the Patent coverage that may
result. Such other Party shall offer its comments, if any, promptly. In respect of the prosecution
of counterpart patent applications of the same Licensor Patent in different
- 44 -
countries, the Parties
shall coordinate such filings so that they take consistent positions with patent offices; if there
are any disputes about such filings, Licensor shall have the right to make all final decisions.
8.2.4 Patent Term Extensions. The JSC shall be responsible for making decisions
regarding patent term extensions, including supplementary protection certificates and any other
extensions that are now or become available in the future, wherever applicable, for Licensor
Patents, Licensee Patents and Joint Patents in any country in the Licensee Territory, provided that
(a) any Dispute with respect thereto shall be resolved by the owner of the applicable Patent or, in
the case of Joint Patents, by Licensee and (b) any applications or filings with respect thereto
shall be made by Licensee in the name of the owner of the applicable Patent. Each Party shall
reasonably cooperate, as requested by the other Party, to promptly and timely implement or effect
such decisions. Notwithstanding the foregoing, the Parties shall coordinate their activities with
respect to any patent term extension with respect to all Patents in order to secure the optimal
protection for the Licensed Products available under Applicable Law.
8.3 Enforcement of Patents and Trademarks.
8.3.1 Rights and Procedures. In the event that either Party reasonably believes that
a Third Party may be infringing any of the Licensor Patents, the Licensee Patents, the Joint
Patents or the Product Trademarks, such Party shall promptly notify the other Party in writing,
identifying the alleged infringer and the alleged infringement complained of and furnishing the
information upon which such determination is based. With respect to such suspected infringement of
the Licensor Patents, the Licensee Patents, the Joint Patents or the Product
Trademarks that is likely or could reasonably be expected to have a material adverse effect on
the sale of the Licensed Products in the Licensee Territory, Licensee shall have the first right,
but not the obligation, through counsel of its choosing, to take any measures it deems appropriate
to stop such infringing activities by such Third Party in any part of the Licensee Territory. In
respect of such infringement and to the extent not in conflict with the terms of this Agreement,
Licensee shall have the right to grant the infringing Third Party adequate rights and licenses
necessary for continuing such activities in any part of the Licensee Territory to the extent
Licensee has the right to grant such rights under Section 2.3; such Third Party shall then be
deemed a Sublicensee hereunder. In the event Licensee fails within ninety (90) days following
notice of such infringement, as provided in the first sentence of this Section 8.3.1, or earlier
notifies Licensor in writing of its intent not to take, or thereafter ceases to take, Commercially
Reasonable steps to stop any such infringement of any Licensor Patent, Licensee Patent, Joint
Patent or Product Trademark in the Licensee Territory and Licensee has not granted the infringing
Third Party rights and licenses to continue its otherwise infringing activities as permitted above,
then Licensor shall have the right, but not the obligation, to do so. Upon reasonable request by
the enforcing Party, the other Party shall give the enforcing Party all reasonable information and
assistance, including allowing the enforcing Party access to the other Party’s files and documents
and to the other Party’s personnel who may have possession of relevant information and, if
necessary for the enforcing Party to prosecute any legal action, joining in the legal action as a
party at its own expense. Licensor retains the sole right to enforce the Licensor Patents in
respect of any infringement not covered by this Section 8.3.1.
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8.3.2 Generic Competition. Notwithstanding the foregoing, if either Party (a)
reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or
abridged Drug Approval Application in the Licensee Territory that refers to or relies on Regulatory
Documentation submitted by either Party to any Regulatory Authority whether or not such a filing
may be in violation of any Regulatory Exclusivity Period or infringe the Licensor Patents, the
Licensee Patents or the Joint Patents or (b) receives any notice of certification regarding the
Licensor Patents, Joint Patents or Licensee Patents pursuant to the U.S. Drug Price Competition and
Patent Term Restoration Act of 1984 (21 United States Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV))
claiming that any such Patents are invalid or unenforceable or claiming that any such Patents will
not be infringed by the Manufacture, use, marketing or sale of a product for which an ANDA is filed
or (c) receives any equivalent or similar certification or notice in any other jurisdiction, it
shall notify the other Party in writing, identifying the alleged applicant or potential applicant
and furnishing the information upon which such determination is based, and provide the other Party
a copy of any such notice of certification within ten (10) days of receipt and the Parties’ rights
and obligations with respect to any legal action as a result of such certification shall be as set
forth in Section 8.3.1; provided, however, that if the enforcing Party elects not to bring suit
against the Third Party providing notice of such certification within thirty (30) days of receipt
of such notice with respect to any Licensor Patent, Joint Patent or Licensee Patent, then the other
Party shall have the right, but shall not the obligation, to bring suit against such Third Party
and to join the enforcing Party as a Party plaintiff if necessary to bring such a suit, in which
event the other Party shall hold the enforcing Party harmless from and against any and all costs
and expenses of such litigation, including reasonable attorney’s fees and expenses.
8.3.3 Cooperation. If either Party is unable to initiate or to prosecute any action
under this Section 8.3 solely in its own name or it is otherwise advisable to obtain an effective
remedy, the other Party will join such action and will execute, and cause its Affiliates to
execute, all documents necessary for the enforcing Party to initiate litigation to prosecute and
maintain such action. In connection with any action brought by either Party for patent
infringement, the Parties will cooperate fully and will provide each other with any information or
assistance that either Party may reasonably request. Each Party shall keep the other Party
informed of developments in any action or proceeding, including the status of any settlement
negotiations and the terms of any offer related thereto. Each Party may be represented by counsel
of its choice.
8.3.4 Costs and Expenses. Each Party shall bear its own costs and expenses relating
to any enforcement action pursuant to Section 8.3.1 or 8.3.2. Any damages or other amounts
collected shall be used to reimburse the Parties for their costs and expenses in making such
recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such
expenses), with any remainder being allocated as follows: (i) if Licensee was the enforcing Party,
any recovery from the enforcement of rights shall be treated as if such remainder amount were Net
Sales of the Licensed Products in the Licensee Territory (and Licensee shall pay a Royalty on such
amount as provided in Section 7.2.1 without any adjustment, deduction or credits under Articles 7
or 8), and (ii) if Licensor were the enforcing party, such remainder amount shall be shared equally
by the Parties.
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8.4 Potential Third Party Rights.
8.4.1 Third Party Licenses. If the Exploitation of the Licensed Products in
accordance with the terms and conditions of this Agreement, by Licensee, its Affiliates or any of
its Sublicensees or Distributors infringes any Patents of a Third Party in any country, such that
Licensee or any of its Affiliates, Sublicensees or Distributors cannot, in the reasonable judgment
of Licensee, after investigation by and consultation with Licensor and competent patent counsel,
Develop or Commercialize the Licensed Products in such country without infringing the Patents of
such Third Party, then (x) if such Patents have claims that cover only the Licensed Products (as
opposed to those Patents which also cover other products of Licensor), Licensee shall have the
first right to take the lead on negotiating the terms of each such license with such Third Party
and (y) otherwise Licensor shall have the first right to take the lead on negotiating the terms of
each such license, and in each case ((x) and (y)), if such Party does not take such lead, then the
other Party may do so; provided that it shall use Commercially Reasonable Efforts to seek to
obtain, but shall not be required to obtain, worldwide rights with the right to sublicense the
other Party for use with its respective products; and provided, further, in either case that the
Party obtaining such license shall consult with the other Party prior to making any proposal
regarding, or otherwise agreeing to, the terms of any such license. If one or both Parties enter
into such a Third Party license agreement, then:
(a) Each Party shall be solely responsible for all license fees, milestones, royalties or
other such payments due to such any Third Party (“Third Party Payments”) (irrespective of
the Party that has entered into an agreement with, or first made a payment to, such Third Party)
consisting of payments with respect to the Commercialization of, on the one hand a Licensed Product
(in the case of Licensee) or, on the other hand, a product other than a Licensed Product (in the
case of the Licensor). For clarity, during the Co-Promotion Period, an allocated portion, as
between Europe and the other countries in the Licensee Territory based upon sales or reasonably
anticipated sales, of the amounts paid by Licensee to a Third Party as a
Third Party Payment for the Licensee Territory in accordance with this Section shall be
included in the Development Costs and Commercialization Costs; and
(b) Licensee shall have the right to deduct up to *** percent (***%) of any Third Party
Payments paid by Licensee with respect to any country(ies) in the Licensee Territory from royalty
payments set forth in Sections 7.2.1 and 7.2.2 hereunder on Net Sales in such country(ies);
provided that such royalties payable to Licensor under Sections 7.2.1 and 7.2.2 on such Net Sales
shall not be reduced by more than ***percent (***%) in any Calendar Year. In the event that any
reduction permitted under this Section is so limited, Licensee may carry the unused portion of such
Third Party Payments forward to subsequent Calendar Years, subject to the application of the
limitations set forth in this Section.
8.4.2 Invalidity or Unenforceability Defenses or Actions.
(a) In the event that a Third Party or Sublicensee asserts, as a defense or as a counterclaim
in any infringement action under Section 8.3.1, that any Product Trademark, Licensor Patent,
Licensee Patent or Joint Patent is invalid or unenforceable, then the Party enforcing such Product
Trademark or Patent in accordance with Section 8.3 shall defend such a defense or as a counterclaim
in accordance with Section 8.3; provided, that, if Licensee is such
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enforcing Party, it shall
obtain the written consent of Licensor with respect to the Licensor Patents and the Joint Patents,
prior to ceasing to defend, settling or otherwise compromising such defense or counterclaim, such
consent not to be unreasonably withheld or delayed.
(b) Similarly, if a Third Party or Sublicensee asserts, in a declaratory judgment action or
similar action or claim filed by such Third Party, that any Product Trademark, Licensor Patent,
Licensee Patent or Joint Patent is invalid or unenforceable, then the Party first becoming aware of
such action or claim shall promptly give written notice to the other Party, then the Party
enforcing such Product Trademark or Patent in accordance with Section 8.3 shall defend such action
in accordance with Section 8.3; provided, that, if Licensee is such enforcing Party, it shall
obtain the written consent of Licensor with respect to the Licensor Patents and the Joint Patents,
prior to ceasing to defend, settling or otherwise compromising such defense or counterclaim, such
consent not to be unreasonably withheld or delayed.
(c) Each Party shall provide to the other Party all reasonable assistance requested by the
other Party in connection with any action, claim or suit under this Section 8.4.2, including
allowing such other Party access to the assisting Party’s files and documents and to the assisting
Party’s personnel who may have possession of relevant information. In particular, the assisting
Party shall promptly make available to the other Party, free of charge, all information in its
possession or control that it is aware will be reasonably necessary to assist the other Party in
responding to any such action, claim or suit.
(d) Licensee shall not enter into any settlement of any claim or action under Sections 8.3 or
8.4 without the prior written consent of Licensor (which consent will not unreasonably be withheld,
delayed or conditioned) if such settlement includes a finding, stipulation or agreement that any
Licensor Patent is invalid or unenforceable, or results in or requires a reduction in the scope or
abandonment of a claim or enforceable right in any Licensor Patent.
8.4.3 Third Party Litigation. In the event of any actual or threatened suit against
Licensee or its Affiliates, Sublicensees, Distributors or customers alleging that the Development
or Commercialization of a Licensed Product in the Licensee Territory infringes the Patents of any
Third Party, Licensee shall assume direction and control of the defense of claims arising therefrom
(including the right to settle such claims at its sole discretion). Licensee shall be entitled to
credit against up to ***percent (***%) of royalties due to Licensor under Sections 7.2.1 and 7.2.2
of this Agreement in any Calendar Year in respect of the allegedly infringing sales up to half of
the out-of-pocket costs and expenses (including attorneys’ and experts’ fees) reasonably incurred
by Licensee in respect of such action. In the event that any reduction of royalties is limited to
***percent (***%) of royalties due to Licensor under Sections 7.2.1 and 7.2.2 of this Agreement in
any Calendar Year, Licensee may carry the unused portion of such costs and expenses forward to
subsequent Calendar Years, subject to the application of the limitations set forth in this Section.
Licensee will keep Licensor reasonably informed of all material developments in connection with
any such claim, suit, or proceeding. Licensee agrees to provide Licensor with copies of all
pleadings filed in such action and to allow Licensor reasonable opportunity to participate in the
defense of the claims, at its own expense. Each Party shall provide the other Party with copies of
any notices it receives from Third Parties relating to any patent nullity actions, declaratory
judgment actions and any alleged infringement or
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misappropriation of the Intellectual Property
Rights of a Third Party by the Development, Manufacture or Commercialization of a Licensed Product
in any country of the world. Such notices shall be provided promptly, but in no event more than
ten (10) days following receipt thereof.
8.4.4 Retained Rights. Nothing in this Section 8.4 shall prevent Licensee, at its own
expense, from obtaining any license or other rights from Third Parties it deems appropriate in
order to permit the full and unhindered exercise of its rights under this Agreement.
8.4.5 Cooperation. In the event that a Third Party institutes a Patent, trade secret
or other infringement suit against Licensor, Licensee or their respective Affiliates or, in the
case of Licensee, Sublicensees or Distributors, during the term of this Agreement with respect to
the Licensed Products, each Party shall, at its own cost and expense, use all reasonable efforts to
assist and cooperate with the other Party in connection with the defense of such suit.
ARTICLE 9
COMPLAINTS AND ADVERSE EVENT REPORTING
During the Co-Promotion Period:
9.1 Complaints. Each Party shall maintain a record of any and all Complaints it
receives with respect to a Licensed Product. Each Party shall investigate the Complaint and, to
the extent required to be reported to any Regulatory Authority or related to any Adverse Event
Experience, notify the other Party in reasonable detail of any Complaint received by it within five
(5) days after the initial report of the event, and in any event in sufficient time to allow such
Party to comply with all Applicable Law in any country. For purposes of this Section 9.1, a
“Complaint” means any oral or written communication of dissatisfaction regarding the
identity, quality, durability, reliability or performance of a Licensed Product. Examples include
appearance, low
fills, foreign materials, foreign product, lack of effect reports, defective packaging or
defective labeling.
9.2 Adverse Event Reporting. Each Party shall provide the other Party with all
information necessary or desirable for such other Party to comply with its pharmacovigilance
responsibilities, including any Adverse Event Experiences from pre-clinical or clinical laboratory,
animal toxicology and pharmacology studies, clinical trials and commercial experiences with a
Licensed Product. “Adverse Event Experience” shall mean (a) any finding from tests in
laboratory animals or in vitro that suggests a significant risk for human subjects including
reports of mutagenicity, teratogenicity or carcinogenicity and (b) any undesirable, untoward or
noxious event or experience associated with the clinical, commercial or other use or occurring
following administration, of a Licensed Product in humans, occurring at any dose, whether expected
or unexpected and whether or not considered related to or caused by a Licensed Product, including
such an event or experience as occurs in the course of the use of a Licensed Product in
professional practice, in a clinical trial, from overdose, whether accidental or intentional, from
abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic
action of a Licensed Product, and including those events or experiences
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that are required to be
reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to Regulatory Authorities under
corresponding Applicable Law outside the United States.
9.3 Pharmacovigilance. Prior to the Effective Date, Licensor and Licensee have
previously executed a Pharmacovigilance Agreement (“Prior Pharmacovigilance Agreement”).
Such Prior Pharmacovigilance Agreement is hereby terminated as of the Effective Date. Subject to
the terms of this Agreement, promptly following the commencement of the Co-Promotion Period,
Licensor and Licensee shall discuss and develop mutually acceptable guidelines and procedures for
the investigation, exchange, receipt, recordation, communication (as between the Parties) and
exchange of Adverse Event Experience information and all other information regarding matters
covered in this ARTICLE 9. Until such guidelines and procedures are set forth in an agreement
between the Parties (the “Pharmacovigilance Agreement”), the terms of Sections 9.1 and 9.2
shall apply. Following the execution of the Pharmacovigilance Agreement, such Sections shall
continue to apply unless expressly amended by the Parties, provided that in the event of any
conflict between the terms of Sections 9.1 and 9.2 and the terms of the Pharmacovigilance
Agreement, the terms of the Pharmacovigilance Agreement shall control. It is anticipated that such
Pharmacovigilance Agreement shall include provisions for the exchange between the Parties of
Adverse Event Experience reports, the creation and maintenance by Licensee of an electronic
database comprised of all adverse events reported on a worldwide basis with respect to the Licensed
Products and the establishment of appropriate mechanisms by which Licensor can, in a timely manner,
access such database to comply with Applicable Law. Each Party shall be responsible for its own
costs incurred in connection with receiving, recording, reviewing, communicating, reporting and
responding to adverse events.
ARTICLE 10
LICENSED PRODUCT RECALL
10.1 Notification and Recall. During the Co-Promotion Period, in the event that any
Regulatory Authority issues or requests a recall or takes similar action in connection with a
Licensed Product or in the event either Party determines that an event, incident or
circumstance has occurred that may result in the need for a recall or market withdrawal, the Party
notified of or desiring such recall or similar action shall, within twenty-four (24) hours, advise
the other Party thereof by telephone (and confirm by email or facsimile), email or facsimile.
Following notification of a recall in the Licensee Territory, the JSC shall meet to discuss such
notification or recall and Licensee shall decide whether to conduct a recall (except in the case of
a government-mandated recall) and the manner in which any such recall shall be conducted.
10.2 Recall Expenses. Licensee shall bear the expenses of any recall of a Licensed
Product in the Licensee Territory; provided, however, that Licensor shall bear the expense of a
recall to the extent that such recall resulted from Licensor’s gross negligence or willful
misconduct.
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ARTICLE 11
CONFIDENTIALITY AND NON-DISCLOSURE
11.1 Confidentiality Obligations. At all times during the term of this Agreement and
for a period of ten (10) years following termination or expiration hereof, each Party shall, and
shall cause its officers, directors, employees and agents to, keep completely confidential and not
publish or otherwise disclose and not use, directly or indirectly, for any purpose, any
Confidential Information furnished or otherwise made known to it, directly or indirectly, by the
other Party, except to the extent such disclosure or use is expressly permitted by the terms of
this Agreement or is reasonably necessary for the performance of this Agreement. “Confidential
Information” means the terms of this Agreement, any information provided by one Party to
another before or after the Original Execution Date that relates to the terms of this Agreement,
the Licensed Compound or the Licensed Products (including the Regulatory Documentation, Regulatory
Approvals and Drug Master Files any information or data contained therein), any Development or
Commercialization of the Licensed Compound or the Licensed Products or the scientific, regulatory
or business affairs or other activities of either Party. All Clinical Data shall be the
Confidential Information of the Party that owns such data, regardless of which Party furnished such
data. Such Confidential Information may be used by the receiving Party only for the purposes of
carrying out obligations or exercising its rights set forth in this Agreement. Notwithstanding the
foregoing, Confidential Information shall not include any information that:
11.1.1 is or hereafter becomes part of the public domain by public use, publication, general
knowledge or the like through no wrongful act, fault or negligence on the part of receiving Party;
11.1.2 can be demonstrated by documentation or other competent proof to have been in the
receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of
confidentiality with respect to said information;
11.1.3 is subsequently received by the receiving Party from a Third Party who is not bound by
any obligation of confidentiality with respect to said information;
11.1.4 has been published by a Third Party or otherwise enters the public domain through no
fault of the receiving Party in breach of this Agreement; or
11.1.5 can be demonstrated by documentation or other competent evidence to have been
independently developed by or for the receiving Party without reference to the disclosing Party’s
Confidential Information.
Specific aspects or details of Confidential Information shall not be deemed to be within the
public domain or in the possession of the receiving Party merely because the Confidential
Information is embraced by more general information in the public domain or in the possession of
the receiving Party. Further, any combination of Confidential Information shall not be considered
in the public domain or in the possession of the receiving Party merely because individual elements
of such Confidential Information are in the public domain or in the
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possession of the receiving
Party unless the combination and its principles are in the public domain or in the possession of
the receiving Party.
11.2 Permitted Disclosures. Each Party may disclose Confidential Information to the
extent that such disclosure is:
11.2.1 Made in response to a valid order of a court of competent jurisdiction or other
supra-national, federal, national, regional, state, provincial and local governmental or regulatory
body of competent jurisdiction or, if in the reasonable opinion of the receiving Party’s legal
counsel, such disclosure is otherwise required by Applicable Law; provided, however, that the
receiving Party shall first have given notice to the disclosing Party and given the disclosing
Party a reasonable opportunity to quash such order and to obtain a protective order requiring that
the Confidential Information and documents that are the subject of such order be held in confidence
by such court or agency or, if disclosed, be used only for the purposes for which the order was
issued; and provided further that if a disclosure order is not quashed or a protective order is not
obtained, the Confidential Information disclosed in response to such court or governmental order
shall be limited to that information which is legally required to be disclosed in response to such
court or governmental order;
11.2.2 Made by the receiving Party to any Regulatory Authorities as required in connection
with any request for Regulatory Approval, any filing or application (including (a) with respect to
Licensee, disclosures to the U.S. Securities and Exchange Commission or other disclosures required
of public companies under Applicable Law in the United States and (b) with respect to Licensor, any
disclosures required of public companies under Applicable Law in Norway); provided, however, that
prior notice of such disclosure shall be provided to the other Party and reasonable measures, to
the extent available and after consultation with the other Party, shall be taken to assure
confidential treatment of such information, including requests for redaction of confidential terms
of this Agreement;
11.2.3 Made by either Party or its Affiliates or sublicensees to Third Parties as may be
necessary or useful in connection with the Manufacture or Exploitation of the Licensed Compound,
the Licensed Product (to the extent permitted or contemplated hereunder), Improvements thereto or
otherwise in connection with the performance of its obligations or exercise of its rights
(including, with respect to Licensor, its rights under Section 2.2 as
contemplated by this Agreement, including subcontracting and sublicensing transactions in
connection therewith; provided, however, that such persons shall be subject to obligations of
confidentiality and non-use with respect to such Confidential Information comparable to the
obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 11;
11.2.4 Made under confidentiality undertakings to any potential acquirer, merger partner, or
potential providers of equity or debt financing and their advisors.
11.3 Use of Name. Except as expressly set forth in Sections 2.1, neither Party shall
mention or otherwise use the name, insignia, symbol, Trademark, trade name or logotype of the other
Party (or any abbreviation or adaptation thereof) in any publication, press release, promotional
material or other form of publicity without the prior written approval of such other
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Party in each
instance. The restrictions imposed by this Section shall not prohibit either Party from making any
disclosure identifying the other Party that is required by Applicable Law.
11.4 Press Releases. Press releases or other similar public communication by either
Party relating to this Agreement shall be approved in advance by the other Party, which approval
shall not be unreasonably withheld or delayed, except for those communications required by
Applicable Law, disclosures of information for which consent has previously been obtained,
information that has been previously disclosed publicly or as otherwise set forth in this
Agreement; provided that, if reasonably practicable, the other Party is given a reasonable
opportunity to review and comment on any such press release or public communication in advance
thereof.
11.5 Patient Information. The Parties agree to abide (and to cause their respective
Affiliates, Sublicensees and Distributors to abide) and to take (and to cause their respective
Affiliates, Sublicensees and Distributors to take) all reasonable and appropriate actions to ensure
that all Third Parties conducting or assisting with any clinical development activities hereunder
in accordance with, and subject to the terms of, this Agreement, shall abide, to the extent
applicable, by all Applicable Law concerning the confidentiality or protection of patient
identifiable information and/or patient’s protected health information, including the regulations
at 45 C.F.R. Parts 160 and 164 and where relevant, the applicable national laws implementing the
European Union Directive 95/46/EC on the protection of individuals with regard to the processing of
personal data and on the free movement of such data of 24 October 1995 and any other Applicable
Law, in the course of their performance under this Agreement.
11.6 Publications. The JSC (or its appropriate designees) shall determine the
strategy for, and coordinate, the publication and presentation of results of studies of the
Licensed Products or other data generated under this Agreement. Each Party recognizes that the
publication of papers regarding results of and other information regarding activities under this
Agreement, including oral presentations and abstracts, may be beneficial to both Parties, provided
such publications are subject to reasonable controls to protect Confidential Information. In
particular, it is the intent of the Parties to maintain the confidentiality of any Confidential
Information included in any Patent application until such Patent application has been filed.
Accordingly, each Party shall have the right to review and approve any paper proposed for
publication by the other Party, including any oral presentation or abstract, which pertains to
results of Clinical Studies, Post Approval Studies or other studies with respect to the Licensed
Products or includes other data generated under this Agreement or which includes Confidential
Information of the other Party. Before any such paper is submitted for publication or an oral
presentation is made, the publishing or presenting Party shall deliver a complete copy of the paper
or materials for oral presentation to the other Party at least fifteen (15) days prior to
submitting the paper to a publisher or making the presentation. The other Party shall review any
such paper and give its comments to the publishing Party within ten (10) days of the delivery of
such paper to the other Party. With respect to oral presentation materials and abstracts, the
other Party shall make reasonable efforts to expedite review of such materials and abstracts, and
shall return such items as soon as practicable to the publishing or presenting Party with
appropriate comments, if any, but in no event later than ten (10) days from the date of delivery to
the other Party. Failure to respond within such ten (10) days shall be deemed approval to publish
or present. If approval is not given or deemed given, either Party may refer the matter to the JSC
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for resolution together with the reasons for withholding approval. Notwithstanding the foregoing,
the publishing or presenting Party shall comply with the other Party’s request to delete references
to such other Party’s Confidential Information in any such paper and shall withhold publication of
any such paper or any presentation of same for an additional sixty (60) days in order to permit the
Parties to obtain patent protection if either Party deems it necessary. Any publication shall
include recognition of the contributions of the other Party according to standard practice for
assigning scientific credit, either through authorship or acknowledgement, as may be appropriate.
Each Party shall use Commercially Reasonable Efforts to cause investigators and institutions
participating in Clinical Studies and Post Approval Studies for the Licensed Products with which it
contracts to agree to terms substantially similar to those set forth in this Section, which efforts
shall satisfy such Party’s obligations under this Section with respect to such investigators and
institutions.
11.7 Return of Confidential Information. Upon the effective date of the termination
of this Agreement for any reason, either Party may request in writing, and the other Party shall
either, with respect to Confidential Information to which such other Party does not retain rights
hereunder: (i) promptly destroy all copies of such Confidential Information in the possession of
the other Party and confirm such destruction in writing to the requesting Party; or (ii) promptly
deliver to the requesting Party, at the other Party’s expense, all copies of such Confidential
Information in the possession of the other Party; provided, however, the other Party shall be
permitted to retain one (1) copy of such Confidential Information for the sole purpose of
performing any continuing obligations hereunder or for archival purposes. Notwithstanding the
foregoing, such other Party also shall be permitted to retain such additional copies of or any
computer records or files containing such Confidential Information that have been created solely by
such Party’s automatic archiving and back-up procedures, to the extent created and retained in a
manner consistent with such other Party’s standard archiving and back-up procedures, but not for
any other use or purpose. All Confidential Information shall continue to be subject to the terms
of this Agreement for the period set forth in Section 11.1.
11.8 Confidential Disclosure Agreement. The terms of this ARTICLE 11 shall supersede
the terms of the existing Confidential Disclosure Agreement, dated as of May 31, 2009, by and
between Licensor and Licensee.
ARTICLE 12
REPRESENTATIONS AND WARRANTIES
12.1 Representations, Warranties and Covenants. Each Party hereby represents,
warrants and covenants to the other Party that, as of the Original Execution Date and as of the
Effective Date:
12.1.1 Corporate Authority. Such Party (a) has the power and authority and the legal
right to enter into this Agreement and perform its obligations hereunder and (b) has taken all
necessary action on its part required to authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder. This Agreement has been duly executed and delivered
on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is
enforceable against it in accordance with its terms subject to the effects of
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bankruptcy,
insolvency or other laws of general application affecting the enforcement of creditor rights and
judicial principles affecting the availability of specific performance and general principles of
equity, whether enforceability is considered a proceeding at law or equity.
12.1.2 Litigation. Such Party is not aware of any pending or threatened litigation
(and has not received any communication) that alleges that such Party’s activities related to this
Agreement have violated or that by conducting the activities as contemplated herein such Party
would violate, any of the Patent or Intellectual Property Rights of any other Person.
12.1.3 Consents and Approvals. All necessary consents, approvals and authorizations
of all regulatory and governmental authorities and other Persons required to be obtained by such
Party in connection with the execution and delivery of this Agreement and the performance of its
obligations hereunder have been obtained.
12.1.4 Conflicts. The execution and delivery of this Agreement and the performance of
such Party’s obligations hereunder (a) do not conflict with or violate any requirement of
Applicable Law or regulation or any provision of the articles of association or limited partnership
agreement or any similar instrument of such Party, as applicable, in any material way, and (b) do
not conflict with, violate or breach or constitute a default or require any consent under, any
contractual obligation or court or administrative order by which such Party is bound.
12.2 Additional Representations, Warranties and Covenants of Licensee. Licensee
represents, warrants and covenants to Licensor that, as of the Original Execution Date and as of
the Effective Date:
12.2.1 Licensee (a) is a corporation duly organized and in good standing under the laws of
Delaware and (b) has full power and authority and the legal right to own and operate its property
and assets and to carry on its business as it is now being conducted and as it is contemplated to
be conducted by this Agreement.
12.2.2 Neither Licensee nor any of its Affiliates has been debarred or is subject to debarment
and neither Licensee nor any of its Affiliates will use in any capacity, in connection with the
services to be performed under this Agreement, any Person who has been debarred
pursuant to Section 306 of the FFDCA or who is the subject of a conviction described in such
section. Licensee shall inform Licensor in writing immediately if it or any Person who is
performing services hereunder is debarred or is the subject of a conviction described in Section
306 or if any action, suit, claim, investigation or legal or administrative proceeding is pending
or, to the best of Licensee’s Knowledge, is threatened, relating to the debarment or conviction of
Licensee or any Person performing services hereunder.
12.3 Additional Representations, Warranties and Covenants of Licensor. Licensor
represents, warrants and covenants to Licensee that, as of the Original Execution Date and as of
the Effective Date:
12.3.1 Licensor is a corporation duly organized under the laws of Norway and has full power
and authority and the legal right to own and operate its property and assets and to
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carry on its
business as it is now being conducted and as is contemplated to be conducted by this Agreement.
12.3.2 Neither Licensor nor any of its Affiliates has been debarred or is subject to debarment
and neither Licensor nor any of its Affiliates will use in any capacity, in connection with the
services to be performed under this Agreement, any Person who has been debarred pursuant to Section
306 of the FFDCA or who is the subject of a conviction described in such section. Licensor shall
inform Licensee in writing immediately if it or any Person who is performing services hereunder is
debarred or is the subject of a conviction described in Section 306 or if any action, suit, claim,
investigation or legal or administrative proceeding is pending or, to the best of Licensor’s
Knowledge, is threatened, relating to the debarment or conviction of Licensee or any Person
performing services hereunder.
12.3.3 Licensor Controls the Patents listed on Exhibit 1.1.91 and the Licensor Know-How, and
is entitled to grant the licenses specified herein. Licensor has not caused any Licensor Patent to
be subject to any liens or encumbrances and Licensor has not granted to any Third Party any rights
or licenses under any of the Licensor Know-How or Licensor Patents that would conflict with the
licenses granted to Licensee hereunder. To Licensor’s Knowledge, neither the Development nor
Commercialization of the Licensed Products as currently conducted by Licensor or as contemplated by
this Agreement does or would literally infringe or result in the misappropriation of any existing
issued Patent of any Third Party.
12.3.4 To Licensor’s Knowledge, the Licensor Patents have been procured or are being procured
from the respective Patent offices in accordance with Applicable Law.
12.3.5 Licensor has no Knowledge of any actual infringement or threatened infringement of the
Licensor Patents or Licensor Know-How by any Person.
12.3.6 Licensor has no Knowledge of any claim or litigation that has been brought or
threatened in writing by any Person alleging that (a) the Licensor Patents or the Licensor Know-How
are invalid or unenforceable or (b) the Development and Commercialization of the Licensed Products
as contemplated by this Agreement infringes any Patent or other Intellectual Property Right
Controlled by any Third Party.
12.3.7 Licensor has not, up through and including the Original Execution Date, Knowingly
withheld (except as previously stated by Licensor to Licensee) any material information, including
reports of Adverse Event Experiences and warning letters from Regulatory Authorities, in Licensor’s
possession from Licensee in response to Licensee’s reasonable written inquiries in connection with
its due diligence relating to the Licensed Compound, Licensed Products, this Agreement and the
underlying transaction. To Licensor’s Knowledge, the clinical data related to Licensed Products
that Licensor has provided to Licensee prior to the Original Execution Date was, when access was
provided to Licensee, up-to-date and accurate in all material respects and Licensor has provided
Licensee with any material updates to such clinical data that have occurred since the time such
access was provided to Licensee.
12.4 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS
ARTICLE 12, NEITHER PARTY MAKES ANY
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REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED,
EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY
DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS
TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES.
ARTICLE 13
INDEMNITY
13.1 Indemnification of Licensor. Licensee shall indemnify Licensor, its Affiliates
and their respective directors, officers, employees, licensors and agents, and defend and save each
of them harmless, from and against any and all losses, damages, liabilities, costs and expenses
(including reasonable attorneys’ fees and expenses) (collectively, “Losses”) in connection
with any and all suits, investigations, claims or demands of Third Parties (collectively,
“Third Party Claims”) arising from or occurring as a result of: (a) the breach by Licensee
or its Affiliates, Sublicensees or Distributors of any term of this Agreement or the
misappropriation by Licensee or its Affiliates, Sublicensees or Distributors of trade secrets or
other know how of any Third Party; (b) the negligence or willful misconduct on the part of Licensee
or its Affiliates or any Sublicensees or Distributors in performing their obligations under this
Agreement; or (c) subject to Section 13.3 and Section 13.4, the Development, Commercialization and
sale by Licensee or its Affiliates or any Sublicensees or Distributors of the Licensed Products in
the Licensee Territory, except for those Losses which Licensor has an obligation to indemnify
Licensee pursuant to Section 13.2 hereof, as to which Losses each Party shall indemnify the other
to the extent of their respective liability; provided, however, that Licensee shall not be
obligated to indemnify Licensor for any Losses to the extent that such Losses arise as a result of
gross negligence or willful misconduct on the part of Licensor or any of its Affiliates.
13.2 Indemnification of Licensee. Licensor shall indemnify Licensee, its Affiliates
and their respective directors, officers, employees and agents, and defend and save each of them
harmless, from and against any and all Losses in connection with any and all Third Party Claims
arising from or occurring as a result of: (a) the breach by Licensor of this Agreement; or (b) the
negligence or willful misconduct on the part of Licensor in performing its obligations under
this Agreement or the misappropriation by Licensor of trade secrets or other know how of any Third
Party; except for those Losses for which Licensee has an obligation to indemnify Licensor and its
Affiliates pursuant to Section 13.1 hereof, as to which Losses each Party shall indemnify the other
to the extent of their respective liability for the Losses; provided, however, that Licensor shall
not be obligated to indemnify Licensee for any Losses to the extent that such Losses arise as a
result of gross negligence or willful misconduct on the part of Licensee or any of its Affiliates,
Sublicensees or Distributors.
13.3 Certain Losses. Any Losses for personal injury or death or damage or destruction
of property, other than those Losses for which indemnification is provided in Section 13.1(a) or
(b) or Section 13.2(a) or (b), in connection with any claim brought against either Party by a Third
Party resulting directly or indirectly from the conduct of Clinical Studies of a Licensed Product
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by either Party (or its Affiliates, employees or agents) in accordance with the Development Plans
or the Commercialization Plans shall be included as a Development Cost only to the extent such
Losses are not covered by insurance policies of such Party. The Parties shall confer through the
JSC with respect to how to respond to the claim and how to handle the claim in an efficient manner.
In the absence of such an agreement, each Party shall have the right to take such action as it
deems appropriate.
13.4 Losses in Europe. Notwithstanding the forgoing and other than those Losses (i)
for which indemnification is provided in Section 13.1(a) or (b) or Section 13.2(a) or (b) and (ii)
arising out of any liabilities to, or claims, of any employee or contractor of a Party (for which
such Party shall be solely responsible), any Losses incurred during the Co-Promotion Period and (a)
arising out of the Development of the Licensed Products shall be deemed Development Costs and (b)
arising out of the Commercialization of the Licensed Products in Europe shall be deemed
Commercialization Costs.
13.5 Notice of Claim. All indemnification claims in respect of a Party, its
Affiliates or their respective directors, officers, employees and agents shall be made solely by
such Party to this Agreement (the “Indemnified Party”). The Indemnified Party shall give
the indemnifying Party prompt written notice (an “Indemnification Claim Notice”) of any
Losses or discovery of fact upon which such Indemnified Party intends to base a request for
indemnification under Section 13.1 or 13.2, but in no event shall the indemnifying Party be liable
for any Losses that result from any delay in providing such notice. Each Indemnification Claim
Notice must contain a description of the claim and the nature and amount of such Loss (to the
extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall
furnish promptly to the indemnifying Party copies of all papers and official documents received in
respect of any Losses and Third Party Claims.
13.6 Control of Defense. At its option, the indemnifying Party may assume the defense
of any Third Party Claim by giving written notice to the Indemnified Party within thirty (30) days
after the indemnifying Party’s receipt of an Indemnification Claim Notice. The assumption of the
defense of a Third Party Claim by the indemnifying Party shall not be construed as an
acknowledgment that the indemnifying Party is liable to indemnify the Indemnified Party in respect
of the Third Party Claim, nor shall it constitute a waiver by the indemnifying Party of any
defenses it may assert against the Indemnified Party’s claim for
indemnification. Upon assuming the defense of a Third Party Claim, the indemnifying Party may
appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the
indemnifying Party. In the event the indemnifying Party assumes the defense of a Third Party
Claim, the Indemnified Party shall immediately deliver to the indemnifying Party all original
notices and documents (including court papers) received by the Indemnified Party in connection with
the Third Party Claim. Should the indemnifying Party assume the defense of a Third Party Claim,
except as provided in Section 13.6.1, the indemnifying Party shall not be liable to the Indemnified
Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the
analysis, defense or settlement of the Third Party Claim. In the event that it is ultimately
determined that the indemnifying Party is not obligated to indemnify, defend or hold harmless the
Indemnified Party from and against the Third Party Claim, the Indemnified Party shall reimburse the
indemnifying Party for any and all costs and expenses
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(including attorneys’ fees and costs of suit)
and any Third Party Claims incurred by the indemnifying Party in its defense of the Third Party
Claim.
13.6.1 Right to Participate in Defense. Without limiting Section 13.6 above, any
Indemnified Party shall be entitled to participate in, but not control, the defense of such Third
Party Claim and to employ counsel of its choice for such purpose; provided, however, that such
employment shall be at the Indemnified Party’s own expense unless, subject to the consent of an
insurer, if applicable, (a) the employment thereof has been specifically authorized by the
indemnifying Party in writing, (b) the indemnifying Party has failed to assume the defense and
employ counsel in accordance with Section 13.6 (in which case the Indemnified Party shall control
the defense) or (c) the interests of the indemnitee and the indemnifying Party with respect to such
Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of
both parties under Applicable Law, ethical rules or equitable principles.
13.6.2 Settlement. With respect to any Third Party Claims relating solely to the
payment of money damages in connection with a Third Party Claim and that shall not result in the
Indemnified Party’s becoming subject to injunctive or other relief or otherwise adversely affecting
the business of the Indemnified Party in any manner, and as to which the indemnifying Party shall
have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, the
indemnifying Party shall have the sole right to consent to the entry of any judgment, enter into
any settlement or otherwise dispose of such Loss, on such terms as the indemnifying Party, in its
sole discretion, shall deem appropriate. With respect to all other Losses in connection with Third
Party Claims, where the indemnifying Party has assumed the defense of the Third Party Claim in
accordance with Section 13.6.1, the indemnifying Party shall have authority to consent to the entry
of any judgment, enter into any settlement or otherwise dispose of such Loss provided it obtains
the prior written consent of the Indemnified Party (which consent shall not be unreasonably
withheld or delayed). The indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by an Indemnified Party that is reached without the written consent of the
indemnifying Party. Regardless of whether the indemnifying Party chooses to defend or prosecute
any Third Party Claim, no Indemnified Party shall admit any liability with respect to or settle,
compromise or discharge, any Third Party Claim without the prior written consent of the
indemnifying Party, such consent not to be unreasonably withheld or delayed.
13.6.3 Cooperation. Regardless of whether the indemnifying Party chooses to defend or
prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each Indemnified
Party to, cooperate in the defense or prosecution thereof and shall furnish such records,
information and testimony, provide such witnesses and attend such conferences, discovery
proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith.
Such cooperation shall include access during normal business hours afforded to indemnifying Party
to, and reasonable retention by the Indemnified Party of, records and information that are
reasonably relevant to such Third Party Claim, and making Indemnified Parties and other employees
and agents available on a mutually convenient basis to provide additional information and
explanation of any material provided hereunder, and the indemnifying Party shall reimburse the
Indemnified Party for all its reasonable out-of-pocket expenses in connection therewith.
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13.6.4 Expenses. Except as provided above, the costs and expenses, including
fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim
shall be reimbursed on a Calendar Year basis by the indemnifying Party, without prejudice to the
indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject
to refund in the event the indemnifying Party is ultimately held not to be obligated to indemnify
the Indemnified Party.
13.7 Limitation on Damages and Liability. EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE
OR INTENTIONAL MISCONDUCT BY A PARTY OR ITS AFFILIATES (OR WITH RESPECT TO LICENSEE, ITS
SUBLICENSEES OR DISTRIBUTORS), OR WITH RESPECT TO LOSSES ARISING FROM THIRD PARTY CLAIMS UNDER
SECTION 13.1 OR 13.2, NO PARTY OR ANY OF THEIR RESPECTIVE AFFILIATES SHALL BE LIABLE FOR SPECIAL,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR FOR LOST PROFITS, MILESTONES OR ROYALTIES,
WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (a)
THE DEVELOPMENT, MANUFACTURE, USE OR SALE OF THE LICENSED PRODUCT OR LICENSED COMPOUND UNDER THIS
AGREEMENT, (b) THE USE OF OR REFERENCE TO ANY PATENTS, KNOW-HOW, REGULATORY DOCUMENTATION OR DRUG
MASTER FILE, OR (c) ANY BREACH OF, OR FAILURE TO PERFORM, ANY OF THE PROVISIONS OF THIS AGREEMENT.
13.8 Insurance. Each Party shall have and maintain such type and amounts of liability
insurance covering (a) in the case of Licensee, the Manufacture, Development, use and sale of the
Licensed Products or (b) in the case of Licensor, Licensor’s Co-Promotion activities during the
Co-Promotion Period, in each case as is normal and customary in the pharmaceutical industry
generally for parties similarly situated, and shall upon request provide the other Party with a
copy of its policies of insurance in that regard, along with any amendments and revisions thereto.
Each Party shall provide the other Party thirty (30) days’ advance written notice of the
termination of coverage in its insurance program. Licensee shall cause Licensor to be named as an
additional insured under all products liability insurance policies applicable to Licensed Products
sold, or otherwise distributed to patients, in Europe during the Co-Promotion Period. To the
extent that Licensor is able to obtain products liability insurance policies applicable to Licensed
Products sold, or otherwise distributed to patients, in Europe during the Co-Promotion Period,
Licensor shall cause Licensee to be named as an additional insured under such policies. The
Parties acknowledge that further investigation and analysis is required concerning the preferred
insurance and risk management arrangements. Accordingly, the Parties will carry out such
investigation and analysis, discuss the preferred arrangements and make mutually acceptable changes
to the foregoing to reflect the preferred arrangement. The Parties shall further agree upon
financial arrangements concerning the sharing of costs and risks associated with self-insurance
arrangements, deductibles and other risk management arrangements so that the Parties shall equally
share total costs of risk management in respect of products liability risks and products liability
Losses in Europe only to the extent that Licensor exercises its Co-Promotion Option pursuant to
Article 5.
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ARTICLE 14
TERM AND TERMINATION
14.1 Term. This Agreement shall continue in each country in the Licensee Territory
until such time as Licensee or its Sublicensee no longer is selling Licensed Products in any
country in the Licensee Territory, unless earlier terminated in accordance with this ARTICLE 14.
14.2 Termination of this Agreement for Material Breach. In the event that either
Party (the “Breaching Party”) shall be in material default in the performance of any of its
material obligations under this Agreement, in addition to any other right and remedy the other
Party (the “Complaining Party”) may have, the Complaining Party may terminate this
Agreement by sixty (60) days’ prior written notice (the “Notice Period”) to the Breaching
Party, specifying the breach and its claim of right to terminate, provided always that the
termination shall not become effective at the end of the Notice Period if the Breaching Party cures
the breach complained about during the Notice Period (or, if such default cannot be cured within
such sixty (60)-day period, if the Breaching Party commences actions to cure such default within
the Notice Period and thereafter diligently continues such actions, provided that such default is
cured within one hundred eighty (180) days after the receipt of such notice), except in the case of
a payment default of amounts not subject to a good faith Dispute, as to which the Breaching Party
shall have only a ten (10)-day cure period. In the event of a Dispute between the Parties for
which either Party has commenced a dispute resolution proceeding under Section 15.7 before
expiration of the applicable cure period, the applicable cure period shall be tolled during the
pendency of such resolution.
14.3 Termination by Licensee. If Licensee reasonably determines that it is not
feasible for Licensee to pursue the Development or Commercialization of the Licensed Products in a
country within the Licensee Territory due to scientific, technical, regulatory or commercial
reasons, including (a) safety or efficacy concerns, including adverse events of a Licensed Product,
(b) concerns relating to the present or future marketability or profitability of a Licensed
Product, (c) reasons related to Patent coverage or (d) existing and anticipated competition, which
renders the Commercialization of a Licensed Product no longer commercially practicable for
Licensee, then Licensee shall promptly notify Licensor in writing of such determination and provide
Licensor with the pertinent information with respect thereto. Promptly following the receipt of
such notice from Licensee, the Parties shall meet and discuss any amendments to this Agreement to
address Licensee’s concerns. If the Parties are not able to agree on such amendments within forty
five (45) days and if Licensee still reasonably believes that it is not feasible for Licensee to
pursue the Development, launch, Commercialization or sale of a Licensed Product in a country,
Licensee shall, if Licensor requests, appoint Licensor as its exclusive Distributor in such country
under which Licensor shall have all economic benefits from the sale of Licensed Products in such
country. If Licensor does not request such appointment, Licensee may terminate this Agreement with
respect to such country or countries in the Licensee Territory upon six (6) months’ prior written
notice to Licensor; provided, that Licensor may accelerate the effective date of such termination
upon notice to Licensee.
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14.4 Termination Upon Insolvency. Either Party may terminate this Agreement if, at
any time, the other Party or its ultimate parent corporation shall file in any court or agency
pursuant to any statute or regulation of any state, country or jurisdiction, a petition in
bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a
receiver or trustee of that Party or of its assets, or if the other Party or its ultimate parent
corporation shall be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed within sixty (60) days after the filing
thereof, or if the other Party or its ultimate parent corporation shall propose or be a party to
any dissolution or liquidation, or if the other Party or its ultimate parent corporation shall make
an assignment for the benefit of its creditors.
14.5 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this
Agreement by Licensee or Licensor are, and shall otherwise be deemed to be, for purposes of Section
365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under
Section 101 of the U.S. Bankruptcy Code. The Parties agree that the Parties, as licensees of such
rights under this Agreement, shall retain and may fully exercise all of their rights and elections
under the U.S. Bankruptcy Code. The Parties further agree that, in the event of the commencement
of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code, the Party
hereto that is not a Party to such proceeding shall be entitled to a complete duplicate of (or
complete access to, as appropriate) any such intellectual property and all embodiments of such
intellectual property, which, if not already in the non-subject Party’s possession, shall be
promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the
non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to
continue to perform all of its obligations under this Agreement or (b) if not delivered under (a)
above, following the rejection of this Agreement by or on behalf of the Party subject to such
proceeding upon written request therefor by the non-subject Party.
14.6 Termination by Licensor for Patent Challenge. Except to the extent the following
is unenforceable under the Applicable Law of a particular country where a patent application within
the Licensor Patents is pending or a patent within the Licensor Patents is issued, Licensor shall
have the right to terminate this Agreement by written notice effective upon receipt if Licensee or
its Affiliates or their Sublicensee or Distributors directly, or indirectly through a Third Party,
commence or maintain any Patent Challenge. If a Sublicensee or Distributor (or an Affiliate of
such Sublicensee or Distributor) undertakes a Patent Challenge of any such Licensor Patent, then
Licensee upon receipt of notice from Licensor of such Patent Challenge may terminate the applicable
sublicense agreement in its entirety. If Licensee fails to so terminate such sublicense agreement,
Licensor shall terminate all licensed rights granted to Licensee covered by such sublicense
agreement. A “Patent Challenge” means any proceeding opposing, challenging the validity or
enforceability of, opposing any extension of or the grant of a supplementary protection certificate
with respect to, or actively participating in any interference proceeding with respect to, any
Licensor Patent.
14.7 Consequences of Termination.
14.7.1 Upon Termination. Upon any termination of this Agreement under Section 14.2,
14.3, 14.4, or 14.6:
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(a) Subject to Sections 14.7.4, 14.7.7 and 14.7.8, all licenses and sublicenses granted to
Licensee by Licensor under this Agreement shall terminate, and Licensee, its Affiliates,
Sublicensees and Distributors shall have no further right in or to the Licensor Patents or to use
the Licensor Know-How or Product Trademarks.
(b) Licensee shall and does hereby automatically and without any further consideration
relinquish its rights hereunder and assign and cause its Affiliates, Sublicensees and Distributors
to assign to Licensor without further compensation therefor, all right, title and interest, if any,
in and to the Regulatory Approvals, Regulatory Documentation and any Drug Master Files, and shall
grant to Licensor with effect from the effective date of termination a perpetual, irrevocable and
exclusive (including with regard to Licensee and its Affiliates, Sublicensees and Distributors),
worldwide, royalty-free license, with the right to grant sublicenses (through multiple tiers of
sublicensees), under the Joint Patents (to the extent Controlled by Licensee), Joint Know-How (to
the extent Controlled by Licensee), Licensee Know-How and Licensee Patents, solely to Exploit the
Licensed Compound and the Licensed Products. To the extent any such assignment is not legally
permissible or such Regulatory Approvals, Regulatory Documentation or Drug Master Files do not
relate solely to the Licensed Products, Licensee shall grant Licensor the exclusive license and
right (with right to sublicense) to access, use, and cross-reference such Regulatory Approvals,
Regulatory Documentation or Drug Master Files to Develop, Manufacture and Commercialize the
Licensed Product worldwide.
(c) Any payments under Section 7.1 shall be retained by Licensor.
(d) Licensee shall cooperate with Licensor to assure a continuing supply of Licensed Product
for Development and Commercialization in the Licensee Territory, including, to the extent requested
by Licensor, assignment of agreements with Third Party manufacturers, transfer of existing
inventories and transfer of Licensee Know-How relating to the manufacturing of Licensed Product to
Licensor or its designee.
(e) Licensee will responsibly wind-down, in accordance with accepted pharmaceutical industry
norms and ethical practices, any on-going Clinical Studies or Post Approval Studies for which it
has responsibility hereunder in which patient dosing has commenced or, if reasonably practicable
and requested by Licensor, allow Licensor or its CRO to complete such trials (and then assign all
related Regulatory Documentation and investigator and other agreements relating to such studies).
Licensee shall be responsible for any Development Costs associated with such wind-down. Licensor
shall pay all Development Costs incurred by either Party to complete such studies should Licensor
request that such studies be completed.
14.7.2 Ceasing Exploitation of Licensed Product. Subject to Section 14.7.4 and
14.7.7, upon termination of this Agreement, however caused or arising, Licensee shall, and shall
cause its Affiliates, Sublicensees and Distributors to, promptly, cease all Exploitation of the
Licensed Products in the Licensee Territory or such terminated countries, as applicable, and,
within thirty (30) days of the effective date of such termination, at Licensor’s election, either
destroy or return to Licensor, at Licensee’s expense, any and all unsold quantities of Licensed
Product.
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14.7.3 Transfer of Materials. Without limitation to Section 11.7, except as provided
in Section 14.7.4, Licensee shall cooperate with Licensor in transferring to Licensor or a Third
Party, as Licensor may direct, within sixty (60) days of the termination hereof, all data, files
and other materials in the possession or under the control of Licensee or its Affiliates,
Sublicensees (subject to Section 14.7.7) or Distributors that are Controlled by Licensor or
licensed to Licensor upon such termination, except that Licensee may retain one (1) copy of such
data, files or materials Controlled by Licensor for the sole purpose of performing any continuing
obligations hereunder or for archival purposes. Notwithstanding the foregoing, Licensee also shall
be permitted to retain such additional copies of or any computer records or files containing such
data or files that have been created solely by Licensee’s automatic archiving and back-up
procedures, to the extent created and retained in a manner consistent with Licensee’s standard
archiving and back-up procedures, but not for any other use or purpose.
14.7.4 Sale of Inventory. Upon termination of this Agreement under Sections 14.2,
14.3, 14.4 or 14.6, provided that Licensee is not in material breach of any obligation under this
Agreement at the time of such termination, Licensee shall have the right for six (6) months after
the effective date of such termination to dispose of all Licensed Product then in its inventory, as
though this Agreement had not terminated. For the avoidance of doubt, Licensee shall continue to
make payments thereon as provided in ARTICLE 7.
14.7.5 Assignments. In connection with any and all assignments contemplated by this
Section 14.7, Licensee shall execute and deliver, and shall cause its Affiliates and Sublicensees
to execute and deliver such instruments and take such actions as may be necessary or desirable to
effect such transfer.
14.7.6 Remedies. Except as otherwise expressly provided herein, termination of this
Agreement in accordance with the provisions hereof shall not limit remedies which may otherwise be
available in law or equity.
14.7.7 Effect of Termination on Sublicenses. A termination of this Agreement, other
than a termination by Licensee under Section 14.3 hereof, shall not terminate any sublicense
granted by Licensee pursuant to Section 2.3 with respect to a Sublicensee, provided that (a) such
Sublicensee is not in breach of any provision of this Agreement or the applicable sublicense
agreement, (b) such Sublicensee shall perform all obligations of Licensee under this Agreement and
(c) Licensor shall have all rights with respect to any and all Sublicensees as it had hereunder
with respect to Licensee prior to termination of this Agreement with respect to Licensee. Licensee
shall include in any sublicense a provision in which said Sublicensee acknowledges its obligations
to Licensor hereunder and the rights of Licensor to terminate this Agreement with respect to any
Sublicensee for material breaches of this Agreement by such Sublicensee that are within the scope
of Section 14.2 hereof. The failure of Licensee to include in a sublicense the provision
referenced in the immediately preceding sentence shall render the affected sublicense void ab
initio. Notwithstanding the foregoing, sublicenses granted by Licensee pursuant to Section 2.3
shall not so continue with respect to a Sublicensee in countries for which Licensor has established
an organization to sell, or granted rights a Third Party to sell, another product or has then filed
an application seeking regulatory approval to sell another product.
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14.7.8 Assistance. In the event of any termination pursuant to this ARTICLE 14,
Licensee shall, and shall cause its Affiliates, Sublicensees and Distributors to, at the request of
Licensor, provide Licensor with such assistance as is reasonably necessary to effectuate a smooth
and orderly transition of any Development and Commercialization of the Licensed Product, including
any ongoing Clinical Studies or Post Approval Studies, to Licensor or its designee so as to
minimize any disruption of such activities, including the assignment of any such contracts (to the
extent such contracts permit assignment) and the transfer of any such materials related to the
Licensed Product, in each case that is the subject of such obligation, to the extent not prohibited
under the terms of such contracts and requested by Licensee. In performing its obligations under
this Section 14.7.8, Licensee shall, and shall cause its Affiliates, Sublicensees and Distributors
to, cooperate with Licensor (at Licensee’s reasonable expense) to effect such transfers and
assignments in an orderly fashion and shall provide to Licensor or its designee any copies of
relevant documents and rights of reference or access necessary to allow Licensor to Exploit the
Licensed Compound and Licensed Product and any Improvements thereto in any particular country or,
in the event the Agreement is terminated in its entirety, in the world. Licensor shall promptly
compensate Licensee for all of its direct and indirect costs associated with the performance of any
of it obligations under this Section 14.7.8 with respect to any termination of this Agreement by
Licensee under Section 14.2.
14.8 Accrued Rights; Surviving Obligations.
14.8.1 Accrued Rights. Termination or expiration of this Agreement for any reason
shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to
such termination or expiration. Such termination or expiration shall not relieve a Party from
obligations that are expressly indicated to survive the termination or expiration of this
Agreement.
14.8.2 Survival. Without limiting the foregoing, Sections 2.2, 3.4.3, 3.4.5, 3.5
(with respect to the license grants), 7.11, 7.12, 7.13, 7.14, 12.4, 14.5, 14.7, this Section 14.8,
Sections 15.3, 15.5, 15.6, 15.7, 15.8, 15.9, 15.11, 15.12, 15.13, 15.14, 15.15, 15.17 and 15.18 and
Articles 8 (with respect to provisions which by their nature must survive termination), 9, 10, 11,
and 13 of this Agreement shall survive the termination or expiration of this Agreement for any
reason.
ARTICLE 15
MISCELLANEOUS
15.1 Force Majeure. Neither Party shall be held liable or responsible to the other
Party or be deemed to have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement when such failure or delay is caused by or
results from events beyond the reasonable control of the non-performing Party, including fires,
floods, earthquakes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be
declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts or other
labor disturbances (whether involving the workforce of the non-performing Party or of any other
Person), acts of God or acts, omissions or delays in acting by any governmental authority. The
non-performing Party shall notify the other Party of such force majeure promptly after such
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occurrence by giving written notice to the other Party stating the nature of the event, its
anticipated duration, and any action being taken to avoid or minimize its effect. The suspension
of performance shall be of no greater scope and no longer duration than is necessary and the
non-performing Party shall use Commercially Reasonable Efforts to remedy its inability to perform.
In the event that such force majeure event lasts for more than ninety (90) days, such other Party
shall have the right to terminate this Agreement upon sixty (60) days written notice to the
non-performing Party.
15.2 Export Control. This Agreement is made subject to any restrictions concerning
the export of products or technical information from the United States or other countries that may
be imposed on related to the Parties from time to time. Each Party agrees that it shall not
export, directly or indirectly, any technical information acquired from the other Party under this
Agreement or any products using such technical information to a location or in a manner that at the
time of export requires an export license or other governmental approval, without first obtaining
the written consent to do so from the appropriate agency or other governmental entity in accordance
with Applicable Law.
15.3 Non-Solicitation. During the term of this Agreement and for a period of one (1)
year thereafter, neither Party shall actively recruit or solicit any employee of the other Party or
its Affiliates. For the avoidance of doubt, nothing shall limit a Party from engaging in general
recruitment efforts through advertisements or recruiting through “head-hunters” so long as the
employees of the other Party and its Affiliates are not specifically targeted in such recruitment
effort.
15.4 Assignment. Without the prior written consent of the other Party hereto, neither
Party shall sell, transfer, assign, delegate, pledge or otherwise dispose of, whether voluntarily,
involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties
hereunder; provided, however, that (a) Licensor may, without such consent, assign this Agreement
and its rights and obligations hereunder to an Affiliate so long as such assignee entity remains an
Affiliate, to the purchaser of the Licensor Patents or Licensor Know-How or to its successor entity
or acquirer in the event of a merger, consolidation or sale of substantially all of the assets of
Licensor and (b) Licensee may, without such consent, assign this Agreement and its rights and
obligations hereunder to an Affiliate so long as such assignee entity remains an Affiliate or to
its successor entity or acquirer in the event of a merger, consolidation or sale of substantially
all of the assets of Licensee; provided further that in either case ((a) or (b)), with respect to
an assignment to an Affiliate, such assigning Party shall remain responsible for the performance by
such Affiliate of the rights and obligations hereunder. Any attempted assignment or delegation in
violation of the preceding sentence shall be void and of no effect. All validly assigned and
delegated rights and obligations of the Parties hereunder shall be binding upon and inure to the
benefit of and be enforceable by and against the successors and permitted assigns of Licensor or
Licensee, as the case may be. In the event either Party seeks and obtains the other Party’s
consent to assign or delegate its rights or obligations to another Party, the assignee or
transferee shall assume all obligations of its assignor or transferor under this Agreement.
15.5 Severability. If any provision of this Agreement is held to be illegal, invalid
or unenforceable under any present or future law, and if the rights or obligations of either Party
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under this Agreement will not be materially and adversely affected thereby, (a) such provision
shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal,
invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions
of this Agreement shall remain in full force and effect and shall not be affected by the illegal,
invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal,
invalid or unenforceable provision, there shall be added automatically as a part of this Agreement
a legal, valid and enforceable provision as similar in terms to such illegal, invalid or
unenforceable provision as may be possible and reasonably acceptable to the Parties. To the
fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that
would render any provision hereof illegal, invalid or unenforceable in any respect.
15.6 Governing Law, Jurisdiction, Venue and Service.
15.6.1 Governing Law. This Agreement shall be governed by and construed in accordance
with the laws of the State of New York, excluding any conflicts or choice of law rule or principle
that might otherwise refer construction or interpretation of this Agreement to the substantive law
of another jurisdiction. The Parties agree to exclude the application to this Agreement of the
United Nations Convention on Contracts for the International Sale of Goods.
15.6.2 Service. Each Party further agrees that service of any process, summons,
notice or document by registered mail to its address set forth in Section 15.8.2 shall be effective
service of process for any action, suit or proceeding brought against it under this Agreement in
any such court.
15.7 Dispute Resolution. If a dispute arises between the Parties in connection with,
relating to or otherwise arising out of this Agreement or any document or instrument delivered in
connection herewith (a “Dispute”), it shall be resolved pursuant to this Section 15.7.
15.7.1 General. Either Party shall have the right to refer any Dispute to the chief
executive officers of the Parties who shall confer on the resolution of the issue. Any final
decision mutually agreed to by such representatives shall be conclusive and binding on the Parties.
If such officers are not able to agree on the resolution of any such issue within fifteen (15)
Business Days after such issue was first referred to them, either Party may, by written notice to
the other Party, elect to initiate arbitration pursuant to Section 15.7.2(a) for purposes of having
the matter settled. Any Disputes concerning the proper characterization of a Dispute subject to
resolution under this Section 15.7.2(a) as opposed to Section 15.7.2(b) shall be submitted
immediately to arbitration to be resolved pursuant to Section 15.7.2(b).
15.7.2 Arbitration. Any arbitration under this Agreement (each an “Arbitration
Matter”) shall be administered by the London Court of International Arbitration under its
Arbitration Rules then in effect (the “Arbitration Rules”) and as otherwise described in
this Section 15.7.2. Participants in the arbitral panel shall be independent experts (including
lawyers) with at least ten (10) years experience with intellectual property licensing agreements in
the pharmaceutical industry. The arbitration shall take place in the English language at a
location to be agreed by the Parties; provided, however, that in the event that the Parties are
unable to agree on a location for an arbitration under this Agreement within five (5) days of the
demand therefor, such arbitration shall be held in London, England.
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(a) Full Arbitration. Unless Section 15.7.2(b) is applicable, the following
procedures shall apply:
(i) The Parties shall appoint an arbitral panel by mutual agreement. If the Parties
cannot agree on the appointment of an arbitral panel within thirty (30) days of the demand
for arbitration, an arbitrator shall be appointed in accordance with the Arbitration Rules.
(ii) Either Party may apply to the arbitrator for interim injunctive relief until the
arbitration decision is rendered or the Arbitration Matter is otherwise resolved. Either
Party also may, without waiving any right or remedy under this Agreement, seek from any
court having jurisdiction any injunctive or provisional relief necessary to protect the
rights or property of that Party pending resolution of the Arbitration Matter pursuant to
this Section 15.7.2. The arbitrator shall have the authority to grant any equitable and
legal remedies that would be available in any judicial proceeding instituted to resolve the
Dispute submitted to such arbitration in accordance with this Agreement; provided, however,
that the arbitrator shall not have the power to alter or amend the terms or the provisions
of this Agreement. Confirmation of, or judgment upon any award rendered pursuant to this
Section may be entered by any court of competent jurisdiction. The arbitrator shall have no
authority to award punitive or any other type of damages excluded under Section 13.7.
(iii) Each Party shall bear its own costs and expenses and attorneys’ fees, and the
Party that does not prevail in the arbitration proceeding shall pay the arbitrator’s fees
and any administrative fees of arbitration.
(iv) Except to the extent necessary to confirm or obtain judgment on an award or
decision or as may be required by Applicable Law, neither Party may, and the Parties shall
instruct the arbitrator not to, disclose the existence, content, or results of an
arbitration without the prior written consent of both Parties. In no event shall an
arbitration be initiated after the date when commencement of a legal or equitable proceeding
based on the Arbitration Matter would be barred by the applicable New York statute of
limitations.
(v) The Parties hereby agree that any payment to be made by a Party pursuant to a
decision of the arbitrator shall be made in United States dollars, free of any tax or other
deduction. The Parties further agree that the decision of the arbitrator shall be the sole,
exclusive and binding remedy between them regarding determination of the Arbitration Matters
presented.
(b) Accelerated Arbitration. To the extent the Arbitration Matter involves a Dispute
that is submitted to arbitration by a Party under either Sections 5.1.3, 5.6, 5.7, 7.13, the final
sentence of Section 15.7.1 or Exhibit 3.3.2, the procedures set forth in Section 15.7.2(a) shall
apply, except that the following procedures shall also apply:
(i) For purposes of arbitration under this Section 15.7.2(b), the arbitrator shall be
appointed pursuant to Section 15.7.2(a)(i), but shall be a single
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independent, conflict-free arbitrator with the requisite licensing and pharmaceutical
industry experience (such arbitrator, the “Expert”). The Parties may select a
different Expert for each Dispute depending on the nature of the issues presented and
desired expertise.
(ii) Each Party shall prepare and submit a written summary of such Party’s position and
any relevant evidence in support thereof to the Expert within thirty (30) days of the
selection of the Expert. Upon receipt of such summaries from both Parties, the Expert shall
provide copies of the same to the other Party. The Expert shall be authorized to solicit
briefing or other submissions on particular questions. Within fifteen (15) days of the
delivery of such summaries by the Expert, each Party shall submit a written rebuttal of the
other Party’s summary and may also amend and re-submit its original summary. Oral
presentations shall not be permitted unless otherwise requested by the Expert. The Expert
shall make a final decision with respect to the Arbitration Matter within thirty (30) days
following receipt of the last of such rebuttal statements submitted by the Parties and shall
make a determination by selecting the resolution proposed by one of the Parties that as a
whole is the most fair and reasonable to the Parties in light of the totality of the
circumstances and shall provide the Parties with a written statement setting forth the basis
of the determination in connection therewith. For purposes of clarity, the Expert shall
only have the right to select a resolution proposed by one of the Parties in its entirety
and without modification.
(iii) The Parties further agree that the decision of the arbitrator shall be the sole,
exclusive and binding remedy between them regarding determination of the Arbitration Matters
presented. Confirmation of, or judgment upon any award rendered pursuant to this Section
may be entered by any court of competent jurisdiction. The arbitrator shall have no
authority to award punitive or any other type of damages excluded under Section 13.7.
15.7.3 No Termination Pending Dispute Resolution.. During the pendency of any dispute
resolution proceeding under this Section 15.7, (i) this Agreement shall remain in full force and
effect, (ii) the provisions of this Agreement relating to termination for material breach shall not
be effective, (iii) the time periods for cure under Section 14.2 as to any termination notice given
prior to the initiation of arbitration shall be tolled, and (iv) neither Party shall issue a notice
of termination pursuant to such sections, until the arbitral panel has confirmed the existence of
the facts claimed by a Party to be the basis for the asserted material breach.
15.7.4 Interim Relief. Nothing in this Section 15.7 shall preclude either Party from
seeking interim or provisional relief in a court of competent jurisdiction, including a temporary
restraining order, preliminary injunction or other interim equitable relief concerning a Dispute,
if necessary to protect the interests of such Party. This Section 15.7 shall be specifically
enforceable.
15.8 Notices.
15.8.1 Notice Requirements. Any notice, request, demand, waiver, consent, approval or
other communication permitted or required under this Agreement shall be in writing,
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shall refer specifically to this Agreement and shall be deemed given only if delivered by hand
or sent by facsimile transmission (with transmission confirmed) or by internationally recognized
overnight delivery service that maintains records of delivery, addressed to the Parties at their
respective addresses specified in Section 15.8.2 or to such other address as the Party to whom
notice is to be given may have provided to the other Party in accordance with this Section 15.8.
Such notice shall be deemed to have been given as of the date delivered by hand or transmitted by
facsimile (with transmission confirmed) or on the second business day (at the place of delivery)
after deposit with an internationally recognized overnight delivery service. Any notice delivered
by facsimile shall be confirmed by a hard copy delivered as soon as practicable thereafter. This
Section 15.8 is not intended to govern the day-to-day business communications necessary between the
Parties in performing their obligations under the terms of this Agreement.
15.8.2 Address for Notice.
If to Licensee, to:
|
If to Licensor, to: | |
| Clavis Pharma ASA | ||
0000 00xx Xxxxxx
|
Xxxxxxxxx 00X | |
Xxxxxxx, Xxxxxxxx 00000
|
0256 Oslo, Norway | |
Attention: Chief Executive Officer
|
Attention: Chief Executive Officer | |
Facsimile: x0 (000) 000-0000
|
Facsimile: x00 00 00 00 00 | |
with a copy to:
|
with a copy to: | |
Xxxxxxx Xxxx & Xxxxxxxxx LLP
|
Xxxxxx and Xxxx LLP | |
000 Xxxxxxx Xxxxxx
|
000 Xxxxxxxx Xxxxxx | |
Xxx Xxxx, Xxx Xxxx 00000
|
Xxxxxxxx, Xxxxxxxxxxx 00000 | |
Attention: Xxxxx X. Xxxxx, Esq.
|
Attention: Xxxxx X. Xxxxxxxxxx, Esq. | |
Facsimile: x0 (000) 000-0000
|
Facsimile: x0 (000) 000-0000 |
15.9 Entire Agreement. This Agreement, together with the Exhibits attached hereto,
sets forth and constitutes the entire agreement and understanding between the Parties with respect
to the subject matter hereof and all prior agreements, understandings, promises and
representations, whether written or oral, with respect thereto are superseded hereby. Each Party
confirms that it is not relying on any representations or warranties of the other Party except as
specifically set forth herein. No amendment, modification, release or discharge shall be binding
upon the Parties unless in writing and duly executed by authorized representatives of both Parties.
15.10 English Language. This Agreement shall be written and executed in, and all
other communications under or in connection with this Agreement shall be in, the English language.
Any translation into any other language shall not be an official version thereof, and in the event
of any conflict in interpretation between the English version and such translation, the English
version shall control.
15.11 Equitable Relief. The Parties acknowledge and agree that the restrictions set
forth in ARTICLE 11 are reasonable and necessary to protect the legitimate interests of the other
Party and that such other Party would not have entered into this Agreement in the absence of such
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restrictions, and that any breach or threatened breach of any provision of ARTICLE 11 may
result in irreparable injury to such other Party for which there will be no adequate remedy at law.
In the event of a breach or threatened breach of any provision of ARTICLE 11, the non-breaching
Party shall be authorized and entitled to obtain from any court of competent jurisdiction
injunctive relief, whether preliminary or permanent, specific performance and an equitable
accounting of all earnings, profits and other benefits arising from such breach, which rights shall
be cumulative and in addition to any other rights or remedies to which such non-breaching Party may
be entitled in law or equity. Both Parties agree to waive any requirement that the other (a) post
a bond or other security as a condition for obtaining any such relief and (b) show irreparable
harm, balancing of xxxxx, consideration of the public interest or inadequacy of monetary damages as
a remedy. Nothing in this Section 15.11 is intended, or should be construed, to limit either
Party’s right to equitable relief or any other remedy for a breach of any other provision of this
Agreement.
15.12 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement
may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver
shall be effective unless set forth in a written instrument duly executed by or on behalf of the
Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or
of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any
other right hereunder or of any other breach or failure by said other Party whether of a similar
nature or otherwise.
15.13 No Benefit to Third Parties. The representations, warranties, covenants and
agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their
successors and permitted assigns, and they shall not be construed as conferring any rights on any
other Persons.
15.14 Further Assurance. Each Party shall duly execute and deliver, or cause to be
duly executed and delivered, such further instruments and do and cause to be done such further acts
and things, including the filing of such assignments, agreements, documents and instruments, as may
be necessary or as the other Party may reasonably request in connection with this Agreement or to
carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto
such other Party its rights and remedies under this Agreement.
15.15 Relationship of the Parties. It is expressly agreed that Licensor, on the one
hand, and Licensee, on the other hand, shall be independent contractors and that the relationship
between the two Parties shall not constitute a partnership, joint venture or agency. Neither
Licensor, on the one hand, nor Licensee, on the other hand, shall have the authority to make any
statements, representations or commitments of any kind, or to take any action, which shall be
binding on the other, without the prior written consent of the other Party to do so, such consent
not to be unreasonably withheld or delayed. All persons employed by a Party shall be employees of
such Party and not of the other Party and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such Party.
15.16 Counterparts. This Agreement may be executed in two (2) or more counterparts,
each of which shall be deemed an original, but all of which together shall constitute one and the
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same instrument. This Agreement may be executed by facsimile signatures and such signatures
shall be deemed to bind each party hereto as if they were original signature.
15.17 References. Unless otherwise specified, (a) references in this Agreement to any
Article, Section or Exhibit shall mean references to such Article, Section or Exhibit of this
Agreement, (b) references in any section to any clause are references to such clause of such
section and (c) references to any agreement, instrument or other document in this Agreement refer
to such agreement, instrument or other document as originally executed or, if subsequently varied,
replaced or supplemented from time to time, as so varied, replaced or supplemented and in effect at
the relevant time of reference thereto.
15.18 Construction. Except where the context otherwise requires, wherever used, the
singular shall include the plural, the plural the singular, the use of any gender shall be
applicable to all genders. The captions of this Agreement are for convenience of reference only
and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent
of any provision contained in this Agreement. The language of this Agreement shall be deemed to be
the language mutually chosen by the Parties and no rule of strict construction shall be applied
against either Party hereto.
[SIGNATURE PAGE FOLLOWS.]
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THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the date
first written above.
| CLAVIS PHARMA ASA | CLOVIS ONCOLOGY, INC. | |||||||
Signature:
|
/s/ OLAV HELLEBØ | Signature: | /s/ XXXXXXX X. XXXXXXX | |||||
Name :
|
Olav Hellebø | Name : | Xxxxxxx X. Xxxxxxx | |||||
Title :
|
Chief Executive Officer | Title : | President and Chief Executive Officer | |||||
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EXHIBIT 1.1.56
FTE RATE
Internal Cost Calculations
| The following hourly rate shall be the FTE Rate for each of the corresponding four levels of employee — whether at Licensor or Licensee |
| • | VP level and above — US $*** per hour | ||
| • | Director level — US $*** per hour | ||
| • | Manager level — US $*** per hour | ||
| • | Below manager level — US $*** per hour |
| Commencing January 1, 2011, and on January 1 of each year thereafter, each of these FTE Rates shall be adjusted based upon changes in both the United States Department of Labor, Bureau of Labor Statistics Consumer Price Index for All Urban Customers ( CPI-U, 1982-84=100) (the “U.S. CPI”) and the Norwegian Consumer Price Index (1998 = 100) as published by Statistics Norway (Statistisk Sentralbyrå) at xxx.xxx.xx/xxx_xx/xxx-00-xx.xxxx (the “Norwegian CPI”) as follows: |
| 1. | by multiplying the applicable FTE Rate for the immediately preceding Calendar Year by a fraction, the numerator of which is the average U.S.CPI rate for each of the three months ending September 30th of the immediately preceding Calendar Year and the denominator of which is the average U.S.CPI rate for each of the three months ending September 30th of the second preceding Calendar Year ; | ||
| 2. | by multiplying the applicable FTE Rate for the immediately preceding Calendar Year by a fraction, the numerator of which is the average Norwegian CPI rate for each of the three months ending September 30th of the immediately preceding Calendar Year and the denominator of which is the average Norwegian CPI for each of the three months ending September 30th of the second preceding Calendar Year; and | ||
| 3. | by calculating the mathematical average between the FTE Rate determined under clause (1) above and the FTE Rate determined under clause (2) above. This mathematical average shall, as to each level of employee, constitute the new FTE Rate for the year Calendar Year commencing on such January 1. |
| If the U.S. CPI and/or the Norwegian CPI is discontinued or modified in some manner so that they no longer are appropriate, the Parties shall agree upon an alternative index to replace the U.S. CPI or the Norwegian CPI, as applicable, in the adjustment of the FTE Rates described above. | ||
| A time tracking system will be adopted by each Party for people directly involved in the project. |
EXHIBIT 1.1.91
LICENSOR PATENTS
| Title of patent | International filing | PCT/WO | ||||||
| Description of patent | application | PCT number | date | publication number | ||||
| [ ***] | [ ***] | [ ***] | [ ***] | [ ***] | ||||
| [ ***] | [ ***] | [ ***] | [ ***] | [ ***] | ||||
| [ ***] | [ ***] | [ ***] | [ ***] | [ ***] | ||||
| [ ***] | [ ***] | [ ***] | [ ***] | [ ***] |
EXHIBIT 1.1.96
MANUFACTURING COSTS
“Manufacturing Costs” shall mean, as to any Licensed Product, Licensee’s cost of such
Licensed Product as determined by GAAP, consistent with Licensee’s current cost of goods accounting
policies, including only (a) Licensee’s product acquisition costs to a Third Party manufacturer of
the License Product, (b) Licensee’s Fully Allocated Costs of making the Licensed Product, and, in
either case, quality assurance and quality control with respect to the manufacture of such Licensed
Product and the direct costs to ship the Licensed Product to Licensee’s warehouses, and (c) other
than in the determination of Manufacturing Costs for the purpose of determining the royalty rate
under Section 7.2.2, direct costs of delivering the Licensed Product to customers (such as import
or VAT taxes, export fees, shipping and insurance costs, and warehousing costs) which are not paid
by the customer and excluding any allocation of any general or administrative expenses.
* * * * *
“Fully Allocated Costs” shall mean the costs of labor (including allocable
employee benefits and employment taxes), material, energy, utilities or other costs directly
incurred and normal overhead (including, without limitation, administrative labor costs,
maintenance, relevant insurance, depreciation of the equipment and depreciation of the facility)
all determined in accordance with GAAP applied on a consistent basis and measured in U.S. dollars.
EXHIBIT 3.2.1
INITIAL AMERICAS/EUROPE DEVELOPMENT PLAN
[ ***]
EXHIBIT 3.2.1A
INITIAL ASIA/ROW DEVELOPMENT PLAN
[ ***]
EXHIBIT 3.3.2
Certain Development Activities to be Conducted in 2011 and Funded by
Licensor Pursuant to Section 3.3.2
Licensor Pursuant to Section 3.3.2
Subject to the quarterly and aggregate limitations described below, Licensor shall reimburse
Licensee pursuant to Section 3.3.2 for the costs of the following studies and Development
activities, the plans for which have previously been discussed at meetings of the Joint Steering
Committee or otherwise previously disclosed by Licensee to Licensor:
| • | CO-101 Clinical Study 002 — Retrospective Observational Study of Tissue Samples | ||
| • | CO-101 Clinical Study 003 — 2nd Line Therapy — Pancreatic Cancer | ||
| • | CO-101 Clinical Study 004 — Pharmacokinetic Study for CO-101 | ||
| • | Drug product supply for all CO-101 clinical studies, including drug product labeling, packaging and distribution | ||
| • | CMC development for CO-101 , including activities associated with improved drug manufacturing scale, optimizing API concentration, drug stability batches, identification of a second manufacturing site and related CMC development activities |
Licensor shall not be obligated to reimburse Licensee more than $*** million of such costs in
respect of any calendar quarter on a cumulative basis (i.e. if one quarter’s reimbursed expenses
were $*** million, the limitation for the subsequent quarter would be $*** million) or $3.0 million
in the aggregate.
Licensee shall render a quarterly invoice to Licensor within thirty (30) days following the close
of each calendar quarter, the first such invoice to relate to the portion of the calendar quarter
commencing on the Effective Date and ending on December 31, 2010, setting forth the costs to be so
reimbursed. Unless aggregate amount of such costs are disputed by Licensor within ten (10) days of
the delivery of each such invoice, Licensor shall pay each such invoice within twenty (20) days of
the date on which it shall have been rendered by Licensee. Any dispute regarding any such invoice
shall be resolved in accordance with Section 15.7.2(b) of the Agreement, with payment to be made
within ten (10) days following the resolution of such dispute.
All such costs that Licensor shall have so reimbursed shall be excluded from any calculation of
Developmental Costs for purposes of Article 5 of the Agreement.
EXHIBIT 3.3.1
LICENSOR PRE-CLINICAL STUDIES
| • | CYP and PgP studies (studies with cold substance only, studies requiring radiolabelled substance need to be considered) | ||
| • | Excretion balance study in rats (with non-radiolabelled substance) | ||
| • | 3 or 6 mo tox, 1 or 2 species (will try to negotiate 3 mo in 1 species but may require 2 species) | ||
| • | In vitro genotoxicity studies | ||
| • | Combination studies (if the development plan includes combination studies in humans) | ||
| • | Environmental tox study — if required | ||
| • | hERG study in vitro — to be determined | ||
| • | Study of cardiovascular effects — to be included in long term tox studies | ||
| • | In vivo xenograft study in hENT1 low tissue — to be determined (the model does currently not exist) |
EXHIBIT 3.4.1
DESCRIPTION OF ON-GOING CLINICAL STUDIES
CP4126-101 — A phase I Clinical Study of CP-4126 in patients with Advanced Solid Tumours
This is an ongoing, non-randomised, open-label, dose-escalation study where the primary endpoints
is to determine the maximum tolerated dose and the recommended dose of CP-4126 by infusion in
patients with advanced solid tumour. The inclusion has stopped, 43 patients have been included, and
one is still ongoing. This is a multi-centre study that has been executed at three sites.
From the dose escalation, a recommended dose has been established for further phase II studies, in
addition assessments of antitumour activity of CP-4126 in patients with measurable disease and/or
tumour markers display promising response.
CP4126-111 — A Phase I Clinical Study of Oral CP-4126 in Patients with Advanced Solid Tumours
This is an ongoing, two steps, multicentre, phase I clinical study with an initial non-randomised,
dose finding step followed by a randomized, cross over step with oral CP-4126 vs. gemcitabine. In
step I of the study, the primary endpoint is to determine the maximum tolerated dose and
recommended dose for further phase II studies. In step II of the study the primary endpoint is to
compare the pharmacokinetic parameters of oral CP-4126 with intravenously administered gemcitabine.
Three sites are initiated, and the first patient was included in October 2008. 23 patients are
included, and seven dose levels are tested, from 100 mg to 3000 mg. The best antitumour response is
stable disease. The study is in the dose escalating stage (Step I), and the maximum tolerated dose
and recommended dose are not yet established.
CP4126-201 — A phase II study of CP-4126 in Patients with Advanced Pancreatic Cancer
This is an ongoing open-label, randomized, multicentre phase II study to compare CP-4126 with
gemcitabine in patients with advanced pancreatic adenocarcinoma. The randomised part will follow
after completion of a pilot single agent (CP-4126) part of the study. Today, the primary endpoint
is response of the tumour marker CA 19-9; however, a new amendment is now under development where
CA 19-9 is replaced by overall survival as a primary endpoint. The effect of CP-4126 will be
compared to the effect of gemcitabine. All patients will have tumour cells
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collected from the primary tumour or from metastasis, and the status of the human equilibrative
nucleoside transporter (hENT1) will be assessed. The effect of treatment will be assessed according
to high or low levels of hENT1.
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