COLLABORATION
AGREEMENT
by
and between
NOVELOS
THERAPEUTICS, INC.
(a
Delaware corporation)
and
MUNDIPHARMA
INTERNATIONAL CORPORATION LIMITED
(a
Bermuda limited company)
February
11, 2009
(Portions of
this exhibit have been omitted pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended and filed separately with the Securities and
Exchange Commission. Omitted portions are indicated herein by
brackets.)
Table
of Contents
| 1. DEFINITIONS |
1
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1.1. Definitions
|
1
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1.2. Interpretations.
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9
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| 2. LICENSE |
9
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2.1. Grant
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9
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2.2. Sublicense
|
10
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2.3. Limitations
and Reservations
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10
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2.4. Improvements
|
10
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2.5. Non-Competition
|
11
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| 3. PAYMENTS |
11
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3.1. License
Fee and Royalties
|
11
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3.2. Calculations
and Payment of Royalties.
|
11
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3.3. Records
|
12
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3.4. Payments
|
13
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3.5. Overdue
Payments
|
13
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3.6. Taxes
|
13
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3.7. Termination
Report and Payment
|
13
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| 4. DEVELOPMENT |
13
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4.1. Alliance
Manager.
|
13
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4.2. Joint
Consultative Committee.
|
14
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4.3. JCC
Responsibilities.
|
15
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4.4. JCC
Meetings.
|
15
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4.5. Decision
Making.
|
16
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4.6. Pre-Clinical,
CMC Development and Manufacturing Development.
|
16
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4.7. Clinical
Development
|
17
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4.8. Data
Sharing.
|
18
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4.9. Collaborator
Commitment to Development of Lead Product.
|
19
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4.10. Development
of Other Licensed Products
|
21
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| 5. REGULATORY
ACTIVITIES. |
21
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5.1. Responsibility
|
21
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5.2. Correspondence
|
21
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| 6. MARKETING,
SELLING AND COMMERCIALIZATION. |
21
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6.1. Commercialization
Efforts
|
21
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6.2. Pricing/Reimbursement
and Product Launch
|
22
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6.3. Collaborator
Trademarks.
|
22
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6.4. Commercialization
|
23
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6.5. Control
|
23
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| 7. MANUFACTURING. |
23
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7.1. Manufacturer
Selection
|
23
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7.2. GMP
Batches
|
23
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7.3. Novelos
as Manufacturer
|
23
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7.4. Collaborator
as Manufacturer
|
24
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7.5. Technology
Transfer
|
24
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| 8. CONFIDENTIALITY |
24
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8.1. Limited
Disclosure and Use
|
24
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8.2. Effect
of Termination
|
25
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8.3. Unauthorized
Use; Remedies
|
25
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8.4. Exclusive
Property
|
25
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| 9. REPRESENTATIONS;
WARRANTIES |
25
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9.1. Limited
Representation and Warranty.
|
25
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9.2. Disclaimer
of Warranties
|
28
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| 10. COVENANTS |
29
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10.1. Mutual
Covenants.
|
29
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10.2. Covenants
of Novelos
|
29
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10.3. Covenants
of Collaborator
|
31
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| 11. INDEMNIFICATION
AND INSURANCE |
31
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11.1. Indemnification.
|
31
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11.2. Insurance
|
32
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| 12. PROTECTION
OF INTELLECTUAL PROPERTY RIGHTS |
33
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12.1. Cooperation
of Collaborator
|
33
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12.2. Third
Party Infringement
|
33
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| 13. TERM
AND TERMINATION; REVERSION OF RIGHTS |
34
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13.1. Term
of Agreement
|
34
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13.2. Novelos
Right to Terminate.
|
34
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13.3. Collaborator
Right to Terminate.
|
35
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13.4. Effect
of Termination
|
36
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| 14. LIMITATION
OF LIABILITY |
38
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| 15. GENERAL |
38
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15.1. Waivers
and Amendments.
|
38
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15.2. Entire
Agreement
|
38
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15.3. Severability
|
38
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15.4. Relationship
of the Parties
|
39
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15.5. Notices
|
39
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15.6. Governing
Law, Jurisdiction and Dispute Resolution.
|
40
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15.7. Counterparts
|
41
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15.8. Assignment
|
41
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15.9. Force
Majeure
|
41
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15.10. Further
Assurances
|
41
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15.11. Intellectual
Property
|
41
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15.12. Press
Releases and External Communications
|
42
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15.13. Non-Solicitation
of Employees
|
42
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15.14. Expenses
|
42
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15.15. Headings
|
42
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| |
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| Schedule
9.1.1(e) Government Consents and Filings |
44
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| Attachment
1 Novelos Patents |
45
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| Attachment
2 Novelos Trials |
46
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| Attachment
3 Territory |
47
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| Attachment
4 Milestone Payments |
48
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| Attachment
5 Part A - Royalty Payments |
49
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| Attachment
5 (continued) Part B – Super Royalty Payments |
51
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| Attachment
6 CMC Work Program |
52
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| Attachment
7 Pre-Clinical Studies |
54
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| Attachment
8 Manufacturing Development Work |
56
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| Attachment
9 Alternative Dispute Resolution |
57
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| Attachment
10 Press Release |
59
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COLLABORATION
AGREEMENT
THIS
COLLABORATION AGREEMENT (this “Agreement”), effective as of February 11, 2009
(the “Effective Date”), is made between Novelos Therapeutics, Inc., a Delaware
corporation (“Novelos”), having a place of business at One Gateway Center, Suite
504, Newton, Massachusetts, and Mundipharma International Corporation Limited, a
Bermuda limited company (“Collaborator”), having a place of business at 14
Par-la-Ville Road, P.O. Box HM2332, Hamilton HMJX Bermuda, with respect to the
following facts:
RECITALS
A.
Novelos has intellectual property rights, technology and know-how related to
oxidized glutathione-based compounds for the treatment of cancer and
hepatitis.
B. The
Parties desire to enter into a collaborative program pursuant to which Novelos
will grant Collaborator an exclusive License in the Territory (capitalized terms
used but not defined in these Recitals shall have the meanings defined below) to
develop, manufacture, market and sell the Licensed Products on the terms and
conditions set forth below.
NOW
THEREFORE, in consideration of the foregoing premises and the mutual covenants
set forth below, the Parties agree as follows:
1. DEFINITIONS
1.1. Definitions. For
purposes of this Agreement, the terms set forth in this Section 1 shall have the
respective meanings set forth below:
1.1.1. “Action”
shall mean all charges, complaints, actions, suits, proceedings, hearings,
investigations, claims, demands, judgments, orders, decrees, stipulations or
injunctions.
1.1.2. “Affiliate”
shall mean, with respect to either Party, any person, firm, trust, corporation
or other entity or combination thereof which directly or indirectly (a) controls
a Party, (b) is controlled by a Party, or (c) is under common control with a
Party; the terms “control” and “controlled” meaning ownership of fifty percent
(50%) or more, including ownership by trusts with substantially the same
beneficial interests, of the voting and equity rights of such person, firm,
trust, corporation or other entity or combination thereof or the power to direct
the management of such person, firm, trust, corporation or other entity or
combination thereof.
1.1.3. “Agreement”
shall have the meaning set forth in the preamble, together with all appendices,
exhibits and schedules attached hereto, as the same may be amended or
supplemented from time to time, by written agreement of the
Parties.
1.1.4. “Alliance
Manager” shall have the meaning set forth in Section 4.1.1.
1.1.5. “API”
shall mean the active pharmaceutical ingredient of a product.
1.1.6. “BAM”
shall mean the Russian private joint stock company BAM, having a principal place
of business at Pskovskaya Str., 17, St Petersburg 190 121, Russia.
1.1.7. “BAM-RL”
shall mean the Russian private joint stock company BAM – Research Laboratories,
having a principal place of business at Pskovskaya Str., 17, St Petersburg 190
121, Russia.
1.1.8. “2000
BAM Agreement” shall mean the Technology, Assignment, Legal Protection and
Consideration Agreement dated June 20, 2000 between BAM-RL and
Novelos.
1.1.9. “2005
BAM Agreement” shall mean the Technology, Assignment, Legal Protection and
Consideration Agreement dated April 1, 2005 between BAM and Novelos
1.1.10. “Bankruptcy
Code” shall mean, as applicable, the U.S. Bankruptcy Code, as amended from time
to time, and the rules and regulations and guidelines promulgated thereunder or
the bankruptcy laws of any Governmental Authority, as amended from time to time,
and the rules and regulations and guidelines promulgated
thereunder.
1.1.11. “CMC”
shall mean chemistry, manufacturing and controls.
1.1.12. “CTD”
shall mean a Common Technical Document providing for a harmonized structure and
format for an NDA suitable for submission for Regulatory Approval in the
Territory, consistent with the ICH Guidelines.
1.1.13. “Co-Chair”
shall have the meaning set forth in Section 4.2.4.
1.1.14. “Collaborator”
shall have the meaning set forth in the preamble of this Agreement.
1.1.15. “Collaborator
Indemnitees” shall have the meaning set forth in Section 11.1.1.
1.1.16. “Collaborator
Know-How” shall mean, information, procedures, instructions, techniques, data,
technical information, knowledge and experience (including, without limitation,
toxicological, pharmaceutical, clinical, non-clinical and medical data, health
registration data and marketing data), designs, dossiers and technology relating
to or concerned with the Licensed Products (or any of their components or
constituent parts) owned or controlled by Collaborator and used in connection
with the Licensed Products, whether now existing or developed by or on behalf of
Collaborator or its Affiliates after the date of this Agreement, in written,
electronic or other form; provided, however, that the Collaborator Know-How
shall not include the Collaborator Patents, the Novelos Know-How or the Novelos
Patents.
1.1.17. “Collaborator
Patents” shall mean all Patents owned or controlled by Collaborator throughout
the Territory that claim any improvements upon or modifications to the
inventions and discoveries disclosed or claimed in any of the Novelos Patents or
which claim the manufacture or use of any composition of matter or method of use
relating to the Licensed Products and/or relating to GSSG in any combination
with heavy metals.
1.1.18. “Collaborator
Technology” shall mean any Collaborator Patents and Collaborator Know-How and
other discoveries and technical information developed, owned or controlled by
Collaborator related to the Licensed Products. All Collaborator
Technology (except published Collaborator Patents) shall be the Confidential
Information of Collaborator.
1.1.19. “Collaborator
Trials” shall mean the following trials in respect of the Lead Product to be
conducted by Collaborator: (i) the Label Expansion Trial, and (ii)
any bridging or other studies that are required by the Japanese Regulatory
Authorities to be conducted to obtain Regulatory Approval in Japan, provided
that the Collaborator decides such trials are commercially viable to conduct
pursuant to Section 4.9.2(c), in each case as such trials may be modified after
the Effective Date in consultation with the JCC.
1.1.20. “Commercially
Reasonable Efforts” shall mean a level of resources, efforts and urgency to
develop and commercialize the Lead Product applied by a Party that is consistent
with such Party’s practices in actively pursuing the development and
commercialization of its other pharmaceutical products at a similar stage of
product life to the Lead Product and of similar market potential, profit
potential and strategic value, based on conditions prevailing at the relevant
time, taking into account, without limitation, competing products, market
demand, proprietary position, safety, regulatory status, medical or scientific
developments in the field of oncology, any adverse governmental intervention and
any potential legal liability or other legal issues.
1.1.21. “Confidential
Information” shall mean, with respect to a Party, all secret, confidential,
proprietary or non-publicly available information, data and materials of any
kind whatsoever, and all tangible and intangible embodiments thereof of any kind
whatsoever, which is disclosed by such Party or its Affiliates (the “Disclosing
Party”) to the other Party or its Affiliates (the “Receiving Party”) pursuant to
this Agreement, together with analyses, data, compilations, studies or other
documents or records prepared by the Receiving Party or its representatives that
contain or otherwise reflect or are generated from such disclosed information,
and, (i) if disclosed in writing or other tangible medium, is marked or
identified in writing as confidential at the time of disclosure to the Receiving
Party or (ii) if otherwise disclosed or if not so marked or identified in
writing, is identified as confidential at the time of disclosure to the
Receiving Party and is summarized and identified as confidential in writing or
by electronic means within thirty (30) days after such disclosure or which would
reasonably be understood to be confidential. Notwithstanding the
foregoing, Confidential Information of a Party shall not include information
which, and only to the extent, the Receiving Party can establish by written
documentation or electronic records (a) has been publicly known prior to
disclosure of such information by the Disclosing Party to the Receiving Party;
(b) has become publicly known without fault on the part of the Receiving Party,
subsequent to disclosure of such information by the Disclosing Party to the
Receiving Party; (c) has been received by the Receiving Party at any time from a
source, other than the Disclosing Party, rightfully having possession of and the
right to disclose such information free of confidentiality obligations; (d) has
been otherwise known by the Receiving Party free of confidentiality obligations
prior to disclosure of such information by the Disclosing Party to the Receiving
Party; or (e) has been independently developed (as demonstrated by
contemporaneous written or electronic evidence maintained in the ordinary course
of business by the Receiving Party) by employees or agents of the Receiving
Party without access to or use of such information disclosed by the Disclosing
Party to the Receiving Party.
1.1.22. “Disclosing
Party” shall have the meaning set forth in Section 1.1.21.
1.1.23. “Effective
Date” shall have the meaning set forth in the preamble of this
Agreement.
1.1.24. “EMEA”
shall mean the European Medicines Agency.
1.1.25. “European
Registration Trial” shall have the meaning set forth in Section
4.7.1.
1.1.26. “FDA”
shall mean the United States Food and Drug Administration.
1.1.27. “First
Commercial Sale” shall mean the first sale, or other distribution for
consideration, of a Licensed Product to a Third Party by Collaborator or its
Affiliate or Sublicensee in a country in the Territory following grant of a
Regulatory Approval and Pricing Approval for a Licensed Product in such country,
but excluding distributions for purposes of product demonstrations, test
marketing, clinical trial purposes or compassionate or similar
uses.
1.1.28. “Force
Majeure” shall have the meaning set forth in Section 15.9.
1.1.29. “GCP”
shall mean the current Good Clinical Practice standards for the design, conduct,
performance, monitoring, auditing, recording, analyses, and reporting of
clinical trials, including without limitation the requirements in 21 C.F.R.
Parts 11, 50, 54, 56, 312, and 314 and principles detailed in ICH Guidelines,
that provide assurance that the data and reported results are credible and
accurate, and that the rights, integrity, and confidentiality of trial subjects
are protected.
1.1.30. “Generic
Product Competition” shall mean where generic products that are chemically
equivalent to the relevant Licensed Product are being legally sold in a country
of the Territory and Collaborator’s volume market share in such country is
reduced as a result of the availability of such generic products by twenty
percent (20%) or more of the market share by volume in the country(ies) where
the generic products are being sold, as evidenced by IMS data.
1.1.31. “GLP”
shall mean the current Good Laboratory Practices as promulgated under the Act at
21 C.F.R. Part 58 and principles detailed in ICH Guidelines related to
laboratory practice.
1.1.32. “GMP”
shall mean all applicable standards relating to current Good Manufacturing
Practices for fine chemicals, API, intermediates, bulk products or finished
pharmaceutical products, including without limitation (i) the principles
detailed in the Act at 21 U.S.C. 351(a)(2)(B), in U.S. FDA regulations at 21
C.F.R. Parts 210 and 211 and in The Rules Governing Medicinal Products in the
European Community, Volume IV, Good Manufacturing Practice for Medicinal
Products, (ii) the principles detailed in ICH Guidelines relating to the
manufacture of API and finished pharmaceuticals, (iii) Laws promulgated by any
Governmental Authority having jurisdiction over the manufacture of compounds or
Licensed Products or any components of either of the foregoing, or (iv) guidance
documents (including advisory opinions, compliance policy guides and guidelines)
promulgated by any Governmental Authority having jurisdiction over the
manufacture of compounds or Licensed Products, which guidance documents are
being implemented within the pharmaceutical manufacturing industry.
1.1.33. “Governmental
Authority” shall mean any (i) federal, state, local, foreign or international
government; (ii) court, arbitral or other tribunal or governmental or
quasi-governmental authority of any nature (including any governmental agency,
political subdivision, instrumentality, branch, department, official, or
entity); or (iii) body exercising, or entitled to exercise, any administrative,
executive, judicial, legislative, police, regulatory, or taxing authority or
power of any nature pertaining to government.
1.1.34. “GSSG”
shall mean oxidized glutathione.
1.1.35. “ICH
Guidelines” shall mean the guidelines of the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use.
1.1.36. “Improvement”
shall mean all discoveries, concepts, ideas, confidential information, trade
secrets, and know-how relating to the Licensed Products, the Novelos Technology
and/or the Collaborator Technology, whether patentable or not, made or conceived
during the Agreement by Novelos or its Affiliates, Collaborator or its
Affiliates, any Sublicensees, or any combination thereof, alone or together,
including, but not limited to, all processes, new uses of known processes,
methods, articles of manufacture, machines, instrumentation, chemical
composition of matter, techniques, and formulae.
1.1.37. “Independent
Data” shall mean, with respect to the Licensed Products, all data, including
without limitation, toxicological, pharmaceutical, clinical, non-clinical and
medical data, health registration data and marketing data, developed or procured
by or on behalf of a Sponsoring Party or its Affiliates in an Independent Trial
in respect of which the Non-Sponsoring Party has not paid to the Sponsoring
Party fifty percent (50%) of its out-of-pocket development costs.
1.1.38. “Independent
Trial” shall have the meaning set out in Section 4.7.5.
1.1.39. “JCC”
shall mean the Joint Consultative Committee established by the Parties pursuant
to Section 4.2.
1.1.40. “Label
Expansion Trial” shall mean a Phase II clinical study of the Lead Product in
first-line advanced NSCLC to be conducted by Collaborator to support a broader
use of the Lead Product in combination with other platinum-based chemotherapy
agents instead of a more limited use of the Lead Product in combination with
carboplatin and paclitaxel, which is a combination used more commonly in the USA
than in the Territory.
1.1.41. “Laws”
shall mean all applicable laws, rules, regulations, judgments, orders, decrees,
statutes, ordinances and other requirements of any Governmental Authority or
instrumentality within the Territory and any other jurisdiction in which
Licensed Products are developed, manufactured or sold, pursuant to the terms of
this Agreement.
1.1.42. “Lead
Product” shall mean NOV-002, a combination of GSSG and cisplatin (1000:1 molar
ratio), including the salts, esters, metabolites, tautomers, isomers, conjugates
and complexes thereof.
1.1.43. “Lee’s
Pharma Agreement” shall mean the Collaboration Agreement dated December 14, 2007
between Novelos and Lee’s Pharma (HK) Ltd. pursuant to which Novelos granted an
exclusive license to Lee’s Pharma (HK) Ltd. to develop, make, have made,
register, use, market, sell, have sold, import, distribute and offer for sale
the Lead Product, NOV-205 or any product containing GSSG and to exploit the
Novelos Technology in the Lee’s Pharma Territory.
1.1.44. “Lee’s
Pharma Territory” shall mean Hong Kong, Macau, the People’s Republic of China
and Taiwan.
1.1.45. “License”
shall have the meaning set forth in Section 2.1.
1.1.46. “Licensed
Products” shall mean all pharmaceutical preparations in all dosage strengths,
formulations and methods of administration that contain the Lead Product or any
other combination of GSSG and any heavy metal in any molar ratio, including in
each case the salts, esters, metabolites, tautomers, isomers, conjugates and
complexes thereof and any Improvements thereto made by either Party individually
or jointly by the Parties as set forth in Section 2.4.
1.1.47. “Losses”
shall have the meaning set forth in Section 11.1.1.
1.1.48. “MAA”
shall mean marketing authorization application.
1.1.49. “NDA”
shall mean a new drug application or supplemental new drug application or any
amendments or supplements thereto in CTD format.
1.1.50. “Net
Sales” shall mean with respect to Licensed Products sold, licensed or otherwise
distributed (hereinafter “Sale”), the gross amount invoiced or otherwise charged
to Third Parties in an arm’s length transaction in connection with the Sale of
the Licensed Products by Collaborator or any Affiliate of Collaborator or any
Sublicensee for all Licensed Products sold by Collaborator or any Affiliate of
Collaborator or any Sublicensee in the Territory, less the following amounts
actually deducted or allowed:
(a) transport,
freight and insurance costs;
(b) sales
and excise taxes and duties;
(c) normal
and customary trade, quantity and cash discounts and rebates;
(d) amounts
repaid, discounted or credited by reason of (i) retroactive price reductions,
(ii) discounts, or (iii) rebates, which are, in each case, imposed upon
Collaborator, its Affiliates or Sublicensees by any Governmental Authority or
non-Governmental Authority with the authority to impose such price reductions,
discounts or rebates;
(e) any
credits or allowances for damaged goods, returns, rebates, delayed ship order
credits or rejections, to the extent these deductions actually pertain to a
Sale.
For
Licensed Products distributed to Third Parties in other than an arm’s length
transaction (for example, at less than fair market value), excluding
distributions for purposes of product demonstrations, test marketing, clinical
trial purposes or compassionate or similar uses, the amount of Net Sales
attributed to such Licensed Products shall be the fair market value of the
Licensed Products based on the Sale in an arm’s length transaction of comparable
amounts thereof.
1.1.51. “Non-Sponsoring
Party” shall have the meaning set forth in Section 4.8.5.
1.1.52. “NOV-205”
shall mean a mixture of GSSG and inosine developed by Novelos which acts as a
hepatoprotective agent with immunomodulating and anti-inflammatory properties
and is currently in Phase 1b clinical trials in the U.S.A.
1.1.53. “Novelos”
shall have the meaning set forth in the preamble of this Agreement.
1.1.54. “Novelos
Indemnitees” shall have the meaning set forth in Section 11.1.2.
1.1.55. “Novelos
Know-How” means all discoveries, information, procedures, instructions,
techniques, data, technical information, knowledge and experience (including,
without limitation, toxicological, pharmaceutical, clinical, non-clinical and
medical data, health registration data and marketing data), designs, dossiers
and technology relating to or concerned with the Licensed Products (or any of
their components or constituent parts) owned or controlled by Novelos and used
in connection with the Licensed Products, whether now existing or developed by
or on behalf of Novelos or its Affiliates after the date of this Agreement, in
written, electronic or other form; provided, however, that the Novelos Know-How
shall not include the Novelos Patents, the Collaborator Know-How or the
Collaborator Patents.
1.1.56. “Novelos
Patents” shall mean all Patents owned or controlled by Novelos throughout the
world that claim the manufacture or use of any composition of matter or method
of use relating to the Licensed Products and relating to oxidized glutathione in
any combination with heavy metals, which are set forth in Attachment 1 to this
Agreement.
1.1.57. “Novelos
Technology” shall mean the Novelos Patents and Novelos Know-How. All
Novelos Technology (except published Novelos Patents) shall be Confidential
Information of Novelos.
1.1.58. “Novelos
Trials” shall mean the Phase II and Phase III clinical trials being or to be
conducted by or on behalf of Novelos for the Lead Product, which are summarized
in Attachment 2 to this
Agreement, as may be modified after the Effective Date in consultation with the
JCC.
1.1.59. “NSCLC”
shall mean non-small cell lung cancer.
1.1.60. “Party”
shall mean Novelos or Collaborator and, when used in the plural, shall mean
Novelos and Collaborator collectively.
1.1.61. “Patents”
shall mean any patents and pending patent applications that have issued or may
be issued in any country, including (i) all provisional and non-provisional
applications, substitutions, divisions, confirmations, continuations,
continuations-in-part, registrations, supplementary protection certificates and
any renewals of any of the above; (ii) all letters patent granted thereon, and
all patents-of-addition, re-issues, re-examinations and extensions or
restorations by existing or future extension or restoration mechanisms; and
(iii) all supplementary protection certificates, together with any foreign
counterpart thereof.
1.1.62. “Pricing
Approval” shall mean the licenses, registrations, authorizations and approvals
of any Regulatory Authority in the Territory necessary for the pricing and/or
reimbursement of the Licensed Products in each country of the
Territory.
1.1.63. “Receiving
Party” shall have the meaning set forth in Section 1.1.21.
1.1.64. “Regulatory
Approval” shall mean the technical, medical and scientific licenses,
registrations, authorizations and approvals of any Regulatory Authority in the
Territory, necessary for the distribution, marketing, promotion, offer for sale,
use, import, export or sale of the Licensed Products in the Territory, but
excluding Pricing Approval.
1.1.65. “Regulatory
Authority” shall mean any international, national (e.g., the Medicines and
Healthcare products Regulatory Agency (the “MHRA”)), supra-national (e.g.,
EMEA), regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity involved in the granting of
Regulatory Approval and/or Pricing Approval in the Territory.
1.1.66. “Royalties”
shall have the meaning set forth in Section 3.1.2.
1.1.67. “Royalty
Period” shall have the meaning set forth in Section 3.2.1.
1.1.68. “Sale”
shall have the meaning set forth in Section 1.1.50.
1.1.69. “Sponsoring
Party” shall have the meaning set forth in Section 4.8.5.
1.1.70. “Sublicensee”
shall mean a non-Affiliate sublicensee appointed by Collaborator in one or more
countries of the Territory and approved by Novelos in accordance with Section
2.2(ii), or a non-Affiliate sublicensee appointed by Novelos in one or more
countries outside the Territory, as the case may be.
1.1.71. “Term”
shall have the meaning set forth in Section 13.1.
1.1.72. “Territory”
shall mean the countries listed in Attachment 3
hereto.
1.1.73. “Third
Party” shall mean any person or entity other than Collaborator, Novelos or an
Affiliate or Sublicensee of Collaborator or Novelos.
1.1.74. “Trademarks”
shall mean the trademarks, domain names and internet sites to be selected and
owned by Collaborator under which the Licensed Products will be promoted,
marketed and sold by Collaborator and its Affiliates and Sublicensees in the
Territory in accordance with Section 6.3.
1.1.75. “USA”
shall mean the United States of America, its territories and
possessions.
1.2. Interpretations.
1.2.1. In
the event an ambiguity or a question of intent or interpretation arises, this
Agreement will be construed as if drafted jointly by the Parties and no
presumption or burden of proof will arise favoring or disfavoring either Party
by virtue of the authorship of any provisions of this Agreement. The
language in this Agreement is to be construed in all cases according to its fair
meaning.
1.2.2. The
definitions of the terms herein apply equally to the singular and plural forms
of the terms defined. Whenever the context may require, any pronoun
will include the corresponding masculine, feminine and neuter
forms. The words “include”, “includes” and “including” will be deemed
to be followed by the phrase “without limitation.” Unless the context
requires otherwise, (i) any definition of or reference to any agreement,
instrument or other document herein will be construed as referring to such
agreement, instrument or other document as from time to time amended,
supplemented or otherwise modified (subject to any restrictions on such
amendments, supplements or modifications set forth herein or therein), (ii) any
reference to any Laws herein will be construed as referring to such Laws as from
time to time enacted, repealed or amended, (iii) any reference herein to any
person will be construed to include the person’s successors and assigns, (iv)
the words “herein”, “hereof” and “hereunder”, and words of similar import, will
be construed to refer to this Agreement in its entirety and not to any
particular provision hereof, (v) any reference herein to the words “mutually
agree” or “mutual written agreement” will not impose any obligation on either
Party to agree to any terms relating thereto or to engage in discussions
relating to such terms except as such Party may determine in such Party’s sole
discretion, (vi) all references herein to Sections or Attachments will be
construed to refer to Sections and Attachments to this Agreement, (vii) the word
“days” means calendar days unless otherwise specified, (viii) except as
otherwise expressly provided herein all references to “$” or “dollars” refer to
the lawful money of the U.S., and (ix) the words “copy” and “copies” and words
of similar import when used in this Agreement include, to the extent available,
electronic copies, files or databases containing the information, files, items,
documents or materials to which such words apply.
2. LICENSE
2.1. Grant. During the
Term hereof and subject to the other terms and conditions of this Agreement,
Novelos hereby grants to Collaborator (i) the exclusive, royalty-bearing,
non-transferable and non-sublicenseable (except as set forth in Section 2.2
hereof) right to research, register, develop, make, have made, use, warehouse,
promote, market, sell, have sold, import, distribute, and offer for sale the
Licensed Products solely and exclusively in the Territory and (ii) the
exclusive, non-transferable and non-sublicenseable (except as set forth in
Section 2.2 hereof) right to exploit the Novelos Technology in the Territory
solely for the purpose of researching, registering, developing, making, having
made, using, warehousing, promoting, marketing, selling, having sold, importing,
distributing and offering for sale the Licensed Products in the Territory (the
foregoing rights referred to hereinafter as the “License”).
2.2. Sublicense. Collaborator
shall be entitled to sublicense its License under Section 2.1 (i) to any of its
Affiliates without Novelos’s approval and (ii) to Sublicensees with Novelos’s
prior written approval, such approval not to be unreasonably delayed or
withheld. Collaborator shall guarantee the performance of its
Affiliates and Sublicensees under this Agreement with respect to any sublicense
granted pursuant to this Section 2.2.
2.3. Limitations and
Reservations. Novelos reserves for itself all rights not
granted herein, including, but not limited to, (i) the irrevocable right to
research, register, develop, make, have made, use, warehouse, market, sell, have
sold, import, distribute, and offer for sale the Licensed Products outside of
the Territory, and (ii) the irrevocable right to exploit the Novelos Technology
outside of the Territory. Except for the license set forth in Section
2.1(ii), no title in or to the Novelos Technology is transferred to Collaborator
pursuant to this Agreement, and no title in or to any Collaborator Technology is
transferred to Novelos pursuant to this Agreement.
2.4. Improvements. Any
Improvement shall be owned exclusively by the Party who discovered, created or
developed such Improvement. If such Improvement rises to the level of
a patentable invention, then the Party who discovered, created or developed it
shall be the sole owner of any Patents related to such
Improvement. Such Party shall be responsible for the preparation,
filing, prosecution and maintenance of any Patent covering such an Improvement,
and shall bear the costs associated with obtaining and maintaining any such
Patent. Any Improvement discovered, created or developed during any
joint trials that the Parties elect to conduct pursuant to Section 4.7.4 shall
be jointly owned by the Parties in proportion to the Parties’ respective
financial contribution to such joint trial, and Collaborator shall be
responsible for the preparation, filing, prosecution and maintenance of any
Patent covering such a joint Improvement in the Territory, and Novelos shall be
responsible for the preparation, filing, prosecution and maintenance of any such
Patent outside the Territory, with each Party bearing the costs associated with
obtaining and maintaining any such Patent in their respective geographic
territories. To the extent that any Improvement discovered, created
or developed by or on behalf of Novelos relates to the Licensed Products,
including new dosage forms, formulations and methods of administration, such
Improvements will be communicated to Collaborator and licensed to Collaborator
pursuant to Section 2.1 hereof without additional compensation, unless such
Improvements are discovered, created or developed by or on behalf of Novelos in
an Independent Trial, in which case such Improvements will be automatically
licensed to Collaborator pursuant to Section 2.1 upon receipt by Novelos of
Collaborator’s cash payment of fifty percent (50%) of the out-of-pocket
development costs in accordance with the procedure set forth in Section
4.8.5. To the extent that any Improvement discovered, created or
developed by or on behalf of Collaborator relates to the Licensed Products,
including new dosage forms, formulations and methods of administration, such
Improvements will be communicated to Novelos and automatically licensed to
Novelos without any compensation, unless such Improvements are discovered,
created or developed by or on behalf of Collaborator in an Independent Trial, in
which case such Improvements will be automatically licensed to Novelos upon
receipt by Collaborator of Novelos’ cash payment of fifty percent (50%) of the
out-of-pocket development in accordance with the procedure set forth in Section
4.8.5.
2.5. Non-Competition. In
further consideration of the payments made and to be made under this Agreement,
Novelos agrees that during the Term it shall not, and shall not grant rights to
an Affiliate or a Third Party to, research, register, develop, make, have made,
use, warehouse, promote, market, sell, have sold, offer for sale, import,
distribute or commercialize pharmaceutical products containing the Licensed
Products or NOV-205 for any indication in the field of oncology in the
Territory. For the avoidance of doubt, nothing in this Agreement
shall be construed to prevent Novelos from developing, registering, making,
using, selling, commercializing or otherwise engaging in any activities outside
the Territory pertaining to pharmaceutical products containing the Licensed
Products or NOV-205 for any indication or granting rights to an Affiliate or a
Third Party to do any of the foregoing outside
the Territory, provided that such activities do not interfere with
Collaborator’s rights under this Agreement inside the Territory, as determined
in accordance with the decision making provisions of Section 4.5.
3. PAYMENTS
3.1. License Fee and
Royalties. For the License granted in Section 2.1 of this
Agreement, Collaborator shall make the following payments to Novelos, subject to
the recovery by Collaborator of the costs of the European Registration Trial in
accordance with the mechanism set forth in Section 4.7.1:
3.1.1. milestone
payments in the amounts described in Attachment 4, at the times set
forth in Attachment 4,
such payment shall be made within 30 days of reaching the applicable
milestone;
3.1.2. a
royalty on Net Sales of the Licensed Products in the percentages described in
Attachment 5 – Part A
(“Royalties”); and
3.1.3. super
royalty payments in the amounts described in Attachment 5 – Part B, at the
times set forth in Attachment 5
– Part B, such payment shall be made within thirty (30) days of reaching
the applicable Net Sales thresholds.
3.2. Calculations and Payment of
Royalties.
3.2.1. Unless
set forth otherwise on Attachment 5 – Part A,
Royalties shall be paid in quarterly (based on a calendar year beginning on
January 1st and ending on December 31st)
increments (the “Royalty Period”). Royalties shall be calculated for
each Royalty Period as of the last day of each such Royalty
Period. Payment of Royalties with respect to each Royalty Period
shall be due within forty-five (45) days after the end of each Royalty Period,
beginning with the Royalty Period in which the First Commercial Sale of a
Licensed Product occurs.
3.2.2. Within
forty-five days of the end of each Royalty Period (whether or not Royalties are
due), Collaborator shall deliver to Novelos true and accurate reports, giving
such particulars of the business conducted by Collaborator and its Affiliates
and Sublicensees under this Agreement as shall be pertinent to an accounting of
Royalties and other payments under this Agreement. Reports shall
include at least the following on a Licensed Product-by-Licensed Product and
country-by-country basis:
(a) The
units/packs of Licensed Products used, sold, licensed, or otherwise
distributed;
(b) The
calculation of Net Sales;
(c) Total
amount due under this Agreement (including, without limitation, the manner in
which all amounts were calculated);
(d) Upon
request by Novelos, any other information that is reasonably necessary for the
purpose of showing the amounts payable to Novelos hereunder and/or the manner in
which such amounts were calculated and/or the compliance by Collaborator with
the diligence provisions of Section 4.9 and 6.1 hereof; and
(e) If
no payment shall be due, then the report shall so state.
3.3. Records. Collaborator
shall keep at its principal place of business, or upon written notice to
Novelos, the principal place of business of the appropriate division to which
this Agreement relates, accurate records in sufficient and customary detail such
that the amounts payable may be verified. During the Term and for a
period of three (3) years following termination, Collaborator, its Affiliates
and Sublicensees shall permit a Third Party accounting firm appointed by Novelos
and reasonably acceptable to Collaborator to inspect, audit and copy its books
and records regarding the sale of Licensed Products, during normal business
hours, provided that Collaborator, its Affiliates or Sublicensees, as
applicable, has received at least thirty (30) business days’ prior written
notice regarding the foregoing. Novelos may request its Third Party
accounting firm to conduct such audit no more than once in any twelve (12) month
period at any one location. Such records shall include but not be
limited to invoice registers and original invoices; product sales analysis
reports; price lists, accounting general ledgers; sublicense and distributor
agreements; product catalogues and marketing materials; sales tax returns; and
shipping documents. Such examination shall be made at Novelos’s
expense, except that if such examination discloses a shortage of eight percent
(8%) or more in the amount of Royalties or other payments due Novelos for any
year, then, in addition to paying the shortage of Royalties, Collaborator shall
reimburse Novelos for the cost of such examination or audit, including any
professional fees and out of pocket costs incurred by Novelos. A
written confidentiality agreement will be required before the Third Party
accounting firm commences such an examination or audit, and the results of the
audit shall be treated as Confidential Information unless and until a related
legal Action (including arbitration) is taken.
3.4. Payments. All
amounts owing to either Party under this Agreement shall be paid in U.S.
dollars, by check or other instrument representing immediately available funds
payable to the receiving Party or in a wire transfer sent to an account
specified by the receiving Party, if any are listed. If Collaborator
(or an Affiliate or Sublicensee) invoices or otherwise charges Third Parties in
connection with the Sale of the Licensed Products in a currency other than U.S.
dollars, Royalties payable shall be expressed in their U.S. dollar equivalent
based on the rate of exchange applicable on the last working day of the
corresponding Royalty Period as published in the Wall Street
Journal. Although Collaborator and Novelos may arrange for direct
payment to Novelos by an Affiliate or Sublicensee of Collaborator (as
applicable), Collaborator shall remain responsible for all unpaid amounts due
pursuant to this Agreement.
3.5. Overdue
Payments. Overdue payments shall bear simple interest until
paid at an annual rate of two percent (2%) or the maximum rate allowed by law,
whichever is lower. Interest accruing under this Section 3.5 shall be
due on demand.
3.6. Taxes. Collaborator
is responsible for all taxes related to this Agreement and the transactions
contemplated hereby, except taxes based on net income or gross receipts of
Novelos. If Collaborator is required by applicable law to deduct any
taxes, assessments or other charges from or in respect of any amounts payable to
Novelos under this Agreement, such deduction shall be made and paid to the
relevant taxing authority or other Governmental Authority in accordance with all
applicable laws, and only the remaining amount after such deduction shall be
paid to Novelos hereunder. The amounts payable by Collaborator to
Novelos pursuant to this Section 3.6 shall in no event be increased by such
taxes, assessments or other charges. The Parties shall reasonably
cooperate in completing and filing documents required under the provisions of
any applicable tax treaty or under any other applicable law, and take any other
reasonable actions in order to enable Collaborator to make such payments to
Novelos without any deduction or withholding. In addition, upon
Novelos’ request, Collaborator shall furnish Novelos with proof of payment of
any taxes, assessment or charges deducted hereunder.
3.7. Termination Report and
Payment. Within forty-five (45) days after the date of
termination of this Agreement (pursuant to Section 13 of this Agreement),
Collaborator shall make a final report and payment to Novelos as set forth in
this Agreement for the then-current Royalty Period.
4. DEVELOPMENT
4.1. Alliance Manager.
4.1.1. Each
Party shall appoint one employee representative who possesses a good
understanding of and experience in technical development and regulatory issues
and the requisite experience to act as its alliance manager for this
relationship (the “Alliance Manager”). As soon as the Lead Product
has achieved Regulatory Approval in any of the United Kingdom, Germany, France,
Spain or Italy, then each Party shall replace its respective Alliance Manager
with an employee representative who possesses a good understanding of
commercialization and marketing issues to act as its Alliance Manager in respect
of the launch, promotion, marketing sale and distribution of the Lead Product in
the Territory.
4.1.2. Each
Party may replace its respective Alliance Manager at any time upon written
notice to the other. Any Alliance Manager may designate a substitute
with due qualification and authority to temporarily perform the functions of
that Alliance Manager. Each Alliance Manager shall be charged with
creating and maintaining a collaborative work environment between the Parties,
including coordinating JCC meetings in conjunction with the
Co-Chairs. The Alliance Managers will meet and confer on a regular
basis, as often as necessary but not less than once per month, either in person
or by teleconference, to discuss the status of the Parties’ alliance under this
Agreement. Each Alliance Manager will also be responsible
for:
(a) coordinating
the relevant functional representatives of the Parties in developing and
executing strategies and plans for the Lead Product at the relevant phase of
development and commercialization in an effort to ensure consistency and
efficiency within and outside the Territory;
(b) providing
a single point of communication for seeking consensus both internally within the
respective Party’s organization and together regarding key strategy and planning
issues within the Territory;
(c) identifying
and raising cross-Party issues to the JCC in a timely manner;
(d) coordinating
and ensuring during the technical development and Regulatory Approval phase of
the Lead Product, the pursuit of cooperative and consistent technical
development and regulatory efforts for the Lead Product within the Territory;
and
(e) coordinating
and ensuring during the launch and commercialization phase of the Lead Product,
the development of appropriate internal and external communications with respect
to the Lead Product in the Territory.
4.2. Joint Consultative
Committee.
4.2.1. The
Parties shall establish a Joint Consultative Committee (“JCC”) to consult and
collaborate on all operational matters related to the Lead Product in the
Territory, including all pre-clinical development, CMC, clinical development,
manufacturing, regulatory, launch strategy and marketing matters.
4.2.2. The
JCC shall consist of an equal number of three (3) representatives of each Party,
which shall include each Party’s Alliance Manager. JCC members shall
be appropriately qualified and experienced to make a meaningful contribution to
JCC meetings. The names of the initial members of the JCC shall be
provided by each Party to the other Party within thirty (30) days after the
Effective Date. A Party’s JCC members may be replaced with an
appropriately qualified representative at any time upon written advance notice
to the other Party.
4.2.3. In
the event a JCC representative from either Party is unable to attend or
participate in a meeting of the JCC, the Party who designated such
representative may designate an appropriately qualified substitute
representative for the meeting, in its sole discretion.
4.2.4. Each
Party shall appoint one of its JCC representatives to co-chair the meetings
(each, a “Co-Chair”). The Co-Chairs shall (i) coordinate and prepare
the agenda and ensure the orderly conduct of the meetings; (ii) attend each
meeting; and (iii) prepare and issue minutes of each meeting within thirty (30)
days thereafter accurately reflecting the discussions and decisions of the
JCC. Such minutes from each meeting shall not be finalized until each
Co-Chair representing each Party has reviewed and confirmed the accuracy of such
minutes in writing. The Co-Chairs shall solicit agenda items from JCC
representatives and provide an agenda along with appropriate information for
such agenda reasonably in advance of any meeting. It is understood
that such agenda will include all items requested by either Co-Chair for
inclusion therein. In the event the Co-Chair from either Party is
unable to attend or participate in a JCC meeting, the Party who designated such
Co-Chair may designate a substitute Co-Chair for such meeting in its sole
discretion.
4.3. JCC
Responsibilities.
4.3.1. The
JCC shall have the following responsibilities:
(a) collaborate
closely on developing the specific plans for the development and
commercialization of the Lead Product in the Territory; and
(b) share
information and keep the other Party informed of any issues affecting the
development and commercialization of the Lead Product within and/or outside the
Territory.
4.3.2. The
JCC shall act solely in an advisory and consultative capacity with respect to
matters concerning the development and commercialization of the Lead Product
both within and outside the Territory.
4.3.3. The
JCC shall conduct its discussions in good faith with a view to operating to the
mutual benefit of the Parties and in furtherance of the successful development
and commercialization of the Lead Product in the Territory.
4.4. JCC Meetings.
4.4.1. The
JCC shall have its initial meeting within sixty (60) days after the Effective
Date. Thereafter, the JCC shall meet as frequently as required, but
in no event less than once every three calendar months.
4.4.2. The
JCC meetings may be conducted by telephone, videoconference or in person as
determined by the Co-Chairs; provided that, at least once every six (6) months,
a meeting shall be held in person. All in-person JCC meetings shall
be held on an alternating basis between Novelos’ head office in Massachusetts
and the office of Collaborator’s Affiliate in Cambridge, United
Kingdom. Each Party shall be responsible for its own expenses
relating to such meetings. As appropriate, other employee
representatives or agents of the Parties may attend JCC meetings as non-voting
observers and/or presenters. Each Party may also call for special
meetings of the JCC to resolve particular matters requested by such Party that
are within the areas of responsibility of the JCC. Each Co-Chair
shall provide its Party’s representatives with no less than fifteen (15)
business days’ notice of each regularly scheduled meeting, and no less than ten
(10) business days’ notice of any special meetings called by either
Party. The initial meeting shall take place at Novelos’ head office
in Massachusetts.
4.5. Decision Making.
4.5.1. Subject
to Section 4.5.2, (i) all decisions with respect to matters relating to the
Licensed Products outside the Territory shall be made solely by Novelos and
Affiliates, with such decisions to be made in a fair and reasonable manner and
in conformity with this Agreement, including without limitation Section 4.3.3,
and (ii) all decisions with respect to matters relating to the Licensed Products
within the Territory shall be made solely by Collaborator and its Affiliates,
with such decisions to be made in a fair and reasonable manner and in conformity
with this Agreement, including without limitation Section 4.3.3.
4.5.2. In
the event that a decision made or proposed to be made by Novelos or its
Affiliates or Third Party licensees or Sublicensees with respect to the Licensed
Products is reasonably believed by Collaborator to have an actual or potential
material adverse effect on a matter relating to the Licensed Products within the
Territory, Collaborator will refer the matter to the JCC for good faith
discussion and consideration, with the aim of resolving the issue promptly and
collaboratively in accordance with the principles of Section
4.3.3. If the issue cannot be resolved within thirty (30) days of its
referral to the JCC, the Parties shall refer the matter to their respective
executive officers referred to in Section 15.6.2 to reach consensus in
accordance with Section 15.6.3. In the event that the Parties’
executive officers do not reach consensus with respect to a particular matter
after endeavoring in good faith for thirty (30) days to do so, then the
mediation and alternative dispute resolution provisions set forth in Sections
15.6.4 and15.6.5 and in Attachment 9 shall
apply.
4.6. Pre-Clinical,
CMC Development and Manufacturing Development.
4.6.1. On
the Effective Date, the Parties anticipate that each of: (i) the CMC work
program set out in Attachment
6, (ii) the pre-clinical work program set out in Attachment 7, and (iii) the
manufacturing development work program set out in Attachment 8, will be required
by the EMEA in respect of the Lead Product in the
Territory. Furthermore, Novelos anticipates that the work programs
set out in Attachments 6,
7 and 8 are
substantially the same as those that will be required by the FDA in respect CMC
development, pre-clinical development and manufacturing of the Lead Product for
the USA, although the FDA may elect to waive one or more of the activities or
guidelines set out in Attachments 6, 7 or 8. The Parties
accordingly agree to work collaboratively to the fullest extent possible with
the aim of expediting development of the Lead Product in the Territory and
eliminating any potential duplication of effort in performing the work programs
set out in Attachments 6,
7 and 8 in
accordance with the following provisions:
(a) Within
thirty (30) days of the Effective Date, the Parties will review the content of
Attachments 6, 7 and
8 and compile a mutually
agreed list of questions to be submitted by Novelos to the FDA for advice,
including a formal request for the FDA’s written confirmation as to whether any
of the specific work activities or guidelines specified in Attachments 6, 7 or 8 will not be required for
development of the Lead Product for the USA. Novelos will inform
Collaborator promptly upon receipt of a reply from the FDA to such
request.
(b) Novelos
shall be responsible for undertaking, at its cost, each of the
following: (i) the CMC development work program set out in Attachment
6, (ii) the pre-clinical development work program set out in Attachment 7, and (iii) the
manufacturing development work program set out in Attachment 8, in each case, in
accordance with the specific guidelines listed therein, except to the extent
that the FDA confirms in writing in accordance with sub-paragraph (a) above that
it waives or will not require completion of a specified activity or adherence to
a specified guideline set out in any of Attachment 6, 7 or 8. In such case, if
the Collaborator believes that notwithstanding the FDA’s position, such activity
or guideline will be required in the Territory, then, at Collaborator’s cost,
Collaborator shall carry out such activity either by itself or by appointing
Novelos or a Third Party to carry out such activity on Collaborator’s behalf, as
appropriate in the circumstances but in Collaborator’s sole discretion, and the
resulting data from such activity shall constitute Collaborator’s Independent
Data.
4.7. Clinical
Development. Each Party shall use Commercially
Reasonable Efforts to undertake its respective clinical development activities
set forth below, all of which shall be conducted in accordance with GLP and GCP
as applicable:
4.7.1. Collaborator
shall be responsible for carrying out the Collaborator Trials at its cost in the
Territory. However, in the unlikely event that the EMEA requires the
Collaborator to conduct an additional clinical trial for the Lead Product in
first-line advanced stage NSCLC in order to obtain Regulatory Approval for that
indication in the European Union (the “European Registration Trial”), then the
Collaborator shall be entitled, in its sole discretion, either (i) to convert the
Label Expansion Trial into the European Registration Trial, subject to
sub-paragraphs (a) and (c) below, or (ii) to commence a new
Phase III clinical trial for the Lead Product in first-line advanced stage NSCLC
as the European Registration Trial, subject to sub-paragraphs (b) and (c)
below:
(a) If
Collaborator elects to convert the Label Expansion Trial into the European
Registration Trial, Collaborator shall pay for the full cost of the Label
Expansion Trial and the European Registration Trial (i.e. pre- and
post-conversion costs) and recover that full combined cost by reducing
subsequent milestones, Royalty and super royalty payments to Novelos, as
follows: Collaborator shall reduce each subsequent milestone, Royalty
and super royalty payment due to Novelos pursuant to Section 3 by up to, but not
more than, 50% until all costs paid by Collaborator in connection with the Label
Expansion Trial and European Registration Trial, both pre- and post-conversion,
have been recovered.
(b) If
Collaborator elects to commence a new Phase III clinical trial for the Lead
Product in first-line advanced stage NSCLC as the European Registration Trial,
instead of converting the Label Expansion Trial, Collaborator shall pay for the
full cost of such new Phase III trial and recover the full cost by reducing
subsequent milestones, Royalty and super royalty payments to Novelos as follows:
Collaborator shall reduce each subsequent milestone, Royalty and super royalty
payment due to Novelos pursuant to Section 3 by up to, but not more than, 50%
until all costs paid by Collaborator in connection with the European
Registration Trial have been recovered.
(c) For
the avoidance of doubt, if the FDA concludes that the results of the Novelos
Trials are unsatisfactory or inadequate for obtaining regulatory approval of the
Lead Product in first-line advanced stage NSCLC in the USA, Collaborator shall
have no obligation to conduct or to continue any clinical trials of the Lead
Product in any indication in the Territory, whether by way of conversion of the
Label Expansion Trial specified in Section 4.7.1(i) or commencement of a new
Phase III clinical trial specified in Section 4.7.1(ii) or
otherwise.
4.7.2. Novelos
shall conduct and complete the Novelos Trials as soon as practicable at its
cost, as well as any other FDA clinical requirements. Novelos shall
forward the final study report for each Novelos Trial to Collaborator within
three (3) months after completion of each such trial in accordance with the
applicable protocol.
4.7.3. Novelos
shall provide Collaborator with a copy of the full NDA in CTD format for the
Lead Product for the indication of NSCLC (first-line advanced stage) at least
five (5) business days prior to its submission to the FDA.
4.7.4. The
Parties may discuss and decide whether or not to conduct additional joint
clinical trials of any of the Licensed Products from time to time, which, if
agreed by the Parties, shall be carried out in accordance with a joint clinical
development plan to be agreed in writing by the Parties and which shall identify
the Parties’ responsibilities with respect to the administration and funding of
the agreed joint clinical trials.
4.7.5. In
addition, each Party may decide, in its sole discretion, to conduct and fund
further development work, including toxicology, formulation and pharmaceutical
development, pharmacoeconomic analyses, market research, non-clinical studies
and/or clinical trial(s) of the Licensed Products in its respective territory
without any financial contribution or involvement of the other Party (an
“Independent Trial”) and with no right of access to the data or intellectual
property resulting therefrom by the non-contributing Party unless it pays fifty
percent (50%) of the cost of generating such data or intellectual property,
respectively, in accordance with the procedure set forth in Section
4.8.5.
4.7.6. Novelos
shall provide clinical trial supplies to Collaborator, if so requested, at the
cost charged to Novelos by its contract manufacturers.
4.8. Data Sharing.
4.8.1. All
data generated by or on behalf of Novelos shall be the property of Novelos; all
data generated by or on behalf of Collaborator or its Affiliates or Sublicensees
shall be the property of Collaborator. All data generated by or on
behalf of the Parties jointly in accordance with Section 4.7.4 above shall be
the joint property of the Parties in proportion to their respective financial
contributions to the generation of such data.
4.8.2. On
the Effective Date, Novelos shall deliver, or will have previously delivered, to
Collaborator all Novelos Know-How in existence on such date. In
addition, Novelos shall provide free of charge to Collaborator all results and
data generated from time to time in the Novelos Trials on a timely basis,
including a copy of the final study report issued in each Novelos Trial within
fifteen (15) days of such report’s completion.
4.8.3. All
data generated by or on behalf of Collaborator at its cost, including without
limitation any data arising from the Label Expansion Trial (if not converted to
the European Registration Trial pursuant to Section 4.7.1 and the costs thereof
recovered from Novelos pursuant to Section 4.7.1(a)), pre-clinical, CMC,
clinical and/or manufacturing development work not required by the FDA but
conducted by or on behalf of Collaborator pursuant to Section 4.6.1(b), shall
only be made available to Novelos upon Collaborator’s receipt of a cash payment
equal to fifty percent (50%) of the documented out-of-pocket development costs
incurred by Collaborator in generating such data.
4.8.4. Collaborator
shall provide free of charge to Novelos all data generated from time to time in
the European Registration Trial, on the basis that Collaborator’s costs of
conducting such trial are to be recovered in full from Novelos from a reduction
in Royalties, super-royalties and milestones in accordance with the mechanism
set forth in Section 4.7.1(a) and (b).
4.8.5. The
Independent Data generated from time to time in any Independent Trials conducted
and funded by a Party (the “Sponsoring Party”), including final study reports
issued in such Independent Trials, shall be owned by the Sponsoring Party and
shall not be provided to the other Party (the “Non-Sponsoring Party”) unless
such Non-Sponsoring Party makes a cash payment equal to fifty percent (50%) of
the documented out-of-pocket development costs incurred by the Sponsoring
Party. Within fifteen (15) days of the Sponsoring Party’s receipt of
the Non-Sponsoring Party’s payment, the Independent Data generated in such
Independent Trial shall be provided to the Non-Sponsoring Party, which may share
such data with its Affiliates and Sublicensees as it sees fit. For
the avoidance of doubt, the Label Expansion Trial to be conducted by
Collaborator shall constitute an Independent Trial and the resulting data shall
be Collaborator’s Independent Data, unless or until the Label Expansion Trial is
converted into the European Registration Trial pursuant to Section 4.7.1 and the
pre- and post-conversion costs are to be recovered in full from Novelos from a
reduction in Royalties, super-royalties and milestones in accordance with the
mechanism set forth in Section 4.7.1(a).
4.8.6. Notwithstanding
the foregoing provisions of this Section 4.8, (i) in no event shall a Party be
obligated to disclose to the other Party protected health information obtained
in its clinical trials, and (ii) the Parties shall exchange adverse event
information regarding the Licensed Products on a timely basis in accordance with
a separate pharmacovigilance agreement to be entered into by the Parties by not
later than ninety (90) days after the Effective Date.
4.9. Collaborator
Commitment to Development of Lead Product.
4.9.1. Subject
to Novelos’ fulfillment of its obligations under Sections 4.6 and 4.7 and
subject further to Sections 6.2 and 6.4, Collaborator shall use its Commercially
Reasonable Efforts to develop and to bring the Lead Product to market throughout
the Territory.
4.9.2. Collaborator
shall not be considered
to have used Commercially Reasonable Efforts in Japan as required under Section
4.9.1 with respect to the Lead Product unless the Collaborator does the
following:
(a) Within
six (6) months of the Effective Date, Collaborator shall submit a written
request to the Japanese Regulatory Authorities for advice with respect to the
pre-clinical, clinical and CMC development work program required for NDA
equivalent submission to the Japanese Regulatory Authorities;
(b) Within
three (3) months of Collaborator’s receipt of advice from the Japanese
Regulatory Authorities requested pursuant to sub-paragraph (a) above,
Collaborator shall create a pre-clinical, CMC and clinical development plan for
the Lead Product in Japan for discussion with the JCC;
(c) Within
six (6) months of Collaborator’s receipt of advice from the Japanese Regulatory
Authorities requested pursuant to sub-paragraph (a) above and discussion of the
Japanese development plan specified in sub-paragraph (b) above with the JCC,
Collaborator will decide whether or not it is commercially viable to commence
any bridging or other studies that are required by the Japanese Regulatory
Authorities to be conducted to obtain Regulatory Approval for the Lead Product
in Japan;
(d) Within
12 months after receiving Regulatory Approval and Pricing Approval from the
Japanese Regulatory Authorities, make a commercial scale launch of the Lead
Product in Japan.
4.9.3. Collaborator
shall not be considered
to have used Commercially Reasonable Efforts in the European Union as required
under Section 4.9.1 with respect to the Lead Product unless the Collaborator
does the following:
(a) Within
six (6) months of the Effective Date, request an EMEA meeting or national
equivalent(s) for the purpose of determining the regulatory requirements for an
MAA submission in the European Union;
(b) Within
twelve (12) months of the receipt of the later of (i) the FDA’s advice pursuant
to Section 4.6.1 and (ii) the EMEA’s or other Regulatory Authority’s advice
referred to in sub-paragraph (a) above, commence any pre-clinical, CMC or
manufacturing development work for the Lead Product that the FDA has confirmed
in writing is not required for approval in the USA as described in Section
4.6.1, but which Collaborator believes (or the EMEA or other Regulatory
Authority has advised) would be required for MAA submission in the European
Union;
(c) Within
twelve (12) months of the Effective Date, initiate the Label Expansion Trial in
the European Union; and
(d) Within
six (6) months of successful completion of the later of (i) the Label Expansion
Trial and (ii) the first to be completed of (A) the Novelos Trials or (B) the
European Registration Trial, if conducted pursuant to Section 4.7.1, submit an
MAA for the Lead Product to the EMEA, provided that Collaborator determines in
its sole judgment that it has sufficient data for inclusion in the MAA to
support a submission that will achieve Regulatory Approval from the
EMEA.
4.10. Development of Other Licensed
Products. In the event that the Parties wish to develop any
further Licensed Products from time to time in addition to the Lead Product,
such development activities, if agreed by the Parties, shall be undertaken
following provisions and principles that are consistent with the development of
the Lead Product under this Section 4. In such event, the Parties
shall agree in good faith to a written development plan for such additional
Licensed Products which shall identify the Parties’ respective responsibilities
and obligations relating to the specific Licensed Products to be
developed.
5. REGULATORY
ACTIVITIES.
5.1. Responsibility. Collaborator
shall be solely responsible for all regulatory filings and related submissions
with respect to of the Lead Product and any other Licensed Products that the
Parties agree to develop pursuant to Section 4.10 in the Territory (including,
without limitation, obtaining all Regulatory Approvals and Pricing Approvals
required to sell the Licensed Products in the Territory) and shall bear all
costs in connection therewith. Collaborator will be the sole
interface with and otherwise handle all correspondence, meetings and other
interactions with the relevant Regulatory Authorities concerning the Regulatory
Approvals of the Lead Product and any other Licensed Products in the
Territory. Novelos will provide whatever assistance Collaborator may
reasonably request to allow Collaborator to fulfill its obligations under this
Section 5.1 and Sections 4.9 and 6.1, subject to the provisions of Section
4.8.5. All Regulatory Approvals in the Territory will be held in the
name of Collaborator or an Affiliate or Sublicensee of the Collaborator,
provided that, upon termination of this Agreement (other than for breach by
Novelos) Collaborator shall, to the extent legally permissible, cause such
Regulatory Approvals to be transferred to Novelos or to its designee, subject to
Section 13.4.
5.2. Correspondence. The
Parties will promptly and in accordance with applicable Law provide to each
other copies of any documents or correspondence received from any Governmental
Authority anywhere in the world, including any minutes from a meeting with
respect thereto, relating to the Licensed Products or the Novelos Technology,
but in no event more than ten (10) business days after each Party’s receipt
thereof. The Parties will provide each other with any documents or
correspondence to be submitted to any Governmental Authority that relate to the
Novelos Technology in sufficient time to allow the other Party a reasonable
opportunity to comment thereon.
6. MARKETING,
SELLING AND COMMERCIALIZATION.
6.1. Commercialization
Efforts. Collaborator shall use its Commercially Reasonable
Efforts to market the Lead Product throughout the Territory, subject to Novelos’
fulfillment of its obligations under Sections 4.6 and 4.7 and subject further to
Sections 6.2 and 6.4.
6.2. Pricing/Reimbursement and Product
Launch. Collaborator, at its cost, will be responsible for
applying for, obtaining and maintaining all Pricing Approvals and planning
launch sequencing activities related to the Lead Product and any other Licensed
Products that the Parties agree to develop pursuant to Section 4.10 within the
Territory. The Parties agree that the foregoing does not require
simultaneous pursuit by Collaborator of Regulatory Approvals and Pricing
Approvals for the Lead Product or any other Licensed Products in all countries
of the Territory. Notwithstanding any other term of this Agreement,
Collaborator shall not be required to pursue Regulatory Approvals and/or Pricing
Approvals in any countries of the Territory in respect of which Collaborator
reasonably concludes that launching and selling the Lead Product or any other
Licensed Products in such country(ies) will not be commercially viable due to
the likelihood of an unfavorable Pricing Approval in such country(ies) or that
such Regulatory Approvals and/or Pricing Approvals are likely to have a material
adverse effect on the registration, reimbursement approval or commercialization
of the Lead Product and/or other Licensed Products elsewhere in the
Territory. In such event, Collaborator’s decision not to pursue
Regulatory Approvals and/or Pricing Approvals in such country(ies) shall not be
deemed a breach of Collaborator’s obligations under this Section 6 or its
obligation to use Commercially Reasonable Efforts in Japan and the European
Union in respect of the Lead Product to the extent provided under Section 4.9
and as set forth in Section 6.1.
6.3. Collaborator
Trademarks.
6.3.1. Collaborator
will select and own the Trademarks for promoting, marketing and selling the
Licensed Products in the Territory. Collaborator shall have the sole
responsibility for the selection, filing, maintenance and protection of such
Trademarks, except that such Trademarks shall be pre-approved by Novelos, which
approval shall not be unreasonably withheld or delayed. All expenses
for (i) registration of such Trademarks, and (ii) bringing, maintaining and
prosecuting any Action to protect or defend such Trademarks will be borne by
Collaborator and Collaborator will retain all recoveries
therefrom. Upon termination of this Agreement, Collaborator will
continue to have unrestricted ownership of such Trademarks in the
Territory.
6.3.2. Novelos
shall not use the Trademarks except as needed to fulfill its obligations under
this Agreement (e.g., providing packaging that bears the Trademark in connection
with supplying Licensed Products to Collaborator). Novelos will use
the Trademarks in association with the Licensed Products in accordance with the
guidelines and standards of use provided by Collaborator to Novelos from time to
time.
6.3.3. Each
Party and their Affiliates retains all rights to its trademarks, trade dress,
logos, slogans, designs, and domain names as well as any modifications thereof
which are not specific to the Licensed Products.
6.3.4. Each
Party shall notify the other Party promptly upon learning of any actual, alleged
or threatened infringement of any Trademarks or of any unfair trade practices,
trade dress imitation, passing off of counterfeit goods, or like offenses
relating to the Licensed Products.
6.3.5. Novelos
hereby covenants and agrees not, either alone or in cooperation with any Third
Party, to bring any Action against Collaborator or its Affiliates or
Sublicensees asserting or claiming any interest in any of the Trademarks, or to
do anything which may adversely affect the validity or enforceability of any
Trademarks or any variation thereof, under any Law providing for registration of
trademarks, service marks, trade names, designs, or the like in the
Territory.
6.4. Commercialization. Collaborator
shall not be obliged to launch or otherwise commercialize the Licensed Products
in any country of the Territory due to one or more of the following
circumstances: (i) the actual or threatened (in writing) infringement of a Third
Party’s intellectual rights by activities undertaken or to be undertaken in
accordance with this Agreement in such country, provided that Collaborator’s
outside intellectual property counsel in the relevant jurisdiction (which
counsel must be reasonably acceptable to Novelos) provides a written legal
opinion stating that such infringement claim is colorable in the relevant
jurisdiction, (ii) the suspension or withdrawal of any of the Regulatory
Approvals for the Licensed Products anywhere in the Territory, or (iii) an
unfavorable Pricing Approval in a country that Collaborator reasonably believes
would have a material adverse effect on the commercialization of the Licensed
Products elsewhere in the Territory (in which case Collaborator’s obligations
solely in the country in which the unfavorable Pricing Approval was received
shall be excused). In case any such circumstance exists, Collaborator
shall retain the exclusive rights and License granted under this Agreement in
respect of such country(ies), and Novelos shall not itself or through an
Affiliate launch or commercialize the Licensed Products in such countries or
grant any license or rights to Commercialize the Licensed Products to any Third
Parties in such country(ies) while such circumstance continues.
6.5. Control. Collaborator
will have full and complete decision-making authority with respect to all
commercialization and marketing activities relating to any and all sales of the
Licensed Products in the Territory, subject to Collaborator’s obligation to use
Commercially Reasonable Efforts in respect of such activities.
7. MANUFACTURING.
7.1. Manufacturer
Selection. As soon as possible after the Effective Date, the
JCC shall meet to evaluate and select a contract manufacturer already approved,
or likely to be approved, by the EMEA or another Regulatory Authority in the
European Union for supply of API and finished packs of the Lead Product to the
Territory. The manufacturer evaluation and selection shall be made in
good faith by the Parties on a closely collaborative basis with the mutually
agreed aims of maximizing efficiencies, minimizing lead timelines to regulatory
submissions, optimizing the manufacturing structure and supply routing for the
Lead Product and reducing the potential for duplication of effort in producing
GMP batches of Lead Product for submission to the Regulatory
Authorities.
7.2. GMP
Batches. Novelos shall appoint the selected contract
manufacturer to produce, at Novelos’ cost, the two GMP batches of Lead Product
that are required by the FDA for NDA submission in the USA. If
further GMP batches of Lead Product are required by the FDA, such additional
batches shall be produced at Novelos’ cost. If no further batches of
Lead Product are required by the FDA but are required by the EMEA or other
Regulatory Authorities in the Territory for MAA submission, such batches shall
be produced at Collaborator’s sole cost.
7.3. Novelos as
Manufacturer. If the Parties decide that the optimal
manufacturing structure and supply routing is for Novelos to be responsible for
the manufacture and supply of Lead Product for distribution and sale by
Collaborator and its designated Affiliates and Sublicensees in the Territory,
then:
7.3.1. Novelos
or its Third Party contract manufacturer approved by the EMEA or a national
Regulatory Authority in the European Union will manufacture, package and supply
the Lead Product to Collaborator or its designated Affiliates and Sublicensees
in accordance with GMP and EMEA requirements;
7.3.2. Collaborator
shall pay for such supplies of the Lead Product at Novelos’ documented costs or
Novelos’ documented Third Party costs and be responsible for all shipping costs
and all import costs related thereto; and
7.3.3. the
Parties will enter into a separate manufacturing and supply agreement setting
out the commercial, technical and legal terms and conditions governing such
arrangement within sixty (60) days of the Parties’ decision to appoint Novelos
to manufacture, or to have manufactured, the Lead Product.
7.4. Collaborator as
Manufacturer. Collaborator shall have the option, at its
election at any time, to manufacture the Licensed Products itself or to appoint
a designated Affiliate or Third Party manufacturer, and Novelos will take all
necessary steps to facilitate the technology transfer necessary to permit
Collaborator or its designated Affiliate or Third Party manufacturer to do so,
in accordance with Section 7.5. below. All reasonable, documented
costs incurred by Novelos in connection with such technology transfer shall be
reimbursed by Collaborator.
7.5. Technology
Transfer. If Collaborator elects to manufacture the Licensed
Products itself or to appoint a designated Affiliate or Third Party manufacturer
to do so, Novelos will undertake at Collaborator’s cost the technology transfer
necessary to permit Collaborator or its Affiliate or a Third Party manufacturer
to manufacture the Licensed Products. Novelos will provide all
reasonable and necessary assistance to facilitate Collaborator’s ability to
transfer the technology of manufacturing the Licensed Products to a
manufacturing facility designated by Collaborator. Novelos’ support
during the technology transfer process will include (i) access to all of
Novelos’ engineering subcontractors, documents and design drawings, (ii) direct
support on-site at the installation of commercial scale manufacturing capacity
at the facility designated by Collaborator, and (iii) technology transfer of the
manufacturing process. Novelos will develop and provide to
Collaborator comprehensive, Licensed Product-specific, development reports
suitable for use in the technology transfer and filings with the appropriate
Regulatory Authority.
8. CONFIDENTIALITY
8.1. Limited Disclosure and
Use. Each of Novelos and Collaborator shall hold in confidence
any Confidential Information disclosed by the Disclosing Party or any Third
Party as a result of this Agreement, and each of Novelos and Collaborator shall
protect the confidentiality thereof with the same degree of care that it
exercises with respect to its own information of a like nature, but in no event
less than reasonable care. Without the prior written consent of the
Disclosing Party, a Receiving Party shall not use, disclose, or distribute any
Confidential Information, in whole or in part, except as required to perform
such Party’s obligations or exercise such Party’s rights hereunder, or as
required to comply with subpoena or order from a court or other governmental
body. Access to the Disclosing Party’s Confidential Information shall
be restricted to the Receiving Party’s Associates, employees, agents,
consultants and advisers, who, in each case, need to have access to carry out a
permitted use and are bound in writing to maintain the confidentiality of such
Confidential Information.
8.2. Effect of
Termination. Each Party shall, upon termination of this
Agreement, immediately discontinue use of the other’s Confidential
Information. Within a reasonable time after termination of this
Agreement, but in no event later than thirty (30) days thereafter, all materials
containing such Confidential Information shall be returned by the Receiving
Party or (with the Disclosing Party’s prior written consent) destroyed provided
that the Receiving Party’s legal advisers may retain one archival copy of the
Confidential Information for purposes of determining the Receiving Party’s
obligations in respect thereof.
8.3. Unauthorized Use;
Remedies. If either Party becomes aware or has knowledge of
any unauthorized use or disclosure of the other Party’s Confidential
Information, it will promptly notify the other Party of such unauthorized use or
disclosure. Each Party understands and agrees that the wrongful
disclosure of the other Party’s Confidential Information may result in serious
and irreparable damage to the other Party, that the remedy at Law for any breach
of this covenant may be inadequate, and that the Disclosing Party will be
entitled to seek injunctive relief, enjoining or restraining any person from any
violation or threatened violation of this Section 8, without prejudice to any
other rights and remedies to which it may be entitled.
8.4. Exclusive
Property. All Confidential Information is the sole and
exclusive property of the Disclosing Party and the permitted use thereof by the
Receiving Party for purposes of its performance hereunder will not be deemed a
right, license or covenant, either express or implied, of the Receiving Party to
use any such Confidential Information for any other purpose.
9. REPRESENTATIONS;
WARRANTIES
9.1. Limited
Representation and Warranty.
9.1.1. Novelos
represents and warrants the following to Collaborator as of the Effective
Date:
(a) Novelos
is a corporation duly organized, validly existing and in good standing under the
laws of Delaware, with its principal place of business as indicated in the
preamble of this Agreement;
(b) Novelos
has the requisite corporate power and authority and the legal right to conduct
its business as now conducted and hereafter contemplated to be
conducted;
(c) Novelos
has the requisite corporate power, authority and legal right to execute and
deliver this Agreement, to grant rights granted to Collaborator hereby and to
perform Novelos’ obligations hereunder, and the person or persons executing this
Agreement on its behalf has been duly authorized to do so by all requisite
corporate action. The execution, delivery and performance of this
Agreement do not and will not violate (i) the certificate of incorporation or
bylaws of Novelos or (ii) any provision of any indenture, agreement or other
instrument or document to which Novelos is a party or by which any of its assets
or properties is bound or affected;
(d) Novelos
is the owner of, or has exclusive rights (for at least as long as the Term) to
all of the Novelos Patents and Novelos Know-How in existence on the Effective
Date and such Novelos Patents and Novelos Know-How are free from any liens,
encumbrances or Third Party claims;
(e) Except
as set forth on Schedule 9.1.1(e), no authorization, consent, approval, license,
permit, exemption of or filing or registration with or notification to, any
court or Governmental Authority will be necessary for the (i) valid execution,
delivery or performance of this Agreement by Novelos, (ii) the consummation of
the transactions contemplated hereby, or (iii) prevention of any termination of
any right, privilege, license or agreement relating to the Novelos Technology or
the continuation thereof following the date hereof. No consent,
approval or authorization of any person is required in connection with the
execution or delivery of this Agreement by Novelos, other than the consent from
the holders of Novelos’ Series D Preferred Convertible Preferred Stock, such
consent to be received prior to signing of this Agreement, the grant of the
License to Collaborator or the performance by Novelos of any other obligation
under this Agreement, or, if any such consent, approval or authorization is
required (in addition to the aforementioned consent of the holders of Novelos’
Series D Convertible Preferred Stock), Novelos has obtained that person’s
consent prior to the date hereof;
(f) To
the best of Novelos’ knowledge, after due inquiry, Novelos has complied with all
Laws in connection with the prosecution of the Novelos Patents, including
without limitation the duty of candor owed to any patent office pursuant to such
Laws;
(g) Novelos
has not granted any rights with respect to the Licensed Products and/or the
Novelos Technology in the Territory, in each case to any person or entity other
than Collaborator;
(h) There
are no claims or investigations pending or threatened against Novelos or any of
its Affiliates, at Law or in equity, or before or by any Governmental Authority
relating to the Licensed Products and/or the Novelos Technology;
(i) Neither
Novelos nor any of its Affiliates is under any obligation to any person,
contractual or otherwise, that is in violation of the terms of this Agreement or
that would impede the fulfillment of Novelos’ obligations
hereunder. Neither Novelos nor any of its Affiliates will enter into
any obligation to any person or entity, contractual or otherwise, that is in
violation of the terms of this Agreement or that would impede the fulfillment of
Novelos’ obligations hereunder;
(j) To
the best of Novelos’ knowledge, the Novelos Technology includes all intellectual
property rights in the possession, custody or control of Novelos which are
reasonably necessary for the exploitation of the Licensed Products by
Collaborator in accordance with the terms of this Agreement;
(k) To
the best of Novelos’ knowledge, no Third Party is infringing or has infringed
the Novelos Technology;
(l) At
the date hereof, Novelos has no notice, and is not aware, that the exercise of
Collaborator’s rights granted under this Agreement infringes or conflicts with
any Third Party intellectual property rights, and to the best of its knowledge
the exercise of Collaborator’s rights granted under this Agreement will not
infringe or conflict with any Third Party intellectual property rights and will
not incur any obligation to any Third Party;
(m) All
material renewal and maintenance fees due as of the Effective Date with respect
to the prosecution and maintenance of the Novelos Patents within the U.S. and
the Territory have been paid;
(n) Novelos
has allowed, and will continue to allow, Collaborator access to all material
information in its possession or control (i) containing the results of all
preclinical testing and human clinical testing of the Licensed Products and
(ii) concerning side effects, injury, toxicity or sensitivity
reaction and incidents or severity thereof with respect to Licensed
Products;
(o) Novelos
has not licensed or granted any rights in connection with GSSG or the Licensed
Products to any Third Party in any indication in the Territory.
(p) The
inventors named in the Novelos Patents listed in Attachment 1 are, to Novelos’
knowledge, all of the true inventors for such Novelos Patents and have assigned,
or are under a written obligation to assign, to Novelos all of their right,
title and interest to such Novelos Patents and the inventions described
therein;
(q) Novelos
does not know of any problems concerning the safety or efficacy of the Lead
Product (including any of its ingredients) or of any questions raised by any
Regulatory Authority and Novelos has informed Collaborator of any questions
raised by the FDA, and of all adverse drug reactions known to Novelos relating
to the Lead Product or its use;
(r) There
is no Action related to, nor has Novelos received any written notice of
termination under, either the 2000 BAM Agreement or the 2005 BAM Agreement, and
to the knowledge of Novelos, neither BAM-RL nor Novelos is in default of any
material obligation under the 2000 BAM Agreement and neither BAM nor Novelos is
in default of any material obligation under the 2005 BAM Agreement;
(s) Novelos
has not provided any data, information or assistance to BAM, BAM-RL or any other
BAM affiliated entity that would enable BAM, BAM-RL or any other BAM affiliated
entity to prepare a MAA or to apply for or achieve regulatory approval of any
Licensed Products in the countries of
[ * ];
and
(t) to
the best of Novelos’ knowledge, none of BAM, BAM-RL or any other BAM affiliated
entity has applied for regulatory approval of any Licensed Products in the
countries of
[ * ],
and Novelos is not aware of any plans by BAM, BAM-RL or any other BAM affiliated
entity to apply for regulatory approval of any Licensed Products in the
countries of
[ * ].
Novelos
acknowledges that Collaborator is relying, and is entitled to rely, on the
foregoing representations and warranties.
9.1.2. Collaborator
represents and warrants the following to Novelos as of the Effective
Date:
(a) Collaborator
has the right, power and authority to enter into and perform its obligations
under this Agreement;
(b) Collaborator
is a corporation duly organized, validly existing and in good standing under the
laws of Bermuda, with its principal place of business as indicated in the
preamble of this Agreement;
(c) Collaborator
has the requisite corporate power and authority and the legal right to conduct
its business as now conducted and hereafter contemplated to be
conducted;
(d) Other
than consents, authorizations, filings, notices and other acts that have been
obtained or anticipated in this Agreement, no consent or authorization of,
filing with, notice to or other act by or in request of, any Governmental
Authority or any other person, in the name of Collaborator, is required in
connection with the execution, delivery, performance, validity or enforceability
of this Agreement;
(e) Collaborator
is not aware of any fact or circumstance that would prevent it from complying
with applicable Laws with respect to the development and commercialization of
the Licensed Products in the Territory.
Collaborator
acknowledges that Novelos is relying, and is entitled to rely, on the foregoing
representations and warranties.
9.1.3. Each
Party represents and warrants that (a) this Agreement has been duly executed and
delivered by such Party and is a valid and binding obligation enforceable
against such Party in accordance with its terms (except as such enforceability
may be limited by the availability of equitable remedies); and (b) neither the
execution, delivery and performance of this Agreement, nor the consummation of
the transactions contemplated hereby will violate or conflict with or constitute
a default under any contractual obligation applicable to such
Party.
9.1.4. Neither
of the Parties is aware of any Action instituted by any Governmental Authority
that questions or threatens the validity of this Agreement.
9.2. Disclaimer of
Warranties. EXCEPT AS OTHERWISE SET FORTH IN THIS AGREEMENT,
THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER
REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION
THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE
AND THE STATUTORY WARRANTY OF INFRINGEMENT.
10. COVENANTS
10.1. Mutual Covenants.
10.1.1. Compliance and
Cooperation. Each Party will maintain in full force and effect
all necessary licenses, permits and other authorizations required by Law to
carry out its duties and obligations under this Agreement. Each Party
will comply in all material respects with all Laws applicable to its activities
under this Agreement. The Parties will handle and store the Licensed
Products in compliance in all material respects with all applicable
Laws. Each Party will keep all records and reports required to be
kept by applicable Laws. The Parties will reasonably cooperate with
one another with the goal of ensuring full compliance in all material respects
with applicable Laws. Each Party will cooperate with the other to
provide such letters, documentation and other information on a timely basis as
the other Party may reasonably require to fulfill its reporting and other
obligations under applicable Laws to applicable Regulatory
Authorities.
10.1.2. Grant of
Rights. Each Party will not during the Term of this Agreement,
grant any right to any Third Party which would conflict with the rights granted
to the other Party hereunder or enter into any agreement which would impair its
ability to perform its obligations under this Agreement.
10.1.3. No Use of Names or
Trademarks. Except as otherwise provided in this Agreement,
neither Party will use the other Party’s name in connection with any publication
or promotion without the other Party’s prior written consent. Neither
Party will use the other Party’s corporate or product logo or trademark in any
manner without the other Party’s prior written consent.
10.1.4. Good
Practices. Each Party will ensure that its respective
obligations to develop the Licensed Products under this Agreement are carried
out in accordance with GCP, GLP and GMP.
10.2. Covenants of
Novelos. Novelos hereby covenants to and with Collaborator
that:
(a) it
will not take any action that would prevent Collaborator from developing and
commercializing the Licensed Products under the Agreement;
(b) it
will perform all acts necessary or desirable to carry out the intent of this
Agreement and will maintain the Novelos Technology in full force and effect
including, without limitation, timely payment of fees due
thereunder;
(c) it
will not, at any time after the Effective Date, and until the Agreement is
terminated, in any manner whatsoever, be a party to or subject to any agreement
in the Territory which would violate the terms of this Agreement;
(d) it
will cooperate and consult with Collaborator with respect to Collaborator’s
obligations to obtain the appropriate Regulatory Approvals for the Licensed
Products in the Territory;
(e) it
will maintain, defend and enforce the Novelos Patents;
(f) it
will use its best efforts to ensure that the Novelos Patents and Novelos
Know-How remain free from any liens, encumbrances or Third Party claims (other
than permitted liens or encumbrances agreed upon in advance by
Collaborator);
(g) it
will not represent itself as an agent or partner of Collaborator for any
purpose, unless required by Law, nor pledge Collaborator’s credit, or make any
representations, warranties or guarantees with respect to the specifications,
features or capabilities of the Licensed Products that conflict with the
Licensed Product’s NDA; and
(h) Novelos
will comply with the material terms of both the 2000 BAM Agreement and 2005 BAM
Agreement. During the Term, Novelos will not terminate the 2000 BAM
Agreement pursuant to Section 24 thereof or the 2005 BAM
Agreement. Novelos shall further not terminate, during the Term, the
2000 BAM Agreement for cause pursuant to Section 23 thereof without the prior
written consent of Collaborator, which shall not be unreasonably withheld or
delayed; provided always that Novelos shall provide Collaborator with prior
written notice of its desire to terminate the 2000 BAM Agreement pursuant to
Section 23 thereof at least thirty (30) days prior to the date Novelos desires
to effect such termination. If Novelos receives a notice of breach
from BAM-RL pursuant to Section 23 of the 2000 BAM Agreement or a notice of
breach under the 2005 BAM Agreement, then Novelos shall promptly inform
Collaborator of the notice and of the plan to cure the breach. If
Novelos does not plan to, or is unable to, cure the breach within the time
period allowed, then Collaborator shall have the right to cure the breach on
Novelos’ behalf. Any monies paid by Collaborator to BAM-RL or BAM
pursuant to either the 2000 BAM Agreement or 2005 BAM Agreement, including any
consideration payable thereunder or other amounts paid in order to cure Novelos’
breach as described in this Section 10.2(h) shall be deducted from the next
payment of Royalties, super-royalties or milestones due from Collaborator to
Novelos.
(i) In
the event that the Lee’s Pharma Agreement is terminated for any reason and the
Lee’s Pharma Territory reverts to Novelos, Novelos shall notify Collaborator in
writing within ten (10) business days of such
termination. Collaborator shall have a continuing right for a period
of three (3) months after receipt of such notification from Novelos to elect to
add the Lee’s Pharma Territory to the Territory under this Agreement in respect
of the Licensed Products (but for the avoidance of doubt, not in respect of
NOV-205), during which three (3) month period Novelos shall not directly or
indirectly negotiate or enter into any agreement with a Third Party in respect
of the Licensed Products in the Lee’s Territory. If Collaborator
confirms in writing to Novelos within such three (3) month period that it wishes
to include the Lee’s Pharma Territory within the Territory under this Agreement
in respect of the Licensed Products, Collaborator shall exercise such right by
paying a fee of $[ * ] to Novelos, and upon
Novelos’ receipt of such payment, the Lee’s Pharma Territory shall automatically
become part of the Territory hereunder and shall thereafter be governed by all
of the relevant terms and conditions of this Agreement. If
Collaborator declines such right or fails to confirm in writing to Novelos
within such three (3) month period that it wishes to include the Lee’s Pharma
Territory within the Territory under this Agreement in respect of the Licensed
Products, then Novelos shall have no further obligations to Collaborator in
relation to the Licensed Products in the Lee’s Pharma Territory.
(j) Novelos
shall use its best efforts to obtain from BAM, BAM-RL and/or any other relevant
BAM entity, within six (6) months of the Effective Date, the exclusive,
sublicenseable right to research, register, develop, make, have made, use,
warehouse, promote, market, sell, have sold, import, distribute, and offer for
sale the Licensed Products in the countries of
[ * ], and immediately upon
Novelos obtaining such rights, the countries of
[ * ]
shall automatically become part of the Territory under this Agreement at no cost
to Collaborator and shall thereafter be governed by all of the relevant terms
and conditions of this Agreement.
(k) Novelos
will not provide, directly or indirectly, any data or information to BAM, BAM-RL
or any other BAM affiliated entity that may be used by BAM, BAM-RL or any other
BAM affiliated entity to prepare a MAA or to apply for or achieve regulatory
approval of any Licensed Products in the countries of
[ * ].
10.3. Covenants of
Collaborator. Collaborator hereby covenants to and with
Novelos that:
(a) it
will promote, market, distribute and sell the Licensed Products in accordance
with all applicable Laws in the Territory; and
(b) it
will not, at any time after the Effective Date, and until the Agreement is
terminated, in any manner whatsoever, be a party to or subject to any agreement
in the Territory which would violate the terms of this Agreement.
11. INDEMNIFICATION
AND INSURANCE
11.1. Indemnification.
11.1.1. Novelos
shall, at its sole expense, indemnify, defend and hold harmless Collaborator,
its Affiliates or Sublicensees and its or their respective officers, directors,
agents and employees (the “Collaborator Indemnitees”) from and against any and
all losses, claims, damages, liabilities, costs and expenses (including
reasonable attorneys’ fees and court costs) (collectively “Losses”) from any
Third Party Actions arising out of or resulting from (i) gross negligence or
willful misconduct by Novelos, its Affiliates or licensees (other than
Collaborator), (ii) breach by Novelos of any its representations, warranties,
covenants or agreements under this Agreement, (iii) the Licensed Products
manufactured by or on behalf of Novelos or its Affiliates or its Third Party
licensees or Sublicensees and supplied to Collaborator or its Affiliates or
Sublicensees, and/or (iv) the Licensed Products marketed, promoted, distributed,
used or sold by or on behalf of Novelos or its Affiliates or its Third Party
licensees or Sublicensees outside the Territory, and all activities related
thereto; provided, however, that in all cases referred to in this Section
11.1.1, Novelos will not be liable to indemnify Collaborator for any Losses of
Collaborator to the extent that such Losses were caused by: (a) the
gross negligence or willful misconduct or wrongdoing of Collaborator or its
Affiliates or Sublicensees, or (b) any breach by Collaborator of its
representations, warranties, covenants or agreements under this
Agreement.
11.1.2. Collaborator
shall, at its sole expense, indemnify, defend and hold harmless Novelos, its
Affiliates and its or their respective officers, directors, agents and employees
(the “Novelos Indemnitees”) from and against any Losses from any Third Party
Actions arising out of or resulting from (i) gross negligence or willful
misconduct by Collaborator, its Affiliates or Sublicensees, (ii) breach by
Collaborator of any its representations, warranties, covenants or agreements
under this Agreement, (iii) the Licensed Products manufactured by or on behalf
of Collaborator or its Affiliates or Sublicensees and supplied to Novelos or its
Affiliates or Third Party licensees, and/or (iv) the Licensed Products marketed,
promoted, distributed or sold by or on behalf of Collaborator or its Affiliates
or Sublicensees in the Territory, and all activities related thereto; provided,
however, that in all cases referred to in this Section 11.1.2, Collaborator will
not be liable to indemnify Novelos for any Losses of Novelos to the extent that
such Losses were: (a) were caused by the gross negligence or willful
misconduct or wrongdoing of Novelos, or (b) were caused by any breach by Novelos
of its representations, warranties, covenants or agreements under this
Agreement, or (c) are covered by Novelos’ indemnification of Collaborator
pursuant to Section 11.1.1.
11.1.3. Novelos
and Collaborator shall notify each other promptly in writing upon learning of
any Third Party Action in respect of which indemnification may be sought under
Section 11.1.1 or Section 11.1.2, as the case may be. The
indemnifying Party shall actively defend against every claim using counsel
approved by the indemnified Party, such approval not to be unreasonably withheld
or delayed, shall promptly inform the indemnified Party and its attorneys of all
developments concerning the indemnified Party and shall generally consult with
the indemnified Party regarding the strategy of the defense of any
claim. To the extent allowed by Law, the Novelos Indemnitees and the
Collaborator Indemnitees, as the case may be, shall reasonably cooperate with
the indemnifying Party in defending or settling any such claim. No
settlement of any claim for which indemnification is sought, shall be made
without the prior written approval of the indemnifying Party. The
indemnifying Party will have sole control over the defense and/or settlement,
subject to the Novelos Indemnitees and the Collaborator Indemnitees, as the case
may be, right to select and use their own counsel at their sole cost and
expense.
11.2. Insurance. With
effect from the initiation of the first clinical trial of any Licensed Product,
Novelos, Collaborator and their respective Affiliates and Sublicensees and Third
Party licensees of Novelos shall obtain and carry in full force and effect
insurance with the coverages and limits as are reasonably adequate to ensure
that each Party can meet its respective obligations to the other Party pursuant
to Section 11.1, the nature and extent of which insurance shall be commensurate
with usual and customary industry practices for similarly situated
companies. Such insurance will be written by a reputable insurance
company and the insured Party shall give thirty (30) days written notice to the
other Party prior to any cancellation, endorsement or other change (but only ten
(10) days’ written notice in the event of cancellation for non-payment of
premium). Upon request, each Party will provide the other Party with
appropriate certificates of insurance reflecting its respective obligations
pursuant to this Section 11.2; provided that with the exception of maintaining
insurance coverage that may be required by Law for conducting clinical trials,
Collaborator may fulfill its obligations under this Section 11.2 by means of
self-insurance arrangements.
12. PROTECTION
OF INTELLECTUAL PROPERTY RIGHTS
12.1. Cooperation of
Collaborator. Collaborator will, upon request of Novelos,
execute all documents and perform all lawful acts that Novelos considers
necessary or advisable to (a) secure its intellectual property rights hereunder,
including having its employees and the employees of its Affiliates execute when
appropriate, patent and other applications and assignments thereof to Novelos,
or persons designated by it, (b) provide reasonable assistance to Novelos in
enforcing Novelos’s rights in the Novelos Technology, including the Novelos
Patents, including, without limitation, testifying in any suit or proceeding
involving any of said Novelos Technology or executing any documents deemed
necessary or advisable by Novelos in connection with such enforcement, all
without further consideration than provided for herein. Novelos
agrees that reasonable travel and out of pocket expenses for such assistance
incurred by Collaborator at the request of Novelos under this Section 12.1 will
be reimbursed by Novelos.
12.2. Third Party
Infringement. Each Party shall promptly inform the other Party
of any suspected infringement in the Territory of any Novelos Patent by a Third
Party. Promptly thereafter the Parties shall confer about the
suspected infringement and its likely legal and economic impact. The
Parties shall have the rights to institute an Action for infringement of the
Novelos Patent against such Third Party in accordance with the
following:
(a) If
the Parties agree to institute an Action jointly against a Third-Party infringer
based upon any Novelos Patent, the Action shall be brought in both their names,
the out-of-pocket costs thereof shall be borne equally or as mutually agreed to,
and any recovery or settlement shall be shared equally or as mutually agreed
to. The Parties shall agree to the manner in which they shall
exercise control over such legal Action. Each Party may, if it so
desires, also be represented by separate counsel of its own selection, the fees
for which counsel shall be paid by that Party. Should either Party
wish to abandon an Action commenced under the provisions of this Section 12.2,
it shall give timely notice to the other Party which may, if it so desires,
continue prosecution of such Action, provided, however, that unless the sharing
of expenses and of recovery in such Action are otherwise agreed upon between the
Parties, the Party prosecuting the Action shall bear the entire cost of such
litigation, including, without limitation, the legal expenses incurred in
connection with the Action, and shall be entitled to retain the entire amount of
any recovery or settlement.
(b) In
the absence of an agreement to institute an Action jointly regarding a
Third-Party infringement, Novelos may institute the Action and, at its option,
join Collaborator as a plaintiff, in which case, Novelos shall bear the entire
cost of such Action, including, without limitation, the legal expenses of
Collaborator, and shall be entitled to retain the entire amount of any recovery
or settlement.
(c) In
no event shall Collaborator prosecute any Action against a Third Party infringer
of a Novelos Patent without Novelos’s prior written
consent. Collaborator’s sole remedy for Novelos’s refusal to
prosecute a Third Party infringer of a Novelos Patent shall be to terminate the
Agreement pursuant to Section 13.3.
13. TERM
AND TERMINATION; REVERSION OF RIGHTS
13.1. Term of
Agreement. Unless otherwise terminated as expressly provided
herein, this Agreement and the License granted hereunder shall commence on the
Effective Date and continue on a country-by-country basis within the Territory
until:
(a) with
respect to each country of the Territory in which a Novelos Patent was in effect
on the Effective Date, the earlier of (i) the expiration of the last of the
Novelos Patents covering the Licensed Products in such country and (ii) a final
judgment of any Governmental Authority that any of the Novelos Patents covering
the Licensed Products, which Collaborator in its sole judgment deems necessary
to exercise its rights under this Agreement, are invalid, obvious or otherwise
unenforceable in such country, and
(b) with
respect to each country of the Territory in which a Novelos Patent was not in
effect on the Effective Date, the earlier of (i) the occurrence of Generic
Product Competition in such country and (ii) the expiration of fifteen (15)
years from the Effective Date
(the
“Term”). Upon expiration of the Term in a country of the Territory
under this Section 13.1, Collaborator shall have a royalty-free, fully paid-up
license for the grant of rights under Section 2 in such country of the
Territory.
13.2. Novelos Right to
Terminate.
13.2.1. Novelos
shall have the right (without prejudice to any of its other rights conferred on
it by this Agreement or otherwise) to terminate this Agreement if Collaborator
or any of its Affiliates:
(a) is
in default in payment of any amount or other consideration or reimbursement
required under this Agreement, and Collaborator fails to remedy any such default
within thirty (30) days after written notice thereof by Novelos;
(b) is
in breach of or defaults with respect to any material provision of this
Agreement and Collaborator fails to remedy any such breach or default within
sixty (60) days after written notice thereof by Novelos; or
(c) files
any Action to challenge any of Novelos’s rights in the Novelos Technology, and
such right to terminate shall be immediate upon the filing of such
Action.
13.2.2. In
the event that Novelos has the right to terminate this Agreement for any of the
reasons stated in Section13.2.1(a) – (c), at the election of Novelos, exercised
in its sole discretion by written notice to Collaborator, and in lieu of
terminating this Agreement, Novelos may (i) declare the License rights granted
under this Agreement to be non-exclusive, and grant to such Third Parties any
and all additional non-exclusive rights to the Technology as Novelos shall
determine in its sole discretion; or (ii) declare the License granted under this
Agreement to be non-exclusive in the specific country or countries in the
Territory in which Collaborator has breached its obligations, and grant to such
Third Parties in such country or countries any and all additional non-exclusive
rights to the Technology as Novelos shall determine in its sole discretion; or
(iii) terminate the License granted under this Agreement in the specific country
or countries in the Territory in which Collaborator has breached its
obligations.
13.3. Collaborator Right to
Terminate.
13.3.1. Collaborator
shall have the right (without prejudice to any of its other rights conferred on
it by this Agreement or otherwise) to terminate this Agreement if
Novelos:
(a) is
in default in payment of any amount or other consideration or reimbursement
required under this Agreement, and Novelos fails to remedy any such default
within thirty (30) days after written notice thereof by Collaborator;
or
(b) is
in breach of or defaults with respect to any material provision of this
Agreement and Novelos fails to remedy any such breach or default within sixty
(60) days after written notice thereof by Collaborator; or
(c) (i)
applies for or consents to the appointment of, or the taking of possession by, a
receiver, custodian, trustee or liquidator of itself or of all or a substantial
part of its property, (ii) makes a general assignment for the benefit of its
creditors, (iii) commences a voluntary case under the Bankruptcy Code, (iv)
files a petition seeking to take advantage of any Laws relating to bankruptcy,
insolvency, reorganization, winding-up, or composition or readjustment of debts,
(v) fails to controvert in a timely and appropriate manner, or acquiesce in
writing to, any petition filed against it in any involuntary case under the
Bankruptcy Code, (vi) takes any corporate action for the purpose of effecting
any of the foregoing, (vii) has a proceeding or case commenced against it in any
court of competent jurisdiction, seeking (A) its liquidation, reorganization,
dissolution or winding-up, or the composition or readjustment of its debts, (B)
the appointment of a trustee, receiver, custodian, liquidator or the like of all
or any substantial part of its assets, or (C) similar relief under the
Bankruptcy Code, or an order, judgment or decree approving any of the foregoing
is entered and continues unstayed for a period of sixty (60) days, or (viii) has
an order for relief against it entered in an involuntary case under the
Bankruptcy Code.
13.3.2. Should
any serious and unexpected events or issues occur with respect to the safety of
Licensed Products, as a result of which, any Regulatory Approval is terminated
or suspended in the Territory, or a Regulatory Authority directs or requests
discontinuance of development, use or sale of a Licensed Product anywhere in the
world, then Collaborator’s obligations under this Agreement with respect to that
Licensed Product will be suspended until such serious safety event is resolved
and the Regulatory Authority has given approval again to distribute the Licensed
Product. Collaborator may, upon written notice to Novelos, terminate
this Agreement pursuant to this Section 13.3.2 if the Agreement is suspended
pursuant to this Section 13.3.2 for a period in excess of 12
months.
13.3.3. Collaborator
may terminate this Agreement immediately on written notice to Novelos in the
event that either the 2000 BAM Agreement or 2005 BAM Agreement terminates for
any reason unless Collaborator has otherwise consented to such termination as
set forth in Section 10.2(i).
13.3.4. Collaborator
may terminate this Agreement at any time by written notice to Novelos at least
thirty (30) days prior to the termination date specified in the
notice.
13.4. Effect of
Termination. Upon the expiration or termination of this
Agreement on a country-by-country basis within the Territory, each of the
following will occur:
13.4.1. Upon
the termination of this Agreement under Section 13.2.1, 13.3.2 or 13.3.4,
Collaborator and its Affiliates shall immediately cease using the Novelos
Technology for any purpose and shall also immediately cease making, having made,
using, selling, and importing the Licensed Products, and shall return to
Novelos, or deliver or destroy as Novelos directs, the Licensed Products, all
copies of the Novelos Technology and any Confidential Information then in its
possession in accordance with Section 8.2, all of the foregoing to be returned,
delivered or destroyed at Collaborator’s cost. Furthermore, all of
the rights granted pursuant to Section 2.1 shall revert to Novelos, Collaborator
shall provide Novelos with access to all data pertaining to the Licensed
Products in the Territory developed pursuant to this Agreement (other than
Independent Data and Improvements arising in any Independent Trial of
Collaborator if Novelos has not paid fifty percent (50%) of the costs of such
data in accordance with Section 4.8.5) and Collaborator shall assign or cause to
be assigned to Novelos all filings pertaining to the Licensed Products
(including any regulatory filings and certifications and trademark and Patent
applications, Regulatory Approvals and Pricing Approvals that are in the name of
Collaborator or any of its Affiliates) with all of such rights, data,
applications, filings and approvals to be delivered, assigned or transferred at
Collaborator’s cost; provided, however, Collaborator shall not assign or
otherwise transfer ownership of Independent Data or Improvements arising in any
Independent Trials.
13.4.2. Upon
the termination of this Agreement under Section 13.3.1 or 13.3.3, Collaborator
may choose, in its sole discretion, either:
(a) along
with its Affiliates, to immediately cease using the Novelos Technology for any
purpose and also to immediately cease making, having made, using, selling, and
importing the Licensed Products, and to return to Novelos, or deliver or destroy
as Novelos directs, the Licensed Products, all copies of the Novelos Technology
and any Confidential Information then in its possession in accordance with
Section 8.2, all of the foregoing to be returned, delivered or destroyed at
Novelos’ cost. Furthermore, all of the rights granted pursuant to
Section 2.1 shall revert to Novelos, Collaborator shall provide Novelos with
access to all data pertaining to the Licensed Products in the Territory
developed pursuant to this Agreement (other than Independent Data and
Improvements arising in any Independent Trial of Collaborator if Novelos has not
paid fifty percent (50%) of the costs of such data in accordance with Section
4.8.5) and Collaborator shall assign or cause to be assigned to Novelos all
filings pertaining to the Licensed Products (including any regulatory filings
and certifications and trademark and Patent applications, Regulatory Approvals
and Pricing Approvals that are in the name of Collaborator or any of its
Affiliates), with all of such rights, data, applications, filings and approvals
to delivered, assigned or transferred at Novelos’ cost; provided, however,
Collaborator shall not assign or otherwise transfer ownership of Independent
Data or Improvements arising in any Independent Trials;
(b) to
require that Novelos promptly takes, and Novelos hereby agrees to take, such
actions as Collaborator may reasonably request, in order to transfer to
Collaborator, or its designated Affiliates or Sublicensees, free of charge, in
respect of the Territory only: all of Novelos’ right, title and interest in and
to, the Licensed Products, Novelos Technology, access to any data relating to
said Licensed Products, all licenses and like permissions and certifications
then in Novelos’ possession or control required for Collaborator to exercise its
rights under Section 2.1, including without limitation the right to research,
register, develop, make, have made, use, warehouse, promote, market, sell, have
sold, offer for sale, import, distribute or commercialize pharmaceutical
products containing the Licensed Products. In the event of such an
assignment, Novelos will, at its expense and Collaborator’s request, deliver,
execute and/or deliver or cause to be delivered, all such assignments, consents,
documents or further instruments of transfer or license, and take or cause to be
taken all such actions as may be reasonably necessary to effectuate such
transfer. Novelos will further reconvey and release to Collaborator
all rights and privileges originally granted to it under this Agreement such
that all such rights and privileges will vest with
Collaborator. Collaborator will, in such circumstances, pay to
Novelos the Royalties on Licensed Products set forth in Section 3 and Attachment 5 – Part A after deducting the
Collaborator’s cost of curing the consequences of Novelos’ breach that resulted
in termination under Section 13.3.1 or Section 13.3.3. Such other
provisions hereof as are necessary to administer the calculation and payment of
such royalties will also survive such termination, including without limitation,
any audit, payment and record retention provisions. Collaborator will
thereafter be free to exercise its rights under the License to the Licensed
Product in the Territory as it may see fit, and Novelos and its Affiliates or
Sublicensees will not take any actions or make any omissions to prevent
Collaborator therefrom.
13.4.3. If
the rights under Section 2.1 are terminated only in specific countries of the
Territory pursuant to Section 13.2.2 rather than throughout the Territory, the
obligation to provide access to data and to assign filings pursuant to Sections
13.4.1 and 13.4.2 shall be limited to the specific countries with respect to
which such rights have been terminated.
13.4.4. Notwithstanding
the termination or expiration of this Agreement for any reason, the following
provisions shall survive:
(a) Collaborator’s
obligation to pay fees and royalties and costs hereunder that are accrued and
remaining unpaid or unperformed under the terms of this Agreement prior to such
termination;
(b) Any
Novelos obligation to reimburse Collaborator for the European Registration Trial
costs that may exist pursuant to Section 4.7.1(a) or (b), as applicable, and
that are accrued and remaining unreimbursed prior to such
termination;
(c) Sections
2.3, 2.4 (the first three sentences only), 3.3, 3.7, 6.3.1 (last sentence),
6.3.3, 6.3.5, 8, 9, 10.1.3, 11, 12, 13.1 (last sentence only), 13.4, 14 and
15;
(d) any
cause of action or claim of Collaborator or Novelos, accrued or to accrue,
because of any breach or default of this Agreement by the other Party;
and
(e) Collaborator,
its Affiliates and Sublicensees shall, after termination, be entitled to sell
any inventory of Licensed Products that have been manufactured at the time
termination takes effect, provided that any Royalties payable on such sales are
paid by Collaborator, subject to any applicable recovery for the European
Registration Trial costs pursuant to Section 4.7.1(a) or (b) as
applicable.
14. LIMITATION
OF LIABILITY
EXCEPT
FOR VIOLATIONS OF NOVELOS’S INTELLECTUAL PROPERTY RIGHTS AND FOR DAMAGES CAUSED
BY A PARTY’S GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT, IN NO EVENT SHALL A
PARTY BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL
DAMAGES, WHETHER OR NOT THE PARTY ALLEGEDLY CAUSING THE DAMAGE HAS BEEN ADVISED
OF THE POSSIBILITY THEREOF. THIS SECTION 14 SHALL NOT BE CONSTRUED TO
LIMIT ANY PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 11.1
HEREOF. IN NO EVENT SHALL NOVELOS’S LIABILITY EXCEED ONE HUNDRED
PERCENT (100%) OF THE AMOUNTS THAT HAVE BEEN PAID TO IT UNDER THIS
AGREEMENT.
15. GENERAL
15.1. Waivers
and Amendments.
(a) This
Agreement may be amended, modified or supplemented only by a written instrument
executed by the Parties hereto.
(b) No
waiver of any provision of this Agreement, or consent to any departure from the
terms hereof, shall be effective unless the same shall be in writing and signed
by the Party waiving or consenting thereto. No failure on the part of
a Party to exercise, and no delay in exercising, any right or remedy hereunder
shall operate as a waiver thereof, nor shall any single or partial exercise of
any such right or remedy by such Party preclude any other or further exercise
thereof or the exercise of any other right or remedy. The waiver by a
Party hereto of a breach of any provision of this Agreement shall not operate as
a waiver of any subsequent breach. All rights and remedies hereunder
are cumulative and are in addition to and not exclusive of any other rights and
remedies provided by Law.
15.2. Entire
Agreement. This Agreement and the Attachments hereto
constitute the entire agreement among the Parties hereto with respect to the
subject matter hereof and supersede all prior agreements and understandings,
whether written or oral, between the Parties, in connection with such subject
matter. There are no covenants, promises, agreements, warranties,
representations, conditions or undertakings, either oral or written, between the
Parties other than as set forth herein.
15.3. Severability. If
any provision of this Agreement is found invalid or unenforceable by a court of
competent jurisdiction, such provision shall be enforced to the maximum extent
permissible by Law and the other provisions of this Agreement shall remain in
full force and effect.
15.4. Relationship of the
Parties. This Agreement shall not be interpreted to constitute
the appointment of one Party the agent or legal representative of the other
Party for any purpose whatsoever, and neither Party shall hold itself out as an
agent of the other Party. This Agreement creates no relationship of
joint venturers, partners, Affiliates, employment or principal and agent between
or among the Parties, and each of the Parties is acting as an independent
contractor. Neither Party is granted herein any right or authority
to, and shall not attempt to, assume or create any obligation or responsibility
for or on behalf of any other Party. Neither Party shall have any
authority to bind the other Party to any contract, whether of employment or
otherwise, and each Party shall bear all of its respective expenses for its
operations, including, without limitation, the compensation of its employees and
salespersons and the maintenance of its offices, service and warehouse
facilities. Each Party shall each be solely responsible for its own
employees and salespersons and for the acts and the things done by
them.
15.5. Notices. All
notices, instructions and other communications hereunder or in connection
herewith will be in writing, will be sent to the addresses below (or at such
other address for a Party as shall be specified by like notice) and will
be: (a) delivered personally; (b) sent by registered or certified
mail, return receipt requested, postage prepaid; (c) sent via a reputable
nationwide overnight courier service; or (d) sent by facsimile
transmission. Any such notice, instruction or communication will be
deemed to have been delivered (i) upon receipt if delivered by hand, (ii) three
business days after it is sent by registered or certified mail, return receipt
requested, postage prepaid, (iii) one business day after it is sent via a
reputable nationwide overnight courier service, or (iv) when transmitted with
electronic confirmation of receipt, if transmitted by facsimile (if such
transmission is prior to 5:00 p.m. local time on a business day; otherwise, on
the next business day following such transmission).
|
For
Novelos:
|
For
Collaborator:
|
| |
|
|
NOVELOS
THERAPEUTICS, INC.
One
Gateway Center, Suite 504,
Newton,
Massachusetts 02458
Attention: Harry
S. Palmin,
President
and CEO
Telephone: +1
617-244-1616 x11
Fax: +1
617-860-1170
Email:
hpalmin@novelos.com
|
Mundipharma
International Corporation Limited
14
Par-la-Ville Road
P.O.
Box HM2332
Hamilton
HMJX
Bermuda
Attention: Douglas
Docherty, General Manager
Telephone: +(441)
295 6480
Fax: +(441)
292 1472
Douglas.docherty@mundipharma.bm
|
| |
|
|
with
a copy to:
|
with
copies to:
|
| |
|
|
Foley
Hoag LLP
155
Seaport Boulevard
Boston,
MA 02210,
Attention: Paul
Bork, Esq.
Telephone: +1
617-832-1113
Fax.: +1
617-832-7000
Email:
pbork@foleyhoag.com
|
Mundipharma
International Limited
Cambridge
Science Park
Milton
Road, Cambridge CB4 0GW, United Kingdom
Attention: Managing
Director, and
European
General Counsel
Chadbourne
& Parke LLP
30
Rockefeller Plaza
New
York, NY 10112
Attention:
Stuart D. Baker
Telephone: (212)
408-5100
Fax: (212)
541-5369
|
15.6. Governing
Law, Jurisdiction and Dispute Resolution.
15.6.1. This
Agreement, including the interpretations, performance, enforcement, breach or
termination hereof and any remedies relating hereto, shall be governed by, and
construed and enforced in accordance with, the substantive laws of the State of
New York, USA, without giving effect to its conflicts of laws
rules. Courts located in New York County, New York, USA shall have
exclusive jurisdiction over claims relating to this Agreement.
15.6.2. Unless
otherwise set forth in this Agreement, in the event of a dispute arising under
this Agreement between the Parties and/or their Affiliates, such dispute shall
be referred to the respective executive officers of the Parties designated
below, or their successors, for good faith negotiations attempting to resolve
the dispute. The designated executive officers are as
follows:
|
For
Collaborator:
|
Regional
Director, Europe
|
| |
|
|
For
Novelos:
|
President
and CEO
|
15.6.3. Any
dispute or claim arising out of or relating to this Agreement (other than with
respect to Patent, copyright, trademark or trade secret rights), or to the
breach, termination, or validity of this Agreement, will be resolved as
follows: the executive officers of each Party referred to in Section
15.6.2 above will meet to attempt to resolve such dispute by good faith
negotiations. If such executive officers cannot resolve the dispute
within 30 days after a Party requests such a meeting, then each Party will
attempt in good faith to settle the dispute by mediation pursuant to Section
15.6.4.
15.6.4. The
mediation of any dispute is to be administered by JAMS or such other mediator as
may be mutually agreed to by the Parties. If mediation is
unsuccessful within 30 days after the Parties request mediation pursuant to
Section 15.6.3, the Parties may then resort to the alternative dispute
resolution procedures set forth in Attachment 9.
15.6.5. Notwithstanding
anything to the contrary in Sections 15.6.2, 15.6.3 and 15.6.4, if either Party
in its sole judgment believes that any such dispute could cause it irreparable
harm, such Party (a) will be entitled to seek equitable relief in order to avoid
such irreparable harm, and (b) will not be required to follow the procedures set
forth in the foregoing Sections 15.6.2, 15.6.3 and 15.6.4.
15.7. Counterparts. This
Agreement may be executed in two or more counterparts, all of which shall be
considered one and the same agreement and shall become effective when two or
more counterparts have been signed by each of the Parties and delivered to the
other Party, it being understood that both Parties need not sign the same
counterpart. Facsimile execution and delivery of this Agreement by
either Party shall be legal, valid and binding execution and delivery of such
document for all purposes.
15.8. Assignment. This
Agreement is personal to the Parties, and neither Party shall assign any of its
rights or delegate any of its obligations hereunder, provided, however, that (i)
Novelos may assign this Agreement to any successor by consolidation, merger or
other corporate action, or to a corporation or other business entity to which
the Novelos may sell all or substantially all of its business, provided that
such assignment is part of the transfer of the business, and (ii) Collaborator
may assign this Agreement, in whole or in part, to any of its
Affiliates.
15.9. Force
Majeure. Neither Party shall be liable for failure to perform
any of its obligations under this Agreement when such failure is due to war,
terrorism, epidemic, explosion, failure of public utilities or common carriers,
fire, flood, earthquake, storm, strikes, labor troubles or other industrial
disturbances, legal restriction, act or pronouncement by any Governmental
Authority or Regulatory Authority, shortages of raw materials, riot,
insurrection, or any other cause beyond the reasonable ability of the Party
affected thereby to foresee and avoid, and without such Party’s fault or
negligence (“Force Majeure”), provided that the Party claiming the existence of
Force Majeure shall give notice to the other Party not more than seven (7) days
after the commencement of the event of Force Majeure, and shall use prompt and
diligent efforts to mitigate the effects of Force Majeure. In the
event that any event of Force Majeure prevents performance for sixty (60) days
or more, any other Party may terminate this Agreement on written notice to the
other Party unless the Party affected by the event of Force Majeure is using and
continues to use Commercially Reasonable Efforts to remove or cure the Force
Majeure event.
15.10. Further
Assurances. After the Effective Date, the Parties shall, from
time to time, execute and deliver such additional instruments, documents,
conveyances or assurances and take such other action as shall be necessary or
other reasonably requested by the other Party, to confirm and assume the rights
and obligations provided for in this Agreement.
15.11. Intellectual
Property. The Parties acknowledge and agree that the License
and all other rights granted under or pursuant to this Agreement are and shall
otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy
Code, licenses of rights to “intellectual property” as defined under Section
101(35A) of the Bankruptcy Code, and that this Agreement is an executory
contract governed by Section 365(n) of the Bankruptcy Code in the event that a
bankruptcy proceeding is commenced involving Novelos. Collaborator,
as the licensee of such rights under this Agreement, shall retain and may fully
exercise all of its rights and elections under the Bankruptcy
Code. The foregoing provisions of this Section 15.11 are without
prejudice to any rights the Parties may have arising under the Bankruptcy Code
or other applicable Law.
15.12. Press Releases and External
Communications. The Parties will issue the initial press
release(s) attached hereto as Attachment 10 on the Effective
Date. Thereafter, neither Party shall issue press releases or make
public announcements relating to the transactions contemplated by this Agreement
without the other Party’s prior written approval, which approval shall not be
unreasonably withheld or delayed; provided, however, that nothing in this
Section 15.12 shall impair either Party’s compliance with any requirements of
the Securities and Exchange Commission or the national securities exchange or
other stock market on which such Party’s securities are traded; and, provided
further, that Novelos may issue external media and investor communications
related to the transactions contemplated by this Agreement if such external
media communications are previously approved by Collaborator, which approval
shall not be unreasonably withheld or delayed. In connection with any
filing by either Party of a copy of this Agreement with the Securities and
Exchange Commission (or the national securities exchange or other stock market
on which such Party’s securities are traded), the filing Party shall endeavor to
obtain confidential treatment of economic and trade secret
information. At least two business days in advance of filing, the
filing Party shall provide to the other Party a copy of the proposed filing and
the Parties shall work cooperatively in good faith, taking into consideration
the other Party’s suggestions, regarding the information for which the filing
Party will seek to obtain confidential treatment.
15.13. Non-Solicitation of
Employees. During the Term, neither Party may, directly or
indirectly, recruit or solicit any employee of the other Party who became known
to the other Party through contact or interactions for the purposes of
negotiating or performing this Agreement, without the prior consent of the other
Party, except pursuant to general solicitations not targeted at such
employees.
15.14. Expenses. Each of
the Parties will bear its own direct and indirect expenses incurred in
connection with the negotiation and preparation of this Agreement and, except as
set forth in this Agreement, the performance of the obligations contemplated
hereby and thereby.
15.15. Headings. The
headings for each Article and Section in this Agreement have been inserted for
convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular Article, and will be of no
force or effect in construing or interpreting any of the provisions of this
Agreement.
[Signature Page
Follows]
IN
WITNESS WHEREOF, the Parties have executed, or caused their duly authorized
representatives to execute, this Agreement under seal as of the date first
written above.
| |
Novelos
Therapeutics, Inc.
|
| |
|
| |
By:
/s/ Harry S.
Palmin
|
| |
Name: Harry
S. Palmin
|
| |
Title: President
and Chief Executive Officer
|
| |
Mundipharma
International Corporation Limited
|
| |
|
| |
By:
/s/ Douglas
Doherty
|
| |
Name: Douglas
Docherty
|
| |
Title: General
Manager
|
Schedule
9.1.1(e)
Government Consents and
Filings
Novelos
will be making various FDA filings in performance of this
Agreement.
Attachment
1
Novelos
Patents
|
US6165979
|
|
US6251857
|
|
US6312734
|
|
US6492329
|
|
US7169412
|
|
US7371411
|
|
EP0869809
|
|
EP1131340
|
|
JP3547400
|
|
JP2007-238577
|
|
CA2239874
|
|
CA2351354
|
|
CH2010/97
|
|
CN1207683
|
|
HK1042306
|
Attachment
2
Novelos
Trials
|
1.
|
A
Randomized, Open-Label, Phase 3 Trial of NOV-002 in Combination with
Paclitaxel and Carboplatin vs. Paclitaxel and Carboplatin Alone for the
Treatment of Advanced Non-small Cell Lung
Cancer
|
|
2.
|
Phase
2 Trial of Neoadjuvant Treatment with NOV-002 in Combination with
Doxorubicin and Cyclophosphamide Followed by Docetaxel in Patients with
Stages IIB-IIIC Breast Cancer
|
Attachment
3
Territory
|
|
|
|
Albania
|
Luxembourg
|
|
Andorra
|
Macedonia
|
|
Australia
|
Malaysia
|
|
Austria
|
Malta
|
|
Belgium
|
Monaco
|
|
Bosnia-Herzegovina
|
Montenegro
|
|
Bulgaria
|
Netherlands
|
|
Croatia
|
New
Zealand
|
|
Cyprus
|
Norway
|
|
Czech
Republic
|
Philippines
|
|
Denmark
|
Poland
|
|
Finland
|
Portugal
|
|
France
|
Republic
of Ireland
|
|
Germany
|
Romania
|
|
Greece
|
Serbia
|
|
Hungary
|
Singapore
|
|
Iceland
|
Slovakia
|
|
India
|
Slovenia
|
|
Indonesia
|
Spain
|
|
Ireland
|
Sweden
|
|
Israel
|
Switzerland
|
|
Italy
|
Thailand
|
|
Japan
|
Turkey
|
|
Korea
(South)
|
United
Kingdom
|
|
Liechtenstein
|
Vietnam
|
|
|
|
Attachment
4
Milestone
Payments
Launch of
Product for Non-small cell
lung cancer
(1st
line advanced)
|
|
·
|
$2.5M
per country of Territory to maximum of $25M
|
$25,000,000
|
Each
$2,500,000 milestone payment is separate. That is, the aggregate
milestone payments set forth in this Attachment 4 equal
$25,000,000. All amounts are in U.S. dollars.
The
milestone payments set forth in this Attachment are separate from and in
addition to the Royalties set forth in Section 3.1.2 (and Attachment 5 – Part A) and the
super royalty payments set forth in Section 3.1.3 (and Attachment 5 – Part
B).
Attachment
5
Part A - Royalty
Payments
|
Column
A
Royalty
Rate
|
Column
B
Royalty
Rate
|
Annual
Net Sales
|
|
[ * ]
|
[ * ]
|
$100,000,000
or less
|
|
[ * ]
|
[ * ]
|
>
$100,000,000 but less than or equal to $250,000,000
|
|
[ * ]
|
[ * ]
|
>
$250,000,000 but less than or equal to $500,000,000
|
|
[ * ]
|
[ * ]
|
>$500,000,000
|
Column A
Royalties
The
Royalty rates set forth above in Column A shall apply in each of the countries
of the Territory in which any Novelos Patent is in effect on the Effective Date,
which are: Austria, Belgium, Denmark, Finland, France, Germany,
Greece, Ireland, Italy, Japan, Liechtenstein, Luxembourg, Monaco, Netherlands,
Portugal, Spain, Sweden, Switzerland and the United Kingdom. The
Royalty rates set forth above in Column A shall remain in effect within a given
country in the Territory until such time as (a) there are no longer Novelos
Patents in effect within such country or (b) Generic Product Competition
occurs. Upon the occurrence of the aforementioned clause (a) and
pursuant to Section 13.1, no further Royalties under Section 3.1.2 and this
Attachment 5 – Part A
shall be due in such country and the Collaborator shall have a royalty-free,
fully paid-up license for the grant of rights under Section
2. Subject to Section 13.1(a), upon the occurrence of the
aforementioned clause (b), the respective royalty rates otherwise specified in
Column A of this Attachment 5 –
Part A shall be reduced to a rate which is the lesser of (i) [ * ]
percent ([ * ]%), and (ii) [ * ] percent ([ * ]%)
more than the percentage consideration payable by Novelos to BAM pursuant to
Clauses 1 and 2 of the current 2005 BAM Agreement for as long as such
consideration is payable to BAM under the current 2005 BAM
Agreement.
Column B
Royalties
The
Royalty rates set forth above in Column B shall apply in each of the countries
of the Territory in which no Novelos Patent is in effect on the Effective Date
and such Royalty rates shall remain in effect for fifteen years from the
Effective Date within a given country in the Territory unless and until such
time as Generic Product Competition occurs. Upon the occurrence of
Generic Product Competition, no further Royalties under Column B shall be due
and the Collaborator shall have a royalty-free, fully paid-up license for the
grant of rights under Section 2.
For the
purpose hereof, “annual Net Sales” shall mean a period commencing January 1st and
ending December 31st of the
same year.
For
example if annual Net Sales in a particular year are $600,000,000 of which
$550,000,000 were from countries where Column A applies and $50,000,000 were
from countries where Column B applies, and in the absence of any Generic Product
Competition, the Royalties would be calculated as follows:
|
(i)
|
a
Royalty rate of [ ]% on sales on the first
$100,000,000,
|
|
(ii)
|
plus
[ * ]% on the next
$150,000,000,
|
|
(iii)
|
plus
[ * ]% on the next
$250,000,000,
|
|
(iv)
|
plus
[ * ]% on the next
$50,000,000
|
and in
countries where a Novelos Patent has not been filed
|
(v)
|
plus
[ * ]% on the next
$50,000,000
|
for a
total Royalty of $[ * ].
The
Royalties set forth in this Attachment 5 – Part A are
separate from and in addition to the milestone payments set forth in Section
3.1.1 and Attachment 4
and the super royalty payments set forth in Section 3.1.3 and Attachment 5 – Part
B.
Attachment
5 (continued)
Part B – Super Royalty
Payments
Super
Royalty Payments
|
·
|
annual
Net Sales exceed $100,000,000 (Territory)
|
$[ * ]
|
|
|
|
|
|
·
|
annual
Net Sales exceed $250,000,000 (Territory)
|
$[ * ]
|
|
|
|
|
|
·
|
annual
Net Sales exceed $500,000,000 (Territory)
|
$[ * ]
|
Each
super royalty payment is separate and may only be earned once. That
is, the aggregate amount of the super royalty payments set forth in this Attachment 5 – Part B that may
be paid to Novelos during the Term if all three thresholds are satisfied is
$60,000,000. All amounts are in U.S. dollars. For the
purpose hereof, “annual Net Sales” shall mean a Net Sales made during a period
commencing January 1st and ending December 31st of the same year.
The super
royalty payments set forth in this Attachment 5 – Part B are
separate from and in addition to the milestone payments set forth in Section
3.1.1 (and Attachment 4)
and the Royalties set forth in Section 3.1.2 (and Attachment 5 – Part
A).
Attachment
6
CMC Work
Program
|
Work
Package
|
Guideline(s)
|
[
2 pages redacted]
Attachment
7
Pre-Clinical
Studies
|
Study
|
International
Guideline(s)
|
[2
pages redacted]
Attachment
8
Manufacturing Development
Work
required
to supply finished product to the Mundipharma Territory
|
Work
Package
|
Guideline(s)
|
[3
pages redacted]
Attachment
9
Alternative Dispute
Resolution
In
accordance with Section 15.6 of the Agreement, either Party may initiate an
Alternative Dispute Resolution (“ADR”) proceeding as
provided herein. The Parties will have the right to be represented by
counsel in such a proceeding.
1. To
initiate an ADR proceeding, a Party must provide written notice to the other
Party of the issues to be resolved by ADR. Within 14 calendar days
after its receipt of such notice, the other Party may, by written notice to the
Party initiating the ADR, add additional issues to be resolved within the same
ADR to the extent disposition of such additional issues are related to the
original issues or it otherwise is efficient to address the issues in a common
proceeding.
2. Within
21 calendar days following receipt of the original ADR notice, the Parties will
select a mutually acceptable neutral to preside in the resolution of any
disputes in the ADR proceeding. If the Parties are unable to agree on
a mutually acceptable neutral within such period, either Party may request the
President of the CPR Institute for Dispute Resolution (the “CPR”), 366 Madison
Avenue, 14th Floor, New York, New York 10017, to select a neutral pursuant to
the following procedures:
(a) The
CPR will submit to the Parties a list of not less than ten candidates within 14
calendar days after receipt of the request, along with a Curriculum Vitae for each
candidate. Consistent with any other CPR rules governing the
impartiality and disinterestedness of the neutral, no candidate may be an
employee, director, or shareholder of either Party or any of their subsidiaries
or Associates or have an interest in the outcome of the dispute.
(b) Such
list will include a statement of disclosure by each candidate of any
circumstances likely to affect his or her impartiality.
(c) Each
Party will number the candidates in order of preference (with the number one
signifying the greatest preference) and will deliver the list to the CPR within
seven calendar days following receipt of the list of candidates. If a
Party believes a conflict of interest exists regarding any of the candidates,
that Party will provide a written explanation of the conflict to the CPR along
with its list showing its order of preference for the candidates. Any
Party failing to return a list of preferences in the required time allowed will
be deemed to have no order of preference.
(d) If
the Parties collectively have identified three or fewer candidates deemed to
have conflicts, the CPR immediately will designate as the neutral the candidate
for whom the Parties collectively have indicated the greatest
preference. If a tie should result between two candidates, the CPR
may designate either candidate. If the Parties collectively have
identified four or more candidates deemed to have conflicts, the CPR will review
the explanations regarding the conflicts and if the CPR, in its reasonable
discretion, finds the conflicts valid for at least four candidates, it shall
issue a new list of not less than ten candidates, in which case the procedures
set forth in subparagraphs 2(a) - 2(d) will be repeated.
3. The
neutral shall conduct the proceedings with due regard for the Parties’ mutual
goal of an expeditious, efficient process. There shall be a
rebuttable presumption in favor of completing the hearing(s) of an ADR
proceeding no later than six (6) months after designation of the neutral and
earlier to the extent appropriate, subject to adjustment on good cause shown
taking into account the nature and subject of the issue(s) in
dispute. The ADR proceeding will take place at a location agreed upon
by the Parties. If the Parties cannot agree, the neutral will
designate a location other than the principal place of business of either Party
or any of their subsidiaries or Associates.
4. The
neutral will be paid a reasonable fee plus expenses. The neutral
shall have discretion to allocate these fees and expenses, along with the
reasonable legal fees and expenses of the prevailing Party (including all expert
witness fees and expenses) to the other Party.
5. The
rulings of the neutral and the allocation of fees and expenses will be binding,
non-reviewable, and non-appealable, and may be entered as a final judgment in
any court having jurisdiction. Upon the written mutual consent of the
Parties, the neutral may amend or alter any provision of this ADR.
6. Except
as provided in paragraph 5 or as required by law, the existence of the dispute,
any settlement negotiations, the ADR hearing, any submissions (including
exhibits, testimony, proposed rulings, and briefs), and the rulings will be
deemed Confidential Information. The neutral will have the authority
to impose sanctions for unauthorized disclosure of Confidential
Information.
Attachment
10
Press
Release
***CONFIDENTIAL*** [FOR
IMMEDIATE RELEASE]
NOVELOS
THERAPEUTICS AND MUNDIPHARMA SIGN EXCLUSIVE
COLLABORATION
AGREEMENT IN EUROPE AND JAPAN
$95mil
for Cancer Compound through
Equity
Investment, Milestones and Fixed Sales-Based Payments, Plus
Royalties
NEWTON, Mass., February__, 2009 –
Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company
focused on the development of therapeutics to treat cancer and hepatitis,
announced today that Novelos signed an exclusive collaboration agreement with
Mundipharma International Corporation Limited to commercialize in Europe and
Asia / Pacific (excluding China) Novelos’ lead compound, NOV-002, which is in a
pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol
Assessment (SPA) and Fast Track. NOV-002 has also demonstrated
positive results in Phase 2 trials for other cancer indications.
In
parallel, Novelos has also closed a private placement with Purdue Pharma L.P.
resulting in $10 million in gross proceeds through the sale of convertible
preferred stock and warrants to purchase its common stock. Novelos
sold 200 shares of Series E convertible preferred stock, having a stated value
equal to $50,000 per share, a cumulative annual dividend of 9% of stated value
and a conversion price of $0.65 per share of common stock. Purdue
also received warrants expiring on December 31, 2015 to purchase an aggregate of
9,230,769 shares of common stock at an exercise price of $0.65 per
share.
Under the
terms of the collaboration agreement, Novelos may receive up to $25 million of
launch milestones and $60 million of fixed sales-based
payments. Novelos will receive a double-digit royalty, which
increases as the annual sales increase in the licensed
territories. Mundipharma will be responsible for certain development
activities, regulatory submissions and commercialization of NOV-002 in the
licensed territories. Novelos retains all rights and responsibilities
in the U.S.A. and the rest of the Americas.
“I am
very pleased to be collaborating with Mundipharma and Purdue, which are
innovative independent associated pharmaceutical companies with ample resources
and a proven track record of developmental and commercialization expertise,”
said Harry Palmin, President and CEO of Novelos. “This transaction
will provide the remaining capital to complete our pivotal, fully-enrolled,
840-patient Phase 3 lung cancer trial, which is currently expected to conclude
in late 2009.”
According
to Åke Wikström, Mundipharma’s Regional Director – Europe, “NOV-002 is an
important addition to our oncology pipeline and reinforces our commitment to
increasing the treatment options available for cancer patients and improving
their quality of life through the development and commercialization of novel
therapeutics.”
Ferghana
Partners (New York, London and Boston) served as financial and strategic
transaction advisor to Novelos. The preferred stock and warrants were
issued in a private placement transaction under Regulation D of the Securities
of Act of 1933 and have not been registered under the Securities Act of 1933, as
amended, or any state securities laws, and may not be offered or sold in the
United States absent registration with the Securities and Exchange Commission
(the “SEC”) or an applicable exemption from the registration
requirements. Novelos has agreed to file a registration statement
with the SEC covering resales of the common stock issuable upon conversion of
the newly issued shares of preferred stock and upon exercise of the
warrants.
About
Mundipharma International Corporation Limited and Purdue Pharma
L.P.
The
Purdue/Mundipharma/Napp independent associated companies are privately owned
companies and joint ventures covering the world’s pharmaceutical
markets. The companies have particular expertise in drug delivery
systems and these are applied to a range of analgesics, respiratory treatments,
and cardiovascular drugs. The companies also have a growing presence
in the oncology market, and products in the areas of attention deficit
hyperactivity disorder, antiseptics and laxatives. For more
information: www.mundipharma.co.uk
About
Novelos Therapeutics, Inc.
Novelos
Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized
glutathione-based compounds for the treatment of cancer and
hepatitis. NOV-002, the lead compound currently in Phase 3
development for lung cancer under SPA and Fast Track, acts together with
chemotherapy as a chemoprotectant and a chemopotentiator. NOV-002 is
also in Phase 2 development for early-stage breast cancer and
chemotherapy-resistant ovarian cancer. Novelos has a partnership with
Mundipharma to develop and commercialize NOV-002 in Europe and
Japan. Novelos’ second compound, NOV-205, acts as a hepatoprotective
agent with immunomodulating and anti-inflammatory properties. NOV-205
is in Phase 1b development for chronic hepatitis C
non-responders. Both compounds have been partnered with Lee’s Pharma
in China. For additional information about Novelos please visit www.novelos.com
# #
#
|
COMPANY
Harry
S. Palmin, President and CEO
Ph:
617-244-1616 x11
Email:
hpalmin@novelos.com
|
|
INVESTOR
RELATIONS
Stephen
Lichaw
Ph:
201-240-3200
Email:
slichaw@novelos.com
|
Novelos
Therapeutics, Inc.
One
Gateway Center, Suite 504
Newton,
MA 02458
This news
release contains forward-looking statements. Such statements are
valid only as of today, and we disclaim any obligation to update this
information. These statements are subject to known and unknown risks
and uncertainties that may cause actual future experience and results to differ
materially from the statements made. These statements are based on
our current beliefs and expectations as to such future outcomes. Drug
discovery and development involve a high degree of risk. Factors that
might cause such a material difference include, among others, uncertainties
related to the ability to attract and retain partners for our technologies, the
identification of lead compounds, the successful preclinical development
thereof, the completion of clinical trials, the FDA review process and other
government regulation, our pharmaceutical collaborators’ ability to successfully
develop and commercialize drug candidates, competition from other pharmaceutical
companies, product pricing and third-party reimbursement.