EXECUTION COPY
Exhibit 10.2
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
LICENSE, DEVELOPMENT AND COMMERCIALIZATION
AGREEMENT
by and between
HYBRIDON, INC.
and
NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD.
EXECUTION COPY
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This License, Development and Commercialization Agreement (this "License
Agreement") is made this 31st day of May, 2005 by and between Hybridon, Inc.
("Hybridon"), a Delaware corporation with principal offices at 345 Vassar
Street, Cambridge, Massachusetts 02139 USA, and Novartis International
Pharmaceutical Ltd. ("Novartis"), a Bermuda corporation with principal offices
at Hurst Holme, 12 Trott Road, Hamilton, HM LX, Bermuda. Hybridon and Novartis
are sometimes referred to herein individually as a "Party" and together as the
"Parties." This License Agreement shall take effect on the Effective Date
pursuant to Section 2.1 hereof.
Capitalized terms used but not defined in this License Agreement shall
have the meanings provided in the Research Collaboration and Option Agreement by
and between Hybridon and Novartis of even date herewith (the "Collaboration
Agreement").
INTRODUCTION
WHEREAS, pursuant to the Collaboration Agreement, the Parties are entering
into a collaboration with the objective of identifying and generating IMO Leads;
and
WHEREAS, Novartis may exercise its Commercialization Option (as defined
herein) to license exclusively the Licensed IMOs (as defined herein) for
worldwide development and commercialization of Products (as defined herein) in
the Commercial Field of Use (as defined herein);
NOW THEREFORE, in consideration of the foregoing premises, the Parties
agree as follows:
ARTICLE I
DEFINITIONS
1.1. "AAA" shall have the meaning set forth in Section 14.3.1 hereof.
1.2. "ACCOUNTING STANDARDS" with respect to Hybridon shall mean that
Hybridon shall maintain records and books of accounts in accordance with United
States Generally
Accepted Accounting Principles and with respect to Novartis shall mean that
Novartis shall maintain records and books of accounts in accordance with IFRS
(International Financial Reporting Standards).
1.3. "ACQUISITION INTELLECTUAL PROPERTY" shall mean (a) Patents or
Know-How held or otherwise controlled by an Acquisition Affiliate immediately
prior to the Acquisition Event between Hybridon and such Acquisition Affiliate
(as defined in Section 1.4 below), other than Patents that do not specifically
relate to drug delivery or formulation technology held or otherwise controlled
by any such Acquisition Affiliate that would, but for a license granted
hereunder, be infringed by the development or commercialization of IMO
Candidates or IMO Leads and (b) Patents or Know-How developed or acquired and
controlled by an Acquisition Affiliate after the Acquisition Event between
Hybridon and such Acquisition Affiliate that specifically relate to drug
delivery or formulation technology, which Patents or Know-How are not developed
or acquired through the use of, or as an improvement to, any Hybridon
Intellectual Property or Hybridon Background Intellectual Property Controlled
(other than through an Acquisition Affiliate) by Hybridon.
1.4. "ACQUISITION EVENT" shall mean any merger or other acquisition
between Hybridon and a Third Party occurring after the Effective Date and
pursuant to which such Third Party becomes an Affiliate of Hybridon, so long as
following such merger or acquisition Hybridon does not control and is not merged
with or into such Affiliate (an "Acquisition Affiliate").
1.5. "ADDITIONAL INDICATION" shall have the meaning set forth in
Section 4.1 hereof.
1.6. "AFFILIATE" means any Person who directly or indirectly controls
or is controlled by or is under common control with a Party. For purposes of
this definition, "control" or "controlled" means ownership directly or through
one or more Affiliates, of fifty percent (50%) or more of the shares of stock
entitled to vote for the election of directors, in the case of a corporation, or
fifty percent (50%) or more of the equity interest in the case of any other type
of legal entity, status as a general partner in any partnership, or any other
arrangement whereby a Party controls or has the right to control the Board of
Directors or equivalent governing body of
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a corporation or other entity, or the ability to cause the direction of the
management or policies of a corporation or other entity. The Parties acknowledge
that in the case of certain entities organized under the laws of certain
countries outside of the United States, the maximum percentage ownership
permitted by law for a foreign investor may be less than fifty percent (50%),
and that in such case such lower percentage shall be substituted in the
preceding sentence; provided, that such foreign investor has the power to direct
the management and policies of such entity.
1.7. "ARBITRATORS" shall have the meaning set forth in Section 14.3.1
hereof.
1.8. "BANKRUPT PARTY" shall have the meaning set forth in Section 10.4
hereof.
1.9. "CHEMICALLY MODIFY" OR "CHEMICAL MODIFICATION" shall mean the
modification of an IMO that [**], but specifically excluding [**].
1.10. "COLLABORATION AGREEMENT" shall have the meaning set forth in the
preamble.
1.11. "COMMERCIAL FIELD OF USE" shall mean prophylaxis, palliation,
diagnosis and treatment of the Initial Indications and Additional Indications
added pursuant to Article IV hereof by Products via any route of administration.
1.12. "COMMERCIALIZATION OPTION" shall have the meaning set forth in
Section 4.2.1 of the Collaboration Agreement.
1.13. "CONFIDENTIAL INFORMATION" shall have the meaning set forth in
Section 7.1 hereof.
1.14. "CONTROLLED" shall mean, with respect to intellectual property,
the legal authority of a Party (either directly or through an Affiliate) to
grant the licenses or sublicenses of intellectual property rights as and to the
extent provided herein, or to otherwise disclose proprietary or trade secret
information as and to the extent provided herein, without breaching the terms of
any agreement with a Third Party, knowingly infringing upon the intellectual
property rights of a Third Party, or misappropriating the proprietary or trade
secret information of a Third Party.
1.15. "COST OF GOODS SOLD" shall mean the total Product cost (standard
cost of
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goods), variances, inventory re- / devaluation costs, non-Product-related
production costs, write-offs and Third Party royalties other than Section 5.6.2
royalties. The total Product cost is the total of material costs and processing
costs pertaining to the Products. Material costs relate to costs of devices used
to administer the Product, raw materials and intermediates needed for the
manufacturing process and costs of packaging material for these raw materials
and intermediates. Processing costs shall mean costs for direct labor, costs of
equipment, costs of production area overhead, costs of quality assurance, costs
of material handling overhead, costs of general factory overhead, costs for
utilities and costs for ecology. These costs are to be established on a regular,
standard basis. In this standard setting process all relevant costs as mentioned
above are determined. Costs of equipment shall be based on a planned utilization
of equipment. Idle capacity costs are not to be included in processing costs.
Costs of equipment are costs of depreciation or rent of the building
accommodating that equipment plus repair and maintenance for the building, and
costs for equipment depreciation, and other equipment costs such as costs for
repair and maintenance. The building costs shall be allocated to the equipment
using an appropriate key such as space occupied by the equipment. Production
area overhead costs are costs for personnel which typically embraces a
controlling and supervisory function, costs of indirect space such as costs for
a break room, costs of in-process control, costs of microbiological monitoring
of production environment, costs of training of process personnel, costs for
utilities and ecology, costs for auxiliary and consumables, costs of shop floor
control systems, costs for cleaning of production buildings, and costs of
working clothes. Quality assurance costs include costs of identifying and
analyzing the raw materials and intermediates needed for the manufacturing
process, costs of finished Product control, costs of production support, costs
of cleaning validation, costs of electronic data processing for the quality
assurance ("QA") / quality control ("QC") department, costs of microbiology
department, costs of laboratory infrastructure, costs of quality systems support
and compliance, costs of overheads within the QA/QC department. Materials
handling overhead costs are costs for warehousing and internal transportation of
raw material and semi-finished goods, costs of quality control of raw and
packaging material, costs of the purchasing department. General factory overhead
("GFO") costs shall mean costs of plant and production management, costs for
ensuring sufficient levels of safety, health and environment such as fire
brigade, medical services, documentation for transportation of hazardous goods.
Other GFO costs include costs for the scheduling of
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production, costs of the maintenance of the bills of materials, costs for the
technical support, expenses of the plant administration and general services,
costs of information technology ("IT") for non-dedicated IT systems such as SAP.
Utility costs are costs associated with the consumption of supportive media such
as electricity, water, nitrogen, steam, and air. Ecology costs are costs
associated with the deposition of solid or liquid waste, purification of
effluent water, and purification of waste air. Variance costs attribute to the
following circumstance: Standard Cost of Goods include cost elements which are
set at so-called standard costs. They serve as a norm on how much typically a
Product costs. Deviations from such standard costs are captured in variances.
Inventory re- / devaluation shall mean the gain or loss as a result of the
inventory value adjustment due to changes in the standard costs. Non-
Product-related production costs shall contain Technical Operations Corporate
Headquarter overhead costs, non-Product-allocated QA costs, validation costs,
directly expensed IT project costs, and other costs that cannot be attributed to
specific Products. Write-offs are captured for the destruction of Products that
cannot be used anymore due to expiration of shelf-life, spoilage in the
production process, and transportation mishaps. Third Party royalties are
manufacturing- and/or supply royalties paid to Third Parties other than Section
5.6.2 royalties. Costs of Goods Sold shall be determined in accordance with
Novartis' usual and customary accounting methods, which are in accordance with
the Accounting Standards.
1.16. "EFFECTIVE DATE" shall have the meaning set forth in Section 2.1
hereof.
1.17. "EMEA" shall mean the European Medical Evaluation Agency, and any
successor agency serving the same function.
1.18. "EPIGENESIS" shall mean EpiGenesis Pharmaceuticals, Inc.
1.19. "EPIGENESIS AGREEMENT" shall mean that certain Development and
License Agreement, dated as of August 9, 2000, between Hybridon and EpiGenesis.
1.20. "EUROPEAN MARKETING APPROVAL" shall mean Marketing Approval by
(i) the EMEA or (ii) the regulatory authorities in no fewer than three of the
Major Market Countries.
1.21. "EVENT OF BANKRUPTCY" shall have the meaning set forth in Section
10.4 hereof.
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1.22. "EXCLUDED ANTISENSE IP" shall mean oligonucleotides or
oligonucleotide analogs or mimics thereof that (a) are targeted to a specific
sequence of RNA and (b) the primary mechanism of action of which is to hybridize
to such sequence of RNA and through such hybridization to modulate the
production of the targeted gene product, provided, that such oligonucleotides or
oligonucleotide analogs or mimics thereof [**] proprietary to Hybridon, [**].
1.23. "FDA" shall mean the United States Food and Drug Administration,
and any successor agency serving the same function.
1.24. "FIRST COMMERCIAL SALE" shall mean the first shipment of a
Product to a Third Party (other than to licensees or sublicensees for resale
rather than their own use) by Novartis or its Affiliate or sublicensee in a
country following applicable Regulatory Approval of the Product in such country
or, if no Regulatory Approval is required in a country, the first sale of the
Product in an arm's-length for-profit transaction to a Third Party (other than
to licensees or sublicensees for resale rather than their own use) by Novartis
or its Affiliate or sublicensee in such country.
1.25. "FPFV" shall mean the first visit of the first patient or first
healthy human volunteer participating in a clinical trial with respect to a
Licensed IMO.
1.26. "HYBRIDON BACKGROUND INTELLECTUAL PROPERTY" shall mean all
Patents and Know-How Controlled by Hybridon as of the Effective Date or at any
time during the term of this License Agreement that are necessary or useful for
the Parties or their Affiliates, contractors, agents or sublicensees to exploit
the licenses contemplated or to carry out the activities contemplated hereunder
and that are not otherwise Hybridon Intellectual Property or Joint Intellectual
Property. Notwithstanding the foregoing, "Hybridon Background Intellectual
Property" shall exclude any Acquisition Intellectual Property.
1.27. "HYBRIDON INTELLECTUAL PROPERTY" shall mean Hybridon Know-How and
Hybridon Patent(s), but explicitly excluding Joint Intellectual Property and any
Acquisition Intellectual Property.
1.28. "HYBRIDON KNOW-HOW" shall have the meaning set forth in Section
1.27 of the Collaboration Agreement.
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1.29. "HYBRIDON PATENTS" shall have the meaning set forth in Section
1.28 of the Collaboration Agreement. Upon Novartis' exercise of the
Commercialization Option, a list of Hybridon Patents shall be appended hereto as
Schedule 1.29, which will be updated periodically to reflect additions thereto
during the course of this License Agreement.
1.30. "IMO" shall have the meaning set forth in Section 1.29 of the
Collaboration Agreement.
1.31. "IMO CANDIDATE" shall have the meaning set forth in Section 1.30
of the Collaboration Agreement.
1.32. "IMO LEAD" shall have the meaning set forth in Section 1.31 of
the Collaboration Agreement.
1.33. "IMPROVEMENTS" shall have the meaning set forth in Section 1.32
of the Collaboration Agreement.
1.34. "INDEMNIFYING PARTY" shall have the meaning set forth in Section
13.3 hereof.
1.35. "INDEMNIFIED PERSON" shall have the meaning set forth in Section
13.3 hereof.
1.36. "INITIAL INDICATIONS" shall mean all human allergic and/or
respiratory diseases, but specifically excluding oncology and infectious
diseases (other than cystic fibrosis, asthma and chronic obstructive pulmonary
disease pathologies, in each case resulting from infectious diseases) and
systemic autoimmune diseases.
1.37. "JOINT INTELLECTUAL PROPERTY" shall mean Joint Know How and Joint
Patent(s).
1.38. "JOINT KNOW-HOW" shall have the meaning set forth in Section 1.39
of the Collaboration Agreement.
1.39. "JOINT PATENTS" shall have the meaning set forth in Section 1.40
of the Collaboration Agreement. Upon Novartis' exercise of the Commercialization
Option, a list of Joint Patents shall be appended hereto as Schedule 1.39, which
list will be updated periodically
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to reflect additions thereto during the course of this License Agreement.
1.40. "LICENSED IMOS" shall mean the IMO Candidates and IMO Leads.
1.41. "LOSS" shall have the meaning set forth in Section 13.1 hereof.
1.42. "MAJOR MARKET COUNTRIES" shall mean the United Kingdom, France,
Germany, Italy and Spain.
1.43. "MARKETING APPROVAL" shall mean the final Regulatory Approval
that ultimately enables Novartis, its Affiliates or sublicensees, directly or
through intermediaries, to sell a Product commercially to the ultimate consumer
in a particular country.
1.44. "MHLW" shall mean the Japanese Ministry of Health, Labor and
Welfare, and any successor agency serving the same function.
1.45. "NET SALES" shall mean, with respect to any Product, the gross
amount invoiced by or on behalf of Novartis or its Affiliates or sublicensees
for that Product sold to Third Parties (other than to licensees or sublicensees
for resale rather than their own use) in bona fide, arm's-length transactions,
less the following deductions, determined in accordance with Novartis' standard
accounting methods as generally and consistently applied by Novartis and its
Affiliates in determining net product sales, to the extent included in the gross
invoiced sales price of any Product or otherwise directly paid or incurred by
Novartis, its Affiliates, or sublicensees with respect to the sale of such
Product:
(a) Normal and customary trade and quantity discounts actually
allowed and properly taken directly with respect to sales of the
Product;
(b) Amounts repaid or credited by reason of defects, rejection
recalls, returns, rebates and allowances of goods, or because of
retroactive price reductions specifically identifiable to the Product;
(c) Chargebacks and other amounts paid on the sale or
dispensing of such Product;
(d) Amounts payable resulting from governmental (or agency
thereof) mandated rebate programs;
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(e) Tariffs, duties, excise, sales, value-added, and other
taxes (other than taxes based on income);
(f) Retroactive price reductions that are actually allowed or
granted;
(g) Cash discounts for timely payment;
(h) Delayed ship order credits;
(i) Discounts pursuant to indigent patient programs and
patient discount programs, including, without limitation, "Together Rx"
and coupon discounts;
(j) All freight, postage and insurance included in the invoice
price;
(k) Uncollectible amounts on previously sold Products that are
written off for financial reporting purposes (provided that if any such
amounts are subsequently collected, such amounts shall be included in
Net Sales upon such collection);
(l) [**] percent ([**]%) for distribution and warehousing
expenses; and
(m) Any other specifically identifiable amounts included in
the gross invoice of the Product that should be credited for reasons
substantially equivalent to those listed above;
all as determined in accordance with Novartis' usual and customary
accounting methods, which are in accordance with the Accounting Standards.
Sales from Novartis to its Affiliates and sublicensees shall be
disregarded for the purpose of calculating Net Sales. Any of the items set
forth above that would otherwise be deducted from the invoice price in the
calculation of Net Sales but which are separately charged to Third Parties
(other than licensees or sublicensees) shall not be deducted from the
invoice price in the calculation of Net Sales.
Furthermore:
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(i) In the case of any sale or other disposal of a Product
between or among Novartis and its Affiliates, licensees and
sublicensees for resale, Net Sales shall be calculated as above only on
the value charged or invoiced on the first arm's-length sale thereafter
to a Third Party (other than licensees or sublicensees);
(ii) In the case of any sale which is not invoiced or is
delivered before invoice, Net Sales shall be calculated at the time of
shipment or when the Product is paid for, if paid for before shipment
or invoice;
(iii) In the case of any sale or other disposal for value,
such as barter or countertrade, of any Product, or part thereof, other
than in an arm's-length transaction exclusively for money, Net Sales
shall be calculated as above on the value of the non-cash consideration
received or the fair market price (if higher) of the Product in the
country of sale or disposal; and
(iv) In the event that the Product is sold in a finished
dosage form containing the Licensed IMO in combination with one or more
other active ingredients (a "Combination Product"), the Net Sales of
the Product, for the purpose of determining royalty payments, shall be
determined by multiplying the Net Sales (as defined above in this
Section) of the Combination Product by the fraction A/(A+B), where A is
the weighted (by sales volume) average sales price in a particular
country of the Product when sold separately in finished form and B is
the weighted average sales price in that country of the other
product(s) sold separately in finished form. In the event that such
average sales price cannot be determined for both the Product and the
other product(s) in the combination, Net Sales for purposes of
determining royalty payments shall be agreed by the Parties based on
the relative value contributed by each component, and such agreement
shall not be unreasonably withheld.
1.46. "NON-SECTION 5.2 PRODUCTS" shall have the meaning set forth in
Section 5.3.2 hereof.
1.47. "NON-VALID CLAIM COUNTRY" shall mean a country in which no Valid
Claim with respect to the applicable Hybridon Patent, Patent that is part of the
Hybridon Background
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Intellectual Property, or Joint Patent in which Hybridon retains an interest has
existed during the term of this License Agreement.
1.48. "PATENTS" shall mean all existing patents and patent applications
and all patent applications hereafter filed, including any continuation,
continuation-in-part, divisional, provisional or any substitute applications,
any patent issued with respect to any such patent applications, any reissue,
reexamination, renewal or extension (including any supplementary protection
certificate) of any such patent, and any confirmation patent or registration
patent or patent of addition based on any such patent, and all foreign
counterparts of any of the foregoing.
1.49. "PERSON" shall mean, any individual, corporation, partnership,
association, joint-stock company, trust, unincorporated organization or
government or political subdivision thereof.
1.50. "PHASE IIB CLINICAL TRIAL" shall mean a human clinical trial, the
principal purpose of which is to allow selection of the particular doses to be
applied in a Phase III Clinical Trial.
1.51. "PHASE III CLINICAL TRIAL" shall mean a human clinical trial, the
principal purpose of which is to establish safety and efficacy of one or more
particular doses in patients being studied, and which will (or are intended to)
satisfy the requirements of a pivotal trial for purposes of preparing and
submitting a filing for Regulatory Approval in a particular country.
1.52. "PRODUCT" shall mean a pharmaceutical product including,
conjugated to, or comprised of, a Licensed IMO with or without other active
ingredients in finished dosage form, ready for administration to the ultimate
consumer, and any Improvements thereto.
1.53. "PROVIDING PARTY" shall have the meaning set forth in Section 7.1
hereof.
1.54. "RECEIVING PARTY" shall have the meaning set forth in Section
7.1.1 hereof.
1.55. "REGULATORY APPROVAL" shall mean all authorizations by the
appropriate governmental entity or entities necessary for commercial sale of a
Product in a particular country including, without limitation and where legally
necessary prior to commercial sale, approval of labeling, price, reimbursement
and manufacturing.
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1.56. "RESEARCH FIELD OF USE" shall have the meaning set forth in
Section 1.60 of the Collaboration Agreement.
1.57. "SALES REPORT" shall mean a written report or reports showing
each of: (a) the Net Sales of each Product in each country in the world during
the reporting period by Novartis and each Affiliate and sublicensee; (b) the
royalties, payable in United States Dollars, which shall have accrued under
Section 5.5 hereof in respect of such Net Sales and the basis of calculating
those royalties; (c) withholding taxes, if any, required by law to be deducted
in respect of any such Net Sales; and (d) dispositions of the Products other
than pursuant to sale for cash.
1.58. "SECTION 5.2 PRODUCTS" shall have the meaning set forth in
Section 5.2 hereof.
1.59. "SECTION 10.3 DISPUTE" shall have the meaning set forth in
Section 14.3 hereof.
1.60. "THIRD PARTY" shall mean any Person that is not a Party or an
Affiliate of either Party.
1.61. "VALID CLAIM" shall mean a claim of any issued, unexpired
Hybridon Patent or Joint Patent in which Hybridon retains an interest that shall
not have been withdrawn, canceled or disclaimed, nor held invalid or
unenforceable by a governmental authority or a court of competent jurisdiction
in an unappealed or unappealable decision, and which has not been admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise.
1.62. "VALID CLAIM COUNTRY" shall mean, with respect to a Product, a
country in which a Valid Claim with respect to the applicable Hybridon Patent or
Joint Patent in which Hybridon retains an interest has existed during the term
of this License Agreement.
ARTICLE II
EFFECTIVENESS; RIGHTS AND LICENSES
2.1. EFFECTIVENESS. Subject to Section 12.3 hereof, this License
Agreement (other than this Section 2.1, which shall become effective upon
execution by the Parties of this
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License Agreement) shall become effective on the date on which Hybridon is
deemed to have received the Commercialization Exercise Notice from Novartis
pursuant to Section 4.2.2 of the Collaboration Agreement or in connection with
termination of the Collaboration Agreement as set forth in Section 9.3.3 thereof
(the "Effective Date").
2.2. NOVARTIS RIGHTS; LIMITATIONS.
2.2.1. Subject to the other provisions of this License Agreement,
Hybridon grants to Novartis and its Affiliates a worldwide, exclusive license
(with the right to sublicense) for the term, subject only to Hybridon's retained
right to perform its obligations under the Collaboration Agreement so long as
such Collaboration Agreement is still in effect and subject to the rights
granted by Hybridon to EpiGenesis under the EpiGenesis Agreement, under the
Hybridon Intellectual Property and Hybridon's interest in the Joint Intellectual
Property, to: (i) make, have made, use, have used, research, have researched,
develop, have developed, commercialize, have commercialized, manufacture, have
manufactured, promote, have promoted, sell, have sold, distribute, have
distributed, market, have marketed, import, have imported, export and have
exported, the Licensed IMOs and Products in the Commercial Field of Use and (ii)
research, have researched, develop and have developed Licensed IMOs in the
Research Field of Use.
2.2.2. Subject to the other provisions of this License Agreement,
Hybridon grants to Novartis and its Affiliates a worldwide, non-exclusive
license (with the right to sublicense) for the term under the Hybridon
Background Intellectual Property to (i) to make, have made, use, have used,
research, have researched, develop, have developed, commercialize, have
commercialized, manufacture, have manufactured, promote, have promoted, sell,
have sold, distribute, have distributed, market, have marketed, import, have
imported, export and have exported, the Licensed IMOs and Products in the
Commercial Field of Use and (ii) research, have researched, develop and have
developed Licensed IMOs in the Research Field of Use.
2.2.3. Notwithstanding the foregoing and subject to Section 4.2
hereof, nothing herein shall give Novartis or its Affiliates the right to, and
Novartis shall not (and shall not permit its Affiliates to): (i) Chemically
Modify any Licensed IMO or use the Hybridon Intellectual Property to create any
immunomodulatory oligonucleotide that is the same or
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substantially structurally equivalent to any Licensed IMO or that is covered by
any claims in the Hybridon Patents; or (ii) conduct any clinical trial designed
to support an indication outside the Commercial Field of Use without Hybridon's
consent.
2.2.4. Any sublicense granted by Novartis pursuant to this License
Agreement must be granted pursuant to a written agreement that subjects the
sublicensee to not less than the relevant restrictions, limitations and
obligations in this License Agreement. Novartis shall remain primarily
responsible for all of its obligations under this License Agreement and shall
take prompt action to enforce its rights against its sublicensees should any
such sublicensee breach its obligation to comply with the restrictions,
limitations or obligations set forth in this License Agreement. Novartis shall
designate Hybridon as a third party beneficiary if Hybridon is damaged as a
result of any breach by a sublicensee of any relevant restriction, limitation,
or obligation pertaining to this License Agreement.
2.3. IMMUNITY FROM SUIT. In the event that the exercise by Novartis
and/or its Affiliates or sublicensees of the licenses and rights granted
pursuant to this License Agreement would infringe during the term of this
License Agreement a claim of an issued Patent Controlled by Hybridon, which
Patent is not otherwise covered by the grant in Section 2.2 or any Acquisition
Intellectual Property, Hybridon hereby grants to Novartis and its Affiliates or
sublicensees a worldwide, non-exclusive, royalty-free license and immunity from
suit by Hybridon and its Affiliates under such issued Patent for Novartis, its
Affiliates and or sublicensees to discover, research, develop, make, use,
import, export, distribute, market, promote, offer for sale, and sell the
Licensed IMOs and the Products in the Commercial Field of Use.
2.4. TECHNOLOGY NECESSARY TO THE LICENSE. If Hybridon conceives and
reduces to practice during the term of this License Agreement any new technology
relating to a Licensed IMO or Product and such new technology is necessary to
Novartis' exercise of its licensed rights pursuant to this License Agreement,
which technology is not otherwise covered by the grant in Section 2.2, then
Hybridon hereby grants to Novartis and its Affiliates and sublicensees a
worldwide, non-exclusive, royalty-free license under such new technology to
discover and have discovered, research and have researched, develop and have
developed, make and have made, use and have used, import and have imported,
export and have exported, distribute and have
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distributed, market and have marketed, promote and have promoted, offer for sale
and have offered for sale, sell and have sold such new technology in connection
with the Licensed IMO or the Product in the Commercial Field of Use.
ARTICLE III
DEVELOPMENT AND COMMERCIALIZATION
3.1. DEVELOPMENT AND COMMERCIALIZATION RIGHTS. The rights granted to
Novartis pursuant to Section 2.2 are exclusive to Novartis, even as to Hybridon,
subject to Hybridon's right to perform its obligations under the Collaboration
Agreement and subject to 35 USC Sections 200-212, 37 CFR Section 401 et seq. and
related governmental implementing regulations, as applicable.
3.2. TRADEMARK AND TRADENAME RIGHTS. Novartis, its Affiliates and
sublicensees shall be entitled, in their sole discretion, to select the
trademarks and tradenames for all Products, which trademarks and tradenames for
any Product may vary by country or within a country, in Novartis' sole
discretion. Novartis shall own all right, title and interest in and to such
trademarks and tradenames, and Hybridon shall have no rights with respect to any
such trademarks and tradenames.
3.3. INFORMATION TRANSFER. Within sixty (60) days after the Effective
Date, Hybridon shall promptly deliver to Novartis all information (including,
without limitation, Know-How) of Hybridon and its Affiliates that is necessary
or useful, or is reasonably requested by Novartis, for further development,
manufacture and commercial exploitation and distribution of a Licensed IMO or
Product subject to any confidentiality obligations owed by Hybridon to Third
Parties. Subject to the foregoing, such information (including, without
limitation, Know-How) shall include a summary of all material written
communications between Hybridon or its other licensees and the FDA concerning
the Licensed IMO or Product and shall also include copies of all Patents,
copyrights, copyright registrations and applications therefor and all other
manifestations of the intellectual property related to the Licensed IMO or
Product of Hybridon or its Affiliates, whether in human or machine readable
form, and, if commercially and technically reasonable, in an electronic form
compatible with Novartis' systems; provided that Novartis shall only reimburse
Hybridon's costs of providing data in a form compatible with its systems so long
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as Hybridon has provided Novartis with a reasonably detailed description of such
costs and obtained Novartis' prior written approval to incur such costs.
Novartis shall reimburse such pre-approved costs actually incurred by Hybridon
within [**] days after receipt by Novartis of Hybridon's Invoice for the same.
3.4. REGULATORY APPROVALS. Novartis, its Affiliates and sublicensees
will be responsible for all required Regulatory Approvals. All filings will be
made by Novartis, its Affiliates or sublicensees. All Regulatory Approvals will
be held in the name of Novartis, its Affiliates or sublicensees. Novartis, its
Affiliates or sublicensees shall have the right to, and Hybridon shall provide
the requisite notification to regulatory authorities to, cross reference any
relevant information such as but not limited to any clinical and pre-clinical
files and regulatory filings, such as but not limited to Drug Master Files of
Hybridon and its Affiliates, with respect to Licensed IMOs and Products, for the
purpose of regulatory filings hereunder.
3.5. DEVELOPMENT AND COMMERCIALIZATION EFFORTS. Novartis shall use
commercially reasonable efforts, similar to those used by Novartis or its
Affiliates in the research, development and commercialization of other products
of Novartis or its Affiliates that are of similar commercial potential and at a
similar stage of development, to develop and commercialize Products hereunder.
ARTICLE IV
ADDITIONAL INDICATION OPTION
4.1. ADDITIONAL INDICATION OPTION. Subject to Section 4.2 hereof,
Novartis shall have the option (each, an "Additional Indication Option") to
include one or more additional indications (each, an "Additional Indication") in
the Commercial Field of Use. Notwithstanding the foregoing, Novartis shall not
have the right to expand the Commercial Field of Use to include oncology
indications, non-human indications, or infectious disease indications not
originally included in the Commercial Field of Use.
4.2. EXERCISE OF AN ADDITIONAL INDICATION OPTION. If Novartis generates
pre-clinical data that supports the inclusion of Additional Indication(s) in the
Commercial Field of Use, Novartis may notify Hybridon that it wishes to include
such Additional Indication(s) in
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the Commercial Field of Use at any time after the second anniversary of the
Effective Date of the Collaboration Agreement (the "Option Notice"). Novartis
shall provide Hybridon with a summary of the pre-clinical data that supports the
inclusion of the Additional Indication(s), which Hybridon may use only in
connection with its review of Novartis' exercise of the Additional Indication
Option. Hybridon may not withhold its consent to the expansion of the Commercial
Field of Use to include such Additional Indication(s) unless, as of the date on
which Hybridon receives such Option Notice, Hybridon: (a) has granted exclusive
rights to such Additional Indication(s) to a Third Party; (b) is actively
negotiating with a Third Party to grant such rights; or (c) has [**] such
Additional Indication(s) in which the first visit of the first patient has
occurred. If Hybridon withholds its consent to the requested expansion for the
reasons set forth above, Hybridon shall use good faith efforts to obtain for
Novartis the agreement of such Third Party to negotiate a co-commercialization
agreement with Novartis with respect to such Additional Indication(s). If
Hybridon withholds its consent to the requested expansion because, as of the
date on which Hybridon receives the Option Notice, Hybridon is actively
negotiating with a Third Party to grant exclusive rights to the Additional
Indication(s), but Hybridon does not grant such rights to such Third Party
within [**] after the receipt of the Option Notice, Hybridon shall agree to the
expansion of the Commercial Field of Use to include such Additional
Indication(s). Novartis may submit multiple Option Notices during the term of
this License Agreement; provided that Novartis may not submit an Option Notice
covering Additional Indication(s) that are closely related to any Additional
Indication(s) for which Novartis has submitted an Option Notice during the
previous [**] period. Upon the successful exercise of an Additional Indication
Option, the term "Commercial Field of Use" shall be deemed to include the
Additional Indication(s) covered by such exercise.
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ARTICLE V
MILESTONE AND ROYALTY PAYMENTS
5.1. OPTION EXERCISE FEE. Upon this License Agreement taking effect in
accordance with Section 2.1 hereof and following delivery of the certificate set
forth in Section 12.3 hereof and subject to the terms thereof, Novartis shall
pay to Hybridon the sum of [**] U.S. Dollars (US$[**]) in accordance with
Section 14.1 (Invoice Requirement).
5.2. MILESTONE PAYMENTS WITH RESPECT TO PRODUCTS FOR INITIAL
INDICATIONS. Novartis shall notify Hybridon within thirty (30) business days
after the occurrence of a milestone event for which payment is due pursuant to
this Section 5.2. Each milestone payment set forth below shall be paid by
Novartis to Hybridon with respect only to the first [**] Products originally
developed for Initial Indications to achieve the related milestone ("Section 5.2
Products"). Notwithstanding the foregoing, achievement of a milestone by
[**]Products that have the same active ingredient shall only trigger separate
payments of the related milestone payment if such Products [**][**] that are
separately approved by the FDA, the EMEA (or not less than [**] of the
regulatory authorities of the Major Market Countries), or the MHLW, as
applicable. Each milestone payment shall be paid in accordance with Section 14.1
(Invoice Requirement) following notice by Novartis that the applicable milestone
has been met. The Parties agree that, if only one (1) Product is in either Phase
IIb Clinical Trials or Phase III Clinical Trials at a particular time and
Novartis, in its sole discretion, ceases development of such Product, then each
milestone payment which has previously been paid for such Product pursuant to
this Section 5.2 shall be credited as a milestone payment for the next Product
developed for any Initial Indication(s). For clarity, the milestone payments set
out in the following table shall be payable only once for each Product (and its
related substituted Product if the original Product was abandoned) and shall be
payable no more than an aggregate of [**] times as to all Products developed for
Initial Indication(s) (even if there are more than [**] Products developed for
Initial Indications). The Parties agree further that each of the [**] milestones
in the table below shall be deemed to have occurred (and, if not made
previously, the related milestone payment shall become payable) upon the
occurrence of any subsequent milestone in the table below with respect to the
same Product. Novartis may deduct from any milestone payments otherwise due to
Hybridon under this Section 5.2 the amount of any
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withholding and similar taxes required under applicable United States law to be
withheld from such payments and paid to United States tax authorities.
MILESTONE PAYMENT
- --------- -------
[**] US$[**]
[**] US$[**]
[**] US$[**]
[**] US$[**]
[**] US$[**]
5.3. MILESTONE PAYMENTS WITH RESPECT TO PRODUCTS FOR ADDITIONAL
INDICATIONS. Novartis shall notify Hybridon within thirty (30) business days
after the occurrence of a milestone event for which payment is due pursuant to
this Section 5.3. Novartis shall pay to Hybridon milestone payments as set forth
below with respect to certain Products developed for Additional Indications in
accordance with Section 14.1 (Invoice Requirement). Novartis may deduct from any
milestone payments otherwise due to Hybridon under this Section 5.3 the amount
of any withholding and similar taxes required under applicable United States law
to be withheld from such payments and paid to United States tax authorities.
5.3.1. Products for Which Milestones Are Payable Under Section 5.2.
Novartis shall make the milestone payments set forth in the following table with
respect to Section 5.2 Products that are later developed for Additional
Indications. For clarity, if a Section 5.2 Product is developed for an
Additional Indication, the achievement of each milestone set forth below with
respect to the Additional Indication shall trigger payment of the related
milestone payment regardless of whether the comparable payment has already been
paid with respect to the Initial Indication. Notwithstanding the foregoing,
achievement of milestones by [**] Products that have the same active ingredient
shall only trigger separate payment of the related milestone payment if such
Products have distinct formulations and distinct labels that are separately
approved by the FDA, the EMEA (or not less than [**] of the regulatory
authorities of the Major Market Countries), or the MHLW, as applicable. The
Parties agree that, if Novartis, in its sole
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discretion, ceases development of a Section 5.2 Product, then all milestone
payments which have previously been paid for such Product pursuant to this
Section 5.3.1 shall be credited as milestone payments for the next Section 5.2
Product or non-Section 5.2 Product developed for the same Additional Indication.
For clarity, the milestone payments set out in the following table shall be
payable only once for each Section 5.2 Product and its related substituted
Section 5.2 Product or non-Section 5.2 Product developed for the same Additional
Indication, if the original Section 5.2 Product was abandoned.
MILESTONE PAYMENT
- --------- -------
[**] US$[**]
[**] US$[**]
[**] US$[**]
5.3.2. Products for Which Milestones Are Not Payable Under Section
5.2. Novartis shall make the milestone payments set forth in the following table
with respect to Products, other than Section 5.2 Products, that are developed
for Additional Indications ("non-Section 5.2 Products"). Notwithstanding the
foregoing, achievement of milestones by [**] non-Section 5.2 Products that have
the same active ingredient shall only trigger separate payment of the related
milestone payment if such non-Section 5.2 Products have distinct formulations
and distinct labels that are separately approved by the FDA, the EMEA (or not
less than [**] of the regulatory authorities of the Major Market Countries), or
the MHLW, as applicable. The Parties agree that, if Novartis, in its sole
discretion, ceases development of a non-Section 5.2 Product, then all milestone
payments which have previously been paid for such non-Section 5.2 Product
pursuant to this Section 5.3.2 shall be credited as milestone payments for the
next Section 5.2 Product or non-Section 5.2 Product developed for the same
Additional Indication. For clarity, the milestone payments set out in the
following table shall be payable only once for each abandoned non-Section 5.2
Product and its related substituted Section 5.2 Product or non-Section 5.2
Product. The Parties agree further that, in the event that, for a particular
non-Section 5.2 Product, the "Initiation of Phase III Clinical Trial" milestone
is achieved prior to the achievement of the "Initiation of Phase IIb Clinical
Trial" milestone for the same Product, then at
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such time as the "Initiation of Phase III Clinical Trial" milestone is achieved,
the milestone payments for both milestones shall become payable.
MILESTONE PAYMENT
- --------- -------
[**] US$[**]
[**] US$[**]
[**] US$[**]
[**] US$[**]
[**] US$[**]
5.4. MILESTONE PAYMENT FOR $[**] IN NET SALES. For each of the first
[**] Products for which worldwide Net Sales in a calendar year exceeds [**] U.S.
Dollars (US$[**]), Novartis shall pay to Hybridon the sum of [**] U.S. Dollars
(US$[**]) in accordance with Section 14.1 (Invoice Requirement) upon the first
achievement of such milestone by each such Product. Notwithstanding the
foregoing, achievement of the milestone by [**] Products that have the same
active ingredient shall only trigger separate payment of the milestone payment
if such Products have distinct formulations and distinct labels that are both
approved by any of the FDA, the EMEA (or not less than [**] of the regulatory
authorities of the Major Market Countries), or the MHLW.
5.5. ROYALTY PAYMENTS. Novartis shall make the following royalty
payments to Hybridon on Net Sales of all Products on an aggregate, cumulative,
basis in accordance with Section 6.1 hereof.
CUMULATIVE WORLDWIDE NET SALES ROYALTY IN VALID ROYALTY IN NON-VALID
FOR ALL PRODUCTS ON A COMBINED BASIS CLAIM COUNTRY CLAIM COUNTRY
- ------------------------------------------------------------------ ---------------- --------------------
On Net Sales less than US$[**] [**]% [**]%
On the increment of Net Sales greater than or equal to US$[**] but
less than US[**] [**]% [**]%
On the increment of Net Sales greater than or equal to US$[**] [**]% [**]%
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For purposes of the second and third columns of the above table, the
determination of whether particular Net Sales are subject to the royalty rate
for Valid Claim Countries or the royalty rate for Non-Valid Claim Countries
shall be made on a country-by-country and Product-by-Product basis.
5.6. REDUCED MILESTONE AND ROYALTY OBLIGATIONS. The obligation of
Novartis, its Affiliates and sublicensees to pay milestones and royalties to
Hybridon under this License Agreement shall be reduced upon the occurrence of
the following events:
5.6.1. In the event that Novartis terminates this License Agreement
in accordance with Section 10.3, the rights of Novartis, its Affiliates and
sublicensees under this License Agreement shall remain unaffected, but its
milestone and post-termination royalty payment obligations shall be reduced by
[**] percent ([**]%).
5.6.2. In the event that Novartis, its Affiliates or sublicensees is
required to pay Third Party royalties, milestones or license fees in order to
use a Licensed IMO or the Hybridon Intellectual Property or Hybridon Background
Intellectual Property as contemplated hereunder, Novartis' obligation to pay
royalties to Hybridon with respect to any Product(s) incorporating such Licensed
IMO shall be reduced dollar for dollar on par with the amounts actually paid by
Novartis, its Affiliate or sublicensee to such Third Party; provided that
Novartis' milestone and royalty payment obligations pursuant to this License
Agreement shall not be reduced by more than [**] percent ([**]%) of the amount
that would otherwise be due from Novartis to Hybridon;
5.6.3. Notwithstanding the foregoing and the provisions of Section
5.7, Novartis' royalty obligations for any Product shall not in any case be
reduced below [**] percent ([**]%) with respect to Net Sales in Valid Claim
Countries or [**] percent ([**]%) with respect to Net Sales in Non-Valid Claim
Countries.
5.7. COST OF GOODS SOLD ADJUSTMENT. For each Product, in any calendar
quarter that the Cost of Goods Sold for such Product, expressed as a percentage
of Net Sales, exceeds [**] percent ([**]%) on an aggregated, worldwide basis,
then the royalty amounts payable by Novartis to Hybridon pursuant to Section 5.5
with respect to sales of such Product during such calendar quarter shall be
reduced by one-third, subject to the minimum royalties set forth in
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Section 5.6.3. Such reduced royalty rates shall remain in effect with respect to
any given Product so long as Cost of Goods Sold continues to exceed [**] percent
([**]%) of Net Sales for such Product on an aggregated, worldwide basis. In the
event that worldwide Cost of Goods Sold ceases to exceed [**] percent ([**]%) of
Net Sales for such Product on an aggregated, worldwide basis, such reduction
shall cease to apply unless and until Cost of Goods Sold again exceeds [**]
percent ([**]%) of Net Sales as set forth herein. Novartis shall determine
worldwide Cost of Goods Sold on a calendar quarterly basis, and, if Cost of
Goods Sold exceeds [**] percent ([**]%) of Net Sales on an aggregated, worldwide
basis, Novartis shall include Cost of Goods in its Sales Reports pursuant to
Section 6.1.
ARTICLE VI
REPORTING OBLIGATIONS
6.1. QUARTERLY ROYALTY OBLIGATIONS. Within forty-five (45) days after
the close of each calendar quarter (each such calendar quarter being sometimes
referred to herein as a "reporting period") during the term of this License
Agreement following the First Commercial Sale of a Product, Novartis shall
furnish to Hybridon a Sales Report for Hybridon's review. Upon receipt of a
Sales Report, Hybridon shall submit an invoice to Novartis substantially in the
form of Exhibit A hereto for all undisputed royalty amounts due from Novartis.
Novartis shall pay such royalty amounts within thirty (30) days after receipt of
the invoice.
6.2. AUDITS. Novartis shall keep, and shall cause its Affiliates and
sublicensees to keep, complete and accurate records of Net Sales relating to
Sales Reports and payments required under Article V. Hybridon will have the
right, at its own expense, except as specified below, to have an independent,
certified public accountant, selected by it and reasonably acceptable to
Novartis, review any such records of Novartis, its Affiliates and sublicensees
in the location(s) where such records are maintained by Novartis, its Affiliates
and sublicensees upon reasonable notice and during regular business hours and
under obligations of confidence, for the sole purpose of verifying the basis and
accuracy of payments made under Article V within the prior thirty-six (36) month
period. Notwithstanding the foregoing, Hybridon shall not be entitled to: (i)
conduct any audit pursuant to this
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Section 6.2 more frequently than once per year and (ii) review any records it
has previously reviewed in connection with an audit pursuant to this Section 6.2
unless Novartis is required or elects to restate its accounts relating to such
records. If the review of such records reveals that Novartis has failed to
accurately report information pursuant to Section 6.1, then Novartis shall
promptly pay to Hybridon any corresponding unpaid amounts due under Article V
(together with interest at the rate of one percent (1%) per annum). If any such
underpayment is greater than five percent (5%) of the amount actually due for
any calendar year, Novartis shall pay all of the costs of such review.
6.3. EXCHANGE RATES. With respect to amounts invoiced in United States
Dollars, all such amounts shall be expressed in United States Dollars. With
respect to amounts invoiced in a currency other than United States Dollars, all
such amounts shall be expressed both in the currency in which the amount was
invoiced and in the United States Dollar equivalent. The United States Dollar
equivalent shall be calculated using Novartis' then-current standard exchange
rate methodology applied in its external reporting (for the purpose of clarity,
this is ultimately based on official rates such as Reuters and the European
Central Bank) for the conversion of foreign currency sales into United States
Dollars.
6.4. CURRENCY OF ROYALTY PAYMENTS. All royalty payments due under this
License Agreement shall be paid in United States Dollars.
ARTICLE VII
CONFIDENTIALITY
7.1. UNDERTAKING. Each Party shall keep confidential, and, other than
as provided herein, shall not use or disclose, directly or indirectly, any trade
secrets, confidential or proprietary information, or any other knowledge,
information, documents or materials, owned, developed or possessed by the other
Party (the "Providing Party"), whether in tangible or intangible form, the
confidentiality of which such other Party takes reasonable measures to protect
(collectively, "Confidential Information"). The Parties hereby agree that, for
the purposes of this License Agreement, discussion between the Parties, if any,
regarding Novartis' plans for developing and commercializing Licensed IMOs and
Products will be deemed to be the confidential information of Novartis.
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7.1.1. A Party receiving Confidential Information (the "Receiving
Party") shall use commercially reasonable efforts not less than those efforts
such Receiving Party uses to protect its own proprietary information to prevent
the unauthorized use and disclosure of such information of the Providing Party
and to prevent unauthorized persons or entities from obtaining or using such
information.
7.1.2. The Receiving Party further agrees to refrain from directly
or indirectly taking any action which would constitute or facilitate the
unauthorized use or disclosure of Confidential Information. The Receiving Party
may disclose Confidential Information to its Affiliates, officers, employees and
agents, to authorized licensees and sublicensees, and to subcontractors in
connection with the identification, generation, development and manufacture of
Licensed IMOs, as applicable, to the extent necessary to enable such parties to
perform their obligations hereunder or under the applicable license, sublicense
or subcontract, as the case may be; provided, however, that such Affiliates,
officers, employees, agents, licensees, sublicensees and subcontractors have
entered into confidentiality agreements for secrecy and non-use of such
Confidential Information offering no less than the protection afforded hereby
which by their terms shall be enforceable by injunctive relief at the instance
of the Providing Party.
7.1.3. The Receiving Party shall be liable for any unauthorized use
and disclosure of such information by its Affiliates, officers, employees and
agents and any such sublicensees and subcontractors.
7.2. EXCEPTIONS.
7.2.1. Non-Confidential Information. Notwithstanding the foregoing,
the provisions of Section 7.1 hereof shall not apply to Confidential Information
that the Receiving Party can establish by clear and convincing evidence:
(a) have entered the public domain without such Receiving
Party's breach of any obligation owed to the Providing Party;
(b) are or have become known to the Receiving Party from a
source other than the Providing Party, other than by breach of an
obligation of confidentiality owed to the Providing Party; or
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PAGE 25 OF 53
(c) are independently developed by the Receiving Party without
reference to or reliance upon knowledge, information, documents or
materials of the Providing Party and without breach of this License
Agreement.
7.2.2. Other Exceptions. In addition, a Receiving Party may,
notwithstanding the obligations of Section 7.1, disclose Confidential
Information:
(a) that the Receiving Party can establish by clear and
convincing evidence is permitted to be disclosed by the prior written
consent of the Providing Party;
(b) that the Receiving Party can establish by clear and
convincing evidence is required to be disclosed by the Receiving Party
to defend litigation or to comply with applicable laws or regulations
(including without limitation disclosure obligations under applicable
securities laws or the regulations of any stock exchange or NASDAQ), or
in connection with filings with the FDA, the United States Patent and
Trademark Office or other similar governmental agencies, provided that
the Receiving Party provides prior written notice of such disclosure to
the Providing Party and takes reasonable and lawful actions to avoid or
minimize the degree of such disclosure; or
(c) concerning the existence and terms of this License
Agreement and the status of transactions described herein, under
obligations of confidentiality, to the Receiving Party's existing and
potential advisors, investors that are bona fide venture capital or
institutional investors that make such investments for the potential
financial return and not for strategic purposes (so long as such
investor does not have more than $1 billion in world-wide
pharmaceutical revenue in the most recently completed calendar year)
and any Person considering to acquire Hybridon or a controlling
interest in Hybridon (a "Potential Acquirer"). Notwithstanding the
foregoing, Hybridon shall not make any such disclosure to any Potential
Acquirer (i) until discussions with such Potential Acquirer progress to
a stage at which the Potential Acquirer is engaged in comprehensive due
diligence of Hybridon's business and Hybridon has a good faith belief
that the consummation of the proposed acquisition
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has become reasonably likely to occur and (ii) unless the Potential
Acquirer has entered into a confidentiality agreement at least as
strict as the provisions of this Section 7.2.2(c), designating Novartis
as a third party beneficiary and prohibiting the Potential Acquirer
from disclosing or using for its own purposes (other than evaluation of
the proposed transaction with Hybridon) any such information. Hybridon
shall notify Novartis in writing prior to any disclosure pursuant to
this Section 7.2.2(c), but shall not be required to disclose the
identity of any Potential Acquirer until after consummation or
abandonment of the transaction, at which time Hybridon shall provide
Novartis with a copy of the confidentiality agreement executed by such
Potential Acquirer.
7.3. PUBLICITY. The Parties will agree upon the timing and content of
any initial press release or other public communications relating to this
License Agreement and the transactions contemplated herein.
7.3.1. Except as set forth in Section 7.3.2 or to the extent already
disclosed in that initial press release or other public communication, no public
announcement concerning the existence or the terms of this License Agreement or
the transactions described herein shall be made, either directly or indirectly,
by Hybridon or Novartis, except as may be legally required by applicable laws,
regulations, or judicial order, without first obtaining the approval of the
other Party and agreement upon the nature, text, and timing of such
announcement.
7.3.2. Subject to this Article VII, a Party may issue press releases
or make public communications or otherwise make disclosures that such Party
determines to be necessary to comply with applicable law (including disclosure
requirements of the U.S. Securities and Exchange Commission, NASDAQ or any stock
exchange on which securities issued by such Party are traded); provided that
such Party shall provide the other Party with a copy of the proposed text of
such press releases, public communications or disclosure in advance of the
scheduled release or publication thereof to afford such other Party a reasonable
opportunity to review and comment upon the proposed text.
7.3.3. The Party desiring to make any such public announcement shall
provide the other Party with a written copy of the proposed announcement in
sufficient time (no less than
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thirty (30) days or such shorter period as may be required to enable a Party to
comply with applicable law) prior to public release to allow such other Party to
comment upon such announcement, prior to public release.
7.4. SURVIVAL. The provisions of this Article VII shall survive for
five (5) years after the expiration or termination of this License Agreement.
ARTICLE VIII
PUBLICATION
8.1. PUBLICATION. Hybridon and its Affiliates agree not to publish or
publicly present any results, data, or scientific findings with respect to the
Research Program (except in connection with filings with the FDA, the United
States Patent and Trademark Office or other similar governmental entities in
other countries or regions) without the prior written consent of Novartis. In
publications authorized by Novartis pursuant hereto, each Party hereto shall
acknowledge appropriately the contribution of the other Party.
8.2. SURVIVAL. The provisions of this Article VIII shall survive until
expiration of this License Agreement.
ARTICLE IX
INTELLECTUAL PROPERTY RIGHTS
9.1. OWNERSHIP.
9.1.1. Subject to any licenses explicitly granted under this License
Agreement, each Party shall retain its intellectual property rights in all
Know-How and Patents Controlled by it on the Effective Date or developed or
acquired solely by it thereafter. For avoidance of any doubts, Novartis shall
retain ownership of all Novartis Intellectual Property, and Hybridon shall
retain ownership of all Hybridon Intellectual Property and Hybridon Background
Intellectual Property.
9.1.2. During the term of this License Agreement, each of Hybridon
and Novartis will keep the other Party fully informed with respect to any new
intellectual property invented or generated by it or its Affiliates under this
License Agreement.
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(a) All intellectual property (including, without limitation,
data, discoveries, technical information, Know-how, Patents,
proprietary information, trade secrets and inventions) invented or
generated under this License Agreement solely by one or more persons
obliged to assign their rights to Novartis or its Affiliates during the
term of this License Agreement shall be owned by Novartis;
(b) All intellectual property (including, without limitation,
data, discoveries, technical information, Know-how, Patents,
proprietary information, trade secrets and inventions) invented or
generated under this License Agreement solely by one or more persons
obliged to assign their rights to Hybridon or its Affiliates during the
term of this License Agreement shall be owned by Hybridon and shall be
deemed Hybridon Patents or Hybridon Know-How, as applicable;
(c) All intellectual property (including, without limitation,
data, discoveries, technical information, Know-how, Patents,
proprietary information, trade secrets and inventions) invented or
generated jointly under this License Agreement by (i) one or more
persons obliged to assign their rights to Novartis or its Affiliates
and (ii) one or more persons obliged to assign their rights to Hybridon
or its Affiliates during the term of this License Agreement shall be
owned jointly by Novartis and Hybridon and shall be Joint Intellectual
Property and, subject to Section 2.2.1, each Party shall have the right
to use and exploit such Joint Intellectual Property without any duty to
account to the other Party with respect to such use and exploitation.
Each Party will take all reasonable actions requested by the other
Party, including execution of appropriate patent filings and
applications for registration, to perfect the requesting Party's
ownership interest to the Joint Intellectual Property; and
(d) Questions of inventorship under this Section 9.1.2 shall
be resolved in accordance with United States patent laws.
9.2. PREPARATION AND COSTS. Hybridon shall take responsibility and pay
for the preparation, filing, prosecution and maintenance of all Hybridon Patents
and Patents that are part of the Hybridon Background Intellectual Property, and
Novartis shall take responsibility and pay for the preparation, filing,
prosecution and maintenance of all Novartis Patents and Joint Patents;
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provided that, with respect to (a) Hybridon Patents and Patents that are part of
the Hybridon Background Intellectual Property that disclose or claim inventions
applicable solely to the Licensed IMOs and (b) Joint Patents that disclose or
claim inventions with applicability beyond the Licensed IMOs, the Party having
responsibility for the preparation, filing, prosecution and maintenance of such
Hybridon Patents, Patents that are part of the Hybridon Background Intellectual
Property and Joint Patents shall promptly provide the other Party with copies of
all substantive communications from any patent office and with drafts of all
substantive filings to be made, reasonably in advance of their filing, with any
patent office with respect thereto; shall consider in good faith any comments
thereon provided by the other Party; and shall not unreasonably decline to
incorporate changes to such filing proposed by such other Party. Each Party
shall assist the other in the preparation and prosecution of such Patents and
shall execute all documents reasonably deemed necessary for the filing thereof
and/or for the vesting of title thereto as provided in this License Agreement.
In good time, before the deadline for foreign filing of any patent application
filed in the United States, Hybridon will notify Novartis whether it intends to
foreign file such patent application, and if it intends to do so, in what
countries it proposes to foreign file.
9.3. DISCONTINUATION. The Party initially responsible under Section 9.2
for the preparation, filing, prosecution and maintenance of a particular Patent
for an invention arising under the Research Program shall give at least thirty
(30) days advance notice to the other Party of any decision to cease
preparation, filing, prosecution or maintenance of that Patent. Discontinuation
may be elected on a country-by-country basis or for a Patent application or
Patent series in total. In such case, the other Party may elect, at its sole
discretion, to continue preparation, filing, and prosecution or maintenance of
the discontinued Patent at its sole expense.
9.4. THIRD PARTY INFRINGEMENT.
9.4.1. If either Party becomes aware of any activity that such Party
believes represents an infringement of the claims of the Hybridon Patents,
Patents that are part of the Hybridon Background Intellectual Property or Joint
Patents with respect to a Licensed IMO or Product, the Party obtaining such
knowledge shall advise the other of all relevant facts and circumstances
pertaining to the potential infringement as soon as practicable.
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9.4.2. Novartis shall have the first right, but no obligation, to
initiate and prosecute such legal proceedings, at its own expense and in the
name of Novartis, and to control the defense of any declaratory judgment action,
if the infringing party is making, having made, using or selling a product, or
proposing to do so, that is or may be competitive with the Licensed IMO or
Product; provided, however, that no settlement shall be entered into by Novartis
without the written consent (which consent shall not be unreasonably withheld)
of Hybridon if such settlement would materially affect Hybridon's interests
(including without limitation the validity or enforceability of any Hybridon
Patent or Patent that is part of the Hybridon Background Intellectual Property).
Hybridon shall reasonably cooperate with Novartis in such effort, including,
without limitation, being joined as a party to such action, and Novartis shall
reimburse Hybridon for the out-of-pocket costs and expenses incurred by Hybridon
in so cooperating with Novartis. In deciding whether to pursue, and in the
pursuit of such legal proceedings, Novartis will use diligent, commercially
reasonable efforts consistent with those used by Novartis for its own compounds
or products of similar commercial potential.
9.4.3. If Novartis does not succeed, within ninety (90) days after
receiving notice from Hybridon of the potential infringement or within sixty
(60) days after providing Hybridon with notice of such potential infringement,
either in terminating such infringement or in instituting an action to prevent
continuation thereof, or if Novartis notifies Hybridon that Novartis does not
plan to seek to terminate the infringement or to institute any such action, then
Hybridon shall have the right to do so at its own cost and expense. In such
case, Novartis shall reasonably cooperate with Hybridon in such effort,
including being joined as a party to such action, if necessary, and Hybridon
shall reimburse Novartis for the out-of-pocket costs and expenses incurred by
Novartis in so cooperating with Hybridon.
9.4.4. The costs and expenses (including attorneys' fees) of any
action against an infringement brought in accordance with this Section 9.4, or
to defend a declaratory judgment suit as provided in this Section 9.4, shall be
borne by the Party controlling the infringement or declaratory judgment action.
9.4.5. Any monetary recovery obtained in legal proceedings brought
against an infringer pursuant to Section 9.4.2 or 9.4.3, whether obtained by
settlement, judgment or otherwise, shall first be applied to reimburse the
Parties for the costs (including reasonable
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attorneys' fees) that each incurred in connection with such legal action. If the
monetary recovery is insufficient to fully reimburse both parties for all such
costs, both parties shall receive the same percentage of their respective costs.
The value of any monetary recovery remaining once both Parties have been
reimbursed for all of their costs shall be treated as Net Sales and subject to
earned royalties as set forth in Article V hereof.
9.4.6. Notwithstanding anything in this Section 9.4 to the contrary,
Hybridon may participate, through its own counsel and at its own cost and
expense, in any proceeding involving a challenge to the validity or
enforceability of any Hybridon Patent, Patent that is part of the Hybridon
Background Intellectual Property or Joint Patent that relates to both a Licensed
IMO and to IMO(s) that are not subject to the licenses granted to Novartis
hereunder.
9.5. NOTIFICATION, DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS.
9.5.1. Hybridon shall promptly notify Novartis in the event Hybridon
becomes aware of the existence of any Third Party Patent that may be infringed
by the making, having made, using, having used, developing, having developed,
commercializing, having commercialized, manufacturing, having manufactured,
promoting, having promoted, selling, having sold, distributing, having
distributed, marketing, having marketed, importing, having imported, exporting
or having exported of a Licensed IMO or Product.
9.5.2. If a Third Party asserts that a Patent owned by it is
infringed by the making, having made, using, having used, developing, having
developed, commercializing, having commercialized, manufacturing, having
manufactured, promoting, having promoted, selling, having sold, distributing,
having distributed, marketing, having marketed, importing, having imported,
exporting or having exported of a Licensed IMO or Product, Novartis shall,
subject to Section 5.6.2, defend and be solely responsible for defending,
against any such assertions and controlling any related litigation at its own
cost and expense. Hybridon shall reasonably cooperate with Novartis in such
effort, including, without limitation, being joined as a party to such action,
if necessary, and Novartis shall reimburse Hybridon for the out-of-pocket costs
and expenses incurred by Hybridon in so cooperating with Novartis.
9.5.3. Notwithstanding anything in this Section 9.5 to the contrary,
Hybridon may participate, at its own cost and expense, in any proceeding
involving a challenge to the
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validity or enforceability of any Hybridon Patent, Patent that is part of the
Hybridon Background Intellectual Property or Joint Patent that relates to both a
Licensed IMO and to IMO(s) that are not subject to the licenses granted to
Novartis hereunder.
9.6. PIRATE GOODS. Novartis and its Affiliates shall exercise
commercially reasonable efforts to monitor sales and take action to prevent
trade in goods by a Third Party that violate Novartis' or its Affiliates'
exclusive legal rights to market, price and sell a Product in such a market. In
the event that Hybridon first becomes aware of such a trade in goods by a Third
Party which violates Novartis' or its Affiliates' exclusive legal rights,
Hybridon shall notify Novartis within seven (7) calendar days of first becoming
aware of such trading by a Third Party.
9.7. DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT AND
PEDIATRIC EXCLUSIVITY.
9.7.1. The Parties shall cooperate in an effort to avoid the loss of
any rights which may otherwise be available to the Parties under the provisions
of the Drug Price Competition and Patent Term Restoration Act of 1984 or
comparable laws outside of the United States and for pediatric exclusivity, and
Novartis shall reimburse Hybridon in accordance with Section 14.1 (Invoice
Requirement) for reasonable out-of-pocket costs and expenses incurred by
Hybridon in so cooperating with Novartis.
9.7.2. Hybridon shall provide any relevant information related to
Patents included in the Hybridon Intellectual Property, Hybridon Background
Intellectual Property or Joint Intellectual Property to Novartis or its
Affiliates such that Novartis or its Affiliates, as an NDA applicant, may
provide accurate and complete information to the FDA or other applicable
regulatory authorities.
ARTICLE X
TERM AND TERMINATION
10.1. TERM. The term of this License Agreement shall extend with
respect to each Product in each Valid Claim Country until the expiration of the
last to expire of a Valid Claim
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included in the Hybridon Patents or Joint Patents covering the Product in such
country. In the case of a Non-Valid Claim Country, the term of this License
Agreement shall extend with respect to each Product in each such country until
the earlier of (a) the date that is ten (10) years after the date of the First
Commercial Sale of the Product in such country or (b) the last day in any
calendar year during which Novartis has lost market exclusivity with respect to
such Product in such country. For purposes of this License Agreement, Novartis
shall be deemed to have lost market exclusivity with respect to a Product in a
particular country if annual Net Sales of such Product in such country have
decreased by [**] percent ([**]%) from Net Sales in the previous calendar year.
Once market exclusivity has been lost with respect to a Product in a particular
country, Novartis' obligations to pay royalties hereunder shall expire with
respect to such Product in such country. For each country, upon expiration of
Novartis' obligation to pay royalties hereunder with respect to a Product, the
licenses granted to Novartis in Section 2.2 shall convert to fully paid-up,
royalty-free, perpetual licenses with respect to such Product, which licenses
shall survive any expiration or termination of this Agreement.
10.2. TERMINATION BY NOVARTIS WITHOUT CAUSE. Upon sixty (60) days'
written notice to Hybridon, Novartis may, at its sole discretion, unilaterally
terminate this License Agreement on a Product-by-Product and/or
country-by-country basis without cause.
10.3. MATERIAL BREACH. In the event either Party shall be in material
breach of its obligations hereunder, the other Party may give written notice to
the breaching Party specifying the claimed particulars of such breach, and, in
the event such material breach is not cured, or effective steps to cure such
material breach have not been initiated or are not thereafter diligently pursued
within ninety (90) days following the date of such written notification, in
addition to any other damages or remedies available to the non-breaching Party,
the non-breaching Party shall have the right thereafter to terminate this
License Agreement by giving not less than thirty (30) days prior written notice
to the breaching Party to such effect. If the breaching Party disputes the basis
for such termination, the breaching Party may institute an arbitration
proceeding pursuant to Section 14.3 by notifying the other Party of such dispute
as set forth in Section 14.3.1 prior to the effective date of termination as set
forth in the immediately preceding sentence, and, in such event, the
non-breaching Party shall not be entitled to terminate this License Agreement
pursuant to this Section 10.3 unless and until the Arbitrators issue an order
pursuant to Section 14.3
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declaring that a material breach has occurred and all opportunities for appeal
of such order have been exhausted.
10.4. BANKRUPTCY. If at any time during the term of this License
Agreement, an Event of Bankruptcy (as defined below) relating to a Party (the
"Bankrupt Party") occurs, the other Party shall have, in addition to all other
legal and equitable rights and remedies available hereunder, the option to
terminate this License Agreement upon thirty (30) calendar days' written notice
to the Bankrupt Party. As used above, the term "Event of Bankruptcy" shall mean,
with respect to a Party, (a) the dissolution, termination of existence or
liquidation of the Party; (b) the institution of a bankruptcy action against the
Party by a Third Party or the appointment of a custodian or receiver with
respect to all or substantially all of the business or assets of the Party,
which action, custodian or receiver is not terminated or dismissed within ninety
(90) calendar days following institution or appointment; (c) the institution by
the Party of any petition for relief or similar proceeding or the making by the
Party with respect to all or substantially all of the business or assets of the
Party of a composition or any assignment or trust mortgage for the benefit of
creditors under any bankruptcy, reorganization, receivership or other similar
law affecting the rights of creditors generally; or (d) the insolvency of the
Party.
10.5. EFFECT OF TERMINATION.
10.5.1. Upon termination of this License Agreement by Novartis
pursuant to Section 10.2 with respect to all Products and all countries covered
by this License Agreement or by Hybridon pursuant to Section 10.3 or 10.4: (a)
except with respect to any provision hereof that by its terms survives
termination and any payment obligation of Novartis that has accrued prior to the
date of termination, all rights and obligations of the Parties under this
License Agreement shall terminate; (b) all license rights granted by Hybridon to
Novartis hereunder shall revert to Hybridon; and (c) each Party shall return to
the other all Confidential Information of a Providing Party, provided, however,
that the Parties may each retain a copy of such Providing Party's Confidential
Information in segregated files solely for archival purposes.
10.5.2. Upon termination of this License Agreement by Novartis
pursuant to Section 10.2 with respect to fewer than all the Products or
countries covered by this License Agreement: (a) except with respect to any
provision hereof that by its terms survives termination
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and any payment obligation of Novartis that has accrued prior to the date of
termination, all rights and obligations of the Parties under this License
Agreement with respect to such country and/or Product subject to such
termination shall terminate; and (b) all license rights granted by Hybridon to
Novartis hereunder with respect to such country and/or Product subject to such
termination shall revert to Hybridon.
10.5.3. In the case of termination by Novartis pursuant to Section
10.3, all rights of Novartis shall survive, and all rights of Hybridon shall
terminate other than Hybridon's rights under Sections 5.2 through 5.7 of Article
V (Milestone and Royalty Payments), except that the royalty payable to Hybridon
pursuant to Section 5.5 shall be reduced by [**] percent ([**]%) as provided in
Section 5.6.1, Section 14.6 (Force Majeure) and Articles VII (Confidentiality),
X (Term and Termination) and XIII (Indemnification).
10.5.4. In the case of termination by Novartis pursuant to Section
10.4, all rights of Novartis shall survive, and all rights of Hybridon shall
terminate other than Hybridon's rights under Sections 5.2 through 5.7 of Article
V (Milestone and Royalty Payments), Section 14.6 (Force Majeure), and Articles
VII (Confidentiality), X (Term and Termination) and XIII (Indemnification).
ARTICLE XI
EXCLUSIVITY
During the term of this License Agreement, Hybridon shall neither grant to
any Third Party rights to any immunomodulatory oligonucleotide other than
Excluded Antisense IP in the Commercial Field of Use, nor shall Hybridon develop
or commercialize, directly or indirectly, any immunomodulatory oligonucleotide
other than Excluded Antisense IP in the Commercial Field of Use. Furthermore,
during the term of this License Agreement, Hybridon shall neither grant to any
Third Party rights to any Licensed IMO for any indication, nor shall Hybridon
develop or commercialize, directly or indirectly, any such Licensed IMO.
Notwithstanding the foregoing, nothing in this License Agreement shall restrict
or prohibit Hybridon from performing its obligations or exercising its rights
under the Collaboration Agreement.
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ARTICLE XII
REPRESENTATIONS AND WARRANTIES
12.1. REPRESENTATIONS AND WARRANTIES OF HYBRIDON. Hybridon hereby
represents and warrants to Novartis that the statements in this Section 12.1 are
true and accurate as of the date of this License Agreement and as of the
Effective Date:
12.1.1. Authorization. This License Agreement has been duly executed
and delivered by Hybridon and constitutes the valid and binding obligation of
Hybridon, enforceable against Hybridon in accordance with its terms, except as
enforceability may be limited by fraudulent conveyance, insolvency, bankruptcy,
reorganization, moratorium and other laws relating to or affecting creditors'
rights generally and by general equitable principles. The execution, delivery
and performance of this License Agreement have been duly authorized by all
necessary action on the part of Hybridon, its officers and directors. No
provision of this License Agreement violates any other agreement that Hybridon
may have with any other person or company, and Hybridon acknowledges that
Novartis has relied on that representation in entering into this License
Agreement.
12.1.2. Hybridon Controlled Rights. Hybridon owns or possesses
adequate licenses or other rights to use all Hybridon Intellectual Property and
Hybridon Background Intellectual Property and to grant the licenses and perform
the obligations contemplated herein. The granting of the licenses to Novartis
hereunder does not violate any right known to Hybridon of any Third Party.
12.1.3. Third Party Patents. Except as disclosed in writing between
the Parties to this License Agreement or their respective agents to Hybridon's
best knowledge, after reasonable inquiry, there are no issued patents or pending
patent applications that, if issued, would be infringed by the exercise by
Novartis of the rights granted herein or the research, development, manufacture,
use or sale of the Licensed IMOs pursuant to this License Agreement.
12.2. REPRESENTATIONS AND WARRANTIES OF NOVARTIS. Novartis represents
and warrants to Hybridon that this License Agreement has been duly executed and
delivered by Novartis and constitutes the valid and binding obligation of
Novartis, enforceable against
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Novartis in accordance with its terms except as enforceability may be limited by
fraudulent conveyance, insolvency, bankruptcy, reorganization, moratorium and
other laws relating to or affecting creditors' rights generally and by general
equitable principles. The execution, delivery and performance of this License
Agreement have been duly authorized by all necessary action on the part of
Novartis, its officers and directors. No provision of this License Agreement
violates any other agreement that Novartis may have with any other person or
company, and Novartis acknowledges that Hybridon has relied on that
representation in entering into this License Agreement.
12.3. CERTIFICATE OF HYBRIDON. Within thirty (30) days of the Effective
Date, Hybridon shall deliver to Novartis a certificate or certificates, dated as
of the Effective Date, of the President of Hybridon certifying on behalf of
Hybridon that the representations and warranties of Hybridon set forth in this
License Agreement are true and correct on and as of the Effective Date. In the
event that the representations and warranties of Hybridon set forth in this
License Agreement are no longer true and correct on and as of the Effective
Date, without exception, Hybridon shall deliver to Novartis such certificate(s)
along with a detailed schedule of exceptions to such representations and
warranties (the "Schedule of Exceptions"). Upon delivery by Hybridon of
certificate(s) together with a Schedule of Exceptions (but not upon delivery of
certificate(s) not accompanied by a Schedule of Exceptions), Novartis, in its
sole discretion, shall either (i) withdraw its exercise of the Commercialization
Option, in which case this License Agreement shall be deemed not to have taken
effect, such Commercialization Option shall remain in full force and effect, and
Novartis shall retain the right to exercise such Commercialization Option at a
later time during the Option Term or (ii) accept the certificate as modified by
the Schedule of Exceptions, in which case this License Agreement shall remain
effective, the Schedule of Exceptions shall be incorporated herein as Schedule
12.3, and the option exercise fee set forth in Section 5.1 hereof shall become
payable by Novartis upon receipt of Invoice; provided that, (x) if Novartis does
not notify Hybridon that Novartis has elected to withdraw its exercise of the
Commericalization Option within sixty (60) days after Novartis receives such
certificate(s) together with a Schedule of Exceptions, Novartis shall be deemed
to have accepted the certificate(s) in accordance with the foregoing clause (ii)
and (y) if Hybridon delivers such certificate(s) together with a Schedule of
Exceptions, then Hybridon shall not Invoice Novartis for the option exercise fee
unless and until such certificate(s) have been
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accepted (or deemed to have been accepted) by Novartis. Acceptance by Novartis
of a certificate modified by the Schedule of Exceptions shall in no way be
deemed to modify or otherwise limit Novartis' rights or possible remedies under
the Collaboration Agreement.
12.4. LIMITATIONS.
12.4.1. NO OTHER WARRANTIES. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH
IN THIS AGREEMENT, ALL IMPLIED WARRANTIES, INCLUDING IMPLIED WARRANTIES OF
NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE
EXCLUDED.
12.4.2. CONSEQUENTIAL AND PUNITIVE DAMAGES. EXCEPT AS OTHERWISE
EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY WILL BE LIABLE FOR
CONSEQUENTIAL, INCIDENTAL, MULTIPLE, SPECIAL OR PUNITIVE DAMAGES OF ANY NATURE
ARISING FROM SUCH PARTY'S ACTIVITIES UNDER THIS AGREEMENT; PROVIDED, HOWEVER,
THAT THIS LIMITATION SHALL NOT LIMIT THE INDEMNIFICATION OBLIGATIONS OF THE
PARTIES WITH RESPECT TO THIRD PARTY CLAIMS OR THE OBLIGATIONS OF EITHER PARTY
WITH RESPECT TO A BREACH OF ARTICLE II OR ARTICLE VII.
ARTICLE XIII
INDEMNIFICATION
13.1. INDEMNIFICATION BY HYBRIDON. Hybridon will indemnify, defend, and
hold Novartis and its Affiliates, their respective employees, shareholders,
officers, directors, agents and consultants, and the successors, heirs and
assigns of each of them, harmless against any loss, damages, action, suit,
claim, demand, liability, expense, bodily injury, death or property damage,
including reasonable attorney fees (a "Loss") that may arise from Third Party
claims brought, instituted or arising against such persons to the extent such
Loss is based on or arises out of the breach by Hybridon of any of its
covenants, representations or warranties set forth in this License Agreement,
but excluding any such Loss that is caused by the negligent, willful or reckless
acts or omissions of Novartis.
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13.2. INDEMNIFICATION BY NOVARTIS. Novartis will indemnify, defend, and
hold Hybridon, and its Affiliates, and their respective employees, shareholders,
officers, directors, agents and consultants, and the successors, heirs, and
assigns of each of them, harmless against any Loss that may arise from Third
Party claims brought, instituted or arising against such persons to the extent
such Loss is based on or arises out of (a) the breach by Novartis of any of its
covenants, representations or warranties set forth in this License Agreement,
(b) the development, manufacture, use, storage or handling of a Licensed IMO by
Novartis or its Affiliates or their representatives, agents, licensees,
sublicensees or subcontractors under this License Agreement, or any actual or
alleged violation of law resulting therefrom, including without limitation any
death or bodily injury caused or allegedly caused by the use of the Licensed IMO
or (c) any actual or alleged infringement of any patent rights, trademarks or
other intellectual property rights, or misappropriation of trade secrets, in
connection with the making, having made, using, having used, developing, having
developed, commercializing, having commercialized, manufacturing, having
manufactured, promoting, having promoted, selling, having sold, distributing,
having distributed, marketing, having marketed, importing, having imported,
exporting or having exported of any Licensed IMO or Product, but excluding any
such Loss that is caused by the negligent, willful or reckless acts or omissions
of Hybridon.
13.3. CLAIMS PROCEDURES. Each Person entitled to be indemnified by a
Party (an "Indemnified Person") pursuant to Sections 13.1 or 13.2 hereof shall
give notice to the other Party (an "Indemnifying Party") promptly after such
Indemnified Person has actual knowledge of any threatened or asserted claim as
to which indemnity may be sought, and shall permit the Indemnifying Party to
assume the sole control of the defense of any such claim or any litigation
resulting therefrom; provided, however:
(a) that counsel for the Indemnifying Party, who shall conduct the
defense of such claim or any litigation resulting therefrom, shall be approved
by the Indemnified Person (whose approval shall not unreasonably be withheld)
and the Indemnified Person may participate in such defense at such Party's
expense (unless: (i) the employment of counsel by such Indemnified Person has
been authorized by the Indemnifying Party; or (ii) the Indemnified Person shall
have reasonably concluded that there may be a conflict of interest between the
Indemnifying Party and the Indemnified Person in the defense of such action, in
each of which cases the Indemnifying
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Party shall pay the reasonable fees and expenses of one law firm serving as
counsel for all Indemnified Persons with respect to such action, which law firm
shall be subject to approval, not to be unreasonably withheld, by the
Indemnifying Party);
(b) the failure of any Indemnified Person to give notice as provided
herein shall not relieve the Indemnifying Party of its obligations under this
License Agreement to the extent that the failure to give notice did not result
in harm to the Indemnifying Party or materially compromise the defense of such
claim;
(c) no Indemnifying Party, in the defense of any such claim or
litigation, shall consent to entry of any judgment or enter into any settlement,
except with the approval of each Indemnified Person (which approval shall not be
unreasonably withheld), except a settlement which imposes only a monetary
obligation on the Indemnifying Party and which includes as an unconditional term
thereof the giving of a release from all liability in respect to such claim or
litigation by the claimant or plaintiff to the Indemnified Person;
(d) each Indemnified Person shall furnish such information or
reasonable assistance regarding itself or the claim in question as an
Indemnifying Party may reasonably request in writing and shall be reasonably
required in connection with the defense of such claim and litigation resulting
therefrom; and
(e) no Indemnified Person shall settle or agree to a judgment with
respect to such claim or litigation without the consent of the Indemnifying
Party (which consent shall not be unreasonably withheld).
13.4. SURVIVAL. The provisions of this Article XIII shall survive
expiration or termination of this Agreement without limitation.
ARTICLE XIV
MISCELLANEOUS PROVISIONS
14.1. INVOICE REQUIREMENT. Except as otherwise set forth in Section
6.1, any amounts payable to Hybridon hereunder shall be made within sixty (60)
calendar days after receipt by Novartis or its designated nominee of an invoice
covering such payment. With respect
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to invoices for milestone payments, Hybridon shall send such invoices following
written notice by Novartis that the particular milestone(s) to which such
invoice pertains has been met.
14.2. GOVERNING LAW, AND JURISDICTION. This License Agreement shall be
governed and construed in accordance with the internal laws of the State of New
York, United States. Both Parties agree to submit to personal jurisdiction in
the State of New York and to accept and agree to venue in the State of New York.
14.3. ARBITRATION WITH RESPECT TO CERTAIN MATTERS. Any controversy or
claim as to whether this License Agreement may be terminated by a Party pursuant
to Section 10.3 (any such controversy or claim being referred to in this Section
14.3 as a "Section 10.3 dispute") shall be resolved through arbitration as
follows:
14.3.1. Notice; Selection of Arbitrators. A Party may submit such
Section 10.3 dispute to arbitration by notifying the other Party, in writing, of
such Section 10.3 dispute. The Party submitting such notice shall include
therein a reasonably detailed summary of the basis for such Section 10.3
dispute. The Parties agree that any such Section 10.3 dispute shall be submitted
to three (3) arbitrators selected from the panel of arbitrators of the American
Arbitration Association ("AAA"). Within twenty (20) days after receipt of notice
pursuant to this Section 14.3.1, each Party shall designate in writing a single
arbitrator. Within ten (10) business days after the designation of the
arbitrators, the arbitrators chosen by the Parties shall choose a third
arbitrator (collectively, the "Arbitrators"). In selecting the third arbitrator,
preference shall be given to a lawyer or former judge knowledgeable and
experienced in the law concerning the subject matter of the Section 10.3
dispute, and shall not be an Affiliate, employee, consultant, officer, director
or stockholder of either Party. The Parties shall obtain the agreement of the
Arbitrators to provide a written ruling, stating in separate sections the
findings of fact and conclusions of law on which their ruling is based. The
Parties will obtain the agreement of the Arbitrators to the terms of this
Section 14.3.
14.3.2. Initial Meeting. Within ten (10) days after the designation
of the Arbitrators, the Arbitrators and the Parties shall meet, at which time
the Parties shall be required to set forth in writing all disputed issues and a
proposed ruling on the merits of each such issue.
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14.3.3. Hearing. The Arbitrators shall set a date for a hearing,
which shall be no later than twenty (20) days after the submission of written
proposals pursuant to Section 14.3.2, to discuss each of the issues identified
by the Parties. The Parties shall have the right to be represented by counsel.
Except as provided herein, the arbitration shall be governed by the Commercial
Arbitration Rules of the AAA, as amended and in effect on the date a demand for
arbitration is filed; provided, however, that the United States Federal Rules of
Evidence shall apply with regard to the admissibility of evidence.
14.3.4. Ruling. The Arbitrators shall use their best efforts to rule
on the Section 10.3 dispute within twenty (20) days after the completion of the
hearing described in Section 14.3.3. Subject to any rights to appeal provided
for by statute, the determination of the Arbitrators as to the resolution of any
Section 10.3 dispute shall be binding and conclusive upon both Parties. All
rulings of the Arbitrators shall be in writing, specifying the basis in law and
in fact of the ruling, and shall be delivered to the Parties.
14.3.5. Costs and Expenses. Each Party shall bear its own costs and
expenses incurred in connection with any arbitration pursuant to this Section
14.3.
14.3.6. Location of Arbitration. Any arbitration pursuant to this
Section 14.3 shall be conducted in New York, New York. Any arbitration award may
be entered in and enforced by a court in accordance with Section 14.2, subject
to each Party's rights to appeal as provided for by statute.
14.3.7. No Limitation. Nothing in this Section 14.3 shall be
construed as limiting in any way the right of a Party to bring an action in aid
of arbitration in a court in accordance with Section 14.2.
14.4. SAFETY ISSUES OR SIGNALS. During the term of this License
Agreement, the Parties will promptly report to appropriate authorities in
accordance with applicable law any safety issue or signal, directly or
indirectly attributable to such Party's use or application of any
immunomodulatory oligonucleotide and shall share any such report with the other
Party. Each Party shall be entitled to use and disclose all such reports or
other information to regulatory authorities as required under applicable law or
regulation and to licensees, sublicensees and collaborators under obligations of
confidentiality for purposes relating to the research,
License, Development and Commercialization Agreement - Confidential
PAGE 43 OF 53
development and/or commercialization of products incorporating immunomodulatory
oligonucleotides.
14.5. WAIVER. No provision of this License Agreement may be waived
except in writing by both Parties. No failure or delay by either Party in
exercising any right or remedy hereunder or under applicable law will operate as
a waiver thereof, or a waiver of any right or remedy on any subsequent occasion.
14.6. FORCE MAJEURE. Neither Party will be in breach hereof by reason
of its delay in the performance of or failure to perform any of its obligations
hereunder, if that delay or failure is caused by strikes, acts of God or the
public enemy, riots, war, terrorism, incendiaries, interference by civil or
military authorities, compliance with governmental priorities for materials, or
any fault beyond its control or without its fault or negligence.
14.7. SEVERABILITY. Should one or more provisions of this License
Agreement be or become invalid, then the Parties shall attempt in good faith to
agree upon valid provisions in substitution for the invalid provisions, which in
their economic effect and other substance come so close to the invalid
provisions that it can be reasonably assumed that the Parties would have
accepted this License Agreement with those new provisions. If the Parties are
unable to agree on such valid provisions, the invalidity of such one or more
provisions of this License Agreement shall nevertheless not affect the validity
of the License Agreement as a whole, unless the invalid provisions are of such
essential importance for this License Agreement that it may be reasonably
presumed that the Parties would not have entered into this License Agreement
without the invalid provisions.
14.8. GOVERNMENT ACTS. In the event that any act, regulation,
directive, or law of a country or its government, including its departments,
agencies or courts, should make impossible or prohibit, restrain, modify or
limit any material act or obligation of the Parties under this License
Agreement, the Party, if any, not so affected, shall have the right, at its
option, to suspend or terminate this License Agreement as to such country, if
good faith negotiations between the Parties to make such modifications herein as
may be necessary to fairly address the impact thereof, are not successful after
a reasonable period of time in producing mutually acceptable modifications to
this License Agreement.
License, Development and Commercialization Agreement - Confidential
PAGE 44 OF 53
14.9. GOVERNMENT APPROVALS. Each Party will obtain any government
approval required to enable this License Agreement to become effective, or to
enable any payment hereunder to be made, or any other obligation hereunder to be
observed or performed. Each Party shall keep the other informed of progress in
obtaining any such government approval, and will cooperate with the other Party
in any such efforts.
14.10. EXPORT CONTROLS. This License Agreement is made subject to any
restrictions concerning the export of a Licensed IMO, Product, Hybridon
Intellectual Property, Hybridon Background Intellectual Property, or Joint
Intellectual Property from the United States that may be imposed upon or related
to either Party from time to time by the Government of the United States.
Furthermore, each Party agrees that it will not export, directly or indirectly,
any Hybridon Intellectual Property, Hybridon Background Intellectual Property,
Joint Intellectual Property or a Licensed IMO or Product utilizing the same to
any countries for which the United States government or any agency thereof at
the time of export requires an export license or other governmental approval,
without first obtaining the written consent to do so (of which Novartis will
promptly inform Hybridon) from the Department of Commerce or other agency of the
United States government when required by applicable statute or regulation.
14.11. ASSIGNMENT. This License Agreement may not be assigned or
otherwise transferred by either Party without the prior written consent of the
other Party; provided, however, that either Party may assign this License
Agreement, without the consent of the other Party: (a) to any of its Affiliates,
if the assigning Party guarantees to full performance of its Affiliates'
obligations hereunder; or (b) in connection with the transfer or sale of all or
substantially all of its assets or business to which this License Agreement
pertains, or a controlling equity interest, or in the event of its merger or
consolidation with another company. Any purported assignment in contravention of
this Section 14.11 shall, at the option of the nonassigning Party, be null and
void and of no effect. No assignment shall release either Party from
responsibility for the performance of any accrued obligation of such Party
hereunder. This License Agreement shall be binding upon and enforceable against
the successor to or any permitted assignees of either of the Parties.
14.12. COUNTERPARTS. This License Agreement may be executed in
counterparts, each of which shall be deemed to be original and both of which
shall constitute one and the same
License, Development and Commercialization Agreement - Confidential
PAGE 45 OF 53
License Agreement.
14.13. NO AGENCY. Nothing in this License Agreement shall be deemed to
create an agency, joint venture, amalgamation, partnership or similar
relationship between Hybridon and Novartis and/or their respective Affiliates.
Notwithstanding any of the other provisions of this License Agreement, neither
Party shall at any time enter into, incur, or hold itself out to Third Parties
as having authority to enter into or incur, on behalf of the other Party, any
commitment, expense, or liability whatsoever, and all contracts, expenses and
liabilities in connection with or relating to the obligations of each Party
under this License Agreement shall be made, paid, and undertaken exclusively by
such Party on its own behalf and not as an agent or representative of the other.
14.14. NOTICE. All communications between the Parties with respect to
any of the provisions of this License Agreement will be sent to the addresses
set out below, or to such other addresses as may be designated by one Party to
the other by notice pursuant hereto, by (i) personal delivery (which shall be
deemed received when delivered), (ii) reputable international express courier
(which shall be deemed received when delivered), (iii) prepaid, certified mail
(which shall be deemed received by the other party on the seventh (7th) business
day following deposit in the mails), or (iv) facsimile transmission, or other
electronic means of communication (which shall be deemed received when
transmitted), with confirmation in the case of clause (iv) prepaid certified
mail, given by the close of business on or before the next following business
day:
if to Novartis, at:
Novartis International Pharmaceutical Ltd.
Hurst Holme
12 Trott Road
P.O. Box 2899
Hamilton, HM LX
Bermuda
Attention: Emil Bock
Fax: (441) 296-5083
License, Development and Commercialization Agreement - Confidential
PAGE 46 OF 53
with a copy to:
Novartis Institutes for BioMedical Research, Inc.
400 Technology Square
Cambridge, Massachusetts 02139
Attention: Robert L. Thompson, Vice President and General
Counsel
Fax: [**]
and:
Novartis Pharma AG
Lichtstrasse 35
CH-4056 Basel
Switzerland
Attn.: General Counsel
Fax: [**]
if to Hybridon, at:
Hybridon, Inc.
345 Vassar Street
Cambridge, Massachusetts 02139
Attention: President
Fax: +(617) 679-5542
with a copy to:
Wilmer Cutler Pickering Hale and Dorr LLP
60 State Street
Boston, Massachusetts 02109
USA
Attention: David E. Redlick, Esq.
Fax: +(617) 526-5000
14.15. HEADINGS. The paragraph headings are for convenience only and
will not be deemed to affect in any way the language of the provisions to which
they refer.
14.16. AUTHORITY. The undersigned represent that they are authorized to
sign this License Agreement on behalf of their respective Party. The Parties
each represent that no provision of this License Agreement will violate any
other agreement that such Party may have with any other person or company. Each
Party has relied on that representation in entering into this License Agreement.
License, Development and Commercialization Agreement - Confidential
PAGE 47 OF 53
14.17. ENTIRE AGREEMENT. This License Agreement and the Collaboration
Agreement contain the entire understanding of the Parties relating to the
matters referred to herein and therein, supersede all prior agreements between
the Parties with respect to such matters (including without limitation the
Confidential Term Sheet dated January 26, 2005, the Material Transfer Agreement
dated July 1, 2003, as amended prior to the Effective Date, and the Mutual
Confidentiality Agreements dated January 23, 2003 and June 8, 2004, each as
amended prior to the Effective Date, but excluding provisions of such Material
Transfer Agreement and Mutual Confidentiality Agreements, relating to
restrictions on the use and disclosure of materials and information prior to the
Effective Date (it being understood that any material and information
transferred or disclosed between the Parties prior to the Effective Date
relating to the matters referred to in this License Agreement and the
Collaboration Agreement will, after the Effective Date, be deemed to have been
transferred or disclosed under, and will be subject to the restrictions on use
and disclosure set forth in, this License Agreement and the Collaboration
Agreement)), and may only be amended by a written document, duly executed on
behalf of the respective Parties.
[Signature page follows]
License, Development and Commercialization Agreement - Confidential
PAGE 48 OF 53
HYBRIDON, INC.
By: /s/ Sudhir Agrawal
----------------------------------------
Name: Sudhir Agrawal
Title: CEO/President
NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD.
By: /s/ Emil Bock
----------------------------------------
Name: Emil Bock
Title: Member of the Board of Directors.
By: /s/ Michael Jones
----------------------------------------
Name: Michael Jones
Title: Member of the Board of Directors
License, Development and Commercialization Agreement - Confidential
PAGE 49 OF 53
EXHIBIT A
SAMPLE INVOICE
HYBRIDON'S LOGO INVOICE
INVOICE DATE:
Street [MONTH][DAY] 200X
Town, Country
Phone and Fax Nr. INVOICE NO.:XXXX
BILL TO: FOR:
Novartis International Pharmaceutical Ltd. Product X Royalties 1st
"Hurst Holme", 12 Trott Road Quarter 2004
Att. Mr. Emil Bock (or Milestone for event Y)
P.O. Box HM 2899
Hamilton, HM LX
Bermuda
DESCRIPTION AMOUNT (USD)
- ------------------------------------------------------------ --------------
Product X royalties January - March 2004 calculated based on US$ 000'000.00
Novartis provided sales report (see attached worksheet)
(Or milestone payment for event Y, according to paragraph XY
of agreement ZZZZ dated ......)
Novartis Contract Code
Please specify the event for which the invoice is due, and
add any copies of invoices from third parties in case
reimbursement for third party work is agreed to
PLEASE REMIT BY WIRE TRANSFER WITHIN 60 DAYS TO:
Receiving Bank -
Swift Code -
ABA Number -
Credit Account -
Beneficiary -
--------------
TOTAL 000'000,00
==============
If you have any questions concerning this invoice, contact ..........
or e-mail to ......
VAT -Reg. No. Xxxxxxxxxx (if partner has one)
BEST REGARDS,
SCHEDULE 1.29
HYBRIDON PATENTS
[TO BE APPENDED UPON EXERCISE OF THE COMMERCIALIZATION OPTION]
SCHEDULE 1.39
JOINT PATENTS
[TO BE APPENDED UPON EXERCISE OF THE COMMERCIALIZATION OPTION]