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Exhibit 10.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
EXCLUSIVE LICENSE AND
RESEARCH COLLABORATION AGREEMENT
BY AND BETWEEN
MERCK & CO., INC.
AND
IDERA PHARMACEUTICALS, INC.
<PAGE>
TABLE OF CONTENTS
1.
DEFINITIONS.............................................................
1
2. RESEARCH
PROGRAM........................................................
11
2.1 General........................................................
11
2.2 Conduct of Research............................................
11
2.3 Use of Research Funding; FTE Commitments.......................
11
2.4 Principal Scientists...........................................
12
2.5 Joint Research Committee.......................................
12
2.6 Exchange of Information........................................
13
2.7 Records and Reports............................................
13
2.8 Disclosure, Evaluation and Selection of Collaboration
Compounds................................................... 14
2.9 Ownership of Materials, Information and Inventions.............
15
2.10 Research Program
Term.......................................... 16
2.11 Merck
Materials................................................ 16
2.12 Exclusive
Efforts.............................................. 16
2.13 Use of Human
Materials......................................... 16
3. LICENSES; DEVELOPMENT AND
COMMERCIALIZATION............................. 17
3.1 License Grants to Merck........................................
17
3.2 License Grants to Idera........................................
18
3.3 No Implied Licenses............................................
18
3.4 Development and Commercialization..............................
18
3.5 Excused Performance............................................
18
3.6 Exclusive Negotiation Period...................................
19
3.7 Adverse Experience Reporting...................................
19
4. CONFIDENTIALITY AND
PUBLICATION...................................... 20
4.1 Nondisclosure Obligation.......................................
20
4.2 Idera Know-How.................................................
21
4.3 Publication....................................................
21
4.4 Publicity/Use of Names.........................................
22
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5. PAYMENTS; ROYALTIES AND
REPORTS......................................... 22
5.1 License Fee....................................................
22
5.2 Research Program FTE Funding; Additional Supply................
22
5.3 Milestone Payments.............................................
23
5.4 Royalties......................................................
25
5.5 Reports; Payment of Royalty....................................
28
5.6 Audits.........................................................
28
5.7 Payment Exchange Rate..........................................
29
5.8 Income Tax Withholding.........................................
29
6. REPRESENTATIONS AND WARRANTIES;
COVENANTS............................... 29
6.1 Representations and Warranties of Idera........................
29
6.2 Representations and Warranties of Merck........................
30
6.3 Covenants of Idera.............................................
30
7. PATENT
PROVISIONS.......................................................
30
7.1 Filing, Prosecution and Maintenance of Patents.................
30
7.2 Option of Merck to Prosecute and Maintain Patents..............
31
7.3 Interference, Opposition, Reexamination and Reissue............
32
7.4 Enforcement and Defense........................................
32
7.5 Cooperation; Patent Term Extension and Restoration.............
34
8. TERM AND
TERMINATION....................................................
34
8.1 Term and Expiration............................................
34
8.2 Termination by Merck...........................................
34
8.3 Termination for Cause..........................................
35
8.4 Effect of Expiration or Termination; Survival..................
37
9.
INDEMNIFICATION.........................................................
37
9.1 Indemnification by Merck.......................................
37
9.2 Indemnification by Idera.......................................
37
9.3 Claims for Indemnification.....................................
37
9.4 Limitation of Liability........................................
38
10.MISCELLANEOUS...........................................................
38
ii
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10.1 Force
Majeure.................................................. 38
10.2 Assignment/ Change of
Control.................................. 38
10.3
Severability...................................................
39
10.4
Notices........................................................
40
10.5 Applicable
Law................................................. 40
10.6 Dispute
Resolution............................................. 40
10.7 Entire Agreement;
Amendments................................... 41
10.8
Affiliates.....................................................
42
10.9
Headings.......................................................
42
10.10 Independent
Contractors........................................ 42
10.11
Waiver.........................................................
42
10.12 Cumulative
Remedies............................................ 42
10.13 Waiver of Rule of
Construction................................. 42
10.14
Counterparts...................................................
42
SCHEDULES
SCHEDULE 1.18 EVALUATION
CRITERIA.................................... i
SCHEDULE 1.25 IDERA BACKGROUND PATENT
RIGHTS......................... ii
SCHEDULE 1.29 IDERA
MATERIALS........................................ ix
SCHEDULE 1.50 MERCK
MATERIALS........................................ x
SCHEDULE 1.73 SELECTION
CRITERIA..................................... xi
SCHEDULE 2.1 RESEARCH
PROGRAM....................................... xii
SCHEDULE 2.3.2 DEPLOYMENT OF
FTEs..................................... xvi
SCHEDULE 2.12 IDERA OBLIGATIONS UNDER THE IMMUNE RESPONSE
CORPORATION
AGREEMENT........................................... xvii
SCHEDULE 4.4 FORM OF PRESS
RELEASE.................................. xviii
SCHEDULE 5.4.4 ROYALTY
REDUCTION...................................... xxii
SCHEDULE 6.1(d) SCHEDULE OF
EXCEPTIONS................................. xxiii
iii
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EXECUTION COPY
EXCLUSIVE LICENSE AND RESEARCH COLLABORATION AGREEMENT
THIS AGREEMENT (this "Agreement"), effective as of December 8, 2006
(the
"Effective Date"), by and between Merck & Co., Inc., a
corporation organized and
existing under the laws of New Jersey ("Merck"), and Idera
Pharmaceuticals,
Inc., a corporation organized and existing under the laws of
Delaware ("Idera").
RECITALS:
WHEREAS, Idera has expertise and possesses Idera Technology (as
hereinafter
defined) relating to certain Toll-like Receptor agonists;
WHEREAS, Merck has expertise and possesses Merck Technology (as
hereinafter
defined) relating to the research, development, manufacturing and
marketing of
Vaccines and other related biological products;
WHEREAS, Merck and Idera desire to enter into a research
collaboration to
develop Collaboration Compounds (as hereinafter defined) for use in
Merck's
Vaccines upon the terms and conditions set forth herein;
WHEREAS, Merck desires to obtain a license upon the terms and
conditions
set forth herein and Idera desires to grant such a license; and
WHEREAS, Merck and Idera have entered into a Stock Purchase
Agreement and
Registration Rights Agreement as of the Effective Date;
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual
covenants herein contained, the Parties hereby agree as
follows:
1. DEFINITIONS
Unless specifically set forth to the contrary herein, the following
terms,
whether used in the singular or plural, shall have the respective
meanings set
forth below:
1.1 "ACT" shall mean, as applicable, the United States Federal
Food, Drug and
Cosmetic Act, 21 U.S.C. Sections 301 et seq., and/or the Public
Health
Service Act, 42 U.S.C. Sections 262 et seq., as such may be amended
from
time to time.
1.2 "ADJUVANT" shall mean a compound, complex or other agent that
enhances the
immune response to an Antigen or Antigens and is intended to act as
an
agonist to TLR 7, TLR 8, TLR 7/8 and/or TLR 9.
1.3 "AFFILIATE" shall mean, with respect to a Person, any
corporation or
business entity of which more than fifty percent (50%) of the
securities or
other ownership interests representing the equity, the voting stock
or
general partnership interest are owned, controlled or held,
directly or
indirectly, by such Person.
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1.4 "ALZHEIMER'S DISEASE FIELD" shall mean the use of Evaluation
Collaboration
Compound(s) and Selected Collaboration Compound(s) as an Adjuvant
contained
in or administered in conjunction with any prophylactic and/or
therapeutic
Vaccine(s) for the prevention and/or treatment of Alzheimer's
disease.
1.5 "ANTIGEN" shall mean any ingredient that either alone or as
part of a
Vaccine elicits a specific immune response to itself and/or to a
pathogenic
micro-organism or a human self molecule, including, without
limitation,
live attenuated or modified micro-organisms, whole killed
micro-organisms,
proteins, polysaccharides, polysaccharide conjugates, peptides,
recombinant
proteins, glycolipids and fragments thereof.
1.6 "CALENDAR QUARTER" shall mean the respective periods of three
(3)
consecutive calendar months ending on March 31, June 30, September
30 and
December 31.
1.7 "CALENDAR YEAR" shall mean each successive period of twelve
(12) months
commencing on January 1 and ending on December 31.
1.8 "CHANGE OF CONTROL" shall mean with respect to a Party: (i) the
sale of all
or substantially all of such Party's assets or business relating to
this
Agreement; (ii) the closing of a merger, reorganization or
consolidation
involving such Party in which the voting securities of such
Party
outstanding immediately prior thereto cease to represent at least
fifty
percent (50%) of the combined voting power of the surviving
entity
immediately after such merger, reorganization or consolidation; or
(iii) a
person or entity, or group of persons or entities, acting in
concert to
acquire more than [**] percent ([**]%) of the voting equity
securities or
management control of such Party.
1.9 "CLINICAL TRIAL" shall mean a Phase I Clinical Trial, Phase II
Clinical
Trial or Phase III Clinical Trial, as applicable.
1.10 "COLLABORATION COMPOUNDS" shall mean (a) any IMO provided by
Idera to Merck
under this Agreement, (b) any other IMO created, modified or
developed by
the Parties pursuant to the Research Program and (c) any
improvement or
enhancement to the IMOs described in (a) or (b).
1.11 "COMPETING PHARMA CHANGE OF CONTROL" means a Change of Control
involving a
Person or group of Persons acting in concert (a) with annual
worldwide
sales of human pharmaceutical, vaccine and/or biological products
greater
than [**] Dollars ($[**]) or (b) having a market capitalization
greater
than [**] U.S. Dollars ($[**]) or (c) having an active clinical
development
or commercialization program for any prophylactic and/or
therapeutic
Vaccine for the prevention and/or treatment of Alzheimer's Disease,
any
type of cancer and/or any disease within the Infectious Disease
Field.
1.12 "COMBINATION PRODUCT" shall mean, on a country by country
basis, with
respect to a given Product, a Product that contains one or more
Antigens in
addition to the Antigen(s) contained in the given Product at the
time it
achieves First Commercial Sale in such country. For example, if a
given
Product in a country, at the time it achieves First Commercial
Sale
contains Antigens A and B, a Combination Product with respect to
such given
Product in such country would be a Product that contains at least
one other
Antigen, in addition to Antigens A and B, and achieves First
Commercial
Sale in such country after the given Product has achieved First
Commercial
Sale.
1.13 "COMPETING PRODUCT" shall mean, with respect to a Product in a
country, a
Vaccine product that (a) contains a compound targeting the same TLR
as the
Adjuvant contained in the Product and
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has received Marketing Authorization for the same Indication in a
Field for
which the Product has received Marketing Authorization in such
country and
(b) has safety and efficacy equivalent or materially similar to the
Product
and has or attains on a Calendar Year basis a market share of [**]
percent
([**]%) or more in the country as measured by prescriptions or
other
similar information.
1.14 "CONTROL," "CONTROLS" OR "CONTROLLED BY" shall mean with
respect to any
item or right under Patent Rights, know-how or other intellectual
property
right or technology, the possession of (whether by ownership or
license,
other than pursuant to this Agreement), or the ability of a Party
to grant
access to, or a license or sublicense of, such item or right as
provided
for herein without violating the terms of any agreement or
other
arrangement with any Third Party existing at the time such Party
would be
required hereunder to grant the other Party such access or license
or
sublicense.
1.15 "DATA PROTECTION" shall mean the exclusive right to reference
data filed in
a Marketing Authorization with a Regulatory Authority in such
country for
Selected Collaboration Compound or Product under a pharmaceutical
law,
regulation or any other governmental decree or order of such
country within
the Territory. For the purposes of clarity, such exclusive right
to
reference data shall exclude any party other than Merck or its
Related
Parties from referencing such data in such party's own regulatory
filings
for authorization to register or sell a generic product in such
country
filed with the Regulatory Authority.
1.16 "EMEA" shall mean the European Medicines Agency.
1.17 "EVALUATION COLLABORATION COMPOUND" shall have the meaning
given such term
in Section 2.8.1.
1.18 "EVALUATION CRITERIA" shall mean the criteria set forth in
Schedule 1.18
attached hereto.
1.19 "FIELDS" shall mean the Oncology Field, the Infectious Disease
Field and
the Alzheimer's Disease Field, collectively.
1.20 "FILING" of an IND or NDA shall mean the acceptance by a
Regulatory
Authority of an IND or NDA for filing, if such a legally-recognized
concept
applies to filings in the applicable jurisdiction or, if such
concept does
not apply, the filing of the IND or NDA.
1.21 "FIRST COMMERCIAL SALE" shall mean, with respect to any
Product, the first
sale for end use or consumption of such Product in a country,
excluding,
however, any sale or other distribution for use in a Clinical
Trial.
1.22 "FULL TIME EQUIVALENT" or "FTE" shall mean the equivalent of a
full-time
scientist's work time over a twelve (12) month period (including
normal
vacations, sick days and holidays), provided that a single person
cannot
account for more than one FTE over the course of any Calendar Year.
For
example, a single person cannot equal one FTE plus a portion of
an
additional FTE resulting in more than one FTE (i.e. 1.5 FTE's) in a
given
Calendar Year, regardless of the aggregate number of hours worked
by such
person during that Calendar Year. The portion of an FTE year
devoted by a
scientist to the Research Program shall be determined by dividing
the
number of full days during any twelve-month period devoted by such
employee
to the Research Program by the total number of working days during
such
twelve-month period.
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1.23 "FTE RATE" shall mean the amount Merck will pay Idera over a
consecutive
twelve (12) month period during the Research Program Term to
support one
(1) Idera FTE dedicated to the Research Program. The FTE Rate shall
be [**]
dollars (USD $[**]) per FTE. The FTE Rate shall include all
personnel,
equipment, reagents and all other expenses including support staff
and
overhead for or associated with an FTE.
1.24 "GLP" or "GOOD LABORATORY PRACTICE" shall mean the applicable
then-current
standards for laboratory activities for pharmaceuticals or
biologicals, as
set forth in the Act and any regulations or guidance documents
promulgated
thereunder, as amended from time to time, together with any
similar
standards of good laboratory practice as are required by any
Regulatory
Authority in the country in which the laboratory activities are
conducted.
1.25 "IDERA BACKGROUND PATENT RIGHTS" shall mean any and all Patent
Rights
Controlled by Idera on the Effective Date that claim or cover (a)
the
composition of matter or method of use of an Evaluation
Collaboration
Compound or a Selected Collaboration Compound or (b) Idera
Materials, and
any divisionals, continuations, continuations-in-part, reissues,
renewals,
substitutions, registrations, re-examinations, revalidations,
supplementary
protection certificates, pediatric exclusivity periods, any other
patent
term extensions and exclusivity periods and the like of any such
Patent
Rights, and any and all U.S. and foreign equivalents of the
foregoing. As
of the Effective Date, the Idera Background Patent Rights include,
without
limitation, the Patent Rights set forth on Schedule 1.25.
1.26 "IDERA FIELD" shall mean the use of Non-Selected Collaboration
Compounds
for any and all purposes outside of the Fields.
1.27 "IDERA INFORMATION AND INVENTIONS" shall mean (a) all
information and
inventions, including, but not limited to, all discoveries,
findings,
improvements, processes, methods, protocols, formulas, data,
composition of
matter, article of manufacture, know-how and trade secrets, that
is
conceived and/or reduced to practice as a result of the Research
Program,
whether or not patentable, that is developed or invented solely
by
employees of Idera or its Affiliates or other Persons acting on
their
behalf (other than Merck, its Affiliates or other Persons acting on
their
behalf) and (b) Idera Oligonucleotide Inventions but shall exclude
Merck
Materials Inventions.
1.28 "IDERA KNOW-HOW" shall mean all information and materials,
including but
not limited to discoveries, improvements, processes, methods,
protocols,
formulas, data, inventions (including, without limitation,
Idera
Information and Inventions and Idera's rights in Joint Information
and
Inventions), know-how and trade secrets, patentable or otherwise,
which
during the term of this Agreement (i) are in the Control of Idera,
(ii) are
not generally known and (iii) are necessary or useful to Merck with
respect
to an Evaluation Collaboration Compound or Selected Collaboration
Compound
in the Fields, including without limitation, in connection with
the
Research Program and the research, development, manufacture,
marketing, use
or sale of Product in the Territory.
1.29 "IDERA MATERIALS" shall mean those IMOs to be provided by
Idera as set
forth on Schedule 1.29, which may be amended from time to time.
1.30 "IDERA OLIGONUCLEOTIDE INVENTIONS" shall mean all information
and
inventions, including, but not limited to, all discoveries,
findings,
improvements, processes, methods, protocols, formulas, data,
composition of
matter, article of manufacture, know-how and trade secrets, that
is
conceived and/or reduced to practice as a result of the Research
Program,
whether or not patentable, that are solely related to the
modification of,
derivatives of, manufacture or use of immunomodulatory
oligonucleotide
structures which do not include Merck Technology, regardless of
whether the
4
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invention is conceived and/or reduced to practice (a) solely by
employees
of Idera or its Affiliates or other Persons acting on their behalf
(other
than Merck, its Affiliates or a Third Party acting on their
behalf); (b)
solely by employees of Merck or its Affiliates or other Persons
acting on
their behalf (other than Idera, its Affiliates or a Third Party
acting on
their behalf); or (c) jointly by employee(s) of Merck, its
Affiliate or a
Third Party acting on behalf of Merck or its Affiliate within the
scope of
the Research Program, on the one hand, and employee(s) of Idera,
its
Affiliate or a Third Party acting on behalf of Idera or its
Affiliate
within the scope of the Research Program, on the other hand.
1.31 "IDERA PATENT RIGHTS" shall mean any Idera Background Patent
Rights and
Idera Program Patent Rights.
1.32 "IDERA PROGRAM PATENT RIGHTS" shall mean any and all Patent
Rights other
than Idera Background Patent Rights, that (a) during the term of
this
Agreement are Controlled by Idera and claim or cover (i) the
composition of
matter or method of use of an Evaluation Collaboration Compound or
a
Selected Collaboration Compound or (ii) Idera Materials, Idera
Information
and Inventions or Joint Information and Inventions; or (b) claim or
cover
Idera Oligonucleotide Inventions. For avoidance of doubt, Idera
Program
Patent Rights shall not include any Patent Rights that claim or
cover Merck
Materials, including, without limitation, any modifications,
derivatives,
or methods of manufacture thereof.
1.33 "IDERA TECHNOLOGY" shall mean Idera Patent Rights, Idera
Know-How, Idera
Materials and Idera Information and Inventions.
1.34 "IMO" shall mean any and all immune modulatory
oligonucleotides, the
primary purpose of which is to induce or modulate an immune
response and
that are targeted to and intended to act as agonists of TLR 7, TLR
8, TLR
7/8 or TLR 9, as the case may be.
1.35 "IND" shall mean an Investigational New Drug application,
Clinical Study
Application, Clinical Trial Exemption, or similar application or
submission
for approval to conduct human clinical investigations filed with
or
submitted to a Regulatory Authority in conformance with the
requirements of
such Regulatory Authority.
1.36 "INDICATION" shall mean a separate and distinct disease or
medical
condition in humans which a Product is intended to treat and/or
prevent and
for which the Product has received Marketing Authorization.
1.37 "INFECTIOUS DISEASE FIELD" shall mean the use of Evaluation
Collaboration
Compound(s) and Selected Collaboration Compound(s) as an Adjuvant
contained
in or administered in conjunction with any prophylactic and/or
therapeutic
Vaccine(s) for the prevention and/or treatment of any viral
and/or
microbial infectious disease, provided that the following diseases
shall be
excluded: (i) [**]; (ii) [**]; (iii) [**]; and (iv) [**].
1.38 "INFORMATION" shall mean any and all information and data,
including
without limitation all Merck Know-How, Idera Know-How, and all
other
scientific, pre-clinical, clinical, regulatory, manufacturing,
marketing,
financial and commercial information or data, whether communicated
in
writing or orally or by any other method, which is provided by one
Party to
the other Party in connection with this Agreement.
1.39 "JOINT INFORMATION AND INVENTIONS" shall mean all information
and
inventions, including, but not limited to, all discoveries,
findings,
improvements, processes, methods, protocols, formulas,
5
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data, composition of matter, article of manufacture, know-how and
trade
secrets combining Merck Technology and Idera Technology, that is
conceived
and/or reduced to practice as a result of the Research Program,
whether or
not patentable, and is conceived and/or reduced to practice jointly
by
employee(s) of Merck, its Affiliate or a Third Party acting on
behalf of
Merck or its Affiliate within the scope of the Research Program, on
the one
hand, and employee(s) of Idera, its Affiliate or a Third Party
acting on
behalf of Idera or its Affiliate within the scope of the Research
Program,
on the other hand. Idera Oligonucleotide Inventions and Merck
Materials
Inventions shall be excluded from Joint Information and
Inventions.
1.40 "JOINT PATENT RIGHTS" shall mean any and all Patent Rights
which claim
Joint Information and Inventions. For avoidance of doubt, Joint
Patent
Rights shall exclude Idera Patent Rights and Merck Patent
Rights.
1.41 "JOINT PROGRAM TECHNOLOGY" shall mean Joint Patent Rights and
Joint
Information and Inventions.
1.42 "JRC" shall mean the joint research committee established to
facilitate the
Research Program, as more fully described in Section 2.5.1.
1.43 "KNOW-HOW ROYALTY" shall have the meaning given such term in
Section 5.4.1
hereof.
1.44 "MAJOR EU MARKET" shall mean France, Germany, Italy, Spain or
the United
Kingdom.
1.45 "MARKETING AUTHORIZATION" shall mean all approvals from the
relevant
Regulatory Authority necessary to market and sell a Product in any
country
(including without limitation, all applicable pricing and
governmental
reimbursement approvals even if not legally required to sell
Product in a
country).
1.46 "MAJOR INDICATION" shall mean an Indication for the treatment
of the
following solid tumor cancers: non-small cell lung cancer, prostate
cancer,
breast cancer and colo-rectal cancer.
1.47 "MERCK ADJUVANT" shall mean a compound, complex or other agent
that
enhances the immune response to an Antigen or Antigens that is
Controlled
by Merck or its Affiliates other than pursuant to this
Agreement.
1.48 "MERCK INFORMATION AND INVENTIONS" shall mean (a) all
information and
inventions, including, but not limited to, all discoveries,
findings,
improvements, processes, methods, protocols, formulas, data,
composition of
matter, article of manufacture, know-how and trade secrets, that
is
conceived and/or reduced to practice as a result of the Research
Program,
whether or not patentable, that is developed or invented solely
by
employees of Merck or its Affiliates or other Persons acting on
their
behalf (other than Idera, its Affiliates or other Persons acting on
their
behalf) and (b) Merck Materials Inventions but shall exclude
Idera
Oligonucleotide Inventions.
1.49 "MERCK KNOW-HOW" shall mean any information and materials,
including but
not limited to discoveries, improvements, processes, methods,
protocols,
formulas, data, inventions (including without limitation
Merck's
Information and Inventions and Merck's rights in Joint Information
and
Inventions), know-how and trade secrets, patentable or otherwise,
which
during the term of this Agreement, (i) are in the Control of Merck
or its
Affiliates, (ii) are not generally known and (iii) are necessary to
Idera
in the performance of its obligations under the Research
Program.
1.50 "MERCK MATERIALS" shall mean [**] and other materials to be
provided by
Merck as set forth on
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Schedule 1.50, which may be amended from time to time.
1.51 "MERCK MATERIALS INVENTIONS" shall mean all information and
inventions,
including, but not limited to, all discoveries, findings,
improvements,
processes, methods, protocols, formulas, data, composition of
matter,
article of manufacture, know-how and trade secrets, that is
conceived
and/or reduced to practice as a result of the Research Program,
whether or
not patentable, that are solely related to the modification of,
derivatives
of, manufacture or use of Merck Materials and which do not include
Idera
Technology, regardless of whether the inventions are conceived
and/or
reduced to practice (a) solely by employees of Idera or its
Affiliates or
other Persons acting on their behalf (other than Merck, its
Affiliates or a
Third Party acting on their behalf); (b) solely by employees of
Merck or
its Affiliates or other Persons acting on their behalf (other than
Idera,
its Affiliates or a Third Party acting on their behalf); or (c)
jointly by
employee(s) of Merck, its Affiliate or a Third Party acting on
behalf of
Merck or its Affiliate within the scope of the Research Program, on
the one
hand, and employee(s) of Idera, its Affiliate or a Third Party
acting on
behalf of Idera or its Affiliate within the scope of the Research
Program,
on the other hand, but shall exclude Idera Oligonucleotide
Inventions.
1.52 "MERCK PATENT RIGHTS" shall mean (a) Patent Rights Controlled
by Merck or
its Affiliates that are necessary to Idera in the performance of
Idera's
obligations under the Research Program and (b) Patent Rights that
claim or
cover Merck Materials Inventions.
1.53 "MERCK TECHNOLOGY" shall mean Merck Patent Rights, Merck
Know-How, Merck
Materials and Merck Information and Inventions.
1.54 "NDA" shall mean a New Drug Application, Biologics License
Application,
Worldwide Marketing Application, Marketing Authorization
Application,
filing pursuant to Section 510(k) of the United States Federal
Food, Drug
and Cosmetics Act, or similar application or submission for
Marketing
Authorization of a Product filed with a Regulatory Authority to
obtain
marketing approval for a biological, pharmaceutical or diagnostic
product
in that country or in that group of countries.
1.55 "NET SALES" shall mean the gross invoice price of Product sold
by Merck or
its Related Parties to the first Third Party after deducting, if
not
previously deducted, from the amount invoiced or received:
(A) trade and quantity discounts other than early payment cash
discounts;
(B) returns, rebates, chargebacks and other allowances;
(C) retroactive price reductions that are actually allowed or
granted; and
(D) a fixed amount equal to [**] percent ([**]%) of the amount
invoiced to
cover bad debt, early payment cash discounts, transportation
and
insurance, and custom duties.
For the avoidance of doubt, the gross invoice price of Product does
not
include value added taxes and other similar taxes on Product.
With respect to sales of Combination Products, Net Sales shall
be
calculated using the following formula:
7
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[**] * Net Sales of = Net Sales for the purpose of calculating
Combination Product royalties for Combination Product
Where:
(I) "A" equals the invoice price of Product containing the same
Antigen(s)
sold without containing one or more other Antigens;
(II) "B" equals the invoice price of the Combination Product;
and
(III) all invoice prices of the Product and the Combination Product
shall
be calculated as the average invoice price during the
applicable
accounting period for which the Net Sales are being calculated.
The
deductions set forth in paragraphs (a) through (d) above will
be
applied in calculating Net Sales for a Combination Product. If,
however, the Product is sold only as a Combination Product, then
the
Parties shall negotiate in good faith an appropriate calculation
of
Net Sales that is subject to the royalty payment under this
Agreement
so as to fairly allocate the relative value of the active
ingredients
in the Combination Product.
With respect to a given Product (containing a given Selected
Collaboration
Compound) to achieve First Commercial Sale in a country, such
Product shall
not be deemed a Combination Product in such country, in which case
the
above Combination Product Net Sales formula shall not apply to such
given
Product, but only to subsequent Combination Products.
1.56 "NON-SELECTED COLLABORATION COMPOUND" shall have the meaning
given such
term in Section 2.8.4.
1.57 "NOVARTIS AGREEMENTS" shall mean the Research Collaboration
and Option
Agreement, dated May 31, 2005, by and between Idera (formerly known
as
Hybridon, Inc.) and Novartis International Pharmaceutical Ltd. and
the
License, Development and Commercialization Agreement, dated May 31,
2005,
by and between Idera (formerly known as Hybridon, Inc.) and
Novartis
International Pharmaceutical Ltd., as such agreements may be
amended from
time to time.
1.58 "ONCOLOGY FIELD" shall mean the use of Evaluation
Collaboration Compound(s)
and Selected Collaboration Compound(s) as an Adjuvant contained in
or
administered in conjunction with any prophylactic and/or
therapeutic
Vaccine(s) for the prevention and/or treatment of any type of
cancer. For
avoidance of doubt, Vaccines for the prevention and/or treatment of
human
papilloma virus and other viruses that are considered precursors to
cancer
are included in the Oncology Field.
1.59 "PARTY" shall mean Merck and Idera, individually, and
"PARTIES" shall mean
Merck and Idera, collectively.
1.60 "PATENT RIGHTS" shall mean any and all issued patents and
patent
applications in the Territory (which for the purposes of this
Agreement
shall be deemed to include certificates of invention and
applications for
certificates of invention) and any divisionals, continuations,
continuations-in-part, reissues, renewals, substitutions,
registrations,
re-examinations, revalidations, supplementary protection
certificates,
pediatric exclusivity periods, any other patent term extensions
and
exclusivity periods and the like of any such patents and patent
applications, and any and all U.S.
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and foreign equivalents of the foregoing.
1.61 "PERSON" shall mean any individual, corporation, joint
venture, limited
liability company, partnership, limited partnership, limited
liability
partnership, trust or any other private, public or governmental
entity.
1.62 "PHASE I CLINICAL TRIAL" shall mean a human clinical trial in
the United
States that would satisfy the requirements of 21 CFR 312.21(a) or
an
equivalent human clinical trial in any country outside the United
States
that would satisfy the requirements applicable to such human
clinical trial
in such country.
1.63 "PHASE II CLINICAL TRIAL" shall mean a human clinical trial in
the United
States that would satisfy the requirements of 21 CFR 312.21(b) or
an
equivalent human clinical trial in any country outside the United
States
that would satisfy the requirements applicable to such human
clinical trial
in such country.
1.64 "PHASE III CLINICAL TRIAL" shall mean a human clinical trial
in the United
States that would satisfy the requirements of 21 CFR 312.21(c) or
an
equivalent human clinical trial in any country outside the United
States
that would satisfy the requirements applicable to such human
clinical trail
in such country.
1.65 "PRODUCT(S)" shall mean any prophylactic or therapeutic
Vaccine(s) that
contains Selected Collaboration Compound or is administered in
conjunction
with Selected Collaboration Compound, for any and all uses in the
Fields,
including without limitation any Combination Product, (i) in final
form for
sale by prescription, over-the-counter or any other method, or (ii)
for
administration in a Clinical Trial.
1.66 "REGISTRATION RIGHTS AGREEMENT" shall mean the Registration
Rights
Agreement, dated as of the Effective Date, by and between Idera and
Merck.
1.67 "REGULATORY AUTHORITY" shall mean any applicable government
regulatory
authority involved in granting approvals for the manufacturing,
marketing,
reimbursement and/or pricing of a Product in the Territory,
including, in
the United States, the United States Food and Drug Administration
and any
successor governmental authority having substantially the same
function.
1.68 "REGULATORY-BASED EXCLUSIVITY" shall mean, with respect to a
Product in a
country in the Territory, that Merck and/or any of the Related
Parties has
been granted the exclusive legal right by a Regulatory Authority
(or is
otherwise entitled to the exclusive legal right by operation of
law) in
such country to market and sell the Product in such country,
including,
without limitation, through orphan drug exclusivity or Data
Protection.
1.69 "RELATED PARTY" shall mean each of Merck, its Affiliates, and
their
respective sublicensees (which term does not include distributors),
as
applicable.
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1.70 "RESEARCH PROGRAM" shall mean the research activities
undertaken by the
Parties hereto as set forth in Article 2 and Schedule 2.1.
1.71 "RESEARCH PROGRAM TERM" shall have the meaning given such term
in Section
2.10. All references to Research Program Term shall be deemed to
include
any Research Program Term extension provided pursuant to Section
2.10.
1.72 "SELECTED COLLABORATION COMPOUND" shall have the meaning given
such term in
Section 2.8.3.
1.73 "SELECTION CRITERIA" shall mean those criteria set forth on
Schedule 1.73
attached hereto.
1.74 "SENSITIVE INFORMATION" shall have the meaning given such term
in Section
10.2.3(d).
1.75 "STARTING MATERIAL" shall have the meaning given such term in
Section
2.8.1.
1.76 "STOCK PURCHASE AGREEMENT" shall mean the Stock Purchase
Agreement, dated
as of the Effective Date, by and between Idera and Merck.
1.77 "TERRITORY" shall mean all of the countries in the world, and
their
territories and possessions.
1.78 "THE IMMUNE RESPONSE CORPORATION AGREEMENT" shall mean the
Collaboration
and License Agreement, dated October 8, 2003, by and between
Idera
(formerly known as Hybridon, Inc.) and The Immune Response
Corporation, as
such agreement may be amended from time to time.
1.79 "THIRD PARTY" shall mean any Person other than Merck and its
Related
Parties, and Idera and its Affiliates.
1.80 "TLR" shall mean Toll-like Receptor.
1.81 "TYPE I PRODUCT" shall mean a Product(s) containing or
administered in
conjunction with (i) a Selected Collaboration Compound targeting
and which
is intended to act as an agonist of TLR 9; or (ii) a Selected
Collaboration
Compound targeting and which is intended to act as an agonist of
TLR 9 and
a Selected Collaboration Compound targeting TLR 7 and/or TLR 8.
1.82 "TYPE II PRODUCT" shall mean a Product(s) containing or
administered in
conjunction with (i) a Selected Collaboration Compound targeting
and which
is intended to act as an agonist of TLR 7; (ii) a Selected
Collaboration
Compound targeting and which is intended to act as an agonist of
TLR 8; or
(iii) a Selected Collaboration Compound targeting and which is
intended to
act as an agonist of both TLR 7 and TLR 8.
1.83 "VACCINE" shall mean any preparation that elicits a cellular
mediated
and/or humoral immune response in humans provided that in each case
such a
preparation contains an Antigen or Antigens.
1.84 "VALID PATENT CLAIM" shall mean a claim of an issued and
unexpired patent
included within the Idera Patent Rights or Joint Patent Rights
which claims
a Selected Collaboration Compound as a composition of matter or
method of
use, which claim has not been revoked or held unenforceable or
invalid by a
decision of a court or other governmental agency of competent
jurisdiction
(which decision is not appealable or has not been appealed within
the time
allowed for appeal), and which claim has not been disclaimed,
denied or
admitted to be invalid or unenforceable through reissue,
re-examination or
disclaimer or otherwise.
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2. RESEARCH PROGRAM
2.1 GENERAL
Idera and Merck shall engage in the Research Program upon the terms
and
conditions set forth in this Agreement. The activities to be
undertaken in
the course of the Research Program are set forth in Schedule 2.1,
which may
be amended from time to time upon mutual written agreement of the
JRC in
accordance with this Article 2. The objectives of the Research
Program are
(a) to discover and synthesize Evaluation Collaboration Compounds
that are
intended to act as agonists of TLR 7, TLR 8 or both TLR 7 and TLR
8, from
which Merck will identify Selected Collaboration Compounds for
further
development by Merck as Type II Products in the Fields and (b) to
evaluate
Evaluation Collaboration Compounds that are intended to act as
agonists of
TLR 9, from which Merck will identify Selected Collaboration
Compounds for
further development by Merck as Type I Products in the Fields.
2.2 CONDUCT OF RESEARCH
Idera and Merck each shall proceed diligently with the work set out
in the
Research Program by using their respective good faith efforts to
allocate
sufficient time, effort, equipment and facilities to the Research
Program
and to use personnel with sufficient skills and experience as are
required
to accomplish the Research Program in accordance with the terms of
this
Agreement and Schedule 2.1.
Merck shall be entitled to utilize the services of its Affiliates
and Third
Parties to perform its Research Program activities. Idera shall be
entitled
to utilize the services of Third Parties to perform its Research
Program
activities only upon Merck's prior written consent or as
specifically set
forth in Schedule 2.1, provided that Merck shall not unreasonably
withhold,
delay or condition its consent to Idera's use of Third Party
service
providers. Notwithstanding any such consent, each Party shall
remain at all
times fully liable for its respective responsibilities under the
Research
Program.
2.3 USE OF RESEARCH FUNDING; FTE COMMITMENTS
2.3.1 Idera shall apply the FTE funding it receives from Merck
under this
Agreement pursuant to Section 5.2 solely to carry out its
Research
Program activities in accordance with Schedule 2.1 and the terms
and
conditions of this Agreement.
2.3.2 During the Research Program Term, Idera shall provide the
number of
FTEs that are approved by the Joint Research Committee pursuant
to
Section 2.5.2 to work on the Research Program. Such FTEs shall
be
funded by Merck in accordance with Section 5.2. The number of FTEs
to
be dedicated by Idera to the Research Program during the first
two
years is set forth in Schedule 2.3.2. If the Research Program Term
is
extended by Merck as provided in Section 2.10 or is otherwise
extended
by mutual agreement of the Parties, the Parties shall discuss in
good
faith the level of FTE staffing during the extended Research
Program
Term. During the Research Program Term, the Joint Research
Committee
shall provide Idera with at least 90 days prior written notice of
any
required increase or decrease in the number of such FTEs,
provided
that the Joint Research Committee cannot increase the number of
FTEs
such that the total number of FTEs exceeds [**].
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2.3.3 Idera shall require (i) by written agreement that all FTEs
and all
other Idera personnel, employees, and agents involved in the
Research
Program have entered into confidentiality and invention
assignment
agreements that are consistent with the provisions of this
Agreement
and shall be obligated to assign any rights they may have in any
Idera
Information and Inventions and Joint Information and Inventions
made
during such work to Idera consistent with any rights granted to
Merck
in any such Information and Inventions under this Agreement; and
(ii)
that each FTE who works on the Research Program is qualified by
appropriate experience and qualifications to perform the
Research
Program work assigned to such FTE in a capable and professional
manner.
2.4 PRINCIPAL SCIENTISTS
The principal scientists for the Research Program are [**] for
Idera and
[**] for Merck. The Research Program and all work assignments to
be
performed by Idera and Merck shall be carried out under the
direction and
supervision of the principal scientists noted above. During the
first year
of the Research Program Term, [**] shall serve as the principal
scientists
for Idera.
After the first year of the Research Program Term, each Party shall
notify
the other Party as soon as practicable upon the changing of its
principal
scientist and shall require that its principal scientist be
qualified by
the appropriate experience and qualifications to direct and
supervise its
performance of the Research Program.
2.5 JOINT RESEARCH COMMITTEE
The Parties hereby establish a committee to facilitate the Research
Program
as follows:
2.5.1 Composition of the Joint Research Committee. The Research
Program
shall be conducted under the direction of a joint research
committee
(the "JRC") comprised of three (3) representatives of Merck and
three
(3) representatives of Idera. Each Party shall name its JRC
representatives and notify the other Party of its JRC
representatives
promptly following the Effective Date. Each Party may change
its
representatives to the JRC from time to time, in its sole
discretion,
effective upon notice to the other Party of such change. These
representatives shall have appropriate technical credentials,
experience and knowledge, and ongoing familiarity with the
Research
Program. Additional representatives or consultants may from time
to
time, by mutual consent of the Parties, be invited to attend
JRC
meetings, subject to such representatives' or consultants'
written
agreement to comply with the requirements of Section 4.1. The
JRC
shall be chaired by a representative of Merck. Each Party shall
bear
its own expenses related to the attendance at such meetings by
its
representatives.
2.5.2 Scope of JRC Oversight. The JRC's oversight responsibilities
shall be
limited to the Research Program activities specified in Schedule
2.1
and within such scope the JRC shall (a) confer regularly regarding
the
status of the Research Program, (b) review relevant data, consider
and
advise on any technical issues that arise, (c) consider issues
of
priority, (d) review and approve the efforts of the Parties in
the
conduct of the Research Program; (e) review and approve amendments
to
the Research Program as set forth in Schedule 2.1; (f)
reallocate
resources, including FTEs, within the Research Program; (g) subject
to
Section 2.3.2, designate the number of FTEs for each Calendar
Quarter,
(h) receive updates on the identity of any Third Party
conducting
Research Program work on behalf of either Party in accordance
with
Section 2.2 (which each Party shall provide to the JRC), (i)
address
such other matters relating to the activities of the Research
Program
as either Party may bring before the JRC; and (j) attempt to
resolve
any disputes within
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the JRC on an informal basis. Notwithstanding anything to the
contrary
in the foregoing, the JRC shall not (i) have any supervisory or
decision making authority beyond the Research Program
activities
specified in Schedule 2.1; (ii) without the consent of Idera,
require
Idera to commit its FTE resources beyond those set forth in
Section
2.3.2; or (iii) except for Schedule 2.1, modify or amend any terms
of
this Agreement.
2.5.3 Decision-Making. Decisions of the JRC shall be made
unanimously, with
each Party having one vote. In the event that the JRC cannot or
does
not, after good faith efforts, reach agreement on an issue, the
issue
shall be elevated to a Vice President of MRL for Merck and the
Chief
Scientific Officer for Idera. If such executives cannot resolve
the
issue, it shall be further elevated to an Executive Vice President
or
Franchise Head of MRL for Merck and the Chief Executive Officer
of
Idera for Idera. If such executives cannot resolve the issue,
the
resolution and/or course of conduct shall be determined by Merck
in
good faith, taking Idera's reasonable interests into account.
2.5.4 Meetings. The JRC shall meet in accordance with a
schedule
established by mutual written agreement of the Parties, but no
less
frequently than once per Calendar Quarter, with the location for
such
meetings alternating between Idera and Merck facilities (or such
other
location as may be determined by the JRC). Alternatively, the JRC
may
meet by means of teleconference, videoconference or other
similar
communications equipment.
2.6 EXCHANGE OF INFORMATION
Upon execution of this Agreement, and on an ongoing basis during
the
Research Program Term, Idera shall promptly disclose to Merck in
writing or
in an electronic format all Idera Know-How not previously
disclosed. Merck
shall promptly disclose to Idera during the Research Program Term
all Merck
Know-How.
2.7 RECORDS AND REPORTS
2.7.1 Records. Idera shall maintain records, in sufficient detail
and in
good scientific manner appropriate for patent and regulatory
purposes,
which shall fully and properly reflect all work done and
results
achieved in the performance of the Research Program by Idera.
2.7.2 Copies and Inspection of Records. Merck shall have the right,
during
normal business hours and upon reasonable notice, to inspect and
copy
all such records of Idera referred to in Section 2.7.1. Merck
shall
maintain such records and the information disclosed therein in
confidence in accordance with Section 4.1. Merck shall have the
right
to arrange for its employees and/or consultants involved in the
activities contemplated hereunder to visit the offices and
laboratories of Idera and any of its Third Party contractors as
permitted under Section 2.2 during normal business hours and
upon
reasonable notice, and at reasonable intervals, to discuss in
the
presence of Idera's principal scientist the Research Program work
and
its results in detail with the technical personnel of Idera
involved
in the Research Program. Upon request, Idera shall provide copies
of
the records described in Section 2.7.1 above.
2.7.3 Quarterly Reports. Within thirty (30) days following the end
of each
Calendar Quarter during the Research Program Term, Idera shall
provide
to Merck a written progress report in English which shall describe
in
sufficient detail the work performed to date by Idera so that
Merck
may evaluate Idera's progress in relation to the goals of the
Research
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Program. Further, Idera shall promptly respond to reasonable
requests
by Merck for additional information regarding Idera's performance
of
Research Program activities.
2.8 DISCLOSURE, EVALUATION AND SELECTION OF COLLABORATION
COMPOUNDS
2.8.1 Disclosure of Evaluation Collaboration Compounds and
Starting
Material. Following the Effective Date and during the Research
Program
Term, Idera shall disclose to Merck in writing all
Collaboration
Compounds satisfying the Evaluation Criteria as set forth in
Schedule
1.18 ("EVALUATION COLLABORATION COMPOUNDS") in the manner and to
the
extent described below. In addition, Idera shall provide Merck
with
sufficient samples of such Evaluation Collaboration Compounds,
along
with their structures, results of characterization studies on
the
Evaluation Collaboration Compounds and such other information as
may
be required by Schedule 2.1.
During the first [**] months of the Research Program Term, Idera
shall
provide Merck with a total of [**] Evaluation Collaboration
Compounds
targeting TLR 9 and a total of [**] Evaluation Collaboration
Compounds
targeting TLR 7, TLR 8 and/or TLR 7 and TLR 8 (collectively
"STARTING
MATERIAL"). The Starting Material shall not incorporate any
Merck
Material. Idera shall use reasonable efforts to deliver
Starting
Material according to the following schedule: [**] Evaluation
Collaboration Compounds targeting TLR 9 and [**] Evaluation
Collaboration Compounds targeting TLR 7, TLR 8 and/or TLR 7 and TLR
8
at the beginning of each [**]. Idera may, subject to JRC
approval,
change the delivery schedule of Starting Material. Following
the
initial delivery of Starting Material, Idera shall use
commercially
reasonable efforts to incorporate guidance from Merck regarding
the
desired properties of the Starting Material so that Idera can
synthesize and/or modify new Starting Material incorporating
such
guidance from Merck or provide Starting Material from Idera's
existing
library to address Merck's guidance. The benchmark for
synthesizing
Starting Material shall be those Collaboration Compounds listed
in
Schedule 1.18. In the event that the JRC determines that the
benchmark
Collaboration Compounds should be replaced by different
Collaboration
Compounds, Schedule 1.18 shall be amended to reflect the new
benchmark
Collaboration Compounds subject to the written consent of both
Parties, which consent shall not be unreasonably withheld. Subject
to
Section 2.8.2, Merck covenants and agrees, for itself and its
Related
Parties, not to re-create any Starting Material.
2.8.2 Creation and Modification of Evaluation Collaboration
Compounds
Targeting TLR 7, TLR 8 and/or TLR 7 and TLR 8. As set forth in
Schedule 2.1, the Parties shall use commercially reasonable efforts
to
perform their respective obligations in the creation, modification
and
development of Evaluation Collaboration Compounds targeting TLR 7,
TLR
8 and/or TLR 7 and TLR 8 throughout the Research Program Term.
There
shall be no limit on the number of such Evaluation
Collaboration
Compounds that the Parties may create, modify or develop during
the
Research Program Term, provided that the number of Starting
Materials
as set forth in Section 2.8.1 cannot be changed without the
mutual
written consent of both Parties.
2.8.3 Designation of Selected Collaboration Compounds. Upon receipt
of
samples of Evaluation Collaboration Compounds and the information
set
forth above, Merck shall use reasonable efforts to evaluate
such
Evaluation Collaboration Compounds to determine in its sole
discretion
whether they satisfy the Selection Criteria. If an Evaluation
Collaboration Compound satisfies the Selection Criteria, Merck
shall
promptly notify Idera in writing and such Evaluation
Collaboration
Compound shall be deemed a "SELECTED COLLABORATION COMPOUND."
Merck
may designate such Selected
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Collaboration Compounds at any time during the Research Program but
no
later than [**] following the end of the Research Program Term.
With
respect to Evaluation Collaboration Compounds targeting TLR 9,
Merck
shall have the right to select up to [**] Selected
Collaboration
Compounds for use in the Fields. With respect to Evaluation
Collaboration Compounds targeting TLR 7 and/or TLR 8, Merck shall
have
the right to select up to [**] Selected Collaboration Compounds
for
use in the Fields.
In the event that a Selected Collaboration Compound fails in
pre-clinical and/or clinical development for reasons due to
safety,
tolerability or efficacy, then at Merck's request, Idera shall
provide
additional Evaluation Collaboration Compounds for consideration as
a
Selected Collaboration Compound in the applicable Field at any
time
during the term of the Agreement, provided that Merck may
exercise
such right only for a period of [**] from the expiration of the
Research Program Term. In the event that Merck, in its sole
discretion, determines such Evaluation Collaboration Compound
satisfies the Selection Criteria, such Evaluation Collaboration
Compound shall be deemed a Selected Collaboration Compound.
2.8.4 Designation of Non-Selected Collaboration Compounds. Within
[**] of
the end of the Research Program Term, Merck shall designate among
the
Evaluation Collaboration Compounds which ones shall be deemed
"NON-SELECTED COLLABORATION COMPOUNDS." Idera may develop and
commercialize Non-Selected Collaboration Compounds only in the
Idera
Field. For avoidance of doubt, Merck and its Affiliates shall
retain
the right to use any Non-Selected Collaboration Compounds that
are
claimed in or covered by the Joint Information and Inventions
solely
for internal research purposes of Merck or its Affiliates which
includes research carried out by any Third Party on behalf of Merck
or
its Affiliates. Internal research purposes expressly excludes use
of
any Non-Selected Collaboration Compounds by Merck or its
Related
Parties in any Clinical Trial.
2.9 OWNERSHIP OF MATERIALS, INFORMATION AND INVENTIONS
2.9.1 Ownership of Materials. Neither Party shall obtain any
ownership
rights in the materials of the other Party by virtue of this
Agreement. Except to the extent licensed herein, Merck shall
retain
all right, title and interest in and to the Merck Materials, and
Idera
shall retain all right, title and interest to the Idera
Materials.
Ownership of materials will remain with the respective Parties
regardless of any modification or derivative thereof made by
either
Party solely or by both Parties jointly. Each Party shall have
the
right to license or transfer any such modification and/or
derivative
thereof, to any Third Party in the Party's sole discretion for
any
purpose, provided that such uses do not conflict with the
licenses
granted under this Agreement.
2.9.2 Ownership of Information and Inventions. The entire right,
title and
interest in:
(A) Idera Information and Inventions shall be owned solely by
Idera;
(B) Merck Information and Inventions shall be owned solely by
Merck;
and
(C) Joint Information and Inventions shall be owned jointly by
Idera
and Merck.
Idera shall promptly disclose to Merck in writing the
development,
making, conception or reduction to practice of Idera Information
and
Inventions, Joint Information and Inventions and Merck
Materials
Inventions. Merck shall promptly disclose to Idera in
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<PAGE>
writing the development, making, conception or reduction to
practice
of Idera Oligonucleotide Inventions and Joint Information and
Inventions.
2.9.3 Inventorship. Inventorship of inventions, whether or not
patentable,
conceived and/or reduced to practice by the Parties in the course
of
exercising rights or performing obligations pursuant to this
Agreement, all related intellectual property rights, and all
other
information developed in the course of the Parties' exercise of
rights
under or performance of this Agreement shall be determined in
accordance with the rules of inventorship under United States
patent
laws.
2.9.4 Assignment of Inventions. The Parties shall execute such
documents
and perform such acts, at their own expense, as may be
reasonably
necessary to effect an assignment of Patent Rights relating to
Oligonucleotide Inventions and Merck Materials Inventions, as the
case
may be, to the other Party in a timely manner to allow such Party
to
prosecute and maintain Patent Rights relating to such
inventions.
2.10 RESEARCH PROGRAM TERM
Except as otherwise provided herein, the initial term of the
Research
Program shall commence on the Effective Date and continue for a
period of
two (2) years. Merck may extend such term by an additional year
by
providing Idera with ninety (90) days written notice, for a total
of up to
two (2) renewals. Merck shall provide Idera with written notice of
such
one-year renewal and the Parties shall amend Schedule 2.1 as
applicable.
The initial term and subsequent extension terms are collectively
referred
to in this Agreement as the "RESEARCH PROGRAM TERM."
2.11 MERCK MATERIALS
Merck shall provide Idera with sufficient quantities of the
materials set
forth in Schedule 1.50 ("MERCK MATERIALS") solely for the purpose
of
enabling Idera to perform its activities under the Research Program
in
accordance with the terms of this Agreement. Idera covenants and
agrees,
for itself and its Affiliates, not to re-create or modify any
Merck
Materials. The Merck Materials are not to be used in humans, nor
shall any
of the Merck Materials, or any derivatives, analogs, modifications
or
components thereof, be transferred, delivered or disclosed to any
Third
Party without the prior written approval of Merck. Any unused
Merck
Materials and any derivatives, analogs, modifications or components
thereof
shall be, at Merck's option, either returned to Merck, or destroyed
in
accordance with instructions by Merck.
2.12 EXCLUSIVE EFFORTS
During the term of the Agreement, except as set forth in Schedule
2.12,
Idera shall work exclusively (even as to Idera itself) with Merck
and its
Affiliates in efforts to research, develop and commercialize
any
Adjuvant(s) for use in conjunction with Vaccine(s) or Vaccine
products
containing such Adjuvant(s), including without limitation,
Evaluation
Collaboration Compound(s) and Selected Collaboration Compound(s),
for the
prevention and/or treatment of Alzheimer's Disease, any type of
cancer
and/or any disease within the Infectious Disease Field.
2.13 USE OF HUMAN MATERIALS
If any human primary cell lines, human tissue, human clinical
isolates or
similar human-derived materials ("HUMAN MATERIALS") have been or
are to be
collected and/or used in the Research Program, Idera represents
and
warrants (i) that it has complied, or shall comply, with all
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applicable laws, guidelines and regulations relating to the
collection
and/or use of the Human Materials and (ii) that it has obtained, or
shall
obtain, all necessary approvals and appropriate informed consents,
in
writing, for the collection and/or use of such Human Materials.
Idera shall
provide documentation of such approvals and consents upon Merck's
request.
Idera further represents and warrants that such Human Materials may
be used
as contemplated in this Agreement without any obligations to
the
individuals or entities ("PROVIDERS") who contributed the Human
Materials,
including, without limitation, any obligations of compensation to
such
Providers or any other Third Party for the intellectual property
associated
with the Human Materials or the commercial use thereof for any
purposes.
3. LICENSES; DEVELOPMENT AND COMMERCIALIZATION
3.1 LICENSE GRANTS TO MERCK
3.1.1 Exclusive License Grant. Subject to the terms and conditions
of this
Agreement, Idera hereby grants to Merck an exclusive license (even
as
to Idera) in the Territory under Idera Technology and Idera's
interest
in Joint Program Technology, with a right of sublicense, (a) to
research and develop Evaluation Collaboration Compounds in the
Fields
and (b) to research, develop, make, have made, use, offer to
sell,
sell, have sold, import and export Selected Collaboration
Compound(s)
and Product(s) in the Fields. The foregoing exclusive license
is
subject to the non-exclusive rights granted to The Immune
Response
Corporation as set forth in Schedule 2.12 attached hereto.
Notwithstanding anything to the contrary contained in this
Agreement,
Idera retains all rights under Idera Technology and Idera's
interest
in Joint Program Technology to research, develop, make, have
made,
use, offer to sell, sell, have sold, import and export IMO-2055
and
IMO-2125 outside the Fields, both during and after the Research
Program Term.
3.1.2 Non-Exclusive License Grant. In the event that the
researching,
developing, making, having made, use, offer for sale, sale, import
or
export by Merck, or Merck's Related Parties, of Evaluation
Collaboration Compound(s), Selected Collaboration Compound(s)
or
Product(s) in accordance with the license granted pursuant to
Section
3.1.1 would infringe during the term of this Agreement a claim
of
issued letters patent which Idera Controls and which patents are
not
covered by the grant in Section 3.1.1, Idera hereby grants to
Merck,
to the extent Idera is legally able to do so, a non-exclusive,
sublicensable, royalty-free license in the Territory under such
issued
letters patent for Merck and Merck's Related Parties to
research,
develop, make, have made, use, sell, offer for sale, import and
export
such Evaluation Collaboration Compound(s), Selected
Collaboration
Compound(s) and Product(s) in the Fields.
3.1.3 Sublicense Rights. Subject to the terms and conditions of
this
Agreement, Merck shall have the right to grant sublicenses of
the
rights granted to it under this Section 3.1 to (i) its
Affiliates,
(ii) Third Parties engaged in research, development and marketing
of
Products, and (iii) contract service providers providing services
for
Merck or its Affiliates, to the extent such sublicenses are
necessary
for the research, development, manufacturing and commercialization
of
Evaluation Collaboration Compounds, Selected Collaboration
Compounds
and Products in the Fields by or on behalf of Merck or its
Affiliates.
Merck shall require each sublicensee to be bound by the
applicable
terms of this Agreement.
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<PAGE>
3.2 LICENSE GRANTS TO IDERA
3.2.1 Exclusive License Grant. Subject to the terms and conditions
of this
Agreement, Merck hereby grants to Idera an exclusive (even as
to
Merck), royalty-free license in the Territory under Merck's
interest
in Joint Program Technology, with a right of sublicense, to
research,
develop, make, have made, use, offer to sell, sell, have sold,
import
and export Non-Selected Collaboration Compounds, IMO-2055 and
IMO-2125
in the Idera Field. For avoidance of doubt, except for IMO-2055
and
IMO-2125, this exclusive license grant shall not include the grant
of
any rights to Idera to research, develop, make, have made, use,
offer
to sell, sell, have sold, import and export Selected
Collaboration
Compounds for any purpose, including, without limitation, in the
Idera
Field.
3.2.2 Non-Exclusive License Grant. Merck hereby grants to Idera
a
non-exclusive, non-sublicensable, royalty-free license in the
Territory under Merck Technology for the sole purpose of
discharging
Idera's obligations under the Research Program during the
Research
Program Term.
3.3 NO IMPLIED LICENSES
Except as specifically set forth in this Agreement, neither Party
shall
acquire any license or other intellectual property interest, by
implication
or otherwise, in any Information or materials disclosed to it under
this
Agreement or under any patents or patent applications owned or
Controlled
by the other Party or its Affiliates.
3.4 DEVELOPMENT AND COMMERCIALIZATION
Merck shall use reasonable efforts and resources, including
reasonably
necessary personnel and financial resources, consistent with the
usual
practice followed by Merck in pursuing the commercialization and
marketing
of its other Vaccine products of a similar commercial value, at its
own
expense, to develop and commercialize a Product in such countries
in the
Territory where in Merck's opinion it is commercially viable to do
so. To
the extent reasonable and relevant, Merck shall take into
consideration the
following factors: issues of safety and efficacy, Product
profile,
difficulty in developing or manufacturing the Product,
competitiveness of
alternative Third Party products in the marketplace, the patent or
other
proprietary position of the Product, the regulatory structure
involved and
market potential of the Product. During the term of the Agreement,
Merck
shall keep Idera regularly informed regarding the development of
Products
by Merck or its Affiliates. Such information shall be communicated
to Idera
through the JRC during the Research Program Term. After the end of
the
Research Program Term, and until the First Commercial Sale of a
Product,
Merck shall promptly respond to reasonable requests by Idera
for
information regarding development activities by Merck and its
Related
Parties but no more than twice per year.
3.5 EXCUSED PERFORMANCE
The obligations of Merck with respect to any Product under Section
3.4 are
expressly conditioned upon the continuing absence of any material
adverse
condition or event relating to the safety or efficacy of the
Product, and
the obligation of Merck to develop or market any such Product shall
be
delayed or suspended so long as in Merck's opinion any such
condition or
event exists. In resolving or addressing such material adverse
condition or
event, Merck shall apply the level of efforts and resources
described in
Section 3.4 that Merck typically devotes to overcome similar
18
<PAGE>
material adverse conditions and events with respect to its own
compounds or
products, regardless of whether such compound or product is subject
to a
license from a Third Party.
3.6 EXCLUSIVE NEGOTIATION PERIOD
Idera agrees that for a period of three (3) months commencing on
the
Effective Date, Idera shall not enter into any negotiations or
any
agreement with any Third Party regarding any rights or licenses to
develop
and commercialize TLR antagonists in the area of immunosuppression.
After
such three (3) month period, Idera shall be free to grant rights
and
licenses to Third Parties with respect to the development and
commercialization of TLR antagonists in the area of
immunosuppression,
subject to any agreement that the Parties may elect, in each
Party's
abso
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