RESEARCH, DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT by and between MERCK & CO., INC. and GERON CORPORATION
|
EXHIBIT
10.1
|
|
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR
PORTIONS
OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT
TO
THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS *. A COMPLETE,
UNREDACTED VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE
SECURITIES AND EXCHANGE COMMISSION.
|
Execution
Copy
by
and between
MERCK
& CO., INC.
and
TABLE
OF CONTENTS
|
1. DEFINITIONS
2. RESEARCH
PROGRAM; CLINICAL DEVELOPMENT PROGRAM
2.1 Research
Program
2.2 Conduct
of Research
2.3 Joint
Research Committee
2.4 Clinical
Development of Non-DC Products
2.5 Records
and Reports
2.6 Program
Patent Rights and Program Know-How
2.7 AE
Reporting
3. LICENSE;
OPTION; DEVELOPMENT AND COMMERCIALIZATION
3.1 License
Grants
3.2 Research
License and Option for DC Products
3.3 License
and Option Grants to Geron
3.4 No
Implied Licenses; Retained Rights
3.5 Diligence
in Development and Commercialization
3.6 Option
of Geron to Co-promote in the United States
3.7 Bankruptcy
4. CONFIDENTIALITY
AND PUBLICATION
4.1 Nondisclosure
Obligation
4.2 Geron
Know-How
4.3 Publication
4.4 Publicity/Use
of Names/Disclosure of Terms
5. PAYMENTS;
ROYALTIES AND REPORTS
5.1 License
Fee
5.2 Option
Fee
5.3 Milestone
Payments
5.4 Royalties
for Non-DC Products
5.5 Reports;
Payment of Royalty
5.6 Audits
5.7 Payment
Exchange Rate
5.8 Income
Tax Withholding
6. REPRESENTATIONS
AND WARRANTIES; COVENANTS
6.1 Representations
and Warranties
6.2 Representation
and Covenant by Geron Related to Colorado Agreement
6.3 Limitation
of Liability.
7. INDEMNIFICATION;
INSURANCE
7.1 Indemnification
by
Geron
7.2 Indemnification
by Merck
7.3 Notification
of Claims; Conditions to Indemnification Obligations
7.4 Insurance
8. PATENT
PROVISIONS
8.1 Geron
Patent Rights
8.2 Licensed
Program Patent Rights
8.3 Patent
Term Restoration
9. TERM
AND TERMINATION
9.1 Term
and Expiration
9.2 Termination
by Merck
9.3 Termination
for Cause
9.4 Effect
of Expiration or Termination; Survival
10. MISCELLANEOUS
10.1 Force
Majeure
10.2 Assignment/
Change of Control
10.3 Severability
10.4 Notices
10.5 Applicable
Law
10.6 Dispute
Resolution
10.7 Entire
Agreement; Amendments
10.8 Headings
10.9 Independent
Contractors
10.10 Waiver
10.11 Cumulative
Remedies
10.12 Waiver
of Rule of Construction
10.13 Counterparts
Telomerase
and Cancer
|
1
8
8
8
10
11
12
12
13
14
14
16
17
17
17
18
19
19
19
20
21
21
22
22
22
22
23
24
25
25
26
26
26
27
27
27
27
28
28
28
29
29
30
33
33
33
33
34
35
35
35
35
36
36
37
38
38
38
38
38
39
3
4
|
|
i
|
|
ii
|
iii
THIS
AGREEMENT, effective as of July 15, 2005, the Effective Date, by and between
MERCK
& CO., INC.,
a
corporation organized and existing under the laws of New Jersey (“Merck”) and
GERON
CORPORATION,
a
corporation organized and existing under the laws of Delaware
(“Geron”).
RECITALS:
WHEREAS,
Geron
has expertise and access to certain intellectual property rights related to
Telomerase (as hereinafter defined) and dendritic cell-based vaccines, and
is
involved in on-going human clinical trials utilizing Telomerase as an antigen
in
dendritic cell-based vaccines;
WHEREAS,
Merck
has expertise and access to intellectual property rights related to various
vaccine platform technologies, including adenovirus and DNA-based
vaccines;
WHEREAS,
Merck
and Geron desire to enter into a research collaboration to develop Telomerase
vaccines in the Field (as hereinafter defined) upon the terms and conditions
set
forth herein; and
WHEREAS,
Merck
desires to obtain an exclusive license under the Geron Patent Rights, Geron
Know-How and Geron’s rights to Program Patent Rights and Program Know-How, to
develop and commercialize Non-DC Products in the Field, and an exclusive option
to enter into an exclusive arrangement (or non-exclusive arrangement if mutually
agreed by the Parties), subject to any pre-existing obligations of Geron to
Third Parties, to develop Products containing Dendritic Cells in the Field
(as
such terms are hereinafter defined), upon the terms and conditions set forth
herein, and Geron desires to grant such a license and option to
license;
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. 301 et seq., and/or the Public Health
Service Act, 42. U.S.C. 262 et seq., as such may be amended
from
time to time.
|
|
1.2
|
“Adeno/DNA
Product”
shall mean a Product comprising an Adenoviral Vaccine and/or a DNA
Vaccine.
|
|
1.3
|
“Adenoviral
Vaccine”
shall mean a vaccine containing an adenoviral vector, which adenoviral
vector encodes a Telomerase Antigen.
|
|
1.4
|
“Affiliate”
means any individual, corporation, association or other business
entity
which directly or indirectly controls, is controlled by or is under
common
control with the Party in question. As used in this definition of
“Affiliate,” the term “control” means the direct or indirect ownership of
fifty percent (50%) or more of the stock having the right to vote
for
directors thereof or the ability to otherwise control the management
of
the corporation or other business entity whether through the ownership
of
voting securities, by contract, resolution, regulation or otherwise;
provided,
however,
that the term “Affiliate” shall not include subsidiaries or other entities
in which a Party or its Affiliates owns a majority of the ordinary
voting
power necessary to elect a majority of the board of directors or
other
governing body, but is restricted from electing such majority by
contract
or otherwise until the time such restrictions are no longer in
effect.
|
1
|
1.5
|
“Antigen”
shall mean a vaccine component which elicits a clinically relevant
humoral
and/or cellular immune response.
|
|
1.6
|
“Boost”
shall mean the administration to a patient of a Non-DC Product
after a
Prime vaccine has been administered to such patient, with the purpose
of
such Boost being to maintain and/or increase the patient’s cellular and/or
humoral immune response.
|
|
1.7
|
“Calendar
Quarter” shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September
30 and
December 31.
|
|
1.8
|
“Clinical
Development Plan” or “CDP” shall have the
meaning provided in Section 2.4.1.
|
|
1.9
|
“Calendar
Year” shall mean each successive period of twelve (12) months
commencing on January 1 and ending on December 31.
|
|
1.10
|
“Clinical
Trial” shall mean a clinical study of a Product involving the
administration of Product to patients, and includes any Phase I
Clinical
Trial, Phase II Clinical Trial or Phase III Clinical Trial, as
applicable.
|
|
1.11
|
“Combination
Product” shall mean a Non-DC Product that contains one or more
Antigens in addition to a Telomerase Antigen.
|
|
1.12
|
“Commercially
Reasonable Efforts”shall mean, (a) with respect to the efforts to
be expended by a Party to accomplish a particular objective, the
good-faith and diligent efforts that such Party would normally
use to
accomplish a similar objective under similar circumstances, and
(b) with
respect to the research, development or commercialization of a
Product,
such efforts as are substantially equivalent to those efforts and
resources commonly used by a Party for a comparable product, taking
into
account commercially relevant factors such as (as applicable) stage
of
development, product life, market potential and regulatory issues.
Commercially Reasonable Efforts shall be determined on a market-by-market
and Indication-by-Indication basis for a particular Product, and
it is
anticipated that the level of effort will be different for different
markets, and will change over time, reflecting changes in the status
of
the Product and the market(s) involved. The determination of Commercially
Reasonable Efforts with respect to Products shall also take into
account
the broad potential applicability of telomerase vaccines across
a wide
range of cancers.
|
|
1.13
|
“Control”,
“Controls” or “Controlled by”shall mean the ownership of or the
ability of a Party to grant access to, or a license or sublicense
of, any
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.
|
|
1.14
|
“Dendritic
Cells” or “DC” shall mean a mammalian cell that,
as part of an ex vivo or in vitro preparation, can be
used to present an antigen to the immune system. For the avoidance
of
doubt, Dendritic Cells shall include, but not be limited to, the
type of
cells commonly referred to scientifically as “dendritic
cells.”
|
2
|
1.15
|
“DC
Technology”
shall mean technology specifically relating to Dendritic Cells, and
the
use and methods of manufacture thereof. For avoidance of doubt, DC
Technology does not include technology related to DC/Non-DC Therapies
and/or DC/Adeno/DNA Therapies.
|
|
1.16
|
“DC
Product”
shall mean a Product that comprises a Dendritic Cell.
|
|
1.17
|
“DC/Adeno/DNA
Therapy” shall mean a treatment regimen comprising the
administration to a patient of both a DC Product and an Adeno/DNA
Product.
|
|
1.18
|
“DC/Non-DC
Therapy”
shall mean a treatment regimen comprising the administration to a
patient
of both a DC Product as a Prime and a Non-DC Product as a Boost,
provided
that the Non-DC Product is not an Adeno/DNA Product.
|
|
1.19
|
“Directed”
shall mean, with respect to a Telomerase Antigen, that such Telomerase
Antigen elicits a detectable humoral and/or cellular immune response
against Telomerase.
|
|
1.20
|
“DNA
Vaccine”
means a vaccine comprising a DNA plasmid vector. For the avoidance
of
doubt, a vaccine that comprises a Dendritic Cell containing a DNA
plasmid
vector is not a DNA Vaccine.
|
|
1.21
|
“Effective
Date”
shall mean the date first set forth in the first paragraph of this
Agreement.
|
|
1.22
|
“EMEA”
shall mean the European Medicines Agency.
|
|
1.23
|
“European
Union” shall mean
the countries that are members of the European Union as of the Effective
Date of this Agreement.
|
|
1.24
|
“Field"
shall mean the treatment, modulation and/or prophylaxis of cancer,
and/or
other diseases mediated by hyperproliferation of cells, in humans.
|
|
1.25
|
“Filing”
of an NDA shall mean the acceptance by a Regulatory Authority of
an NDA
for filing.
|
|
1.26
|
“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.
|
|
1.27
|
“Fusion
Protein”
shall mean a conjugate which, (i) is Directed to Telomerase; (ii)
comprises a heterologous protein conjugated with a Telomerase Antigen,
which conjugate is not specifically covered by a Valid Patent Claim
at the
time such conjugate is Invented; and (iii) provides benefit as a
vaccine
component due to its capacity to induce an immune response cross-reactive
against Telomerase which response is superior in quality to that
induced
by the corresponding wild-type epitope, as assessed by (x) *; (y)
*; or
(z) * and (b) any nucleic acid sequence which encodes the conjugate
set
forth in (a).
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
3
|
1.28
|
“Geron
Know-How”
shall mean all
information and Materials, other than Geron Patent Rights, including
but
not limited to discoveries, improvements, processes, methods, protocols,
formulas, data, inventions know-how and trade secrets, patentable
or
otherwise, which during the term of this Agreement
(i) are Controlled by Geron or its Affiliates, (ii) are not generally
known and (iii) relate to Telomerase Antigen or are otherwise mutually
agreed by the Parties to be necessary or useful to Merck in the
Field,
including without limitation, in connection with the Research Program
and
the research, development, manufacture, marketing, use or sale
of a Non-DC
Product in the Territory; excluding, however, any Program Patent
Rights
and Program Know-How.
|
|
1.29
|
“Geron
Patent Rights”
shall mean any and all Patent Rights in the Territory which during
the
term of this Agreement (i) are Controlled by Geron, exist as of
the
Effective Date and which claim or cover Telomerase, Telomerase
Antigens
and/or Non-DC Products; or (ii) arise after the Effective Date,
are
Controlled by Geron, and which claim or cover Telomerase and/or
Telomerase
Antigens, excluding, however, any Program Patent Rights. Geron
Patent
Rights shall include, but not be limited to, those Patent Rights
attached
as Schedule 1.28.
|
|
1.30
|
“Geron
Program Patent Rights”
shall mean Program Patent Rights which are owned by Geron pursuant
to
Sections 2.6.2, 2.6.3, or 2.6.4(a).
|
|
1.31
|
“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
Territory.
|
|
1.32
|
“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.
|
|
1.33
|
“Indication”
shall mean the
primary prophylactic and/or therapeutic purpose for which a Non-DC
Product
is developed specifically directed towards obtaining regulatory
approval
for use of such Non-DC Product pursuant to an approved label claim.
A
single Indication shall include the primary disease and variants
or
sub-divisions or sub-classifications within such primary disease.
For
example, for purposes of the Agreement, breast cancer is a single
Indication; treatment of refractory metastatic breast cancer and
first
line treatment of breast cancer shall be treated as sub-classifications
within the single Indication of breast cancer. Treatment, modulation
and/or prophylaxis of the same disease (e.g. breast cancer) shall
be
treated as the same Indication. Treatment, modulation and/or prophylaxis
of the same disease in adults as in pediatrics shall be treated
as the
same Indication. However, treatment, modulation and/or prophylaxis
of any
other type of cancer, e.g. colorectal cancer, shall be deemed a
different
Indication from treatment, modulation and/or prophylaxis of breast
cancer.
|
|
1.34
|
“Information”
shall mean any and all information and data, including without
limitation
all Merck Know-How, Geron Know-How, Program 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.
|
4
|
1.35
|
“Initiates”
or “Initiation”
shall mean, with respect to a Clinical Trial, the administration
of the
first dose to a patient in such Clinical Trial.
|
|
1.36
|
“Invention”
shall mean any process, method, composition of matter, article of
manufacture, discovery or finding that is conceived and/or reduced
to
practice during and as a result of the Research Program or the Clinical
Development Program, and “Invent”
shall mean the act of conception and/or reduction to practice of
such
Invention.
|
|
1.37
|
“JDC”shall
mean the joint development committee, as more fully described in
Section
2.4.
|
|
1.38
|
“Joint
Program Patent Rights”
shall mean Program Patent Rights jointly owned by the Parties under
2.6.4(c).
|
|
1.39
|
“JRC”
shall mean the joint research committee, as more fully described
in
Section 2.3.
|
|
1.40
|
“Licensed
Program Patent Rights”
shall mean: (1) Geron Program Patent Rights (2) Merck Telomerase
Program
Patent Rights and (3) Joint Program Patent Rights.
|
|
1.41
|
“Licensed
Subject Matter”
shall mean, (i) with respect to the licenses granted by Geron to
Merck
hereunder, Geron Patent Rights, Geron Know-How, Geron Program Patent
Rights, Geron’s interest in Joint Program Patent Rights and Geron’s
interest in Program Know-How; and (ii) with respect to the licenses
granted by Merck to Geron hereunder, Merck Telomerase Program Patent
Rights, and Merck’s interest in Program Know-How relating to Telomerase
Antigen.
|
|
1.42
|
“Major
Market” shall mean any one of the following countries:
*.
|
|
1.43
|
“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).
|
|
1.44
|
“Materials”shall
mean such materials that are indicated in Schedule 2.1 as being provided
by Geron to Merck.
|
|
1.45
|
“Merck
Know-How”
shall mean any information and materials, including, but not limited
to,
discoveries, improvements, processes, methods, protocols, formulas,
data,
inventions, know-how and trade secrets, patentable or otherwise,
which
during the term of this Agreement, (i) are Controlled by Merck, (ii)
are
not generally known and (iii) are mutually agreed by the Parties
to be
necessary or useful to Geron in the performance of its obligations
under
the Research Program, excluding, however, any Program Patent Rights
and
Program Know-How.
|
|
1.46
|
“Merck
Program Patent Rights”
shall mean Program Patent Rights which are owned by Merck pursuant
to
Sections 2.6.1 or 2.6.4(b).
|
|
1.47
|
“Merck
Telomerase Program Patent Rights”
shall mean Merck’s interest in Program Patent Rights claiming or covering
Synthetic Epitopes and/or Fusion Proteins.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
5
|
1.48
|
“NDA”
shall mean a New Drug Application, Biologics License Application,
Marketing Authorization Application, filing pursuant to Section
510(k) of
the U.S. 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
product
in that country or in that group of countries.
|
|
1.49
|
“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) | ordinary and customary trade and quantity discounts actually allowed by Merck, other than early pay cash discounts; | |
| (b) | returns, rebates and chargebacks; | |
| (c) | retroactive price reductions that are actually allowed or granted; | |
|
(d)
|
a fixed amount equal to * percent (*%) of the amount invoiced to cover bad debt, sales or excise taxes, early payment cash discounts, transportation and insurance, custom duties, and other governmental charges; and | |
| (e) | the standard direct inventory cost incurred by Merck with respect to devices or delivery systems used for dispensing or administering Product. |
In
the
event that a Non-DC Product that is a Combination Product *.
|
1.50
|
“Non-DC
Product”
shall mean any Product that is not a DC Product, DC/Non-DC Therapy
or a
DC/Adeno/DNA Therapy, regardless of whether such Product employs
any
delivery enhancement technology (e.g. with or without electroporation).
Non-DC Products shall include, but not be limited to, Adeno/DNA
Products.
|
|
1.51
|
“Non-DC
Technologies”
shall mean antigen-delivery technology, adjuvants, electroporation
technology, adenoviral vectors and/or DNA plasmid vectors, viral
vectors,
virus like particles, which technologies comprise Program Patent
Rights
and Program Know-How. For avoidance of doubt, Non-DC Technologies
does not
include DC Technologies or any therapy that includes Dendritic Cells.
|
|
1.52
|
“Party”
shall mean Merck and Geron, individually, and “Parties”
shall mean Merck and Geron,
collectively.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
6
|
1.53
|
“Patent
Rights”
shall mean 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
divisions, continuations, continuations-in-part, reissues, reexaminations,
registrations, renewals, substitutions, and supplementary protection
certificates based thereon and other governmental actions that
extend any
of the patents and patent applications, and any and all equivalents,
U.S.
and foreign, to any of the foregoing.
|
|
1.54
|
“Phase I
Clinical Trial”
shall mean a human clinical trial in any country that would satisfy
the
requirements of 21 CFR 312.21(a).
|
|
1.55
|
“Phase II
Clinical Trial”
shall mean a human clinical trial in any country that would satisfy
the
requirements of 21 CFR 312.21(b).
|
|
1.56
|
“Phase III
Clinical Trial”
shall mean a human clinical trial in any country that would satisfy
the
requirements of 21 CFR 312.21(c).
|
|
1.57
|
“Prime”
shall mean the administration to a patient of a DC Product in a
sufficient
quantity and/or number of doses to elicit a humoral and/or cellular
immune
response against Telomerase in such patient.
|
|
1.58
|
“Product”
shall mean a vaccine that produces a humoral and/or cellular immune
response against Telomerase when administered to a patient. “Product”
shall include “DC Products”; “Non-DC Products,”“DC/Non-DC Therapies”; and
“DC/Adeno/DNA Therapies”.
|
|
1.59
|
“Program
Patent Rights”
shall mean all Patent Rights covering Inventions conceived and/or
reduced
to practice during and as a result of the Research Program or the
Clinical
Development Program.
|
|
1.60
|
“Program
Know How”
shall mean any information and materials, including but not limited
to
discoveries, improvements, processes, methods, protocols, formulas,
data,
inventions, know-how and trade secrets, patentable or otherwise,
which
arise during and as a result of the Research Program or the Clinical
Development Program, (i) are conceived, developed, or reduced to
practice
solely by a Party or jointly by the Parties and, (ii) are not generally
known and (iii) are Controlled by a Party or jointly by the Parties.
For
the avoidance of doubt, Program Know-How shall exclude Geron Know-How
and
Merck Know-How.
|
|
1.61
|
“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 U.S.,
the United
States Food and Drug Administration and any successor governmental
authority having substantially the same function.
|
|
1.62
|
“Related
Party”
shall mean each of Merck, its Affiliates, and their respective
sublicensees (which term does not include distributors), as
applicable.
|
|
1.63
|
“Research
Program”
shall mean the research activities undertaken by the Parties hereto
as set
forth in Sections 2.1 through 2.4 and Schedule 2.1.
|
|
1.64
|
“Research
Program Term”
shall have the meaning provided in Section 2.2.6.
|
|
1.65
|
“Synthetic
Epitope”
means (a) any peptide, which (i) is Directed to Telomerase; (ii)
comprises
a modification to the naturally-occurring sequence of Telomerase
which
modification is not specifically covered by a Valid Patent Claim
at the
time such modification is Invented; and (iii) provides benefit
as a
vaccine component due to its capacity to induce an immune responses
cross-reactive against Telomerase which response is superior in
quality to
that induced by the corresponding wild-type epitope, as assessed
by (x) *;
(y) *; or (z) *, and (b) any nucleic acid sequence which encodes
the
peptide set forth in (a).
|
*
Certain information on this page has been omitted and
filed separately with the Commission. Confidential treatment has been requested
with respect to the omitted portions.
7
|
1.66
|
“Telomerase
Antigen”
shall mean (i) Telomerase, or (ii) any epitope, which epitope is
Directed
to Telomerase, or (iii) a nucleic acid sequence which encodes (i)
or (ii).
For clarity, a Telomerase Antigen does not need to possess properties
identical to Telomerase, so long as it elicits a humoral and/or
cellular
immune response against Telomerase.
|
|
1.67
|
“Telomerase”
shall mean the enzyme encoded by Telomerase reverse transcriptase
(“TERT”), including any fragments thereof.
|
|
1.68
|
“Territory”
shall mean all of the countries in the world, and their territories
and
possessions.
|
|
1.69
|
“Third
Party”
shall mean an entity other than Merck and its Related Parties,
and Geron
and its Affiliates.
|
|
1.70
|
“U.S.”
shall mean the United States of America, its territories and possessions,
including but not limited to the Commonwealth of Puerto
Rico.
|
|
1.71
|
“Valid
Patent Claim”
shall mean a claim of an issued and unexpired patent included within
the
Geron Patent Rights, Geron Program Patent Rights or Joint Program
Patent
Rights, 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 as of the date
of sale
of a Product.
|
|
2.
|
RESEARCH
PROGRAM; CLINICAL DEVELOPMENT PROGRAM
|
|
2.1
|
Research
Program
|
|
2.1.1
|
Geron
and Merck shall engage in the Research Program upon the terms and
conditions set forth in this Agreement. In the initial Research Program,
as set forth in Schedule 2.1 as of the Effective Date (the “Initial
Research Program”), the Parties shall investigate *. The Initial Research
Program may be amended only by mutual written agreement of the Parties.
When used herein, any reference to “Research Program” shall include the
Initial Research Program as amended by the Parties.
|
|
2.2
|
Conduct
of Research
|
|
2.2.1
|
Performance.
Geron 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.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
8
|
2.2.2
|
Compliance.
Geron and Merck each shall conduct the Research Program in compliance
with
all applicable laws, rules and regulations, including, without
limitation,
Good Laboratory Practices, as applicable. In addition, if animals
are used
in research hereunder, the Parties will comply with the Animal
Welfare Act
or any other applicable local, state, national and international
laws and
regulations relating to the care and use of laboratory animals.
Merck and
Geron each are encouraged to use the highest standards, such as
those set
for the in the Guide for the Care and Use of Laboratory Animals
(NRC,
1996), for the humane handling care and treatment of such research
animals. Any animals which are used in the course of the Research
Program,
or products derived from those animals, such as eggs or milk, will
not be
used for food purposes, nor will these animals be used for commercial
breeding purposes. Geron shall notify Merck in writing of any deviations
from applicable regulatory or legal requirements that it becomes
aware of.
Geron and Merck hereby certify that to the best of their knowledge
they
have not employed or otherwise used in any capacity, and will not
employ
or otherwise use in any capacity, the services of any person debarred
under United States law, including but not limited to Section 21
USC 335a,
in performing any portion of the Research Program.
|
|
2.2.3
|
Use
of Third Party Contractors. Merck and Geron shall each be
entitled to utilize the services of Third Parties to perform its
Research
Program activities, provided that such services are conducted in
a manner
that is consistent with and preserves the rights of the Parties
under this
Agreement. Each Party shall remain at all times fully liable for
its
respective responsibilities under the Research Program and the
activities
of any Third Parties utilized in connection therewith.
|
|
2.2.4
|
Use
of Human Materials. If any human cell lines, 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, Geron and Merck each represent and warrant: (i)
that it
and its Affiliates have in all material respects complied, or shall
comply, with all applicable laws, guidelines and regulations relating
to
the collection and/or use of the Human Materials used in the Research
Program; and (ii) that it and its Affiliates have obtained, or
shall
obtain, all necessary approvals and appropriate informed consents,
in
writing, for the collection and/or use of such Human Materials.
Each Party
shall provide documentation of such approvals and consents upon
the other
Party’s request. Each Party further represents and warrants that it will
ensure 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, provided that if a Party is unable to obtain all necessary
approvals and appropriate informed consents it shall have no obligation
to
provide Human Materials hereunder.
|
|
2.2.5
|
Funding.
Merck will be responsible for all costs incurred by Merck in the
performance of the Initial Research Program, and Geron will be
responsible
for all costs incurred by Geron in the performance of the Initial
Research
Program. Merck will not be responsible for funding any Geron activities
during the Initial Research Program Term, unless otherwise agreed
in
writing between the Parties. Geron will make Commercially Reasonable
Efforts to provide any Materials or scientific support for the
Initial
Research Program as reasonably requested by Merck through the JRC,
and
agreed by Geron during the Initial Research Program Term, and all
such
support and Materials will be provided at Geron’s
expense.
|
9
|
2.2.6
|
Research
Program Term.
Except as otherwise provided herein, the term of the Research Program
shall commence on the Effective Date and continue for a period of
* (*)
years after the Effective Date (“Research
Program Term”).
The Initial Research Program described in Schedule 2.1 is expected
to be
completed within * to * months after the Effective Date (“Initial Research
Program Term”).
Additional Research Program activities after the Initial Research
Program,
and the funding obligations of the Parties with respect thereto,
shall be
agreed upon between Geron and Merck at the conclusion of the Initial
Research Program Term, including those activities provided in Section
2.3.4. The Parties may extend the Initial Research Program Term only
by
mutual written agreement of the authorized representative of the
Parties,
and shall, in such case, amend Schedule 2.1 as
applicable.
|
|
2.3
|
Joint
Research Committee
|
|
2.3.1
|
The
Parties hereby establish a joint research committee (the “JRC”)
as a scientific forum for discussion of the work and technical review
of
activities and results of the Research Program, and to facilitate
the
execution of the Research Program. Unless otherwise agreed between
the
Parties, the JRC shall remain in effect from the Effective Date of
this
Agreement up to and including the date three (3) months after commencement
by Merck of IND-enabling GLP toxicology studies for a Non-DC Product,
at
which point a JDC will be formed in accordance with Section
2.4.1.
|
|
2.3.2
|
Composition
of the Joint Research
Committee.
The Research Program shall be conducted under the direction of the
JRC,
comprised of * (*) representatives
of Merck and * (*) representatives of Geron. Each Party may change
its
representatives to the JRC from time to time, in its sole discretion,
effective upon prior written 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 representative’s or consultant’s written agreement to
comply with the requirements of Section 4. The JRC shall be chaired
by a
representative of Merck. Decisions of the JRC shall be made unanimously
by
the representatives. In the event that the JRC cannot or does not,
after
good faith efforts, reach agreement on an issue related to the Research
Program, the resolution and/or course of conduct shall be determined
by
Merck, in its sole discretion, provided that Geron shall have the
right to
raise issues of substance to the appropriate Executive Vice President
of
Merck Research Laboratories if not in agreement with a Merck decision.
Each Party shall bear its own expenses related to the attendance
of such
meetings by its representatives.
|
|
2.3.3
|
JRC
Meetings. During the Research Program Term and until the
formation of the JDC, 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 Geron 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. The JRC shall confer regarding the status
of the
Research Program, review relevant data, and consider and advise on
any
technical issues that arise under the Research Program. Prior to
the JRC
meetings, the Parties shall exchange written summaries of the matters
to
be presented to the Committee. At JRC meetings, the Parties, through
the
JRC, will share Information arising from the performance of the Research
Program, and any Information exchanged at JRC meetings shall be
appropriately documented.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
10
|
2.3.4
|
Additional
Technologies.
The JRC shall review the results of the Research Program and consider
those results in the context of other technologies that may be
applicable
for Non-DC Products. *. For the avoidance of doubt, Merck shall
have final
say over additional and subsequent research and development activities
and
any decision to engage in additional pre-clinical studies, subject
to the
decision making procedures set forth in Section 2.3.2.
|
|
2.4
|
Clinical
Development of Non-DC Products
|
|
2.4.1
|
Merck
shall inform Geron in writing when it commences * and Merck
and Geron shall form the Joint Development Committee (“JDC”) within * (*)
months of such commencement . Effective upon the formation of the
JDC,
Merck shall provide to Geron a Clinical Development Plan (“CDP”)
and the JDC shall review on an ongoing basis the status of the
CDP. Upon
commencement of such IND-enabling GLP toxicology studies, Merck
shall
thereafter be responsible for performing and shall bear the cost
for all
clinical and non-clinical development for Non-DC Products, including
the
performance of the CDP (other than those activities of Geron set
forth in
the Research Program).
|
|
2.4.2
|
Joint
Development Committee. The JDC shall be comprised of *
(*) representatives of Merck and * (*)
representatives of Geron. Each Party may change its representatives
to the
JDC from time to time, in its sole discretion, effective upon prior
written notice to the other Party of such change. These representatives
shall have appropriate technical credentials, experience and knowledge,
and ongoing familiarity with the CDP. Additional representatives
or
consultants may from time to time, by mutual consent of the Parties,
be
invited to attend JDC meetings, subject to such representative’s or
consultant’s written agreement to comply with the requirements of Section
4. The JDC shall be chaired by a representative of Merck. Decisions
of the
JDC shall be made unanimously by the representatives. In the event
that
the JDC cannot or does not, after good faith efforts, reach agreement
on
an issue related to the CDP, the resolution and/or course of conduct
shall
be determined by Merck, in its sole discretion, provided that Geron
shall
have the right to raise issues of substance to the appropriate
Executive
Vice President of Merck Research Laboratories if not in agreement
with a
Merck decision. Each Party shall bear its own expenses related
to the
attendance of such meetings by its representatives.
|
|
2.4.3
|
JDC
Meetings.
During the clinical development of a Non-DC Product, the JDC 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 Geron and Merck
facilities
(or such other location as may be determined by the JDC). Alternatively,
the JDC may meet by means of teleconference, videoconference or
other
similar communications equipment. At JDC meetings, Merck will share
data
and information arising from the performance of the CDP. The JDC
shall
confer regarding the status of the CDP, review relevant data, consider
and
advise on any technical issues that arise during the development
of a
Non-DC Product. Notwithstanding the foregoing, Merck shall have
final say
over all development decisions, provided that Geron shall have
a right to
review and provide comments on the CDP. Merck will provide a report
each
Calendar Quarter to Geron in conjunction with JDC meetings regarding
the
development, commercialization and regulatory status of the Non-DC
Product.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
11
|
2.4.4
|
Clinical
Development Program Term. The Clinical Development Program
will commence as provided in Section 2.4.1, and shall expire upon
the
earlier of (i) termination of the Agreement pursuant to Article
8, or (ii)
the First Commercial Sale by Merck or its Related Parties of the
first
Non-DC Product anywhere in the Territory.
|
|
2.5
|
Records
and Reports
|
|
2.5.1
|
Records.
The Parties shall maintain records of activities under the Research
Program, 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.
|
|
2.5.2
|
Copies
and Inspection of Records.
|
|
(a) Upon
request, in furtherance of a patent or regulatory filing being
performed
by a Party or its designee, each Party shall provide to the other
in a
timely manner copies of records referred to in Section 2.5.1 maintained
by
that Party. All such records and the information disclosed therein
shall
be maintained in confidence in accordance with Section 4.
|
|
|
(b) Each
Party 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 the other and any of its Third Party contractors
as
permitted under Section 2.2.3 during normal business hours and
upon
reasonable advance written notice, and to discuss the Research
Program
work and its results in detail with technical personnel and consultants.
Each Party shall have the right, during normal business hours and
upon
reasonable advance written notice, to inspect and copy all such
records
referred to in Section 2.5.2(a).
|
|
|
2.6
|
Program
Patent Rights and Program Know-How
|
|
2.6.1
|
Non-DC
Technologies. Program Patent Rights and Program Know-How by
either Party relating solely to Non-DC Technologies shall be owned
solely
by Merck.
|
|
2.6.2
|
DC
Technology. Program Patent Rights and Program Know-How by
either Party relating solely to DC Technology shall be owned solely
by
Geron, subject to the non-exclusive research license to Merck pursuant
to
Section 3.2.1 and the DC Option set forth in Section
3.2.3.
|
|
2.6.3
|
Telomerase
Antigen. Program Patent Rights and Program Know-How relating
solely to Telomerase Antigens shall be owned solely by Geron, subject
to
the exclusive license granted to Merck pursuant to Section 3.1;
provided, however, that ownership of Inventions relating
to (i) Fusion Proteins and/or (ii) Synthetic Epitopes shall be
determined
as specified in Section 2.6.4.
|
|
2.6.4
|
Other
Program Patent Rights and Program Know-How. Ownership of
Program Patent Rights and Program Know-How other than as set forth
in
Sections 2.6.1, 2.6.2, and 2.6.3, shall be determined as
follows:
|
|
(a) Program
Patent Rights and Program Know-How conceived and/or reduced to
practice
solely by employees of Geron, or by persons not employed by Merck
and
acting on behalf of Geron, shall be owned solely by Geron, subject
to any
applicable rights granted to Merck pursuant to Sections 3.1 or
3.2;
and
|
|
|
(b)
Program
Patent Rights
and Program Know-How conceived and/or reduced to practice solely
by
employees of Merck, or by persons not employed by Geron and acting
on
behalf of Merck, shall be owned solely by Merck, subject to any
applicable
rights granted to Geron pursuant to Section 3.3;
and
|
12
|
(c) Program
Patent Rights and Program Know-How conceived and/or reduced to
practice
jointly by employees of Merck or Geron or others acting on behalf
of Merck
and Geron shall be jointly owned by the Parties, subject to any
applicable
rights granted to Merck pursuant to Sections 3.1 or
3.2.
|
|
|
2.7
|
AE
Reporting
|
|
2.7.1
|
Each
Party shall, and shall cause its respective Affiliates to,
furnish timely notice as required by applicable worldwide regulations
(i.e. currently seven (7) calendar days for deaths and immediately
life-threatening adverse experiences and fifteen calendar (15)
days for
serious adverse experiences) to all competent governmental agencies
in the
Territory of all side effects, drug interactions and other adverse
experiences identified or suspected with respect to any Product
administered, distributed, marketed and sold under authority
of any IND or
Marketing Authorization issued by such Regulatory Authority.
Each Party
shall provide the other Party hereto with all necessary assistance
in
complying with all adverse experience reporting requirements
established
by, or required under, any applicable IND and/or Marketing Authorization
in the Territory. Accordingly:
|
|
(a) Geron
shall provide Merck with timely information, in accordance with
the time
frames set forth below, on any side effects, drug interactions
and serious
adverse experiences relating to any DC Product to the extent
that such
serious adverse experiences could affect the Marketing Authorization
for
any Non-DC Product in the Territory, or relate to the safety,
efficacy or
potency of any Non-DC Product; and
|
|
|
(b) Merck
shall provide Geron with timely information, in accordance with
the time
frames set forth below, on any side effects, drug interactions
and serious
adverse experiences relating to any Non-DC Product to the extent
that such
serious adverse experiences could affect the Marketing Authorization
for
any DC Product in the Territory, or relate to the safety, efficacy
or
potency of any DC Product.
|
|
|
2.7.2
|
Each
Party shall, and shall cause its Affiliates to, furnish the
other Party within five (5) calendar days of written notice of
all such
side effects, drug interactions and other serious adverse experiences
reported to such Party or its Affiliates regarding Non-DC Products
or DC
Product. Each Party shall also use its best efforts to obtain,
and to
furnish to the other Party hereto, such information, including,
but not
limited to, patients, circumstances, consequences and sources
of
information, reasonably sufficient to permit that other Party
to evaluate
such side effects, drug interactions or other serious adverse
experiences
of the DC Product and/or Non-DC Product. Each Party shall retain
all
documents, reports, studies and other materials relating to any
and all
such side effects, drug interactions, or other serious adverse
experiences, as the case may be. Upon reasonable written notice,
each
Party shall permit the other Party hereto to inspect, and to
make copies
of, all such documents, reports, studies and other materials,
subject to
the ability of Geron to inspect such Third Party records, and
subject
further to laws and regulations regarding patient confidentiality
and
privacy.
|
|
2.7.3
|
As
soon as practicable after the Effective Date, but in no event
later than the commencement of Phase I Clinical Trials by Merck,
the
Parties shall enter into a separate and more detailed agreement
concerning
adverse experience reporting.
|
13
|
2.7.4
|
For
purposes of this Section 2.7.1, the term “adverse experience”
means any unfavorable and unintended change in the structure (signs),
function (symptoms), or chemistry (laboratory data) of the body temporally
associated with any use of a Product, whether or not considered related
to
the use of such Product. Changes resulting from normal growth and
development which do not vary significantly in frequency or severity
from
expected levels are not to be considered adverse experiences. Examples
of
this may include, but are not limited to, teething, typical crying
in
infants and children, and onset of menses or menopause occurring
at a
physiologically appropriate time.
|
|
(a) Adverse
experiences may occur in the course of the use of a Product in Clinical
Trials or within the follow-up period specified in the protocol of
such
Clinical Trial, or prescribed in clinical practice, from overdose
(whether
accidental or intentional), from abuse, and from
withdrawal.
|
|
|
(b) Adverse
experiences may also occur in screened patients during any preallocation
baseline period as a result of a protocol-specified intervention
including
washout or discontinuation of usual therapy, diet, placebo treatment,
or a
procedure.
|
|
|
(c) The
term “adverse experience” does not pertain to events that are a result of
investigator-initiated changes to the patient’s usual care during any
preallocation baseline period. The term “adverse experience” does not
pertain to nonprotocol specified intervention events or to preexisting
conditions which occur in screened/nonrandomized patients unless
the event
causes the patient to be excluded from the study.
|
|
|
(d) For
a marketed Product, (clinical practice and post-marketing study)
any
significant failure of expected pharmacologic, immunologic, or therapeutic
effect also constitutes an adverse
experience.
|
|
|
(e) While
the reason for a procedure, e.g., chest pain necessitating cardiac
catheterization, may be an adverse experience, a procedure in and
of
itself is not an adverse experience.
|
|
|
2.7.5
|
For
purposes of this Section 2.7.1, “serious” means any untoward medical
occurrence that at any dose is fatal or immediately life-threatening,
results in persistent or significant disability/incapacity, or requires
in-patient hospitalization or prolongation of an existing hospitalization,
or is a congenital anomaly, cancer, or overdose. Other important
medical
events that may jeopardize the patient or may require intervention
to
prevent one of the outcomes listed previously, should also be considered
“serious”.
|
|
2.7.6
|
Information
provided by one Party to the other Party under this Section 2.7 shall
be
maintained in confidence by the receiving Party, except as expressly
permitted by Article 4 of this Agreement.
|
|
3.
|
LICENSE;
OPTION; DEVELOPMENT AND
COMMERCIALIZATION
|
|
3.1
|
License
Grants
|
|
3.1.1
|
Exclusive
Non-DC Products License.
Subject to the terms and conditions of this Agreement, including
Section
3.1.2, Geron hereby grants to Merck an exclusive license (even as
to
Geron) in the Territory under Geron Patent Rights, Geron Program
Patent
Rights, Geron’s interest in Joint Program Patent Rights, Geron Know-How,
and Geron’s interest in Program Know-How to make, have made, use, offer to
sell, sell and/or import Non-DC Product(s) (including use for research
and
development of such Non-DC Product(s)) for any and all uses in the
Field.
|
14
|
3.1.2
|
Limits
on Exclusivity for Non-DC Products Other than Adeno/DNA
Products.
|
|
(a) For
the * year period following the Effective Date, the license granted
to
Merck pursuant to Section 3.1.1 shall be exclusive to Merck,
even as to
Geron, except to the extent Geron may conduct any activity under
the
Research Program pursuant to Article 2. During such *-year period,
Geron
may not conduct independent work outside the Research Program
related to
Non-DC Products or DC/Non-DC Therapy or DC/Adeno/DNA
Therapy.
|
|
|
(b) Following
the initial * year period described in Section 3.1.2, and subject
to any
agreement arising from Merck’s exercise of the Option set forth in Section
3.2.3, Geron may conduct research and/or development activities
on a
Non-DC Product only for the purpose of, and in connection with,
the
development of a DC/Non-DC Therapy, provided, however, that Geron
shall
not conduct such research and/or development activities (i) with
regard to
Adeno/DNA Products, or (ii) with regard to any other Non-DC Product
if
Merck has previously disclosed to Geron, through the JRC, the
JDC (as
documented by minutes of the meetings of the JRC or JDC) or through
a
formal written management communication, that Merck is actively
engaged in
research in, or development of, or in negotiation for rights
to, the type
of Non-DC Product regarding which Geron wishes to conduct research
and/or
development activities.
|
|
|
3.1.3
|
For
the avoidance of doubt, prior to any agreement arising from
Merck’s exercise of the Option set forth in Section 3.2.3, Geron’s ability
to conduct research into and development and commercialization
of DC
Products is not affected in any way by this Agreement.
|
|
3.1.4
|
Non-Exclusive
License to Conduct
Assays.
Subject to terms and conditions of this Agreement, Geron hereby
grants to
Merck a non-exclusive license in the Territory under Geron Patent
Rights,
Geron Know-How, Geron Program Patent Rights, Geron’s interest in Joint
Program Patent Rights and Geron’s interest in Program Know-How, to the
extent necessary to perform assays solely to measure immunological
responses to Telomerase in the research, development, and
commercialization of Non-DC Products under this Agreement, including
(i)
monitoring of treatment in clinical trials and (ii) in support
of
commercial use of such Non-DC Products.
|
|
3.1.5
|
Sublicense
Rights.
Subject to the terms and conditions of this Agreement, Merck
will have the
right to grant sublicenses of the rights granted to it under
Section 3.1
(i) to its Affiliates; and (ii) to Third Parties engaged in research,
development and marketing of Products, and to contract service
providers
providing services for Merck, to the extent such sublicenses
to Third
Parties are required for the research, development and commercialization
of Non-DC Products or to perform assays as permitted pursuant
to Section
3.1.4, in each case for use in the Field by or on behalf of
Merck.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
15
|
3.2
|
Research
License and Option for DC
Products
|
|
3.2.1
|
Research
License. Geron hereby grants to Merck
a non-exclusive license in the Territory under the Geron Patent
Rights,
Geron Know-How, Geron Program Patent Rights and Geron’s interest in Joint
Program Patent Rights and Geron’s interest in Program Know-How, and
Materials, solely for the purpose of conducting research in those
aspects
of the Research Program pertaining to DC Products and DC/Adeno/DNA
Therapies. The license set forth in this Section 3.2.1 shall automatically
terminate * (*) years from the Effective Date, unless otherwise
agreed by
the Parties. Notwithstanding the non-exclusive nature of such license,
in
order to preserve the exclusive nature of Merck’s option pursuant to
Section 3.2.3, Geron shall not grant any license in the Territory
to any
Third Party under Geron Patent Rights, Geron Know-How, Geron Program
Patent Rights, Geron’s interest in Joint Program Patent Rights or Geron’s
interest in Program Know-How to develop or commercialize DC Products,
DC/Non-DC Therapies or DC/Adeno/DNA Therapies in the Field during
such
*-year period.
|
|
3.2.2
|
Provision
of Clinical Trial Information by Geron. During
the term of the license set forth in Section 3.2.1, and subject
to the
provisions of Article 4, Geron shall provide updates to Merck on
developments in on-going Clinical Trials of DC Products sponsored
by
Geron. Such updates shall be subject to nondisclosure obligations
pursuant
to Article 4 hereof.
|
|
3.2.3
|
Option
for Commercial License to DC Products
|
|
(a)
Geron hereby grants to Merck an exclusive option to enter into
an
exclusive arrangement (or non-exclusive arrangement if mutually
agreed by
the Parties), subject to any pre-existing obligations of Geron
to Third
Parties, to develop and commercialize DC Products, DC/Non-DC Therapies
and
DC/Adeno/DNA Therapies, and obtain an exclusive license (or non-exclusive
license if mutually agreed by the Parties), subject to any pre-existing
obligations of Geron to Third Parties, under the Geron Patent Rights,
Geron Know-How, and Geron’s interest in Program Patent Rights and Program
Know-How, in the Field (the “DC Option”). Merck’s right to exercise the DC
Option shall expire two (2) years after the Effective Date,
unless
otherwise agreed by the Parties. Merck shall be entitled to exercise
the
DC Option by providing written notice to Geron at any time prior
to
expiration of the DC Option.
|
|
|
(b)
Upon exercise of the DC Option by Merck, Merck shall have the right
to
exclusively negotiate with Geron as set forth in this Section 3.2.3(b)
for
the development and commercialization of DC Products, DC/Non-DC
Therapies
and/or DC/Adeno/DNA Therapies in the Field. The Parties shall meet
and
negotiate in good faith for the purpose of entering into an agreement
regarding such an arrangement. If, after negotiating in good faith
for *
(*) days, subject to any mutually agreed extension (such extension
not to
be unreasonably withheld), Merck and Geron are unable to agree
on the
commercial terms of such an agreement, Merck’s DC Option shall be
extinguished.
|
|
|
3.2.4
|
Relation
to Initial Research Program.
For avoidance of doubt, while the Initial Research Program will
focus on
an evaluation of *, this Agreement provides Merck with the exclusive
right
to develop Non-DC Products not limited to Adeno/DNA Products. Geron
retains the exclusive right to develop DC Products, including DC/Non-DC
Therapies.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
16
|
3.3
|
License
and Option Grants to Geron
|
|
3.3.1
|
Merck
hereby grants to Geron a fully paid-up non-exclusive, non-sublicensable
(except for the limited right to grant a sublicense to make on
behalf of
Geron) license in the Territory under Merck Telomerase Program
Patent
Rights and under Merck’s interest in Program Know-How relating to
Telomerase Antigens, to make, have made, use, sell, offer to sell
and
import DC Products and DC/Non-DC Therapies in the
Field.
|
|
3.3.2
|
Merck
hereby grants to Geron an option to negotiate in good faith a
non-exclusive but sublicensable license in the Territory on commercially
reasonable terms to be negotiated under Merck Telomerase Program
Patent
Rights and under Merck’s interest in Program Know-How relating to
Telomerase Antigens, to make, have made, use, sell, offer to sell
and
import DC Products and DC/Non-DC Therapies in the
Field.
|
|
3.4
|
No
Implied Licenses; Retained
Rights
|
|
3.4.1
|
No
Implied Licenses.Neither
Party shall obtain any license or other intellectual property interest
in,
to, or under any Information or Patent Rights of the other Party,
by
implication or otherwise except as expressly set forth in this
Article
3.
|
|
3.4.2
|
Retained
Rights.
Each Party retains all rights not explicitly granted in this Article
3. In
particular, but without limitation, except as provided in Section
3.3,
Merck retains all of its rights and grants no license relating
to Non-DC
Technologies.
|
|
3.5
|
Diligence
in Development and Commercialization
|
|
3.5.1
|
Merck
shall use Commercially Reasonable Efforts, at its own
expense, to develop and commercialize one or more Non-DC Product(s)
for
use in the Field. The obligations of Merck with respect to any
Non-DC
Product under this Section 3.5 are expressly conditioned upon the
continuing absence of any adverse condition or event relating to
the
safety or efficacy of the Non-DC Product, and the obligation of
Merck to
develop or market any such Non-DC Product shall be delayed or suspended
so
long as in Merck’s opinion any such condition or event exists. Merck shall
be obligated to use Commercially Reasonable Efforts to investigate
and
attempt to resolve any such adverse condition or event. If, in
Merck’s
opinion, such material or adverse condition arises, Merck shall
promptly
inform Geron at the next quarterly JDC meeting, and shall provide
the JDC
with an explanation for any decision to delay or suspend the development
or marketing of a Non-DC Product, together with a description of
actions
planned by Merck to resolve the underlying cause of such delay
or
suspension. If Geron reasonably believes that Merck has made a
decision to
cease, or has actually ceased, development of all Non-DC Products
for a
period of * (*) or more consecutive months, Geron shall so notify
Merck in
writing. Upon receipt of such written notice, Merck shall prepare
and
present a revised CDP to the next JDC meeting occurring more than
* (*)
days after delivery of such notice by Geron (but in any event no
more than
one Calendar Quarter after delivery of such notice). Such revised
CDP
shall include an identification of all obstacles in the development
of a
Non-DC Product and Merck’s plan for overcoming such obstacles. Geron shall
inform Merck of any concerns that it has with Merck’s revised CDP, and the
Parties shall meet as necessary to discuss such concerns. Merck
may, in
its discretion, further revise
the CDP to reflect Geron’s concerns. If, after Merck and Geron have had an
opportunity to fully explore any concerns of Geron with Merck’s revised
CDP, Geron continues to remain reasonably dissatisfied with Merck’s
revised CDP, Geron may provide written notice of material breach
to Merck
pursuant to Section
9.3.1.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
17
|
3.6
|
Option
of Geron to Co-promote in the United
States
|
|
3.6.1
|
Geron
Right to Co-Promote.
Subject to the obligations of Merck existing as of the Effective
Date,
Merck hereby grants Geron an option to co-promote any Product developed
hereunder in the U.S. only (the “Co-promotion
Option”)
by Detailing (as such term is defined in Schedule 3.6) the Non-DC
Product
to physicians other than primary care providers who are designated
by
Merck as candidates for Detailing the Product (“Target
Prescribers”)
Geron’s right to co-promote any Product hereunder is subject to the
provisions of this Section 3.6, and is conditioned on Geron’s exercise of
the Co-Promotion Option set forth in Section 3.6.3, Geron’s demonstrated
ability to perform such mutually agreed co-promotion obligations
as are
set forth in a Co-Promotion Agreement mutually acceptable to the
Parties
and containing terms and conditions substantially consistent with
Schedule
3.6. Any rights to co-promote Non-DC Products shall only be granted
to
Geron or a wholly-owned subsidiary of Geron, and shall not be assignable
or transferable except as may be otherwise agreed in the Co-Promotion
Agreement.
|
|
3.6.2
|
Procedure.
(a) Merck shall determine the projected Launch Date (as such term
is
defined in Schedule 3.6) of the Product, and shall keep Geron apprised
at
quarterly JDC meetings of any changes in the projected Launch Date
for the
Non-DC Product, so that Geron has reasonable notice thereof. Merck
will
notify Geron in writing of the projected Launch Date for each Product
hereunder at least * (*) months in advance of such projected Launch
Date.
Subject to notice by Merck as set forth in the preceding sentence,
Geron
will notify Merck in writing of its intent to exercise the Co-Promotion
Option at any time but no later than * (*) months prior to the projected
Launch Date as communicated by Merck(the “Exercise
Date”). If Geron chooses to exercise the Co-Promotion Option,
Merck and Geron will enter into a definitive Co-Promotion Agreement
consistent with the terms and conditions set forth in Schedule 3.6
*.
|
|
(b)
Notwithstanding Section 3.6.2(a), if Merck determines that an accelerated
time schedule for the Exercise Date and execution of a Co-Promotion
Agreement is necessary to optimally plan and execute the launch of
the
Product, Merck will inform Geron and the Parties will agree on the
revised
schedule for exercise of the Co-Promotion Option and execution of
a
definitive Co Promotion Agreement *.
|
|
|
3.6.3
|
Co-Promotion
Obligations. If Geron exercises the Co-Promotion Option,
Geron shall be required to commence Detailing the Product on the
Launch
Date, and shall be required to deploy a sufficient number * of Specialty
Sales Representatives (as such term is defined in Schedule 3.6),
based on
the reach and frequency of Detailing that Merck determines is desirable
to
the Target Prescribers. Merck shall inform Geron at least * (*) days
before the Exercise Date of the total number of Specialty Sales
Representatives required for the Detailing of the Product on the
Launch
Date. Merck and Geron will mutually agree on the number of Specialty
Sales
Representatives Geron will deploy as outlined in Schedule 3.6.
Compensation in any event shall be as described in Schedule
3.6.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
18
|
3.6.4
|
Lapse
of Co-Promotion
Option.
Geron’s right to co-promote a Product hereunder shall lapse if, with
respect to such Product:
|
|
(a) Geron
does not notify Merck in writing of its intent to exercise the
Co-Promotion Option by the Exercise Date (subject to reinstatement
of the
Co-Promotion Option as provided in Section 3.6.2); or
|
|
|
(b) Geron
cannot provide the number of Specialty Sales Representatives set
forth in
Schedule 3.6; or
|
|
|
(c)
For the reasons set forth in Schedule 3.6; or
|
|
|
(d) Geron
is involved in a Major Pharma Change of Control as set forth in Section
9.2; or
|
|
|
(e) The
Agreement is terminated pursuant to Article 9.
|
|
|
3.7
|
Bankruptcy
|
|
3.7.1
|
All
licenses granted under or pursuant to this Agreement by Geron to
Merck
are, and shall otherwise be deemed to be, for purposes of Section
365(n)
of the Code, licenses of rights to “intellectual property” as defined
under Section 101(35A) of the Code. The Parties agree that Merck,
as a
licensee of such rights under this Agreement, shall retain and may
fully
exercise all of its rights and elections under the Code, and that
upon
commencement of a bankruptcy proceeding by or against Geron under
the
Code, Merck shall be entitled, to the extent necessary for Merck
to
continue to preserve its license rights under this Agreement, to
a
complete duplicate of any such intellectual property and all embodiments
of such intellectual property. Such intellectual property and all
embodiments thereof shall be promptly delivered to Merck (i) upon
any such
commencement of a bankruptcy proceeding upon written request therefor
by
Merck, unless Geron elects to continue to perform all of its obligations
under this Agreement or (ii) if not delivered under (i) above, upon
the
rejection of this Agreement by or on behalf of Geron upon written
request
therefor by Merck. The foregoing provisions of this Section 3.7 are
without prejudice to any rights Merck may have arising under the
Code or
other applicable law.
|
|
4.
|
CONFIDENTIALITY
AND PUBLICATION
|
|
4.1
|
Nondisclosure
Obligation
|
|
4.1.1
|
All
Information disclosed by one Party to the other Party hereunder shall
be
maintained in confidence by the receiving Party and shall not be
disclosed
to any Third Party or Related Party, or used for any purpose except
as set
forth herein without the prior written consent of the disclosing
Party,
except to the extent that such Information:
|
|
(a) is
known by the receiving Party at the time of its receipt, and not
through a
prior disclosure by the disclosing Party, as documented by the receiving
Party’s business records;
|
|
|
(b) is
in the public domain by use and/or publication before its receipt
from the
disclosing Party, or thereafter enters the public domain through
no fault
of the receiving Party;
|
|
|
|
(c)
is subsequently disclosed to the receiving Party by a Third Party
who may
lawfully do so and is not under an obligation of confidentiality
to the
disclosing Party;
|
19
|
(d) is
developed by the receiving Party independently of Information received
from the disclosing Party, as documented by the receiving Party’s business
records;
|
|
|
(e) is
disclosed to governmental or other regulatory agencies in order to
obtain
patents or to gain or maintain approval to conduct clinical trials
or to
market Product, but such disclosure may be only to the extent reasonably
necessary to obtain patents or authorizations;
|
|
|
(f) is
(i) Licensed Subject Matter licensed to Merck hereunder and is deemed
necessary by Merck to be disclosed to Related Parties, agents,
consultants, and/or other Third Parties for any and all purposes
Merck and
its Affiliates deem necessary or advisable for the research and
development, manufacturing and/or marketing of the Non-DC Product
(or for
such entities to determine their interest in performing such activities)
or (ii) Licensed Subject Matter licensed to Geron hereunder and is
deemed
necessary by Geron to be disclosed to Affiliates, agents, consultants,
permitted sublicensees and/or other Third Parties for any and all
purposes
Geron and its Affiliates deem necessary and advisable for the research
and
development, manufacturing or marketing of any DC-Product or DC/Non-DC
Therapy (or for such entities to determine their interest in performing
such activities), provided that such activities by either Party shall
be
in accordance with this Agreement on the condition that such Third
Parties
agree in writing to be bound by the confidentiality and non-use
obligations contained in this Agreement; and further provided that
the
term of confidentiality for such Third Parties shall be no less than
ten
(10) years; or
|
|
|
(g) is
deemed necessary by counsel to the receiving Party to be disclosed
to such
Party’s attorneys, independent accountants or financial advisors for the
sole purpose of enabling such attorneys, independent accountants
or
financial advisors to provide advice to the receiving
Party.
|
|
|
Any
combination of features or disclosures shall not be deemed to
fall within the foregoing exclusions merely because individual features
are published or available to the general public or in the rightful
possession of the receiving Party unless the combination itself and
principle of operation are published or available to the general
public or
in the rightful possession of the receiving Party.
|
|
|
4.1.2
|
If
a Party is required by judicial or administrative process to disclose
Information that is subject to the non-disclosure provisions of this
Section 4.1 or Section 4.2, such Party shall promptly inform the
other
Party of the disclosure that is being sought in order to provide
the other
Party an opportunity to challenge or limit the disclosure obligations.
Information that is disclosed by judicial or administrative process
shall
remain otherwise subject to the confidentiality and non-use provisions
of
this Section 4.1 and Section 4.2, and the Party disclosing Information
pursuant to law or court order shall take all steps reasonably necessary,
including without limitation obtaining an order of confidentiality,
to
ensure the continued confidential treatment of such Information.
Each
Party agrees that it shall cooperate fully and in a timely manner
with the
other with respect to all disclosures to the Securities and Exchange
Commission and any other governmental or regulatory agencies, including
requests for confidential treatment of Information of either party
included in any such disclosure.
|
|
4.2
|
Geron
Know-How
|
|
4.2.1
|
Geron
agrees to use Commercially Reasonable Efforts to keep all Geron Know-How
and Geron’s interest in Program Know-How that is exclusively licensed to
Merck pursuant to Section 3.1 confidential, subject to exception
(b) in
Section 4.1 above.
|
20
|
4.3
|
Publication
|
|
4.3.1
|
Merck
and Geron each acknowledge the other Party’s interest in
publishing the results of its research in order to obtain recognition
within the scientific community and to advance the state of scientific
knowledge. However, any publication of Information arising from the
Research Program shall be solely by agreement of the Parties. Each
Party
also recognizes the mutual interest in obtaining valid patent protection
and in protecting business interests and trade secret information.
Consequently, except for disclosures permitted pursuant to Section
4.1,
either Party, its employees or consultants wishing to make a publication
containing Program Know-How or confidential Information of the other
Party
shall deliver to the other Party a copy of the proposed written
publication or an outline of an oral disclosure at least * (*) days
prior
to submission for publication or presentation. The reviewing Party
shall
have the right (a) to propose modifications to the publication or
presentation for patent reasons, trade secret reasons or business
reasons
or (b) to request a reasonable delay in publication or presentation
in
order to protect patentable information. If the reviewing Party requests
a
delay, the publishing Party shall delay submission or presentation
for a
period of * (*) days to enable patent applications protecting each
Party’s
rights in such information to be filed in accordance with Article
8 below.
Upon expiration of such * (*) days, the publishing Party shall be
free to
proceed with the publication or presentation. If the reviewing Party
requests modifications to the publication or presentation, the publishing
Party shall edit such publication to prevent disclosure of trade
secret or
proprietary business information of the reviewing Party prior to
submission of the publication or presentation. Notwithstanding anything
in
this Section 4.3.1 (i) Merck may publish its clinical or manufacturing
Information relating to Non-DC Products with advance written notice
to
Geron and (ii) Geron may publish its clinical or manufacturing Information
relating to DC Products, provided, however, that for any such publication
relating to any DC Product covered by a license granted to Geron
by Merck
under this Agreement, Geron shall provide advance written notice
to
Merck.
|
|
4.4
|
Publicity/Use
of Names/Disclosure of
Terms
|
|
4.4.1
|
Both
Parties hereby agree that, on or after the Effective Date, Geron
may issue
the press release set forth in Schedule 4.4.1.
|
|
4.4.2
|
No
disclosure of the terms of this Agreement beyond those otherwise
described
in the press release in Schedule 4.4.1, or otherwise previously publicly
disclosed as required by law, may be made by either Party. Neither
Party
shall use the name, trademark, trade name or logo of the other Party,
its
Affiliates or their respective employees in any publicity, promotion,
news
release or disclosure relating to this Agreement or its subject matter,
without the prior express written permission of the other Party,
except as
may be required by law. Each Party hereby consents to the use of
its name
by the other Party in making reference to the existence of the Agreement
only to the extent permitted in this Section 4.4.2.
|
|
4.4.3
|
Notwithstanding
the above, either Party may disclose the terms of this Agreement
to
accredited investors, investment bankers, or potential acquirors
or merger
candidates in the context of due diligence investigations of such
Party,
provided that the party to which such information is disclosed is
subject
to a nondisclosure obligation no less stringent that that specified
in
Section 4.1.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
21
|
5.
|
PAYMENTS;
ROYALTIES AND REPORTS
|
|
5.1
|
License
Fee
|
|
5.1.1
|
In
consideration for license rights granted pursuant to Section 3.1,
Merck
will pay Geron a non-refundable upfront license fee of two and
one-half
million dollars ($U.S. 2.5 million). Such payment shall be made
within
thirty (30) days after the Effective Date.
|
|
5.2
|
Option
Fee
|
|
5.2.1
|
In
consideration of the Option rights set forth in Section 3.2, Merck
will
pay Geron a nonrefundable option fee of one million dollars ($U.S.
1
million) within thirty (30) days after the Effective
Date.
|
|
5.3
|
Milestone
Payments
|
|
5.3.1
|
Subject
to the terms and conditions of this Agreement, Merck shall pay
a
non-refundable and non-creditable one-time only retention fee of
* dollars
($U.S. *) no later than the earlier of (a) * months
* or (b) within * (*) days *;
|
|
5.3.2
|
Subject
to the terms and conditions of this Agreement, Merck shall pay
a one-time
only non-refundable and non-creditable milestone of * dollars ($U.S.
*)
within * (*) days after *.
|
|
5.3.3
|
Subject
to the terms and conditions of this Agreement, Merck shall
pay to Geron non-refundable and non-creditable payments set forth
below in
Section 5.3.2 below for the * to achieve such
milestone:
|
| (a) * |
$
U.S. *
|
| (b) * |
$
U.S. *
|
| (c) * |
$
U.S. *
|
| (d) * |
$
U.S. *
|
| (e) * |
$
U.S. *
|
| (f) * |
$
U.S. *
|
|
5.3.4
|
For
the first Non-DC Product to achieve a milestone set forth in Section
5.3.3
for the second Indication, Merck shall pay Geron for the achievement
of
such milestone at a rate equal to *
percent (*%) of the amounts set forth in Section 5.3.3. For the
first
Non-DC Product to achieve a milestone set forth in Section 5.3.3
for the
third Indication, Merck shall pay Geron for the achievement of
such
milestone at a rate equal to *
percent (*%) of the amounts set forth in Section 5.3.3. No further
milestones shall be payable for subsequent achievement of such
milestones
by the first or any subsequent Non-DC
Product.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
22
| 5.3.5 |
Merck
shall notify Geron in writing within thirty (30) days following the
achievement of each milestone set forth in Sections 5.3.2, 5.3.3,
or
5.3.4, and shall make the appropriate milestone payment within thirty
(30)
days after the achievement of such
milestone.
|
| 5.4 |
Royalties
for Non-DC Products
|
Royalties
Payable By Merck.
Subject
to the terms and conditions of this Agreement, Merck shall pay Geron royalties
on Net Sales of Non-DC Products, calculated on a Product-by-Product basis,
as
set forth in this Section 5.4.
| 5.4.1 |
Royalties.
|
(a) Patent
Royalty Tiers.
Subject
to the remaining provisions of Section 5.4, Merck shall pay Geron patent
royalties in an amount equal to the following percentage of Net Sales of Non-DC
Products by Merck or its Related Parties, provided that either (x) *; or (y)
*:
(i) *
percent
(*%) of worldwide Net Sales in each Calendar Year up to and including
*
dollars
($U.S. *);
(ii) *
percent
(*%)
of
worldwide Net Sales in each Calendar Year for the portion of Net Sales exceeding
*
dollars
($U.S. *)
up to
and including *
dollars
($U.S. *);
and
(iii) *
percent
(*%)
of
worldwide Net Sales in the Territory in each Calendar Year for the portion
of
Net Sales exceeding *
dollars
($U.S. *).
For
the
avoidance of doubt, Merck’s royalty obligations under this Section 5.4.1(a)
shall apply to Merck’s Net Sales with respect to any Non-DC Product that meets
the requirements of Section 5.4.1(a), above; even if sale or manufacture of
such
Non-DC Product is also covered by Merck Telomerase Program Patent Rights;
provided,
that
(i) it is understood that Merck Telomerase Program Patent Rights are not
included in the definition of Valid Patent Claims, and (ii) royalties shall
be
due pursuant to this Section 5.4.1(a) only for the duration set forth in Section
5.4.1(b).
(b) By
negotiated agreement of the Parties with respect to all aspects of consideration
applicable to this Agreement, payment of patent royalties pursuant to Section
5.4.1(a) shall continue on a country-by-country basis until the later of (1)
*,
or (2) *.
(c) Know-How
Royalty.
Except
as provided for in Section 5.4.1(a) above, in countries where the * would not
infringe a Valid Patent Claim, and provided that *, Merck shall pay Geron a
royalty rate on Net Sales at * percent *% of the rate determined in Section
5.5.1(a). Such royalties shall be calculated after first calculating royalties
under Section 5.4.1(a) above.
| 5.4.2 |
Royalty
tiers pursuant to 5.4.1(a) and 5.4.1(b) shall be calculated based
on
worldwide Net Sales of each Product , provided that the determination
of
whether the royalty shall be calculated under 5.4.1(a) or 5.4.1(b)
shall
be determined on a country-by-country basis. Royalties on each Product
at
the rates set forth above shall continue on a country-by-country
basis
until the later of: (i) the end of the royalty obligation under Section
5.4.1(a); or (ii) for a period of *
(*) years after First Commercial Sale of such Product in such country
(the
“Royalty
Period”).
All royalties are subject to the following
conditions:
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
23
(a) that
only
one royalty shall be due with respect to the same unit of Product;
(b) that
no
royalties shall be due upon the sale or other transfer among Merck or its
Related Parties, but in such cases the royalty shall be due and calculated
upon
Merck’s or its Related Party’s Net Sales to the first independent Third
Party;
(c) no
royalties shall accrue on the sale or other disposition of Product by Merck
or
its Related Parties for use in a Clinical Trial; and
(d) no
royalties shall accrue on the disposition of Product in reasonable quantities
by
Merck or its Related Parties as promotional samples;
(e) no
royalties shall accrue on the disposition of Product as donations made by Merck
in the ordinary course of business; provided,
that
*.
| 5.4.3 |
Compulsory
Licenses.
*
|
| 5.4.4 |
Retroactive
Lump-Sum Payment of Royalties.
*.
|
(a) *.
(b) *.
(c) *.
| 5.4.5 |
Non-cash
Compensation.
The Parties acknowledge that it may be impracticable to anticipate
all
possible ways for Merck and its Related Parties to commercialize
and
exploit the licenses granted to them hereunder or which are later
sublicensed to them, as the case may be, with respect to Non-DC Products,
or for Merck and/or its Affiliates to receive compensation therefor
directly or indirectly from Third Parties, but that Geron is properly
entitled to compensation therefor. Except as permitted pursuant to
Section
5.4.2, if any of Merck or its Related Parties transfers to a Third
Party
any Non-DC Products, and does not receive compensation for such transfer
equivalent to commercial sale of Non-DC Products, (including if Merck
or
any of its Related Parties receive Net Sales in the form of non-cash
consideration for any Non-DC Product sold or otherwise transferred
to a
Third Party) Merck shall be obligated to promptly report such transfer
to
Geron. In such event, Merck and Geron shall discuss in good faith
and
agree upon new ways of compensating Geron to the extent currently
contemplated under Section 5.4.1 and 5.4.2; provided
that this provision shall not apply to services received by Merck
or its
Related Parties from Third Parties in the ordinary course of
business.
|
| 5.5 |
Reports;
Payment of Royalty
|
| 5.5.1 |
During
the term of this Agreement following the First Commercial Sale of
a
Product, Merck shall furnish to Geron a quarterly written report
for the
Calendar Quarter showing the Net Sales of all Products subject to
royalty
payments sold by Merck and its Related Parties in the Territory during
the
reporting period and the royalties payable under this Agreement.
Reports
shall be due on the * (*) day following the close of each Calendar
Quarter. Royalties shown to have accrued by each
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
24
|
royalty
report shall be due and payable on the date such royalty report is
due.
Merck shall keep complete and accurate records in sufficient detail
to
enable the royalties payable hereunder to be determined.
|
| 5.6 |
Audits
|
| 5.6.1 |
Upon
the written request of Geron and not more than once in each Calendar
Year,
Merck shall permit an independent certified public accounting firm
of
nationally recognized standing selected by Geron and reasonably acceptable
to Merck, at Geron’s expense, to have access during normal business hours
to such of the records of Merck as may be reasonably necessary to
verify
the accuracy of the royalty reports within twenty-four (24) months
after
receipt by Geron of such royalty reports. The accounting firm shall
disclose to Geron only whether the royalty reports are correct or
incorrect and the amount of any discrepancy. No other information
shall be
provided to Geron.
|
| 5.6.2 |
If
such accounting firm identifies a discrepancy made during such period,
the
appropriate Party shall pay the other Party the amount of the discrepancy
within thirty (30) days of the date Geron delivers to Merck such
accounting firm’s written report so concluding, or as otherwise agreed
upon by the Parties. The fees charged by such accounting firm shall
be
paid by Geron, provided,
however,
that if such audit uncovers an underpayment of royalties by Merck
that
exceeds * of
the total royalties owed, then the fees of such accounting firm shall
be
paid by Merck.
|
| 5.6.3 |
Merck
shall include in each sublicense granted by it pursuant to this Agreement
a provision requiring the sublicensee to make reports to Merck, to
keep
and maintain records of sales made pursuant to such sublicense and
to
grant access to such records by Geron’s independent accountant to the same
extent required of Merck under this
Agreement.
|
| 5.6.4 |
Upon
the expiration of *
(*) months following the end of any Calendar Year, the calculation
of
royalties payable with respect to such year shall be binding and
conclusive upon Geron, and Merck and its Related Parties shall be
released
from any liability or accountability with respect to royalties for
such
year.
|
| 5.6.5 |
Geron
shall treat all financial information subject to review under Section
5.6.1 or under any sublicense agreement in accordance with the
confidentiality and non-use provisions of this Agreement, and shall
cause
its accounting firm to enter into an acceptable confidentiality agreement
with Merck and/or its Related Parties obligating it to retain such
information in confidence pursuant to such confidentiality agreement.
|
| 5.7 |
Payment
Exchange Rate
|
| 5.7.1 |
All
payments to be made by Merck to Geron under this Agreement shall
be made
in United States dollars and may be paid by bank wire transfer in
immediately available funds to such bank account in the United States
as
may be designated in writing by Geron from time to time. In the case
of
sales outside the United States, the rate of exchange to be used
in
computing the monthly amount of currency equivalent in United States
dollars due Geron shall be made at the monthly rate of exchange utilized
by Merck in its worldwide accounting system, prevailing on the third
to
the last business day of the month preceding the month in which such
sales
are recorded by Merck.
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
25
| 5.8 |
Income
Tax Withholding
|
| 5.8.1 |
If
laws, rules or regulations require withholding of income taxes or
other
taxes imposed upon payments set forth in this Article 5, Merck shall
make
such withholding payments as may be required and shall subtract such
withholding payments from the payments set forth in this Article
5. Merck
shall deliver to Geron a proof of payment within a reasonable period
of
time after making such withholding
payment.
|
| 6. |
REPRESENTATIONS
AND WARRANTIES; COVENANTS
|
| 6.1 |
Representations
and Warranties
|
| 6.1.1 |
Geron
Representations and Warranties.
Geron represents and warrants to Merck that, except as indicated
in
Schedule 6.1.1, as of the Effective Date of this
Agreement:
|
(a) to
Geron’s knowledge, the Geron Patent Rights and Geron Know-How exist and are not
invalid or unenforceable, in whole or in part in the Field;
(b) it
has
the full right, power and authority to enter into this Agreement, to perform
its
obligations under the Research Program and to grant the licenses granted under
Article 3 hereof;
(c) it
has
not previously assigned, transferred, conveyed or otherwise encumbered its
right, title and interest in Geron Patent Rights or Geron Know-How in the
Field;
(d) to
Geron’s knowledge, it is the sole and exclusive owner or licensee of the Geron
Patent Rights and Geron Know-How, all of which are (and shall be, in the case
of
Geron’s
interest in Program Patent Rights and Program Know-How)
free
and clear
of any
liens, charges and encumbrances, and no other person, corporate or other private
entity, or governmental entity or subdivision thereof, has or shall have any
claim of ownership whatsoever with respect to the Geron Patent Rights and Geron
Know-How in the Field;
(e) to
Geron’s knowledge there are no claims, judgments or settlements against or owed
by Geron and no pending or threatened claims or litigation relating to the
Geron
Patent Rights and Geron Know-How; and
(f) to
Geron’s knowledge Geron has disclosed to Merck all reasonably relevant
information regarding the Geron Patent Rights and Geron Know-How in the Field
licensed under this Agreement; and
(g) Geron
has
been informed of the potential co-promotion rights held by a Third Party, and
is
aware that its co-promotion
rights pursuant to Section 3.6 are limited by Merck’s pre-existing obligations
to such Third Party, as detailed in Schedule 6.1.2.
| 6.1.2 |
Merck
Representations and Warranties.
Merck represents and warrants to Geron that, except as indicated
in
Schedule 6.1.2, as of the Effective
Date:
|
(a) it
has
the full right, power and authority to enter into this Agreement, and to perform
its obligations under the Research Program, and to grant the licenses granted
under Article 3 hereof;
26
(b) to
Merck’s knowledge, it owns or Controls all intellectual property rights that as
of the Effective Date *;
(c) it
has
had a full opportunity to conduct, and has conducted, a diligence review of
the
Geron Patent Rights, Geron Know-How and the information disclosed in Schedule
6.1.1 and other matters relevant to this Agreement.
(d) Merck
has
been informed of the license rights granted by Geron, and the pre-existing
obligations of Geron, to a Third Party, and is aware that exclusivity with
respect to any license to Merck to develop and commercialize DC Products,
DC/Non-DC Therapies, and DC/Adeno/DNA Therapies
under
the
option
rights set forth in Section 3.2.3 is limited by the license rights granted,
and
Geron’s pre-existing obligations, to such Third Party, as detailed in Schedule
6.1.1.
| 6.2 |
Representation
and Covenant by Geron Related to Colorado
Agreement
|
Geron
represents and warrants to Merck that as of the Effective Date, Geron is party
to an Intellectual Property License Agreement with the University Technology
Corporation (“Colorado”)
dated
December 9, 1996, as such agreement is amended as of the Effective Date, true
and correct copies of which have been provided to Merck prior to the Effective
Date (“Colorado
Agreement”).
Geron
hereby covenants that in no event shall Geron terminate or amend, or knowingly
take any action or fail to take any action that will cause the termination
or
amendment of, the Colorado Agreement after the Effective Date in a manner that
would prejudice the rights of Merck pursuant to the Colorado Agreement.
| 6.3 |
Limitation
of Liability.
|
IN
NO
EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, SPECIAL, PUNITIVE,
INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION,
ANY LOSS OF PROFITS, LOSS OF BUSINESS, LOSS OF USE, LOSS OR INACCESSIBILITY
OF
DATA, OR INTERRUPTION OF BUSINESS, ARISING UNDER OR RELATING TO THIS AGREEMENT
OR THE SUBJECT MATTER HEREOF, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.
| 7. | INDEMNIFICATION; INSURANCE |
| 7.1 |
Indemnification
by
Geron
|
Subject
to the limitation of liability set forth in Section 6.1.4 hereof, Geron hereby
agrees at all times during the term of this Agreement to indemnify, defend
and
hold harmless Merck and its Affiliates (collectively, “Merck Indemnified
Parties”) from and against any and liabilities, actions, losses, damages, claims
or expenses, including reasonable attorneys’ fees and costs (collectively,
“Indemnified Losses”), arising from or based on a breach of Geron’s
representations and warranties contained in Section 6.1.1, provided that such
indemnification obligation shall not apply to Indemnified Losses on the part
of
a Merck Indemnified Party to the extent such Merck Indemnified Party is
adjudicated (in a final non-appealable judgment) to have acted in a grossly
negligent or willfully wrongful manner.
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
27
| 7.2 |
Indemnification
by Merck
|
Merck
agrees to defend, indemnify and hold harmless Geron and its Affiliates; the
University of Colorado; University License Equity Holdings, Inc.; and the Xxxxxx
Xxxxxx Medical Institute, and each of their directors, officers, employees,
and
agents (collectively the "Geron Indemnified Parties") from and against any
and
all Indemnified Losses (a) arising
from or based on a breach of Merck’s representations and warranties contained in
Section 6.1.2, or (b) resulting from personal injury, product liability or
property damage relating to or arising from: (i) the manufacture, use, promotion
or sale of any Product by Merck or its Related Parties; or (ii) the use by
any
person of a Product made, created, sold or otherwise transferred by Merck or
its
Related Parties; or (iii) the use by Merck or its Related Parties of Geron
Patent Rights, Geron Know-How, Geron Program Patent Rights or any Geron interest
in Program Know-How outside the Field;
provided
that
such indemnification obligation shall not apply to Indemnified Losses on the
part of a Geron Indemnified Party to the extent such Geron Indemnified Party
is
adjudicated (in a final non-appealable judgment) to have acted in a grossly
negligent or willfully wrongful manner.
| 7.3 |
Notification
of Claims; Conditions to Indemnification
Obligations
|
The
Parties shall promptly notify each other of any claims or suits with respect
to
which indemnification under this Agreement is or could be sought. The Party
requesting indemnification shall permit the indemnifying Party to assume the
defense of such claims or suits giving rise to the request at the indemnifying
Party’s sole expense. The Party requesting indemnification shall cooperate with
the indemnifying Party in such defense when reasonably requested to do so.
In no
event shall the indemnifying Party compromise or settle any claim or suit in
a
manner that admits fault or negligence on the part of the indemnified Party,
or
that would otherwise adversely affect any rights of the indemnified Party,
without the prior written consent of the indemnified Party. The indemnifying
Party shall have no liability under this Article 7 with respect to claims or
suits settled or compromised without the indemnifying Party’s prior knowledge
and express written consent.
| 7.4 |
Insurance
|
Throughout
the term of this Agreement, Merck shall obtain and keep in force comprehensive
general liability insurance or shall self insure covering each occurrence of
bodily injury and property damage in amounts consistent with other similar
contractual arrangements of Merck. Merck shall deliver to Geron, at Geron’s
request, an insurer or insurer’s agent signed Certificates of Insurance, as
evidence that policies providing such coverage of insurance are in full force
and effect and with insurers, having an AM Best (A-) or higher rating.
Thereafter, the certificates of insurance shall be provided annually. These
Certificates shall provide that not less than thirty (30) calendar days advance
notice will be given in writing to Geron of any cancellation, termination,
or
material alteration of said insurance policies. The Geron Indemnified Parties
shall be added as additional insureds on all policies. Except for Indemnified
Losses on the part of a Geron Indemnified Party to the extent such Geron
Indemnified Party is adjudicated (in a final non-appealable judgment) to have
acted in a grossly negligent or willfully wrongful manner, Merck's insurance
shall be primary with no contribution by Geron's insurance.
28
| 8. |
PATENT
PROVISIONS
|
| 8.1 |
Geron
Patent Rights
|
| 8.1.1 |
Filing
Prosecution and Maintenance of Geron Patent
Rights
|
Geron
shall use Commercially Reasonable Efforts to file, prosecute and maintain in
the
Territory the Geron Patent Rights licensed to Merck under this Agreement. Geron
shall provide Merck with periodic updates on prosecution of Geron Patent Rights
relevant to the Field and shall cooperate with Merck with respect to strategies
for securing patent protection for the Field. In particular, Geron shall consult
with Merck and consider Merck’s suggestions regarding countries where such Geron
Patent Rights shall be filed. All final decisions with respect to prosecution
of
Geron Patent Rights shall be made by Geron.
| 8.1.2 |
Interference,
Opposition, Reexamination and Reissue of Geron Patent
Rights
|
(a)
Geron
shall, within ten (10) days of learning of such event, inform Merck of any
request for, or filing or declaration of, any interference, opposition, reissue
or reexamination relating to Geron Patent Rights. Merck and Geron shall
thereafter consult and cooperate fully to determine a course of action with
respect to any such proceeding. All final decisions with respect to such
proceedings shall be made by Geron.
(b)
Any
decision to initiate any reexamination, interference or reissue proceeding
relating to Geron Patent Rights relevant to the Field shall be taken in
consultation with Merck, but any final decision with respect to such proceedings
shall be made by Geron.
(c)
In
connection with any interference, opposition, reissue, or reexamination
proceeding relating to Geron Patent Rights relevant to the Field, Merck and
Geron will cooperate fully and will provide each other with any information
or
assistance that either may reasonably request. Geron shall keep Merck informed
of developments in any such action or proceeding, including, to the extent
permissible by law, consultation on any settlement, the status of any settlement
negotiations and the terms of any offer related thereto. Any final decision
to
settle any such action shall be made by Geron.
(d)
Geron
shall bear the expense of any interference, opposition, reexamination, or
reissue proceeding relating to Geron Patent Rights.
| 8.1.3 |
Enforcement
and Defense of Geron Patent Rights and Geron
Know-How
|
(a)
Each
Party shall provide the other with notice of any infringement or declaratory
judgment action with respect to Geron Patent Rights or misappropriation or
misuse of Geron Know-How with respect to Non-DC Products in the Field that
may
come to its attention. Merck and Geron shall thereafter consult and cooperate
fully to determine a course of action, including but not limited to the
commencement of legal action to terminate such infringement or misappropriation.
As between Merck and Xxxxx, Xxxxx shall have the right to initiate and prosecute
such legal action at its own expense, and to control the defense of any
declaratory judgment action, relating to Geron Patent Rights. Geron shall keep
Merck informed of developments in any such action or proceeding, including
consultation on any settlement, the status of any settlement negotiations and
the terms of any offer related thereto.
29
(b)
At
Geron’s request, Merck shall join any such action as a party. Merck and Geron
may agree to jointly undertake a legal action to defend or enforce the Geron
Patent Rights or Geron Know-How in the Field.
(c)
With
respect to infringement of Geron Patent Rights or misappropriation or misuse
of
Geron Know-How in connection with a product which would, under this Agreement
constitute a Non-DC Product for use in the Field then, where such product is
either (1) a product marketed by a Third Party, or (2) a product proposed to
be
marketed by a Third Party and in respect of which Geron or Merck has received
certification under 21 U.S.C. §§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its
successor provisions, or any similar provisions relating to biologicals in
a
country in the Territory, Geron’s right to initiate and prosecute an appropriate
legal action shall be a first right. Within five (5) business days of receipt
of
such certification, Geron shall provide Merck with a copy of such certification
and Geron shall timely inform Merck if it elects not to exercise such first
right and, subject to any other obligations of Geron existing as of the
Effective Date, Merck shall thereafter have the right to initiate and prosecute
such action to terminate infringement, of Geron Patent Rights, or
misappropriation or misuse of Geron Know-How in the names of Merck and, if
necessary, Geron. If Merck exercises its right to assume initiation and/or
prosecution of such actions, Merck shall keep Geron informed of developments
in
any such action or proceeding, including consultation on any settlement, the
status of any settlement negotiations and the terms of any offer related
thereto. No settlement or other concession of any action related to Geron Patent
Rights initiated by Merck as permitted by this paragraph shall be entered into
without Geron’s written agreement.
(d)
In
any
action pursuant to this Section 8.1.3, each Party shall have the right to be
represented by counsel of its own choice, and Merck and Geron will cooperate
fully and will provide each other with any information or assistance that either
may reasonably request.
| 8.1.4 |
Any
recovery obtained by either Geron or jointly by Merck and Geron in
connection with or as a result of any action contemplated by this
Section
8.1, whether by settlement or otherwise, shall be shared in order
as
follows:
|
(a) The
Party
which initiated and prosecuted the action shall recoup all of its costs and
expenses incurred in connection with the action;
(b) The
other
Party shall then, to the extent possible, recover its costs and expenses
incurred in connection with the action; and
(c) the
amount of any recovery remaining shall then be allocated between the Parties
on
a pro rata
basis
taking into consideration the relative economic losses suffered by each
Party.
| 8.2 |
Licensed
Program Patent Rights
|
| 8.2.1 |
Filing,
Prosecution and Maintenance of Licensed Program Patent
Rights
|
(a) Geron
shall have the first right to file, prosecute and maintain in the Territory,
upon appropriate consultation with Merck, the Geron Program Patent Rights,
and
Merck shall have the first right to file, prosecute and maintain in the
Territory, upon appropriate consultation with Geron, the Merck Program Patent
Rights and Joint Program Patent Rights. Each Party shall promptly provide a
written report to the other Party of any potentially patentable Program Know-How
that may be solely or partially owned by the other Party prior to the filing
of
any corresponding patent application, together with the Party’s determination of
inventorship for that Invention. With respect to all proposed Licensed Program
Patent Rights for which a patent application is to be filed, the filing Party
shall give the non-filing Party an opportunity to review the text of the
application before filing, shall consult with the non-filing Party with respect
thereto, including with respect to determination of inventorship and ownership.
The filing Party shall supply the non-filing Party with a copy of the
application as filed, together with notice of its filing date and serial number.
Upon request by the non-filing Party, the filing Party shall also provide the
non-filing Party with timely copies of all papers related to the prosecution
and
maintenance of patents and patent applications covering Licensed Program Patent
Rights at least fifteen (15) days in advance of the filing of any response
and
shall take into account any comments and suggestions made by the non-filing
Party. Each Party shall promptly give notice to the other of the allowance,
grant, lapse, revocation, surrender, invalidation or abandonment of any Licensed
Program Patent Rights for which it is responsible for the filing, prosecution
and maintenance. With respect to all filings hereunder, the filing Party shall
be responsible for payment of all costs and expenses related to such
filings.
30
(b) If
the
Party with the first right to file, prosecute or maintain Licensed Program
Patent Rights elects not to do so, it shall timely notify the other Party,
and
the other Party shall have the right to file, prosecute or maintain, as
applicable, such Licensed Program Patent Rights. The non-filing Party shall
execute such documents and perform such acts at its expense as may be reasonably
necessary for the other to perform such filing, prosecution and/or maintenance.
In the event that Geron elects not to file, prosecute or maintain Licensed
Program Patent Rights , and Merck assumes the burden of doing so, then the
associated expenses and costs incurred by Merck shall be fully creditable
against any royalties owed by Merck under this Agreement; provided,
however,
that no
royalty payment when due, regardless of the number of such credits available
in
accordance with the terms of this Agreement, shall be reduced by more than
*
percent (*%). Unused credits may be carried over into subsequent royalty
periods. In the event that Merck elects, pursuant to the notice provisions
of
Section 10.4, not to file, prosecute or maintain Licensed Program Patent Rights,
and Geron assumes the burden of doing so, then the associated expenses and
costs
incurred by Geron shall be borne by Geron, and Geron shall receive an automatic,
irrevocable fully paid-up and freely sublicensable license under any such
Licensed Program Patent Rights.
| 8.2.2 |
Interference,
Opposition, Reexamination and
Reissue
|
(a) Each
Party shall, within ten (10) days of learning of such event, inform the other
of
any request for, or filing or declaration of, any interference, opposition,
reissue or reexamination relating to Program Patent Rights. The right to control
any such proceeding with respect to Licensed Program Patent Rights shall be
as
specified with respect to patent filing, prosecution and maintenance in Section
8.2.1.
(b) Neither
Party shall initiate any reexamination, interference or reissue proceeding
relating to Licensed Program Patent Rights without the prior written consent
of
the other, which consent shall not be unreasonably withheld.
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
31
(c) In
connection with any interference, opposition, reissue, or reexamination
proceeding relating to Licensed Program Patent Rights, Merck and Geron will
cooperate fully and will provide each other with any information or assistance
that either may reasonably request. Each Party shall keep the other informed
of
developments in any such action or proceeding, including, to the extent
permissible by law, consultation on and approval of any settlement, the status
of any settlement negotiations and the terms of any offer related
thereto.
(d) Geron
shall bear the expense of any interference, opposition, reexamination, or
reissue proceeding relating to Geron Program Patent Rights. Merck shall bear
the
expense of any interference, opposition, reexamination, or reissue proceeding
relating to Merck Program Patent Rights or Joint Program Patent
Rights.
| 8.2.3 |
Enforcement
and Defense of Program Know-How and Licensed Program Patent Rights
|
(a) Each
Party shall give the other notice of either (i) any infringement of Licensed
Program Patent Rights, (ii) any declaratory judgment action relating to Licensed
Program Patent Rights or (iii) any misappropriation or misuse of Program
Know-How that is licensed hereunder, that may come to its attention. Geron
shall
have the right to initiate and prosecute, at its own expense, actions to
terminate any infringement of Geron Program Patent Rights and/or to control
the
defense of any declaratory judgment action relating to Geron Program Patent
Rights. Merck shall have the right to initiate and prosecute, at its own
expense, actions to terminate any infringement of Merck Program Patent Rights
and/or to control the defense of any declaratory judgment action relating to
Merck Program Patent Rights. The Parties shall mutually agree on any strategy
to
initiate and prosecute actions to terminate any infringement of Joint Program
Patent Rights and/or to control the defense of any declaratory judgment action
relating to Joint Program Patent Rights. The Parties shall mutually agree on
any
strategy to bring non-patent legal action to address any misappropriation or
misuse of Program Know-How . (b) With
respect to infringement of Licensed Program Patent Rights , if the Party having
the right to initiate and prosecute an action as provided in this Section 8.2.3
elects not to exercise such right, it shall promptly inform the other, and
at
the request of the other Party, the Parties shall agree upon a strategy and
cost-sharing arrangement under which the other Party may initiate and prosecute
such action and/or control the defense of such declaratory judgment action
in
the name of one or both of the Parties as necessary and/or appropriate. For
any
action to terminate any infringement of Licensed Program Patent Rights or
address any misappropriation or misuse of Program Know-How, in the event that
a
first Party is unable to initiate or prosecute such action solely in its own
name, the other Party will join such action voluntarily and will execute and
cause its Affiliates and/or Related Parties to execute all documents necessary
for the first Party to initiate litigation to prosecute and maintain such
action.
(c) In
connection with any action under this Section 8.2.3, Merck and Geron will
cooperate fully and will provide each other with any information or assistance
that either may reasonably request. Each Party shall keep the other informed
of
developments in any action or proceeding, including, to the extent permissible
by law, consultation on and approval of any settlement, the status of any
settlement negotiations and the terms of any offer related thereto. Each Party
shall have the right to be represented by counsel of its own
choice.
| 8.2.4 |
Any
recovery obtained by either or both Merck and Geron in connection
with or
as a result of any action contemplated by this Section, whether by
settlement or otherwise, shall be shared in order as
follows:
|
32
(a) the
Party
which initiated and prosecuted the action shall recoup all of its costs and
expenses incurred in connection with the action;
(b) the
other
Party shall then, to the extent possible, recover its costs and expenses
incurred in connection with the action; and
(c) the
amount of any recovery remaining shall then be allocated between the Parties
on
a pro rata
basis
taking into consideration the relative economic losses suffered by each
Party.
| 8.2.5 |
Each
Party shall inform the other of any certification regarding any Licensed
Program Patent Rights it has received pursuant to either 21 U.S.C.
§§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor provisions,
or
any similar provisions relating
to biologicals in
a country in the Territory , and shall provide the other Party with
a copy
of such certification within five (5) days of receipt. Geron’s and Merck’s
rights with respect to the initiation and prosecution of any legal
action
as a result of such certification or any recovery obtained as a result
of
such legal action shall be as defined in Section 8.2.3 hereof. Regardless
of which Party has the right to initiate and prosecute such action,
both
Parties shall, as soon as practicable after receiving notice of such
certification, convene and consult with each other regarding the
appropriate course of conduct for such action. The non-initiating
Party
shall have the right to be kept fully informed and participate in
decisions regarding the appropriate course of conduct for such action,
and
the right to join and participate in such
action.
|
| 8.3 |
Patent
Term Restoration
|
| 8.3.1 |
The
Parties hereto shall cooperate with each other, including without
limitation to provide necessary information and assistance as the
other
Party may reasonably request, in obtaining patent term restoration
or
supplemental protection certificates or their equivalents in any
country
in the Territory where applicable to any Patent Rights subject to
this
Agreement.
|
| 9. |
TERM
AND TERMINATION
|
| 9.1 |
Term
and Expiration
|
| 9.1.1 |
This
Agreement shall be effective as of the Effective Date and unless
terminated earlier pursuant to Sections 9.2 or 9.3 below, this Agreement
shall continue in effect until expiration of all royalty obligations
hereunder. Upon natural expiration of this Agreement, Merck’s licenses
pursuant to Section 3.1 shall become fully paid-up, perpetual
licenses.
|
| 9.2 |
Termination
by Merck
|
| 9.2.1 |
Notwithstanding
anything contained herein to the contrary, Merck shall have the right
to
terminate this Agreement at any time after the second anniversary
of the
Effective Date in its sole discretion by giving ninety (90) days’ advance
written notice to Geron. No later than thirty (30) days after the
effective date of such termination, each Party shall return or cause
to be
returned to the other Party all Information in tangible form received
from
the other Party and all copies thereof; provided,
however,
that each Party may retain any Information reasonably necessary for
such
Party’s continued practice under any license(s) which do not terminate
pursuant to this Section, and may keep one copy of Information received
from the other Party in its confidential files for record purposes.
In the
event of termination under this Section 9.2.1 each Party shall pay
any
amounts then due and owing to the other Party as of the termination
date;
(ii) except for the surviving provisions set forth in Section 9.5
hereof
and Section 3.3, the rights and obligations of the Parties hereunder
shall
terminate as of the date of such termination, provided, however,
that
Merck shall have a fully paid up non-exclusive license to use Geron’s
interest in Joint Program Patent Rights and Joint Program Know-How
for
research purposes only; and (iii) in the event that Merck has obtained
an
exclusive license right from a Third Party to the use of Telomerase
Antigen with such Third Party’s intellectual property, Merck shall
promptly terminate Merck’s exclusive rights under such license with such
Third Party specifically related to Telomerase Antigen and shall
promptly
notify Geron of the date of such termination. In the event of termination
under this Section 9.2, in addition to other provisions of the Agreement
that are specified to survive termination in Section 9.4.2, Article
5 of
the Agreement (other than any and all aspects of patent royalties
payable
under 5.4.1(a)) shall also survive
termination.
|
33
| 9.3 |
Termination
for Cause
|
| 9.3.1 |
Notice
and Cure.
In
the event that a first Party views that the second Party is in material
breach of its obligations hereunder as a result of causes and reasons
within the control of the second Party then the first Party shall
provide
written notice to the second Party providing a detailed explanation
of the
asserted material breach. The second Party shall then either (1)
cure such
asserted material breach within ninety (90) days after actual receipt
of
such written notice (or such longer period as may be agreed by the
Parties) or, if the second Party disagrees that it is in material
breach,
(2) initiate dispute resolution pursuant to Section 10.6, whereupon
the
ninety (90) day cure period shall be tolled until the dispute is
resolved.
|
| 9.3.2 |
Material
Breach.
Either Party may terminate this Agreement upon written notice for
material
breach but only after (1) the non-breaching Party has provided the
breaching Party with notice and an opportunity to cure as specified
in
9.3.1 and has failed to cure the breach; and (2) any dispute resolution
invoked under Section 10.6 pertaining to the existence of a material
breach has been resolved.
|
| 9.3.3 |
Financial
Insolvency.
Either Party may terminate this Agreement upon written notice upon
the
filing or institution of bankruptcy, reorganization, liquidation
or
receivership proceedings, or upon an assignment of a substantial
portion
of the assets for the benefit of creditors by the other Party;
provided,
however,
that in the case of any involuntary bankruptcy proceeding such right
to
terminate shall only become effective if the Party consents to the
involuntary bankruptcy or such proceeding is not dismissed within
ninety
(90) days after the filing thereof.
|
| 9.3.4 |
Effect
of Termination for Cause on Licenses.
If Merck terminates this Agreement under Section 9.4 on the basis
of
material breach for which Merck cannot otherwise be made whole by
Geron,
Merck’s licenses pursuant to Section 3.1 shall continue and shall remain
fully subject to all financial obligations set forth in Section 5,
except
that, with respect to the royalty obligations set forth in Section
5.4.1,
Merck shall only be obligated to pay a royalty pursuant to Section
5.4.1(a) for the duration of any Valid Patent Claim pursuant to Section
5.4.1(b)(1), and Merck shall not be obligated to pay a know-how royalty
pursuant to Section 5.4.1(c). Upon such termination by Merck, Geron
shall,
within thirty (30) days after the effective date of such termination,
return or cause to be returned to Merck all Information in tangible
form,
and all substances or compositions delivered or provided by Merck,
as well
as any other material provided by Merck in any medium. If Geron terminates
this Agreement under Section 9.4, Merck’s licenses pursuant to Section 3.1
shall terminate as of such termination date and Merck shall, within
thirty
(30) days after the effective date of such termination, return or
cause to
be returned to Geron all Information in tangible form and substances
or
compositions delivered or provided by Geron, as well as any other
material
provided by Geron in any medium.
|
34
| 9.4 |
Effect
of Expiration or Termination;
Survival
|
| 9.4.1 |
If,
after termination of this Agreement by Merck pursuant to Section
9.2 or by
Geron pursuant to Section 9.4, should Geron thereafter undertake
development of a Product, then at Merck’s sole discretion, Geron and Merck
shall meet to negotiate a license to Geron under any Merck Know-How
that
was conveyed to Geron during the course of the Agreement. For the
avoidance of doubt, Merck shall not be obligated to provide such
a license
to Geron.
|
| 9.4.2 |
Expiration
or termination of this Agreement shall not relieve the Parties of
any
obligation accruing prior to such expiration or termination. Any
expiration or termination of this Agreement shall be without prejudice
to
the rights of either Party against the other accrued or accruing
under
this Agreement prior to expiration or termination, including without
limitation the obligation to pay royalties for Product(s) sold prior
to
such expiration or termination. The provisions of Article 4 shall
survive
the expiration or termination of this Agreement and shall continue
in
effect for ten (10) years. In addition, the provisions of Articles
1, 6,
7, 8, and 9 (other than Section 9.2) shall survive any expiration
or
termination of this Agreement.
|
| 10. | MISCELLANEOUS |
| 10.1 |
Force
Majeure
|
| 10.1.1 |
Neither
Party shall be held liable to the other Party nor be deemed to have
defaulted under or breached this Agreement for failure or delay in
performing any obligation under this Agreement to the extent that
such
failure or delay is caused by or results from causes beyond the reasonable
control of the affected Party, potentially including, but not limited
to,
embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other
labor
disturbances, fire, floods, or other acts of God, or acts, omissions
or
delays in acting by any governmental authority or the other Party.
The
affected Party shall notify the other Party of such force majeure
circumstances as soon as reasonably practical, and shall promptly
undertake all reasonable efforts necessary to cure such force majeure
circumstances.
|
| 10.2 |
Assignment/
Change of Control
|
| 10.2.1 |
Except
as provided in this Section 10.2, this Agreement may not be assigned
or
otherwise transferred, nor may any right or obligation hereunder
be
assigned or transferred, by either Party without the consent of the
other
Party. Merck may, without Geron’s consent, assign this Agreement and its
rights and obligations hereunder in whole or in part to a Merck Affiliate
or in connection with a Change of Control (as defined below). Geron
may,
without Merck’s consent, assign this Agreement and its rights and
obligations hereunder (except as specified below) in connection with
a
Change of Control; provided,
however,
that Geron must notify Merck at least thirty (30) days prior to completion
of any Major Pharma Change of Control, and Merck shall have the right,
at
any time after receipt of such notice, to notify Geron of the termination
of the Research Program.
|
| 10.2.2 |
Notwithstanding
the foregoing, the rights and obligations of Geron in Section 3.6
may not
be assigned in the event of a Major Pharma Change of Control under
any
circumstances without Merck’s prior written
consent.
|
| 10.2.3 |
For
purposes of this Section 10.2, a “Change
of Control”
of a Party shall be deemed to occur if such Party is involved in
a merger,
reorganization or consolidation, or if there is a sale of all or
substantially all of such Party’s assets or business relating to this
Agreement or if a person or group other than the current controlling
person or group shall effectively acquire control of the management
and
policies of such Party, and a “Major
Pharma Change of Control”
shall mean a Change of Control in which the acquiring or merging
or entity
either (i) has any cancer vaccine product in clinical development
or
approved in any country, or (ii) had worldwide pharmaceutical sales
in
excess of * during the Calendar Year preceding such merger or
acquisition.
|
35
| 10.2.4 |
Any
permitted assignee shall assume all assigned obligations of its assignor
under this Agreement. Any attempted assignment not in accordance
with this
Section 10.2 shall be void.
|
| 10.3 |
Severability
|
| 10.3.1 |
If
any one or more of the provisions contained in this Agreement is
held
invalid, illegal or unenforceable in any respect, the validity, legality
and enforceability of the remaining provisions contained herein shall
not
in any way be affected or impaired thereby, unless the absence of
the
invalidated provision(s) adversely affects the substantive rights
of the
Parties. The Parties shall in such an instance use their best efforts
to
replace the invalid, illegal or unenforceable provision(s) with valid,
legal and enforceable provision(s) which, insofar as practical, implement
the purposes of this Agreement.
|
| 10.4 |
Notices
|
| 10.4.1 |
All
notices which are required or permitted hereunder shall be in writing
and
sufficient if delivered personally, sent by facsimile (and promptly
confirmed by personal delivery, registered or certified mail or overnight
courier), sent by nationally-recognized overnight courier or sent
by
registered or certified mail, postage prepaid, return receipt requested,
addressed as follows:
|
|
If
to Geron, to:
|
000
Xxxxxxxxxxxx Xxxxx,
Xxxxx
Xxxx, XX 00000
Attention:
Corporate Development
Facsimile
No.: (000) 000-0000
|
|
and:
|
Xxxxxx
& Xxxxxxx LLP
000
Xxxxxxxxxxxx Xx.
Xxxxx
Xxxx, XX 00000
Facsimile
No.: (000) 000-0000
|
|
If
to Merck, to:
|
Merck
& Co., Inc.
Xxx
Xxxxx Xxxxx
X.X.
Xxx 000, XX0X-00
Xxxxxxxxxx
Xxxxxxx, XX 00000-0000
Attention:
Office of Secretary
Facsimile
No.: *
|
|
and:
|
Merck
& Co., Inc.
One
Merck Drive
Attention:
Chief Licensing Officer
X.X.
Xxx 000, XX0X-00
Xxxxxxxxxx
Xxxxxxx, XX 00000-0000
Facsimile:
*
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
36
or
to
such other address(es) as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. Any such notice
shall be deemed to have been given: (a) when delivered, if personally delivered
or sent by facsimile on a business day (or if delivered or sent on a
non-business day, then on the next business day); (b) on the business day after
dispatch, if sent by nationally-recognized overnight courier; or (c) on the
fifth (5th)
business day following the date of mailing, if sent by mail.
| 10.5 |
Applicable
Law
|
| 10.5.1 |
This
Agreement shall be governed by and construed in accordance with the
laws
of the State of Delaware and the patent laws of the United States,
without
reference to any rules of conflict of
laws.
|
| 10.6 |
Dispute
Resolution
|
| 10.6.1 |
The
Parties shall negotiate in good faith and use reasonable efforts
to settle
any dispute, controversy or claim arising from or related to this
Agreement or the breach thereof. If the Parties do not fully settle,
and a
Party wishes to pursue the matter, each such dispute, controversy
or claim
that is not an “Excluded Claim” shall be finally resolved by binding
arbitration in accordance with the Commercial Arbitration Rules and
Supplementary Procedures for Large Complex Disputes of the American
Arbitration Association (“AAA”), and judgment on the arbitration award may
be entered in any court having jurisdiction
thereof.
|
| 10.6.2 |
The
arbitration shall be conducted by a panel of three persons experienced
in
the pharmaceutical business: within thirty (30) days after initiation
of
arbitration, each Party shall select one person to act as arbitrator;
and
the two Party-selected arbitrators shall select a third arbitrator
within
thirty (30) days of their appointment. If the arbitrators selected
by the
Parties are unable or fail to agree upon the third arbitrator, the
third
arbitrator shall be appointed by the AAA. The place of arbitration
shall
be New York, New York, and all proceedings and communications shall
be in
English.
|
| 10.6.3 |
Either
Party may apply to the arbitrators for interim injunctive relief
until the
arbitration award is rendered or the controversy is otherwise resolved.
Either Party also may, without waiving any remedy under this Agreement,
seek from any court having jurisdiction any injunctive or provisional
relief necessary to protect the rights or property of that Party
pending
the arbitration award. The arbitrators shall have no authority to
award
punitive or any other type of damages not measured by a Party’s
compensatory damages. Each Party shall bear its own costs and expenses
and
attorneys’ fees and an equal share of the arbitrators’ fees and any
administrative fees of arbitration.
|
| 10.6.4 |
Except
to the extent necessary to confirm an award or as may be required
by law,
neither a Party nor an arbitrator may disclose the existence, content,
or
results of an arbitration without the prior written consent of both
Parties. In no event shall an arbitration be initiated after the
date when
commencement of a legal or equitable proceeding based on the dispute,
controversy or claim would be barred by the applicable Delaware statute
of
limitations.
|
| 10.6.5 |
The
Parties agree that, in the event of a dispute over the nature or
quality
of performance under this Agreement, neither Party may terminate
this
Agreement until final resolution of the dispute through arbitration
or
other judicial determination. The Parties further agree that any
payments
made pursuant to this Agreement pending resolution of the dispute
shall be
refunded if an arbitrator or court determines that such payments
are not
due.
|
37
| 10.6.6 |
As
used in this Section, the term “Excluded
Claim”
shall mean a dispute, controversy or claim that concerns (a) the
validity
or infringement of a patent, trademark or copyright; or (b) any antitrust,
anti-monopoly or competition law or regulation, whether or not statutory.
Notwithstanding this Section 10.6.6, the Parties agree that any dispute
as
to ownership arising under Sections 1.65 (Synthetic Epitope) and
1.27
(Fusion Protein) shall be subject to the dispute resolution provisions
of
this Section 10.6 and shall not be considered an Excluded
Claim.
|
| 10.7 |
Entire
Agreement; Amendments
|
| 10.7.1 |
This
Agreement contains the entire understanding of the Parties with respect
to
the Research Program and the licenses granted hereunder. Any other
express
or implied agreements and understandings, either oral or written,
with
regard to the Research Program or the licenses granted hereunder
are
superseded by the terms of this Agreement. This Agreement may be
amended,
or any term hereof modified, only by a written instrument duly executed
by
authorized representatives of both Parties
hereto.
|
| 10.8 |
Headings
|
| 10.8.1 |
The
captions to the several Articles and Sections hereof are not a part
of
this Agreement, but are merely for convenience to assist in locating
and
reading the several Articles and Sections
hereof.
|
| 10.9 |
Independent
Contractors
|
| 10.9.1 |
It
is expressly agreed that Geron and Merck shall be independent contractors
and that the relationship between the Parties shall not constitute
a
partnership, joint venture or agency. Neither Geron nor Merck shall
have
the authority to make any statements, representations or commitments
of
any kind, or to take any action, which shall be binding on the other
Party, without the prior written consent of the other
Party.
|
| 10.10 |
Waiver
|
| 10.10.1 |
The
waiver by either Party hereto of any right hereunder, or of any failure
of
the other Party to perform, or of any breach by the other Party,
shall not
be deemed a waiver of any other right hereunder or of any other breach
by
or failure of such other Party, whether of a similar nature or
otherwise.
|
| 10.11 |
Cumulative
Remedies
|
| 10.11.1 |
No
remedy referred to in this Agreement is intended to be exclusive,
but each
shall be cumulative and in addition to any other remedy referred
to in
this Agreement or otherwise available under
law.
|
| 10.12 |
Waiver
of Rule of
Construction
|
| 10.12.1 |
Each
Party has had the opportunity to consult with counsel in connection
with
the review, drafting and negotiation of this Agreement. Accordingly,
the
rule of construction that any ambiguity in this Agreement shall be
construed against the drafting Party shall not
apply.
|
38
| 10.13 |
Counterparts
|
| 10.13.1 |
This
Agreement may be executed in two or more counterparts, each of which
shall
be deemed an original, but all of which together shall constitute
one and
the same instrument.
|
39
IN
WITNESS WHEREOF,
the
Parties have executed this Agreement as of the date first set forth
above.
| MERCK & CO., INC. | GERON CORPORATION | |
| BY: /s/ Xxxxxxx Xxxxx | BY: /s/ Xxxxxx X. Xxxxxx | |
|
|
|
|
|
XXXXXXX
X. CLARK CHIEF
EXECUTIVE OFFICER AND PRESIDENT |
XXXXXX
X. XXXXXX
TITLE:
CHIEF EXECUTIVE OFFICER AND PRESIDENT
|
|
| DATE: 7/14/05
|
DATE:
July
14, 2005
|
8/2/05
40
SCHEDULE
1.28
GERON
PATENT RIGHTS
 |
|||||
|
Patent
|
Serial
No.
|
Geron
Docket
|
Status
|
Title
|
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
| |
*.
|
|||||
|
Patent
|
Serial
No.
|
Geron
Docket
|
Ownership
|
Status
|
Title
|
|
|
*
|
*
|
*
|
*
|
*
|
*
|
*
|
|
*
|
*
|
*
|
*
|
*
|
*
|
*
|
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
SCHEDULE
2.1
RESEARCH
PROGRAM
*
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
SCHEDULE
3.6
CO-PROMOTION
TERMS
*
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
SCHEDULE
4.4.2
DRAFT
PRESS RELEASE
GERON
ENTERS INTO A COLLABORATION AND LICENSE AGREEMENT WITH MERCK & CO., INC. FOR
CANCER VACCINES TARGETING TELOMERASE
Menlo
Park, CA - July XX, 2005
- Geron
Corporation (Nasdaq: GERN) announced today it has entered into a collaboration
and license agreement with Merck & Co., Inc. (NYSE: MRK) to develop a cancer
vaccine targeting telomerase utilizing Merck’s expertise in vaccine
technologies.
Under
the
terms of the agreement, Geron will receive an upfront payment, milestone
payments upon achievement of certain development and regulatory events, and
royalties. Merck has also agreed to acquire equity in Geron at a future date
as
part of Geron’s next round of financing. Additional financial terms were not
disclosed.
In
addition, Merck has acquired an exclusive option to negotiate a separate
agreement for Geron’s dendritic cell-based telomerase vaccine currently in Phase
I/II clinical trials at Duke University Medical Center. Geron will receive
an
option payment from Merck in consideration for the option. The structure and
terms of an agreement for the dendritic cell vaccine will be negotiated should
Merck exercise its rights under the option.
“This
alliance reflects Merck’s recognition of telomerase as an important cancer
target and Geron’s recognition of the strength of Merck’s vaccine platform,”
said Xxxxxx Xxxxxx, M.D., Ph.D., Geron’s president and chief executive officer.
“Our decision to collaborate with Merck was an easy one to make. In the course
of our discussions, we have been impressed with Merck’s focus and commitment to
developing cancer vaccines.”
Geron
and
Merck have jointly developed a research and development plan to optimize and
expedite the demonstration of efficacy and tolerability of a potential vaccine
against telomerase using Merck’s platform. Meanwhile, Geron will continue
development of its dendritic cell-based vaccine product, which is currently
in
Phase I/II clinical trials and is the subject of the exclusive option obtained
by Merck.
“We
at
Merck are excited about what Geron has demonstrated with telomerase in cancer.
Our objective is to combine our technologies with the hope of bringing a product
to market that may have application across a large number of cancers,” said
Xxxxxxx Xxxxxx, M.D., Ph.D., executive vice president, Advanced Technology
and
Oncology at Merck Research Laboratories. “This is a project of high interest and
commitment at Merck, and is indicative of Merck’s strategic direction in
developing new anti-cancer therapies.”
TELOMERASE
AND CANCER
Telomerase
is an enzyme, active in most cancer cells, that maintains telomere length at
the
ends of chromosomes. This activity confers replicative immortality to the cells
in the tumor, allowing the cancer to grow and metastasize over long periods
of
time. Because telomerase is inactive or only transiently expressed in normal
human tissues, and is critical to the growth and progression of most cancer
types, it is regarded as a universal and specific cancer target.
(more)
Page
Two / Geron Enters Into a Collaboration and License Agreement with Merck &
Co., Inc. for Cancer Vaccines Targeting Telomerase
Geron
is
a biopharmaceutical company developing and commercializing three groups of
products: i) therapeutic products for oncology that target telomerase; ii)
pharmaceuticals that activate telomerase in tissues impacted by senescence,
injury or degenerative disease; and iii) cell-based therapies derived from
its
human embryonic stem cell platform for applications in multiple chronic
diseases.
Geron
has
two anti-cancer products in the clinic that target telomerase: GRN163L, a potent
and specific telomerase inhibitor drug that has just received clearance from
the
FDA to begin testing in patients with chronic lymphocytic leukemia (CLL); and
GRNVAC1, a telomerase therapeutic vaccine currently in multiple Phase I/II
trials at Duke in patients with prostate cancer.
In
March,
results of the first completed Phase I/II clinical trial at Duke of GRNVAC1
in
metastatic prostate cancer patients was published in the Journal
of Immunology
(JI,
2005, 174:3798-38097). The vaccine protocol successfully generated telomerase
specific T-cell responses in 19 of 20 subjects. The vaccine was well tolerated
with no major treatment-related toxicities. Peak immune responses to vaccination
were remarkably high, with between 1%-2% of circulating CD8+ T-cells
demonstrating anti-telomerase specificity. Clinically, vaccination was
associated with a statistically significant increase in PSA doubling time and
clearance of prostate cancer cells from the patients’ blood.
This
news
release may contain forward-looking statements made pursuant to the “safe
harbor” provisions of the Private Securities Litigation Reform Act of 1995.
Investors are cautioned that such forward-looking statements in this press
release regarding potential applications of Geron’s technologies constitute
forward-looking statements that involve risks and uncertainties, including,
without limitation, risks inherent in the development and commercialization
of
potential products, need for future capital, dependence on collaborators and
maintenance of our
intellectual property rights.
Actual
results may differ materially from the results anticipated in these
forward-looking statements. Additional information on potential factors that
could affect our results and other risks and uncertainties are detailed from
time to time in Geron’s periodic reports, including the quarterly report on Form
10-Q for the quarter ended March 31, 2005.
Contact:
Xxxxx
X.
Xxxxxxxxx
Chief
Financial Officer
000-000-0000
###
SCHEDULE
6.1.1
GERON
SCHEDULE OF EXCEPTIONS
*
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
SCHEDULE
6.1.2
MERCK
SCHEDULE OF EXCEPTIONS
*
*
Certain
information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
