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Exhibit
10.1
Confidential Materials
omitted and filed separately with the
Securities and Exchange
Commission. Asterisks denote omissions.
COLLABORATIVE
RESEARCH & LICENSE AGREEMENT
Dated August 13,
2007
Between
ICAGEN,
INC.
and
PFIZER INC
TABLE OF
CONTENTS
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Section 1
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Definitions |
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1 |
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Section 2
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Collaborative Research Program |
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8 |
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Section 3
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Licenses |
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14 |
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Section 4
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Funding |
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16 |
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Section 5
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Stock
Purchase |
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22 |
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Section 6
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Treatment
of Confidential Information |
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22 |
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Section 7
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Intellectual Property Rights |
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25 |
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Section 8
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Acquisition of Rights from Third Parties |
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27 |
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Section 9
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Legal
Action |
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27 |
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Section 10
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Term,
Termination & Disengagement |
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28 |
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Section 11
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Representations & Warranties |
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32 |
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Section 12
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Indemnification |
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34 |
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Section 13
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Notices |
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35 |
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Section 14
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Miscellaneous |
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36 |
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Exhibit A
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Permitted
Disclosures |
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Exhibit B
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Stock
Purchase Agreement |
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C
OLLABORATIVE R ESEARCH
AND L ICENSE A
GREEMENT
This COLLABORATIVE
RESEARCH & LICENSE AGREEMENT is entered into as of
August 13, 2007 (the “Effective Date”) by and
between PFIZER INC , a Delaware corporation, having an
office at 235 East 42 nd Street, New York, New York 10017 (“Pfizer”), and
ICAGEN, INC. (“Icagen”), a Delaware corporation,
having an office at 4222 Emperor Boulevard, Suite 350, Durham,
North Carolina 27703.
WHEREAS , Icagen has expertise in
the discovery, research, and development of ion channels and ion
channel modulators that may be useful as therapeutics;
and
WHEREAS , Icagen is a
biotechnology company that has research programs directed to the
identification of modulators of the Research Targets (as defined
below); and
WHEREAS , Pfizer is a major
pharmaceutical company that has the capability to undertake
research for the discovery and evaluation of agents for treatment
of disease and also the capability for clinical analysis,
manufacturing and marketing of such agents; and
WHEREAS , the parties plan to
collaborate to identify one or more drug candidates suitable for
development and commercialization as pharmaceutical products;
and
WHEREAS , Pfizer desires to
obtain and Icagen is willing to grant an exclusive license under
Icagen's right, title and interest in the Patent Rights and
Technology so that Pfizer can manufacture, use, sell, offer for
sale and import the Products.
NOW, THEREFORE , the parties
agree as follows:
1. D EFINITIONS
.
Wherever used in this Agreement, the
terms defined in this Section 1 shall have the following
specified meanings:
1.1 “[**]
Royalty-Bearing Product” means any Compound or Product
that is not developed for a Research Target Indication and contains
(a) a Pfizer Compound Developed In The Research Program or
(b) a Joint Compound.
1.2
“Affiliate” means, with respect to Pfizer or Icagen
(as applicable), any corporation or other legal entity owning,
directly or indirectly, [**] percent ([**]%) or more of the
voting
capital shares or similar voting
securities of Pfizer or Icagen; or any corporation or other legal
entity [**] percent ([**]%) or more of the voting capital shares or
similar voting rights of which is owned, directly or indirectly, by
Pfizer or Icagen; or any corporation or other legal entity [**]
percent ([**]%) or more of the voting capital shares or similar
voting rights of which is owned, directly or indirectly, by a
corporation or other legal entity which owns, directly or
indirectly, [**] percent ([**]%) or more of the voting capital
shares or similar voting securities of Pfizer or Icagen; or any
corporation or other legal entity the board of which is controlled
by Pfizer or Icagen.
1.3 “Area”
means research, development or commercialization with respect to
modulators of the Research Targets.
1.4 “Candidate
Compound” or “CAN” means a Compound that is
formally endorsed by the appropriate Pfizer governance body as
having met the requirements for advancement into clinical
development and designated as a Candidate Compound in accordance
with Section 2.8.
1.5 “Combination
Product” means any human pharmaceutical product in which
one or more active pharmaceutical ingredients that are not
Compounds are either (i) physically, chemically or otherwise
combined or mixed with the Compound to produce a single entity for
commercial distribution or (ii) packaged together with the
Compound in a single package or unit for commercial
distribution.
1.6 “Commercially
Reasonable Efforts” means, with respect to a Research
Program obligation, Compound or Product, those efforts and
resources that the party required to make such efforts generally
uses (as applicable in the context used in this Agreement) in
researching, developing, seeking regulatory approvals,
manufacturing, promoting, detailing and marketing its other
pharmaceutical products that are comparable to the applicable
Compound(s) or Product(s), or in carrying out its other research
programs relating to such comparable products, taking into account
product labeling or anticipated labeling, market potential, past
performance (if any), economic return potential, medical and
clinical considerations, the present and future regulatory
environment, and competitive market conditions in the therapeutic
area, all as measured by the facts and circumstances at the time
such efforts are due, but without taking into account any payment
obligations to the other party under this Agreement and, with
respect to Pfizer’s efforts and resources, without taking
into account considerations relating to Excluded Pfizer
Compounds.
1.7 “Commitment
Year” means a twelve-month period commencing on the
Effective Date or any anniversary of the Effective Date during the
Research Term.
1.8
“Compound” means a Pfizer Compound, Icagen Compound
or Joint Compound.
1.9
“Controlled” means the legal authority or right of
a party hereto, whether direct or through Affiliates controlled by
such party, to grant a license or sublicense of intellectual
property rights to the other party hereto, or to provide compounds
or biological material to or otherwise disclose proprietary or
trade secret information to such other party, without breaching the
terms of any agreement with a third party, infringing the
intellectual property rights of a third party, or misappropriating
the proprietary or trade secret information of a third
party.
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1.10
“Cover” , “Covering” or
“Covered” means, with respect to a Compound, a
Product or Technology, that, in the absence of a license granted
under a Valid Claim, the making, use, offering for sale, sale, or
importation of the Compound or Product or the practice of the
Technology would infringe such Valid Claim or, in the case of Valid
Claims that have not yet issued, would infringe such Valid Claim
after issuance.
1.11 “Developed In
The Research Program” means generated, identified or
created in the Research Program. With respect to Research
Compounds, any Compound designated as such during the [**] months
following the Research Term shall be considered to have been
Developed In The Research Program. For clarity, Patent Rights and
Technology will not be deemed to have been Developed In The
Research Program to the extent that such Patent Rights and
Technology are claimed or disclosed in the patents, patent
applications, patent disclosures or notebooks of the relevant party
as of the Effective Date.
1.12 “Excluded
Pfizer Compounds” means compounds excluded pursuant to
Sections 2.3(b)(ii), 2.3(b)(iii), 2.3(b)(iv), 2.3(b)(v), or
2.3(b)(vi).
1.13 “Excluded
Research Target 3 Compounds” means the compounds
Controlled by Pfizer that are within the existing Pfizer Research
Target 3 research program and identified in the Research Plan as
Excluded Research Target 3 Compounds.
1.14 “FTE”
means the time and work output equal to one full time employee who
is proficient in the performance of the duties assigned to such
employee pursuant to the Research Plan.
1.15 “Full
Royalty-Bearing Product” means any Compound or Product
that contains (a) a Candidate Compound that is developed for a
Research Target Indication or a non-Research Target Indication, or
(b) a Pfizer Compound Developed in the Research Program that
is developed for a Research Target Indication, or (c) a Joint
Compound that is developed for a Research Target
Indication.
1.16 “Generic
Product” means, with respect to a Product in any country,
a product that is a “pharmaceutical equivalent” (as
that term is used in the Approved Drug Products with Therapeutic
Equivalence Evaluations published by the FDA Center for Drug
Evaluation and Research or any successor publication).
Notwithstanding the foregoing, Generic Products shall not include
products that Pfizer or any of Pfizer’s Affiliates or
sublicensees have authorized or otherwise permitted to become
available.
1.17 “Icagen
Compound” means any synthetic or natural chemical
compound or biological material that is introduced into the
Research Program and is:
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(a) |
Covered by Icagen Patent Rights or otherwise Controlled by
Icagen; or |
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(b) |
any salt, ester, amide, complex, chelate, hydrate,
stereoisomer, crystalline or amorphous form, prodrug, metabolite or
metabolic precursor of any of the compounds or materials described
in the preamble above. |
For the avoidance of doubt,
virtual screening of Icagen’s compound file does not
constitute the introduction of such compounds into the Research
Program and the results of such screening and associated
intellectual property shall belong to Icagen regardless of whether
the
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algorithm used to screen the Icagen
compound file is provided by Icagen or Pfizer; provided that
, if the compounds identified in the virtual screen are screened in
an assay in the Research Program such compounds shall be considered
Icagen Compounds introduced into the Research Program.
1.18 “Icagen
Confidential Information” means all information
Controlled by Icagen and regarding Icagen’s technology,
products, business or objectives or regarding the Compounds or
Products that is disclosed by Icagen to Pfizer pursuant to this
Agreement to the extent that such information is not (i) as of
the date of disclosure to Pfizer, known to Pfizer other than by
virtue of a prior confidential disclosure to Pfizer by Icagen; or
(ii) disclosed in published literature, or otherwise generally
known to the public through no fault or omission of Pfizer; or
(iii) obtained from a third party free from any obligation of
confidentiality to Icagen; or (iv) independently developed by
Pfizer without using Icagen Confidential Information.
1.19 “Icagen Patent
Rights” means all Patent Rights, other than Joint Patent
Rights, Controlled by Icagen and Covering Icagen Technology
including Icagen Compounds and, without limitation, the Patent
Rights listed in the Research Plan.
1.20 “Icagen
Technology” means Technology Controlled by Icagen
that:
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(a) |
was developed by employees of or consultants to Icagen alone in
the course of the Research Program, or |
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(b) |
(x) in the case of Compounds, is introduced into the Research
Program and (y) in the case of Technology other than
Compounds, relates to a Research Compound, Candidate Compound or
Product, and, in either case, is or was: |
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(i) |
developed by employees of or consultants to Icagen alone or
jointly with third parties, either prior to the Effective Date, at
any time during the Research Term; or |
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(ii) |
acquired by purchase, license, assignment or other means from
third parties by Icagen, either prior to the Effective Date, at any
time during the Research Term. |
1.21 “Joint
Compound” means any (a) synthetic or natural
chemical compound or biological material other than an Icagen
Compound or a Pfizer Compound that is Covered by Joint Patent
Rights or (b) salt, ester, amide, complex, chelate, hydrate,
stereoisomer, crystalline or amorphous form, prodrug, metabolite or
metabolic precursor of any compound or material described in the
foregoing clause (a).
1.22 “Joint Patent
Rights” means all Patent Rights jointly Controlled by the
parties and Covering Joint Technology including Joint
Compounds.
1.23 “Joint
Technology” means Technology other than Icagen Technology
or Pfizer Technology that is:
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(a) |
developed by employees of or consultants to Pfizer and Icagen
jointly with each other in the performance of the Research Program;
or |
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(b) |
acquired by purchase, license, assignment or other means from
third parties by Icagen and Pfizer jointly with each other as part
of the conduct of the Research Program. |
1.24 “NDA”
means a New Drug Application or other application for authority to
market a Product filed with the U.S. FDA.
1.25 “Net
Sales” means:
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(a) |
with respect to a Product that is not a Combination Product,
the gross amount invoiced by Pfizer, its Affiliates and its
sublicensees on sales of such Product to third parties, less
(i) bad debts related to such Product and (ii) sales
returns and allowances actually paid, granted or accrued with
respect to invoiced amounts, including trade, quantity and cash
discounts and any other adjustments, including, those granted on
account of price adjustments, billing errors, rejected goods,
damaged or defective goods, recalls, returns, rebates, chargeback
rebates, reimbursements or similar payments granted or given to
wholesalers or other distributors, buying groups, health care
insurance carriers or other institutions, adjustments arising from
consumer discount programs or other similar programs, customs or
excise duties, sales tax, consumption tax, value added tax, and
other taxes (except income taxes) or duties relating to sales, and
including allowances, discounts, adjustments, rebates,
reimbursements and similar payments in respect of sales to the
United States government, any state government or any foreign
government, or to any other governmental authority, or with respect
to any government-subsidized program or managed care organization,
and (iii) freight and shipping insurance (to the extent that
Pfizer bears the cost of freight and shipping insurance for a
Product); and |
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(b) |
with respect
to a Combination Product, (x) if Pfizer and/or its Affiliates
and/or any third party separately sells in such country during such
year when it sells such Combination Product both (1) the
Product(s) contained in such Combination Product as single chemical
entity(-ies), and (2) the other products contained in such
Combination Product containing active ingredient(s) as single
entity(-ies), the Net Sales attributable to such Combination
Product during such year shall be calculated by multiplying actual
Net Sales of such Combination Product by the fraction A/(A+B)
where: A is Pfizer’s (or its Affiliates’ or third
parties’, as applicable) average Net Sales price per daily
dose during such year for the Product(s) in such Combination
Product in such country and B is the sum of the average of
Pfizer’s (or its Affiliates’ or third parties’,
as applicable) Net Sales price per daily dose during such year in
such country, for the other product(s) containing active
ingredient(s) in such Combination Product; (y) if Pfizer
and/or its Affiliates and/or any third party separately sells, in
such country during such year when it sells such Combination
Product, the Product(s) contained in such Combination Product as
single chemical entity(-ies) but do not separately sell, in such
country, other product(s) containing active ingredient(s) that are
also contained in such Combination Product, the Net Sales
attributable to such Combination Product during such year shall be
calculated by multiplying the Net Sales of such Combination Product
by the fraction A/C where: A is Pfizer’s (or its
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Affiliates’ or third
parties’, as applicable) average Net Sales price per daily
dose during such year for the Product(s) in such Combination
Product in such country, and C is Pfizer’s (or its
Affiliates’ or third parties’, as applicable) average
Net Sales price per daily dose during such year for the Combination
Product in such country; and (z) if Pfizer and/or its
Affiliates and/or third parties does not separately sell, in such
country during such year when it sells such Combination Product,
the Product(s) contained in such Combination Product as single
chemical entity(-ies), the Net Sales attributable to such
Combination Product shall be D/(D+E) where: D is the fair market
value of the portion of the Combination Product that contains the
Product(s) and E is the fair market value of the portion of the
Combination Product that contains the other active ingredient(s)
included in such Combination Product, as such fair market values
are determined by mutual agreement of the parties. If the parties
are unable to agree upon such fair market values, the parties shall
jointly appoint a third party expert to determine such matter or,
in the absence of agreement regarding the appointment of a third
party expert, submit such matter to binding arbitration for
resolution by a single arbitrator pursuant to the commercial
arbitration rules of the American Arbitration
Association.
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Net Sales shall be determined
from books and records maintained in accordance with generally
accepted accounting principles in the United States (“US
GAAP” ), as consistently applied by Pfizer with respect
to sales of all its pharmaceutical products.
1.26
“[**]” means [**].
1.27 “Patent
Rights” means patents, and patent applications that have
been pending less than [**] years, whether domestic or foreign,
including all continuations, continuations-in-part, divisionals,
and renewals, and letters of patent granted thereon, and all
reissues, re-examination and extensions thereof.
1.28 “Pfizer
Compound” means any synthetic or natural chemical
compound or biological material that is introduced into the
Research Program and is:
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(a) |
Covered by Pfizer Patent Rights or otherwise Controlled by
Pfizer; or |
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(b) |
any salt, ester, amide, complex, chelate, hydrate,
stereoisomer, crystalline or amorphous form, prodrug, metabolite or
metabolic precursor of any of the compounds or materials described
in the preamble above. |
For the avoidance of doubt,
virtual screening of Pfizer’s compound file does not
constitute the introduction of such compounds into the Research
Program and the results of such screening and associated
intellectual property shall belong to Pfizer regardless of whether
the algorithm used to screen the Pfizer compound file is provided
by Pfizer or Icagen; provided that , if the compounds
identified in the virtual screen are screened in an assay in the
Research Program such compounds shall be considered Pfizer
Compounds introduced into the Research Program.
1.29 “Pfizer
Confidential Information” means all information
Controlled by Pfizer and regarding Pfizer’s technology,
products, business or objectives or regarding the
Compounds
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or Products that is disclosed by Pfizer
to Icagen pursuant to this Agreement to the extent that such
information is not (i) known, as of the date of disclosure to
Icagen, to Icagen other than by virtue of a prior confidential
disclosure to Icagen by Pfizer; or (ii) disclosed in published
literature, or otherwise generally known to the public through no
fault or omission of Icagen; or (iii) obtained from a third
party free from any obligation of confidentiality to Pfizer; or
(iv) independently developed by Icagen without using Pfizer
Confidential Information.
1.30 “Pfizer Patent
Rights” means all Patent Rights, other than Joint Patent
Rights, Controlled by Pfizer and Covering Pfizer Technology
including Pfizer Compounds.
1.31 “Pfizer
Technology” means Technology Controlled by Pfizer
that:
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(a) |
was developed by employees of or consultants to Pfizer alone in
the course of the Research Program, or |
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(b) |
(x) in the case of Compounds, is introduced into the Research
Program and (y) in the case of Technology other than
Compounds, relates to a Research Compound, Candidate Compound or
Product, and, in either case, is or was: |
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(i) |
developed by employees of or consultants to Pfizer alone or
jointly with third parties, either prior to the Effective Date, at
any time during the Research Term; or |
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(ii) |
acquired by purchase, license, assignment or other means from
third parties by Pfizer, either prior to the Effective Date, at any
time during the Research Term. |
1.32 “Phase I
Trial” means a clinical trial that generally provides for
the first introduction into humans of a Product with the primary
purpose of determining safety, metabolism and pharmacokinetic
properties and clinical pharmacology of the Product, and is
generally consistent with U.S. 21 C.F.R. §312.21(a) or any
foreign counterpart thereof.
1.33 “Phase II
Trial” means a clinical trial generally consistent with
U.S. 21 C.F.R. §312.21(b) or any foreign counterpart
thereof.
1.34 “Phase III
Trial” means a clinical trial generally consistent with
U.S. 21 C.F.R. §312.21(c) or any foreign counterpart
thereof.
1.35
“Product” means any pharmaceutical product
(including a Combination Product), in all dosage forms and
formulations, that contains a Compound, and is Covered by a Valid
Claim.
1.36 “Research
Compound” means a Compound that has been selected by the
Joint Research Committee as evidenced by meeting minutes, based on
having met the criteria therefor set forth in the Research Plan,
for further investigation.
1.37 “Research
Plan” means the written plan describing the research in
the Area to be carried out during each Commitment Year by Pfizer
and Icagen pursuant to this Agreement.
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1.38 “Research
Program” means the collaborative research program in the
Area to be conducted by Pfizer and Icagen during the Research Term
pursuant to the Research Plan and this Agreement.
1.39 “Research
Target(s)” means any (or all) as the context requires of
the ion channel targets identified in the Research Plan as
“Research Target 1”, “Research Target 2”
and “Research Target 3”.
1.40 “Research
Target Indication(s)” means an indication for which the
modulation of a Research Target by the relevant Compound is or
would reasonably be expected to be material to the expected
therapeutic effect of such Compound.
1.41 “Research
Term” means the period beginning on the Effective Date
and ending on the date on which the Research Program terminates,
including any extensions thereto that are mutually agreed by the
parties pursuant to Section 2.1.
1.42
“Technology” means and includes all materials,
compounds, technology, technical information, intellectual
property, know-how, expertise and trade secrets.
1.43
“Term” means the period commencing on the Effective
Date and ending as set forth in Section 10.1.
1.44 “Valid
Claim” means a claim within Icagen Patent Rights, Pfizer
Patent Rights or Joint Patent Rights so long as such claim shall
not have been (a) abandoned by either Pfizer (in the case of
Pfizer Patent Rights) or Icagen (in the case of Icagen Patent
Rights) or both (in the case of Joint Patent Rights) or
(b) held invalid in a final decision rendered by a tribunal of
competent jurisdiction from which no appeal has been or can be
taken.
2. C OLLABORATIVE R
ESEARCH P ROGRAM .
2.1 Purpose.
Throughout the Research Term, Icagen and Pfizer shall conduct the
Research Program to discover and develop Products. The Research
Term shall begin on the Effective Date and, unless terminated
earlier in accordance with Section 10.3, continue for two
years. The Research Term may be extended upon mutual agreement of
the parties. Pfizer shall notify Icagen at least [**] days prior to
the end of the then-current Research Term whether Pfizer desires to
extend the Research Term and, if Pfizer so notifies Icagen that
Pfizer does desire to extend the Research Term, the parties shall
discuss whether and on what terms they would be willing to agree to
such extension, including without limitation the Research Targets
with respect to which the parties will continue to conduct research
during such extension.
2.2 Research Plan .
The Research Plan for the first Commitment Year has been approved
by Pfizer and Icagen as of the date of this Agreement. For each
Commitment Year after the first year, the Research Plan shall be
prepared by the Joint Research Committee for submission to and
approval by Pfizer and Icagen no later than sixty (60) days
before the end of the prior Commitment Year.
2.3 Exclusivity
.
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(a) |
Icagen
Exclusivity . During the Research Term and for six
(6) months thereafter, Icagen agrees that neither it nor any
of its Affiliates that it controls shall conduct
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research itself or sponsor
any other research, or engage in any research sponsored by any
third party, in the Area, without Pfizer’s consent;
provided that , if at any time during the Research Term or
during the six (6) months immediately following the Research
Term Pfizer ceases to conduct research and development on Compounds
that modulate any Research Target, Pfizer shall notify Icagen of
such cessation and thereafter the foregoing prohibition shall not
apply to such Research Target.
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(b) |
Pfizer Exclusivity . During the Research Term and for
six (6) months thereafter, Pfizer agrees that neither it nor
any of its Affiliates shall conduct research itself or sponsor any
other research, or engage in any research sponsored by any third
party, in the Area, without Icagen’s consent; provided
that , subject to Section 3.3, the exclusivity provisions
herein shall not apply to: |
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(i) |
research activities of Pfizer or any of its Affiliates
(including sponsored research) in the event that an Affiliate of
Icagen, that is not controlled by Icagen, conducts research itself
or sponsors any other research, or engages in any research
sponsored by any third party, in the Area; or |
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(ii) |
the Excluded Research Target 3 Compounds and the research
activities of Pfizer or any of its Affiliates (including sponsored
research) with respect thereto; or |
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(iii) |
compounds that Pfizer or any of its Affiliates licenses or
acquires from a third party that are in a Phase II Trial or further
advanced in development; or |
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(iv) |
compounds acquired by Pfizer or any of its Affiliates from a
third party through an acquisition by Pfizer or any of its
Affiliates of all or substantially all of the assets of such third
party, an acquisition of more than fifty percent (50%) of the
shares or other equity interests of such third party or a merger or
consolidation of such third party or an affiliate of such third
party with or into Pfizer or any of its Affiliates; or |
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(v) |
compounds licensed or acquired by Pfizer or any of its
Affiliates, that at the time of license or acquisition (x) are
not yet in a Phase II Trial or later development but
(y) are at least one stage of development more advanced than
any Compound or Product under this Agreement and have reached a
stage of development equivalent to Candidate Compound status or
later (e.g., if the most-advanced Compound under this Agreement is
a Candidate Compound, then the in-licensed compound must be at
least at the Phase I Trial stage); or |
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(vi) |
non-small molecule compounds. |
Each of the foregoing
exclusions may be claimed jointly or independently.
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(c) |
Consequences of Breach . If Pfizer or any of its
Affiliates conducts, sponsors or engages in any research in breach
of the exclusivity obligations set forth in Section 2.3(b)
above, then Pfizer’s sole and exclusive liability and
Icagen’s sole and exclusive remedy for such breach shall be
that (i) any compounds and products arising from such research
shall be deemed to be Compounds and Products for all purposes under
this Agreement with prospective effect from the date of such
breach, including without limitation for purposes of Pfizer’s
milestone and royalty payment obligations hereunder and
(ii) from and after such breach, Icagen shall have no further
obligation under Section 2.3(a) above. For the avoidance of
doubt, a breach by Pfizer or any of its Affiliates of the
exclusivity obligations set forth in Section 2.3(b) above
shall not constitute an Event of Termination. |
2.4 Joint Research
Committee .
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(a) |
Purpose . Pfizer and Icagen shall establish a joint
research committee (the “ Joint Research Committee
”): |
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(i) |
to review and evaluate progress under the Research
Plan; |
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(ii) |
to prepare the Research Plan for each Commitment
Year; |
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(iii) |
to approve any budgets or resource allocation; |
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(iv) |
to approve and reject Research Compounds for or from the
Research Program; |
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(v) |
to identify and recommend CANs for acceptance by Pfizer;
and |
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(vi) |
to coordinate and monitor publication of research results
obtained and the exchange of information and materials that relate
to the Research Program. |
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(b) |
Membership . Pfizer and Icagen each shall appoint, in
its sole discretion, three members to the Joint Research Committee.
Substitutes may be appointed at any time. The members initially
shall be: |
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(i) |
Pfizer Appointees: [**] |
| |
(ii) |
Icagen Appointees: [**] |
| |
(c) |
Chair . The Joint Research Committee shall be chaired by
two co-chairpersons, one appointed by Pfizer and the other
appointed by Icagen. |
| |
(d) |
Meetings . The Joint Research Committee shall meet at
least quarterly during the Research Term and thereafter as needed
for the purpose described in Section 2.8(b), at places and on
dates selected by each party in turn. Representatives of Pfizer or
Icagen or both, in addition to members of the Joint Research
Committee, may attend such meetings at the invitation of either
party. |
10
| |
(e) |
Minutes . The Joint Research Committee shall keep
accurate minutes of its deliberations which record all proposed
decisions and all actions recommended or taken. Drafts of the
minutes shall be delivered to all Joint Research Committee members
within ten (10) business days after each meeting. The party
hosting the meeting shall be responsible for the preparation and
circulation of the draft minutes. Draft minutes shall be edited by
the co-chairpersons and shall be issued in final form only with
their approval and agreement. |
| |
(f) |
Decisions . All decisions of the Joint Research
Committee shall be made by consensus; provided that the
Joint Research Committee may not amend this Agreement or increase
Pfizer’s or Icagen’s obligations hereunder without the
consent of Pfizer or Icagen (as applicable). If the Joint Research
Committee is unable to reach any decision by consensus, either
party may, by notice to the other party, escalate the matter to the
President of Icagen and the Global Head of Research of Pfizer for
resolution, and in the event of any such escalation, such
escalation officers shall promptly meet and discuss the matter in
an effort to reach a mutually agreeable resolution. |
| |
(g) |
Expenses . Pfizer and Icagen shall each bear all
expenses of their respective members related to their participation
on the Joint Research Committee. |
| |
(h) |
Dissolution . Unless otherwise agreed by the parties,
the Joint Research Committee shall dissolve upon the completion of
its responsibilities pursuant to Section 2.8(b). |
2.5 Reports and
Materials .
| |
(a) |
Reports . During the Research Term, Pfizer and Icagen
each shall furnish to the Joint Research Committee: |
| |
(i) |
summary written reports within thirty (30) days after the
end of each three-month period commencing on the Effective Date,
describing its progress under the Research Plan; and |
| |
(ii) |
comprehensive written reports within thirty (30) days
after the end of each Commitment Year, describing in detail the
work accomplished by it under the Research Plan during the
Commitment Year and discussing and evaluating the results of such
work. |
| |
(b) |
Materials . Icagen and Pfizer shall, during the Research
Term, as a matter of course as described in the Research Plan, or
upon each other’s written or oral request, furnish to the
other samples of biochemical, biological or synthetic chemical
materials that are part of Pfizer Technology, Icagen Technology or
Joint Technology and that (i) are necessary or useful for the
other party to carry out its responsibilities under the Research
Plan or (ii) are generated in the Research Program. To the
extent that the quantities of materials requested by either party
exceed the quantities set forth in the Research Plan, the
requesting party shall reimburse the other party for the reasonable
costs of such materials if they are furnished. |
11
| |
(c) |
Post-Research Term Reports. After the Research Term,
Pfizer shall furnish to Icagen semi-annual written reports
summarizing in reasonable detail Pfizer’s development and
commercialization activities with respect to Compounds and Products
and material developments with respect thereto, which reports
shall, without limiting the foregoing, include: progress on
research and development, status and results of clinical trials,
status of applications for regulatory approvals, a summary of
manufacturing, marketing and sales activities for the prior
six-month period, as well as plans therefor for the subsequent
twelve-month period. The post-Research Term reports delivered by
Pfizer to Icagen hereunder will be considered Pfizer Confidential
Information. |
2.6 Laboratory Facility
and Personnel . Icagen shall provide suitable laboratory
facilities, equipment and personnel for the work to be done by
Icagen in carrying out the Research Program.
2.7 Commercially
Reasonable Efforts . Pfizer and Icagen each shall use
Commercially Reasonable Efforts to achieve the objectives of the
Research Program and Research Plan, including without limitation by
using Commercially Reasonable Efforts to provide for screening in
the Research Program all small molecule compounds Controlled by
such party (other than, in the case of Pfizer, the Excluded Pfizer
Compounds) that such party believes have potential to modulate a
Research Target and by using Commercially Reasonable Efforts to
identify Research Compounds and Candidate Compounds. In
addition:
| |
(a) |
Pfizer shall use Commercially Reasonable Efforts to develop and
commercialize Candidate Compounds and Products containing Candidate
Compounds throughout the Term; and |
| |
(b) |
Pfizer’s license rights pursuant to Section 3.4
shall terminate with respect to any Candidate Compound with respect
to which Pfizer ceases to exercise such Commercially Reasonable
Efforts and the consequences set forth in Section 10.4(c)
shall apply to such Candidate Compound unless (i) Pfizer is
using Commercially Reasonable Efforts to develop a Compound that is
more advanced than such Candidate Compound or that is a back-up for
such Candidate Compound and (ii) upon such cessation, Pfizer
notifies Icagen in writing of such back-up or more advanced
Compounds, provided that such back-up or more advanced
Compounds shall be subject to the milestone payment and royalty
provisions of this Agreement as if the Compounds were Research
Compounds, Candidate Compounds or Products; and |
| |
(c) |
after the Research Term, Icagen shall use Commercially
Reasonable Efforts, as reasonably requested by Pfizer and at
Pfizer’s expense, to provide to Pfizer or any Affiliate or
sublicensee of Pfizer any agreed technical assistance reasonably
necessary to enable Pfizer or such Affiliate or sublicensee to
manufacture, use, sell, offer for sale or import any Product for
which Pfizer retains its license rights under
Section 3.4. |
2.8 Identification of
Research Compounds and Candidate Compounds .
12
| |
(a) |
Within [**] days after the results of the initial screening of
a Compound are presented to the Joint Research Committee, the Joint
Research Committee shall determine whether such Compound meets the
criteria for further study set forth in the Research Plan and
either designate such Compound as a Research Compound or a Compound
that is henceforth eliminated from the Research Program. In any
event, any Compound that is not so designated as a Research
Compound during the Research Term and for [**] months thereafter
shall thereupon cease to be subject to the Research Program,
provided that any Compound designated as a Research Compound
during the [**] month period following the Research Term shall, for
all purposes under this Agreement, be deemed to be a Compound
designated as a Research Compound in the Research Program. With
respect to any such Compound that ceases to be subject to the
Research Program (i) that is a Pfizer Compound, Icagen shall
have no rights therein pursuant to this Agreement except as
otherwise set forth in Sections 2.8(c), 3.2 and 4, (ii) that
is an Icagen Compound, Pfizer shall have no rights therein pursuant
to this Agreement except as otherwise set forth in Section 3.2
and (iii) that is a Joint Compound, the parties shall have the
rights therein set forth in Section 3.2, provided that
Pfizer shall have the right to pursue development of such Joint
Compound in accordance with Section 2.8(c) (in which case all
of the provisions of this Agreement shall apply to such Joint
Compound as if such Joint Compound had never been eliminated from
the Research Program) or to license the rights to such Joint
Compound in accordance with Section 3.5. |
| |
(b) |
On at least a [**] basis during the Research Term and on an as
needed basis during the [**] years immediately following the
Research Term, the Joint Research Committee shall review the
development status of each Research Compound and shall eliminate
from the Research Program any Research Compound that the Joint
Research Committee determines does not demonstrate potential to
become a Candidate Compound or otherwise is inappropriate to
continue to develop. In making any such determination and in
designating Candidate Compounds, the parties and the Joint Research
Committee shall be guided by the [**] set forth in the Research
Plan. All eliminated Research Compounds shall cease to be subject
to the Research Program. With respect to any such Research Compound
that ceases to be subject to the Research Program (i) that is
a Pfizer Compound, Icagen shall have no rights therein pursuant to
this Agreement except as otherwise set forth in Sections 2.8(c),
3.2 and 4, (ii) that is an Icagen Compound, Pfizer shall have
no rights therein pursuant to this Agreement except as otherwise
set forth in Section 3.2 and (iii) that is a Joint
Compound, the parties shall have the rights therein set forth in
Section 3.2, provided that Pfizer shall have the right
to pursue development of such Joint Compound in accordance with
Section 2.8(c) (in which case all of the provisions of this
Agreement shall apply to such Joint Compound as if such Joint
Compound had never been eliminated from the Research Program) or to
license the rights to such Joint Compound in accordance with
Section 3.5. |
| |
(c) |
Pfizer shall
determine whether to prepare a [**] attached to the Research Plan)
as to any Research Compound, and the appropriate governance body
within Pfizer
|
13
| |
shall determine whether
any Research Compound that is the subject of such a Notice shall be
designated a Candidate Compound. Subject to the expiration of
Pfizer’s right to designate Icagen Compounds as Candidate
Compounds as set forth in Section 2.8(d), any Compound, other
than an Icagen Compound or a Pfizer Compound introduced into the
Research Program and subsequently eliminated from the Research
Program in accordance with Section 2.8(a) or 2.8(b) above,
that is clinically developed by Pfizer or any of its Affiliates or
sublicensees for a Research Target Indication at any time after the
Effective Date and as to which, at the time of commencement of the
first Phase I Trial of such Compound, the modulation of a Research
Target by such Compound is or would reasonably be expected to be
material to its therapeutic effect, shall be deemed to be a
Candidate Compound. Pfizer shall notify Icagen of any such
designation (or initiation of clinical trials) within [**] days of
the date that such event occurs.
|
| |
(d) |
Notwithstanding anything in this Agreement to the contrary,
Pfizer shall have no rights pursuant to this Agreement to any
Icagen Compound that is eliminated from the Research Program
pursuant to Section 2.8(a) or 2.8(b) or is not designated by
Pfizer as a Candidate Compound within [**] years after the end of
the Research Program, except as provided in Section 3.2.
Nothing in this Section 2.8 shall be construed as limiting in
any way the other terms of this Agreement, including but not
limited to, the provisions of Section 2.3 and
Section 7.1. |
3. L ICENSES ; C
OMPOUND O WNERSHIP AND
R IGHTS .
3.1 Ownership . All
Icagen Confidential Information, Icagen Technology and Icagen
Patent Rights shall be owned by Icagen. All Pfizer Confidential
Information, Pfizer Technology and Pfizer Patent Rights shall be
owned by Pfizer. All Joint Technology and Joint Patent Rights shall
be owned jointly by Icagen and Pfizer. Subject to Sections 2.7(b)
and 3.5 and without limiting the rights provided to Pfizer under
clause (i) of Section 3.4(a), in any country in which the
use of Joint Patent Rights requires the consent of all owners, each
of Icagen and Pfizer will grant such consent upon written request
of the other.
3.2 Grants of Research
Licenses . Icagen and Pfizer each grants to the other a
nonexclusive, irrevocable, worldwide, royalty-free, perpetual
license, including the right to grant sublicenses to Affiliates,
(a) under Patent Rights and Technology Controlled by such
party to make and use Compounds developed in or introduced into the
Research Program solely for research purposes, and (b) under
Patent Rights and Technology Controlled by such party and Developed
In The Research Program solely for research purposes. For clarity,
this Section 3.2 does not grant either party any right or
license under or with respect to Patent Rights or Technology
Controlled by the other party to develop, sell or manufacture for
sale any Compound or Technology.
3.3 Excluded Pfizer
Compounds . Icagen acknowledges that the Excluded Pfizer
Compounds are excluded in their entirety from this Agreement and
shall not be deemed Compounds, Research Compounds, Candidate
Compounds or Products subject to the terms of this Agreement.
Except for limited testing of Excluded Research Target 3 Compounds
approved by the Joint Research Committee, with Icagen’s
express consent, Pfizer shall not introduce any
14
of the Excluded Pfizer Compounds into
the Research Program. In the event that Pfizer introduces Excluded
Research Target 3 Compounds into the Research Program in accordance
with the immediately preceding sentence, Pfizer shall not disclose
to Icagen the compound structures of such Excluded Research Target
3 Compounds without Icagen’s prior written
consent.
3.4 Grant of Commercial
License .
| |
(a) |
License Grant . Subject to the terms and conditions of
this Agreement, Icagen hereby grants to Pfizer as of the Effective
Date (i) an exclusive (even as to Icagen), worldwide license,
including the right to grant sublicenses in accordance with
Section 3.4(f), to manufacture, use, sell, offer for sale and
import Products under all of Icagen's right, title and interest in
the Icagen Patent Rights, Joint Patent Rights, Joint Technology and
Icagen Technology, and (ii) a non-exclusive, worldwide
license, including the right to grant sublicenses in accordance
with Section 3.4(f), to manufacture, use, sell, offer for sale
and import pharmaceutical products (other than Products) under all
Icagen Patent Rights and Icagen Technology Developed In The
Research Program, provided that any such pharmaceutical
product manufactured, used, sold, offered for sale or imported
pursuant to this clause (ii) shall require payment by Pfizer
to Icagen of [**] percent ([**]%) of the milestone and royalty
payments specified in Section 4 of this Agreement payable with
respect to Candidate Compounds and Full Royalty-Bearing Products
but will not otherwise be subject to the provisions of this
Agreement applicable to Candidate Compounds and Products.
Notwithstanding the foregoing, Pfizer shall not have any license
pursuant to this Section 3.4(a) with respect to Products
containing Compounds as to which Pfizer’s rights have lapsed
pursuant to Section 2.8. |
| |
(b) |
Term of License . The term of the grant set forth in
Section 3.4(a) shall commence on the Effective Date and shall
terminate on the date of the last to expire of the licensed Patent
Rights. |
| |
(c) |
Paid-Up License . With respect to each Product, Pfizer
shall have a fully paid-up perpetual, royalty-free license under
the Icagen Technology and the Joint Technology to manufacture, use,
sell, offer for sale and import of such Product, on a
country-by-country basis, after the expiration (but not the early
termination pursuant to Section 10.3) of the Term applicable
to such Product in such country. |
| |
(d) |
Retained Rights . The license granted by Icagen in
Section 3.4(a) is subject to a retained right of Icagen to
perform Icagen’s obligations and exercise Icagen’s
rights under this Agreement. |
| |
(f) |
Sublicensing . Any sublicense granted by Pfizer must be
granted pursuant to a written agreement that subjects the
sublicensee to all relevant restrictions, limitations and
obligations in this Agreement. Pfizer shall be responsible for
failure by its sublicensees to comply, and Pfizer guarantees to
Icagen the compliance by each of its sublicensees, with all
relevant restrictions, limitations
|
15
| |
and obligations in this
Agreement. In the event of a material default by any sublicensee
that is not an Affiliate of Pfizer under a sublicense agreement,
Pfizer will inform Icagen and take such action, after consultation
with Icagen, that in Pfizer’s reasonable business judgment is
required to address such default. Pfizer shall provide Icagen with
a copy of each sublicense agreement, in final executed form, that
Pfizer enters into in accordance with this Section 3.4(f) with
sublicensees that are not Affiliates of Pfizer not later than
thirty (30) days after the execution of such sublicense
agreement; provided that , subject to the applicable
requirements of the [**] licensor of copies of sublicense
agreements, Pfizer may redact the financial terms from such
copies.
|
3.5 Rights to Joint
Compounds . After the expiration of the Research Term and [**]
months thereafter, Icagen may request that Pfizer grant Icagen a
license to develop and commercialize specified Joint Compounds. The
granting of any license to Icagen under this Section 3.5 shall
be in Pfizer’s sole discretion and on terms and conditions to
be negotiated in good faith. Notwithstanding anything to the
contrary in this Agreement, and for the avoidance of doubt
notwithstanding anything to the contrary in Section 3.1 or
Section 6.1(a),Pfizer’s development and
commercialization of any Joint Compound shall require payment by
Pfizer to Icagen of royalties and milestones pursuant to
Section 4.
4. F UNDING
.
4.1 Technology Access and
License Fee . In consideration of the licenses granted in
Sections 3.2 and 3.4, the exclusivity granted by Icagen in
Section 2.3 and Icagen’s related technical knowledge and
expertise, Pfizer shall pay to Icagen the following one-time
technology access and license fees upon execution of this
Agreement:
|
|
|
|
|
|
a. Technology Access and License Fee
with respect to Research Target 1:
|
|
$ |
[ |
**] |
|
|
|
b. Technology Access and License Fee
with respect to Research Target 2:
|
|
$ |
[ |
**] |
|
|
|
c. Technology Access and License Fee
with respect to Research Target 3:
|
|
$ |
[ |
**] |
|
|
|
Total:
|
|
$ |
12,000,000 |
|
4.2 Research Funding .
The annual research funding for each year of the Research Term
shall be $5,500,000 (five million five hundred thousand US
Dollars), which shall be payable by Pfizer to Icagen in equal
quarterly installments in advance for research and development
activities scheduled to be performed by [**] FTEs at Icagen during
each three (3) month quarterly period.
4.3 Additional Research
Funding . Pfizer shall provide up to a further $[**]US Dollars)
per annum to fund additional FTEs at Icagen or elsewhere (for
example, a contract research
16
organization) if required by the
Research Plan and agreed by the Joint Research Committee. Payments
will be made in advance in equal quarterly installments.
4.4 Development Milestone
Payments . Pfizer shall pay Icagen, on the completion of each
development event set forth below by Pfizer or any of its
Affiliates or sublicensees ( “Development Event”
), (i) the payment listed opposite such Development Event with
respect to Full Royalty-Bearing Products, or (ii) [**] percent
([**]%) of the payment listed opposite such Development Event with
respect to [**] Royalty-Bearing Products. For the sake of clarity,
should both clause (i) and clause (ii) above be
applicable to a Compound or Product, Icagen shall be entitled to
receive the greater of the applicable payments, but in no
circumstances shall Icagen receive payment under both clauses
(i) and (ii) in respect of the same Compound or Product.
Except as otherwise set forth below for Development Events (a),
(b), (c), (d), (e), (f) and (g), Pfizer shall be obligated to
make a payment with respect to each Compound or Product that is the
subject of the Development Event:
|
|
|
|
|
Development
Event
|
|
Amount |
|
a. Designation* of a CAN by Pfizer for
each of the first three Candidate Compounds
|
|
$ |
[**] |
|
|
|
b. Commencement (dosing of first
subject) of a Phase I Trial in any country for the first Candidate
Compound targeting Research Target 1
|
|
$ |
[**] |
|
|
|
c. Commencement (dosing of first
subject) of a Phase I Trial in any country for the first Candidate
Compound targeting Research Target 2
|
|
$ |
[**] |
|
|
|
d. Commencement (dosing of first
subject) of a Phase I Trial in any country for the first Candidate
Compound targeting Research Target 3
|
|
$ |
[**] |
|
|
|
e. Commencement (dosing of first
patient) of a Phase II Trial in any country for the first
Candidate Compound targeting Research Target 1
|
|
$ |
[**] |
|
|
|
f. Commencement (dosing of first
patient) of a Phase II Trial in any country for the first
Candidate Compound targeting Research Target 2
|
|
$ |
[**] |
|
|
|
g. Commencement (dosing of first
patient) of a Phase II Trial in any country for the first
Candidate Compound targeting Research Target 3
|
|
$ |
[**] |
|
|
|
h. Commencement (dosing of first
patient) of the first Phase III Trial for each Candidate
Compound
|
|
$ |
[**] |
|
|
|
i. NDA filing in USA for each
Product
|
|
$ |
[**] |
|
|
|
j. NDA approval in USA for each
Product
|
|
$ |
[**] |
17
|
|
|
|
|
k. Approval of an application for
marketing authorization by EMEA (or by the applicable regulatory
authority in the first of the United Kingdom, France, Spain, Italy
or Germany if EMEA approval is not sought) for each
Product
|
|
$ |
[**] |
|
|
|
l. Approval of an application for
marketing authorization by the applicable regulatory authority in
Japan for each Product
|
|
$ |
[**] |
* Includes a deemed
designation as set forth in Section 2.8(c).
|
|
|
|
Pfizer shall promptly notify Icagen of
each achievement of a Development Event and, within thirty
(30) days after each such achievement, pay to Icagen the
corresponding milestone payment amount.
4.5 Sales Milestones .
Pfizer shall pay Icagen, on achievement of each commercialization
event set forth below (“ Commercialization Event
”), the payment listed opposite such Commercialization Event
with respect to each Product. Pfizer shall be obligated to make
each such payment only once with respect to each Product that is
the subject of the Commercialization Event. All payments made by
Pfizer pursuant to this Section 4.5 with respect to a Product
shall be credited fully against future sums due to Icagen pursuant
to Section 4.6 of this Agreement with respect to Net Sales of
such Product; provided that such crediting does not reduce
any particular future payment pursuant to Section 4.6 by more
than [**]% of the amount otherwise due:
|
|
|
|
|
Commercialization
Event
|
|
Amount |
|
a. First twelve-calendar-month period in
which aggregate annual sales of such Product exceed
$[**]
|
|
$ |
[**] |
|
|
|
b. First twelve-calendar-month period in
which aggregate annual sales of such Product exceed
$[**]
|
|
$ |
[**] |
|
|
|
c. First twelve-calendar-month period in
which aggregate annual sales of such Product exceed
$[**]
|
|
$ |
[**] |
Pfizer shall promptly notify Icagen of
each achievement of a Commercialization Event and, within sixty
(60) days after each such achievement, pay to Icagen the
corresponding milestone payment amount.
4.6
Royalty.
18
| |
(a) |
Pfizer shall pay Icagen a royalty based on the Net Sales of
each Full Royalty-Bearing Product and each [**] Royalty-Bearing
Product. Except as otherwise set forth in Sections 4.6(b) and
4.6(c), such royalty shall be paid on a country-by-country basis
from the date of the first commercial sale (the date of the invoice
of Pfizer or any Affiliate or sublicensee of Pfizer with respect to
such sale) of such Product in each such country until the
expiration of the last Valid Claim within the Icagen Patent Rights,
Pfizer Patent Rights or Joint Patent Rights to expire with respect
to such Product in such country. |
| |
(b) |
If the manufacture and sale of a Product takes place in
countries where there are no Icagen Patent Rights, Pfizer Patent
Rights or Joint Patent Rights Covering such Product but Icagen
Patent Rights, Pfizer Patent Rights or Joint Patent Rights Covering
the Product exist in the U.S., Pfizer will pay to Icagen a royalty
on the Net Sales of such Product in each such country for the
period from the first commercial sale of such Product in such
country until the earlier of (i) ten (10) years after the
first commercial sale of such Product in such country or
(ii) the expiration of the last to expire Valid Claim within
the Icagen Patent Rights, Pfizer Patent Rights or Joint Patent
Rights Covering the Product in the U.S. |
| |
(c) |
Notwithstanding Sections 4.6(a) and 4.6(b) above, Pfizer will
pay no royalty on Net Sales of any Product in any country during
any calendar quarter in which a Generic Product (with respect to
such Product) launched by a third party accounts for more than [**]
percent ([**]%) of the combined unit sales of the Product and such
Generic Product in such country in such calendar
quarter. |
4.7 Royalty Rates .
The royalty payable (or to be paid) on each Full Royalty-Bearing
Product each calendar year shall be based on increments of
worldwide Net Sales with respect to such Full Royalty-Bearing
Product according to the following schedule. The corresponding
royalty payable (or to be paid) on each [**] Royalty-Bearing
Product, will be [**] percent ([**]%) of that specified in the
following schedule:
|
|
|
|
|
Annual Net
Sales
|
|
Royalty
Rate
(%) |
|
|
Less than $[**]
|
|
[**] |
% |
|
|
|
[**]
|
|
|
|
|
|
|
Greater than $[**]
|
|
[**] |
% |
By way of example only, if the Net Sales
of a Full Royalty-Bearing Product were $[**], subject to any
adjustments permitted under this Agreement, a royalty of [**]%
would be due in respect of the first $[**] of Net Sales, with the
remaining $[**] of Net Sales being subject to a royalty of [**]%.
By way of further example only, if the Net Sales of a [**]
Royalty-Bearing Product were $[**], subject to any adjustments
permitted under this Agreement, a royalty of [**]% would be due in
respect of the first $[**] of Net Sales, with the remaining $[**]
of Net Sales being subject to a royalty of [**]%.
4.8 Royalty Reduction
. If Pfizer's manufacture, use or sale of a Product (excluding any
portion of a Combination Product comprising active ingredient(s)
other than Compounds) in any country would, in the reasonable
opinion of Pfizer, infringe a claim in an issued,
unexpired
19
patent or in a published patent
application owned by a third party, Pfizer may deduct [**] percent
([**]%) of any royalty payment that Pfizer is required to pay to
such third party from the royalty that would otherwise be payable
to Icagen with respect to such Product in such country, provided
that the total royalty amount payable to Icagen with respect to
such Product in such country for any calendar quarter is never
reduced by more than [**]% in this manner. Notwithstanding the
foregoing provisions of this Section 4.8, [**].
4.9 [**] Payments . If
[**] is required to make license royalty or milestone payments
pursuant to the [**] as a consequence of [**] will reimburse [**]
for such payments, in the case of royalty payments, up to a maximum
of [**] percent ([**]%) of Net Sales and, in the case of milestone
payments, only payments made by [**] pursuant to [**] as a result
of [**] receipt of milestone payments under Sections 4.4 and 4.5
hereof resulting from [**], of each Development Event or
Commercialization Event, up to a maximum of [**] percent ([**]%) of
each such [**] milestone payment.
4.10 Animal Health
Products. The parties acknowledge that the royalty rates set
forth in Section 4.7 and the milestone payments set forth in
Sections 4.4 and 4.5 are based on the expectation that Products
will be administered to human patients. If Pfizer identifies or
develops a Product which represents a commercial opportunity in the
area of animal health, the parties will negotiate, as mutually
agreed, a new royalty rate and milestone schedule for such Product
applicable to the animal field to account for development costs and
changes in the cost of goods, selling price and projected annual
Net Sales. It is understood, however, that the royalty rate
specified in Section 4.7 and the milestones set forth in
Sections 4.4 and 4.5 shall be modified only as Pfizer and Icagen
agree.
4.11 Royalty Payment
Dates . Royalties shall be paid by Pfizer on Net Sales within
sixty (60) days after the end of each calendar quarter in
which such Net Sales are made. Such payments shall be accompanied
by a statement showing the Net Sales of each Product by Pfizer or
any Affiliate or sublicensee of Pfizer in each country, the
applicable royalty rate for such Product, and a calculation of the
amount of royalty due, including any offsets.
4.12 Royalty
Accounting. The Net Sales used for computing the royalties
payable to Icagen by Pfizer shall be computed and paid in US
dollars by wire transfer in immediately available funds to a U.S.
account designated by Icagen, or by other mutually acceptable
means. For purposes of determining the amount of royalties due, the
amount of Net Sales in any foreign currency shall be computed by
(a) converting such amount into U.S. dollars at the prevailing
commercial rate of exchange for purchasing dollars with such
foreign currency as published in The Wall Street Journal for
the close of the last business day of the calendar quarter for
which the relevant royalty payment is to be made by Pfizer and
(b) deducting the amount of any governmental tax, duty,
charge, or other fee actually paid in respect of such conversion
into, and remittance of U.S. dollars.
4.13 Other Payments .
Unless otherwise specified in this Agreement, payments pursuant to
this Agreement other than royalty payments shall be paid by Pfizer
in U.S. currency by wire transfer in immediately available funds to
an account designated by Icagen, or by other mutually acceptable
means within sixty (60) days of Pfizer’s receipt of an
invoice from Icagen.
4.14 Taxes. It is
understood and agreed between the parties that any payments made
under this Agreement are inclusive of any value added or similar
tax imposed upon such
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payments. In addition, in the event any
such payments made by either party to the other party become
subject to withholding taxes under the laws or regulations of any
jurisdiction (including any applicable international tax
conventions), the paying party shall deduct and withhold the amount
of such taxes for the account of the other party to the extent
required by applicable laws or regulations, such amounts payable to
such other party shall be reduced by the amount of taxes deducted
and withheld, and the paying party shall pay the amounts of such
taxes to the proper governmental authority in a timely manner and
promptly transmit to such other party an official tax certificate
or other evidence of such tax obligations together with proof of
payment from the relevant governmental authority of all amounts
deducted and withheld sufficient to enable such other party to
claim such payment of taxes. Any such withholding taxes required
under applicable laws or regulations to be paid or withheld shall
be an expense of, and borne solely by, such other party. The paying
party will provide the other party with reasonable assistance to
enable such other party to reduce the amount of such taxes or
recover such taxes as permitted by applicable laws or regulations.
Notwithstanding the foregoing, if any payments made by a party to
the other party under this Agreement become subject to withholding
taxes as a consequence of this Agreement having been assigned to
such paying party (e.g., if the paying party is the assignee of an
original party to this Agreement and payments made by companies in
such paying party’s jurisdiction do not enjoy the benefits of
tax treaty(-ies) that are applicable to payments made by companies
in the jurisdiction of such paying party’s assignor), then
the paying party shall pay to the other party such additional
amounts as are necessary so that such other party receives the
amounts that such other party would have received if such payments
were not subject to such withholding taxes.
4.15 Record-keeping by
Icagen. Icagen shall keep (a) for [**] years from the
conclusion of each calendar year during the Research Term complete
and accurate records of its efforts under the Research Program and
its provision of FTEs required pursuant to the Research Plan and
(b) for [**] years from the date of each payment of any
royalties pursuant to Section 4.9 complete and accurate
records of such payments. The records shall conform to good
accounting principles as applied to a similar company similarly
situated. Pfizer shall have the right at its own expense during the
relevant [**] year period to appoint an independent certified
public accountant reasonably acceptable to Icagen to inspect said
records to verify such provision of FTEs pursuant to the Research
Plan and such royalty payments pursuant to Section 4.9. Upon
reasonable notice by Pfizer, Icagen shall make its records
available for inspection by the independent certified public
accountant during regular business hours at the place or places
where such records are customarily kept, to verify the accuracy of
the expenditures of efforts. This right of inspection shall not be
exercised [**] in any calendar year and not [**] with respect to
records covering any specific period of time. All information
concerning such expenditures of efforts and royalty payments, and
all information learned in the course of any audit or inspection,
shall be deemed to be Icagen Confidential Information, except to
the extent that it is necessary for Pfizer to reveal the
information in order to enforce any rights it may have pursuant to
this Agreement or if disclosure is required by law. The failure of
Pfizer to request verification of any expenditures of efforts prior
to the end of the relevant [**] year period shall be considered
acceptance by Pfizer of the accuracy of such expenditures of
efforts, and Icagen shall have no obligation to maintain any
records pertaining to such expenditures of efforts beyond such [**]
year period. If Icagen’s provision of FTEs over any calendar
year was less, on average over the course of the calendar year,
than [**] percent ([**]%) of the FTEs funded by Pfizer pursuant
to
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Sections 4.2 and 4.3, Icagen shall
reimburse Pfizer for any overpayment of FTE funding and for the
cost of such audit.
4.16 Record-keeping by
Pfizer. Pfizer shall, and shall require its Affiliates and
sublicensees to, keep for [**] years from the date of each payment
of royalties under this Agreement complete and accurate records, on
a country-by-country basis, of gross sales by Pfizer, its
Affiliates and sublicensees, and deductions from gross sales taken
in determining Net Sales, of each Product in such country in
sufficient detail to allow the accruing royalties to be determined
accurately. Icagen shall have the right for a period of [**] years
after the end of the calendar year for which any royalty report or
statement is received with respect to royalties due and payable to
appoint at its expense an independent certified public accountant
reasonably acceptable to Pfizer to inspect the relevant records of
Pfizer to verify such report or statement. Pfizer shall make its
records available for inspection by such independent certified
public accountant during regular business hours at such place or
places where such records are customarily kept, upon reasonable
notice from Icagen, to verify the accuracy of the reports and
payments. Such inspection right shall not be exercised [**] in any
calendar year nor [**] with respect to sales in any given period.
All information learned in the course of any audit or inspection
shall be deemed to be Pfizer Confidential Information, except to
the extent that it is necessary for Icagen to reveal the
information in order to enforce any rights it may have pursuant to
this Agreement or if disclosure is required by law or regulation or
the rules of any stock exchange. The failure of Icagen to request
verification of any report or statement during said [**] year
period shall be considered acceptance of the accuracy of such
report, and Pfizer shall have no obligation to maintain records
pertaining to such report or statement beyond said [**] year
period. Any underpayment determined by such audit or inspection
shall promptly be paid by Pfizer, plus interest at the interest
rate set forth in Section 4.17, from the date of any such
underpayment. If Pfizer has underpaid amounts due under this
Agreement by more than [**] percent ([**]%) over any reporting
period, Pfizer shall also reimburse Icagen for the cost of such
audit.
4.17 Late Payments .
All payments under this Agreement shall bear interest from the date
due until paid at a rate equal to the prime rate of Citibank, NA as
announced on the date such payment was due plus [**] percent
([**]%), compounded on a calendar quarterly basis. In addition,
Pfizer shall reimburse Icagen for all reasonable costs and
expenses, including without limitation reasonable attorneys’
fees and legal expenses, incurred in the collection of late
payments.
5. S TOCK P
URCHASE . On the date hereof, Pfizer and Icagen
are entering into a Stock Purchase Agreement substantially in the
form attached hereto as Exhibit B .
6. T REATMENT
OF C ONFIDENTIAL I
NFORMATION .
6.1 Confidentiality
.
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(a) |
Except as
otherwise provided herein, Pfizer and Icagen will, during the term
of this Agreement and for [**] years thereafter, keep confidential
and not use for any purpose other than the research, development,
manufacture and commercialization of Compounds and Products and the
seeking of patent protection and regulatory approvals for Compounds
and Products in accordance with this Agreement, and will cause its
Affiliates to keep confidential and not use
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for any purpose other than
the research, development, manufacture and commercialization of
Compounds and Products and the seeking of patent protection and
regulatory approvals for Compounds and Products in accordance with
this Agreement, any Icagen Confidential Information (in the case of
Pfizer and its Affiliates) or Pfizer Confidential Information (in
the case of Icagen and its Affiliates), as the case may be. For the
purposes of this Section 6 it is understood that Joint
Technology shall be deemed Confidential Information of both parties
such that neither party may use or disclose such Confidential
Information except to the extent provided herein with respect to
the licenses granted each party with respect to Joint Technology;
provided that each party shall have the right, subject to
such party’s obligations under Section 2.3 and
Section 4, to use, disclose and otherwise exploit, either
alone or with third parties, Joint Technology (other than Joint
Compounds), including such Joint Technology that is Covered by
Joint Patent Rights, for research, development and
commercialization activities outside the Research Program without
any duty to account to the other party.
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(b) |
Pfizer and Icagen each agree that any disclosure of the
other’s Confidential Information to any officer, employee or
agent of (including without limitation any contract research
organization employed by) such receiving party or of any of its
Affiliates shall be made only if and to the extent necessary to
carry out its responsibilities under this Agreement and shall be
limited to the maximum extent possible consistent with such
responsibilities (i.e., shall only be disclosed to those officers,
employees and agents who have a need to know the Confidential
Information in furtherance of the purposes of this Agreement). Each
party shall take such action, and shall cause its Affiliates to
take such action, to preserve the confidentiality of the other
party’s Confidential Information as required under
Section 6.1(a) as it would customarily take to preserve the
confidentiality of its own Confidential Information. Each party,
upon the other’s request, will return all the Confidential
Information, including all remaining biological, synthetic chemical
and biochemical materials, disclosed or transferred to such party
by such other party pursuant to this Agreement, including all
copies and extracts of documents, within sixty (60) days of
such request after expiration or termination of this Agreement,
except for (i) one (1) copy of any such copies and
extracts of documents, which may be kept solely for the purpose of
monitoring such party’s compliance with and complying with
continuing obligations under this Agreement and (ii) any
copies or materials necessary for such party to exercise its rights
with respect to Compounds and Products, including without
limitation those set forth in Section 3.2, that survive
expiration or termination of this Agreement. |
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(c) |
Icagen and Pfizer each represent to the other that all of its
employees, and any consultants to such party, participating in the
Research Program who shall have access to Pfizer Technology, Icagen
Technology, Joint Technology, Pfizer Confidential Information or
Icagen Confidential Information are bound by agreement or other
legal obligation to maintain such information in
confidence. |
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(d) |
Neither
Icagen nor Pfizer shall disclose or transfer any information or
material to the other party hereunder if such disclosure or
transfer would violate any duty or
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obligation to any third
party, including any duty of confidentiality to any third
party.
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6.2 Publication .
Notwithstanding any matter set forth in this Agreement to the
contrary, results obtained in the course of the Research Program
may only be submitted for publication following scientific review
by the Joint Research Committee and subsequent written approval by
both Icagen and Pfizer. Written approval or disapproval of the
proposed publication shall be provided by both Pfizer and Icagen
within thirty (30) days for a manuscript, within fourteen
(14) days for an abstract for presentation at, or inclusion in
the proceedings of, a scientific meeting, and within fourteen
(14) days for a transcript of an oral presentation to be given
at a scientific meeting.
6.3 Publicity . The
parties recognize that each party may from time to time desire to
issue press releases and make other public statements or
disclosures regarding the subject matter of this Agreement. In such
event, the party desiring to issue a press release or make a public
statement or disclosure shall provide the other party with a copy
of the proposed press release, statement or disclosure for review
and approval in advance, which advance approval shall not be
unreasonably withheld, conditioned or delayed. No other public
statement or disclosure concerning the existence or terms of this
Agreement shall be made, either directly or indirectly, by either
party hereto, without first obtaining the written approval of the
other party. Once any public statement or disclosure has been
approved in accordance with this Section 6.3, then either
party may appropriately communicate information contained in such
permitted statement or disclosure. Notwithstanding the foregoing
provisions of this Section 6.3, a party may (a) disclose
the existence, terms and subject matter of this Agreement where
required, as reasonably determined by the disclosing party, by
applicable law or regulation, by applicable stock exchange rule or
by order of a court or other legal process, (b) disclose the
existence and terms of this Agreement under obligations of
confidentiality to agents, advisors, contractors, investors,
acquirors and sublicensees, and to potential agents, advisors,
contractors, investors, acquirors and sublicensees, in connection
with such party’s activities hereunder and in connection with
such party’s financing or strategic activities and
(c) publicly announce any of the matters set forth in
Exhibit A , provided that such announcements do not
entail disclosure of non-public technical or scientific information
(which, for clarity, excludes clinical trial results) and the
announcing party provides the other party with a copy of the
proposed text of such announcement sufficiently in advance of the
scheduled release or publication thereof to afford such other party
a reasonable opportunity to review and comment upon the proposed
text, and provided further that, subject to the announcing
party’s obligations to comply with requirements imposed by
applicable law or regulation, by applicable stock exchange rule or
by order of a court or other legal process, the announcing party
shall use reasonable efforts to provide the other party with an
advance draft of any such public announcement in order to provide
such other party with an opportunity to review such draft and
provide comments thereon to the announcing party prior to such
public announcement.
6.4 Disclosure of
Inventions . Each party shall promptly inform the other about
all inventions that are conceived, made or developed in the course
of carrying out the Research Program by employees of, or
consultants to, either of them solely, or jointly with employees
of, or consultants to the other.
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6.5 Disclosure Required by
Law. If either party is requested to disclose the other's
Confidential Information in connection with a legal or
administrative proceeding or is otherwise required by law,
regulation or legal process to disclose the other's Confidential
Information, such party will if practicable give the other party
prompt notice of such request. The party whose Confidential
Information is subject to such request or requirement may seek, at
its expense, an appropriate protective order or other remedy or
waive compliance with the provisions of this Agreement. If such
party seeks a protective order or other remedy, the other party
will cooperate as reasonably requested by the party seeking such
order or other remedy. If the party seeking such order or other
remedy fails to obtain a protective order or waive compliance with
the relevant provisions of this Agreement, the other party will
disclose only that portion of Confidential information that its
legal counsel reasonably determines such party is required to
disclose.
6.6 Clinical Trial
Register. Each party acknowledges and agrees that the other
party may publish the protocols and results of clinical studies
conducted by such other party with Compounds on its clinical trial
register or a government sponsored clearinghouse such as
www.clinicaltrials.gov or other publicly available websites such as
www.clinicalstudyresults.org and that such publication will not be
a breach of the confidentiality and publications obligations
provided in this Section 6. The foregoing does not give a
party the right to make such disclosures in respect of clinical
trials sponsored by the other party.
6.7 Use of Materials .
Pfizer and Icagen recognize that the biological, synthetic chemical
and biochemical materials that are part of Pfizer Technology,
Icagen Technology or Joint Technology, represent commercial assets.
The use by a party of such materials Controlled by the other party
is limited to activities to be performed under this Agreement or
otherwise permitted under Section 3.2. Both parties
acknowledge that such materials are for laboratory use only and are
not for consumption by, or treatment of, humans or non-laboratory
animals. Both parties will use these materials in compliance with
all applicable federal, state and local laws, regulations and
ordinances.
7. I NTELLECTUAL P
ROPERTY R IGHTS . The following
provisions relate to the filing, prosecution and maintenance of
Icagen and Joint Patent Rights during the term of this
Agreement:
7.1 Filing, Prosecution
and Maintenance by Icagen . With respect to Icagen Patent
Rights, as between Icagen and Pfizer, Icagen shall have the
exclusive right:
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(a) |
to file applications for letters patent on any invention
included in such Patent Rights; provided, however, that Icagen
shall consult with Pfizer regarding countries in which such patent
applications should be filed and shall file patent applications in
those countries where Pfizer requests that Icagen file such
applications; and, further provided, that Icagen, at its option,
may file in countries where Pfizer does not request that Icagen
file such applications; |
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(b) |
to take all reasonable steps to prosecute all pending and new
patent applications included within such Patent Rights with counsel
selected by Icagen in its sole discretion, but after considering in
good faith Pfizer’s views with respect to such
counsel; |
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(c) |
to respond to oppositions, interferences, nullity actions,
re-examinations, revocation actions and similar proceedings filed
by third parties against the grant of letters patent for such
applications; |
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(d) |
to maintain in force any letters patent included in such Patent
Rights by duly filing all necessary papers and paying any fees
required by the patent laws of the particular country in which such
letters patent were granted; and |
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(e) |
and obligation to notify Pfizer in a timely manner of any
decision not to file an application or to abandon a pending
application or an issued patent included in such Patent Rights.
Thereafter, subject to any limitations imposed on Icagen by any
third party agreement, Pfizer shall have the option, at its
expense, of filing and/or continuing to prosecute any such patent
application or of keeping the issued patent in force. |
Pfizer shall have the right to file, on
behalf of and as an agent for Icagen, all applications and take all
actions necessary to obtain patent extensions pursuant to 35 U.S.C.
Section 156 and foreign counterparts for Patent Rights
described in this Section 7.1 licensed to Pfizer that are
available based on regulatory approvals of Products for which
Pfizer retains its license rights under Section 3.4;
provided that , with respect to all patent extensions for
such Products, Pfizer shall consult with Icagen and its counsel as
to the patent to be chosen for extension and Pfizer shall base its
selection of the patent for extension solely on the best commercial
interest of the Product. Icagen will execute such further documents
and take such further actions as may be requested by Pfizer in this
regard at Pfizer’s expense.
7.2 Copies of
Documents . Each party shall provide or cause to be provided to
the other party (or the other party’s designee), prior to
filing, copies of all patent applications and substantive
correspondence with patent offices that such party has prepared for
filing pursuant to Section 7.1 or 7.4, for the purpose of
obtaining substantive comment of the other party’s patent
counsel. Each party shall also provide to the other party copies of
all documents relating to prosecution of all such patent
applications in a timely manner.
7.3 Reimbursement of Costs
for Filing, Prosecuting and Maintaining Patent Rights . Within
[**] days of receipt of invoices from Icagen, Pfizer shall
reimburse Icagen for all the costs of Icagen’s performance of
the duties set forth in Section 7.1 with respect to patent
applications and patents in countries where Pfizer requests that
patent applications and patents be filed, prosecuted and maintained
except that in the event Pfizer objects to Icagen’s choice of
patent counsel in Section 7.1(b) in good faith, including
provision of legal services at reasonable fees consistent with
Pfizer practice, and after considering Pfizer’s views Icagen
selects such patent counsel, Pfizer shall only be obliged to
reimburse [**] percent ([**]%) of the costs incurred by Icagen in
using such patent counsel. Such reimbursement shall be in addition
to payments under Section 4. However, Pfizer may, upon [**]
days notice, request that Icagen discontinue the performance of
duties set forth in Section 7.1 with respect to given patent
applications and patents in any country. Icagen shall pay the costs
of Icagen’s performance of the duties set forth in
Section 7.1 in those countries in which Pfizer does not
request that Icagen perform such duties, but in which Icagen, at
its option, elects to do so; provided that if Pfizer elects
not to pay for Icagen’s performance of the duties set forth
in Section 7.1, with respect to patent applications and
patents in any country, such patent applications and patents shall
be
26
solely owned by Icagen and shall be
excluded from the Icagen Patent Rights and Pfizer’s licenses
thereunder.
7.4 Filing, Prosecution
and Maintenance by Pfizer . With respect to Joint Patent
Rights, Pfizer shall have those rights and duties ascribed to
Icagen and Icagen shall have those rights and duties ascribed to
Pfizer in Section 7.1 (but not the duties ascribed to Pfizer
in Section 7.3), and Pfizer shall conduct such duties with
in-house counsel of Pfizer or with counsel selected by Pfizer in
its sole discretion, but after considering in good faith
Icagen’s views with respect to such counsel.
8. A CQUISITION
OF R IGHTS FROM T
HIRD P ARTIES . During the
Research Term, Icagen and Pfizer shall each promptly notify each
other of all material opportunities to acquire in any manner from
third parties, technology or patents or information which may be
useful in or may relate to the Research Program that come to the
attention of such party; provided that Pfizer shall not be
obligated to notify Icagen of any third party technology that
relates to the Excluded Pfizer Compounds. Icagen and Pfizer shall
decide if such rights should be acquired in connection with the
Research Program and, if so, whether by Icagen, Pfizer or both. If
acquired, such rights shall become part of the Confidential
Information, Technology or Patent Rights, whichever is appropriate,
of the acquiring party or parties.
9. L EGAL A
CTION .
9.1 Actual or Threatened
Infringement. When information comes to the attention of Pfizer
to the effect that any Icagen Patent Rights, Pfizer Patent Rights
or Joint Patent Rights relating to a Candidate Compound or Product
has been or is threatened to be unlawfully infringed, Pfizer shall
have the first right at its expense to take such action as it may
deem necessary to prosecute or prevent such unlawful infringement,
including the right to bring or defend any suit, action or
proceeding involving any such infringement. Pfizer shall notify
Icagen promptly of the receipt of any such information and of the
commencement of any such suit, action or proceeding. If Pfizer
determines that it is necessary or desirable for Icagen to join any
such suit, action or proceeding, Icagen shall, at Pfizer's expense,
execute all papers and perform such other acts as may be reasonably
required to permit Pfizer to commence such action, suit or
proceeding in which case Pfizer shall indemnify and hold Icagen
free, clear and harmless from any and all damages and costs and
expenses of litigation, including attorneys fees. If Pfizer brings
a suit, it shall have the right first to reimburse itself out of
any sums recovered in such suit or in its settlement for all costs
and expenses, including attorney's fees, related to such suit or
settlement, and any remainder shall be paid [**] percent ([**]%) to
Icagen and [**] percent ([**]%) to Pfizer. If Pfizer does not,
within [**] days after giving notice to Icagen of the
above-described information (or within [**] days after any
paragraph IV certification under 21 C.F.R. Part 314 by a third
party to the effect that any Icagen Patent Right, Pfizer Patent
Right or Joint Patent Right is invalid, unenforceable or otherwise
not infringed by a generic version of a Product), notify Icagen of
Pfizer's intent to bring suit against any infringer, Icagen shall
have the right to bring suit for such alleged infringement, but it
shall not be obligated to do so. If Icagen determines that it is
necessary or desirable for Pfizer to join any such suit, action or
proceeding, Pfizer shall, at Icagen's expense, execute all papers
and perform such other acts as may be reasonably required to permit
Icagen to commence such action, suit or proceeding in which case
Icagen shall indemnify and hold Pfizer free, clear and harmless
from any and all damages and costs and expenses of litigation,
including attorneys fees. If Icagen brings a suit, it shall have
the
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