EXHIBIT 10.30
COLLABORATIVE RESEARCH AND
LICENSE AGREEMENT
THIS COLLABORATIVE RESEARCH AND
LICENSE AGREEMENT (the
“Agreement”) is entered into as of January 18,
2005 by and between RIGEL PHARMACEUTICALS, INC. , a Delaware
corporation with its offices at 1180 Veterans Boulevard, South San
Francisco, California 94080 (“Rigel”), and PFIZER
INC. , a Delaware corporation with its offices at 235 East 42
nd Street, New York, New York 10017
(“Pfizer”). Rigel and Pfizer may be referred to
herein individually as a “Party” or collectively, as
the “Parties.”
RECITALS
WHEREAS, Pfizer is a pharmaceutical company engaged in
the discovery, development, marketing, manufacture and distribution
of pharmaceutical products;
WHEREAS, Rigel is a pharmaceutical company engaged in the
discovery and development of novel pharmaceuticals including Syk
tyrosine kinase inhibitors;
WHEREAS, Rigel and Pfizer desire to enter into a
relationship to identify, develop and commercialize Syk tyrosine
kinase inhibitors for use in the diagnosis, treatment or prevention
of certain Allergy and Respiratory Conditions;
WHEREAS, Rigel is prepared to grant Pfizer a license to
allow Pfizer to commercialize products arising from this
relationship for such purposes; and
WHEREAS, Rigel is separately engaged in the development
of products for allergic rhinitis, and the Parties have agreed to
exclude that indication from the field of Allergy and Respiratory
Conditions for purposes of this Agreement, subject to
Section 5.5;
NOW, THEREFORE,
in consideration of the foregoing
and the covenants and promises contained in this Agreement, the
Parties agree as follows:
1.
DEFINITIONS
1.1
“Acquisition
Proposal” shall
mean any tender offer or exchange offer to the stockholders of
Rigel, or an offer accepted by the Board of Directors of Rigel,
with respect to a Business Combination or involving the purchase of
[ * ] or more of the outstanding Voting Stock of Rigel, or
newly issued securities, which after the issuance thereof,
represent [ * ] or more of the Voting Stock of
Rigel.
1.2
“Advanced Preclinical
Development” means
any of the following activities: (i) the commencement of
manufacturing process scale-up of a Compound, (ii) the selection of
a solid dose formulation of a Compound, (iii) the initiation of
preclinical toxicology studies of a Compound, or (iv) the synthesis
by Pfizer or receipt by Pfizer of quantities of a Compound in
excess of 200 grams as needed to commence toxicology
studies.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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1.3
“Affiliate” means a person, corporation, partnership, or
other entity that controls, is controlled by or is under common
control with a Party. For the purposes of this
Section 1.3, the word “control” (including, with
correlative meaning, the terms “controlled by” or
“under the common control with”) means the actual
power, either directly or indirectly through one or more
intermediaries, to direct the management and policies of such
entity, whether by the ownership of at least fifty percent (50%) of
the voting stock of such entity, or by contract or
otherwise.
1.4
“Allergy and Respiratory
Conditions” means
all human diseases and disorders resulting from an allergic
reaction to an antigen, or primarily involving respiratory or
pulmonary dysfunction, and shall include without limitation asthma
and chronic obstructive pulmonary disease (“COPD”), but
shall specifically exclude allergic rhinitis. Allergy and
Respiratory Conditions shall exclude autoimmune disorders, provided
that asthma and COPD shall always be considered Allergy and
Respiratory Conditions even if the underlying basis of asthma and
COPD is an autoimmune disorder.
1.5
“Business
Combination” shall
mean (a) merger, consolidation, reorganization, acquisition,
liquidation, scheme or other analogous arrangement with a Third
Party in which Rigel is a constituent corporation or party and
pursuant to which Voting Stock of Rigel is or may be exchanged for
cash, securities or other property, or (b) a sale of a material
portion of the assets of Rigel representing not less than [ *
] of the fair market value of Rigel.
1.6
“Business
Day” means a day
other than a Saturday, Sunday, bank or other public holiday in the
state of New York.
1.7
“Change of
Control” means that
any of the following has occurred:
(a)
any Person becomes the beneficial
owner, directly or indirectly, of [ * ] or more of the
Voting Stock of Rigel; or
(b)
Rigel enters into an agreement with
any Person providing for the sale or other disposition of all or
substantially all of the assets of Rigel; or
(c)
Rigel closes an agreement with any
Person providing for a consolidation or merger of Rigel with
another person or other entity (other than with any of
Rigel’s subsidiaries) that results in the shareholders of
Rigel immediately before the occurrence of the consolidation or
merger receiving only cash for their Rigel shares or securities
(whether or not in combination with cash) representing, in the
aggregate, less than [ * ] of the Voting Stock of the
surviving entity immediately after consolidation or merger;
or
(d)
a change in Rigel’s Board of
Directors occurs with the result that the members of the Board on
the date of this Agreement (the “Incumbent Directors”)
no longer constitute a majority of such Board of Directors,
provided that any person becoming a director (other than a director
whose initial assumption of office is in connection with an actual
or threatened election contest or the settlement thereof, including
but not limited to a consent solicitation, relating to the election
of directors of Rigel) whose election or nomination for election
was supported by at least two-thirds (2/3) of the then Incumbent
Directors shall be considered an Incumbent Director for purposes
hereof; or
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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(e)
Rigel enters into an agreement with
any Person providing for the matters described in subsections (a)
or (d) above.
1.8
“Collaboration”
means all activities performed by or
on behalf of Rigel or Pfizer in the course of performing their
obligations pursuant to the Research Program.
1.9
“Combination
Product” means a
Product containing a Compound and one or more other
pharmaceutically active agents.
1.10
“Commence”
or “Commencement”
when used to describe a Phase I Trial, Phase II Trial, or Phase III
Trial, means the first dosing of the first patient for such
trial.
1.11
“Commercialization”
means all activities that are
undertaken after Regulatory Approval of an NDA for a particular
Product and that relate to the commercial marketing and sale of
such Product including advertising, marketing, promotion,
distribution, and Phase IV Trials.
1.12
“Competing
Product” means any
Syk Inhibitor for Intrapulmonary Administration that has received
Regulatory Approval for an indication in the Field, which Syk
Inhibitor is not a Product.
1.13
“Compound”
means, initially, the compounds
listed on Schedule 1.13 as of the Effective Date, and
thereafter (i) shall exclude any of the compounds listed on
Schedule 1.13 that are determined to fall within clause
(a), (b) or (c) below, and (ii) shall be expanded to include all
Compound Analogs and Derivatives, and all prodrugs, salts and
polymorphs of each Compound, that are shown to inhibit SYK with an
[ * ] and are not excluded from the definition of
“Compound” pursuant to clauses (a), (b) or (c)
below. The following compounds shall be excluded from the
definition of “Compound”:
(a)
any such compound that is shown to
have an oral bioavailability in rats of greater than [ * ] ;
and
(b)
any such compound that is eliminated
from the definition of “Compound” pursuant to
Section 3.3 or Section 3.4; and
(c)
any such compound that reverts to
Rigel under Section 9.3.
Schedule 1.13 shall be updated from time to time, upon the
request of either Party, to reflect additions or deletions that
have occurred after the Effective Date.
1.14
“Compound Analogs and
Derivatives” shall
mean (a) all compounds created through the addition or deletion of
chemical moieties that are covalently bound to the [ * ] of
the compounds listed on Schedule 1.13 (including
compounds listed on such Schedule that are determined not to
be Compounds), and (b) all stereoisomers of Compounds or of the
compounds described in clause (a) of this Section 1.14,
whether or not such stereoisomers are created through the addition
or deletion of chemical moieties that are covalently bound to the
[ * ] of such compounds. For clarity, Compound Analogs
and Derivatives shall exclude salts, polymorphs and physical forms
of Compounds.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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1.15
“Confidential
Information” means
all Information, and other information and materials, received by
either Party from the other Party pursuant to this Agreement and
that is designated as confidential at the time of disclosure or
promptly thereafter.
1.16
“ Control ”
means, with respect to any intellectual property right, that a
Party owns or has a license to such item or right, and has the
ability to grant a license or sublicense in or to such right
without violating the terms of any agreement or other arrangement
with any Third Party.
1.17
“Develop” or
“Development” means, with respect to the Product, the
performance of all research, pre-clinical, clinical and regulatory
activities required to obtain Regulatory Approval of a Product in
the Territory; provided , however , that Develop or
Development shall not include the performance by either Party of
its obligations under the Research Program.
1.18
“Development
Plan” has the
meaning set forth in Section 4.1.
1.19
“ Diligent Efforts
” means the carrying out of obligations or tasks in a manner
consistent with the efforts a Party devotes to research,
development or marketing of a pharmaceutical product or products of
similar market potential, profit potential or strategic value
resulting from its own research efforts, taking into account
technical and regulatory factors, target product profiles, product
labeling, past performance, economic return, the regulatory
environment and competitive market conditions in the therapeutic
area, all based on conditions then prevailing. Diligent
Efforts requires that a Party, at a minimum, assign responsibility
for such obligations to qualified employees, set annual goals and
objectives for carrying out such obligations, and allocate
resources designed to meet such goals and objectives.
1.20
“Effective
Date” means the
date that the applicable waiting period under the HSR Act shall
have expired or been terminated with respect to this
Agreement.
1.21
“ FDA ” means the
United States Food and Drug Administration, or any successor
federal agency thereto.
1.22
“ Field ” means
the prevention and treatment of Allergy and Respiratory Conditions
in humans.
1.23
“FTE”
means the equivalent of one person
working full time for one 12-month period in a research,
development, commercialization, regulatory or other relevant
capacity, approximating 1800 hours per year. In the interests
of clarity, though, a single individual who works more than 1800
hours in a single year shall be treated as one FTE regardless of
the number of hours worked.
1.24
“Generic
Product” means any
pharmaceutical product, other than a Product, that contains the
same Compound as the relevant Product and can reasonably be or is
reasonably used for the same indication or indications as such
Product.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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1.25
“Good Clinical
Practices” or “GCP” means current Good Clinical Practices as
specified in the United States Code of Federal Regulations, at the
time of testing, and all FDA and ICH guidelines, including the ICH
Consolidated Guidelines on Good Clinical Practices.
1.26
“Good Laboratory
Practices” or “GLP” means current Good Laboratory Practices as
specified in the United States Code of Federal Regulations at 21
CFR § 58 at the time of testing and all applicable ICH
guidelines.
1.27
“Good Manufacturing
Practices” or “GMP” means current Good Manufacturing Practices and
standards as provided for (and as amended from time to time) in
European Community Directive 91/356/EEC (Principles and Guidelines
of Good Manufacturing Practice for Medicinal Products) and in the
Current Good Manufacturing Practice Regulations of the United
States Code of Federal Regulations Title 21 (21 CFR
§§ 210-211) in relation to the production of
pharmaceutical intermediates and active pharmaceutical ingredients,
as interpreted by ICH Harmonized Tripartite Guideline, Good
Manufacturing Practice Guide for Active Pharmaceutical Ingredients,
and subject to any arrangements, additions or clarifications agreed
from time to time between the Parties.
1.28
“Governmental
Authority” means
any court, agency, department or other instrumentality of any
foreign, federal, state, county, city or other political
subdivision.
1.29
“HSR Act”
means the United States
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended.
1.30
“IND”
means an Investigational New Drug
Application filed with the FDA or the equivalent application or
filing filed with any equivalent agency or government authority
outside of the United States (including any supra-national agency
such as in the European Union) necessary to Commence human clinical
trials in such jurisdiction, and including all regulations at 21
CFR § 312 et. seq. and equivalent foreign
regulations.
1.31
“ Information ”
means information, results and data of any type whatsoever,
including without limitation, databases, inventions, practices,
methods, techniques, specifications, formulations, formulae,
knowledge, know-how, skill, experience, test data including
pharmacological, biological, chemical, biochemical, toxicological
and clinical test data, analytical and quality control data,
stability data, studies and procedures, and patent and other legal
information or descriptions.
1.32
“Intrapulmonary
Administration” means the delivery of a pharmaceutical product
to the lung, and shall include without limitation dry powder
formulations and aerosolized liquids or suspensions for delivery to
the lung by means of the mouth, but shall exclude without
limitation liquids or suspensions designed for intranasal
administration. Intrapulmonary Administration shall exclude
the Oral Delivery and intravenous administration of
drugs.
1.33
“Know-How”
means any non-public, proprietary
Information and other data, instructions, processes, methods,
formulae, materials, expert opinions and information, including
without limitation, biological, chemical, pharmacological,
toxicological, pharmaceutical,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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physical and analytical, clinical, safety,
manufacturing and quality control data and information.
Know-How does not include any rights under Patents.
1.34
“Joint Research
Committee” or
“JRC” means the committee described in
Section 2.1.
1.35
“Launch”
means the first shipment of a
Product in commercial quantities for commercial sale by Pfizer, its
Affiliates or its sublicensees to an unaffiliated Third Party in a
country after receipt by Pfizer of the first Regulatory Approval
for such Product in such country.
1.36
“Major European
Country” means the
United Kingdom, Spain, France, Germany and Italy.
1.37
“NDA”
means a New Drug Application filed
with the FDA or the equivalent application or filing filed with any
equivalent Governmental Authority outside of the United States
necessary for approval of a drug in such jurisdiction.
1.38
“Net
Sales” means
(a)
with respect to a Product (subject
to subsections (b) and (c) below), the amount received by a Party
or its Affiliate or a Third Party sublicensee for sales of such
Product, to Third Parties, less (i) actual bad debts related to
such Product and (ii) sales returns and allowances actually paid,
granted or accrued, including, without limitation, trade, quantity
and cash discounts and any other adjustments, including, but not
limited to, 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,
including without limitation Pfizer Pfriends or 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 any payment in respect of sales to the United States
government, any State government or any foreign government, or to
any governmental or regulatory authority, or with respect to any
government-subsidized program or managed care organization, and
freight and insurance (to the extent that Pfizer bears the cost of
freight and insurance for a Product); and
(b)
in the case of Combination
Products,
(i)
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) one or more
Products as a single chemical entity and (2) other products
containing active ingredient(s) as a single entity that are also
contained in such Combination Product, 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 each Product 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
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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in such country, for each product(s) containing,
the active ingredient(s) in such Combination Product (other than
the Product);
(ii)
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, one or more
Products as a single chemical entity but do not separately sell, in
such country, other products 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 Affiliates
or Third Parties, as applicable) average Net Sales price per daily
dose during such year for each Product 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;
(iii)
if Pfizer and/or its Affiliates
and/or Third Parties do not separately in such country during such
year sell each Product contained in the Combination Product, then
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 and E is the fair
market value of the portion of the Combination Product containing
the other active ingredient(s) and the delivery device included in
such Combination Product, as such fair market values are determined
by mutual agreement of the Parties; and
(c)
if a Product is packaged with a
delivery device or sold together with a delivery device for a
single price, then the Net Sales for the purpose of determining the
royalty due to the other Party pursuant to Section 6.3 shall
include the sales price of both the Product and the delivery
device.
1.39
“Oral
Delivery” means the
administration of a human pharmaceutical product via the mouth in
any form other than for the purpose of delivery of such product
specifically to the lung. Oral Delivery shall include without
limitation the delivery of products in the form of a pill or a
non-aerosolized liquid or suspension, or sublingually.
1.40
“Other Topical
Administration” means any topical administration of a human
pharmaceutical product, including without limitation patches and
ophthalmologic application, but excluding Intrapulmonary
Administration and intranasal administration.
1.41
“Patent”
means: (a) an issued unexpired
patent (including inventor’s certificate) that has not been
held invalid or unenforceable by a court of competent jurisdiction
from which no appeal can be taken or has been taken within the
required time period, including without limitation any
substitution, extension, registration, confirmation, reissue,
re-examination, renewal or any like filing thereof; or (b) any
pending patent application, including without limitation any
continuation, division or continuation-in-part thereof and any
provisional application.
1.42
“Person”
means an individual, corporation,
partnership, company, joint venture, unincorporated organization,
limited liability company or partnership, sole
proprietorship,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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association, bank, trust company or trust,
whether or not legal entities, or any governmental entity or agency
or political subdivision thereof.
1.43
“Pfizer
Know-How” means all
Know-How Controlled by Pfizer or its Affiliates that is developed
by or on behalf of Pfizer pursuant to the Collaboration and is
necessary or useful for the research, development, manufacture,
importation, use or sale of Compounds or Products, including
without limitation Pfizer’s rights in any jointly-owned
Know-How.
1.44
“Pfizer
Patents” means any
Patents Controlled by Pfizer or its Affiliates that are based on
inventions made by or on behalf of Pfizer pursuant to the
Collaboration and are necessary or useful for the development,
manufacture, importation, use or sale of Products, including
without limitation Pfizer’s rights in any jointly-owned
Patents.
1.45
“Pfizer
Quarter” means (i)
in the United States, each of the four (4) thirteen (13) week
periods as used by Pfizer in its audited financial reports, the
first commencing on January 1 of any year, and (ii) in any
country in the Territory other than the United States, each of the
four (4) thirteen (13) week periods as used by Pfizer in its
audited financial reports, the first commencing on December 1
of any year.
1.46
“Pfizer
Technology” means
Pfizer Patents and Pfizer Know-How.
1.47
“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 generally consistent with 21 CFR
§ 312.21(a).
1.48
“Phase II
Trial” means a
clinical trial of a Product on patients, including possibly
pharmacokinetic studies, the principal purpose of which is to make
a preliminary determination that such Product is safe for its
intended use and to obtain sufficient information about such
Product’s efficacy to permit the design of further clinical
trials, and generally consistent with 21 CFR
§ 312.21(b). A Phase II Trial may be either a Phase
II(a) Trial or a Phase II(b) Trial.
1.49
“Phase II(a)
Trial” means a
Phase II Trial intended for dose exploration, dose response,
duration of effect, kinetic/dynamic relationship and preliminary
efficacy and safety study of a candidate drug in the target patient
population.
1.50
“Phase II(b)
Trial” means a
controlled dose ranging Phase II Trial to evaluate further the
efficacy and safety of a candidate drug in the target patient
population and to define the optimal dosing regimen.
1.51
“Phase III
Trial” means a
clinical trial that provides for a pivotal human clinical trial of
a Product, which trial is designed to: (a) establish that a Product
is safe and efficacious for its intended use; (b) define warnings,
precautions and adverse reactions that are associated with the
Product in the dosage range to be prescribed; (c) support
Regulatory Approval of such Product; and (d) generally consistent
with 21 CFR § 312.21(c).
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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1.52
“Phase IV
Trial” means
clinical trial of a Product Commenced in a particular country after
Regulatory Approval for such Product in such country in order to
support commercialization of the Product.
1.53
“Preclinical
Development” means
those Development activities performed prior to the filing of an
IND.
1.54
“Product”
means any pharmaceutical product
comprised of a Compound, alone or in combination with one or more
therapeutically active ingredients, whether or not combined with an
inhalation or similar device, the manufacture, use, sale, offer for
sale or importation of which, in the absence of a license, would
infringe any of the Rigel Patents including Patents jointly-owned
by the Parties.
1.55
“Proxy
Solicitation” means
any solicitation of proxies or stockholder consents (as such terms
are defined under Regulation 14A and Regulation 14C of the
Securities Exchange Act) to vote or seek to advise or influence in
any manner whatsoever any Person with respect to the Voting Stock
of Rigel.
1.56
“R-112”
means the Rigel Syk tyrosine kinase
inhibitor that (a) is identified in IND No. 66,176 filed with the
FDA for Rigel’s R-112 Nasal Spray; and (b) was the product
candidate that entered into a Phase I Trial to treat allergic
rhinitis in September 2002, and was the product candidate that
entered into a Phase II Trial for allergic rhinitis in
April 2004, sponsored by Rigel.
1.57
“[ * ]”
means the Syk tyrosine kinase
inhibitor set forth in Schedule 1.57 .
1.58
“Regulatory
Approval” means any
and all approvals (including supplements, amendments, pre- and
post-approvals, pricing and reimbursement approvals), licenses,
registrations or authorizations of any national, supra-national
(e.g., the European Commission or the Council of the European
Union), regional, state or local regulatory agency, department,
bureau, commission, council or other governmental entity, that are
necessary for the manufacture, distribution, use or, in
Pfizer’s reasonable judgment, widespread sale of a Product in
a regulatory jurisdiction.
1.59
“Regulatory
Authority” means
any Governmental Authority with responsibility for granting any
licenses or approvals necessary for the marketing and sale of
pharmaceutical products including, without limitation, the FDA and
any drug regulatory authority of countries of the European Union,
and Japan, and where applicable any ethics committee or any
equivalent review board.
1.60
“Regulatory
Filing” means the
NDA, biologic license application (“BLA”), IND, or any
foreign counterparts thereof and any other filings required by
regulatory authorities relating to the study, manufacture or
commercialization of any Product.
1.61
“Research
Plan” has the
meaning set forth in Section 3.1.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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1.62
“Research
Program” means the
Research Program established by the Parties pursuant to this
Agreement.
1.63
“Research
Term” means the
period from the Effective Date to the later of (a) [ * ]
thereafter, or (b) the completion by [ * ] on Exhibits
A-1 and A-2 , subject to extension in the event the Parties
commence de novo compound discovery under
Section 3.10.
1.64
“Rigel
Know-How” means all
Know-How Controlled by Rigel or its Affiliates that is necessary or
useful for the research, development, manufacture, importation, use
or sale of the Compounds or Products, including without limitation
Rigel’s rights in any jointly-owned Know-How.
1.65
“Rigel
Patents” means any
Patents Controlled by Rigel or its Affiliates that are necessary or
useful for the research, development, manufacture, importation, use
or sale of the Compounds or Products, including without limitation,
the Patents listed on Schedule 1.65 , as well as
Rigel’s rights in any jointly-owned Patents. Patents
owned jointly by the Parties shall be deemed Controlled by Rigel
for purposes of this Section 1.65.
1.66
“Rigel
Technology” means
Rigel Patents and Rigel Know-How.
1.67
“Royalty
Term” means on a
country-by-country and Product-by-Product basis, the later
of: (A) the last to expire Valid Claim Controlled by Rigel
covering a Product in such country, and (B) [ * ] years
following the Launch of such Product in such country.
1.68
“Standstill
Period” shall mean
the period commencing on the execution date of this Agreement and
terminating [ * ] after such date.
1.69
“SYK”
shall mean an enzyme comprised of
the amino acid sequence for spleen tyrosine kinase as identified on
Schedule 1.69 , including all allelic variations or
derivatives thereof, or homologues whose amino acid sequence has
[ * ] or greater homology with such sequence.
1.70
“Syk
Inhibitor” means a
compound whose primary known mechanism of action is the direct
inhibition of SYK.
1.71
“Term”
has the meaning assigned to it in
Section 9.1.
1.72
“Territory” means worldwide.
1.73
“Third
Party” means a
person or entity other than (a) Pfizer, (b) Rigel or (c) an
Affiliate of either of them.
1.74
“Valid
Claim” means a
claim of any issued, unexpired United States or granted foreign
Rigel Patent (as Patent is defined in Section 1.41(a)) that
has not been dedicated to the public, disclaimed, abandoned or held
invalid or unenforceable by a court or other body of competent
jurisdiction in an unappealed or unappealable decision, and that
has not been explicitly disclaimed, or admitted by Rigel in writing
to be invalid or unenforceable or of a scope not covering Products
through reissue, disclaimer or otherwise.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
10
1.75
“Voting
Stock” means
securities of any class or series of a corporation or association
the holders of which are ordinarily, in the absence of
contingencies, entitled to vote generally in matters put before the
shareholders or members of such corporation or
association.
2.
MANAGEMENT OF THE RESEARCH
PROGRAM
2.1
Joint Research
Committee.
(a)
The Research Program established by
this Agreement shall be overseen by a joint research committee
composed of four (4) representatives from each Party (the
“Joint Research Committee” or “JRC”).
The Parties shall designate their JRC representatives within ten
(10) days after the Effective Date. An alternate member
designated by a Party may serve temporarily in the absence of a
permanent member of the JRC for such Party. Each Party shall
designate one of its representatives as a co-chair of the
JRC. The co-chairs of the JRC shall be jointly responsible
for setting the agenda for each meeting, and each co-chair will be
responsible for chairing alternating JRC meetings. From time
to time, the JRC may establish subcommittees or subordinate
committees (that may or may not include members of the JRC itself)
to oversee particular projects or activities, and such
subcommittees or subordinate committees shall be constituted and
shall operate as the JRC agrees. The JRC shall disband
automatically at the end of the Research Term, provided, however,
that after termination of the Research Term, the JRC may continue
to meet at its own discretion for purposes related to the
Collaboration should the JRC unanimously decide that such continued
meetings are in the best interest of the Collaboration.
(b)
All decisions of the JRC made
pursuant to this Agreement shall be made by unanimous consent of
its members. If for any reason the JRC cannot reach unanimity
within ten (10) Business Days of the JRC meeting at which such
matter was first discussed, then, except as set forth in
Section 2.1(c), the matter shall be referred to a vice
president of Pfizer and a senior executive of Rigel for
resolution. Neither of such Pfizer vice president or Rigel
senior executive shall at the time of determination be a member of
the JRC or of any subcommittee of the JRC. If such Pfizer
vice president and Rigel senior executive cannot resolve the matter
in good faith within ten (10) Business Days after attempting to
find a mutually satisfactory resolution to the issue, then the
matter shall be decided in good faith by such Pfizer vice
president.
(c)
Any changes to the Research Plan
expanding Rigel’s obligations or requiring Rigel to exert
additional efforts shall require the unanimous consent of the
JRC. If the JRC fails to reach unanimous consent regarding
any such change to the Research Plan, then the obligations of Rigel
shall not be increased.
2.2
Meetings. The JRC shall hold meetings at such times
and places as shall be determined by the JRC (it being expected
that any in-person meetings will alternate between the offices of
each Party), but in no event shall such meetings be held less
frequently than once every three (3) months during the Research
Term; and the JRC may:
(a)
conduct meetings in person, by
videoconference or by telephone conference;
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
11
(b)
invite other personnel of the
Parties to attend meetings of the JRC as appropriate to the agenda
for such meeting, after giving notice to the other
Party;
(c)
act without a meeting if, prior to
such action, a consent thereto is signed by the co-chairs of the
JRC; and
(d)
by unanimous consent, amend or
expand upon the foregoing procedures for its internal
operation.
2.3
Minutes. At each meeting, the JRC shall elect a
secretary who will prepare, within fifteen (15) Business Days after
each meeting, minutes reporting in reasonable detail the actions
taken by the JRC during such meeting, the status of the Research
Program as described in the relevant JRC meeting, issues requiring
resolution, and resolutions of previously reported issues.
Such minutes are to be reviewed and, if reasonably complete and
accurate, signed by one JRC member from each Party. The
secretary shall revise such minutes as necessary to obtain such
signatures.
2.4
JRC Functions and
Powers. The
research activities of the Parties under this Agreement shall be
managed by the JRC only to the extent set forth herein (unless
otherwise mutually agreed in writing by the Parties). The JRC
shall foster the collaborative relationship between the Parties in
order to assist each Party in fulfilling its obligations under this
Agreement, and shall in particular:
(a)
encourage and facilitate ongoing
cooperation and information exchange between the
Parties;
(b)
monitor the progress of the Research
Program and the Parties’ diligence in carrying out their
responsibilities thereunder;
(c)
prepare any amendments to the
Research Plan, if the JRC should determine that any such amendments
are necessary;
(d)
set priorities, allocate tasks and
coordinate activities between the Parties, in each case as required
to perform the Research Program;
(e)
perform such other functions as
appropriate to further the purposes of this Agreement as mutually
determined by the Parties.
The JRC shall have no power to amend this
Agreement and shall have only such powers as are specifically
delegated to it hereunder.
2.5
Independence.
Subject to the terms of this
Agreement, the activities and resources of each Party shall be
managed by such Party, acting independently and in its individual
capacity. The relationship between Rigel and Pfizer is that
of independent contractors and neither Party shall have the power
to bind or obligate the other Party in any manner, other than as is
expressly set forth in this Agreement.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
12
3.
CONDUCT OF THE RESEARCH PROGRAM
AND SELECTION OF COMPOUNDS FOR PRECLINICAL
DEVELOPMENT.
3.1
Research Plan.
The Parties shall conduct the
Research Program according to a research plan (the “Research
Plan”). The initial Research Plan has been approved by
the Parties concurrent with the execution of this Agreement and is
attached hereto as Exhibits A-1 and A-2 . The Research
Plan may be amended from time to time by the JRC during the
Research Term, based upon the data obtained in the Research
Program, provided such amendments do not violate or contradict any
provision of this Agreement. In the event of an inconsistency
or disagreement between the Research Plan and this Agreement, the
terms of this Agreement shall prevail.
3.2
Conduct of Research.
The Parties shall use
Diligent Efforts to conduct their respective tasks as assigned
under the Research Plan throughout the Research Program. In
addition, the Parties shall conduct the Research Program in
compliance in all material respects with the requirements of
applicable laws, rules and regulations and all applicable GLP to
attempt to achieve their objectives efficiently and
expeditiously.
3.3
Assessment of [ * ].
Rigel and Pfizer shall, [ * ]
, use Diligent Efforts to carry out its obligations under the
Research Plan as set forth in Exhibit A-1 with respect to
the Compound designated as [ * ] . With respect to
such Compound, Pfizer shall have the option to retain the exclusive
rights to [ * ] granted in Section 5.1 by paying to
Rigel the amount set forth in Section 6.2(a)(i) no later than
the earlier of (i) the date that is one hundred and eighty (180)
days following Rigel’s completion of the tasks designated in
Exhibit A-1 to be carried out by Rigel for [ * ] ,
and the delivery to Pfizer of the data resulting from such Rigel
tasks; and (ii) Pfizer’s decision to commence Advanced
Preclinical Development for [ * ] . If Pfizer has not
made the payment under Section 6.2(a)(i) within the time
period set forth in this Section 3.3 (as such time period may
be extended pursuant to Section 3.5), then [ * ] shall
be deleted from the definition of “Compound” and Rigel
may thereafter license, develop and commercialize such compound,
subject to the restrictions set forth in
Section 5.3.
3.4
Assessment Of Other
Compounds.
(a)
Rigel’s undertaking with
respect to the Compounds under Sections 3.3 and 3.4 shall be to
perform work directed towards the delivery to Pfizer of at least
two (2) candidates for Advanced Preclinical Development within [
* ] from the Effective Date. If Pfizer selects [ *
] for Advanced Preclinical Development under Section 3.3,
then Rigel shall perform work directed towards the delivery to
Pfizer of at least one (1) additional candidate for Advanced
Preclinical Development under this Section 3.4. If
Pfizer does not select [ * ] for Advanced Preclinical
Development under Section 3.3, then Rigel shall perform work
directed towards the delivery to Pfizer of two (2) other candidates
for Advanced Preclinical Development under this
Section 3.4. The Parties may also agree to extend the
Research Term under Section 3.10 in pursuit of additional
candidates for Advanced Preclinical Development. Rigel and
Pfizer shall, each at its own expense, use Diligent Efforts to
carry out its obligations under the Research Plan as set forth in
Exhibit A-2 , with respect to the Compounds other than [
* ] , but not to perform the tasks set forth on Exhibit
A-2 with respect to various Compounds beyond the level
reasonably necessary to deliver more than two (2) candidates for
Advanced Preclinical Development. With respect to Compound(s)
other than [ * ] proposed by Rigel for Advanced Preclinical
Development, Pfizer
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
13
shall have the right to retain the exclusive
license to such Compound(s) granted in Section 5.1 by paying
to Rigel the amount set forth in Section 6.2(a)(i) or
Section (a)(ii), as applicable, no later than the earlier of
(i) the date that is one hundred and eighty (180) days following
Rigel’s completion of the tasks designated in the Research
Plan to be carried out by Rigel to enable Pfizer to consider a
candidate for Advanced Preclinical Development, and the delivery to
Pfizer of the data resulting from such Rigel tasks, provided
, however , that such delivery takes place no sooner than
twelve (12) months after the delivery of the data resulting from
Rigel’s tasks for the first candidate, or such earlier time
as the JRC might establish; and (ii) Pfizer’s decision
to commence Advanced Preclinical Development for such
Compound. For avoidance of doubt, the payment by Pfizer of
any Event Milestone Payment under Sections 6.2(a)(i) or 6.2(a)(ii)
shall not relieve Rigel of its obligation to complete any remaining
work under the Research Plan related to the delivery to Pfizer of
two (2) candidates for Advanced Preclinical Development.
(b)
If Pfizer makes a payment under
Section 6.2(a)(i) but does not make a payment under
Section 6.2(a)(ii) within the time period specified in
Section 3.4(a) (as such time period may be extended pursuant
to Section 3.5), then, effective as of the date Pfizer is
obligated to make its payment under Section 6.2(a)(ii), the
definition of “Compound” shall thereafter be limited
only to the Compound for which Pfizer has made its payment under
Section 6.2(a)(i), and Rigel may thereafter license, develop
and commercialize such compounds subject to the restrictions set
forth in Section 5.3.
(c)
If Pfizer makes payments under both
of Section 6.2(a)(i) and Section 6.2(a)(ii), then,
subject to the other terms and conditions of this Agreement, all
Compounds (i.e., after deletion of compounds by reason of
Section 1.13(a), (b), (c) and (d)) shall remain available to
Pfizer pursuant to the license set forth in Section 5.1, and
Rigel shall remain subject to the restrictions set forth in
Section 5.3. If Pfizer should select additional
Compounds for Advanced Preclinical Development other than the two
(2) Compounds for which the Event Milestone Payments were made
under Sections 6.2(a)(i) and 6.2(a)(ii), then Pfizer shall provide
Rigel with written notice within thirty (30) days after any such
Compound selection that does not trigger an Event Milestone
Payment.
3.5
Extension of Time
Period.
(a)
Pfizer shall have the option (the
“First Extension Option”) to extend the time period set
forth in Section 3.3, with respect to [ * ] , by an
additional one hundred and eighty (180) days if, in Pfizer’s
good faith judgment, additional time is required for Pfizer to
decide whether to commence Advanced Preclinical Development with
respect to [ * ] . Pfizer may exercise the First
Extension Option by paying to Rigel fifty percent (50%) of the
Event Milestone Payment due under Section 6.2(a)(i) prior to
the date Pfizer’s option to retain exclusive rights to [ *
] expires under Section 3.3. If Pfizer should
exercise the First Extension Option, Pfizer shall have the right to
retain the exclusive license to [ * ] granted in
Section 5.1 by paying to Rigel the remaining fifty percent
(50%) of the Event Milestone Payment due under
Section 6.2(a)(i) within such one hundred and eighty (180) day
extension period. Each payment made to Rigel under this
Section 3.5(a), if any, shall be fully-credited against the
Event Milestone Payment due under Section 6.2(a)(i) should
Pfizer make such Event Milestone Payment. During the
extension period set forth in this Section 3.5(a), Pfizer
shall not commence
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
14
Advanced Preclinical Development with respect to
[ * ] until the Event Milestone Payment under
Section 6.2(a)(i) has been paid in full.
(b)
Pfizer shall have the option (the
“Second Extension Option”) to extend the time period
set forth in Section 3.4(a), with respect to any Compound
other than [ * ] , by an additional one hundred and eighty
(180) days if, in Pfizer’s good faith judgment, additional
time is required for Pfizer to decide whether to commence Advanced
Preclinical Development with respect to such other Compound.
Pfizer may exercise the Second Extension Option by paying to Rigel
fifty percent (50%) of the Event Milestone Payment due with respect
to such Compound under Section 6.2(a)(i) or 6.2(a)(ii), as
applicable, depending on whether Pfizer has previously made an
Event Milestone Payment under Section 6.2(a)(i) prior to the
date Pfizer’s option to retain exclusive rights to such
Compound expires under Section 3.4. If Pfizer should
exercise the Second Extension Option, Pfizer shall have the right
to retain the exclusive license to such Compound granted in
Section 5.1 by paying to Rigel the remaining fifty percent
(50%) of the Event Milestone Payment due with respect to such
Compound under Section 6.2(a)(i) or 6.2(a)(ii), as applicable,
within such one hundred and eighty (180) day extension
period. Each payment made to Rigel under this
Section 3.5(b), if any, shall be fully-credited against the
Event Milestone Payment due under Section 6.2(a)(i) or
6.2(a)(ii) should Pfizer make such Event Milestone Payment.
During the extension period set forth in this Section 3.5(b),
Pfizer shall not commence Advanced Preclinical Development with
respect to such other Compound until the Event Milestone Payment
under Section 6.2(a)(i) or 6.2(a)(ii) for such Compound has
been paid in full.
3.6
Research Costs.
Except as provided in
Section 3.10 and in this Section 3.6, [ * ] , and
any external payments to Third Parties that [ * ] of the
Research Program unless otherwise agreed upon by the JRC.
Regarding payments made in connection with the supply of clinical
materials or the scale up of manufacturing processes for Compounds,
(a) [ * ] , (b) [ * ] shall pay for the manufacture
of the [ * ] , provided, however, that Pfizer has approved
in advance the manufacture by Third Parties of such Compound and
the selection of any such Third Party manufacturer. In
addition, Pfizer shall bear the costs of the services described in
Schedule 3.6 .
3.7
Records. Each Party shall maintain complete and
accurate records of all work conducted under the Research Program
and all results, data and developments made pursuant to its efforts
under the Research Program. Such records shall be complete
and accurate and shall fully and properly reflect all work done and
results achieved in the performance of the Research Program in
sufficient detail and in a manner appropriate for patent and
regulatory purposes. Subject to bona fide confidentiality
obligations to a Third Party, each Party shall have the right to
request copies of such records of the other Party at reasonable
times and upon reasonable notice to the extent necessary for such
Party to conduct its research or perform its other obligations
under this Agreement, or to secure or enforce Patents licensed
under this Agreement.
3.8
Reports. During the Research Term, each Party
shall report to the JRC no less than once per calendar quarter,
which report shall include a written progress report summarizing
the work performed under the Research Program, including analoging
activities performed pursuant to Section 3.9. The JRC
shall define the format and the nature of the content of the
quarterly report, which format and nature shall be adopted by both
Parties.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
15
3.9
Analogs. Under the Research Plan, Pfizer shall
have the right to design and synthesize salts, polymorphs and
physical forms of Compounds as part of Pfizer’s activities
under this Agreement. Pfizer shall also have the right to
make Compound Analogs and Derivatives as provided in this
Section 3.9, and to request Rigel to commence de novo Compound
discovery pursuant to Section 3.10. De novo synthesis
pursuant to Section 3.10 shall refer to the preparation of
chemical compounds other than those containing the [ * ] of
the compounds listed on Schedule 1.13 , that are
designed to be Syk Inhibitors.
(a)
Pfizer’s chemistry efforts
related to Compounds (other than the creation of salts, polymorphs
and physical forms) shall be limited to the creation of Compound
Analogs and Derivatives. Pfizer shall inform the JRC of the
nature of its chemistry efforts related to Compounds as part of its
quarterly reports under Section 3.8, and such reports shall
identify all Compound Analogs and Derivatives made or conceived by
Pfizer during the period since its most recent report.
Ownership of any compounds conceived or created by Pfizer in the
course of working with the Compounds shall be allocated as
follows:
(i)
The JRC shall determine, as part of
the Research Plan, the extent to which any particular Compound
Analogs and Derivatives shall be tested to determine which of those
compounds satisfy the definition of a Compound. In the event
that the JRC has determined that particular Compound Analogs and
Derivatives satisfy the definition of a Compound, Pfizer shall have
the right to file, prosecute and maintain patent applications
covering such Compounds, which patent applications and patents
issuing therefrom shall be Joint Patents, regardless of
inventorship, and shall be prosecuted by Pfizer in compliance with
Section 7.3(b). Should Pfizer determine not to file,
prosecute or maintain patent applications covering any Compounds
created by Pfizer pursuant to this Section 3.9, Rigel shall
then have the right to file, prosecute and maintain such patent
applications, as Joint Patents, with Rigel playing the role
assigned to Pfizer under Section 7.3(b).
(ii)
In the event that (A) the JRC
determines that any of the particular Compound Analogs and
Derivatives created under this Section 3.9 does not satisfy
the definition of a Compound, or (B) the JRC has decided not to
make further efforts to determine whether any of the particular
Compound Analogs and Derivatives satisfies the definition of a
Compound, then Pfizer shall assign to Rigel its entire right, title
and interest in and to such compound and inventions and patent
rights covering such compound, and Rigel shall have the sole right
to file, prosecute and maintain patents covering such inventions as
Rigel Patents, but without any duty to inform Pfizer as to its
patenting activities. If it is later determined that any
compounds assigned to Rigel pursuant to this
Section 3.9(a)(ii) satisfy the definition of a Compound, the
rights to such Compounds shall be allocated in accordance with this
Agreement (including without limitation the license and exclusivity
provisions of Article 5 and the payment provisions of
Article 6) and Rigel shall thereafter prosecute any Rigel
Patents covering such Compounds in accordance with
Article 7. Pfizer agrees to execute any instruments of
assignment reasonably necessary or useful to facilitate
Rigel’s filing of patent applications related to such
inventions under this Section 3.9(a)(ii).
(iii)
In the event Pfizer’s
activities in connection with making Compound Analogs and
Derivatives pursuant to this Section 3.9 result in inventions
that cover both Compounds and compounds that do not satisfy the
definition of a Compound, the Parties
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
16
shall use commercially reasonable efforts to
prepare patent applications that cover, on the one hand, only
Compounds, and on the other hand, only compounds other than
Compounds.
(iv)
Subject to the restrictions set
forth in Section 5.3, Pfizer hereby grants Rigel an exclusive
(even as to Pfizer), perpetual, royalty free, sublicensable license
under Patents owned or Controlled by Pfizer that cover compositions
of matter that (A) are conceived or created by Pfizer under this
Section 3.9, and (B) do not satisfy the definition of a
Compound, to make, have made, use, import, offer for sale and sell
such compounds for all indications both within and outside the
Field and in the Territory.
(b)
Pfizer may also request that Rigel
commence a program to design or synthesize Compound Analogs and
Derivatives as part of the Research Program, and Pfizer may request
that the JRC amend the Research Plan to include such analog
work.
(i)
If the JRC (with the consent of
Rigel) should determine that such analog work is minor, then the
JRC may amend the Research Plan accordingly to include
Rigel’s performance of such analog work. If the JRC
should determine that such analog work is not minor, then Pfizer
may request that Rigel commence an analog program pursuant to a new
research plan that shall specify the nature and magnitude of the
analog program and the budget for such program (it being understood
that Rigel’s internal costs would be borne by Pfizer at an
FTE rate of [ * ] ) but shall otherwise be subject to the
terms and conditions of this Agreement except as the Parties may
then agree. Rigel shall not be obligated to conduct any
analog work under this Section 3.9 without its
consent.
(ii)
Rigel shall inform the JRC of the
nature of its efforts related to the design and synthesis of
Compound Analogs and Derivatives to the extent conducted by Rigel
at the request of the JRC pursuant to this Section 3.9.
Such reporting shall occur as part of Rigel’s quarterly
reports under Section 3.8, and such reports shall identify all
Compound Analogs and Derivatives made or conceived by Rigel under
this Section 3.9 during the period since its most recent
report. The JRC shall determine, as part of the amended
Research Plan or new research plan, as appropriate, the extent to
which any of such Compound Analogs and Derivatives shall be tested
to determine which of those compounds satisfy the definition of a
Compound. In the event that the JRC determines that any
particular Compound Analogs and Derivatives designed or synthesized
by Rigel satisfy the definition of a Compound, then the rights to
such Compound shall be allocated in accordance with this Agreement
(including without limitation the license and exclusivity
provisions of Article 5 and the payment provisions of
Article 6). Rigel shall own all compounds designed and
synthesized by Rigel under this Section 3.9(b), and shall
thereafter prosecute any patents covering Compounds as Rigel
Patents in accordance with Article 7. To the extent any
patent applications cover compounds that are created by Rigel under
this Section 3.9(b), none of which satisfy the definition of a
Compound, Rigel shall have the sole right to file, prosecute and
maintain patents covering such inventions without any duty to
inform Pfizer as to its patenting activities.
3.10
Pfizer Option To Request De Novo
Compound Discovery. As of the Effective Date, the Research
Plan contemplates only the assessment of the existing Rigel library
of compounds that have been demonstrated to be Syk tyrosine kinase
inhibitors with a specified level of activity for potential
Development and Commercialization by Pfizer, together with
the
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
17
provisions of Section 3.9 regarding the
creation of Compound Analogs and Derivatives. However, Pfizer
may request that Rigel commence a research program pursuant to a
new research plan which plan will include, without limitation, de
novo discovery of new Compounds, by providing notice to Rigel prior
to the end of the Research Term. If Pfizer provides such
notice, then the Parties shall negotiate in good faith the terms
and conditions of an amendment to this Agreement to provide for
such a program. Such amendment would need to specify, among
other things, the nature and magnitude of the new discovery
program, the allocation of costs (it being understood that
Rigel’s internal costs would be borne by Pfizer at an FTE
rate of [ * ] ), and the respective rights of the Parties
regarding the ownership and licensing of any resulting compositions
of matter. If the Parties have not mutually agreed on an
amendment of this Agreement within one hundred and eighty (180)
days following the delivery of a notice by Pfizer pursuant to this
Section 3.10, then Rigel shall have no obligation to conduct
such a discovery program or to continue the negotiations with
Pfizer.
4.
DEVELOPMENT AND
COMMERCIALIZATION
4.1
Development Plan.
The Development of each
Product shall be governed by a development plan that describes the
proposed overall program of Development (the “Development
Plan”). Pfizer shall have the sole right and
responsibility for preparing the Development Plan for each Product.
Pfizer shall provide annual written reports to Rigel regarding
continuing Development activities and plans for the Products, and
shall, upon Rigel’s request and no more than once per
calendar year, meet with Rigel and discuss such Development
activities and plans. Pfizer shall conduct any Development of
Products in compliance in all material aspects with the
requirements under applicable laws, rules and regulations,
including without limitation GLP, GCP and GMP, to attempt to
achieve its objectives.
4.2
Development
Diligence.
(a)
Following its election to commence
Advanced Preclinical Development of a Compound, Pfizer shall use
Diligent Efforts to Develop or Commercialize, as applicable, at
least one Compound at all times during the Term of this
Agreement.
(b)
Pfizer shall inform Rigel within ten
(10) Business Days following the occurrence of any event described
under Schedule 8.5(b) .
4.3
Regulatory
Affairs.
(a)
Pfizer shall own and be responsible
for preparing and submitting Regulatory Filings, seeking Regulatory
Approvals, and maintaining Regulatory Approvals for Products,
including preparing all reports necessary as part of an IND, NDA,
DMF, BLA or other necessary filing required for Regulatory
Approval.
(b)
With regard to sharing of Regulatory
Filings, each Party shall permit the other Party to access, and
shall provide the other Party with sufficient rights to reference
and use in association with exercising its rights and performing
its obligations under this Agreement, all of its, its
Affiliates’ and their respective suppliers’ Regulatory
Filings, and Regulatory Approvals for Products.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
18
(c)
In conducting any Development
activities hereunder, each Party shall: (a) ensure that its
employees, agents, clinical institutions and clinical investigators
comply with all FDA statutory and regulatory requirements with
respect to Products, including but not limited to: the
Federal Food, Drug and Cosmetic Act, as amended (FFDCA), the Public
Health Service Act (PHSA), regulatory provisions regarding
protection of human subjects, financial disclosure by clinical
investigators, Institutional Review Boards (IRB), GCP, GLP, IND
regulations, and any conditions imposed by a reviewing IRB or the
FDA; and (b) not utilize, in conducting studies on Products any
person or entities that at such time are debarred by FDA, or that,
at such time, are under investigation by FDA for debarment action
pursuant to the provisions of the Generic Drug Enforcement Act of
1992 (21 U.S.C. Section 335).
4.4
Manufacture and
Supply. Except as
otherwise specified in the Research Plan or in Section 3.6,
Pfizer shall be responsible for the manufacture of preclinical and
clinical materials for each Product, and for the commercial supply
of each Product, and for all costs associated therewith.
Pfizer shall use Diligent Efforts to make necessary filings to
obtain, or cause a Third Party manufacturer to obtain, Regulatory
Approval for the manufacture of Products.
4.5
Development Costs.
Pfizer shall be responsible
for all costs associated with the Development and Commercialization
of Products. If Pfizer requests Rigel’s assistance with
certain tasks related to the Development of Products, and Rigel
agrees to assist, then Pfizer shall reimburse Rigel for any
reasonable costs Rigel should incur associated with such
tasks. Within thirty (30) days after the end of each calendar
quarter, Rigel shall submit to the Pfizer an accounting of all
costs Rigel incurs under the Development Plan during that quarter,
including reasonable detail demonstrating the specific basis for
the costs and expenses included in the summary. Such summary
may include an allocation of time spent by Rigel personnel in
conducting such Development activities, that shall be reimbursed at
an FTE rate of [ * ] . Pfizer shall on a quarterly
basis, within forty five (45) days after the end of each Pfizer
Quarter (provided that Rigel submitted its accounting report on
time), prepare and submit to Rigel a reimbursement of the costs
incurred by Rigel.
4.6
Trademarks.
Pfizer shall select trademarks for
the Product and shall own all such trademarks.
4.7
Pricing. Pfizer shall be solely responsible for
the pricing and other terms of sale for Products.
5.
LICENSES AND RELATED
RIGHTS
5.1
License to Pfizer.
Subject to the terms of this
Agreement, Rigel grants to Pfizer the following:
(a)
a worldwide, exclusive (even as to
Rigel) license, with the right to sublicense, under the Rigel
Technology, to make, have made, use, import, offer for sale and
sell Compounds and Products for Intrapulmonary Administration in
the Territory and in the Field; and
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
19
(b)
solely with respect to those
Compounds for which Pfizer has Commenced human clinical trials of a
Product for Intrapulmonary Administration, a worldwide, exclusive
(even as to Rigel) license, with the right to sublicense, under the
Rigel Technology, to make, have made, use, import, offer for sale
and sell such Compounds and Products for Other Topical
Administrations in the Territory.
For the avoidance of doubt, the licenses granted
to Pfizer in this Section 5.1 convey no rights with respect to
any Syk Inhibitor owned or Controlled by Rigel other than
Compounds.
5.2
Residual Know-How.
Except as provided in this
Section 5.2, neither Party shall use Confidential Information
of the other Party for any purpose outside the Collaboration.
In this regard, the Parties recognize that during the course of
this Agreement, certain information in intangible form (excluding
for this purpose, in electronic medium), may be retained by those
employees or agents of a Party who have had access to the other
Party’s Confidential Information (the “Residual
Information”). Each Party shall be free to use the
Residual Information of the other Party for any purpose.
Notwithstanding the foregoing, compounds, materials, and written or
tangible data (including data in electronic medium) of the other
Party, to the extent not in the public domain, shall not be used
for any purpose outside the Collaboration.
5.3
Exclusivity.
(a)
During [ * ] : Rigel
and its Affiliates shall not, except pursuant to this Agreement,
directly or indirectly, by itself or with any Third Party,
Commercialize (i) any Syk Inhibitor in the Field, or (ii) any
Compound for any purpose (unless the rights to such Compound have
reverted to Rigel pursuant to Section 9.3), and Pfizer and its
Affiliates shall not, except pursuant to this Agreement, directly
or indirectly, by itself or with any Third Party, Commercialize (i)
any Syk Inhibitor in the Field, or (ii) any Compound for any
purpose.
(b)
During [ * ] : Rigel
and its Affiliates shall not, except pursuant to this Agreement,
directly or indirectly, by itself or with any Third Party, conduct
research on or Develop any Syk Inhibitor in the Field, and Pfizer
and its Affiliates shall not, except pursuant to this Agreement,
directly or indirectly, by itself or with any Third Party, conduct
research on or Develop any Syk Inhibitor in the Field.
5.4
Acquisition of Competing
Product.
Notwithstanding the provisions of Section 5.3, which
provisions shall not be deemed breached as a result of an
acquisition or merger described in this Section 5.4, if Pfizer
acquires a Competing Product through acquisition or merger with the
whole or substantially the whole of the business or assets of
another Person, Pfizer shall, within forty five (45) days from the
date of Pfizer’s board approval of such acquisition or
merger, notify Rigel of such merger or acquisition and as to
whether Pfizer intends to divest its interest in such Competing
Product. If Pfizer elects to divest its interest in such
Competing Product, Pfizer shall use reasonable efforts to identify
a Third Party purchaser to whom Pfizer will divest its interest in
such Competing Product and to enter into a definitive agreement
with such Third Party for such divestiture as soon as reasonably
practicable under the circumstances (which may be subject to the
terms of a Hold Separate Transaction (as defined
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
20
below) as applicable). If Pfizer elects
not to divest its interest in such Competing Product or fails to
enter into a definitive agreement with a Third Party to divest such
Competing Product (other than as part of any Hold Separate
Transaction) within [ * ] months after the closing of the
acquisition or merger for which Pfizer has provided Rigel with
notice, or if such divestiture is subject to the terms of a Hold
Separate Transaction, within [ * ] months after the closing
of the acquisition or merger for which Pfizer has provided Rigel
with notice, then Rigel shall have the option, upon notice to
Pfizer given no later than ninety (90) days after the earlier of:
(i) Pfizer’s election not to divest such Competing
Product; and (ii) the end of either of such [ * ] month or
[ * ] month period described above, as applicable, to
terminate this Agreement, such termination to be effective upon the
expiration of such ninety (90) day notice period unless waived by
Rigel during such period. As used herein, a “ Hold
Separate Transaction ” shall mean any “hold
separate” transaction (whether through the establishment of a
trust or otherwise) involving the proposed sale of the applicable
Competing Product pursuant to an agreement with any Governmental
Authority responsible for antitrust laws.
5.5
Pfizer’s Option to R-112
and Allergic Rhinitis. In the event that Rigel either (a)
terminates its active development of R-112 for allergic rhinitis,
or (b) completes Phase II(b) Trials with respect to R-112; and
Rigel has not licensed, assigned, or otherwise conveyed the right
to develop and commercialize R-112 to a Third Party prior to the
completion of such Phase II(b) Trials, then Rigel shall promptly
provide Pfizer with notice of such occurrence together with all
material information regarding the formulation, stability, safety
and efficacy of R-112 and its backups; the status of discussions
with FDA or any Governmental Authorities directly relating thereto;
and relevant patent information (together, the “R-112
Notice”). Upon Pfizer’s receipt of such notice
and supporting information, Pfizer shall have [ * ] to
provide Rigel with notice of Pfizer’s intent to negotiate an
expansion of the Field to include allergic rhinitis, or an
exclusive license to R 112 and its backups, or both. If
Pfizer elects to engage in such negotiations, then the Parties
shall negotiate in good faith, for up to [ * ] following
Pfizer’s receipt of the R-112 Notice (the “ [ *
] Day Period”), the terms and conditions of a license to
expand Pfizer’s rights under this Agreement to include
allergic rhinitis, R-112 and such additional Syk tyrosine kinase
inhibitors as the Parties agree. During the [ * ] Day
Period, Rigel shall not negotiate with Third Parties with respect
to such subject matter. However, such negotiation shall be
without obligation to actually enter into any agreement. If
Pfizer and Rigel do not agree on the terms and conditions of such a
license within the [ * ] Day Period, then Rigel shall be
free to grant such license(s) to any Third Party(ies) without
further obligation to Pfizer.
5.6
Bankruptcy.
All rights and licenses
granted under or pursuant to any section of this Agreement
are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code, licenses of rights
to “intellectual property” as defined under
Section 101(35A) of the U.S. Bankruptcy Code. The
Parties shall retain and may fully exercise all of their respective
rights and elections under the U.S. Bankruptcy Code. The
Parties agree that a Party that is a licensee of such rights under
this Agreement shall retain and may fully exercise all of its
rights and elections under the U.S. Bankruptcy Code, and that upon
commencement of a bankruptcy proceeding by or against the licensing
Party (such Party, the “Involved Party”) under the U.S.
Bankruptcy Code, the other Party (such Party, the
“Noninvolved Party”) shall be entitled to a complete
duplicate of or complete access to (as such Noninvolved Party deems
appropriate), any such intellectual property and all embodiments of
such intellectual property,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
21
provided the Noninvolved Party continues to
fulfill its payment or royalty obligations as specified herein in
full. Such intellectual property and all embodiments thereof
shall be promptly delivered to the Noninvolved Party (a) upon any
such commencement of a bankruptcy proceeding upon written request
therefore by the Noninvolved Party, unless the Involved Party
elects to continue to perform all of its obligations under this
Agreement or (b) if not delivered under (a) above, upon the
rejection of this Agreement by or on behalf of the Involved Party
upon written request therefor by the Noninvolved Party. The
foregoing is without prejudice to any rights the Noninvolved Party
may have arising under the U.S. Bankruptcy Code or other applicable
law.
5.7
Negative Covenant.
Pfizer and its Affiliates
shall not Develop or Commercialize Compounds or Products outside of
the scope of the license granted to Pfizer under
Section 5.1.
5.8
HSR. Promptly following signing of this
Agreement, Pfizer and Rigel shall take (i) all actions necessary to
make the filing required under the HSR Act, and (ii) reply at the
earliest possible date with any requests for information received
from the United States Federal Trade Commission (“ FTC
”) or Antitrust Division of the United States Department of
Justice (“ DoJ ”) pursuant to the HSR Act.
The Parties shall, to the extent reasonably practicable, consult
with one another prior to making any filings, responses to
inquiries or other contacts with the FTC or DoJ concerning the
transactions contemplated hereby and shall use commercially
reasonable efforts to obtain any clearances related to this
Agreement that are necessary under the HSR Act. Each Party
shall be responsible for its own costs in connection with such
filing, except that Pfizer shall be solely responsible for the
applicable filing fees.
5.9
Access to Documents
. From and after the date of
this Agreement and until the Effective Date, upon reasonable
advance notice, each Party shall permit the other Party to have
access, during normal business hours, to all Information concerning
the Compounds as such Party from time to time may reasonably
request.
6.
FINANCIAL TERMS
6.1
Upfront Payment.
Pfizer shall pay to Rigel (a)
an upfront payment of [ * ] payable within fifteen (15) days
after the date of Pfizer’s receipt of an invoice from Rigel
issued on or at any time after the Effective Date, and (b) on the
date such [ * ] payment is made, five million dollars
($5,000,000), payable in exchange for 190,694 shares of Rigel
common stock pursuant to the Common Stock Purchase Agreement
attached hereto as Exhibit B .
6.2
Milestone
Payments.
(a)
Pfizer shall pay Rigel a milestone
payment (each, an “ Event Milestone Payment ”)
in respect of each of the following events (each, an “
Event Milestone ”) in the particular amounts specified
below no later than ten (10) Business Days after the date of
Pfizer’s receipt of an invoice from Rigel. Pfizer will
notify Rigel within ten (10) Business Days of the occurrence of
each Event Milestone described in (iii) to (xii) below that
entitles Rigel to issue the invoice concerned.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
22
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For Compounds
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Event Milestone
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(i)
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[ * ]
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Earlier of Pfizer’s determination to
commence Advanced Preclinical Development of the first Compound, or
180 days (as this may be extended pursuant to Section 3.5)
from delivery to Pfizer by Rigel of the data resulting from the
completion by Rigel of its tasks under the Research Plan for such
Compound.
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(ii)
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[ * ]
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Earlier of Pfizer’s determination to
commence Advanced Preclinical Development of a second Compound, or
180 days (as this may be extended pursuant to Section 3.5)
from delivery to Pfizer by Rigel of the data resulting from the
completion by Rigel of its tasks under the Research Plan for such
Compound.
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(iii)
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[ * ]
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Commencement of Phase I Trial for the first
Compound
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(iv)
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[ * ]
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Commencement of Phase II(a) Trial for the first
Compound
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(v)
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[ * ]
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Commencement of Phase II(b) Trial for the first
Compound
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(vi)
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[ * ]
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Commencement of Phase III Trials for the first
Compound
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For Products
(other than
Combination Products)
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For Combination
Products
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Event Milestone
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(vii)
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[ * ]
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[ * ]
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Acceptance of an NDA for the first Product or
Combination Product, as applicable, in the United States
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(viii)
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[ * ]
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[ * ]
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Acceptance of filings for Regulatory Approval
for the first Product or Combination Product, as applicable, in
three of the five Major European Countries
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(ix)
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[ * ]
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[ * ]
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Acceptance of filing for Regulatory Approval for
the first Product or Combination Product, as applicable, in
Japan
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(x)
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[ * ]
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[ * ]
|
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Launch of the first Product or Combination
Product, as applicable, in the United States
|
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
23
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(xi)
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[ * ]
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[ * ]
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Launch of the first Product or Combination
Product, as applicable, in three of the five Major European
Countries
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(xii)
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[ * ]
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[ * ]
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Launch of the first Product or Combination
Product, as applicable, in Japan
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(b)
[ * ] of the Event Milestone Payments in subsections
(vii) through (xii) above, shall be credited against the royalty
payments set forth in Section 6.3, provided ,
however , no royalty payment shall be reduced by more than
[ * ] by any such credit.
(c)
All Event Milestone Payments set
forth in this Section 6.2 shall be paid to Rigel only once
regardless of the number of Compounds or Products developed under
the Collaboration. Event Milestone Payments owed to Rigel
under this Section 6.2 which refer to the “first
Compound” or “first Product” shall be paid to
Rigel for the first Compound or first Product to achieve such Event
Milestone, regardless of whether such Compound or Product comprises
the first Compound selected by Pfizer pursuant to Section 3.3
or 3.4(a). Royalty payments set forth in Section 6.3
shall be paid to Rigel for each Product sold.
(d)
If a Phase II(b) Trial or Phase III
Trial of a Product Commences, or a Product is the subject of an
NDA, such Product shall be deemed to have achieved the Event
Milestones prior to that stage of Development, and if a related
Event Milestone Payment for such earlier stage of clinical trial
has not been previously paid, it shall then be paid.
(e)
In the event that a Party has given
the other Party any notice of termination of this Agreement under
Section 9, no further Event Milestone Payments shall become
due during such notice period.
6.3
Royalty Payments.
Pfizer shall pay Rigel the
following royalty payments based on Net Sales of each Product in
the Territory:
(a)
[ * ] for Net Sales in a calendar year up to [ *
] ;
(b)
[ * ] for Net Sales in a calendar year over [ *
] and up to [ * ] ;
(c)
[ * ] for Net Sales in a calendar year over [ *
] and up to [ * ] ; and
(d)
[ * ] for Net Sales in a calendar year over [ *
] .
Notwithstanding the foregoing, (i) for Net Sales
based on sales of a Product in the United States, any payments owed
with respect to such Product pursuant to this Section 6.3
shall be reduced (x) by [ * ] for any period of time
during the Royalty Term during which no Patent under the Rigel
Patents with a Valid Claim covering such Product are in effect in
the United States, subject to Section 6.4, and (y) by [ *
] if during the relevant Pfizer Quarter there is Generic
Competition
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
24
in the United States; provided that in no
event shall such payments be reduced by more than [ * ] as a
result of the events described in clauses (x) and (y) above
occurring; and (ii) for Net Sales based on sales of a Product in a
country in the Territory, other than the United States, any
payments owed with respect to such Product pursuant to this
Section 6.3 shall be reduced by [ * ] in the country
concerned if during the relevant Pfizer Quarter there is Generic
Competition in such country.
6.4
Pending Patent
Applications. If a
pending patent application that is included within the Rigel
Patents issues in a country after the Royalty Term has already
expired in such country, and such issued Patent contains a Valid
Claim, then Pfizer shall, (a) within sixty (60) days after receipt
from Rigel of evidence of such issuance from the relevant
Governmental Authority, pay to Rigel royalties based on Net Sales
in such country from the date of the expiration of the Royalty Term
in such country up to and including the date of issuance of such
Patent and (b) continue to make Royalty Payments in such country so
long as there is a Valid Claim Controlled by Rigel covering a
Product in such country. This Section 6.4 shall also
apply if there has been a reduction in the royalty payments paid to
Rigel pursuant to Section 6.3 and a Rigel Patent with a Valid
Claim later issues (in which case the amount of any related royalty
reduction effected pursuant to Section 6.3 shall then be paid
to Rigel).
6.5
Payments and Payment
Reports. All
royalties due under Section 6.3 shall be paid within sixty
(60) days of the end of the relevant Pfizer Quarter for which such
royalties are due. Each royalty payment shall be accompanied
by a statement stating the number, description, and aggregate Net
Sales, by country, of each Product sold during the relevant Pfizer
Quarter.
6.6
Payment Method.
All payments due under this
Agreement to Rigel shall be made by bank wire transfer in
immediately available funds to an account designated by
Rigel. All payments hereunder shall be made in the legal
currency of the United States of America.
6.7
No Credits or Refunds.
Other than as set forth under
Sections 3.5, 6.2(b) and 6.12, all payments to Rigel hereunder
shall be noncreditable and nonrefundable.
6.8
Taxes. It is understood and agreed between the Parties
that any payments made under Section 6.1 or 6.2 of this
Agreement are inclusive of any value added or similar tax imposed
upon such payments. In addition, in the event any of the
payments made by Pfizer pursuant to Section 6 become subject
to withholding taxes under the laws of any jurisdiction, Pfizer
shall deduct and withhold the amount of such taxes for the account
of Rigel to the extent required by law, such amounts payable to
Rigel shall be reduced by the amount of taxes deducted and
withheld, and Pfizer shall pay the amounts of such taxes to the
proper Governmental Authority in a timely manner and promptly
transmit to Rigel 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 Rigel to claim such payment of taxes.
Any such withholding taxes required under applicable law to be paid
or withheld shall be an expense of, and borne solely by,
Rigel. Pfizer will provide Rigel with reasonable assistance
to enable Rigel to recover such taxes as permitted by
law.
6.9
Blocked Currency.
In each country where the
local currency is blocked and cannot be removed from the country,
royalties accrued in that country shall be paid to Rigel
in
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
25
the country in local currency by deposit in a
local bank designated by Rigel, unless the Parties otherwise
ag