Exhibit 10.2
[ * ] = 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.
COLLABORATION
AGREEMENT
T HIS C OLLABORATION A GREEMENT (this “ Agreement ”) is made
and entered into as of May 31, 2005 (the “ Effective
Date ”) by and between E XELIXIS , I NC . , a
Delaware corporation having its principal place of business at 170
Harbor Way, P.O. Box 511, South San Francisco, California
94083-0511 (“ Exelixis ”), and G
ENENTECH
, I NC ., a
Delaware corporation having its principal place of business at 1
DNA Way, South San Francisco, California 94080 (“
Genentech ”). Exelixis and Genentech are sometimes
referred to herein individually as a “ Party ”
and collectively as the “ Parties .”
R ECITALS
A. Genentech is a health care company that has
expertise and capability in developing and marketing human
biopharmaceuticals and has research and development
programs.
B. Exelixis is a drug discovery company that has
expertise and proprietary technology relating to the Notch
signaling pathway.
C. Genentech and Exelixis desire to establish a
collaboration to apply each Party’s technology and expertise
as part of a program for the generation, screening and validation
of therapeutics directed against certain targets in the Notch
signaling pathway, and to provide for the development and
commercialization of such therapeutics.
N OW ,
T HEREFORE
, the Parties agree as
follows:
1. D EFINITIONS
Capitalized terms used in this Agreement (other
than the headings of the Sections or Articles) shall have the
following meaning set forth in this Article 1, or, if not listed in
this Article 1, the meaning as designated in the text of this
Agreement.
1.1 “ Adam-10 ” means the gene
Adam-10 (for any species) and the protein (or fragment or epitope
thereof) encoded by such gene, including the protein encoded by the
nucleic acid sequence set forth in REFSEQ accession No. NM 001110
and NP 001101, and naturally occurring variants and fragments
thereof.
1.2 “ Affiliate ” means any
person, corporation, partnership or other entity that directly or
indirectly controls or is controlled by or is under common control
with a Party. For purposes of this definition,
“control” or “controlled” means ownership
directly or through one or more Affiliates, of fifty percent (50%)
or more of the shares of stock entitled to vote for the election of
directors, in the case of a corporation, or fifty percent (50%) or
more of the equity interest in the case of any other type of legal
entity, status as a general partner in any partnership, or any
other
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arrangement whereby a Party controls or has the
right to control the Board of Directors or equivalent governing
body of a corporation or other entity, or the ability to cause the
direction of the management or policies of a corporation or other
entity. Notwithstanding the foregoing, for Genentech,
“Affiliate” excludes any parent entity that controls
Genentech, including F. Hoffman La Roche, Ltd. and its successors
(“ Roche ”), and entities that control, are
under common control (as defined in this Section) with, such parent
entity, and entities that are controlled by such parent entity,
other than entities controlled through Genentech.
1.3 “ BLA ” means a Biologics
License Application filed pursuant to the requirements of the FDA,
or the equivalent application or filing in another country (as
applicable). “ sBLA ” means a supplemental
BLA.
1.4 “ Class I Claim ” means a
Valid Claim of [ * ] which Valid Claim either: (a) [ *
] or (b) [ * ] .
1.5 “ Class II Claim ” means a
Valid Claim (other than a Class I Claim) of [ * ] which
Valid Claim claims [ * ] .
1.6 “ Collaboration Assay ” means
any assay that is created during or improved during the Research
Term pursuant to the Research Plan by or on behalf of either Party,
and that [ * ] or [ * ] .
1.7 “ Collaboration Invention ”
means any Information, machine, manufacture, process, design,
formulation, or composition of matter, or any new and useful
improvement thereof, which is made pursuant to the Research Plan,
whether jointly by or on behalf of the Parties or solely by or on
behalf of one Party. Collaboration Inventions include but are not
limited to Collaboration Assays and Collaboration
Reagents.
1.8 “ Collaboration IP ” means:
(a) any and all Collaboration Patents; and (b) proprietary and
confidential Information (including intellectual property and
proprietary rights other than Patents in and to such Information),
or other intellectual property rights (excluding Patents that Cover
a Collaboration Invention), but for both (a) and (b), only to the
extent such rights were created pursuant to the Research
Plan.
1.9 “ Collaboration Patent ”
means any Patent that: (a) [ * ] ; and (b) [ * ]
.
1.10 “ Collaboration Reagent ”
means any [ * ] reagents that are created or made by or on
behalf of a Party (or the Parties jointly) during the Research Term
pursuant to the Research Plan, excluding: (a) Collaboration Assays;
(b) any Licensed Products; and (c) [ * ] .
1.11 “ Collaboration Target ”
means: (a) [ * ] ; and (b) any other target added to Exhibit
A pursuant to Section 2.4.
1.12 “ Collaboration Target Activity
” of any product is the same as that of a Licensed Product if
the other product [ * ] and [ * ] (e.g., if the
Licensed Product is [ * ] , then the other product also is
[ * ] , if the Licensed Product is [ * ] , then the
other product also is [ * ] , and if the Licensed Product is
[ * ] , then the other product also is [ * ]
).
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[ * ] =
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.
1.13 “ Commercializing Party ”
means that Party commercializing a particular product under this
Agreement: (a) Exelixis with respect to an Exelixis Reagent Product
or Exelixis Screening Product, and (b) Genentech with respect to a
Licensed Product or a Genentech Screening Product.
1.14 “ Competing Product ” means,
with respect to a Licensed Product in a country, any product that
is [ * ] and that: (a) [ * ] ; and (b) [ * ] .
If a Licensed Product is [ * ] , then a Competing Product
could be [ * ] .
1.15 “ Confidential Information ”
has the meaning set forth in Section 9.1.
1.16 “ Control ” means ownership
or other legal authority or right of a Party or any of its
Affiliates, to grant a license or sublicense of intellectual
property rights to another Party or its Affiliates, without the
grant or such license or sublicense alone constituting a breach of
an agreement between that Party (or its Affiliates) and a Third
Party.
1.17 “ Cost Sharing Ratio ” means,
for each Licensed Product designated by Exelixis as a Profit Share
Product under Section 4.2 [ * ] for each such Profit Share
Product.
1.18 “ Covered ” or “
Covers ” means:
(a) with respect to a Patent (and a given product
will be deemed “Covered” by that Patent), if the [ *
] would, in the country of sale and at the time of sale,
infringe a Valid Claim in that country; and
(b) with respect to proprietary and confidential
Information, know-how (either Genentech Know-How or Exelixis
Know-How) or any other intellectual property rights other than
Patents (and a given product will be deemed “Covered”
by such proprietary and confidential Information, know-how or other
non-Patent intellectual property rights), if the [ * ] , or
if the [ * ] .
1.19 “ Development Costs ” has the
meaning set forth in the Financial Appendix.
1.20 “ Diagnostic ” means a
product intended and designed for use solely or primarily for the
purpose of testing recipients or potential recipients: (a) [ *
] ; (b) [ * ] ; or (c) [ * ] .
1.21 “ Diligent Efforts ” means,
as applied to a Party or Parties, those efforts and diligence
(including the deployment of resources) that [ * ] . Where
“Diligent Efforts” is to be applied to development of a
Licensed Product, [ * ] is considered not to be using
Diligent Efforts.
1.22 [ * ]
.
1.23 “ Exelixis Know-How ” means
all proprietary and confidential Information (including
intellectual property and proprietary rights other than Patents in
and to such Information) Controlled by Exelixis or its Affiliates,
[ * ] and [ * ] . Exelixis Know-How excludes: (a)
Information (and intellectual property and proprietary rights other
than Patents in and to such Information) regarding
[ * ] ; (b) Collaboration IP; and (c) Yale
Know-How.
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[ * ] =
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.
1.24 “ Exelixis Reagent Product ”
means any product discovered, identified, developed or
commercialized by or on behalf of Exelixis: (a) [ * ] ; or
(b) [ * ] ; or (c) [ * ] . For clarity, a product
will not be [ * ] if those Collaboration Assays or
Collaboration Reagents are [ * ] . “Exelixis Reagent
Product” excludes any Licensed Product.
1.25 “ Exelixis Research IP ”
means the Exelixis Know-How and the Exelixis Research
Patents.
1.26 “ Exelixis Research Patents ”
means any and all Patents that are Controlled by Exelixis or its
Affiliates, [ * ] , and that [ * ] . Exelixis
Research Patents excludes: (a) Patents Covering [ * ] ; (b)
Yale Patents; and (c) Collaboration Patents.
1.27 “ Exelixis Screening Product
” means any [ * ] product, other than an Exelixis
Reagent Product, that [ * ] and that [ * ] , where
the [ * ] are, at the time of such [ * ] , Covered by
[ * ] .
1.28 “ FDA ” means the U.S. Food
and Drug Administration, or any successor entity
thereto.
1.29 “ Field ” means the
diagnosis, treatment or prevention of human diseases and
conditions.
1.30 “ Financial Appendix ” means
Exhibit E to this Agreement, which sets forth certain financial
terms and conditions.
1.31 “ First Commercial Sale ”
means, for any product, and on a country-by-country basis in each
country in which that product is sold, the first arm’s-length
sale to a Third Party for use or consumption by an end-user (e.g.,
a physician) of that product in that country, after obtaining
Regulatory Approval of that product in that country. A First
Commercial Sale shall not include a sale of any product for use in
clinical trials, for research or for other non-commercial uses, or
supply of a product as part of a compassionate use or similar
program. For purposes of this Agreement, “ Regulatory
Approval ” means all necessary 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 Medicines
Evaluation Agency), regional, state or local regulatory agency,
department, bureau, commission, council or other governmental
entity, have been obtained for the manufacture, distribution, use
or sale of that product in a regulatory jurisdiction.
1.32 “ Follow-On Exelixis Inventions
” means any [ * ] which is made [ * ]
.
1.33 “ Follow-On Exelixis IP ”
means: (a) any and all Patents that Cover the Follow-On Exelixis
Inventions and that [ * ] ; and (b) any other intellectual
property rights (including know-how, rights in and to Information,
but excluding Patents) that Cover a Follow-On Exelixis Invention
and that [ * ] .
1.34 “ FTE ” means the equivalent
of a full-time scientist’s work time over a twelve (12) month
period (including normal vacations, sick days and holidays). [ *
] .
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[ * ] =
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.
1.35 “ GAAP ” means United States
generally accepted accounting principles, consistently
applied.
1.36 “ Genentech Excluded IP ”
means: (a) all rights in and to any of the following, each of which
is defined on Exhibit C : (i) [ * ] ; (ii) [ *
] ; (iii) [ * ] ; (iv) [ * ] ; (v) [ * ] ;
or (b) Patents Covering [ * ] .
1.37 “ Genentech Know-How ” means
all proprietary and confidential Information (including
intellectual property and proprietary rights other than Patents in
and to such Information) Controlled by Genentech or its Affiliates,
[ * ] , and [ * ] . Genentech Know-How excludes: (a)
Information (and intellectual property and proprietary rights other
than Patents in and to such Information) regarding [ * ] ;
and (b) Collaboration IP.
1.38 “ Genentech Licensed IP ”
means the Genentech Know-How and the Genentech Licensed
Patents.
1.39 “ Genentech Licensed Patents
” means any and all Patents Controlled by Genentech or its
Affiliates, [ * ] , that [ * ] . Genentech Licensed
Patents excludes: (a) the Genentech Excluded IP; and (b)
Collaboration Patents.
1.40 “ Genentech Screening Product
” means any [ * ] product that [ * ] and that:
(a) [ * ] , where the [ * ] are, at the time of such
[ * ] , Covered by [ * ] ; and (b) [ * ]
.
1.41 “ IND ” means an
Investigational New Drug Application filed with the FDA or the
equivalent application in any country outside the U.S. where a
regulatory filing is required or obtained to conduct a clinical
trial.
1.42 “ Inflammatory Disease ”
means: (a) [ * ] ; and (b) [ * ] ; and (c) [ *
] . Inflammatory Disease excludes [ * ] .
1.43 “ Information ” means
information (including results and data) or material of any type,
in any tangible or intangible form, including without limitation,
inventions, databases, methods, techniques, assays, processes,
specifications, formulations, formulae, cell lines, cell media,
skills, experience, manufacturing materials, financial data, test
data including pharmacological, biological, models, designs,
chemical, biochemical, toxicological and clinical test data,
analytical and quality control data, quality assurance data,
stability data, studies and procedures, and legal information or
descriptions.
1.44 “ Interest Rate ” means a
rate equal to [ * ] on the last business day of the
applicable quarter prior to the date on which such payment is due,
calculated daily on the basis of a 365-day year, or, if lower, the
highest rate permitted under applicable law
1.45 [ * ] .
1.46 [ * ] .
1.47 “ Joint Collaboration IP ”
means a Joint Collaboration Patent or other Collaboration IP owned
jointly by the Parties pursuant to Section 8.2.
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[ * ] =
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.
1.48 “ Joint Collaboration Patent
” means a Collaboration Patent owned jointly by the Parties
pursuant to Section 8.2.
1.49 “ Joint Research Committee ”
or “ JRC ” means the committee described in
Section 2.2(a).
1.50 “ Licensed Product ” means
any [ * ] product: (a) [ * ] ; (b) [ * ] ; or
(c) [ * ] , but in any case excluding (x) Adam-10 and (y)
[ * ] . Each Licensed Product that is [ * ] will be
considered [ * ] .
1.51 “ Marketing Approval Application
” or “ MAA ” means an NDA, an sNDA, a BLA
or an sBLA.
1.52 “ NDA ” means a New Drug
Application filed pursuant to the requirements of the FDA, or the
equivalent application or filing in country other than the United
States (as applicable). “ sNDA ” means a
supplemental NDA.
1.53 “ Net Sales ” means, with
respect to a particular time period, the gross amount invoiced by a
Commercializing Party and its Sublicensees (or by a distributor on
behalf of either of such Commercializing Party or its Sublicensees)
for sales of a product exploited pursuant to the licenses under
this Agreement and subject to a potential royalty on Net Sales,
including a Royalty Product, a Genentech Screening Product, an
Exelixis Reagent Product, or an Exelixis Screening Product (each or
all, a “ Commercial Product ” for purposes of
this Section 1.53) (such Commercial Product being in final form
intended for use by the end user) in arms length transactions
between the Commercializing Party and a Third Party during such
time period, less [ * ] , to the extent each is actually
incurred and included in the invoiced gross sales price: (a) trade,
cash and quantity discounts or rebates actually allowed or taken;
(b) credits or allowances given or made for rejection or return of,
and for uncollectible amounts on, previously sold products or for
retroactive price reductions (including rebates similar to Medicare
and/or Medicaid); (c) sales tax, VAT taxes, and other taxes, duties
or other governmental charges levied on or measured by the billing
amount, as adjusted for rebates or refunds, that are borne by the
seller thereof and that are not refundable and to the extent
noncreditable; (d) charges for freight and insurance directly
related to the distribution of Commercial Products (to the extent
not paid by the Third Party customer); and (e) credits or
allowances given or made for wastage replacement, indigent patient
and similar programs. The specific deductions taken under, and the
general provisions of, (a) through (e) above shall be adjusted
periodically as necessary to reflect amounts actually incurred.
Sales between a Commercializing Party and its Sublicensees (or
distributors of such Commercializing Party or its Sublicensees)
shall be disregarded for purposes of calculating Net Sales.
Notwithstanding anything herein to the contrary, in all cases Net
Sales shall be determined in accordance with GAAP. In the event a
Commercial Product is sold in combination with one or more other
active pharmaceutical ingredients (as used in this definition of
Net Sales, a “ Combination ”), then Net Sales
for that Commercial Product shall be calculated by multiplying the
Net Sales of such Combination by the fraction A/B, where A is the
gross selling price of the Commercial Product sold separately and B
is the gross selling price of the Combination. In the event that no
such separate sales are made, Net Sales for royalty determination
shall be calculated by multiplying Net Sales of the Combination by
the fraction
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[ * ] =
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.
C/(C+D), where C is the fully allocated cost of
the Commercial Product and D is the fully allocated cost of the
other active pharmaceutical ingredient(s) in the
Combination.
Genentech and Exelixis agree that
for purposes of this definition, [ * ] shall not be deemed
to be “ active pharmaceutical ingredients ”, the
presence of which in a product sold by a Commercializing Party
hereunder would be deemed to create a Combination subject to the
terms of the preceding paragraph.
If a product sold by a
Commercializing Party hereunder is sold under a bundled or
capitated arrangement with other products of a Party and its
Sublicensees, then, solely for the purpose of calculating Net
Sales, any [ * ] shall be [ * ] , than [ * ]
.
1.54 [ * ] .
1.55 [ * ] .
1.56 [ * ] .
1.57 [ * ] .
1.58 “ Oncology ” means [ *
] .
1.59 “ Operating Profits (Losses)
” has the meaning set forth in the Financial
Appendix.
1.60 “ Other Target ” means a
target within the Notch signaling pathway that is not a
Collaboration Target and is listed on Exhibit D .
1.61 “ Patents ” means all: (a)
U.S. issued patents, re-examinations, reissues, renewals,
extensions and term restorations, inventors’ certificates and
foreign counterparts thereof; (b) pending applications for U.S.
patents, including provisional applications, continuations,
continuations-in-part, continued prosecution, divisional and
substitute applications; and (c) non-U.S. counterparts or
equivalents of the foregoing in subsection (a) and (b).
1.62 “ Phase I Clinical Trial ”
means a human clinical trial with a principal purpose of
preliminarily determining the safety of a pharmaceutical product in
healthy individuals or patients as required in 21 C.F.R.
§312.21(a), or similar clinical study in a country other than
the United States, and for which there are no primary endpoints
related to efficacy.
1.63 “ Phase II Clinical Trial ”
means a human clinical trial with a principal purpose of
determining efficacy and dosing of a pharmaceutical products in
patients with the disease being studied as described in 21 C.F.R.
§312.21(b), or similar clinical study in a country other than
the United States.
1.64 “ Phase III Clinical Trial ”
means a human clinical trial with a principal purpose of
establishing safety and efficacy of a pharmaceutical product in
patients with the disease being studied as required in 21 C.F.R.
§312.21(c) or similar clinical study in a country other than
the United States. A Phase III Clinical Trial shall also include
any other human clinical trial
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[ * ] =
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.
intended as a pivotal trial for Regulatory
Approval purposes, or that results in data actually used to support
the filing of a Marketing Approval Application, whether or not such
trial is a traditional Phase III Clinical Trial.
1.65 “ Profit Share Field ” means
either the field of Inflammatory Disease or the field of TGR, as
selected by Exelixis pursuant to Section 4.1.
1.66 “ Profit Share Product ”
means any Licensed Product designated as a Profit Share Product
under Section 4.2.
1.67 “ Research Funding ” means
the payments made by Genentech to Exelixis for purposes of funding
research under the Research Plan, as described in Section
7.2.
1.68 “ Research Plan ” has the
meaning set forth in Section 2.1.
1.69 “ Research Term ” means the
period beginning on the Effective Date and ending on its third
(3 rd ) anniversary, as may be extended
under Section 2.5.
1.70 “ Royalty Product ” means a
Licensed Product that is not then subject to a designation as a
Profit Share Product. For clarity, although sales of a Genentech
Screening Product may be subject to royalty obligations, it is not
a Royalty Product.
1.71 “ Royalty Term ”
means:
(a) in the case of payments under Section 7.4(a)
(i.e., for each Royalty Product Covered by a Class I Claim), on a
country-by-country and Royalty Product by Royalty Product basis,
the period beginning with [ * ] and ending on the earlier of
the date on which (i) [ * ] , or (ii) [ * ]
;
(b) in the case of payments under Section 7.4(b)
(i.e., for each Royalty Product Covered by a Class II Claim), on a
country-by-country basis, the period beginning with [ * ]
and ending on the earlier of the date on which (i) [ * ] ,
or (ii) [ * ] ;
(c) in the case of payments under Section 7.4(c)
(i.e., for each Royalty Product Covered by [ * ] , on a
country-by-country basis, the period beginning with [ * ]
and ending on [ * ] ; and
(d) in the case of payments under Section 7.5 by
Genentech for each Genentech Screening Product on a
country-by-country basis, or payments under Section 7.6 or Section
7.7 by Exelixis for each Exelixis Screening Product or Exelixis
Reagent Product on a country-by-country basis, the period beginning
with [ * ] and ending [ * ] .
1.72 “ Small Molecule Compound ”
means any molecule that has a molecular weight [ * ]
.
1.73 “ Sole Collaboration IP ”
means Collaboration IP invented solely by one Party: “
Genentech’s Sole Collaboration IP ” refers to
Collaboration IP owned solely by Genentech and “
Exelixis’ Sole Collaboration IP ” refers to
Collaboration IP owned solely by Exelixis.
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[ * ] =
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.
1.74 “ Sole Collaboration Patents
” means Patents within a Party’s Sole Collaboration
IP.
1.75 “ Sublicensee ” means any
Third Party or Affiliate to whom Genentech or Exelixis grants a
sublicense (or license, as applicable) under any portion of the
rights licensed to the respective Party under this Agreement, but
excluding any Third Party authorized only to make a product (and
not use or sell that product), only to use a product, or only to
sell a product.
1.76 “ Third Party ” means any
entity other than a Party or a Party’s Affiliate that is its
wholly-owned subsidiary.
1.77 “ Tissue Growth and Repair ”
or “ TGR ” means [ * ] of disease by
means of: (a) [ * ] ; (b) [ * ] ; or (c) [ * ]
. Tissue Growth and Repair excludes [ * ] , and excludes
[ * ] .
1.78 “ Valid Claim ” means any
claim in [ * ] that has not expired, lapsed, been withdrawn,
been canceled, been declared invalid or unenforceable in a decision
from which no appeal can be taken, or been admitted to be invalid
or unenforceable through reissue, disclaimer or
otherwise.
1.79 “ Yale Agreement ” means the
License Agreement, dated August 27, 1996, among Exelixis, Yale
University and Indiana University Foundation, as
amended.
1.80 “Yale
Know-How” means all
proprietary and confidential Information (including any proprietary
rights therein or thereto, but excluding any Patents) or know-how
that is licensed to Exelixis under the Yale Agreement.
1.81 “Yale Licensed
IP” means the Yale
Patents and the Yale Know-How.
1.82 “ Yale Patents ” means any
and all Patents licensed to Exelixis under the Yale Agreement,
including but not limited to those listed on Exhibit G
.
2. R ESEARCH P ROGRAM
2.1 General
. The Parties have agreed on a
detailed plan and budget for the research to be carried out by the
Parties during the Research Term, which research plan is attached
as Exhibit F and incorporated herein by reference, as may be
amended pursuant to Article 2 in accordance with this Agreement
(the “ Research Plan ”).
2.2 Joint Research Committee .
(a) Membership . Promptly after the Effective Date, the Parties
shall establish a JRC to manage, plan and coordinate the research
activities of the Parties under the Research Plan. The JRC shall be
composed of an equal number of representatives from each Party, but
in no event to exceed four (4) representatives from each Party.
Each Party may replace its appointed JRC representatives at any
time upon reasonable written notice to the other Party. For the
first year of the Research Term, Genentech shall designate one (1)
of its representatives as chairperson of the JRC. Thereafter, the
Parties shall alternately designate a chairperson of the JRC for
each subsequent year of the Research Term.
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[ * ] =
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.
(b) Responsibilities . During the Research Term, the JRC shall: (i)
implement the research objectives for the Research Plan in
accordance with this Agreement; (ii) evaluate the data generated by
the Parties in the course of conducting the Research Plan; (iii)
allocate Exelixis or Third Party resources for the work under the
Research Plan in accordance with this Agreement and the Research
Plan; (iv) review and amend the Research Plan (subject to Sections
2.4(b) and 2.4(c)); (v) review annual progress against the goals of
the Research Plan; and (vi) determine standards (based on
scientifically reasonable principles) for evaluating the molecules
generated by the Parties under the Research Plan. The JRC shall not
have the right to amend this Agreement.
(c) Decision Making . The JRC shall make decisions unanimously, and
each Party’s representatives shall collectively have one (1)
vote. In the event of a deadlock regarding a decision within the
JRC’s authority, decisions will be escalated to [ * ]
and [ * ] , or their designees when appropriate. For
decisions within the JRC’s authority that are [ * ] ,
[ * ] may make the final determinations in the event of a
deadlock in the JRC. Consistent with Section 2.4(c) below, however,
neither Party has a deciding vote with respect to adding new
Collaboration Targets or Other Targets.
2.3 JRC Meetings
. JRC meetings shall be held
quarterly on an alternating basis in each Party’s facilities.
With the consent of the representatives of each Party serving on
the JRC, other representatives of each Party may attend meetings as
nonvoting observers (provided such nonvoting observers have
confidentiality obligations to such Party that are at least as
stringent as those set forth in this Agreement). A JRC meeting may
be held by audio, video or internet teleconference with the consent
of each Party, but at least half (1/2) of the minimum number of
meetings in each year shall be held in person. Meetings of the JRC
shall be effective only if at least one (1) representative of each
Party is present or participating. Each Party shall be responsible
for all of its own expenses of participating in the JRC
meetings.
2.4 Research Plan Review; Other Targets and
Adding Collaboration Targets .
(a) Research Plan Review. At least on an annual basis, the JRC shall
review the Research Plan in light of the Parties’ actual
progress.
(b) Work on Other Targets . During the Research Term, either Party may
propose that the Research Plan be expanded to include the
performance of work on one or more Other Targets. The JRC shall
review each such proposal in good faith and determine if such work
on such Other Target(s) should be added. If the JRC unanimously
determines that such work should be added, the Research Plan will
be revised accordingly. Notwithstanding anything to the contrary,
determinations under this Section 2.4(b) are not subject to a
deciding vote under Section 2.2 or to dispute resolution under
Section 13.3.
(c) Additional Collaboration Targets and Other
Targets . During the
Research Term, either Party may propose that the Research Plan be
expanded by the inclusion of additional Collaboration Targets or
Other Targets. The JRC shall review each such proposal in good
faith and determine if such targets should be added as
Collaboration Targets or Other Targets. If the JRC unanimously
determines that such a target should be added, the JRC shall expand
the scope of the Research Plan by adding such additional
Collaboration Targets to
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[ * ] =
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.
Exhibit A or additional Other Targets to Exhibit D
. Notwithstanding anything to the contrary, determinations under
this Section 2.4(c) are not subject to a deciding vote under
Section 2.2 or to dispute resolution under Section 13.3.
2.5 Research Term
Extension . The Parties
may extend the Research Term by additional [ * ] periods
upon their mutual written agreement executed at least [ * ]
days prior to the expiration of the then-current Research Term. At
the last JRC meeting prior to the expiration of the Research Term,
the JRC shall make a determination whether [ * ] . The
Parties may agree in writing to attempt to complete such [ *
] ; neither Party is, however, required to so [ * ] . If
the Parties do agree to [ * ] , then [ * ] shall [
* ] . In the event of an extension, Exelixis shall continue
such research during the extended Research Term, subject to the
standards in Section 2.1 above and Section 2.7 below. Upon
completion of the extended Research Term, Exelixis shall have no
obligation to complete any further research under this
Agreement.
2.6 Obligations of
Parties . During the
Research Term, Exelixis and Genentech shall provide the JRC and its
authorized representatives with reasonable access during regular
business hours to all Information the JRC may reasonably require in
order to perform its obligations hereunder.
2.7 Conduct of
Research . The Parties
shall use Diligent Efforts to conduct their respective tasks under
the Research Plan in good scientific manner, and in compliance in
all material respects with the requirements of all applicable laws,
rules and regulations and all applicable good laboratory practices
to attempt to achieve their objectives as efficiently and
expeditiously as reasonably practicable. Each Party shall use
Diligent Efforts to complete its assigned activities under the
Research Plan. Exelixis will not be required to incur any financial
costs in excess of the Research Funding.
2.8 Expenses
. Except as otherwise set forth in
Section 7.2, each Party shall bear its own costs and expenses
associated with performing the activities assigned to it in the
Research Plan.
2.9 Right to Engage Third Parties
for Collaboration Efforts . Either Party may use its Affiliates or
subcontractors, contract manufacturers, services providers or other
Third Parties to complete its research responsibilities under the
Research Plan, as it deems necessary or advisable; provided,
however, that such Party shall assure, and hereby guarantees, that
any intellectual property developed by such Affiliate or Third
Party shall be governed by the provisions of this Agreement (and
subject to the licenses set forth in Article 5) as if such
intellectual property had been developed by such Party, and
provided further that no Third Party may undertake to provide a
majority of the work required to be undertaken by a Party to this
Agreement. Any agreement with such an Affiliate or Third Party
relating to the conduct of work under the Research Plan shall
provide for terms that are consistent with this Agreement.
Notwithstanding any delegation of obligations under this Agreement
by a Party to any of its Affiliates or to a Third Party, each Party
shall remain primarily liable and responsible for the performance
of all of its obligations under this Agreement and for causing its
Affiliates and/or Third Parties to act in a manner consistent
herewith.
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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.
2.10 Records and
Reports . During the
Research Term, each Party shall use commercially reasonable efforts
to keep the other Party informed of its research and development
activities hereunder, and shall provide the other Party’s JRC
representatives with regular summary updates at JRC meetings.
(Those updates are the providing Party’s Confidential
Information.) Each Party also shall maintain records of progress in
research and development hereunder (or cause such records to be
maintained) in sufficient detail and in good scientific manner as
will properly reflect all work done and results achieved by or on
behalf of such Party therewith. If reasonably necessary for a Party
to perform its work under the Research Plan or to exercise its
rights under this Agreement, that Party may request that the other
Party provide more detailed information and data regarding the
updates it earlier provided, and the recording Party shall promptly
provide the requesting Party with information and data as is
reasonably available and reasonably related to the work under the
Research Plan. Neither Party is required to generate additional
data or prepare additional reports to comply with the foregoing
obligation. All such reports, information and data provided by a
Party shall be considered the providing Party’s Confidential
Information.
2.11 Delivery of Information and
Collaboration Inventions . At the completion of the Research Plan under
this Agreement, at Genentech’s request from time to time
during the Research Term and for [ * ] , Exelixis shall
deliver to Genentech any materials, documentation and other
Information created or discovered pursuant to the Research Plan,
including but not limited to any Collaboration Reagents, any
Collaboration Assays and/or descriptions thereof, and any other
Collaboration Inventions (in tangible form if existing and
otherwise in the form of a full description). Except as set forth
in this Section 2.11, as set forth in Article 8, or as required by
the Research Plan, neither Party is required to deliver to the
other Party any materials or other tangible items.
3. D EVELOPMENT AND C OMMERCIALIZATION OF P RODUCTS
3.1 Genentech Development and
Commercialization . As
between the Parties, Genentech or its Affiliates or Sublicensees
have sole authority to conduct all commercial research, clinical
development, manufacturing and commercialization activities,
including without limitation all regulatory activities, with
respect to any Licensed Products in the Field (whether those
Licensed Products are Profit Share Products or Royalty Products).
All regulatory applications with respect to the Licensed Products
will be owned by Genentech and/or its Affiliates or Sublicensee(s),
as applicable. Upon Genentech’s or its Sublicensees’ or
Affiliates’ reasonable written request (and at the requesting
entity’s expense), Exelixis shall [ * ] . Genentech
shall have sole control and responsibility for, and shall bear all
of its costs and expenses associated with, the development,
manufacture (including formulation) and commercialization of all
Licensed Products as applicable, except to the extent that
Genentech receives reimbursement from Exelixis for any Profit Share
Product.
3.2 Genentech
Diligence . Genentech
shall use Diligent Efforts to develop and commercialize one or more
Licensed Products during the term of this Agreement. [ * ] .
Exelixis may [ * ] . Exelixis may [ * ] . If
Genentech has not [ * ] within [ * ] , then Genentech
shall [ * ] . [ * ] fully satisfies [ * ] . If
Genentech [ * ] Genentech has [ * ] .
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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.
3.3 Engaging Third Parties for
Development, Manufacture and/or Commercialization
. It is understood that when
Genentech engages its Affiliates or any Third Parties with respect
to the development, manufacture and commercialization of any
Licensed Products, that engagement may require a license or
sublicense of rights obtained from Exelixis under this Agreement.
In addition to Genentech’s rights to sublicense under Article
5, Genentech may disclose Confidential Information of Exelixis
solely as necessary to fulfill the business purposes of the
engagement, and then only pursuant to terms and conditions that are
substantially as protective of that Confidential Information as are
the terms and conditions of this Agreement. Notwithstanding any
delegation of obligations under this Agreement by Genentech to its
Affiliates or a Third Party, Genentech shall remain primarily
liable and responsible for the performance of all of its
obligations under this Agreement and for causing such Affiliates or
Third Parties to act in a manner consistent herewith.
3.4 Development, Manufacturing
and Commercialization Records . Genentech shall maintain complete and accurate
records of all development, manufacturing and commercialization
conducted by it or on its behalf related to each Licensed Product.
Genentech shall maintain such records until the later of: (a) [
* ] after such records are created, or (b) [ * ] after
the First Commercial Sale of the Licensed Product to which such
records pertain. Such records shall be at a level of detail
appropriate for patent and regulatory purposes.
3.5 [ * ] .
4. D ESIGNATION OF P ROFIT S HARE F IELD AND P ROFIT S HARE P RODUCTS
4.1 Election of Profit Share
Field. Within [ *
] after the end of the Research Term, Exelixis shall notify
Genentech in writing whether it desires to elect a Profit Share
Field and, if so, whether the Profit Share Field is Inflammatory
Disease or TGR. Exelixis may not elect a Profit Share Field after
the expiration of the foregoing time period, and once elected, the
Profit Share Field may not be modified. If Exelixis does not elect
a Profit Share Field, then it may not elect any Profit Share
Products, and all Licensed Products will be designated Royalty
Products for the remainder of the term of the Agreement.
4.2 Designation by Exelixis of
Licensed Products as Profit Share Products .
(a) Generally . All Licensed Products are Royalty Products
unless designated as Profit Share Products in accordance with this
Section 4.2. Designation is on a Licensed Product-by-Licensed
Product basis, and worldwide for any Licensed Product so
designated. No Licensed Product simultaneously will be a Royalty
Product and a Profit Share Product.
(b) Genentech Notices to Exelixis
. If Genentech intends to develop a
Licensed Product Covered by [ * ] , for an indication in the
Profit Share Field (where for purposes of this Agreement
Genentech’s intention to develop is conclusively determined
by [ * ] ), then Genentech shall provide written notice to
Exelixis within [ * ] days after the date of [ * ] .
That notice must include all of the following: (i) the identity of
the Licensed Product; (ii) the relevant Collaboration Target to
which that Licensed Product [ * ] ; (iii) whether that
Licensed Product is [ * ] ; and (iv) the indication(s) for
which the Licensed Product is then being developed. After
Exelixis’ receipt of the notice, Exelixis may request
additional information,
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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.
and Genentech shall make available to Exelixis,
in a reasonable manner and at a convenient location: (w) [ *
] ; (x) [ * ] ; (y) [ * ] ; and (z) [ * ]
. In addition to the foregoing information, during the [ * ]
days after Exelixis receives that notice, Genentech shall respond
promptly to Exelixis’ reasonable inquiries regarding that
Licensed Product.
(c) Designation by Exelixis . Exelixis may designate a Licensed Product that
was the subject of a notice in Section 4.2(b) as a Profit Share
Product by providing written notice of that designation to
Genentech. If Exelixis declines to designate a Licensed Product as
a Profit Share Product within [ * ] days after receipt of
Genentech’s notice, then that Licensed Product, [ * ]
are not subject to further election or designation as Profit Share
Products, and will be Royalty Products for the remainder of the
term of this Agreement.
(d) Notification Limits . Genentech has no obligation to provide notice
to Exelixis or permit Exelixis to make a designation for a Licensed
Product that was [ * ] and that was subsequently [ *
] . In addition, Genentech’s obligation to provide notice
under Section 4.2(b) and Exelixis’ right to designate a
Licensed Product as a Profit Share Product under Section 4.2(c)
extends [ * ] .
(e) Future Profit Share Products
. Where a Licensed Product has been
designated as a Profit Share Product, all future Licensed Products
that have the same Collaboration Target Activity also are Profit
Share Products.
4.3 Terms for Profit Share
Products . The financial
terms for Profit Share Products, including the relevant Cost
Sharing Ratio and Operating Profits (Losses), are set forth in
Section 7.11 and in the Financial Appendix.
4.4 Exelixis One-Time Right to Designate Profit
Share Product as Royalty Product . At any time prior to [ *
] , Exelixis may (re-)designate that Profit Share Product as a
Royalty Product, by providing written notice to Genentech of that
designation. That designation will become effective within the
longer of [ * ] . The foregoing right is one-time only for
any Licensed Product; in other words, once (re-)designated under
this Section 4.4, the Licensed Product [ * ] remains a
Royalty Product for the remainder of the term of this Agreement.
Exelixis and Genentech shall continue to share Operating Profits
(Losses) in accordance with the Cost Sharing Ratio and the
Financial Appendix until the date on which the new designation is
effective (as described above in this Section 4.4); thereafter, the
Licensed Product is a Royalty Product [ * ] subject to
Genentech’s milestone obligations in Section 7.3 (only with
respect to milestones not already achieved at the time of
designation as a Royalty Product under this Section 4.4) and
subject to Genentech’s royalty obligations in Section
7.4.
5. L ICENSES
5.1 Licenses to
Genentech . Subject to
the terms of this Agreement:
(a) Exelixis Research IP . Exelixis agrees to grant and hereby grants (on
behalf of itself and its Affiliates) Genentech a worldwide,
co-exclusive license (with the right to grant and authorize
sublicenses) (i) under the Exelixis Research IP to perform its
obligations and carry out any tasks or activities pursuant to the
Research Plan, and (ii) under the Exelixis Know-
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[ * ] =
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.
How to research, develop, make (and have made),
use, sell, offer for sale, and import Licensed Products in the
Field, in each case including the right to practice any methods or
processes. With respect to any given Licensed Product,
Genentech’s license in this Section 5.1(a) shall be
royalty-bearing if, and to the extent, set forth in Section 7.4 and
revenue-bearing if, and to the extent, set forth in Section
7.11.
(b) Yale Licensed IP . Exelixis agrees to grant and hereby grants (on
behalf of itself and its Affiliates) Genentech a worldwide,
exclusive (subject to the license back from Genentech to Exelixis
in Section 5.2(c) (Screening License)) license (with the right to
grant and authorize sublicenses) under the Yale Licensed IP, (i) to
perform its obligations and carry out any tasks or activities
pursuant to the Research Plan, and (ii) to research, develop, make
(and have made), use, sell, offer for sale, and import Licensed
Products in the Field, in each case including the right to practice
any methods or processes. With respect to any given Licensed
Product, Genentech’s license in this Section 5.1(b) shall be
royalty-bearing if, and to the extent, set forth in Section 7.4 and
revenue-bearing if, and to the extent, set forth in Section
7.11.
(c) Collaboration IP . Exelixis agrees to grant and hereby grants (on
behalf of itself and its Affiliates) Genentech a worldwide,
exclusive (subject to the licenses back from Genentech to Exelixis
under Section 5.2(a) and Section 5.2(b)) license (with the right to
grant and authorize sublicenses) under Exelixis’ interest in
and to any Collaboration IP (whether Joint Collaboration IP or
Exelixis’ Sole Collaboration IP), (i) to perform its
obligations and carry out tasks and activities pursuant to the
Research Plan, and (ii) to research, develop, make (and have made),
use, sell, offer for sale, and import Licensed Products in the
Field, in each case including the right to practice any methods or
processes. With respect to a given Licensed Product,
Genentech’s license in this Section 5.1(c) shall be
royalty-bearing if, and to the extent, set forth in Section 7.4 and
revenue-bearing if, and to the extent, set forth in Section
7.11.
(d) Screening License . Exelixis agrees to grant and hereby grants (on
behalf of itself and its Affiliates) Genentech a worldwide,
non-exclusive, royalty-bearing license, under the Yale Patents, to
screen Small Molecule Compounds against targets that are not
Collaboration Targets but are within the Notch signaling pathway.
The foregoing license does not include the right to grant or
authorize sublicenses; however, Genentech may have any of the
foregoing performed on its behalf, where the benefit of that
performance accrues primarily or exclusively to
Genentech.
(e) Collaboration Reagents and Collaboration
Assays . Exelixis agrees
to grant and hereby grants (on behalf of itself and its Affiliates)
Genentech a worldwide, royalty-free license to make and use
Collaboration Reagents and Collaboration Assays for any purpose,
which license is (i) exclusive (subject to the licenses back from
Genentech to Exelixis under Section 5.2(a) and Section 5.2(b))
under the Yale Licensed IP and Collaboration IP, and (ii)
non-exclusive under the Exelixis Know-How. The foregoing license
includes the right to grant and authorize sublicenses, but only (x)
where the Sublicensee either is an Affiliate of Genentech or is
also a Sublicensee with respect to Licensed Products or (y) in
connection with a Diagnostic.
(f) Collaboration Inventions . Exelixis agrees to grant and hereby grants (on
behalf of itself and its Affiliates) Genentech a worldwide,
royalty-free license (including the right to grant and authorize
sublicenses) to Collaboration Inventions (other than
Collaboration
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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.
Reagents, Collaboration Assays, or Licensed
Products), including making (and having made), using and selling
any such Collaboration Inventions, which license is (i) exclusive
under the Yale Licensed IP and Collaboration IP, and (ii)
non-exclusive under the Exelixis Know-How.
(g) Follow-On Exelixis IP . Exelixis agrees to grant and hereby grants (on
behalf of itself and its Affiliates) Genentech a worldwide,
non-exclusive, royalty-free, fully paid up license (with the right
to grant and authorize sublicenses) under the Follow-On Exelixis
IP, to research, develop, make (and have made), use, sell, offer
for sale, and import Licensed Products in the Field, in each case
including the right to practice any methods or
processes.
(h) Sublicensing . For those licenses granted under this Section
5.1 that grant Genentech the right to grant and authorize
sublicenses, sublicenses must not be inconsistent with, or cause
Genentech to be in breach of, with the terms and conditions of this
Agreement. Genentech shall also provide to Exelixis the name of
each Sublicensee and a copy of the sublicense agreement (which may
be redacted to remove highly confidential information), except
where the Sublicensee is an Affiliate of Genentech. Genentech shall
remain responsible for each permitted Sublicensee’s
compliance with the material and applicable terms and conditions of
this Agreement. Except when the sublicense is to an Affiliate of
Genentech, Genentech’s rights to sublicense do not include
rights to [ * ] ; in other words, sublicenses shall not
include any right [ * ] except in connection with a
Diagnostic.
5.2 Licenses to
Exelixis . Subject to the
terms of this Agreement:
(a) Research License . Genentech agrees to grant and hereby grants
(on behalf of itself and its Affiliates) Exelixis a worldwide,
non-exclusive license (with the right to grant and authorize
sublicenses) under the Genentech Licensed IP, under
Genentech’s Sole Collaboration IP, and under other
Collaboration IP and the Yale Licensed IP to the extent exclusively
licensed to Genentech under Section 5.1 above, during the Research
Term, to perform its obligations and carry out any tasks or
activities pursuant to the Research Plan, including the right to
practice any methods or processes.
(b) Collaboration Reagents and Collaboration
Assays . [ * ]
.
(c) Screening License . Genentech agrees to grant and hereby grants
(on behalf of itself and its Affiliates) Exelixis a worldwide,
non-exclusive, royalty-bearing license, under the Yale Patents to
the extent exclusively licensed to Genentech under Section 5.1
above, to screen Small Molecule Compounds against the Collaboration
Targets. The foregoing license does not include the right to grant
or authorize sublicenses, or to have any screening activities
performed on its behalf.
5.3 Information and
Know-How . The Parties
understand and agree that neither Party is required to provide the
other with any Information other than Information either expressly
required to be provided, Information to which access is expressly
provided or required, or Information created pursuant to the
Research Plan. Without limiting the foregoing, neither Party is
required to provide to the other any Information regarding [ *
] .
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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.
5.4 No Additional
Licenses . Except as
expressly provided in Sections 5.1 and 5.2, nothing shall grant
either Party any right, title or interest in and to the
intellectual property rights of the other Party (either expressly
or by implication or estoppel).
6. G ENENTECH AND E XELIXIS N EGOTIATION R IGHTS
6.1 Exelixis [ * ]
. Notwithstanding the limitations
on Exelixis’ license under Section 5.2(b), Exelixis may [
* ] , but only (a) [ * ] , or (b) [ * ] . Whether
or not Exelixis has an obligation or Genentech has a right under
Section 6.2 below, [ * ] is subject to the conditions in
Section 6.3 below.
6.2 Genentech Right to
Negotiate.
(a) Notice by Exelixis . If Exelixis intends to work with a Third Party
to develop or commercialize an Exelixis Reagent Product, then
unless Exelixis already has [ * ] , Exelixis first shall
offer such opportunity to Genentech by providing written notice to
Genentech. That notice must include all of the following: (i) the
identity of the Exelixis Reagent Product; (ii) [ * ] ; and
(iii) the indication(s) for which the Exelixis Reagent Product is
being developed. After Genentech’s receipt of the notice,
Genentech may request additional information, and Exelixis shall
make available to Genentech, in a reasonable manner and at a
convenient location: (x) [ * ] then a copy of all such
items; (y) [ * ] ; and (z) [ * ] . In addition to the
foregoing information, during the [ * ] days after Genentech
receives that notice, Exelixis shall respond promptly to
Genentech’s reasonable inquiries regarding that Exelixis
Reagent Product.
(b) Designation by Genentech . At any time during the [ * ] days after
Exelixis provides notice to Genentech under Section 6.2(a) above,
Genentech may inform Exelixis, in writing, that it wishes to
negotiate the terms on which Exelixis and Genentech would work
together to develop and commercialize any Exelixis Reagent Product.
If Genentech declines in writing to negotiate such terms, then
Exelixis is free to work with a Third Party to further develop and
to commercialize that Exelixis Reagent Product, but subject to the
terms of Section 6.3. If Genentech does not decline in writing to
negotiate such terms, then the Parties shall negotiate in good
faith exclusively for [ * ] days the terms on which Exelixis
and Genentech would work together to develop and commercialize that
Exelixis Reagent Product. If the Parties are unable to agree on
terms prior to the end of the [ * ] -day negotiation period,
then Exelixis is free to work with a Third Party to develop and
commercialize that Exelixis Reagent Product, but subject to the
terms of Section 6.3. In addition, Exelixis’ obligation to
provide notice under Section 6.2(a) and Genentech’s right to
negotiate the terms on which Exelixis and Genentech would work
together to develop and commercialize any Exelixis Reagent Product
under this Section 6.2(b) extends [ * ] .
6.3 Terms for Third Party Partner
for Exelixis Reagent Products . Exelixis may work with a Third Party with
respect to any particular Exelixis Reagent Product no longer
subject to either the notice requirements of Section 6.2(a) or
Genentech’s rights under Section 6.2(b), and further may
disclose to that Third Party Confidential Information of Genentech
related to Collaboration Assays and Collaboration Reagents, solely
as necessary to further develop and to commercialize that Exelixis
Reagent Product, subject to the following three (3) conditions: (a)
Exelixis’ agreement with that Third Party must include [ *
] ; (b) Exelixis shall [ * ] ; and (c) [ * ]
.
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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.
6.4 Exelixis Right to
Negotiate .
(a) Notice by Genentech . If Genentech intends to sublicense to a Third
Party Genentech’s rights to develop or commercialize a Profit
Share Product in the United States, then Genentech first shall
offer such opportunity to Exelixis by providing written notice to
Exelixis. That notice must include all of the following: (i) the
identity of the Profit Share Product; (ii) [ * ] ; and (iii)
if Genentech is developing that Profit Share Product for [ *
] , then the [ * ] . After Exelixis’ receipt of
the notice, Exelixis may request additional information, and
Genentech shall make available to Exelixis, in a reasonable manner
and at a convenient location, the following information to the
extent it relates to the United States: (x) [ * ] ; (y) [
* ] ; and (z) [ * ] . In addition to the foregoing
information, during the [ * ] days after Exelixis receives
that notice, Genentech shall respond promptly to Exelixis’
reasonable inquiries regarding that Profit Share
Product.
(b) Designation by Exelixis . At any time
during the [ * ] days after Genentech provides notice to
Exelixis under Section 6.4(a) above, Exelixis may inform Genentech,
in writing, that it wishes to negotiate the terms on which
Genentech would sublicense to Exelixis Genentech’s rights to
develop or commercialize that Profit Share Product in the United
States. If Exelixis declines in writing to negotiate such terms,
then Genentech is free to offer a Third Party the opportunity to
negotiate the terms of a sublicense to Genentech’s rights to
develop or commercialize that Profit Share Product in the United
States. If Exelixis does not decline in writing to negotiate such
terms, then the Parties shall negotiate in good faith exclusively
for [ * ] days the terms on which Exelixis would sublicense
Genentech’s rights to develop or commercialize that Profit
Share Product in the United States. If the Parties are unable to
agree on terms prior to the end of the [ * ] -day
negotiation period, then Genentech is free to offer a Third Party
the opportunity to negotiate the terms of a sublicense to
Genentech’s rights to develop or commercialize that Profit
Share Product in the United States. In addition, Genentech’s
obligation to provide notice under Section 6.4(a) and
Exelixis’ right to negotiate the terms on which Exelixis
would acquire a sublicense to Genentech’s rights to develop
or commercialize a Profit Share Product under this Section 6.4(b)
extends [ * ] .
7. C OMPENSATION
7.1 Upfront Fee
. Genentech shall pay Exelixis a
one-time fee of [ * ] within thirty (30) days after the
Effective Date. Such fee shall be noncreditable and
nonrefundable.
7.2 Research Support for the
Research Plan . Genentech
shall provide Exelixis with a guaranteed [ * ] in Research
Funding for each twelve (12) month period during the Research Term.
Genentech has no obligation to provide any Research Funding in
excess of the foregoing. The foregoing Research Funding is to be
used for (a) FTEs to the extent working on the Research Plan and
for (b) the costs of work performed by Third Parties under the
Research Plan on behalf of Exelixis, all as determined by the JRC
pursuant to Section 2.2. The rate for Exelixis FTEs assigned to the
Research Plan is a fully-burdened annual rate of [ * ] in
the first year, to increase in subsequent years of the Research
Term by no more than the [ * ] .
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[ * ] =
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.
Genentech shall pay to Exelixis the Research
Funding in equal quarterly payments, [ * ] . Within [ *
] days after the Effective Date, Genentech will make the first
such quarterly payment (which, if prorated to coincide with a
calendar quarter, will cause the final quarterly payment also to be
prorated). [ * ] . All Research Funding paid by Genentech to
Exelixis pursuant to this Section 7.2 shall be noncreditable and
nonrefundable.
7.3 Milestone Payments for
Royalty Products .
Genentech shall pay Exelixis the milestone payments set forth in
the table below within [ * ] days of each occurrence (by
Genentech, or by its Affiliates or Sublicensees) of the milestone
events described in subsection (a) – (g) of the table below
for each Licensed Product that, at the time the milestone occurs,
[ * ] . Such milestone payments are payable [ * ] .
Milestones are not payable for Licensed Products that are [ *
] . All milestone payments shall be nonrefundable and
noncreditable.
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Milestone Events
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Amounts
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(a) [ * ]
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[ * ]
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(b) [ * ]
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[ * ]
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(c) [ * ]
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[ * ]
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(d) [ * ]
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[ * ]
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(e) [ * ]
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[ * ]
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(f) [ * ]
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[ * ]
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(g) [ * ]
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[ * ]
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*
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A European
Major Market Country is the [ * ] .
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7.4 Royalties for Royalty
Products . The following
royalties are payable on Royalty Products. In no event are such
royalties payable for [ * ], and in no event shall a Licensed
Product be [ * ]
(a) Class I Claims. Subject to Section 7.8, on a Royalty
Product-by-Royalty Product and a country-by-country basis,
Genentech shall pay Exelixis royalties equal to [ * ]
of
- 19 -
[ * ] =
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.
the Net Sales that occur during the Royalty Term
for each sale of a Royalty Product Covered by any Class I Claim in
the country of sale.
(b) Class II Claims. Subject to Section 7.8, on a Royalty
Product-by-Royalty Product and a country-by-country basis,
Genentech shall pay Exelixis royalties equal to [ * ] of the
Net Sales that occur during the Royalty Term for each sale of a
Royalty Product Covered by any Class II Claim in the country of
sale.
(c) [ * ]
. Subject to Section 7.8, on a Royalty
Product-by-Royalty Product and country-by-country basis, Genentech
shall pay Exelixis royalties equal to [ * ] of the Net Sales
that occur during the Royalty Term for each Royalty Product Covered
by [ * ] .
(d) Generally. [ * ] .
7.5 Royalties Paid by Genentech
for Genentech Screening Products . On a Genentech Screening Product-by-Genentech
Screening Product and country-by-country basis, Genentech shall pay
Exelixis royalties equal to [ * ] of the Net Sales of such
Genentech Screening Product in that country during the Royalty
Term.
7.6 Royalties Paid by Exelixis
for Exelixis Screening Products . On an Exelixis Screening Product-by-Exelixis
Screening Product and country-by-country basis, Exelixis shall pay
Genentech royalties equal to [ * ] of the Net Sales of such
Exelixis Screening Product in that country during the Royalty
Term.
7.7 Royalties Paid by Exelixis
for Exelixis Reagent Products . On an Exelixis Reagent
Product-by-Exelixi