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 406 of the Securities Act of 1933, as amended.
Exhibit 10.9
Amendment No. 1 TO Research Collaboration and License Agreement
Between Tularik Inc. and Syntex (U.S.A.) Inc.
This Amendment No. 1 (this "Amendment") to the Research Collaboration
and License Agreement dated as of July 8, 1997 (the "Agreement") by and between
Syntex (U.S.A.) Inc., a Delaware corporation, through its Roche Bioscience
division, having offices at 0000 Xxxxxxxx Xxxxxx, Xxxx Xxxx, Xxxxxxxxxx 00000
("Roche Bioscience"), and Tularik Inc., a Delaware corporation having offices
at Xxx Xxxxxxxxx Xxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000 ("Tularik"), is
entered into as of December 19, 1997.
Whereas, the parties previously entered into the Agreement, which
provided for a collaboration between Roche Bioscience and Tularik to discover
proprietary Targets to use to identify proprietary compounds for development
into Products;
Whereas, the Parties wish to clarify certain Sections of the Agreement
relating to the disclosure of structural information on Validated Hits and the
transferring of compounds between the Parties;
Whereas, the parties desire to modify Schedule B of the Agreement to
clarify the universe of Tularik Background Patent Rights and Existing Third
Party Agreements;
Whereas, in order to accomplish the foregoing, the parties have agreed
to amend the Agreement in part;
Now, Therefore, in consideration of the premises and the mutual
covenants and agreements expressed herein, and for other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, and
intending to be legally bound, Tularik and Roche Bioscience hereby agree as
follows:
1. Section 1 of the Agreement is hereby amended by adding the following
Sections:
1.77 "Collaboration Medicinal Chemistry Program" means a program
for the chemical synthesis of structural analogs of a Validated Hit in
order to improve the biological properties of such Validated Hit towards a
Target as part of the Research Collaboration
1.78 "Primary Interest" means a small molecule that (i) is, at
the time of identification of such molecule as a Validated Hit, [ * ].
[ * ] = 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 406 of the Securities Act of 1933, as amended.
1.
1.79 "Roche Medicinal Chemistry Program" means a program
conducted by or on behalf of Roche for the chemical synthesis of structural
analogs of a compound in order to improve the biological properties of such
compound, excluding [ * ].
1.80 "Screening Party" has the meaning set forth in Section 5.7.
1.81 "Transferring Party" has the meaning set forth in Section
5.7.
2. Section 5.5 is hereby amended to read in its entirety as set forth
below:
5.5 Roche Bioscience Screening Library. The Roche Bioscience
Screening Library is not part of the Research Compound Library, but may, in
Roche Bioscience's sole discretion, be used in HTS against the Targets.
Except for the Roche Bioscience Screening License, Tularik shall have no
rights to compounds originating from the Roche Bioscience Screening Library
unless a Library Compound becomes a Development Compound under Section 5.2.
Roche Bioscience shall provide structural information on Validated Hits
from the Roche Bioscience Screening Library; [ * ]. Structural information
on compounds in the Roche Bioscience Screening Library that are not
Validated Hits shall [ * ]. Derivatives made as part of a Collaboration
Medicinal Chemistry Program from compounds originating from the Roche
Bioscience Screening Library shall be considered part of the Roche Compound
Library. The Roche Bioscience Screening Library shall be treated as Roche
Bioscience's Confidential Information. .
3. The penultimate sentence of Section 5.6 of the Agreement is hereby
amended to read as follows:
Derivatives made as part of a Collaboration Medicinal Chemistry Program
from compounds originating from the Tularik Screening Library shall be
considered part of the Research Compound Library.
4. Article 5 of the Agreement is hereby amended by adding a new Section
5.7:
Section 5.7 Transfer of Compounds. If either party (the "Transferring
Party") transfers compounds to the other party (the "Screening Party")
pursuant to the screening licenses set forth in Section 12.2 below, the
Screening Party shall use such compounds solely in accordance with the
terms of this Agreement. Such use must be at the Screening Party's place
of business and in accordance with the Research Plan. Any unused quantities
of the compounds shall be returned to the Transferring Party no later than
the end of the Research Term or, upon written request by Transferring
Party, destroyed according to prescribed federal, state and local
guidelines, including any written instructions received from the
Transferring Party. THE TRANSFERRING PARTY DOES NOT MAKE ANY WARRANTY AS
TO THE IDENTITY, PURITY OR ACTIVITY OF THE COMPOUNDS. The Screening Party
shall bear all risk and liability for all harm arising from its use of the
compounds.
5. Schedule B of the Agreement is hereby amended to read in its entirety
as set forth on Schedule B hereto.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
2.
6. Capitalized terms used herein but not otherwise defined herein shall
have the respective meanings assigned to such terms in the Agreement.
7. Except as expressly modified by this Amendment, all of the terms and
conditions of the Agreement shall remain in full force and effect.
8. This Amendment may be executed in two or more counterparts, each of
which shall be deemed an original but all of which shall be considered one and
the same instrument.
In Witness Whereof, the parties have executed, or caused their duly
authorized officer or representative to execute, this Amendment as of October
__, 1997.
Tularik Inc.
By: /s/ Xxxxx X. Xxxxxxx
----------------------------------------
Name: Xxxxx X. Xxxxxxx, Ph.D.
Title: President and Chief Executive Officer
Syntex (U.S.A.) Inc.,
through its Roche Bioscience division
By: /s/ Xxxxx X. Xxxxx
----------------------------------------
Name: Xxxxx X. Xxxxx, M.D., Ph.D.
Title: President
[ * ] = 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 406 of the Securities Act of 1933, as amended.
3.
Schedule B
TULARIK BACKGROUND PATENT RIGHTS AND EXISTING THIRD PARTY
AGREEMENTS
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ] = 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 406 of the Securities Act of 1933, as amended.
4.
Exhibit 10.9
Research Collaboration and License Agreement
This Research Collaboration and License Agreement is entered into on July
8, 1997 (the "Effective Date"), by and between Syntex (U.S.A.) Inc., a Delaware
corporation, through its Roche Bioscience division, having offices at 0000
Xxxxxxxx Xxxxxx, Xxxx Xxxx, Xxxxxxxxxx 00000 ("Roche Bioscience"), and Tularik
Inc., a Delaware corporation having offices at Xxx Xxxxxxxxx Xxxxx, Xxxxx Xxx
Xxxxxxxxx, Xxxxxxxxxx 00000 ("Tularik"). Roche Bioscience and Tularik may be
referred to herein as a "Party" or, collectively, as "Parties."
Whereas, Tularik is a recognized leader in conducting research in
inflammatory pathways with assays available or under development for certain key
targets.
Whereas, Roche Bioscience wishes to collaborate with Tularik to discover
proprietary Targets to use to identify proprietary compounds for development
into Products.
Now, Therefore, the Parties agree as follows:
1. Definitions
As used herein, the following terms shall have the following meanings:
1.1 "Additional Indications" means a medical condition that is not
included within the definition of Roche Bioscience Indication or Tularik
Indication.
1.2 "Adjusted Gross Sales" means the amount of gross sales invoiced by a
Developing Party, its Affiliates (which, with respect to Roche Bioscience, shall
include Genentech for purposes of this Section 1.2 only), or sublicensees for a
Product to Third Parties less deductions of returns (including withdrawals and
recalls), rebates (price reductions, including Medicaid and similar types of
rebates, e.g. chargebacks), volume (quantity) discounts, discounts granted at
the time of invoicing, sales taxes and other taxes (other than income taxes),
all to the extent directly linked to and included in the gross sales amount as
computed on a product by product basis for the countries concerned.
1.3 "Affiliate" means a business entity that owns, is owned by or is under
common ownership with a Party. For the purposes of this definition, the term
"owns" (including, with correlative meanings, the terms "owned by" and "under
common ownership with") as used with respect to any Party, shall mean the
possession (directly or indirectly) of more than fifty percent (50%) of the
outstanding voting securities of a corporation or comparable equity interest in
any other type of entity; provided, however, in any country where the local law
does not permit foreign equity participation of at least fifty percent (50%),
then an "Affiliate" includes any business entity in which a Party owns the
maximum percentage of outstanding stock or voting rights permitted by local law
and of which such Party exercises practical control of the management of such
entity's operations with respect to a Product; provided, further, however,
Genentech, Inc., with offices located at Xxx XXX Xxx, Xxxxx Xxx Xxxxxxxxx,
Xxxxxxxxxx, 00000,
[ * ] = 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 406 of the Securities Act of 1933, as amended.
1
shall not be considered an Affiliate of Roche Bioscience (other than for
purposes of Section 1.2 only) unless a duly authorized officer of Roche
Bioscience notifies Tularik in writing that Genentech shall be deemed an
Affiliate.
1.4 "Agreement" means the present agreement together with all appendices
and schedules, including the Research Plan.
1.5 "Application" has the meaning set forth in Section 11.3.2.
1.6 "Compound Libraries" means the Roche Bioscience Screening Library, the
Tularik Screening Library, and the Research Compound Library.
1.7 "Confidential Information" means, subject to the limitations contained
in Section 13.2, all information and materials received by either Party from
the other Party pursuant to this Agreement, including but not limited to the
information disclosed pursuant to Sections 6.3.2, 6.3.3, and 6.3.4.
1.8 "Cover" (including variations thereof such as "Covered, "Coverage", or
"Covering) means that the making, having made, using, offering for sale, selling
or importing of a particular product would infringe a Valid Claim of an issued
patent in the absence of rights under such patent. The determination of whether
a product is Covered by particular patent rights shall be made on a country by
country basis.
1.9 "Developing Party" means the Party whom the Research Management
Committee designates to develop a Research Compound into a Product as provided
in Section 5.2.
1.10 "Development Compound" means a Roche Bioscience Compound or a Tularik
Compound.
1.11 "Effective Date" has the meaning set forth in the first paragraph
hereof.
1.12 "Entry into Portfolio" means the date upon which [ * ].
1.13 "FDA" means the United States Food and Drug Administration.
1.14 "Field" means research, development and commercialization of [ * ],
for use in the treatment of Roche Bioscience Indications, Tularik Indications or
Additional Indications.
1.15 "Filing Party" has the meaning set forth in Section 11.3.1.
1.16 "First Commercial Sale" of a Product shall mean the first sale for use
or consumption of such Product in a country after required marketing and pricing
approval has been granted by the governing health regulatory authority of such
country.
1.17 "First Right of Negotiation" has the meaning set forth in Section 7.1.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
2
1.18 "FTE" means one full time-equivalent research employee.
1.19 "HTS" means high throughput screening.
1.20 "IND" means an Investigational New Drug application as defined in the
rules and regulations of the FDA.
1.21 "Independent Research" has the meaning set forth in Section 2.5.2.
1.22 "Invention" means any possibly patentable discovery or invention made
during the course of the Research Collaboration and within the scope of the
Research Plan. Determination of inventorship shall be made in accordance with
the patent laws of the United States of America.
1.23 "Inventing Party" means the Party having made an Invention.
1.24 "Joint Inventions" has the meaning set forth in Section 11.1.
1.25 "Joint Patent" means a Patent claiming a Joint Invention.
1.26 "Library Compound" means a compound from a Roche Bioscience Screening
Library or a Tularik Screening Library.
1.27 "Licensee" has the meaning set forth in Section 7.2.
1.28 "Major Market" means [ * ].
1.29 "NDA" means a New Drug Application filed pursuant to the requirements
of the FDA or the equivalent application in any other country.
1.30 "Net Sales" means the amount calculated by [ * ].
1.31 "Offer" has the meaning set forth in Section 7.2.
1.32 "Officers" has the meaning set forth in Section 2.5.3.
1.33 "Patent" means (a) patents (including inventors certificates) that
include one or more Valid Claims, including without limitation any substitution,
extension (including supplemental protection certificate), registration,
confirmation, reissue, reexamination or renewal
[ * ] = 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 406 of the Securities Act of 1933, as amended.
3
thereof and (b) pending applications, including provisional applications,
continuations, divisionals, and continuations-in-part of any of the foregoing.
1.34 "Patent Management" has the meaning set forth in Section 11.3.1.
1.35 "Patent Costs" means the fees and expenses paid to outside legal
counsel and other Third Parties, and filing, prosecution and maintenance
expenses, incurred in connection with the establishment and maintenance of
Patent Rights.
1.36 "Patent Rights" means all rights under Patents.
1.37 "Pathways" means the [ * ], as described on Exhibit A, and any
additional pathways added to this Agreement upon the written agreement of the
Parties.
1.38 "Phase I" means that portion of the clinical development program which
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, as more precisely defined by the rules
and regulations of the FDA and corresponding rules and regulations in other
countries.
1.39 "Phase II" means that portion of the clinical development program
which provides for the initial trials of a product on a limited number of
patients for the primary purpose of evaluating safety, dose ranging and efficacy
in the proposed therapeutic indication, as more precisely defined by the rules
and regulations of the FDA and corresponding rules and regulations in other
countries.
1.40 "Phase III" means that portion of the clinical development program
which provides for the continued trials of a product on sufficient numbers of
patients to establish the safety and efficacy of a product for the desired
claims and indications, as more precisely defined by the rules and regulations
of the FDA and corresponding rules and regulations in other countries. Any
trial designed to support a NDA without further clinical studies will be
considered a Phase III trial for purposes of this Agreement.
1.41 "Product" means any product incorporating a Development Compound, in
any formulation, designed for treatment of a Roche Bioscience Indication,
Tularik Indication or an Additional Indication, delivered by any route of
administration.
1.42 "Research Collaboration" means the research conducted by the parties
during the Research Term pursuant to the Research Plan and this Agreement.
1.43 "Research Compound" means any analog or other derivative compound,
including a peptidomimetic, that has been synthesized or acquired pursuant to
the Research Plan or at the direction of the Officers as provided in Section
2.5, and is based upon any Validated Hit.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
4
1.44 "Research Compound Library" means all Research Compounds.
1.45 "Research Plan" has the meaning set forth in Section 4.1.
1.46 "Research Term" has the meaning set forth in Section 6.1.
1.47 "Responsible Party" means the Party responsible for Patent Management.
1.48 "Right of First Refusal" has the meaning set forth in Section 7.2.
1.49 "RMC or Research Management Committee" has the meaning set forth in
Section 3.1.
1.50 "Roche" means Roche Bioscience together with its Affiliates.
1.51 "Roche Bioscience Compound" means a small molecule from any of the
Compound Libraries which the Research Management Committee designates as a
"Roche Bioscience Compound" pursuant to Section 5.2 or which Roche Bioscience
designates as a "Roche Bioscience Compound" pursuant to Section 6.3.2.
1.52 "Roche Bioscience Indications" means [ * ].
1.53 "Roche Bioscience Invention(s)" has the meaning set forth in Section
11.1.
1.54 "Roche Bioscience Patent" means a Patent claiming a Roche Bioscience
Invention.
1.55 "Roche Bioscience Screening Library" means the library consisting of
compounds that have been synthesized or acquired by or on behalf of either Roche
Bioscience or its Affiliates either (a) prior to the Effective Date or (b)
during the Research Term or the applicable Tail Period, if any, but independent
of the Research Collaboration.
1.56 "Roche Bioscience Screening License" has the meaning set forth in
Section 12.2.2.
1.57 "Royalty Receiving Party" has the meaning set forth in Section 10.1.
1.58 "Royalty Term" means, in the case of any Product, in any country, the
period of time commencing on the First Commercial Sale of such Product and
ending upon the later of (a) [ * ] from the date of First Commercial Sale of
such Product in such country or (b) the expiration of the last to expire of the
Patent Rights Covering such Product in such country. Royalty Term shall be
determined on a Product by Product, country by country basis.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
5
1.59 "Scientifically Reasonable and Diligent Efforts" means, unless the
Parties agree otherwise, those efforts consistent with the exercise of prudent
scientific and business judgment, as applied to other products of similar
scientific and commercial potential within the relevant product lines of the
Developing Party and its Affiliates.
1.60 [ * ]
1.61 "Substantial Competition" means market penetration in a country with
respect to a Product by one or more Third Parties with a product [ * ].
1.62 "Tail Period" has the meaning set forth in Section 6.3.2.
1.63 "Target" means an [ * ] and is either (a) listed as an included target
on Exhibit A or (b) discovered by one or both Parties as part of the Research
Collaboration (excluding any molecule that is subject to prior rights of any
Third Party under an agreement with either Party at the time it is discovered,
which agreement is either listed on Exhibit 2 or is subject to the provisions of
Section 2.5) or (c) licensed by either Party during the Research Collaboration
pursuant to Section 2.5.
1.64 "Target Information" has the meaning set forth in Section 2.4.
1.65 "Third Party" means any entity other than Tularik or Roche Bioscience
or an Affiliate of Tularik or Roche Bioscience.
1.66 "Third Party Technology" has the meaning set forth in Section 2.5.2.
1.67 "Tularik Background Patent Rights" means all rights under Patents
existing as of the Effective Date that Tularik owns or to which it has a license
(with rights to sublicense as provided herein) and which relate to the Field,
and which Patents are set forth on Schedule B.
1.68 "Tularik Compound(s)" means a small molecule from any of the Compound
Libraries which the Research Management Committee designates as a "Tularik
Compound" pursuant to Section 5.2 or which Tularik designates as a "Tularik
Compound" pursuant to Section 6.3.2.
1.69 "Tularik Indications" means [ * ].
1.70 "Tularik Invention" has the meaning set forth in Section 11.1.
1.71 "Tularik Patent" means a Patent claiming a Tularik Invention.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
6
1.72 "Tularik Screening Library" means the library consisting of compounds
that have been synthesized or acquired by or on behalf of either Tularik or its
Affiliates either (a) prior to the Effective Date or (b) during the Research
Term or the applicable Tail Period, if any, but independent of the Research
Collaboration.
1.73 " Tularik Screening License" has the meaning set forth in Section
12.2.1.
1.74 "Valid Claim" means a claim of an issued patent which claim has not
lapsed, expired, been canceled or become abandoned and has not been declared
invalid by an unreversed and unappealable decision or judgment of a court or
other appropriate body of competent jurisdiction, and which has not been
admitted to be invalid or unenforceable through reissue or disclaimer.
1.75 "Validated Hit" means a small molecule that has shown activity against
a Target in primary screening as part of the Research Collaboration.
2. Research Collaboration
2.1 Scope of Research Collaboration. The Research Collaboration will
focus on Targets in the Pathways, both in finding new proprietary Targets as
well as with respect to Targets identified by Tularik prior to the Effective
Date, and the use of Targets for HTS assay development to discover proprietary
drug leads. The Research Collaboration will initially focus on elucidating
proprietary drug discovery Targets in the Pathways and is anticipated to be
restricted to proprietary Targets in the Pathways. Roche Bioscience and Tularik
shall conduct the Research Collaboration on a collaborative basis with the goal
of identifying Research Compounds that are suitable for development into
Products for commercialization. The Research Collaboration is intended to be
flexible to allow for pursuit of unforeseen opportunities in the area of
inflammation biology involving the Targets and the Pathways.
2.2 New Targets. If a Target is discovered as part of the Research
Collaboration, the Party discovering such new Target shall notify the Research
Management Committee. At the next Research Management Committee meeting, the
parties shall discuss such new Target. If the Research Management Committee
decides that the new Target should be included in the Research Collaboration,
then Roche Bioscience shall [ * ]. If the new Target is not [ * ] at such time,
such new Target shall be [ * ]. If the new Target is [ * ] at such time, Roche
Bioscience shall [ * ]. If the Research Management Committee or Roche
Bioscience elects to [ * ], then each Party may [ * ] of the other Party
(including its Affiliates) or any Third Party; provided, however, that the Party
that did not discover such Target shall not [ * ].
2.3 [ * ].
2.4 [ * ].
[ * ] = 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 406 of the Securities Act of 1933, as amended.
7
2.5 Exclusivity/Third Party Agreements.
2.5.1 Exclusivity. Neither Tularik (nor any future Affiliates) nor
Roche Bioscience shall, during the Research Term and applicable Tail Period, if
any, enter into an agreement that grants rights in the Field to a Third Party,
without the prior written consent of the other Party, which consent may be
withheld in its sole discretion.
2.5.2 Activities Relating to the Field. Except as provided in this
Section 2.5, neither Tularik (nor any future Affiliates) nor Roche Bioscience
shall, during the Research Term and applicable Tail Period, if any, [ * ].
2.5.3 Joint Decision-Making Process. If either Party wishes to
acquire or use any Third Party Technology or conduct or fund any Independent
Research, it shall present such opportunity to the officers designated in
Section 17.2 (the "Officers"). If the Officers wish to include such Third Party
Technology or Independent Research in the Research Plan, then the Parties shall
mutually agree in writing on the terms under which such Third Party Technology
or Independent Research will be incorporated into the Research Collaboration,
including a reasonable sharing of the costs thereof; provided, however, that
Roche Bioscience shall [ * ]. If a Third Party agreement is relevant to such
decision, it shall be disclosed in full to the other Party. Each Party shall be
bound by the applicable terms and conditions of any Third Party agreement prior
to receiving access to Third Party Technology, including but not limited to any
milestones or royalty payments applicable to any compounds or products developed
by such Party using such Third Party Technology. The Developing Party shall be
responsible for fulfilling all such Third Party financial obligations applicable
to Development Compounds in accordance with Section 9.6. Each Party
acknowledges that any rights that derive from such Third Party agreements are
subject to the terms of such agreements, notwithstanding any provisions of this
Agreement. If the Officers do not agree to include such Third Party Technology
or Independent Research in the Research Plan on mutually-agreeable terms, then
the provisions of Section 2.5.5 shall apply.
2.5.4 Re-Presentation to Officers. If a Party proposes to acquire
Third Party Technology and the Officers do not agree to acquire such Third Party
Technology, then either Party may negotiate such an agreement with such Third
Party; provided however, that the negotiating Party shall re-present such
opportunity to the other Party pursuant to Section 2.5.3 promptly following
execution of such Third Party agreement.
2.5.5 Outside Activities. If the Officers do not agree to include
any particular Third Party Technology or Independent Research in the Research
Plan on mutually-agreeable terms, then, subject to Section 2.5.4, either Party
may conduct or fund such Independent
[ * ] = 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 406 of the Securities Act of 1933, as amended.
8
Research, or use such Third Party Technology, outside the Research Collaboration
(the "Outside Activities"); provided, however, that [ * ]. Should such [ * ]
occur, the Party conducting the Outside Activities shall indemnify the other
Party for any [ * ]; provided, however, that the other Party takes commercially
reasonable steps, if any are possible or practical, to [ * ]; and provided,
further, that the other Party permits [ * ]. If a Party conducts or funds
Independent Research outside the Research Collaboration, and [ * ], then during
the Research Term such Party may not [ * ], except with the prior written
consent of the other Party, which consent may be withheld in its sole
discretion.
3. Research Management Committee
3.1 Formation of Research Management Committee. The Research
Collaboration shall be managed by the Research Management Committee comprised of
an equal number of members appointed by each of Roche Bioscience and Tularik;
provided that the size of the Research Management Committee shall not exceed a
total of eight members. Either Party may appoint substitute or replacement
members of the Research Management Committee to serve as their representatives.
The initial members of the Research Management Committee shall be appointed by
the Parties within 30 days following the Effective Date. The Research
Management Committee shall have the responsibility and authority to: (a) plan
and monitor the research; (b) assign tasks and responsibilities under the
Research Plan to Tularik and Roche Bioscience; (c) review and modify the
Research Plan as it shall deem appropriate to achieve the Parties' objectives of
developing commercially successful Products; and (d) nominate Research Compounds
for IND-enabling studies (and designate any such Research Compounds as either
Roche Bioscience Compounds or Tularik Compounds prior to the commencement of
such studies); provided that the Research Management Committee may not take any
action in conflict with the express terms of this Agreement.
3.2 Meetings of Research Management Committee. The Research Management
Committee shall initially meet at least four times per year at locations and
times to be determined by the Research Management Committee, with the intent of
meeting at alternating locations in South San Francisco, California and Palo
Alto, California, with each Party to bear all travel and related costs for its
members.
3.3 Decision-Making Process. All decisions made or actions taken by the
Research Management Committee shall be made unanimously by its members with the
Tularik members cumulatively having one vote and the Roche Bioscience members
cumulatively having one vote. Any disagreement which cannot be resolved by the
vote of the Research Management Committee shall be referred to the Officers for
resolution under Section 17.2. [ * ]. It is the intent of the Parties to
resolve issues relating to the Research Collaboration through the Research
Management Committee whenever possible and to refer issues to the Officers only
when resolution through the Research Management Committee cannot be achieved.
4. Conduct of Research
[ * ] = 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 406 of the Securities Act of 1933, as amended.
9
4.1 Research Plan. The research shall be conducted in accordance with the
initial research plan agreed upon and exchanged by the Parties concurrent with
the execution of this Agreement, as such research plan may be amended from time
to time in writing by the Research Management Committee (the "Research Plan").
The Research Plan defines the key decision points, timing to key decision
points, resource and funding allocation and other details identified by the
Research Management Committee. The Research Plan will be reviewed and approved
annually by the Research Management Committee to ensure adequate resource and
funding allocation to key activities at Tularik and Roche Bioscience [ * ]. If
there is a conflict between the provisions of the body of this Agreement and the
Research Plan, then the provisions of the body of this Agreement shall govern.
4.2 Tularik Responsibilities. Tularik shall provide [ * ]. Tularik shall
be responsible for [ * ]. Tularik shall [ * ]. Tularik shall conduct [ * ].
Tularik shall [ * ]. Based upon resources, Tularik may [ * ]. Tularik shall
conduct [ * ]. Tularik shall be responsible for [ * ]; provided, however, that
Tularik shall [ * ].
4.3 Roche Bioscience Responsibilities. Roche Bioscience may conduct [ *
]. Roche Bioscience (or its Affiliates) shall be responsible for [ * ].
4.4 Research Efforts. Each Party shall use Scientifically Reasonable and
Diligent Efforts to perform the respective responsibilities set forth in Section
4.2 and 4.3 and under the Research Plan; provided that Tularik shall not be
required to allocate more than [ * ] FTEs to the Research Collaboration in any
year. Except as expressly provided in Section 9.2 or as otherwise agreed from
time to time by the Parties, each of Roche Bioscience and Tularik shall bear all
of its own expenses incurred in connection with the Research Collaboration.
4.5 Abandonment. Roche Bioscience shall have the right to abandon one or
more of the Pathways if any of the following circumstances occur: [ * ];
provided however, that the occurrence of such circumstances shall not give rise
to a right to terminate the Research Collaboration or to reduce the research
support below the minimum provided in Section 9.2, provided, further, that the
Parties will use best efforts to substitute alternative inflammation targets or
pathways for further research, upon the mutual written agreement of both
Parties, to fully utilize the funding provided for in Section 9.2.
4.6 Availability of Resources. Each Party shall maintain laboratories,
offices and all other facilities reasonably necessary to carry out the Research
Collaboration. Each Party agrees to make its employees and non-employee
consultants reasonably available at their respective places of employment to
consult with the other Party on issues arising in the course of the Research
Collaboration and in connection with any request from any regulatory agency,
including, without limitation, regulatory, scientific, technical and clinical
testing issues. Representatives of Tularik and Roche Bioscience may, upon
reasonable notice and at times reasonably acceptable to the other Party (a)
visit the facilities where the Research Collaboration is being conducted; and
(b) consult informally, during such visits and by telephone and electronic mail,
with personnel of the other Party performing work on the Research Collaboration.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
10
4.7 Reports. Each Party shall make summary presentations of research
progress at each meeting of the Research Management Committee. Each Party will
also communicate informally and through the Research Management Committee to
inform the other of research done under the Research Collaboration. Each Party
will provide the other with raw data in original form or photocopies thereof for
any and all work carried out under the Research Collaboration as reasonably
requested by the other Party hereto. To avoid potential conflicts of interest,
[ * ]; provided, however, that if the parties cannot agree, [ * ]. To avoid
potential conflicts of interest, [ * ].
5. Compounds and Compound Libraries
5.1 Research Compound Library.
5.1.1 During the Research Term. During the Research Term, (a) each
Party may use Research Compounds in models compatible with their respective
Indications within the Field; (b) all data generated on Research Compounds as
part of the Research Collaboration shall be made available to each Party; and
(c) Roche Bioscience and Tularik shall each provide samples of the Research
Compounds it has synthesized (e.g. aliquots of Research Compounds) to the other
Party at such Party's request.
5.1.2 During and After the Research Term. During and after the
Research Term, (a) a common numbering system shall be maintained for the
Research Compounds; (b) each party may use all Research Compounds in any manner
such party deems appropriate, subject to Sections 5.2, 5.3, 6.3.2, 6.3.3, and
Article 8; (c) each Party shall, immediately prior to the filing of an IND for a
Research Compound outside the Field, disclose such filing, and the research
number of such Research Compound for which it is filed, to the other Party [ *
]; (d) the Parties shall cross-license to each other rights to the Research
Compounds in accordance with Sections 12.3, 12.4, and 12.5, as applicable.
5.2 Designation of Development Compounds. During the Research Term,
immediately prior to the [ * ] by either Party on any Research Compound or
Library Compound that is primarily directed against a Target, such Party shall
take such Research Compound or Library Compound to the Research Management
Committee for review. The Research Management Committee shall designate such
Research Compound or Library Compound as a Roche Bioscience Compound for
development by Roche Bioscience or a Tularik Compound for development by Tularik
based upon [ * ]. Neither Party may commence such studies on any Research
Compound or Library Compound that is primarily directed against a Target until
the Research Management Committee has made such designation. If, based on [ *
], a Research Compound is [ * ], the Research Management Committee shall
designate such Research Compound as [ * ].
5.3 [ * ]. Under no circumstances during the term of this Agreement and
thereafter, shall the [ * ]. If a Research Compound or Library Compound is
designated a Development Compound, or if a Party notifies the other Party that
it is [ * ] for a
[ * ] = 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 406 of the Securities Act of 1933, as amended.
11
Research Compound pursuant to Section 5.1.2 or Section 6.3.3, [ * ]. However,
during the Research Term and applicable Tail Period, the other Party shall [ *
].
5.4 Additional Indication(s). Assignment of an Additional Indication as
either a Roche Bioscience Indication or a Tularik Indication shall be negotiated
in good faith between the Parties on an as needed basis. Following such
negotiation, such Additional Indication shall become a Roche Bioscience
Indication or a Tularik Indication, as the case may be; provided, however, that
if after such negotiations, the parties cannot agree on the assignment of an
Additional Indication, [ * ].
5.5 Roche Bioscience Screening Library. The Roche Bioscience Screening
Library is not part of the Research Compound Library, but may, in Roche
Bioscience's sole discretion, be used in HTS against the Targets. Except for
the Roche Bioscience Screening License, Tularik shall have no rights to
compounds originating from the Roche Bioscience Screening Library unless a
Library Compound becomes a Development Compound under Section 5.2. Roche
Bioscience shall provide structural information on Validated Hits[ * ].
Derivatives made as a result of HTS as part of the Research Collaboration from
compounds originating from the Roche Bioscience Screening Library shall be
considered part of the Research Compound Library. The Roche Bioscience
Screening Library shall be treated as Roche Bioscience's Confidential
Information.
5.6 Tularik Screening Library. The Tularik Screening Library is not part
of the Research Compound Library, but may be used in HTS against the Targets.
Except for the Tularik Screening License, Roche Bioscience shall have no rights
to compounds originating from the Tularik Screening Library unless a Library
Compound becomes a Development Compound under Section 5.2. Tularik shall
provide structural information to Roche Bioscience on Validated Hits [ * ].
Derivatives made as a result of HTS as part of the Research Collaboration from
compounds originating from the Tularik Screening Library shall be considered
part of the Research Compound Library. The Tularik Screening Library shall be
treated as Tularik's Confidential Information.
6. Research Term
6.1 Research Term. The term of the Research Collaboration shall commence
on the Effective Date and end on the fifth anniversary of such Effective Date
unless it is terminated early in accordance with Section 6.2 or Section 15.2
(the "Research Term").
6.2 Early Termination of Research Term.
6.2.1 Third Anniversary. Roche Bioscience may terminate the Research
Collaboration effective as of the third anniversary of the Effective Date upon
four months' advance written notice if the Research Management Committee decides
that (a) the then current Research Plan does not provide opportunities for new
Products (i.e. the Pathways have been fully exploited and no opportunities
remain within the Field) or (b) Tularik has been unable to meet its obligations
as defined in the Research Plan.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
12
6.2.2 [ * ].
6.3 Impact of Expiration or Termination.
6.3.1 Survival. Upon conclusion of the Research Term or applicable
Tail Period, if any, all terms and obligations of this Agreement shall remain in
full force and effect unless a Development Compound does not exist, in which
case this Agreement shall expire in accordance with Article 15.
6.3.2 Tail Period. Notwithstanding the provisions of Section 6.3.1,
if the Research Collaboration terminates pursuant to Section 6.2.1, then for a
period of [ * ] months following the end of the Research Term or, if the
Research Collaboration continues for five (5) years, for a period of [ * ]
following the end of the Research Term (each period of time, a "Tail Period"),
each Parties' use of compounds from any Compound Library in the Field (other
than Outside Activities pursuant to Section 2.5) shall be subject to the terms
of this Section 6.3.2. Upon initiation of any [ * ] on any such compound that
is [ * ] during the applicable Tail Period, the Party developing such compound
shall notify the other Party that such studies are to commence and, if such
compound is a Research Compound, disclose the research number of such Research
Compound. Thereafter, such compound shall be treated as a Development Compound
of the notifying Party subject to all terms of this Agreement. If the Research
Term terminates early pursuant to Section 15.2, then there shall be no Tail
Period for the non-breaching Party and a [ * ] Tail Period for the breaching
Party as provided in Sections 15.3.2 and 15.3.3.
6.3.3 Post Research Term/Tail Period Notifications. At the end of
the Research Term or the applicable Tail Period, if any, both Parties are free
to use the Research Compound Library within the Field (other than the
Development Compounds) without regard to the terms of this Agreement; provided,
however, that each Party shall, immediately prior to the filing [ * ] for a
Research Compound in the Field, disclose such filing, and the research number of
such Research Compound for which it is filed, to the other Party and the other
Party shall not, in accordance with Section 5.3, develop the same Research
Compound.
6.3.4 Status Reports. Each Party shall prepare and deliver to the
other Party status reports every [ * ] following expiration of the Research
Term. Each such status report shall be a summary of progress with respect to
the Development Compounds. Status reports shall continue to be prepared and
delivered for the longer of (i) the applicable Tail Period or (ii) the period of
time that a Party is developing a Development Compound, to enable the Parties to
ensure that each Party is discharging the obligations contained in Article 8, [
* ], and to ensure that each Party is otherwise in compliance with this
Agreement.
7. First Right of Negotiation and Right of First Refusal
7.1 First Right of Negotiation. Under the terms and conditions set forth
herein, Roche Bioscience shall have a first right to negotiate with Tularik for
an exclusive license,
[ * ] = 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 406 of the Securities Act of 1933, as amended.
13
including the right to grant sublicenses, to develop, make, have made, use,
offer for sale, sell and import certain compounds or products as described in
this Section 7.1 (the "First Right of Negotiation"). Roche Bioscience shall
provide written notice to Tularik if Roche Bioscience wishes to exercise a First
Right of Negotiation and Tularik shall provide written notice to Roche
Bioscience prior to entering into any negotiation in the areas described in this
Section 7.1. During the [ * ] period following any such notice, Roche Bioscience
and Tularik shall negotiate in good faith regarding the terms and conditions of
such agreement. If Roche Bioscience and Tularik are unable to agree upon
mutually acceptable terms for any such agreement by the end of the applicable [
* ] period, Tularik shall be free to grant such rights to a Third Party. The
Right of First Negotiation shall expire upon the termination of the Research
Term or applicable Tail Period.
7.1.1 [ * ] Pathways. Roche Bioscience shall have a First Right of
Negotiation to collaborate with Tularik to discover compounds [ * ], all as
described on Schedule A.
7.1.2 [ * ] Roche Bioscience shall have the First Right of
Negotiation for [ * ].
7.2 Right of First Refusal. Under the terms and conditions set forth
herein, Tularik shall xxxxx Xxxxx Bioscience a right of first refusal for an
exclusive license, including the right to grant sublicenses, to develop, make,
have made, use, offer for sale, sell and import certain compounds or products as
described in this Section 7.2 (the "Right of First Refusal"). Tularik shall
negotiate exclusively with Roche Bioscience for [ * ] for such licenses prior to
Tularik offering such opportunity to any Third Party. If the Parties have not
reached agreement by the end of such [ * ] exclusive negotiation period, Tularik
may negotiate with Third Parties. When Tularik and such Third Party have
reached consensus on the financial terms and general scope of a proposed license
agreement, Tularik must offer Roche Bioscience the opportunity to enter into a
license agreement with Tularik on the same financial terms and general scope of
such proposed license agreement (the "Offer"). Roche Bioscience has [ * ] to
unqualifiedly accept or decline such Offer in writing. If Roche Bioscience
fails to respond within such time period, it shall be deemed to have declined
such Offer. If Roche Bioscience declines the Offer, Tularik has no further
obligation to grant such a Right of First Refusal to Roche Bioscience with
respect to the license opportunity that Roche Bioscience has declined; provided,
however, that if Tularik and any Third Party materially reduce the financial
terms that were offered to Roche Bioscience, Tularik must re-offer the new terms
to Roche Bioscience. Roche Bioscience has [ * ] to unqualifiedly accept or
decline such Offer in writing. If Roche Bioscience fails to respond within such
time period, it shall be deemed to have declined such Offer.
7.2.1 [ * ] Roche Bioscience shall have the Right of First Refusal
[ * ]. If Roche Bioscience declines its Right of First Refusal and Tularik [
* ]. This Right of First Refusal shall expire upon the expiration or
termination of this Agreement.
7.2.2 [ * ] Roche Bioscience shall have the Right of First Refusal
to collaborate with Tularik to develop [ * ]. This Right of First Refusal shall
expire upon the expiration or termination of 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 406 of the Securities Act of 1933, as amended.
14
7.2.3 [ * ] Roche Bioscience shall have the Right of First Refusal
to collaborate with Tularik to develop [ * ]. This Right of First Refusal shall
commence upon the third anniversary of the Effective Date and expire upon the
expiration or termination of the Research Term or applicable Tail Period.
8. Reversion Rights
8.1 Diligence. The Developing Party shall use Scientifically Reasonable
and Diligent Efforts to develop and commercialize Development Compounds into
Products; provided, however, that either Party may terminate development of a
Development Compound at any time for any reason and, subject to Section 8.4, the
Developing Party may elect in its sole discretion whether to market a Product in
a given country.
8.2 Pre-IND. After a compound has been designated as a Development
Compound and prior to acceptance of an IND for such Development Compound, if a
Developing Party (a) determines to discontinue development of such Development
Compound for any reason or (b) fails to [ * ] of such designation, then the
other Party shall have the right to designate such Development Compound in
writing as its own Development Compound for its own Indications and shall pay
the subsequent applicable milestone(s) (if Roche Bioscience is the other Party)
and royalties to the former Developing Party at the rates set forth in Sections
9.4 and 9.5. If such Party does not designate such Development Compound in
writing as its own Development Compound within [ * ], or if such Party does make
such written designation but subsequently determines to discontinue development
of such Development Compound for any reason, then such Development Compound
shall return to the Compound Library from which it originated (i.e., the
Research Compound Library, the Roche Bioscience Screening Library or the Tularik
Screening Library, as appropriate).
8.3 Post-IND/Pre-NDA. After acceptance of an IND for a Development
Compound but prior to NDA approval for such Development Compound, if a
Developing Party (a) determines to discontinue development of a Development
Compound for any reason or (b) fails to [ * ], then the other Party shall have
the right to designate such Development Compound in writing as its own
Development Compound for its own Indications and shall pay the subsequent
applicable milestone(s) (if Roche Bioscience is the other Party) and royalties
to the former Developing Party at the rates set forth in Sections 9.4 and 9.5.
If such Party does not designate such Development Compound in writing as its own
Development Compound within [ * ], or if such Party does make such written
designation but subsequently determines to discontinue development of such
Development Compound for any reason, then such Development Compound shall return
to the Compound Library from which it originated (i.e., the Research Compound
Library, the Roche Bioscience Screening Library or the Tularik Screening
Library, as appropriate). Any dispute as to whether or not the Developing Party
shall have [ * ] shall be resolved in accordance with Section 17.
8.4 Failure to [ * ] Following approval of an NDA for a Product
containing a Development Compound in a Major Market, if Tularik fails to [ * ],
Roche Bioscience may, at its
[ * ] = 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 406 of the Securities Act of 1933, as amended.
15
option, [ * ] and have the right to [ * ]. If Tularik licenses or sublicenses a
Development Compound or Product, this Section 8.4 shall not apply to the
licensee or sublicensee.
9. Payments
9.1 Technology Access Fee. Within ten (10) calendar days of the Effective
Date, Roche Bioscience shall pay Tularik a technology access fee equal to [ * ].
Such technology access fee shall be non-refundable and shall not be credited
against royalties payable to Tularik under this Agreement.
9.2 Research Funding. Roche Bioscience shall provide funding to support
Tularik research in the Field during the Research Term in accordance with the
Research Plan. During the Research Term, Roche Bioscience shall [ * ] for an
aggregate cost of [ * ] per year to support the Research Plan. [ * ].
9.3 Development Costs. Roche Bioscience or its Affiliates shall be
responsible for development costs of Roche Bioscience Compounds in Roche
Bioscience Indications. Tularik shall be responsible for development costs of
Tularik Compounds in Tularik Indications.
9.4 Milestones.
9.4.1 Milestones Payments. Roche Bioscience shall pay Tularik the
following amounts within thirty (30) days after each occurrence of the following
events. Each payment under this Section 9.4.1 shall be made for, and only for,
the first Roche Bioscience Compound directed against each particular Target that
achieves such milestone.
Payment Milestone
------------------------------------------------------------------------------
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
Roche Bioscience shall notify Tularik of the occurrence of each milestone for
each Roche Bioscience Compound. Such milestone payments shall be non-refundable
[ * ]. Further milestone payments shall not be paid with respect to any
particular Roche Bioscience Compound if it [ * ]. If a Roche Bioscience
Compound is developed for additional Roche Bioscience Indications, [ * ].
[ * ] = 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 406 of the Securities Act of 1933, as amended.
16
9.4.2 Additional Clinical Milestones. If Roche Bioscience develops
another Roche Bioscience Compound directed against the same Target for which all
milestones under Section 9.4.1 have previously been paid, and such new Roche
Bioscience Compound is being developed for a different Roche Bioscience
Indication than the original Roche Bioscience Compound for which Roche
Bioscience has previously paid the milestones, then Roche Bioscience shall
[ * ].
Payment Additional Clinical Milestone
--------------------------------------------------------------------------
[ * ] [ * ]
[ * ] [ * ]
9.4.3 No Milestone Payments by Tularik. Tularik shall not be
obligated to make any milestone payments to Roche Bioscience.
9.5 Royalties.
9.5.1 Reciprocal Royalties. The Developing Party shall owe the other
Party the following royalties based on the Net Sales of each Product during the
Royalty Term.
Royalty Rate Net Sales
--------------------------------------------------------------------------
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
9.5.2 Royalty Reduction. If the Developing Party is required to pay
royalties to a Third Party to avoid infringing Third Party patent rights [ * ],
then the royalties due to the other Party in any calendar quarter shall be
reduced by [ * ] percent [ * ] of the amount of such Third Party royalties in
such calendar quarter, provided that in no calendar quarter shall the other
Party receive less than the minimum royalty rates set forth in the chart below
by reason of this Section 9.5.2.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
17
Minimum Royalty Rate Net Sales
--------------------------------------------------------------
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
9.5.3 Further Reduction in Minimum Royalties. If the aggregate Third
Party royalties the Developing Party is required to pay to Third Parties to [ *
], including but not limited to Third Party royalties described in Section 9.5.2
and royalties due to the other Party under Sections 9.5.1 or 9.5.2, exceed an
aggregate of [ * ] of Net Sales of the Product in any calendar year, then the
last two minimum royalty rates set forth in Section 9.5.2 shall be further
reduced as follows. [ * ].
9.5.4 [ * ] If Tularik licenses or sublicenses a Research Compound
to a Third Party to commercialize such [ * ], then Tularik shall pay Roche
Bioscience royalties of [ * ] of the minimum royalty rates set forth in the
table in Section 9.5.2, as adjusted pursuant to Section 9.5.5, on Net Sales of
such Research Compound determined as if such product was a Product, including
the provisions of Article 10.
9.5.5 No Patent Protection. If a Product is not Covered by a Valid
Claim of a Patent and there is Substantial Competition in a country with respect
to such Product in a calendar year, each Royalty Rate, including each Minimum
Royalty Rate, shall be reduced for Net Sales in such country by [ * ].
9.6 Third Party Agreements. The Developing Party shall be responsible for
fulfilling all Third Party obligations, including but not limited to financial
obligations, arising with respect to the development and commercialization of
Development Compounds under agreements either Party has with Third Parties,
including but not limited to agreements for [ * ], subject to Sections 9.5.2 and
9.5.3; provided, however, that such Third Party agreement has been approved by
the Officers in accordance with Section 2.5.
10. Records; Audits; and Reports
10.1 Records. During the term of this Agreement and for a period of [ * ]
thereafter, the Developing Party shall keep complete and accurate records
pertaining to the sale or other disposition of Products in sufficient detail to
permit the other Party (the "Royalty Receiving Party") to confirm the accuracy
of all payments due hereunder.
10.2 Audit
[ * ] = 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 406 of the Securities Act of 1933, as amended.
18
10.2.1 Independent Audit by Developing Party's Auditors. During the
term of this Agreement and for a period of [ * ]] thereafter, the Developing
Party shall keep complete and accurate records pertaining to the sale or other
disposition of Products in sufficient detail to permit the Royalty Receiving
Party to confirm the accuracy of all payments due hereunder. Upon the request
of the Royalty Receiving Party, the Developing Party shall, at its own expense,
instruct its independent accounting firm to perform, during the Developing
Party's annual audit, such additional auditing and accounting procedures as are
necessary to enable such accounting firm to confirm to the Royalty Receiving
Party the correctness of (a) the amounts stated in any reports provided by the
Developing Party to Royalty Receiving Party and (b) to the extent specifically
and reasonably requested, in a timely manner, by an independent accounting or
audit specialty firm designated by the Royalty Receiving Party, other relevant
details pertaining to the sale of other disposition of Products and of the
royalty and other amounts payable or receivable under this Agreement, including
the relevant details of Adjusted Gross Sales and Net Sales; such additional
accounting and auditing procedures need only to be performed for countries
specifically requested by the Royalty Receiving Party.
10.2.2 Independent Audit by Royalty Receiving Party's Auditors.
Notwithstanding the foregoing, if (a) the Royalty Receiving Party believes that
an additional audit is appropriate after reviewing the information received from
the Developing Party's independent accounting firm, (b) the Developing Party
elects not to have its independent auditors prepare such an audit report for the
Royalty Receiving Party, or (c) a Royalty Receiving Party believes in good faith
that inaccuracies in the reporting have occurred, the Royalty Receiving Party
shall have the right to cause an independent, major certified public accountant
firm reasonably acceptable to the Developing Party to audit such records to
confirm the Developing Party's Net Sales for the preceding three years. Any
information obtained during such audit shall be treated as Confidential
Information of the Developing Party. Such audits may be exercised during normal
business hours once a year upon at least thirty (30) working days' prior written
notice to the Developing Party. The Royalty Receiving Party shall bear the full
cost of such audit unless such audit discloses a variance of more than [ * ]
from the amount of the Net Sales reported by the Developing Party for such
audited period. In such case, the Developing Party shall bear the full cost of
such audit. The terms of this Section 10.2 shall survive any termination or
expiration of this Agreement for a period of two years.
10.3 Payment; Reports. All royalty payments due to either Party under this
Agreement shall be paid within [ * ] of the end of each calendar quarter, unless
otherwise specifically provided herein. Each payment of royalties shall be
accompanied by a report of Net Sales in sufficient detail to permit confirmation
of the accuracy of the royalty payment made.
10.4 Exchange Rate. Royalty payments and reports for the sale of Products
shall be calculated and reported for each calendar quarter. With respect to
each quarter, for countries other than the United States, whenever for the
purpose of calculating royalties conversion from any foreign currency shall be
required, such conversion shall be made as follows:
[ * ] = 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 406 of the Securities Act of 1933, as amended.
19
10.4.1 [ * ] When calculating the Adjusted Gross Sales for Roche,
the amount of such sales in foreign currencies shall be converted into [ * ].
When calculating the royalties on Net Sales for Roche, such conversion shall be
at [ * ].
10.4.2 Tularik Exchange Rate. When calculating the Adjusted Gross
Sales for Tularik, the amount of such sales in foreign currencies shall be
converted into United States dollars for the countries concerned, using the [ *
] or such other exchange mechanism as Roche Bioscience shall approve, which
approval shall not be unreasonably withheld or delayed.
10.5 Manner and Place of Payment. All payments owed under this Agreement
shall be made by wire transfer, unless otherwise specified by the receiving
Party.
10.6 Late Payments. In the event that any payment, including royalty,
milestone and research payments, due hereunder is not made when due, the payment
shall accrue interest from the date due until the date paid at the rate of [ * ]
per month; provided that in no event shall such rate exceed the maximum legal
annual interest rate. The payment of such interest shall not limit any Party
from exercising any other rights it may have as a consequence of the lateness of
any payment.
10.7 Taxes. All turnover and other taxes levied on account of the
royalties and other payments accruing to each Party under this Agreement shall
be paid by the Party receiving such royalty or other payment for its own
account, including taxes levied on income of the Royalty Receiving Party. If
provision is made in law or regulation for withholding, such tax shall be
deducted from the royalty or other payment made by the Party making such payment
to the proper taxing authority and a receipt of payment of the tax secured and
promptly delivered to the Royalty Receiving Party. Each Party agrees to assist
the other Party in claiming exemption from such deductions or withholdings under
any double taxation or similar agreement or treaty from time to time in force.
11. Patent Rights and Infringement
11.1 Ownership and Inventorship. Any Invention that is made (a) solely by
one or more representatives of Tularik shall be owned solely by Tularik (a
"Tularik Invention"); (b) solely by one or more representatives of Roche
Bioscience shall be owned solely by Roche Bioscience (a "Roche Bioscience
Invention"); and (c) jointly by one or more representatives of Tularik and one
or more representatives of Roche Bioscience shall be owned jointly by Tularik
and Roche Bioscience (a "Joint Invention"). Determination of inventorship shall
be made in accordance with the patent laws of the United States of America. If
the parties cannot agree on inventorship, determination of inventorship shall be
made by mutually agreed upon patent counsel in accordance with the patent laws
of the United States of America.
11.2 Disclosure. As soon as an Inventing Party determines that an
Invention may have been made, it shall promptly inform the other Party in
writing and then provide a summary of the possible Invention as soon as possible
and in no event no later than the date of filing a priority patent application
for the Invention.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
20
11.3 Patent Management.
11.3.1 Filing Party. Only one Party shall be responsible for the
preparation, filing, prosecution, and maintenance (the "Patent Management") of a
Patent (the "Filing Party"), subject to the provisions of Section 11.3.2. The
Inventing Party shall be initially responsible for the Patent Management of any
Patent Covering an Invention; provided however, that when the Research
Management Committee designates the first Research Compound claimed within such
Patent as a Development Compound and the Developing Party is not the Inventing
Party, responsibility for the Patent Management of such Patent shall be
transferred to the Developing Party. With respect to Joint Patents, the
Research Management Committee shall initially allocate responsibility for Patent
Management in accordance with the relative inventive contributions of the
Parties, with Patent Management responsibility being transferred as described
above if and when a compound Covered in the Joint Patent is designated as a
Development Compound. Subject to Section 11.4, once Patent Management is
transferred as described above, Patent Management shall remain the
responsibility of the Developing Party, subject to Section 11.3.2, even if the
other Party begins to develop a related compound Covered in the Patent. If a
Party begins development of a Research Compound pursuant to Section 5.1.2 or
6.3.3 and such Party is not the Inventing Party, the Inventing Party shall
transfer responsibility for Patent Management for such Patent to the Party
developing such Research Compound; [ * ]. In the event of any disagreement
concerning any Joint Patent, the matter shall be resolved in accordance with
Section 17.2.
11.3.2 Review Procedures. The Filing Party shall provide the other
Party with drafts of any patent application directed to an Invention (the
"Application") prior to filing the Application, with a request for review within
a certain time period. The Filing Party shall endeavor to allow at least [ * ]
but a minimum of [ * ] for review and comment by the other Party. The Filing
Party shall endeavor in good faith to incorporate such comments, particularly if
the other Party is developing a compound that may be Covered in such Patent. If
the other Party fails to respond within the time period specified by the Filing
Party (which shall be at least [ * ], the Filing Party shall not be obligated to
delay the filing of such Application. In addition, the Filing Party shall
promptly provide the other Party with copies of all substantive communications
to and from the United States or any foreign patent office regarding such patent
applications and resulting patents, allowing at least [ * ] for review and
comment by the other Party prior to the due date for the response to the patent
office. Each Party shall maintain any information received from the other Party
relating to a Patent as Confidential Information of the other Party.
11.4 Reversion. If (a) a Development Compound for which an Application has
been filed is returned to the Research Compound Library and the other Party is
either developing a related compound or elects to develop such Research Compound
pursuant to Section 8.2 or 8.3, or (b) the Filing Party elects upon prior
written notice to the other Party (given at least ninety (90) days prior to any
relevant deadline) to (i) discontinue prosecution or maintenance or (ii) not to
file or conduct any further activities (including conducting any interferences,
re-examinations, reissues, or oppositions) with respect to an Application or a
Patent, then the Filing Party shall
[ * ] = 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 406 of the Securities Act of 1933, as amended.
21
offer to transfer such Application or Patent to the other Party, who may, at its
sole discretion, accept such transfer.
11.5 Patent Costs. Except for Patents Covering Research Compounds, [ * ]
shall be responsible for all Patent Costs for the Patent Rights [ * ]. All
Patent Costs for the Joint Patents shall be divided equally between the Parties,
[ * ]. The Party developing a Research Compound shall pay the Patent Costs for
Patents Covering such Research Compound; provided, however, that if both Parties
are developing compounds claimed in such Patent, then the Patent Costs shall be
divided equally between the Parties.
11.6 Non-Patentable Technology. All non-patentable information and
materials generated or developed in the course of the Research Collaboration
solely by one or more representatives of Roche Bioscience shall be owned solely
by Roche Bioscience. All non-patentable information and materials generated or
developed in the course of the Research Collaboration solely by one or more
representatives of Tularik shall be owned solely by Tularik. All non-patentable
information and materials generated or developed in the course of the Research
Collaboration by one or more representatives of both Roche Bioscience and
Tularik shall be owned jointly by Roche Bioscience and Tularik.
11.7 Foreign Patent Filings. For a given priority Application, the Filing
Party shall provide to the other Party no later than [ * ] after its filing date
in the United States, a list of countries in which it intends to perform
corresponding foreign filing. Upon written request by the other Party, the
Filing Party shall file and prosecute the Application in all other additional
countries requested by the other Party at the sole expense of the other Party
(out-of-pocket expenses only).
11.8 Cooperation of the Parties. Each Party agrees to cooperate fully in
the Patent Management of any Patent Rights under this Agreement. Such
cooperation includes, but is not limited to: (a) turning over to the Party to
whom responsibility for Patent Management has been transferred, all files,
papers and documents relating to such transferred Patent; (b) executing all
papers and instruments, or requiring its employees or agents, to execute such
papers and instruments, so as to effectuate the ownership of Patent Rights set
forth in Section 11.1 and to enable the other Party to apply for and to
prosecute Applications in any country; and (c) promptly informing the other
Party of any matters coming to such Party's attention that may affect the Patent
Management of any such Application.
11.9 Infringement by Third Parties. Each Party shall promptly notify the
other Party in writing of any alleged or threatened infringement by a Third
Party of any Tularik Patent, Roche Bioscience Patent or Joint Patent of which
they become aware and provide the other Party with all evidence in its
possession supporting said infringement. The Parties agree to cooperate in
taking commercially reasonable legal actions to protect the commercial interests
of the Parties in the Research Collaboration, Research Compounds, Development
Compounds or a Product against infringement by Third Parties. The Party having
responsibility for Patent Management shall take the lead in any such action.
If, within [ * ] following learning of the infringement by a Third Party, such
Party fails to take commercially reasonable action against the Third Party to
[ * ] = 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 406 of the Securities Act of 1933, as amended.
22
halt such alleged infringement, the other Party shall, in its sole discretion,
have the right to take such action in such country as it deems warranted in its
own name and/or in the name of the other Party; the Party maintaining such
action shall be responsible for [ * ] and shall be entitled to receive [ * ]. If
more than one Party wishes to participate in taking action to protect the
commercial interests of the Parties in the Product against infringement, then an
authorized representative of each Party shall control such action; the costs of
maintaining such action shall be [ * ], and the damages recovered from such
action for the past infringement shall be [ * ]. Each Party shall render such
reasonable assistance as the prosecuting Party may request.
11.10 Third Party Patent Rights. Each Party shall promptly notify the
other if it receives any notice that activities involving the Research
Collaboration or the development or commercialization of Development Compounds
allegedly infringe a Third Party's proprietary rights. The Parties shall consult
concerning the action(s) to be taken. The Developing Party shall have the sole
right and responsibility for addressing such alleged infringement regarding
Development Compounds, and bearing the cost thereof, subject to Sections 9.5.2
and 9.5.3.
12. Licenses and Other Commercial Rights
12.1 Tularik Background Patent Rights
12.1.1 Research License. Tularik hereby grants Roche Bioscience a
non-exclusive, worldwide license (without the right to sublicense) under Tularik
Background Patent Rights to conduct research during the Research Term and the
applicable Tail Period in accordance with the Research Plan.
12.1.2 Non-Infringement. Tularik shall not claim at any time that
[ * ]. The Parties acknowledge that [ * ].
12.2 Screening Licenses
12.2.1 Tularik Screening Library. Subject to Section 5.6, Tularik
hereby grants to Roche Bioscience a non-exclusive, royalty-bearing (in
accordance with Section 9.5) license to use the Tularik Screening Library solely
for HTS and confirmation of "hits" during the Research Term in accordance with
the Research Plan (the "Tularik Screening License").
12.2.2 Roche Bioscience Screening Library. Subject to Section 5.5,
Roche Bioscience hereby grants to Tularik a non-exclusive, royalty-bearing (in
accordance with Section 9.5) license to use those compounds in the Roche
Bioscience Screening Library to which Roche Bioscience permits Tularik access in
Roche Bioscience's sole discretion, which license is solely for HTS and
confirmation of "hits" during the Research Term in accordance with the Research
Plan (the "Roche Bioscience Screening License").
12.3 Tularik Patents. Tularik hereby grants Roche Bioscience (and its
Affiliates in accordance with Section 2.4), a sole and exclusive, worldwide,
royalty-bearing (in accordance with Section 9.5) license (with the right to
sublicense, subject to Section 2.4) under Tularik
[ * ] = 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 406 of the Securities Act of 1933, as amended.
23
Patents and under Tularik's interest in any Joint Patents (and if the Product is
from the Tularik Screening Library, any other Tularik Patent Rights claiming
such Library Compound) to develop, make, have made, use, offer to sell, sell or
import Products incorporating Roche Bioscience Compounds for the treatment of
Roche Bioscience Indications during the term of this Agreement.
12.4 Roche Bioscience Patents. Roche Bioscience hereby grants Tularik a
sole and exclusive, worldwide, royalty-bearing (in accordance with Section 9.5)
license (with the right to sublicense, subject to Section 2.4, if applicable)
under Roche Bioscience Patents and under Roche Bioscience's interest in any
Joint Patents (and if the Product is from the Roche Bioscience Screening
Library, any other Roche Bioscience Patent Rights claiming such Library
Compound) to develop, make, have made, use, offer to sell, sell or import
Products incorporating Tularik Compounds for the treatment of Tularik
Indications during the term of this Agreement.
12.5 Cross-License to Research Compounds. Each Party hereby grants to the
other Party a non-exclusive, worldwide, royalty-free license, with the right to
sublicense, under any composition of matter claims in a Tularik Patent or Roche
Bioscience Patent claiming any Research Compound, to develop, make, have made,
use, offer to sell, sell or import any Research Compound Covered by such claims,
subject to the terms of Sections 5.1.2, 5.3, and 6.3.3, except to the extent
that such Research Compounds are already licensed under Section 12.3 or Section
12.4, as applicable.
12.6 [ * ] Products.
12.6.1 [ * ] Products. Except as set forth herein, neither Party may
develop, make and commercialize a [ * ] product for a Development Compound. If a
Developing Party wishes to develop, make and commercialize a [ * ] product that
the Developing Party believes necessary to [ * ], then the Developing Party
shall contact the other Party and the Parties shall negotiate an agreement
providing compensation to the other Party on terms that are commercially
reasonable in the [ * ], as mutually agreed; provided, however, that if such
[ * ] product is being sold at or below the Developing Party's fully-allocated
cost, then such rights shall be royalty-free for so long as such products are
being sold at or below the Developing Party's fully-allocated cost.
12.6.2 Other [ * ] Products. Tularik has the exclusive right to
develop, make and commercialize diagnostic products based upon the [ * ] but,
during the term of this Agreement, Roche Bioscience has the exclusive option to
acquire any or all of such rights [ * ].
12.7 Other Technologies. Subject to the provisions of this Section 12.7
and Section 7.2, Tularik shall have the exclusive right to develop, make and
commercialize therapeutic products incorporating agents that are directed
against Targets but are not [ * ]. For the first [ * ] of the Research Term,
Roche Bioscience shall have the exclusive right to enter into an agreement with
Tularik to develop [ * ].
[ * ] = 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 406 of the Securities Act of 1933, as amended.
24
12.8 Covenant of Non-Use. Neither Party shall practice the Patent Rights
and/or non-patentable information and materials of the other Party other than as
expressly licensed under this Article 12.
13. Confidentiality
13.1 Nondisclosure. During the term of this Agreement and for a period of
[ * ] after termination hereof, neither Party shall disclose any Confidential
Information received from the other Party to any Third Party, or use any such
Confidential Information for any purpose other than accomplishing the purposes
of this Agreement, except as expressly authorized by this Agreement or as
required by any regulatory agency or by any governmental rule, regulation, law
or court order. Each Party may disclose such Confidential Information to its
Affiliates (except as otherwise provided in Section 2.4), employees, agents,
consultants, collaborators, and other representatives with a need to know such
Confidential Information for such authorized purposes. Each Party shall promptly
notify the other upon discovery of any unauthorized use or disclosure of such
Confidential Information. At such time as a Party is no longer licensed under
Article 12 to use certain Confidential Information, such Party shall return to
the other Party promptly upon request any tangible embodiment of such
Confidential Information provided by the other Party; provided, however, that
one copy shall be kept by the receiver Party's legal department for purposes of
interpreting this Agreement.
13.2 Exceptions. Confidential Information shall not include any
information which the receiving Party can prove by competent evidence:
13.2.1 is now, or hereafter becomes, through no act or failure to
act on the part of the receiving Party, generally known or available;
13.2.2 is known by the receiving Party at the time of receiving such
information, as evidenced by its records;
13.2.3 is hereafter furnished to the receiving Party by a Third
Party, as a matter of right and without restriction on disclosure;
13.2.4 is independently developed by the receiving Party without the
aid, application or use of Confidential Information; or
13.2.5 is the subject of a written permission to disclose provided
by the disclosing Party.
13.3 Publications. Each Party to this Agreement recognizes that the
publication of papers regarding results of the Research Collaboration, including
oral presentations and abstracts, may be beneficial to both Parties provided
such publications are subject to reasonable controls to protect Confidential
Information. In particular, it is the intent of the Parties to maintain the
confidentiality of any Confidential Information regarding results of the HTS or
other information regarding the Research Compounds included in any foreign
patent application
[ * ] = 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 406 of the Securities Act of 1933, as amended.
25
until such foreign patent application has been published. Accordingly, each
Party shall have the right to review and approve any paper proposed for
publication by the other Party regarding results of the Research Collaboration
hereunder, including oral presentations and abstracts, which utilizes data
generated from the Research Collaboration and/or includes Confidential
Information of the other Party. Before any such paper is submitted for
publication, the Party proposing publication shall deliver a complete copy to
the other Party at least [ * ] prior to submitting the paper to a publisher. The
receiving Party shall review any such paper and give its comments to the
publishing Party within [ * ] of the delivery of such paper to the receiving
Party. With respect to oral presentation materials, the Parties shall make
reasonable efforts to expedite review of such materials, and shall return such
items as soon as practicable to the disclosing Party with appropriate comments,
if any, but in no event later than [ * ] from the date of delivery to the
receiving Party. The disclosing Party shall comply with the other Party's
request to delete references to such other Party's Confidential Information in
any such paper and agrees to withhold publication of same for an additional
[ * ] in order to permit the Parties to obtain patent protection, if either of
the Parties deem it necessary, in accordance with the terms of this Agreement.
If there is a dispute regarding publications, such dispute shall be resolved by
the Research Management Committee or if the Research Management Committee has
been dissolved, by the Officers in accordance with Section 17.2.
14. Representations, Warranties and Covenants
14.1 Corporate Power. Each Party hereby represents and warrants that such
Party is duly organized and validly existing under the laws of the state of its
incorporation and has full corporate power and authority to enter into this
Agreement and to carry out the provisions hereof.
14.2 Due Authorization. Each Party hereby represents and warrants that
such Party is duly authorized to execute and deliver this Agreement and to
perform its obligations hereunder.
14.3 Binding Agreement. Each Party hereby represents and warrants that
this Agreement is a legal and valid obligation binding upon it and is
enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by such Party does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a Party
or by which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it.
14.4 Disclaimer of Warranties. Neither Party guarantees the safety or
usefulness of any Target, Research Compound or Product. EXCEPT AS EXPRESSLY SET
FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO
THE OTHER PARTY OF ANY NATURE, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION
ANY WARRANTY OF NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
14.5 Mutual Indemnification. Each Party hereby agrees to save, defend and
hold the other Party and its officers, directors, employees, consultants and
agents harmless from and against any and all liabilities, expenses and losses,
including reasonable legal expense 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 406 of the Securities Act of 1933, as amended.
26
attorneys' fees ("Losses") incurred as a result of Third Party suits, claims,
actions, or demands of personal injury or death resulting from the manufacture,
development, use, handling, storage, sale or other disposition of Products by
such Party, its Affiliates or sublicensees except to the extent such Losses
result from the [ * ] of the Party claiming a right of indemnification under
this Section 14.5. In the event either Party seeks indemnification under this
Section 14.5, it shall inform the other Party of a claim as soon as reasonably
practicable after it receives notice of the claim, shall permit the other Party
to assume direction and control of the defense of the claim (including the right
to settle the claim solely for monetary consideration), and shall cooperate as
requested (at the expense of the other Party) in the defense of the claim.
15. Term and Termination
15.1 Term. The term of this Agreement shall begin on the Effective Date
and terminate at (a) the end of the Research Term (or the applicable Tail
Period, if any), if no Development Compound exists at the end of the Research
Term (or the applicable Tail Period, if any), or (b) so long as there is at
least one Development Compound being developed or commercialized hereunder, at
the end of the Royalty Term for the last Development Compound in the country
with the last to expire royalty obligation, unless terminated earlier in
accordance with the provisions of Section 15.2.
15.2 Termination for Cause. Either Party may terminate this Agreement
upon [ * ] written notice upon the occurrence of any of the following:
15.2.1 Upon or after the bankruptcy, dissolution or winding up of
the other Party (other than dissolution or winding up for the purposes of
reconstruction or amalgamation); or
15.2.2 Upon or after the material breach of this Agreement by the
other Party if the breaching Party has not cured such breach within the [ * ]
following written notice of such termination by the other Party.
15.3 Effect of Expiration or Termination.
15.3.1 Expiration or termination of this Agreement shall not relieve
the Parties of any obligation accruing prior to such expiration or termination.
Except as otherwise specifically set forth in this Section 15 or elsewhere in
this Agreement, the obligations and rights of the Parties under Sections 2.3,
2.5.5 (but only the mutual indemnification provisions contained therein), 5.1.2,
5.3, 6.3.3, 6.3.4, 9.4, 9.5, 12.1.2, 12.5, 12.6, 12.7, 12.8, 14.4, 14.5, and
15.3, and Articles 10, 11,13,16, and 17, shall survive termination or expiration
of this Agreement.
15.3.2 Without limiting any remedies otherwise available to Roche
Bioscience, if Roche Bioscience terminates this Agreement for cause pursuant to
Section 15.2 (a) the license set forth in Section 12.3 shall continue for so
long as Roche Bioscience continues to pay to Tularik the milestone payments and
royalty payments as due in accordance with Sections 9.4 and 9.5; (b) if the
Agreement terminates during the Research Term, the Tail Period shall apply to
Tularik (but not Roche Bioscience) for six months following such termination;
(c) the Rights of
[ * ] = 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 406 of the Securities Act of 1933, as amended.
27
First Refusal set forth in Section 7.2 shall survive; and (d) any and all claims
and payment obligations that accrued prior to the date of such termination or
expiration shall survive such termination.
15.3.3 Without limiting any remedies otherwise available to Tularik,
if Tularik terminates this Agreement for cause pursuant to Section 15.2, (a) the
license set forth in Section 12.4 shall continue for so long as Tularik
continues to pay to Roche Bioscience the royalty payments as due in accordance
with Section 9.5; (b) if the Agreement terminates during the Research Term, the
Tail Period shall apply to Roche Bioscience (but not Tularik) for six months
following such termination; and (c) any and all claims and payment obligations
that accrued prior to the date of such termination or expiration shall survive
such termination.
16. Publicity
16.1 Publicity Review. Roche Bioscience and Tularik shall jointly discuss
and agree, based on the principles of Section 16.2, on any statement to the
public regarding the execution and the subject matter of this Agreement or any
other aspect of this Agreement, except with respect to disclosures required by
law or regulation. Within fifteen (15) days following the Effective Date, the
Parties shall issue a joint press release. Except with respect to information
disclosed in the joint press release, neither Party shall (a) disclose the
material terms of this Agreement, or (b) use the name of the other Party, in any
public statement, prospectus, annual report, or press release without the prior
written approval of the other Party, which may not be unreasonably withheld or
delayed, provided, however, that both parties shall endeavor in good faith to
give the other Party a minimum of five business days to review such press
release, prospectus, annual report, or other public statement; provided,
further, that either Party may (a) disclose the material terms of this Agreement
or (b) use the name of the other party in any public statement, prospectus,
annual report, or press release without the prior written approval of the other
Party, if such Party is advised by counsel that such disclosure is required to
comply with applicable law.
16.2 Standards. In the discussion and agreement referred to in Section
16.1, the principles observed by Roche Bioscience and Tularik will be accuracy,
the requirements for confidentiality under Section 13, [ * ], the requirements
of disclosure under any securities laws or regulations of the United States,
including those associated with public offerings, and the standards and customs
in the pharmaceutical industry for such disclosures by companies comparable to
Roche Bioscience and Tularik.
17. Dispute Resolution
17.1 Disputes. The Parties recognize that disputes as to certain matters
may from time to time arise during the term of this Agreement which relate to
either Party's rights and/or obligations hereunder or thereunder. It is the
objective of the Parties to establish procedures to facilitate the resolution of
disputes arising under this Agreement in an expedient manner by mutual
cooperation and without resort to litigation. To accomplish this objective, 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 406 of the Securities Act of 1933, as amended.
28
agree to follow the procedures set forth in this Section 17 if and when a
dispute arises under this Agreement between the Parties.
17.2 Dispute Resolution Procedures. If the Parties cannot resolve the
dispute within [ * ] of formal request by either Party to the other, any Party
may, by written notice to the other, have such dispute referred to their
respective officers designated below or their successors, for attempted
resolution by good faith negotiations within [ * ] after such notice is
received. Said designated officers are as follows:
For Roche Bioscience: [ * ]
For Tularik: [ * ]
17.3 Arbitration. Any such dispute arising out of or relating to this
Agreement which is not resolved between the Parties or the designated officers
of the Parties pursuant to the foregoing shall be resolved by final and binding
arbitration conducted in Palo Alto, California under the then current Commercial
Arbitration Rules of the American Arbitration Association ("AAA") at the request
of either Party; provided, however, that depositions shall be permitted as
follows: each Party may take no more than three depositions with a maximum of
six hours of examination time per deposition, and each such deposition shall
take place in Palo Alto, California, unless otherwise agreed by the Parties. The
arbitration shall be conducted by one arbitrator who is knowledgeable in the
subject matter which is at issue in the dispute and who is selected by mutual
agreement of the Parties or, failing such agreement, shall be selected according
to the AAA rules. In conducting the arbitration, the arbitrator shall apply the
California Evidence Code, and shall be able to decree any and all relief of an
equitable nature, including but not limited to such relief as a temporary
restraining order, a preliminary injunction, a permanent injunction, or replevin
of property. The arbitrator shall also be able to award actual or general
damages, but shall not award any other form of damage (e.g., consequential,
punitive damages). The Parties shall [ * ] the arbitrator's fees and expenses
pending the resolution of the arbitration unless the arbitrator, pursuant to its
right but not its obligations, requires the non-prevailing Party to [ * ] the
costs of the prevailing Party. The decision of the arbitrator shall be final and
may be sued on or enforced by the Party in whose favor it runs in any court of
competent jurisdiction at the option of such Party. This Agreement shall be
governed by the laws of the State of California, as such laws are applied to
contracts entered into and to be performed within such state.
18. Assignment and Delegation
18.1 Third Parties. Neither Party may assign or delegate any or all of
its rights or obligations under this Agreement to any Third Party without the
prior written permission of the other Party, except pursuant to Section 18.3.
18.2 Affiliates. Neither Party may assign or delegate any or all of its
rights or obligations under Sections 12.1 and 12.2, or Articles 2, 3, 4, 5
(except for Section 5.1.2), 6, and 13 without the prior written consent of the
other Party which may not be unreasonably withheld
[ * ] = 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 406 of the Securities Act of 1933, as amended.
29
or delayed. Except as set forth in the previous sentence, either Party may
assign or delegate any or all of its rights or obligations under this Agreement
to any Affiliate; [ * ].
18.3 Merger. Either Party may also assign all of its rights or
obligations under this Agreement (but not a portion thereof) in connection with
the sale of all or substantially all of its assets relating to the subject
matter hereof, or may otherwise assign all of its rights or obligations under
this Agreement (but not a portion thereof) with the prior written consent of the
other Party. This Agreement shall survive any merger of either Party with or
into another Party and no consent for a merger or similar reorganization shall
be required hereunder; provided, that in the event of such merger or in the
event of a sale of all assets, no intellectual property rights of the acquiring
corporation shall be included in the technology licensed hereunder.
18.4 Miscellaneous. This Agreement shall be binding upon and inure to the
benefit of the successors and permitted assigns of the Parties; provided,
however, that any such permitted assignment or delegation shall not relieve the
assigning Party of its responsibilities for performance of its obligations under
this Agreement. Any assignment not in accordance with this Agreement shall be
void.
19. Additional Terms
19.1 Force Majeure. Neither Party shall lose any rights hereunder or be
liable to the other Party for damages or losses on account of failure of
performance by the defaulting Party if the failure is occasioned by government
action, war, fire, explosion, flood, strike, lockout, embargo, act of God, or
any other similar cause beyond the control of the defaulting Party, provided
that the Party claiming force majeure has exerted all reasonable efforts to
avoid or remedy such force majeure.
19.2 Notices. Any notices or communications provided for in this
Agreement to be made by either of the Parties to the other shall be in writing,
in English, and shall be made by prepaid air mail with return receipt addressed
to the other at its address set forth below. Any such notice or communication
may also be given by hand, or facsimile to the appropriate designation. Either
Party may by like notice specify an address to which notices and communications
shall thereafter be sent. Notices sent by mail, facsimile or cable shall be
effective upon receipt and notices given by hand shall be effective when
delivered.
If to Tularik:
Tularik Inc.
Xxx Xxxxxxxxx Xxxxx
Xxxxx Xxx Xxxxxxxxx, XX 00000
Fax: (000) 000-0000
Attention: President
If to Roche Bioscience
[ * ] = 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 406 of the Securities Act of 1933, as amended.
30
Roche Bioscience
0000 Xxxxxxxx Xxxxxx
Xxxx Xxxx, XX 00000
Fax: (000) 000-0000
Attention: President
with a copy to
Roche Bioscience
0000 Xxxxxxxx Xxxxxx
Xxxx Xxxx, XX 00000
Fax: (000) 000-0000
Attention: Legal Affairs
19.3 Waiver. Except as specifically provided for herein, the waiver from
time to time by either of the Parties of any of their rights or their failure to
exercise any remedy shall not operate or be construed as a continuing waiver of
same or of any other of such Party's rights or remedies provided in this
Agreement.
19.4 Severability. If any term, covenant or condition of this Agreement
or the application thereof to any Party or circumstance shall, to any extent, be
held to be invalid or unenforceable, then (a) the remainder of this Agreement,
or the application of such term, covenant or condition to Parties or
circumstances other than those as to which it is held invalid or unenforceable,
shall not be affected thereby and each term, covenant or condition of this
Agreement shall be valid and be enforced to the fullest extent permitted by law;
and (b) the Parties hereto covenant and agree to renegotiate any such term,
covenant or application thereof in good faith in order to provide a reasonably
acceptable alternative to the term, covenant or condition of this Agreement or
the application thereof that is invalid or unenforceable, it being the intent of
the Parties that the basic purposes of this Agreement are to be effectuated.
19.5 Independent Contractors. It is expressly agreed that Tularik and
Roche Bioscience shall be independent contractors and that the relationship
between the two Parties shall not constitute a partnership or agency of any
kind. Neither Tularik nor Roche Bioscience shall have the authority to make any
statements, representations or commitments of any kind, or to take any action,
which shall be binding on the other, without the prior written authorization of
such other Party to do so.
19.6 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
19.7 Entire Agreement. This Agreement sets forth all of the covenants,
promises, agreements, warranties, representations, conditions and understandings
between the Parties hereto and supersedes and terminates all prior agreements
and understanding between the Parties, including the Confidentiality Agreement
dated December 18, 1996. Information disclosed under
[ * ] = 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 406 of the Securities Act of 1933, as amended.
31
the Confidentiality Agreement shall be treated as "Confidential Information" of
the disclosing Party subject to this Agreement. There are no covenants,
promises, agreements, warranties, representations conditions or understandings,
either oral or written, between the Parties other than as set forth herein and
therein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties hereto unless reduced to writing and
signed by the respective authorized officers of the Parties.
In Witness Whereof, the Parties have executed this Agreement in duplicate
originals by their proper officers as of the date and year first above written.
Syntex (U.S.A.) Inc., Tularik Inc.
through its Roche Bioscience division
By: /s/ Xxxxx X. Xxxxx By: /s/ Xxxxx X. Xxxxxxx
------------------------- -----------------------------
Xxxxx X. Xxxxx, M.D., Ph.D. Xxxxx X. Xxxxxxx, Ph.D.
President President and Chief Executive Officer
Syntex (U.S.A.) Inc. Tularik Inc.
[ * ] = 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 406 of the Securities Act of 1933, as amended.
32
Schedule A
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ]
[ * ] = 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 406 of the Securities Act of 1933, as amended.
Schedule B
TULARIK BACKGROUND PATENT RIGHTS AND EXISTING THIRD PARTY
AGREEMENTS
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ] = 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 406 of the Securities Act of 1933, as amended.
Research Collaboration and License Agreement
between
Roche Bioscience
and
Tularik Inc.
July 8, 1997
[ * ] = 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 406 of the Securities Act of 1933, as amended.
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TABLE OF CONTENTS
1. Definitions.............................................. 1
2. Research Collaboration................................... 7
2.1 Scope of Research Collaboration.......................... 7
2.2 New Targets.............................................. 8
2.3 [ * ].................................................... 8
2.4 [ * ].................................................... 8
2.5 Exclusivity/Third Party Agreements....................... 9
2.5.1 Exclusivity.............................................. 9
2.5.2 Activities Relating to the Field......................... 9
2.5.3 Joint Decision-Making Process............................ 9
2.5.4 Re-Presentation to Officers.............................. 10
2.5.5 Outside Activities....................................... 10
3. Research Management Committee............................ 10
3.1 Formation of Research Management Committee............... 10
3.2 Meetings of Research Management Committee................ 11
3.3 Decision-Making Process.................................. 11
4. Conduct of Research...................................... 11
4.1 Research Plan............................................ 11
4.2 Tularik Responsibilities................................. 11
4.3 Roche Bioscience Responsibilities........................ 12
4.4 Research Efforts......................................... 12
4.5 Abandonment.............................................. 12
4.6 Availability of Resources................................ 13
4.7 Reports.................................................. 13
5. Compounds and Compound Libraries......................... 13
5.1 Research Compound Library................................ 13
5.1.1 During the Research Term................................. 13
5.1.2 During and After the Research Term....................... 13
5.2 Designation of Development Compounds..................... 14
[ * ] = 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 406 of the Securities Act of 1933, as amended.
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5.3 [ * ].................................................... 14
5.4 Additional Indication(s)................................. 14
5.5 Roche Bioscience Screening Library....................... 15
5.6 Tularik Screening Library................................ 15
6. Research Term............................................ 15
6.1 Research Term............................................ 15
6.2 Early Termination of Research Term....................... 15
6.2.1 Third Anniversary........................................ 15
6.2.2 [ * ].................................................... 15
6.3 Impact of Expiration or Termination...................... 16
6.3.1 Survival................................................. 16
6.3.2 Tail Period.............................................. 16
6.3.3 Post Research Term/Tail Period Notifications............. 16
6.3.4 Status Reports........................................... 16
7. First Right of Negotiation and Right of First Refusal.... 17
7.1 First Right of Negotiation............................... 17
7.1.1 [ * ].................................................... 17
7.1.2 [ * ].................................................... 17
7.2 Right of First Refusal................................... 17
7.2.1 [ * ].................................................... 18
7.2.2 [ * ].................................................... 18
7.2.3 [ * ].................................................... 18
8. Reversion Rights......................................... 18
8.1 Diligence................................................ 18
8.2 Pre-IND.................................................. 18
8.3 Post-IND/Pre-NDA......................................... 19
8.4 Failure to [ * ]......................................... 19
9. Payments................................................. 19
9.1 Technology Access Fee.................................... 19
9.2 Research Funding......................................... 19
9.3 Development Costs........................................ 20
[ * ] = 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 406 of the Securities Act of 1933, as amended.
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9.4 Milestones............................................... 20
9.4.1 Milestones Payments...................................... 20
9.4.2 Additional Clinical Milestones........................... 21
9.4.3 No Milestone Payments by Tularik......................... 21
9.5 Royalties................................................ 21
9.5.1 Reciprocal Royalties..................................... 21
9.5.2 Royalty Reduction........................................ 22
9.5.3 Further Reduction in Minimum Royalties................... 22
9.5.4 [ * ].................................................... 22
9.5.5 No Patent Protection..................................... 22
9.6 Third Party Agreements................................... 23
10. Records; Audits; and Reports............................. 23
10.1 Records.................................................. 23
10.2 Audit.................................................... 23
10.2.1 Independent Audit by Developing Party's Auditors......... 23
10.2.2 Independent Audit by Royalty Receiving Party's Auditors.. 23
10.3 Payment; Reports......................................... 24
10.4 Exchange Rate............................................ 24
10.4.1 [ * ].................................................... 24
10.4.2 Tularik Exchange Rate.................................... 24
10.5 Manner and Place of Payment.............................. 24
10.6 Late Payments............................................ 24
10.7 Taxes.................................................... 24
11. Patent Rights and Infringement........................... 25
11.1 Ownership and Inventorship............................... 25
11.2 Disclosure............................................... 25
11.3 Patent Management........................................ 25
11.3.1 Filing Party............................................. 25
11.3.2 Review Procedures........................................ 26
11.4 Reversion................................................ 26
11.5 Patent Costs............................................. 26
[ * ] = 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 406 of the Securities Act of 1933, as amended.
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11.6 Non-Patentable Technology................................ 26
11.7 Foreign Patent Filings................................... 27
11.8 Cooperation of the Parties............................... 27
11.9 Infringement by Third Parties............................ 27
11.10 Third Party Patent Rights................................ 27
12. Licenses and Other Commercial Rights..................... 28
12.1 Tularik Background Patent Rights......................... 28
12.1.1 Research License......................................... 28
12.1.2 Non-Infringement......................................... 28
12.2 Screening Licenses....................................... 28
12.2.1 Tularik Screening Library................................ 28
12.2.2 Roche Bioscience Screening Library....................... 28
12.3 Tularik Patents.......................................... 28
12.4 Roche Bioscience Patents................................. 29
12.5 Cross-License to Research Compounds...................... 29
12.6 [ * ] Products........................................... 29
12.6.1 [ * ] Products........................................... 29
12.6.2 Other [ * ] Products..................................... 29
12.7 Other Technologies....................................... 29
12.8 Covenant of Non-Use...................................... 30
13. Confidentiality.......................................... 30
13.1 Nondisclosure............................................ 30
13.2 Exceptions............................................... 30
13.3 Publications............................................. 31
14. Representations, Warranties and Covenants................ 31
14.1 Corporate Power.......................................... 31
14.2 Due Authorization........................................ 31
14.3 Binding Agreement........................................ 31
14.4 Disclaimer of Warranties................................. 31
14.5 Mutual Indemnification................................... 32
15. Term and Termination..................................... 32
[ * ] = 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 406 of the Securities Act of 1933, as amended.
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15.1 Term..................................................... 32
15.2 Termination for Cause.................................... 32
15.3 Effect of Expiration or Termination...................... 32
16. Publicity................................................ 33
16.1 Publicity Review......................................... 33
16.2 Standards................................................ 33
17. Dispute Resolution....................................... 34
17.1 Disputes................................................. 34
17.2 Dispute Resolution Procedures............................ 34
17.3 Arbitration.............................................. 34
18. Assignment and Delegation................................ 35
18.1 Third Parties............................................ 35
18.2 Affiliates............................................... 35
18.3 Merger................................................... 35
18.4 Miscellaneous............................................ 35
19. Additional Terms......................................... 35
19.1 Force Majeure............................................ 35
19.2 Notices.................................................. 35
19.3 Waiver................................................... 36
19.4 Severability............................................. 36
19.5 Independent Contractors.................................. 37
19.6 Counterparts............................................. 37
19.7 Entire Agreement......................................... 37
Schedule A....................................................... 39
Schedule B....................................................... 40
[ * ] = 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 406 of the Securities Act of 1933, as amended.
v
