1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
Exhibit 10.89
AXYS PHARMACEUTICALS, INC.
AND
ROCHE BIOSCIENCE
-------------------------------------------------------------
COLLABORATION AGREEMENT
------------------------------------------------------------
JUNE 1, 1998
2
TABLE OF CONTENTS
PAGE
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1. DEFINITIONS..........................................................................1
2. MANAGEMENT AND SCOPE OF COLLABORATION................................................8
2.1 Undertaking and Scope.........................................................8
2.2 Limited Use...................................................................8
2.3 Formation of JRPC.............................................................9
2.4 Meetings of JRPC..............................................................9
2.5 JRPC Decision-Making Process..................................................9
2.6 Collaboration Term Extension..................................................9
3. COLLABORATIVE ACTIVITIES............................................................10
3.1 Mutual Responsibilities; Cooperation.........................................10
3.2 Conduct of Research..........................................................10
3.3 Availability of Resources....................................................10
3.4 Transfer of Materials........................................................10
3.5 Disclosure; Reports..........................................................10
3.6 Identification of NemaPharm Targets..........................................11
3.7 Screening of Compounds; Discontinuation of Development.......................11
3.8 Axys Development of Gene Therapy Products and Protein Products...............11
3.9 Facility Visits..............................................................12
4. GRANT OF LICENSES...................................................................12
4.1 Research Licenses............................................................12
4.2 Licenses To Roche Bioscience in the Commercialization Field..................12
4.3 License to Roche Bioscience Outside the Commercialization Field..............14
4.4 Licenses To Axys.............................................................15
4.5 Sublicenses..................................................................16
4.6 Diligence Obligations of Roche Bioscience Related to NemaPharm Targets.......16
4.7 Diligence Obligations of Roche Bioscience With Respect to Development
and Promotion of Roche Bioscience Products...................................17
5. PAYMENT OBLIGATIONS.................................................................18
5.1 Upfront Payment..............................................................18
5.2 Research Funding.............................................................18
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TABLE OF CONTENTS
(CONTINUED)
PAGE
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5.3 Term Extension...............................................................18
5.4 Milestone Payments...........................................................18
5.5 [*]..........................................................................20
5.6 Royalty Payments ............................................................21
5.7 Third Party Royalties........................................................21
6. PAYMENTS; RECORDS; AUDITS...........................................................21
6.1 Payment; Reports.............................................................21
6.2 Exchange Rate; Manner and Place of Payment...................................22
6.3 Late Payments................................................................22
6.4 Records and Audits...........................................................23
6.5 Taxes........................................................................24
6.6 Prohibited Payments..........................................................24
7. PATENT RIGHTS AND INFRINGEMENT......................................................24
7.1 Ownership of Patent Rights...................................................24
7.2 Confidentiality Obligations..................................................24
7.3 Prosecution and Maintenance of Patent Rights.................................24
7.4 Cooperation of the Parties...................................................25
7.5 Infringement by Third Parties................................................26
7.6 Infringement of Third Party Rights...........................................27
8. INDEPENDENT CONTRACTOR..............................................................27
9. CONFIDENTIALITY.....................................................................27
9.1 Nondisclosure................................................................27
9.2 Exceptions...................................................................28
9.3 Publications.................................................................28
10. REPRESENTATIONS, WARRANTIES AND COVENANTS...........................................28
10.1 Corporate Power..............................................................29
10.2 Due Authorization............................................................29
10.3 Binding Agreement............................................................29
10.4 Disclaimer of Warranties.....................................................29
10.5 Mutual Indemnification.......................................................29
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
ii.
4
TABLE OF CONTENTS
(CONTINUED)
PAGE
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11. TERM AND TERMINATION................................................................29
11.1 Term.........................................................................30
11.2 Termination for Cause........................................................30
11.3 Effect of Expiration or Termination..........................................30
12. PUBLICITY...........................................................................31
12.1 Publicity Review.............................................................31
12.2 Standards....................................................................31
13. DISPUTE RESOLUTION..................................................................31
13.1 Disputes.....................................................................31
13.2 Procedure....................................................................31
14. MISCELLANEOUS.......................................................................32
14.1 Assignment...................................................................32
14.2 Force Majeure................................................................33
14.3 Payment in U.S. Dollars......................................................33
14.4 Notices......................................................................33
14.5 Governing Law................................................................34
14.6 Waiver.......................................................................34
14.7 Severability.................................................................34
14.8 Entire Agreement.............................................................34
14.9 Counterparts.................................................................35
iii.
5
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (the "Agreement") is made as of June 1,
1998 (the "Effective Date") by and among AXYS PHARMACEUTICALS, INC., a Delaware
corporation with its principal office at 180 Kimball Way, South San Francisco,
California 94080 and its subsidiaries, NemaPharm, Inc. and Sequana Therapeutics,
Inc., ("Axys"), and ROCHE Bioscience, a division of Syntex (U.S.A.) Inc., a
Delaware corporation with its principal office at 3401 Hillview Avenue, Palo
Alto, California, 94304 ("Roche Bioscience") and, for purposes only of Sections
4.1.2, 4.4 and 4.7.2 , both of F. Hoffmann-La Roche, Ltd., a Swiss corporation
located in Basel, Switzerland ("FHLR") and Hoffmann-La Roche Inc., a New Jersey
corporation located in Nutley, New Jersey ("HLR").
RECITALS
WHEREAS, the Parties desire to collaborate to perform functional
analysis of rat or human ESTs provided by Roche Bioscience using their
respective bioinformatics and genomics capabilities;
WHEREAS, the goal of the collaboration is to identify therapeutic,
prophylactic and diagnostic products through such analysis for applications in
Pain, Peripheral Arterial Occlusive Disease and Lower Urinary Tract Disorders as
hereinafter defined in Article 1; and
WHEREAS, the Parties desire to provide for the allocation of rights to
intellectual property, products and services for the prevention, treatment and
diagnosis of Pain, Peripheral Arterial Occlusive Disease and Lower Urinary Tract
Disorders resulting from the collaboration on the terms and subject to the
conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing recitals and the
mutual covenants and agreements contained herein, the Parties hereto, intending
to be legally bound, do hereby agree as follows:
AGREEMENT
1. DEFINITIONS
1.1 "AFFILIATE" means any person, organization or entity that is, directly
or indirectly, controlling, controlled by, or under common control with Roche
Bioscience or Axys as the case may be. The term "Control" as used in this
section 1.1 (including, with correlative meaning, the terms "controlled by" and
"under common control with"), as used with respect to any person or entity,
means the possession, directly or indirectly, of the power to direct, or cause
the direction of, the management and policies of such person, an organization or
entity, whether through the ownership of
6
voting securities, or by contract or court order or otherwise. The ownership of
voting securities of a person, organization or entity shall not, in and of
itself, constitute "control" for purposes of this definition, unless said
ownership is of a majority of the outstanding securities entitled to vote of
such a person, organization or entity. For purposes of this Agreement,
Genentech, Inc. shall not be considered to be an Affiliate of Roche Bioscience
unless an authorized officer of Roche Bioscience notifies Axys in writing that
Genentech, Inc. is an Affiliate of Roche Bioscience. Axys Pharmaceuticals, Inc.
shall determine which of its subsidiaries shall be responsible for performing
individual obligations required, or receiving individual benefits or rights, of
Axys pursuant to this Agreement.
1.2 "ANTISENSE PRODUCT" shall mean any product for the prevention, treatment
or diagnosis of any disease or disorder, that contains an antisense product
which consists of any complete, partial, altered or mutated RNA or DNA sequence
complementary to or derived from an RNA or DNA sequence of one or more NemaPharm
Target(s) licensed to Roche Bioscience pursuant to Section 4.2.1(a) or any human
or other animal homolog of that NemaPharm Target(s).
1.3 "AXYS KNOW-HOW" means the Know-How owned or Controlled by Axys, relating
to Axys' activities under the Research Plan necessary or useful to conduct the
Collaboration or to develop, manufacture, commercialize, distribute, import,
export and sell Roche Bioscience Products.
1.4 "AXYS PATENT RIGHTS" means the Patent Rights owned or Controlled by
Axys, relating to Axys' activities under the Research Plan necessary or useful
to conduct the Collaboration or to develop, manufacture, commercialize,
distribute, import, export and sell Roche Bioscience Products, but excluding
Joint Patent Rights.
1.5 "AXYS PRODUCT" means a Gene Therapy Product, a Protein Product or any
other product for the prevention, treatment or diagnosis of any disease or
disorder, which, in each case, is discovered or developed using a NemaPharm
Target; provided, however, that the term "Axys Product" shall not include any
Small Molecule Product, Antisense Product or Diagnostic Product.
1.6 "AXYS TECHNOLOGY" means the Axys Patent Rights and the Axys Know-How.
1.7 "CDNA" means a DNA copy of an mRNA, including, without limitation, all
cDNA clones and cDNA templates derived from a given gene transcript and its
corresponding coding sequence, including the full length sequence.
1.8 "COLLABORATION" means the activities of the Parties carried out in
performance of, and the relationship between the Parties established by, this
Agreement.
2.
7
1.9 "COLLABORATION TERM" means the period commencing on the Effective Date
and ending on the first to occur of (i) termination of this Agreement according
to Article 11 or (ii) the date that is fifteen (15) months following the
Effective Date, or twenty-four (24) months following the Effective Date if
extended pursuant to Section 2.6.
1.10 "COMBINATION PRODUCT" means a Product containing or using both a
NemaPharm Target and one or more ingredients that are diagnostically useable or
therapeutically active alone or in a combination.
1.11 "COMMERCIALLY REASONABLE EFFORTS" means efforts ordinarily undertaken
by the applicable Party on products of similar scientific and commercial
potential within the relevant product lines of the Parties.
1.12 "COMMERCIALIZATION FIELD" means the development or commercialization of
products or services for the prevention, treatment or diagnosis of Pain,
Peripheral Arterial Occlusive Disease or Lower Urinary Tract Disorders.
1.13 "CONFIDENTIAL INFORMATION" means all information and materials received
by a Party from another Party pursuant to this Agreement and all information and
materials developed in the course of the Collaboration, including, without
limitation, Know-How of such other Party.
1.14 "CONTROL" means possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of any agreement
with or other arrangement with, or the rights of, any Third Party.
1.15 "DIAGNOSTIC PRODUCT" means any product or service or combination
thereof used for the diagnosis, prognosis and/or monitoring of progression of a
disease or disorder or that [*] that is developed utilizing, or is comprised of,
any one or more NemaPharm Target(s) licensed to Roche Bioscience pursuant to
Section 4.2.1(b) or which incorporates any complete, partial, altered or mutated
RNA or DNA sequence corresponding to or complementary to an RNA or DNA sequence
of any such NemaPharm Target(s) or any human or other animal homolog of that
NemaPharm Target(s).
1.16 "EST" or "EXPRESSED SEQUENCE TAG" means a partial or whole sequence of
an expressed gene that comprises fifty (50) or more nucleotides.
1.17 "FDA" means the United States Food and Drug Administration, or the
successor thereto.
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
3.
8
1.18 "Final Axys Report" means a report by Axys detailing all major research
findings, including summaries of relevant data, resulting from the
Collaboration.
1.19 "FIRST COMMERCIAL SALE" of a Roche Bioscience Product means the first
sale for use or consumption of such Roche Bioscience Product in a country after
Regulatory Approval and necessary pricing approval has been granted by the
governing health regulatory authority of such country. Sale to an Affiliate or
sublicensee shall not constitute a First Commercial Sale unless the Affiliate or
sublicensee is the end user of the Roche Bioscience Product.
1.20 "FTE" means [*].
1.21 "GENE PRODUCT" means all partial cDNAs, DNAs, genes, ESTs, full length
cDNAs corresponding thereto, proteins encoded therefrom and corresponding gene
expression levels.
1.22 "GENE THERAPY PRODUCT" means any product for the prevention, treatment
or diagnosis of any disease or disorder through gene therapy that consists of
any complete, partial, altered or mutated RNA or DNA sequence corresponding to
an RNA or DNA sequence of a NemaPharm Target licensed to Roche Bioscience
pursuant to Section 4.2.2 or any human or other animal homolog of that NemaPharm
Target.
1.23 "IND" means an Investigational New Drug Application to the FDA to
commence human clinical testing of a Roche Bioscience Product, as defined by the
FDA, or the equivalent application in any other country or jurisdiction.
1.24 "JOINT PATENT RIGHTS" means the Patent Rights covering any and all
inventions conceived of and reduced to practice jointly by employees or agents
of Roche Bioscience, on the one hand, and employees or agents of Axys, on the
other hand, in the course of the Collaboration.
1.25 "JRPC" means the Joint Research Project Committee established pursuant
to Section 2.3 hereof.
1.26 "KNOW-HOW" means inventions, software, techniques, practices, methods,
protocols, processes, procedures, knowledge, know-how, trade secrets, skill,
experience, data, including pharmacological, toxicological and clinical test
data, analytical and quality control data, materials, samples, chemicals,
compounds, formulations, DNA, RNA, peptides, proteins, cell lines, genes,
transgenic animals and compositions (whether or not patentable).
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
4.
9
1.27 "LOWER URINARY TRACT DISORDERS" means [*].
1.28 "MAJOR EUROPEAN COUNTRIES" means the United Kingdom, France, Germany,
Italy, and/or Spain.
1.29 "NDA" means a New Drug Application or Product License Application (or
Biologics License Application), as appropriate, and all supplements filed
pursuant to the requirements of the FDA, including all documents, data and other
information concerning Roche Bioscience Products that are necessary for or
included in FDA approval to market a Roche Bioscience Product, or the equivalent
application in any other country or jurisdiction.
1.30 "NEMAPHARM TARGET" means a Gene Product that is discovered by a Party
or jointly by the Parties in the course, or as a direct or indirect result, of
the Collaboration through the use of a Roche Bioscience Gene within [*] after
the Effective Date and that, [*] the Roche Bioscience Gene.
1.31 "NET SALES" and the related term "Adjusted Gross Sales" mean:
1.31.1 "ADJUSTED GROSS SALES" means the amount of gross sales invoiced
by Roche Bioscience or Axys or one of their Affiliates, or sublicensees as the
case may be, for a Product (including special license sales of the Product),
whether in active ingredient form or finished product form, to non-affiliated
third party purchasers, less, to the extent such amounts are included in the
amount of gross sales, deductions for [*].
1.31.2 "NET SALES" means the amount calculated by subtracting from the
amount of Adjusted Gross Sales [*] of Adjusted Gross Sales, [*].
1.32. "NOTICE OF ABANDONMENT" shall have the meaning set forth in Section
3.7.
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
5.
10
1.33 "PAIN" means[*].
1.34 "PARTY" or "Parties" means Roche Bioscience or Axys.
1.35 "PATENT RIGHTS" means (i) the patents and the patent applications owned
or Controlled by a Party that are referred to in Schedule 1.35; (ii) any and all
patents arising or resulting from said applications, and all patents and patent
applications based upon or claiming priority to any of the foregoing; (iii) any
and all extensions or other governmental actions with respect to the foregoing
that provide exclusive rights to the patent holder beyond the original patent
expiration date), (iv) any and all substitutions, confirmations, registrations,
revalidations, re-examinations, reissues, additions, continuations,
continuations-in-part, or divisions of or to any of the foregoing and (v) all
rights under foreign and domestic patents that include one or more Valid Claims,
including without limitation any substitution, extension (including supplemental
protection certificate), registration, confirmation, reissue, continuation,
divisional, continuation in part, re-examination, renewal or the like, and
domestic pending applications for patents, including without limitation, any
continuation, division or continuation in part thereof, and any provisional
applications.
1.36 "PERIPHERAL ARTERIAL OCCLUSIVE DISEASE" (PAOD) means [*].
1.37 "PHASE I" means that portion of the clinical development program that
generally provides for the first introduction into humans of a Roche Bioscience
Product with the primary purpose of determining safety, metabolism and
pharmacokinetic properties and clinical pharmacology of the Roche Bioscience
Product, as more specifically defined by the rules and regulations of the FDA
and corresponding rules and regulations in any Major European Country or Japan.
1.38 "PHASE III" means that portion of the clinical development program that
provides for the continued trials of a Roche Bioscience Product on sufficiently
large numbers of patients to confirm the safety and efficacy of a Roche
Bioscience Product for the desired claims and indications, as more specifically
defined by the rules and regulations of the FDA and corresponding rules and
regulations in Major European Countries or Japan.
1.39 "PRODUCT" means a Roche Bioscience Product or an Axys Product.
1.40 "PROTEIN PRODUCT" means any product for the prevention, treatment or
diagnosis of any disease or disorder that incorporates a protein or peptide
encoded by the complete, partial, altered or mutated RNA or DNA sequence
corresponding to an RNA or DNA sequence of one or more NemaPharm Target(s)
licensed to Roche
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
6.
11
Bioscience pursuant to Section 4.2.2 or any human or other animal homolog of
that NemaPharm Target(s).
1.41 "REGULATORY APPROVAL" means (i) approval of an NDA by the FDA
permitting commercial sale of a Product and (ii) any comparable approval
permitting commercial sale of a Product granted by applicable authorities in any
other country or jurisdiction including approval of price and reimbursement.
1.42 "RESEARCH FIELD" means research, discovery and characterization of Gene
Products associated with Pain, Peripheral Arterial Occlusive Disease and Lower
Urinary Tract Disorders through the [*].
1.43 "RESEARCH PLAN" shall have the meaning set forth in Section 2.1.
1.44 "RESULTS" means any and all inventions, discoveries, methods, ideas,
Know-How, data, software, techniques and information, including any gene, genes
and sequence information, whether or not patentable, and all Patent Rights and
other proprietary rights appurtenant thereto, that are conceived, made, created
or reduced to practice by Axys and/or its Affiliates in the course of the
Collaboration, as well as any reports relating to the conduct of the
Collaboration during the Collaboration Term.
1.45 "ROCHE BIOSCIENCE GENE" means any Gene Product owned or Controlled by
Roche Bioscience that is provided by Roche Bioscience to Axys and/or its
Affiliates for purposes of the Collaboration as set out in Exhibit 1.45 as may
be amended from time to time.
1.46 "ROCHE BIOSCIENCE KNOW-HOW" means the Know-How owned or Controlled by
Roche Bioscience or its Affiliates relative to the Roche Bioscience Genes that
is necessary or useful to conduct the Collaboration or to develop, manufacture
and commercialize Products.
1.47 "ROCHE BIOSCIENCE PATENT RIGHTS" means the process Patent Rights owned
or Controlled by Roche Bioscience or an Affiliate, covering a Roche Bioscience
Gene, that are required to conduct the Collaboration or to develop, manufacture,
commercialize, distribute, import, export and sell Products, but excluding Joint
Patent Rights.
1.48 "ROCHE BIOSCIENCE PRODUCT" means a Small Molecule Product, Antisense
Product or Diagnostic Product, or an Axys Product that Roche Bioscience has
licensed upon exercise of its right of first negotiation pursuant to Section
4.2.2.
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
7.
12
1.49 "ROCHE BIOSCIENCE TECHNOLOGY" means the Roche Bioscience Patent Rights
and the Roche Bioscience Know-How.
1.50 "ROYALTY TERM" means, in the case of any Roche Bioscience Product, in
any country, the period of time commencing on the First Commercial Sale and
ending upon the [*].
1.51 "SMALL MOLECULE PRODUCT" means any product for the prevention,
treatment or diagnosis of any disease or disorder, that contains [*] one or more
NemaPharm Target(s) licensed to Roche Bioscience pursuant to Section 4.2.1(a) or
any corresponding human or other animal homolog, and such activity is a primary
mechanism of action of such product, excluding any Antisense Product, Gene
Therapy Product, Diagnostic Product or Protein Product.
1.52 "TERRITORY" means the entire world.
1.53 "THIRD PARTY" means any entity other than Axys or Roche Bioscience or
an Affiliate of Axys or Roche Bioscience.
1.54 "VALID CLAIM" means a claim of an issued patent or pending patent
application which claim has not expired, lapsed, 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 or otherwise.
2. MANAGEMENT AND SCOPE OF COLLABORATION
2.1 UNDERTAKING AND SCOPE. The Parties hereby agree to establish and
conduct, during the Collaboration Term, a collaborative research program in
accordance with a plan (the "Research Plan") and the terms of this Agreement
with the goal of developing and commercializing Products. The initial Research
Plan for conducting such research program is attached hereto as Exhibit A.
2.2 LIMITED USE. It is understood and agreed that Axys may use any EST that
it, or a Third Party collaborating with Axys, identifies independently of Roche
Bioscience Know-How, even in each case if such ESTs are the same as, or
substantially similar to, the ESTs provided by Roche Bioscience and/or
corresponding full-length
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
8.
13
clone sequences, provided that for a period of [*] from the Effective Date Axys
will not perform research, primarily utilizing C. elegans technologies, on the
same or substantially similar ESTs as those provided by Roche Bioscience and/or
corresponding full-length clone sequences for itself or any Third Party, in the
field of Pain.
2.3 FORMATION OF JRPC. The conduct of the Collaboration will be managed by
the JRPC, which will be comprised of two (2) representatives appointed by Axys
and two (2) representatives appointed by Roche Bioscience. Either Axys or Roche
Bioscience may appoint substitute or replacement members of the JRPC to serve as
their representatives upon notice to the other Party. The JRPC shall decide on
the principal aspects of the Collaboration during the Collaboration Term. The
JRPC shall have the responsibility and authority to (a) plan and monitor the
conduct of the Collaboration, (b) assign tasks and responsibilities under the
Research Plan to Roche Bioscience or Axys , (c) review and modify the Research
Plan, as it shall deem appropriate to achieve the Parties' objectives under this
Agreement and (d) confirm the achievement of milestones and approve payments
therefor. Notwithstanding the foregoing, Axys will not be obligated under the
Research Plan to the extent that such plan requires Axys to devote more than [*]
to the Collaboration; provided that additional FTEs may be included in the
Research Plan if the addition of such FTEs is approved in writing by the JRPC
and Roche Bioscience increases the research funding payable to Axys pursuant to
Section 5.3.
2.4 MEETINGS OF JRPC. The JRPC will initially meet at least once per quarter
at locations and times to be determined by the JRPC, with the intent of meeting
at alternating locations in South San Francisco and Palo Alto, California, with
each Party to bear all travel and related costs for its representatives. The
hosting Party shall pay for any meeting room and related costs.
2.5 JRPC DECISION-MAKING PROCESS. Each Party shall have one vote on the
JRPC, and all decisions by the JRPC shall be made by unanimous vote. Any
disagreement among members of the JRPC will be resolved within the JRPC based on
the efficient achievement of the objectives of this Agreement. Any disagreement
which cannot be resolved by a unanimous vote of the JRPC shall be referred to
the appropriate officers of Axys and Roche Bioscience for resolution under
Article 13. It is the intent of the Parties to resolve issues through the JRPC
whenever possible and to refer issues to the officers of Axys and Roche
Bioscience only when resolution through the JRPC cannot be achieved.
2.6 COLLABORATION TERM EXTENSION. No later than the date that is [*]
following the Effective Date, Roche Bioscience shall provide written notice to
Axys as to whether it wishes to extend the Collaboration Term for an additional
nine (9) month period. Upon notice from Roche Bioscience to Axys that it desires
to extend the Collaboration Term, the Collaboration Term shall be extended until
the date that is
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
9.
14
twenty-four (24) months following the Effective Date, unless earlier terminated
in accordance with Article 11. If not so extended, the Collaboration Term shall
terminate fifteen months after the Effective Date.
3. COLLABORATIVE ACTIVITIES
3.1 MUTUAL RESPONSIBILITIES; COOPERATION. Each Party shall use Commercially
Reasonable Efforts to perform its responsibilities under the Research Plan.
3.2 CONDUCT OF RESEARCH. During the Collaboration Term, each Party shall use
its Commercially Reasonable Efforts to conduct the Collaboration in accordance
with the then current Research Plan and in a good scientific manner and in
compliance in all material respects with all applicable requirements of
applicable laws and regulations.
3.3 AVAILABILITY OF RESOURCES. Within a reasonable time following the
Effective Date, each Party will maintain laboratories, offices and all other
facilities reasonably necessary to carry out the activities to be performed by
such Party pursuant to the Research Plan. Axys shall devote to the Collaboration
[*] research scientists each of whom is experienced in activities described in
the Research Plan. Axys will provide Roche Bioscience with a report on a
quarterly basis of the number of hours spent by Axys researchers conducting the
Collaboration.
3.4 TRANSFER OF MATERIALS. Commencing promptly after the Effective Date and
from time to time thereafter, Roche Bioscience shall transfer to Axys materials
relating to the Roche Bioscience Genes, i.e., EST sequences and clones and gross
tissue expression profiles, and shall disclose to Axys such information
regarding such Roche Bioscience Genes, as, in each case, is reasonably necessary
to enable Axys to perform its Collaboration activities hereunder in accordance
with the Research Plan.
3.5 DISCLOSURE; REPORTS. Each Party will make available and disclose to the
other Party promptly after the Effective Date all Axys Technology or Roche
Bioscience Technology, as applicable, known by such Party as of the Effective
Date, and will also disclose all Axys Technology or Roche Bioscience Technology,
as applicable, learned, acquired or discovered by such Party at any time prior
to the end of the Collaboration Term, as promptly as is reasonably practicable
after such technology is obtained or learned, in each case, to the extent
necessary to permit the Parties to perform their respective obligations under
this Agreement and otherwise to exercise fully the licenses granted hereunder.
Axys will provide at a minimum quarterly written reports (with copies to the
JRPC) presenting a meaningful summary of the activities conducted by such Party
pursuant to the Research Plan or in furtherance of the Collaboration. In
addition, on reasonable request by a Party, the other Party will make
presentations of its activities under this Agreement to inform such Party of the
details of the work done
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
10.
15
under this Agreement. Know-How and other information regarding the research
disclosed by one Party to the other Party pursuant hereto may be used only in
accordance with the rights granted under this Agreement.
3.6 IDENTIFICATION OF NEMAPHARM TARGETS. In accordance with the Research
Plan, Axys shall use Commercially Reasonable Efforts to identify potential
NemaPharm Targets in the Research Field. Axys shall promptly notify Roche
Bioscience of the discovery at any time during the first [*] after the Effective
Date by Axys of a NemaPharm Target in the Research Field and with sufficient
information including but not limited to, [*] for Roche to assess its interest
in the NemaPharm Target.
3.7 SCREENING OF COMPOUNDS; DISCONTINUATION OF DEVELOPMENT. Upon obtaining a
license with respect to a NemaPharm Target in accordance with Section 4.2, Roche
Bioscience [*] against such NemaPharm Target. Promptly after completing the
screening of compounds against such NemaPharm Target, or at least on a
semi-annual basis, Roche Bioscience shall provide written notice to Axys [*].
Such notice shall include [*]. Roche Bioscience shall, in its sole discretion,
select compounds for further development; provided, however, that in the event
that, having become obligated to pay at least one (1) milestone under this
Agreement (beginning with Section 5.4.2) with respect to a NemaPharm Target,
Roche Bioscience subsequently determines for any reason other than insufficient
efficacy or safety not to pursue further development of any compounds acting
against that NemaPharm Target or that NemaPharm Target, Roche Bioscience shall
provide prompt notice of such intention to Axys (a "Notice of Abandonment"), and
Axys shall have the rights set forth in Section 4.4.3 with respect to such
compound and such NemaPharm Target.
3.8 AXYS DEVELOPMENT OF GENE THERAPY PRODUCTS AND PROTEIN PRODUCTS. In the
event that, in accordance with the license granted to Axys pursuant to Section
4.4.1, Axys determines to begin internal research and/or development efforts
with respect to one or more Gene Therapy Products and/or Protein Products based
on a NemaPharm Target licensed to Roche Bioscience under Section 4.2.1, or to
commence efforts to license its rights for Gene Therapy Products or Protein
Products to one or more Third Parties, Axys shall provide prompt written notice
of such intention to Roche Bioscience, and Roche Bioscience shall thereupon have
the rights set forth in Section 4.2.2.
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
11.
16
3.9 FACILITY VISITS. Members of the JRPC shall have reasonable access to the
facilities of the other Party where research activities pursuant to the Research
Plan under this Agreement are in progress, for the sole purpose of performing
their duties as members of the JRPC, but only during normal business hours and
with reasonable prior notice. Each party shall bear its own expenses in
connection with such visits.
4. GRANT OF LICENSES
4.1 RESEARCH LICENSES.
4.1.1 Subject to the terms and conditions of this Agreement and during
the Collaboration Term, Axys grants to Roche Bioscience a worldwide,
non-exclusive license, including the right to grant sublicenses to Affiliates
only, under the Axys Technology solely to conduct Collaboration activities in
accordance with the Research Plan.
4.1.2 Subject to the terms and conditions of this Agreement and during
the Collaboration Term, Roche Bioscience, HLR and FHLR grant to Axys a
worldwide, non-exclusive license, including the right to grant sublicenses to
Affiliates only, under the Roche Bioscience Patent Rights and the Roche
Bioscience Know-How solely to conduct Collaboration activities in accordance
with the Research Plan. Within thirty (30) days after the end of the
Collaboration Term, Axys shall return to Roche Bioscience all copies of
documentation regarding Roche Bioscience Know-How and shall make no further use
thereof except, in both cases, to the extent required to allow Axys to exercise
the licenses granted to it pursuant to this Agreement. If the JRPC, prior to
identification of a NemaPharm Target relative to a particular Roche Bioscience
Gene, decides to discontinue work on such Roche Bioscience Gene, Axys shall
return to Roche Bioscience all copies of documentation regarding Roche
Bioscience Know-How for that particular Roche Bioscience Gene and shall make no
further use thereof.
4.1.3 For Internal Research Purposes. Axys grants to Roche Bioscience a
worldwide, non-exclusive license, including the right to grant sublicenses to
Affiliates only, to use the Results for its, and, as applicable, its
Affiliates', evaluation of any NemaPharm Target solely for the purpose of
licensing such Results pursuant to this Section 4
4.2 LICENSES TO ROCHE BIOSCIENCE IN THE COMMERCIALIZATION FIELD.
4.2.1 With respect to any NemaPharm Target, Axys hereby grants to Roche
Bioscience and its Affiliates an exclusive and non-transferable option
(exercisable solely during the [*] following written notice of identification of
such NemaPharm Target in accordance with Section 3.6) upon written notice
provided by Roche Bioscience to Axys, which is to be immediately
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
12.
17
acknowledged in writing by Axys, to obtain the following licenses, subject to
the provisions of Article 5:
(a) an exclusive (even as to Axys and its Affiliates) worldwide,
royalty-bearing license, including the right to grant sublicenses to Affiliates
or any Third Party, under the Axys Technology and Axys' interest in the Joint
Patent Rights, to use each such NemaPharm Target with respect to which Roche
Bioscience has exercised its option under this Section 4.2.1(a) to discover,
develop, make, have made, use, sell, offer to sell, have sold and import Small
Molecule Products and Antisense Products in the Commercialization Field;
provided, however, [*] obligations set forth in Section 4.6 with respect to such
NemaPharm Target;
(b) a nonexclusive, worldwide, royalty-bearing license, including
the right to grant sublicenses to Affiliates only, under the Axys Technology and
Axys' respective interests in the Joint Patent Rights, to use each such
NemaPharm Target with respect to which Roche Bioscience has exercised its option
under this Section 4.2.1(b) to discover, develop, make, have made, use, sell,
offer to sell, have sold and import Diagnostic Products in the Commercialization
Field.
(c) In the event that Roche Bioscience does not provide written
notice of its exercise of such option with respect to a NemaPharm Target within
the [*] following notice of identification of such NemaPharm Target in
accordance with Section 3.6 or provides written notice of its intention not to
exercise such option, the license granted by Roche Bioscience to Axys pursuant
to Section 4.4.2 shall become effective and all rights with respect to such
NemaPharm Target shall be retained by Axys.
4.2.2 With respect to any NemaPharm Target licensed to Roche Bioscience,
pursuant to Section 4.2.1, and effective upon the occurrence of the events
described in Section 3.8, Axys hereby grants to Roche Bioscience and its
Affiliates an exclusive and non-transferable right [*] to obtain a license under
the Axys Technology, and Axys' interest in the Joint Patent Rights, including
the right to grant sublicenses as allowed pursuant to this Agreement, to use
such NemaPharm Target to discover, develop, make, have made, use, sell, offer to
sell, have sold and import Gene Therapy Products and Protein Products in the
Commercialization Field. Such right [*] shall be exercisable solely during the
[*] following Roche Bioscience's receipt of written notice from Axys under
Section 3.8. During such [*], Roche Bioscience shall provide written notice to
Axys, which is to be immediately acknowledged in writing by Axys, as to whether
it would like to exercise its right [*] with respect to such NemaPharm Target
pursuant to this Section 4.2.2. If Roche Bioscience does not elect to so
exercise its right [*], or if such written notice from Roche Bioscience is not
received within such [*], Roche Bioscience shall have no further rights under
this Section
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
13.
18
4.2.2 with respect to such NemaPharm Target, and Axys shall be free to proceed
with the discovery, development, manufacture, use and sale of Gene Therapy
Products and Protein Products based thereon in the Commercialization Field
either by itself or with one or more Third Parties. If Roche Bioscience does
elect to exercise its right [*] with respect to such NemaPharm Target pursuant
to this Section 4.2.2, then for a period of up to [*] following written notice
of such election by Roche Bioscience, the Parties shall [*]; provided, however,
that if at the end of such [*], the Parties have not reached mutual agreement
with regard to such terms as evidenced by a written agreement, Roche Bioscience
shall have no further rights with respect to such NemaPharm Target under this
Section 4.2.2, and Axys shall be free to proceed with the discovery,
development, manufacture, use and sale of Gene Therapy Products and Protein
Products based thereon in the Commercialization Field, either by itself or with
one or more Third Parties.
4.3 LICENSE TO ROCHE BIOSCIENCE OUTSIDE THE COMMERCIALIZATION FIELD. With
respect to any NemaPharm Target licensed to Roche Bioscience pursuant to Section
4.2.1(a), Axys hereby grants to Roche Bioscience an exclusive and
non-transferable right of first negotiation to obtain a license under the Axys
Technology, and Axys' respective interests in the Joint Patent Rights, to use
such NemaPharm Target to discover, develop, make, have made, use, sell, offer to
sell, have sold and import Small Molecule Products and Antisense Products for
indications outside the Commercialization Field. Such right of first negotiation
shall be exercisable solely during the [*] following Roche Bioscience's exercise
of its option to license such NemaPharm Target pursuant to Section 4.2.1(a).
During such [*], Roche Bioscience shall provide written notice to Axys, which
shall be acknowledged immediately in writing by Axys, as to whether it would
like to exercise its right of first negotiation with respect to such NemaPharm
Target pursuant to this Section 4.3. If Roche Bioscience does not exercise its
right of first negotiation, or if such written notice from Roche Bioscience is
not received within such [*], Roche Bioscience shall have no further rights
under this Section 4.3 with respect to such NemaPharm Target, and Axys shall be
free to proceed with the use of such NemaPharm Target for the discovery,
development, manufacture, use and sale of Small Molecule Products and Antisense
Products for indications outside the Commercialization Field either by itself or
with one or more Third Parties. If Roche Bioscience does elect to exercise its
right of first negotiation with respect to such NemaPharm Target pursuant to
this Section 4.3, then for a period of up to [*] following written notice of
such election by Roche Bioscience, the Parties shall negotiate in good faith
regarding the terms (including but not limited to royalty rates, scope of
exclusivity and milestone payments) upon which such license would be granted to
Roche Bioscience. If at the end of such [*] period, the Parties have not reached
mutual agreement with regard to such terms as evidenced by a written agreement,
Roche Bioscience shall have no further rights with respect to such
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
14.
19
NemaPharm Target under this Section 4.3, and Axys shall be free to proceed with
the use of such NemaPharm Target for the discovery, development, manufacture,
use and sale of Small Molecule Products and Antisense Products for indications
outside the Commercialization Field, either by itself or with one or more Third
Parties.
4.4 LICENSES TO AXYS
4.4.1 With respect to any NemaPharm Target licensed to Roche
Bioscience pursuant to Section 4.2.1 , Roche Bioscience, HLR and FHLR hereby
grants to Axys an exclusive, worldwide, royalty-free license, with the right to
sublicense, under the Roche Bioscience Technology and Roche Bioscience's
interest in the Joint Patent Rights, to use such NemaPharm Target to discover,
develop, make, have made, use, sell, offer to sell, have sold and import Axys
Products.
4.4.2 Effective upon the earlier of the expiration of Roche
Bioscience's Option pursuant to Section 4.2.1 or the delivery of written notice
to Axys of Roche Bioscience's election not to exercise such option, Roche
Bioscience, HLR and FHLR hereby grant to Axys an exclusive, worldwide,
royalty-free license, with the right to sublicense, under the Roche Bioscience
Technology and Roche Bioscience's interest in the Joint Patent Rights, to use
such NemaPharm Target to discover, develop, make, have made, use, sell, offer to
sell, have sold and import (i) products for the prevention, treatment or
diagnosis of any disease or disorder, that contain an antisense product, which
consists of any complete, partial, altered or mutated RNA or DNA sequence
complementary to or derived from an RNA or DNA sequence of such NemaPharm Target
or any human or other animal homolog of that NemaPharm Target, (ii) products for
the prevention, treatment or diagnosis of any disease or disorder that contain a
small molecule [*] that is biologically active directly or indirectly against
such NemaPharm Target or any corresponding human or other animal homolog, (iii)
products or services or combinations thereof used for the diagnosis, prognosis
and/or monitoring of progression of a disease or disorder or which predict an
individual's response to drugs, including but not limited to, adverse events,
effects and efficacy which are developed utilizing, or are comprised of, such
NemaPharm Target or which incorporate any complete, partial, altered or mutated
RNA or DNA sequence corresponding to or complementary to an RNA or DNA sequence
of such NemaPharm Target or any human or other animal homolog of that NemaPharm
Target and (iv) Axys Products.
4.4.3 With respect to any compound or NemaPharm Target for which
Roche Bioscience delivers to Axys a Notice of Abandonment, Roche Bioscience, HLR
and FHLR hereby grant to Axys an exclusive and non-transferable right of first
negotiation to obtain a license under the Roche Bioscience Technology and Roche
Bioscience's interest in the Joint Patent Rights, to discover, develop, make,
have made, use, sell, offer to sell, have sold and import products incorporating
such compound or
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
15.
20
derivatives thereof or NemaPharm Target. Such right of first negotiation shall
be exercisable solely during the [*] following Axys' receipt of a Notice of
Abandonment from Roche Bioscience with respect to such compound or NemaPharm
Target. During such [*], Axys shall provide written notice to Roche Bioscience
as to whether it would like to exercise its right of first negotiation with
respect to such compound or NemaPharm Target pursuant to this Section 4.4.3 . If
Axys does not exercise its right of first negotiation, or if such written notice
from Axys is not received within such [*], Axys shall have no further rights
under this Section 4.4.3 with respect to such compound or NemaPharm Target, and
Roche Bioscience shall be free to negotiate with Third Parties regarding rights
to such compound or NemaPharm Target. If Axys does exercise its right of first
negotiation with respect to such compound or NemaPharm Target pursuant to this
Section 4.4.3, then for a period of up to [*] following written notice of such
election by Axys, the Parties shall negotiate in good faith regarding the terms
upon which such license would be granted to Axys; provided, however, that if at
the end of such [*], the Parties have not reached mutual agreement with regard
to such terms as evidenced by a written agreement, Axys shall have no further
rights with respect to such compound or NemaPharm Target under this Section
4.4.3, and Roche Bioscience shall be free to negotiate with Third Parties
regarding rights to such compound or NemaPharm Target.
4.4.4 Royalty payments shall be made to the Roche Party designated
by Roche Bioscience according to ownership of the Roche Bioscience Patent Rights
or other Know-How.
4.5 SUBLICENSES. Each Party shall notify any permitted sublicensee hereunder
of all rights and obligations of such Party under this Agreement licensed to
such sublicensee.
4.6 DILIGENCE OBLIGATIONS OF ROCHE BIOSCIENCE RELATED TO NEMAPHARM TARGETS.
The licenses granted to Roche Bioscience with respect to a NemaPharm Target
pursuant to this Article 4 will terminate, on a target-by-target basis, and all
rights to such NemaPharm Target will revert to Axys in the event that Roche
Bioscience does not satisfy the conditions in Sections 4.6.1 and 4.6.2.
4.6.1 For Small Molecule Products, within [*] of licensing such
NemaPharm Target, Roche Bioscience shall have [*] if Roche Bioscience meet the
requirement in Section 4.6.2 [*]; and
4.6.2
(a) Within [*] of licensing such NemaPharm Target, Roche
Bioscience shall have [*] in a screen incorporating a NemaPharm Target at a
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
16.
21
[*]; or, Antisense Product that disrupts the NemaPharm Target in an appropriate
disease model state; or
(b) Within [*] of licensing such NemaPharm Target, Roche
Bioscience shall have [*] Diagnostic Product.
4.6.3 After achievement of the requirement in Section 4.6.2, the
licenses granted to Roche Bioscience with respect to a NemaPharm Target will
also terminate on a target by target basis and all rights to such NemaPharm
Target shall revert to Axys if Roche Bioscience thereafter fails to use
Commercially Reasonable Efforts to [*].
4.7 DILIGENCE OBLIGATIONS OF ROCHE BIOSCIENCE WITH RESPECT TO DEVELOPMENT
AND PROMOTION OF ROCHE BIOSCIENCE PRODUCTS.
4.7.1 REASONABLE EFFORTS. Roche Bioscience shall use Commercially
Reasonable Efforts to [*].
4.7.2 LACK OF DILIGENCE. In the event that Roche Bioscience (i) fails to
use or continue to use Commercially Reasonable Efforts to [*] or (ii) notifies
Axys in writing that it will not conduct further commercialization with respect
to a particular Roche Bioscience Product and in either case [*], Roche
Bioscience, HLR and FHLR will grant Axys an exclusive, non-transferable right of
first negotiation to obtain an exclusive license under the Roche Bioscience
Technology and Roche Bioscience's interest in the Joint Patent Rights for the
Roche Bioscience Product for which Commercially Reasonable Efforts have not been
expended or notice has been given to Axys as described in (ii) above.
4.7.3 MARKETING PARTNER. Roche Bioscience shall notify its Affiliates
that in the event that such Affiliate seeks a marketing partner for a Roche
Bioscience Product in a specific country, such Affiliate should provide prompt
written notice of
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
17.
22
such intention to Axys and give Axys an exclusive and non-transferable right of
first negotiation to become such Affiliate's marketing partner in that country.
Such right of first negotiation shall be exercisable solely during the [*]
following Axys' receipt of written notice from such Affiliate under this Section
4.7.3. If Axys elects to exercise its right of first negotiation then for a
period of [*] thereafter the parties shall negotiate in good faith regarding the
terms of such marketing agreement. So long as Roche Bioscience fulfills its duty
to notify its Affiliates pursuant to the first sentence in this Section 4.7.3,
no breach of this Agreement shall arise from the provisions of this Section.
5. PAYMENT OBLIGATIONS
5.1 UPFRONT PAYMENT. Within ten (10) days after the Effective Date, Roche
Bioscience shall pay to Axys a nonrefundable upfront fee of [*] in partial
consideration of the licenses granted herein.
5.2 RESEARCH FUNDING. During the Collaboration Term, including any extension
thereof, Roche Bioscience agrees to provide Axys with research funding for a
total of [*] at an annual rate of [*] to be used by Axys to pursue the
activities set forth in the Research Plan; provided, however, that, in the event
that the Collaboration Term is extended pursuant to Section 2.5, the annual rate
per FTE will be increased for such extension period by a factor which reflects
the increase, if any, in the U.S. Consumer Price Index, as reported as of the
date that is sixty (60) days prior to the commencement of such extension period
when compared to the comparable statistic for the Effective Date. Such research
funding payments shall be made in accordance with the following schedule:
AMOUNT OF PAYMENT DATE PAYABLE
[*] [*] after the Effective Date
[*] [*] following the Effective Date
[*] [*] after receipt of Final NemaPharm
Report pursuant to Section 3.5 and statement of account.
5.3 TERM EXTENSION. In the event that the Collaboration Term is extended
pursuant to Section 2.6, the payment schedule for research funding during such
extended period shall be agreed upon in writing by the Parties. Upon a decision
of the JRPC, the number of FTEs to be supported by Roche Bioscience may be
increased to support Collaboration efforts.
5.4 MILESTONE PAYMENTS. Within [*] after achievement of each of the
milestones set forth below, Roche Bioscience shall pay to Axys the nonrefundable
milestone payment set forth below, on a target-by-target basis:
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
18.
23
5.4.1 [*] Upon [*] with respect to each NemaPharm Target pursuant to
Section 4.2.1 ;
5.4.2 [*] Upon identification by Roche Bioscience of [*]; provided,
however, that this milestone shall be [*];
5.4.3 [*] Upon the [*];
5.4.4 [*] Upon the [*] for a Small Molecule Product or Antisense
Product; provided, however, that this milestone shall be [*];
5.4.5 With respect to a Diagnostic Product:
(a) [*] Upon the occurrence of each of:
(i) the [*] of a Diagnostic Product for which [*] for the first
Diagnostic Product ; and
(ii) the [*] for such Diagnostic Product or the derivative
thereof for the first Diagnostic Product ; or
(b) [*] Upon the [*] for the first Diagnostic Product [*];
5.4.6 [*] upon the [*] for a Small Molecule Product or Antisense Product
[*];
5.4.7 [*] Upon [*] for each Small Molecule Product and each Antisense
Product; provided, however, that this milestone shall [*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
19.
24
[*];
5.4.8 [*] Upon [*] for each Diagnostic Product; and
5.4.9 [*] Upon [*] for each Small Molecule Product and each Antisense
Product; provided, however, that this milestone shall [*].
5.5 [*]
5.6 ROYALTY PAYMENTS.
5.6.1 SMALL MOLECULE PRODUCTS. Roche Bioscience shall pay to Axys the
following royalty on Net Sales of each Small Molecule Product:
(a) [*] of Net Sales on the [*];
(b) [*] of Net Sales on the portion of aggregate worldwide Net Sales
between [*] and [*];
(c) [*] of Net Sales on the portion of aggregate worldwide Net Sales
between [*] and [*]; and
(d) [*] of Net Sales on the portion of aggregate worldwide Net Sales
exceeding [*].
5.6.2 Antisense Products. Roche Bioscience shall pay to Axys a royalty
of [*] on Net Sales of each Antisense Product.
5.6.3 DIAGNOSTIC PRODUCTS. Roche Bioscience shall pay to Axys a royalty
of [*] on Net Sales of each Diagnostic Product.
5.6.4 ROYALTY TERM. Royalties for sales of any Roche Bioscience Product
in any given country shall be paid for a period equal to the Royalty Term. In
the event that, in a given country, patents included in the Axys Patent Rights,
the Roche Bioscience Patent Rights, or the Joint Patent Rights covering a Roche
Bioscience Product
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
20.
25
have issued in such country, all such issued patents in that country have
expired and the Royalty Term is still in effect, then the royalties payable
under this Section 5.6 on sales of such Roche Bioscience Product in that country
shall be [*] from and after the date of expiration of the last to expire of such
issued patents unless and until a patent included in the Axys Patent Rights, or
the Joint Patent Rights covering such Roche Bioscience Product thereafter issues
in such country.
5.6.5 COMBINATION PRODUCT. Net Sales on a Combination Product shall be
the [*] by Roche Bioscience, its Affiliates or Sublicensees from a sale of a
Roche Bioscience Product containing only a compound discovered or developed
using the NemaPharm Target (NemaPharm Target Sole Product) as an active
ingredient in an arm's length transaction with an unAffiliated third party. If
the NemaPharm Target Sole Product is not sold separately, the Parties shall [*]
for such NemaPharm Target Sole Product. The Net Sales upon which a royalty is
paid shall then be computed by [*].
5.7 THIRD PARTY ROYALTIES. Roche Bioscience shall be responsible for the
payment of royalties under all Third Party licenses that are payable in
connection with each Roche Bioscience Product's development and
commercialization and that are incurred by Roche Bioscience, the costs of
conducting the clinical trials and the costs associated with Regulatory
Approval. Notwithstanding the foregoing or the provisions of Section 5.6.2,
Roche Bioscience shall be entitled to [*] with respect to sales of such
Antisense Product; provided, however, that in no event will the effect of this
Section 5.7 cause the royalty payable to Axys with respect to such Antisense
Product under Section 5.6.3 to [*] of Net Sales.
Axys will discuss with Roche Bioscience Third Party licenses that it
proposes to enter into after the Effective Date. At the time that Axys obtains a
license under Section 4.4.2 or after Roche Bioscience has elected not to acquire
a license, Axys shall become responsible for payment of royalties that
thereafter accrue under Third Party licenses described above with respect to the
compounds so licensed.
6. PAYMENTS; RECORDS; AUDITS
6.1 PAYMENT; REPORTS. All royalty payments due to Axys 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 of Roche Bioscience Products in sufficient detail to
permit confirmation of the accuracy of the royalty payment made.
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
21.
26
6.2 EXCHANGE RATE; MANNER AND PLACE OF PAYMENT. All payments shall be in
United States dollars. Any required conversion of Adjusted Gross Sales, Net
Sales and any milestone or royalty amounts to Untied States dollars shall be
done using the monthly average rate of exchange for the calendar month in which
such Adjusted Gross Sales, Net Sales and any royalty or milestone amounts were
incurred or first determined.
6.2.1 The conversion from a foreign currency to United States dollars
shall be made by using the average of the daily official rates of exchange for
each day in the calendar month, using the rates of exchange as computed in
Roche's central foreign currency exchange data base built from the Reuters
System, or another qualified source that is mutually acceptable to the parties.
Roche shall disclose to Axys the contents of such central foreign currency
exchange data base.
6.2.2 To the extent that free conversion from the local currency to
United States dollars is permitted, payments shall be made in United States
dollars to a bank account designated by the creditor party. If, due to
restrictions or prohibitions imposed by a national or international authority,
payments cannot be made as aforesaid, the parties shall consult with a view to
finding a prompt and acceptable solution, and a party shall, from time to time,
deal with such moneys as the other party(s) may lawfully direct, but at no
additional out-of-pocket expense. Notwithstanding the foregoing, if required
remittances in any country cannot be converted or remitted to a party for any
reason within three (3) months after such remittance is otherwise due, then the
remitting party shall be obligated to deposit the local currency equivalent of
the required United States dollar remittance in a bank account in such country
in the name of the other party(s). If free conversion of such funds to United
States dollars is not possible within twelve (12) months of the original
remittance due date, the remitting party shall pay to the other party(s) at such
time the United States dollar equivalent of such local currency funds (including
any interest earned from the deposit of the local currency) and the local
currency account shall become the property of the remitting party. The
conversion of local currency to United States dollars shall be based on the
monthly average rate of exchange for the calendar month immediately preceding
the month in which such remittance is made, as such average rate of exchange is
computed above.
6.3 LATE PAYMENTS. In the event that any payment, including royalty,
milestone and research payments, due hereunder is not made when due without
Force Majeure pursuant to Section 14.2, the payment shall accrue interest from
the date due at the average one (1) month London Interbank Offered Rates, as
reported by Datastream from time to time, plus one hundred (100) basis points,
per month; provided, however, 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.
22.
27
6.4 RECORDS AND AUDITS. For a period of [*] after the end of the
calendar year of sale of a Roche Bioscience Product, Roche Bioscience shall
maintain and cause its Affiliates and sublicensees to maintain books of account
and complete and accurate records pertaining to the sale or other disposition of
Roche Bioscience Products and of the royalty and other amounts payable under
this Agreement in sufficient detail to permit Axys to confirm the correctness of
such items. Upon timely request by Axys, Roche Bioscience agrees to instruct its
independent accounting firm to perform, during Roche Bioscience's annual audit,
such additional auditing and accounting procedures as are reasonably necessary
to enable such accounting firm to confirm to Axys the correctness of (i) the
amounts stated in any reports provided by Roche Bioscience; and (ii) to the
extent specifically and reasonably requested, in a timely manner, by Axys, other
relevant details pertaining to the sale or other disposition of Roche Bioscience
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 be performed for
countries specifically requested by the authorized representative of Axys. Such
audit shall be performed no more than once per year and shall occur no more than
once with respect to records covering any specific period of time. All
information, data, documents and abstracts herein referred to shall be used only
for the purpose of verifying royalty statements or compliance with this
Agreement, shall be treated as Roche Bioscience's Confidential Information
subject to the obligations of this Agreement. Axys shall pay for any reasonable
expense over and above Roche's regular audit fee, if any, incurred for such
additional audit work.
The failure of Axys to request verification of any royalty calculation
during the period when records must be maintained shall be considered acceptance
of the accuracy of such reporting. In the event that such audit shall indicate
that in any calendar year, the royalties that should have been paid by Roche
Bioscience are greater that those that were actually paid by Roche Bioscience,
then Roche Bioscience shall promptly pay the underpaid amount to Axys and/or its
Affiliates and in the event that the royalties that should have been paid by
Roche Bioscience are at least [*] than those that were actually paid by Roche
Bioscience, then Roche Bioscience [*], Adjustments in the amounts due
because of an audit shall be settled on or before the next quarterly payment
date. In the event that such audit shall indicate that in any calendar year the
royalties that were actually paid by Roche Bioscience are greater than those
that should have been paid, then such overpayment shall be credited to the next
royalty payment due to Axys if there is to be one within six (6) months;
otherwise Axys shall remit such overpayment to Roche Bioscience within thirty
(30) days after receipt of written notice to that effect. Any payments due
pursuant to the terms of this Section 6.4 that are not paid on or before the
date such payments are due shall bear interest at the rate described in Section
6.3.
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
23.
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6.5 TAXES. Roche Bioscience shall be entitled to withhold from a royalty or
other payment due Axys, the amount, if any, of any withholding tax assessable to
the party due the payment, provided evidence of payment of any such tax is
promptly provided to the Party for which the tax is withheld. If any taxes
(other than value-added taxes) are imposed on payments of royalties to Axys and
are required to be withheld therefrom, such taxes shall be for the account of
Axys, respectively, and the payments due to the Party for which tax is withheld
shall be reduced accordingly. Roche Bioscience shall advise Axys and provide it
with copies of the tax receipts for all taxes deducted from the payment of
royalties due them.
6.6 PROHIBITED PAYMENTS. Notwithstanding any other provision of this
Agreement, if any Party is prevented from paying any such royalty by virtue of
the statutes, laws, codes or governmental regulations of the country from which
the payment is to be made, then such royalty may be paid by depositing funds in
the currency in which accrued to the other Party's account in a bank acceptable
to the other Party in the country whose currency is involved.
7. PATENT RIGHTS AND INFRINGEMENT
7.1 OWNERSHIP OF PATENT RIGHTS. Roche Bioscience shall own all right, title,
and interest in and to all Roche Bioscience Patent Rights and Roche Bioscience
Know-How and all inventions conceived of and reduced to practice during the
Collaboration Term solely by its employees and agents, and all patent
applications and patents claiming such inventions. Axys shall own all right,
title, and interest in and to all Axys Patent Rights and Axys Know-How and all
inventions conceived of and reduced to practice during the Collaboration Term
solely by its employees and agents, and all patent applications and patents
claiming such inventions. All inventions conceived of and reduced to practice
jointly by employees or agents of Roche Bioscience and/or its Affiliates, on the
one hand, and employees or agents of Axys and/or its Affiliates, on the other
hand, and all Joint Patent Rights claiming such inventions, shall be owned
jointly by Roche Bioscience and/or its Affiliates and Axys and/or its
Affiliates.
7.2 CONFIDENTIALITY OBLIGATIONS. Each Party hereby represents and warrants
that all employees and Persons (Persons shall include individuals and any
business entity) acting on its behalf in performing its obligations under this
Agreement shall be obligated to assign to it, or as it shall direct, all
inventions, ideas, trade secrets, copyrights conceived by such employees or
other Persons and all such employees and other Persons shall be subject to
confidentiality provisions at least as restrictive as those in this Agreement.
7.3 PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
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7.3.1 It is the intention of the Parties to secure broad patent
protection for discoveries and inventions made in connection with the
Collaboration. Roche Bioscience shall be responsible for the filing, prosecution
and maintenance of all Roche Bioscience Patent Rights and all patent
applications and patents covering Roche Bioscience Know-How and any discoveries
and inventions conceived of or reduced to practice by its employees and agents
in the course of the Collaboration. Axys shall be responsible for the filing,
prosecution and maintenance of all Axys Patent Rights and all patent
applications and patents covering the Axys Know-How and any discoveries and
inventions conceived of or reduced to practice by the employees and agents of
Axys and/or its Affiliates in the course of the Collaboration. Each Party shall
consider in good faith the requests and suggestions of the other Party with
respect to strategies for filing and prosecuting such patent applications. The
inventing Party shall keep the other Party informed of progress with regard to
the filing, prosecution, maintenance, enforcement and defense of patents
applications and patents subject to this Section 7.3.1.
7.3.2 [*] shall be responsible for the filing, prosecution, and
maintenance of all Joint Patent Rights, provided that [*] shall have the sole
right to decide to keep an invention as a trade secret instead of filing for
patent protection provided that [*] holds a license to such invention or, if
such invention is related to a NemaPharm Target, has not yet [*]. [*] shall
furnish [*] copies of all relevant documents with respect to preparation,
filing, prosecution and maintenance of such Joint Patent Rights on a regular
basis reasonably in advance of any deadline or action with the U.S. Patent &
Trademark Office or any foreign patent office. [*] shall consult [*] as to the
preparation, filing, prosecution, and maintenance of such Joint Patent Rights on
a regular basis. Selection of outside counsel relative to Joint Patent Rights
shall be with the concurrence of [*] shall not be unreasonably withheld. In the
event that [*] desires to abandon any Joint Patent Right, [*] shall provide
reasonable prior written notice [*] of such intention to abandon, and [*] shall
have the right, at its expense, to prepare, file, prosecute, and maintain any
such Joint Patent Right and in such event [*] shall have no further rights in
relation to such Joint Patent Right. Nothing herein shall negate [*] license or
other rights under the Joint Patent Rights. Except for the abandonment provision
above , reasonable expenses associated with the prosecution and maintenance of
the Joint Patent Rights shall be shared equally between the Parties.
7.4 COOPERATION OF THE PARTIES. Each Party agrees to cooperate fully in the
preparation, filing, and prosecution of any Patent Rights under this Agreement.
Such cooperation includes, but is not limited to:
7.4.1 making, executing and delivering any and all papers and
instruments, or requiring its employees or agents, to execute such papers and
instruments, and performing any and all acts necessary for a Party to prepare,
file,
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
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prosecute and maintain Patent Rights, or, so as to effectuate the ownership of
Patent Rights set forth in Section 7.1 and to enable the other Party to apply
for and to prosecute and maintain patent applications and patents in any
country; and
7.4.2 promptly informing the other Party of any matters coming to such
party's attention that may affect the preparation, filing, prosecution or
maintenance of any such patent applications and patents.
7.5 INFRINGEMENT BY THIRD PARTIES. Roche Bioscience and Axys shall promptly
notify each other in writing of any alleged or threatened infringement of any
patent included in the Axys Patent Rights, the Roche Bioscience Patent Rights or
the Joint Patent Rights of which it becomes aware. The Parties shall use their
best efforts in cooperating with one another to terminate such infringement
without litigation. Axys shall have the sole right to bring and control any
action or proceeding with respect to infringement of any patent included in the
Axys Patent Rights at its own expense and by counsel of its own choice. Roche
Bioscience shall have the sole right to bring and control any action or
proceeding with respect to infringement of any patent included in the Roche
Bioscience Patent Rights at its own expense and by counsel of its own choice.
Roche Bioscience shall have the first right to bring and control any action or
proceeding with respect to infringement of any patent included in any Joint
Patent Rights at its own expense and by counsel of its own choice, and Axys
shall have the right to be represented in any action involving such Joint Patent
Rights at its own expense and by counsel of its own choice. If Roche Bioscience
fails to bring an action or proceeding with respect to any infringement of any
Joint Patent Rights within (i) [*] following the notice of alleged infringement
or (ii) [*] before the time limit, if any, set forth in the appropriate laws and
regulations for the filing of such actions, whichever comes first, Axys shall
have the right to bring and control any such action at its own expense and by
counsel of its own choice, and Roche Bioscience shall have the right, at its own
expense, to be represented in any such action by counsel of its own choice.
In the event a Party brings an infringement action, the other Parties shall
cooperate fully, including if required to bring such action, the furnishing of a
power of attorney. No Party shall have the right to settle any patent
infringement litigation under this Section 7.5 in a manner that diminishes the
rights or interests of another Party or obligates another Party to make any
payment or take any action without the consent of such other Party. Except as
otherwise agreed to by the Parties as part of a cost sharing arrangement, any
recovery realized as a result of such litigation involving any Joint Patent
Rights, after reimbursement of any reasonable litigation expenses of Roche
Bioscience, and Axys shall belong to the Party who brought the action. With
respect to any recovery net of litigation expenses relative to Joint Patent
Rights received by Roche Bioscience, to the extent compensatory for expected but
lost sales by Roche Bioscience of a Product, such net recovery shall [*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
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[*] of this Agreement, and, to the extent punitive, Roche Bioscience shall [*]
with Axys.
7.6 INFRINGEMENT OF THIRD PARTY RIGHTS. Roche Bioscience and Axys shall
promptly notify one another in writing of any allegation by a Third Party that
the activity of any of the Parties in connection with this Collaboration
infringes or may infringe the intellectual property rights of such Third Party.
Roche Bioscience shall have the first right to control any defense of such claim
at its own expense and by counsel of its own choice, and Axys shall have the
right, at their own expense, to be represented in any such action by counsel of
their own choice. If Roche Bioscience fails to proceed in a timely fashion with
regard to such defense, Axys shall have the right to control any such defense of
such claim at its own expense and by counsel of its own choice, and Roche
Bioscience shall have the right, at its own expense, to be represented in any
such action by counsel of its own choice. No Party shall have the right to
settle any patent infringement litigation under this Section 7.6 in a manner
that diminishes the rights or interests of another Party or obligates another
Party to make any payment or take any action without the consent of such other
Party.
8. INDEPENDENT CONTRACTOR
This Agreement shall not constitute, create, or otherwise imply a joint
venture, pooling arrangement, partnership or formal business organization of any
kind. The parties agree that the obligations and duties of each party arising
under this Agreement regardless of whether shared, identical, or otherwise
similar, are separate and distinct from the obligations and duties of the other
party. Actions or failures to act by one party shall not confer joint and
several liability to the other party. No party shall have the authority to act
on behalf of any other party, or to commit any other party in any manner or
cause whatsoever. No party shall be liable for any act, omission,
representation, obligation, or debt of any other party, even if informed of such
act, omission, representation, obligation or debt.
9. CONFIDENTIALITY
9.1 NONDISCLOSURE. During the longer of the Collaboration Term and the
Royalty Term, and for a period of [*] thereafter, each Party shall maintain all
Confidential Information as confidential and shall not disclose any Confidential
Information to any Third Party or use any Confidential Information for any
purpose except (a) as expressly authorized by this Agreement, (b) as required by
law or court order or (c) to its Affiliates. Each Party may use such
Confidential Information only to the extent required to accomplish the purposes
of this Agreement. Each Party shall use at least the same standard of care as it
uses to protect proprietary or confidential information of its own to ensure
that its Affiliates, employees, agents, consultants and other representatives do
not disclose or make any unauthorized use of the Confidential
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
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Information. Each Party will promptly notify the others upon discovery of any
unauthorized use or disclosure of the Confidential Information.
9.2 EXCEPTIONS. Confidential Information shall not include any information
which the receiving Party can prove by competent, written evidence:
9.2.1 is now, or hereafter becomes, through no act or failure to act on
the part of the receiving Party, generally publicly known or available;
9.2.2 is known by the receiving Party at the time of receiving such
information, as evidenced by its records;
9.2.3 is hereafter furnished to the receiving Party by a Third Party, as
a matter of right and without restriction on disclosure;
9.2.4 is independently developed by the receiving Party without the aid,
application or use of Confidential Information; or
9.2.5 is the subject of a written permission to disclose provided by the
disclosing Party.
9.3 PUBLICATIONS. Each Party to this Agreement recognizes that the
publication of papers, abstracts, presentations, or other public disclosures
("Publications") regarding results of Collaboration activities hereunder may be
beneficial to both Parties provided such publications are subject to reasonable
controls to protect Confidential Information and Patent Rights. In particular,
it is the intent of the Parties to maintain the confidentiality of any
Confidential Information included in any U.S. or foreign patent application
until such U.S. or foreign patent application has been published. Accordingly,
each Party shall have the right to review, comment upon and approve any proposed
Publication by the other Party that utilizes data generated from the
Collaboration activities and/or includes Confidential Information of the other
Party. Before any such Publication is submitted, the Party proposing the
Publication shall deliver a complete copy to the other Party at least [*] prior
to submitting the proposed Publication to a third party. The receiving Party
shall review any such proposed Publication and give comments to the submitting
Party within [*] of the delivery of such proposed Publication to the receiving
Party. The submitting Party shall comply with the other Party's requests to
delete references to such other Party's Confidential Information in any such
proposed Publication and agrees to withhold Publication of same for an
additional [*] days 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.
10. REPRESENTATIONS, WARRANTIES AND COVENANTS
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended."
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10.1 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.
10.2 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.
10.3 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.
10.4 DISCLAIMER OF WARRANTIES. No Party to this Agreement guarantees the
safety or usefulness of any Product. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, NO PARTY MAKES ANY REPRESENTATION OR WARRANTY TO ANY OTHER PARTY OF
ANY NATURE, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
NONINFRINGEMENT, VALIDITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
10.5 MUTUAL INDEMNIFICATION. Each Party hereby agrees to save, defend, hold
harmless and indemnify the other Party and its officers, directors, employees,
consultants and agents harmless from and against any and all suits, claims,
actions demands, liabilities, expenses and losses, including reasonable legal
expense and attorneys' fees ("Losses") resulting directly or indirectly from the
manufacture, development, use, handling, storage, sale or other disposition of
chemical agents or Products by such Party, its Affiliates or sublicensees,
except to the extent such Losses result from the gross negligence or willful
misconduct of the Party claiming a right of indemnification under this Section
10.5, provided that Roche Bioscience's indemnification shall not extend to
patent infringement allegations relative to the Joint Patent Rights, Axys Patent
Rights, Axys Know-How, and Axys' obligations shall not extend to allegations of
infringement involving Joint Patent Rights, Roche Bioscience Patent Rights, or
Roche Bioscience Know-How. In the event a Party seeks indemnification under this
Section 10.5, it shall inform the other Party in writing 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.
11. TERM AND TERMINATION
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11.1 TERM. This Agreement shall commence as of the Effective Date and,
unless sooner terminated as provided herein, the rights and obligations of the
Parties under this Agreement, shall expire on the later of (i) the last day of
the Royalty Term, or (ii) if no NemaPharm Target has been identified, then five
years after the Effective Date.
11.2 TERMINATION FOR CAUSE. Either Party may terminate this Agreement during
the Collaboration Term or during the Royalty Term, as applicable, upon [*]
written notice upon the occurrence of any of the following:
11.2.1 Upon or after the bankruptcy, insolvency, dissolution or winding
up of the other Party (other than dissolution or winding up for the purposes of
reconstruction or amalgamation); or
11.2.2 Upon or after the breach of any material provision of this
Agreement by the other Party if the breaching Party has not cured such breach
(or if such breach is not reasonably capable of being cured within such [*]
period, and the defaulting Party is diligently proceeding to cure such breach)
and the breach could not be settled by arbitration within the [*] period
following written notice of termination by the other Party. As a general rule,
termination shall apply NemaPharm Target by NemaPharm Target, Product by Product
and country by country rather than to the Agreement as a whole.
11.3 EFFECT OF EXPIRATION OR TERMINATION.
11.3.1 Expiration or termination of the Collaboration Term or the
Royalty Term, as applicable, shall not relieve the Parties of any obligation
accruing prior to such expiration or termination. Except as set forth below or
elsewhere in this Agreement, the obligations and rights of the Parties under
Sections 6.4, 7.1, 10.4, 10.5, and 11.3, Articles 9, 13 and 14 shall survive
termination or expiration of both the Collaboration Term and the Royalty Term.
11.3.2 Without limiting any remedies otherwise available to a Party, if
such Party terminates this Agreement for cause pursuant to Section either prior
to the end of the Collaboration Term or prior to the end of the Royalty Term,
(i) all licenses granted by such Party to the other Party hereunder shall
terminate and revert to the non-breaching Party, (ii) the breaching Party shall
return to the non-breaching Party all of the non-breaching party's Confidential
Information (retaining one copy thereof for the breaching party's records), and
(iii) in addition to the survival of certain rights and obligations of the
Parties pursuant to Section 11.4.1 [*] under this Agreement.
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
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12. PUBLICITY
12.1 PUBLICITY REVIEW. Roche Bioscience and Axys will jointly discuss and
agree, based on the principles of Section 12.2, 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. Neither Party shall use the name of the other Party, or name(s) of
the other Party's officers, directors, employees, or agents, 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 (5) business days to review such press release,
prospectus, annual report, or other public statement.
12.2 STANDARDS. In the discussion and agreement referred to in Section 12.1,
the principles observed by Roche Bioscience and Axys will be accuracy, the
requirements for confidentiality under Article 9, the advantage a competitor of
Roche Bioscience or Axys may gain from any public or Third Party statements
under Section 12.1, 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 Axys.
13. DISPUTE RESOLUTION
13.1 DISPUTES. The Parties recognize that disputes as to certain matters may
from time to time arise which relate to either party's rights and/or obligations
hereunder. It is the objective of the Parties to establish procedures to
facilitate the resolution of such disputes in an expedient manner by mutual
cooperation and without resort to litigation. To accomplish this objective, the
Parties agree to follow the procedures set forth in this Article 13 if and when
such a dispute arises between the Parties.
13.2 PROCEDURE.
13.2.1 If the Parties or the JRPC cannot resolve the dispute within
twenty (20) days of formal request by either Party to the other, either 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 thirty (30) days after such notice
is received. Said designated officers are as follows:
For Roche Bioscience: President
For Axys: President
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13.2.2 Any unresolved disputes arising between the Parties relating to,
arising out of or in any way connected with this Agreement or any term or
condition hereof, or the performance by either Party of its obligations
hereunder, whether before or after termination of this Agreement, shall be
finally resolved by final and binding arbitration. Whenever a Party shall decide
to institute arbitration proceedings, it shall give written notice to that
effect to the other Party. Arbitration shall be held in San Francisco,
California, according to the American Arbitration Association ("AAA") rules. The
arbitration shall be conducted by a single arbitrator mutually chosen by the
Parties. If the Parties cannot agree upon a single arbitrator within fifteen
(15) days after the institution of the arbitration proceeding, then the
arbitration shall be conducted by a single neutral, impartial and independent
arbitrator appointed in accordance with AAA rules. All arbitrator(s) eligible to
conduct the arbitration must agree to render their opinion(s) within thirty (30)
days of the final arbitration hearing. No arbitrator (nor the panel of
arbitrators) shall have the power to award punitive damages under this Agreement
and such award is expressly prohibited. Decisions of the arbitrator(s) shall be
final and binding on all of the Parties. Judgment on the award so rendered may
be entered in any court having jurisdiction thereof. In any arbitration pursuant
to this Agreement, the arbitrators shall apply the laws of the State of
California. Except as required by law, no Party, nor the arbitrator, may
publicly disclose the existence, content, or results of any arbitration
hereunder with the prior written consent of all Parties participating in the
arbitration.
14. MISCELLANEOUS
14.1 ASSIGNMENT.
14.1.1 Notwithstanding any provision of this Agreement to the contrary,
any Party may assign any or all of its rights or obligations under this
Agreement in any country to any Affiliates; provided, however, that such
assignment shall not relieve the assigning Party of its responsibilities for
performance of its obligations under this Agreement.
14.1.2 Any Party may also assign its rights or obligations under this
Agreement with the prior written consent of the other Party. This Agreement
shall survive (i) any merger or reorganization of a Party with or into another
Party, and (ii) any sale of all or substantially all of the assets of a Party to
a Third Party. No consent for such transaction shall be required hereunder;
provided, however, that in the event of such transaction, intellectual property
rights of a Party to such transaction, other than one of the Parties to this
Agreement (the "Acquiring Party"), shall not be included in the technology
licensed hereunder unless shareholders of a Party hereto beneficially own 50% or
more of the total outstanding voting stock or other voting rights of such
Acquiring Party and a majority control of the Board of Directors of the
Acquiring Party immediately following such transaction.
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14.1.3 This Agreement shall be binding upon and inure to the benefit of
the successors and permitted assigns of the Parties. Any assignment not in
accordance with this Agreement shall be void.
14.2 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, earthquake, explosion, flood, strike, lockout, embargo, act
of God, or any other similar cause beyond the control of the defaulting Party;
provided, however, that the Party claiming force majeure has exerted all
reasonable efforts to avoid or remedy such condition; and provided further, that
the other Party may suspend any payment obligations due under this Agreement
until the defaulting Party resumes its performance if such condition continues
for a period of one hundred eighty (180) days or more.
14.3 PAYMENT IN U.S. DOLLARS. All payments due to a Party under this
Agreement shall be paid in U.S. Dollars.
14.4 NOTICES. Any notices or communications provided for in this Agreement
to be made by any of the Parties to the other shall be in writing, in English,
and shall be deemed to have been duly given upon the date of receipt if
delivered by hand, recognized overnight courier, confirmed facsimile
transmission, or registered or certified mail, return receipt requested, postage
prepaid to the addresses or facsimile numbers below. A Party may by like notice
specify an address to which notices and communications shall thereafter be sent.
If to Roche Bioscience:
Roche Bioscience With a copy to:
3401 Hillview Avenue Roche Bioscience
Palo Alto, CA 94304 A division of Syntex (U.S.A.) Inc.
Attention: Vice President, Neurobiology 3401 Hillview Avenue
Palo Alto, CA 94304
Fax: (650)852-1932 Attn: Vice President, Legal Affairs
Fax: (650) 852-1338
If to Axys:
With a copy to:
Axys Pharmaceuticals, Inc. Axys Pharmaceuticals, Inc.
180 Kimball Way 11099 N. Torrey Pines Road, Suite 160
South San Francisco, CA 94080 La Jolla, CA 92037
Attention: Senior Director, Legal
Attention: President and Chief Operating Officer
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Fax: (619) 452-6653 Fax: (619) 452-4378
If to F. Hoffmann-La Roche Ltd. With a copy for both F. Hoffmann-La
Roche Ltd and Hoffmann-La Roche,
Inc. to Roche Bioscience
Vice President, Legal
Affairs at the address above.
F. Hoffmann-La Roche Ltd
Corporate Law, Building 21
H-4070 Basel
Switzerland Fax: 41-61-688-1396
If to Hoffmann-La Roche, Inc.
Hoffmann-La Roche, Inc.
General Counsel
340 Kingsland St
Nutley, New Jersey 07110-1199 Fax: 973-235-3500
14.5 GOVERNING LAW. 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, without regard to the choice of law provisions
of it or any other jurisdiction.
14.6 WAIVER. Except as specifically provided for herein, the waiver from
time to time by 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.
14.7 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 alter-native 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.
14.8 ENTIRE AGREEMENT. This Agreement sets forth all of the covenants,
promises, agreements, warranties, representations, conditions and understandings
among the Parties hereto, and supersedes and terminates all prior agreements and
understanding among the Parties with respect to the subject matter hereof. There
are
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no covenants, promises, agreements, warranties, representations conditions or
understandings, either oral or written, among 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.
14.9 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.
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed in duplicate by their duly authorized officers as of the Effective
Date.
ROCHE BIOSCIENCE, A DIVISION OF AXYS PHARMACEUTICALS, INC.
SYNTEX (U.S.A.) INC.
By: /s/ Roger Whiting By:
--------------------------------- --------------------------------------
Name: Roger Whiting Name:
------------------------------- ------------------------------------
Name: /s/ James N. Woody
-------------------------------
Name: James N. Woody
-------------------------------
NEMAPHARM, INC. SEQUANA THERAPEUTICS, INC.
By: /s/ Daniel H. Petree By: /s/ Daniel H. Petree
--------------------------------- --------------------------------------
Name: Daniel H. Petree Name: Daniel H. Petree
------------------------------- ------------------------------------
Title: Title:
------------------------------- ------------------------------------
For purposes of Sections 4.1.2, 4.4 and 4.7.2 only:
F. HOFFMANN-LA ROCHE LTD. HOFFMANN-LA ROCHE, INC.
By: /s/ Claudius Wamlek By: /s/ Stefan Arnold
--------------------------------- --------------------------------------
Name: Claudius Wamlek Name: Stefan Arnold
------------------------------- ------------------------------------
36.
41
Title: Title:
------------------------------- ------------------------------------
37.
42
EXHIBIT 1.45
ROCHE BIOSCIENCE GENES
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
43
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
2.
44
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
3.
45
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
4.
46
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
5.
47
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
6.
48
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
7.
49
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
8.
50
EXHIBIT A
RESEARCH PLAN
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
9.
51
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
10.
52
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
11.
53
[*]
* "Certain confidential information contained in the document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended."
12.