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EXHIBIT 10.15
CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4), 200.83
AND 230.406 * INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST THAT IS FILED SEPARATELY WITH THE COMMISSION
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
BETWEEN
ROCHE BIOSCIENCE
AND
ALANEX CORPORATION
JUNE 27, 1996
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COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
THIS AGREEMENT is entered into on June 27, 1996 (the "Effective Date"),
by the between ROCHE BIOSCIENCE, a division of Syntex (U.S.A.) Inc., a Delaware
corporation, having offices at 0000 Xxxxxxxx Xxxxxx, Mail Stop R7-101, Xxxx
Xxxx, Xxxxxxxxxx 00000 ("Roche Bioscience"), and ALANEX CORPORATION, a
California corporation having offices at 0000 Xxxxxxx Xxxxxxx Xxxxx, Xxx Xxxxx,
Xxxxxxxxxx 00000 ("Alanex"). Roche and Alanex may be referred to herein as a
"Party" or, collectively, as "Parties."
WHEREAS, Alanex has developed and owns certain drug discovery
technology and intellectual property rights, including feature extraction and
chemical library design software, combinatorial organic synthesis methods, high
throughput biological screening assays and medicinal chemistry;
WHEREAS, Roche Bioscience, together with its Affiliates, has
substantial experience in the pre-clinical and clinical development of
therapeutic agents and the distribution, marketing and sale of such agents as
pharmaceuticals;
WHEREAS, the Parties desire to engage in collaborative research
regarding a drug discovery and optimization program intended to discover or
identify small molecule antagonists of ***** that have potential for being
developed as therapeutic drugs, as generally described in the Research Plan (as
defined below);
WHEREAS, if the research collaboration is successful, the resulting
compounds may have application in the therapeutic treatment of diseases in
humans; and
WHEREAS, Roche Bioscience and Alanex are interested in entering into a
collaborative research and licensing arrangement under which Roche Bioscience
shall develop and commercialize certain selected compounds resulting from such
research.
NOW, THEREFORE, the Parties agree as follows:
SECTION 1 DEFINITIONS
As used herein, the following terms shall have the following meanings:
1.1 "Affiliate" means an individual, trust, business trust, joint
venture, partnership, corporation, association or any other entity which owns,
is owned by or is under common ownership with a Party. For the purposes of this
definition, the term "owns" (including, with correlative meanings, the terms
"owned by" and "under common ownership with") as used with respect to any
Party, shall mean the possession (directly or indirectly) of at least 51% of
the outstanding voting securities of a corporation or comparable equity
interest in any other type of entity; provided, however, Genentech, Inc., with
offices located at 000 Xxxxx Xxx Xxxxx Xxxxxxxxx, Xxxxx Xxx Xxxxxxxxx,
Xxxxxxxxxx, 00000, shall not be considered an Affiliate of Roche Bioscience.
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1.2 "Agreement" means the present agreement together with all
appendices and schedules.
1.3 "Alanex Discovery Technology" means Alanex's proprietary drug
discovery technology, pharmacophore directed parallel synthesis, including
AlaSyn)(TM) for parallel organic chemical synthesis, LiBrain(TM) for design of
exploratory and targeted chemical libraries, and Alanet(TM) for pharmacophore
hypothesis generation.
1.4 "Alanex Compound" means any Compound that is synthesized by
Alanex at the direction of the Research Management Committee during the
Research Term and within the scope of the Research Plan.
1.5 "Alanex Know-How" means Know-How which (a) Alanex or an Alanex
Affiliate discloses to Roche Bioscience under this Agreement and (b) is at the
Effective Date or during the Research Term within the control of Alanex or an
Alanex Affiliate.
1.6 "Alanex Compound Patent Rights" means all Patent Rights
Controlled by Alanex or an Affiliate of Alanex necessary or appropriate for the
full exploitation of the Field, where such Patent Rights cover (a) Inventions
related to the Alanex Compounds made by employees or agents of Alanex or an
Affiliate of Alanex after the Effective Date and prior to the end of the
Research Term in connection with activities conducted pursuant to the Research
Plan, or (b) any such Inventions which come under the Control of Alanex or its
Affiliates after the Effective Date and prior to the end of the Research Term.
1.7 "Collaboration" means the activities, rights and obligations of
Alanex and Roche Bioscience encompassed in their relationship in accordance
with the terms and conditions of the Research Plan.
1.8 "Compound" means any compound or agent that exhibits a binding
affinity to a molecular target equal to a pKi of seven (7) or greater
targeted at the ***** receptor, the *** receptors (if the option is
exercised in accordance with Section 5.2 hereof) or any replacement target
substituted for ***** pursuant to Section 2.3 hereof.
1.9 "Confidential Information" means all information and materials
received by either Party from the other Party pursuant to this Agreement and
all information and materials developed in the course of the Collaboration,
including, without limitation, Know-How of each Party.
1.10 "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 any Third Party.
1.11 "FDA" means the United States Food and Drug Administration.
1.12 "Field" means the use of any Compound for the therapeutic
treatment (including prophylactic treatment) of diseases and disorders in
humans.
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1.13 "FIRST COMMERCIAL SALE" of a Product shall mean the first sale
for use or consumption of such Product in a country after required marketing
and pricing approval has been granted by the governing health regulatory
authority of such country. Sale to an Affiliate or sublicensee shall not
constitute a First Commercial Sale unless the Affiliate or sublicensee is the
end user of the Product.
1.14 "FTE" means one full time-equivalent qualified scientist.
1.15 "INVENTION" means any discovery or invention made during the
course of the Research and within the scope of the Research Plan.
1.16 "KNOW-HOW" means techniques, data, materials and chemicals
relating to the Field, including, without limitation, inventions, techniques,
practices, methods, knowledge, know-how, skill, experience, test data,
including pharmacological, toxicological and clinical marketing, sales and
manufacturing data.
1.17 "LEAD-COMPOUND" means any Roche Bioscience Compound or
Alanex Compound which compound (i) satisfies the Preclinical Development
Criteria and (ii) is selected for development by Roche Bioscience pursuant to
Section 6.1.
1.18 "LEAD COMPOUND PATENT RIGHTS" means all Patent Rights necessary or
appropriate for the full exploitation of the Lead Compound.
1.19 "MAJOR EUROPEAN COUNTRY" means Germany, France, United Kingdom,
Italy, or Spain.
1.20 "NDA" means a New Drug Application or Product License
Application, as appropriate, and all supplements filed pursuant to the
requirements of the FDA, including all documents, data and other information
concerning Products which are necessary for or included in FDA approval to
market a Product, or the equivalent application in any other country.
1.21 "Net Sales"*****************************************************
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1.22 **************** means sub-type selective peptidic and
non-peptidic antagonists and agonists to ************* that have been
identified by Alanex or are in the public domain and are available through
Alanex.
1.23 "PATENT" means (i) valid and enforceable Letters Patent,
including any extension (including Supplemental Protection Certificate),
registration, confirmation, reissue, continuation, divisionals,
continuation-in-part, reexamination or renewal thereof, and (ii) pending
applications for any of the foregoing.
1.24 "PATENT PROTECTED" means that a Product is covered by a Valid
Claim of Roche Bioscience Patent Rights or the Alanex Compound Patent Rights
with respect to such Product.
1.25 "PATENT RIGHTS" means all rights existing during or after the
term of this Agreement under (a) patents (including inventor's certificates)
that include one or more Valid Claims, including without limitation any
substitution, extension, registration, confirmation, reissue, re-examination,
renewal or the like and (b) pending applications for patents, including without
limitation any continuation, division or continuation-in-part thereof and any
provisional applications.
1.26 "PATENT COSTS" means the fees and expenses paid to outside
legal counsel and other Third Parties, and filing, prosecution and maintenance
expenses, incurred in connection with the establishment and maintenance of
rights under Patents.
1.27 "PHASE I" means that portion of the clinical development
program which generally provides for the first introduction into humans of a
product with the primary purpose of determining safety, metabolism and
pharmacokinetic properties and clinical pharmacology of the product, as more
closely defined by the rules and regulations of the FDA and corresponding rules
and regulations in other Major European Countries or Japan.
1.28 "PHASE II" means that portion of the clinical development
program which provides for the initial trials of a product on a limited number
of patients for the primary purpose of evaluating safety, dose ranging and
efficacy in the proposed therapeutic indication, as more closely defined by the
rules and regulations of the FDA and corresponding rules and regulations in
other Major European Countries or Japan.
1.29 "PHASE III" means that portion of the clinical development
program which provides for the continued trials of a product on sufficient
numbers of patients to establish the safety and efficacy of a product for the
desired claims and indications, as more closely defined by the rules and
regulations of the FDA and corresponding rules and regulations in other Major
European Countries or Japan.
1.30 "PRECLINICAL DEVELOPMENT" means the preclinical investigations
and other work performed on a Lead Compound necessary to generate the data
required to initiate clinical development, commencing at such time as the Lead
Compound has been recommended for such preclinical development by the Research
Management Committee and approved by Roche Bioscience.
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1.31 "PRECLINICAL DEVELOPMENT CRITERIA" means the preclinical
development criteria set forth in Appendix A.
1.32 "PRODUCT" means any form or dosage of an Alanex Compound or a
Roche Bioscience Compound discovered or identified using the Alanex Discovery
Technology during the course of this Collaboration or the manufacture, use or
sale of which is otherwise covered by one or more of Alanex Compound Patent
Rights and Alanex Know-How. Without limiting the foregoing, Product includes
any analog of an Alanex Compound or Roche Bioscience Compound or any derivative
compound developed from such compound using the Alanex Discovery Technology.
1.33 "RESEARCH" means all work performed by Alanex and Roche Bioscience
in the Field during the Research Term directed toward or in connection with the
discovery, identification, synthesis and investigation of Compounds in
accordance with the Research Plan.
1.34 "RESEARCH MANAGEMENT COMMITTEE" means a committee of Alanex and
Roche Bioscience employees as described in Section 3 below.
1.35 "RESEARCH TERM" means the period commencing on the first of the
month following the Effective Date and ending on the third anniversary of such
commencement date, subject to extension as contemplated by Section 2.4 and
subject to early termination in accordance with Section 13.
1.36 "ROCHE BIOSCIENCE COMPOUND" means any Compound that is identified
by Roche Bioscience prior to the Effective Date and is part of the Research.
Roche Bioscience Compounds shall be listed on Schedule I and such Schedule I
shall be updated from time to time.
1.37 "ROCHE BIOSCIENCE KNOW-HOW" means Know-How which (a) Roche
Bioscience discloses to Alanex under this Agreement, and (b) is at the
Effective Date or during the Research Term within the Control of Roche
Bioscience; provided, however, that Roche Bioscience Know-How shall not include
Know-How of Affiliates of Roche Bioscience or under the Control of Affiliates
of Roche Bioscience.
1.38 "ROCHE BIOSCIENCE PATENT RIGHTS" means all Patent Rights
Controlled by Roche Bioscience necessary or appropriate for the full
exploitation of the Field, where such Patent Rights cover (a) inventions made
prior to the Effective Date of this Agreement, (b) inventions made solely by
employees or agents of Roche Bioscience after the Effective Date and prior to
the end of the Research Term, or (c) inventions which come under the Control of
Roche Bioscience after the Effective Date and prior to the end of the Research
Term; provided, however, that Roche Bioscience Patent Rights shall not include
Patent Rights of Affiliates of Roche Bioscience or under the Control of
Affiliates of Roche Bioscience. A list of the Roche Bioscience Patent Rights as
of the Effective Date is set forth on Schedule III.
1.39 "ROYALTY TERM" means, in the case of any Product, in any country,
the period of time commencing on the First Commercial Sale and ending upon the
later of (a) ten (10)
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***** from the date of First Commercial Sale in such country; or (b) the
expiration of the last to expire of the rights included in the Roche Patent
Rights or the Alanex Compound Patent Rights covering such Products in such
country.
1.40 "THIRD PARTY" means any entity other than Alanex or Roche
Bioscience or an Affiliate or sublicensee of Alanex or Roche Bioscience.
1.41 "VALID CLAIM" means a claim of an issued patent which claim has
not 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.
SECTION 2 RESEARCH COLLABORATION
2.1 SCOPE OF COLLABORATION. Roche Bioscience and Alanex will conduct
the Research on a collaborative basis with the goal of identifying Compounds
which are subsequently characterized as Lead Compounds that are suitable for
development into Products for commercialization.
2.2 EXCLUSIVITY. During the Research Term, neither Alanex nor its
Affiliates shall conduct or fund or enter into any agreement with any
sublicensee or Third Party which provides for the conduct or funding of
research, development or commercialization of products directed toward the
Field except pursuant to the terms of this Agreement. During the Research Term,
Roche Bioscience shall not enter into any agreement with a Third Party which
provides for the conducting or funding of any research involving the
application of combinatorial chemistry technologies with the objective of
identifying a lead compound which has its primary mechanism of action through
binding to the *************** (or any replacement target substituted for
******* pursuant to Section 2.3 hereof). If the **** option described in Section
5.2 is exercised by Roche Bioscience, the provisions set forth in this Section
2.2 shall be deemed amended to include the *******. Nothing herein shall
limit the ability of the Parties to enter into agreements with contract
research organizations, academic institutions, and similar entities for the
performance of Research activities in the ordinary course of their respective
businesses.
2.3 TARGET SUBSTITUTION. At any time during the Research Term, the
definition of Compound may be amended upon mutual written agreement of the
Parties to provide for the substitution of a new molecular target.
2.4 EXTENSION OF RESEARCH TERM. The Research Term shall commence on
the first of the month following the Effective Date and shall continue at least
until the third anniversary of the Effective Date. Not fewer than 180 days
prior to the third anniversary of the Effective Date, each Party shall inform
the other whether it wishes to continue the Research. If both Parties wish to
continue the Research, the Parties shall negotiate in good faith during such
180-day period in order to define mutually acceptable terms for an extension of
the Research Period. If the Parties are unable to agree upon mutually agreeable
terms for
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an extension of the Research Period, such failure to agree shall not be
considered a breach of the terms of this Agreement and the Research Term shall
not be extended.
SECTION 3 RESEARCH MANAGEMENT COMMITTEE
3.1 Formation of Research Management Committee. The Research will be
managed by the Research Management Committee comprised of an equal number of
members appointed by each of Roche Bioscience and Alanex; provided that the
size of the Research Management Committee shall not exceed a total of eight
members. Either Party may appoint substitute or replacement members of the
Research Management Committee to serve as their representatives. The initial
members of the Research Management Committee will be appointed by the Parties
within 30 days following the Effective Date. The Research Management Committee
shall have the responsibility and authority to: (a) plan and monitor the
Research, (b) assign tasks and responsibilities under the Research Plan to
Alanex and Roche Bioscience, respectively, subject to the terms and conditions
of this Agreement which may not be amended except in accordance with Section
16.11 hereof (c) review and modify the Research Plan, as it shall deem
appropriate to achieve the Parties' objectives under this Agreement, subject to
the terms and conditions of this Agreement which may not be amended except in
accordance with Section 16.11 hereof (d) review data related to Compounds to
evaluate whether such Compounds satisfy the Preclinical Development Criteria,
and (e) recommend Compounds to Roche Bioscience for selection as Lead
Compounds. Notwithstanding the provisions of this Section 3.1, the Research
Management Committee shall not have the authority to amend the Preclinical
Development Criteria.
3.2 Meetings of Research Management Committee. The Research Management
Committee will initially meet at least three times per year at locations and
times to be determined by the Research Management Committee, with the intent of
meeting at alternating locations in San Diego, California and Palo Alto,
California, with each Party to bear all travel and related costs for its
members.
3.3 Decision-Making Process. All decisions made or actions taken by
the Research Management Committee will be made unanimously by its members with
the Alanex members cumulatively having one vote and the Roche Bioscience
members cumulatively having one vote. Any disagreement which cannot be resolved
by the vote of the Research Management Committee shall be referred to the
appropriate officers of Alanex and Roche Bioscience for resolution under
Section 15.2. If a disagreement is still unresolved, Roche Bioscience shall make
the final decision in its sole discretion. It is the intent of the Parties to
resolve issues through the Research Management Committee whenever possible and
to refer issues to the officers of Alanex and Roche Bioscience only when
resolution through the Research Management Committee cannot be achieved.
SECTION 4 CONDUCT OF RESEARCH
4.1 Research. The Parties agree that the Research shall be conducted
in accordance with the initial Research Plan attached hereto as Exhibit A, as
such Research Plan
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may be amended from time to time in writing by the Research Management
Committee. The Parties currently expect that, under the Research Plan, Alanex
will have primary responsibility for Research relating to the identification of
Compounds and Lead Compounds, and that Roche Bioscience will have primary
responsibility for the pre-clinical development of all Lead Compounds.
4.2 RESEARCH EFFORTS. Each Party shall use commercially reasonable
and diligent efforts (as defined below) to perform its responsibilities under
the Research Plan. In particular, Roche Bioscience will provide Research funding
to Alanex pursuant to Section 8.1 to support at Alanex a minimum of ***********
in Year 1, ************ in Year 2, and ********** in Year 3, all in
accordance with the Research Plan. In addition, Roche Bioscience shall have the
option to increase the number of FTEs in a given year to up to ****** for such
year, upon reasonable notice to Alanex. Except as expressly provided in Section
8.1, or as agreed from time to time by the Parties, each of Roche Bioscience and
Alanex will bear all of its own expenses incurred in connection with the
Research. As used herein, the term "commercially reasonable and diligent
efforts" will mean, unless the Parties agree otherwise, those efforts consistent
with the exercise of prudent scientific and business judgment, as applied to
other products of similar scientific and commercial potential within the
relevant product lines of Roche Bioscience and its Affiliates.
4.3 AVAILABILITY OF RESOURCES. Each Party will maintain laboratories,
offices and all other facilities necessary to carry out the Research. Each
Party agrees to make its employees and non-employee consultants reasonably
available at their respective places of employment to consult with the other
Party on issues arising during the Collaboration and in connection with any
request from any regulatory agency, including, without limitation, regulatory,
scientific, technical and clinical testing issues. Representatives of Alanex
and Roche Bioscience may, upon reasonable notice and at times reasonably
acceptable to the other Party (a) visit the facilities where the Collaboration
is being conducted; and (b) consult informally, during such visits and by
telephone and electronic mail, with personnel of the other Party performing
work on the Collaboration.
4.4 DISCLOSURE; REPORTS. During the Research Term, Roche Bioscience
and Alanex will make available and, upon request, disclose to each other all
Know-How regarding Compounds discovered or synthesized by Roche Bioscience or
Alanex in the course of the Collaboration for use in accordance with this
Agreement. All such Know-How which is significant will be disclosed to the
other Party promptly after it is learned or its significance is appreciated.
Each Party will make summary presentations of Research progress at each meeting
of the Research Management Committee. Each Party will also communicate
informally and through the Research Management Committee to inform the other of
Research done under this Agreement. Each Party will provide the other with raw
data in original form or photocopies thereof for any and all work carried out
under this Agreement as reasonably requested by the other Party hereto. To
avoid potential conflicts of interest, Alanex shall not disclose compound class
or structural data to outside members of its Scientific Advisory Board. In
addition and also to avoid potential conflicts of interest, Alanex shall not
disclose compound class or structural data to outside members of its Board of
Directors except as is necessary in order for the directors to fulfill their
fiduciary duties as directors of Alanex.
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SECTION 5 POTENTIAL EXPANSION OF THE FIELD
5.1 MATERIAL TRANSFER AGREEMENT. The Parties agree to enter into a
Material Transfer Agreement in the form attached hereto as Exhibit B as of the
Effective Date (the "Material Transfer Agreement"). Pursuant to the terms of the
Material Transfer Agreement, Alanex will provide Roche Bioscience with ***
******* for a 90-day period (the "Option Period") commencing on the Effective
Date. During the Option Period, Roche Bioscience will conduct pharmacology
studies employing the *************** After completion of the Option Period,
Roche Bioscience will (i) return all unused materials to Alanex, and (ii)
provide a written summary of research results of the research pharmacology to
Alanex within 30 days of completion of the Option Period. With the written
approval of Alanex, *********** may remain in the possession of the Roche
Bioscience beyond the 90-day period, if both parties agree that additional
testing is needed.
5.2 OPTION TO EXPAND THE FIELD. At any time during the Option Period,
Roche Bioscience may elect to expand the Field to include one or more ***
********************************************** Roche Bioscience shall notify
Alanex of such election in writing. Upon Roche Bioscience's election, (i) the
definition of Compound as set forth in this Agreement shall be expanded as
mutually agreed in writing by the Parties, (ii) the number of appropriately
qualified scientists (measured on a full time equivalent basis) supported by the
Research funding pursuant to Section 4.2 will be increased by an additional
************ in Year 1 and (iii) the Research funding to be provided by Roche
Bioscience pursuant to Section 8.1 shall be increased on a pro-rata basis of
******** per FTE per year. At the end of year 1, the parties will address
amending the Research Plan and the number of FTEs per year in order to further
the Research with a comparable level of support to what is currently in the
Research Plan.
SECTION 6 DEVELOPMENT
6.1 SELECTION OF LEAD COMPOUNDS. Following the identification of a
Compound, the further optimization and characterization of such Compound and
the collection of data on such Compound, the Research Management Committee
shall determine whether such Compound satisfies the Preclinical Development
Criteria. The Research Management Committee shall notify Roche Bioscience in
writing when a Compound is determined to have satisfied the Preclinical
Development Criteria (the "RMC Notice"). Roche Bioscience shall have a 90-day
period beginning on the date of the RMC Notice in which to select such Compound
for development by providing written notice of such election to Alanex. If
Roche Bioscience selects such Compound, the Compound will then be considered a
Lead Compound for purposes of this Agreement and Roche Bioscience shall have
the exclusive license to such Lead Compound, its analogues, all
structurally-related compounds, and progenitors of the Lead Compound back to
and including the predecessor Compound, as contemplated by Section 7.2. If
Roche Bioscience does not select such Compound and if Roche Bioscience is not
developing a structurally-related compound on which Roche Bioscience will be
paying Milestones and Royalties under this Agreement, Alanex shall retain all
rights to such Compound; provided, however, that Alanex cannot conduct any
research with respect to or sublicense such Compound in the Field until
termination of this Collaboration. If Roche
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Bioscience (or its Affiliates or sublicensees) terminates the development of a
Lead Compound and if Roche Bioscience (or its Affiliates or sublicensees) is
not developing any other Lead Compound under this Agreement directed at the
same molecular target, Alanex shall retain all rights to such Lead Compound;
provided, however, that Alanex cannot conduct any research with respect to or
sublicense such Lead Compound in the Field until termination of this
Collaboration. Roche Bioscience can discontinue the development of a Lead
Compound or Product at any time in its sole discretion.
6.2 DEVELOPMENT ACTIVITIES. All preclinical and clinical development
necessary or appropriate for the registration of Lead Compounds shall be
designed and conducted by Roche Bioscience or its designees. Roche Bioscience
will keep Alanex informed of the progress of development of each Lead Compound
and Alanex may provide input with respect to development matters, as
appropriate. Roche Bioscience will be responsible for selecting Lead Compounds
for development. The expenses of all preclinical and clinical development of the
Lead Compounds shall be paid by Roche Bioscience.
6.3 DILIGENCE. Roche Bioscience shall use commercially reasonable and
diligent efforts (as defined in Section 4.2 above) to develop each Lead
Compound and commercialize each Product, taking into account the scientific and
commercial potential for such Product. Alanex may provide 90 days written
notice to Roche Bioscience if, in its opinion, Roche Bioscience is not using
commercially reasonable and diligent efforts, in order for the Parties to
discuss the situation and for Roche Bioscience to make diligent and continuing
efforts to rectify the situation during such 90 day period. In the event that
the Parties are unable to resolve their differences within such 90 day period,
such dispute shall be submitted for resolution in accordance with Section 15.
SECTION 7 GRANT OF LICENSES
7.1 RESEARCH LICENSE. Roche Bioscience grants to Alanex, during the
Research Term, the non-exclusive paid-up worldwide license in the Field, with
the right to grant sublicenses to Affiliates only, under the Roche Bioscience
Patent Rights and Roche Bioscience Know-How to make and use methods and
materials for the sole purpose of carrying out the Research.
7.2 COMMERCIALIZATION LICENSE. Alanex hereby grants to Roche
Bioscience an exclusive, worldwide, royalty-bearing license, with the right to
grant sublicenses subject to Section 7.3 below, under the Alanex Compound
Patent Rights and Alanex Know-How related to the Lead Compounds, to develop,
make, have made, use, offer for sale, sell and import Products; provided,
however, that except as specifically contemplated by Sections 6.1 and 6.2,
Alanex shall have no right to use such Alanex Compound Patent Rights and Alanex
Know-How related to the Lead Compounds, to develop, make, have made, use, offer
for sale, sell and import Products during the term of this Agreement. No rights
or licenses, express or implied, are granted to Roche Bioscience for the Alanex
Discovery Technology.
7.3 SUBLICENSES. Any sublicenses under this Section 7 shall contain
terms comparable to Section 11, and no sublicense shall relieve Roche
Bioscience or Alanex of any
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obligation under this Agreement. Within 30 days after the grant of any
sublicense, Roche Bioscience will provide written notice to Alanex of the
granting of the sublicense.
SECTION 8 PAYMENT OBLIGATIONS
8.1 RESEARCH FUNDING. Roche Bioscience agrees to fund the Research at
Alanex during the Research Term in the amount of ******** per FTE per year.
Such annual funding shall be payable in advance in four equal quarterly
installments during each calendar year on or before January 1, April 1, July 1,
and October 1. Any payment for a portion of a quarter shall be made on a pro
rata basis. The first such payment shall be made on the Effective Date. Such
annual Research funding shall be increased appropriately in the event that the
Research Management Committee determines that the number of scientists
conducting Research at Alanex should be increased.
8.2 PROJECT INITIATION FEE. Roche Bioscience shall pay Alanex a
non-refundable, non-contingent project initiation fee of $4,000,000, payable in
two installments. The first payment of $2,000,000 shall be made upon the
execution of this Agreement. The second payment of $2,000,000 shall be made on
October 31, 1996.
8.3 MILESTONE PAYMENTS. Within 30 days after receipt of notice that
each of the milestones set forth below has been completed by Alanex, Roche
Bioscience or any sublicensee of Roche Bioscience, Roche Bioscience shall pay
to Alanex the non-refundable milestone payment set forth below:
(a) upon the identification by Alanex of the first Compound
directed at a particular molecular target, such as ********* with a Ki <100nM
if ***************************************************** ********
if ***************************************************** ********
if ****************************************************** ********
(b) ******** upon the selection by Roche Bioscience of the
first Lead Compound directed at a particular molecular target, such as *****
(c) ******* upon the initiation of Phase I for the first
Product containing a Lead Compound directed at a particular molecular target,
such as *****
(d) ******* upon the initiation of Phase II for the first
therapeutic indication for each Product containing a Lead Compound;
(e) ********** upon the initiation of Phase III for the
first therapeutic indication for each Product containing a Lead Compound;
(f) ********** upon the first NDA approved for the first
therapeutic indication for each Product containing a Lead Compound in the U.S.;
and
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(g) ********** upon the first NDA-equivalent filing approved
for the first therapeutic indication for any Product containing a Lead Compound
in a Major European Country or Japan.
The first achievement of each of the milestone events described in Section
8.3(a)-(c) need not be by the same Compound. Roche Bioscience will be obligated
to make the milestone payments set forth above in Section 8.3(a)-(c) only one
time with respect to each molecular target, such as *****. Notwithstanding the
foregoing, separate Milestone Payments with respect to Section 8.3(d)-(g) shall
not be paid with respect to any particular Product if it represents a change in
form or dosage of such product for which Milestones have previously been paid.
8.4 ROYALTIES
(a) Roche Bioscience shall pay to Alanex the following royalty
on Net Sales of each Product based on or incorporating any Lead Compound and
sold by Roche Bioscience or its Affiliates or sublicensees:
(i) ** of Net Sales in all countries where Patent
Protected on the portion of aggregate annual worldwide Net Sales up to
************* and
(ii) ** of Net Sales in all countries where Patent
Protected on the portion of aggregate annual worldwide Net Sales exceeding
*************
(iii) **** of Net Sales in all countries where a
Product is not Patent Protected.
(b) If Roche Bioscience is required to pay royalties to a
third party (other than an Affiliate of Roche Bioscience), to make, use or sell
Product for which Roche Bioscience is currently paying royalties to Alanex to
avoid infringing such third party's patent rights (the "Additional Royalties"),
then the Royalties to be paid to Alanex by Roche Bioscience pursuant to this
Agreement shall be ************************** of the amount of the Additional
Royalties, provided, however, that at no time during the Royalty Term will
Alanex receive less than a **** royalty on Net Sales whether or not there is
Patent Protection.
(c) Royalties for Net Sales of any Product in any given
country shall be paid for a period equal to the Royalty Term for such Product
in such country.
SECTION 9 PAYMENT; RECORDS; AUDITS
9.1 PAYMENT; REPORTS. All royalty payments due to either Party under
this Agreement shall be paid within 60 days 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 Products in
sufficient detail to permit confirmation of the accuracy of the royalty
payment made.
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9.2 EXCHANGE RATE; MANNER AND PLACE OF PAYMENT. Royalty payments and
reports for the sale of Products shall be calculated and reported for each
calendar quarter. With respect to each quarter, for countries other than the
United States, whenever for the purpose of calculating royalties conversion
from any foreign currency shall be required, such conversion shall be made as
follows:
(i) when calculating the Adjusted Gross Sales, the amount of such
sales in foreign currencies shall be converted into Swiss Francs as computed in
the central Roche's Swiss Francs Sales Statistics for the countries concerned,
using the average monthly rate of exchange at the time for such currencies as
retrieved from the Reuters System;
(ii) when calculating the royalties on Net Sales, such conversion
shall be at the average rate of the Swiss Franc to the United States dollar as
retrieved from the Reuters System for the applicable calendar quarter.
All payments owed under this Agreement shall be made by wire transfer, unless
otherwise specified by the receiving Party.
9.3 LATE PAYMENTS. In the event that any payment, including royalty,
milestone and research payments, due hereunder is not made when due, the
payment shall accrue interest from the date due at the rate of 1.5% per month;
provided that in no event shall such rate exceed the maximum legal annual
interest rate. The payment of such interest shall not limit any Party from
exercising any other rights it may have as a consequence of the lateness of any
payment.
9.4 RECORDS AND AUDIT.
(a) During the term of this Agreement and for a period of two
years thereafter, Roche Bioscience shall keep complete and accurate records
pertaining to the sale or other disposition of Products in sufficient detail to
permit Alanex to confirm the accuracy of all payments due hereunder. Alanex
shall have the right to cause an independent, major (big six) certified public
accountant firm reasonably acceptable to Roche to audit such records to confirm
Roche Bioscience's Net Sales for the preceding year. Any information obtained
during such audit shall be treated as Confidential Information. Such audits may
be exercised during normal business hours once a year upon at least thirty (30)
working days' prior written notice to Roche Bioscience. Alanex shall bear the
full cost of such audit unless such audit discloses a variance of more than 5%
from the amount of the Net Sales reported by Roche Bioscience for such audited
period. In such case, Roche Bioscience shall bear the full cost of such audit.
The terms of this Section 9.4 shall survive any termination or expiration of
this Agreement for a period of two years.
(b) During the term of this Collaboration and for a period of two
years thereafter, Alanex shall keep complete and accurate records documenting
the time spent by Alanex employees in direct support of the Collaboration.
Roche Bioscience shall have the right to audit such records to confirm Alanex
time records and research costs for the preceding year upon thirty (30) working
days' prior written notice. Such audits may be exercised during normal business
hours once a year upon notice to Alanex.
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9.5 TAXES. All turnover and other taxes levied on account of the
royalties and other payments accruing to each Party under this Agreement shall
be paid by the Party receiving such royalty or other payment for its own
account, including taxes levied thereon as income to the receiving Party. If
provision is made in law or regulation for withholding, such tax shall be
deducted from the royalty or other payment made by the Party making such
payment to the proper taxing authority and a receipt of payment of the tax
secured and promptly delivered to the Party entitled to the royalty. Each Party
agrees to assist the other Party in claiming exemption from such deductions or
withholdings under any double taxation or similar agreement or treaty from time
to time in force.
SECTION 10 PATENT RIGHTS AND INFRINGEMENT
10.1 OWNERSHIP OF ROCHE BIOSCIENCE PATENTS AND ALANEX COMPOUND
PATENTS. Alanex shall retain all right, title and interest in and to any Alanex
Compound Patents and to the Alanex Discovery Technology, subject only to the
exclusive licenses expressly granted herein. Roche Bioscience shall retain all
right, title and interest in and to any Roche Bioscience Patents, subject only
to the licenses expressly granted herein.
10.2 DISCLOSURE OF PATENTABLE INVENTIONS. In addition to the
disclosures required under Section 4.4, each Party shall provide to the other
any invention disclosure submitted in the normal course and disclosing an
Invention arising in the course of the Collaboration. Such Invention
disclosures shall be provided to the other Party promptly after submission and
in no event later than 30 days after the disclosure was submitted to patent
counsel. In addition, the Research Management Committee will from time to time
provide information relating to Inventions and will recommend to the Parties
the filing of applications for Inventions it believes are patentable.
10.3 PATENT FILINGS.
(a) Alanex Compounds.
(i) The Parties intend to establish broad patent protection
for Alanex Compounds and other patentable inventions arising from the Research.
The parties intend that Roche Bioscience shall file and prosecute all patent
applications covering the Lead Compounds, but the parties recognize that some
initial patent work may need to be performed prior to the selection of Alanex a
Compound as a Lead Compound. Subject to the above, Alanex shall file and
prosecute all patent applications covering Inventions containing claims which
cover Alanex Compounds or other patentable inventions arising from the Research,
provided, however, that Alanex shall give Roche Bioscience the right of first
refusal to file and prosecute such Alanex Compound Patents on behalf of Alanex.
If Roche Bioscience declines such opportunity, Alanex shall file and prosecute
such Alanex Compound Patents, using counsel reasonably acceptable to Roche
Bioscience. Upon selection of such Compound as a Lead Compound (the "Selection
Date"), Alanex shall turn over to Roche Bioscience all files relating to such
Patent filing and prosecution and Roche Bioscience shall have full
responsibility for such Patent filing and prosecution. Roche Bioscience shall
pay Alanex for all Patent Costs incurred up to the Selection Date of filing,
prosecuting and maintaining such
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Patents necessary to protect such Lead Compound. Alanex shall provide invoices
of Patent Costs as costs are incurred and Roche Bioscience shall reimburse
Alanex within 30 days of the invoice date. The Parties shall each bear their
own internal costs and expenses of filing, prosecuting and maintaining such
Alanex Compound Patents. Roche Bioscience shall maintain all Patents that issue
on such applications.
(ii) If Roche Bioscience elects not to handle the filing or
prosecution of such Patent, Alanex shall provide Roche Bioscience with drafts
of any patent application covering Alanex Compounds or other patentable
inventions arising from the Research prior to filing that application, allowing
adequate time for review and comment by Roche if possible; provided, however,
that Alanex shall not be obligated to delay the filing of any patent
application. Roche shall maintain any such patent application in confidence,
pursuant to Section 11.
(iii) If Alanex decides, at any time, not to file or maintain
an application or a Patent as provided hereunder, it shall give Roche notice to
this effect and upon such notice Roche shall have the right, but not the
obligation, to file and maintain, such application or Patent, in its own name
and at its own expense, and, if it so elects to file and maintain, Alanex shall
assign to such other Party the rights in such application or Patent.
(b) Lead Compounds.
(i) To the extent not previously filed in accordance with
Subsection 10.3(a) above, Roche Bioscience shall file and prosecute all patent
applications covering Inventions containing claims which cover Lead Compounds
or other patentable inventions arising from the Research. Roche Bioscience
shall bear all Patent Costs of filing, prosecuting and maintaining such Lead
Compound Patents. Roche Bioscience shall maintain all Patents that issue on
such applications.
(ii) Roche Bioscience shall provide Alanex with drafts of any
patent application covering Lead Compounds prior to filing that application,
allowing adequate time for review and comment by Alanex if possible; provided,
however, that Roche Bioscience shall not be obligated to delay the filing of
any patent application. Alanex shall maintain any such patent application in
confidence, pursuant to Section 11.
(iii) If Roche Bioscience decides on a world-wide basis, at any
time, not to file or maintain an application on all Lead Compound Patents as
provided hereunder, it shall give Alanex notice to this effect and upon such
notice Alanex shall have the right, but not the obligation, to file and
maintain, such applications or Patents, in its own name and at its own expense,
and, if it so elects to file and maintain, Roche Bioscience shall assign to
such other Party the rights in such applications or Patents.
10.4 ENFORCEMENT RIGHTS.
(a) DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS. If a Third Party
asserts that a patent or other right owned by it is infringed by the
manufacture, use or sale of any Product, Roche Bioscience shall be solely
responsible for defending against any such
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assertions at its cost and expense.
(b) INFRINGEMENT BY THIRD PARTIES WITH RESPECT TO PRODUCTS. If
any Patent is infringed by a Third Party in any country in connection with the
manufacture, use and sale of any Product in such country, the Party to this
Agreement first having knowledge of such infringement shall promptly notify the
other in writing. The notice shall set forth the facts of that infringement in
reasonable detail. Roche Bioscience shall have the primary right, but not the
obligation, to institute, prosecute, and control any action or proceeding with
respect to such infringement, by counsel of its own choice against such third
party in the name of Alanex and/or in the name of Roche Bioscience, and to join
Alanex as a party plaintiff (at Roche Bioscience's expense) if required, and
Alanex shall have the right, at its own expense, to be represented in any
action involving an Alanex Patent by counsel of its own choice. If Roche
Bioscience fails to bring an action or proceeding within a period of 120 days
after having knowledge of infringement of an Alanex Patent, Alanex shall have
the right to bring and control any such action by counsel of its own choice, and
Roche Bioscience shall have the right to be represented in any such action by
counsel of its own choice at its own expense. If one Party brings any such
action or proceeding, the other Party agrees to be joined as a Party plaintiff
if necessary to prosecute the action and to give the first Party reasonable
assistance and authority to file and prosecute the suit.
(c) MONETARY AWARDS. Any damages or other monetary awards
recovered shall be allocated first to the costs and expenses of the Party
bringing suit, then to the costs and expenses, if any, of the other Party. Any
amounts remaining shall be allocated two-thirds to the Party bringing suit and
one-third to the other Party. A settlement or consent judgment or other
voluntary final disposition of a suit under Sections 10.4(b) may be entered
into only with the consent of the Party not bringing the suit, which consent
shall not be unreasonably withheld.
SECTION 11 CONFIDENTIALITY
11.1 NONDISCLOSURE. During the term of this Agreement and for a period
of five years after termination thereof, each Party will maintain all
Confidential Information in trust and confidence and will not disclose any
Confidential Information to any third Party or use any Confidential Information
for any purpose except (i) as expressly authorized by this Agreement, (ii) as
required by law or court order, (iii) as provided in Section 11.3, or (iv) to
its Affiliates. Each Party may use such Confidential Information only to the
extent required to accomplish the purposes of this Agreement. Each Party will
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 Information. Each Party will promptly
notify the other upon discovery of any unauthorized use or disclosure of
the Confidential Information.
11.2 EXCEPTIONS. Confidential Information shall not include any
information which the receiving Party can prove by competent evidence:
(a) is now, or hereafter becomes, through no act or failure to
act on the part
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of the receiving Party, generally known or available;
(b) is known by the receiving Party at the time of receiving
such information, as evidenced by its records;
(c) is hereafter furnished to the receiving Party by a third
Party, as a matter of right and without restriction on disclosure;
(d) is independently developed by the receiving Party without
the aid, application or use of Confidential Information; or
(e) is the subject of a written permission to disclose provided
by the disclosing Party.
11.3 FINANCIAL TERMS. The Parties agree that the material financial
terms of this Agreement will be considered Confidential Information of both
Parties. Notwithstanding the foregoing, either Party may disclose such terms as
are required to be disclosed in its financial statements or under strictures of
confidentiality to bona fide potential sublicensees. Either Party shall have
the further right to disclose the material financial terms of this Agreement
under strictures of confidentiality to any potential acquiror or merger
partner.
11.4 PUBLICATIONS. Each Party to this Agreement recognizes that the
publication of papers regarding results of Research hereunder and other
information resulting from the Collaboration, including oral presentations and
abstracts, may be beneficial to both Parties provided such publications are
subject to reasonable controls to protect Confidential Information. In
particular, it is the intent of the Parties to maintain the confidentiality of
any Confidential Information included in any foreign patent application until
such foreign patent application has been published. Accordingly, each Party
shall have the right to review and approve any paper proposed for publication
by the other Party, including oral presentations and abstracts, which utilizes
data generated from the Collaboration and/or includes Confidential Information
of the other Party. Before any such paper is submitted for publication, the
Party proposing publication shall deliver a complete copy to the other Party at
least 45 days prior to submitting the paper to a publisher. The receiving Party
shall review any such paper and give its comments to the publishing Party
within 30 days of the delivery of such paper to the receiving Party. With
respect to oral presentation materials and abstracts, the Parties shall make
reasonable efforts to expedite review of such materials and abstracts, and
shall return such items as soon as practicable to the publishing Party with
appropriate comments, if any, but in no event later than 30 days from the date
of delivery to the receiving Party. The publishing Party shall comply with the
other Party's request to delete references to such other Party's Confidential
Information in any such paper and agrees to withhold publication of same for an
additional 180 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.
SECTION 12 REPRESENTATIONS, WARRANTIES AND COVENANTS
12.1 CORPORATE POWER. Each Party hereby represents and warrants that
such Party
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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.
12.2 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.
12.3 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.
12.4 DISCLAIMER OF WARRANTIES. The Parties understand that the
Research will involve technologies that have not been approved by any
regulatory authority and that neither Party guarantees the safety or usefulness
of any Alanex Compound, Roche Bioscience Compound, Lead Compound or Product.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY
REPRESENTATION OR WARRANTY TO THE OTHER PARTY OF ANY NATURE, EXPRESS OR
IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF NONINFRINGEMENT,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
12.5 MUTUAL INDEMNIFICATION. Each Party hereby agrees to save, defend
and hold the other Party and its officers, directors, employees, consultants
and agents harmless from and against any and all 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, Compounds 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 12.5. In the event either Party seeks indemnification under this
Section 12.5, it shall inform the other Party of a claim as soon as reasonably
practicable after it receives notice of the claim, shall permit the other Party
to assume direction and control of the defense of the claim (including the
right to settle the claim solely for monetary consideration), and shall
cooperate as requested (at the expense of the other Party) in the defense of
the claim.
SECTION 13 TERM AND TERMINATION
13.1 TERM. The term of this Agreement will begin on the Effective Date
and terminate at the end of the Royalty Term unless terminated earlier in
accordance with the provisions of Section 13.2 or 13.3 or 13.4.
13.2 TERMINATION BY MUTUAL AGREEMENT. After the expiration of the
Research Term, the Parties may terminate this Agreement by written agreement
executed by both
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*CONFIDENTIAL TREATMENT REQUESTED
Alanex and Roche Bioscience.
13.3 TERMINATION FOR CAUSE. Either Party may terminate this Agreement
upon 60 days' written notice upon the occurrence of any of the following:
(a) 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
(b) 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
within the 60-day period following written notice of termination by the other
Party.
13.4 TERMINATION WITHOUT CAUSE. Following the end of the first twelve
month of this Agreement, Roche Bioscience may terminate this Agreement at any
time without cause upon six months notice, provided, however, that for the first
three months of the notice period, Roche Bioscience shall ********************
********************************************************************************
previously agreed upon by the Research Management Committee for such **********
********************************************************************************
************************************************************* in existence at
the time notice was given or (ii) the ******** previously agreed upon by the
Research Management Committee for such ****************** period. At the end
of the notice period, Roche Bioscience shall ******************************
*********************.
13.5 EFFECT OF EXPIRATION OR TERMINATION.
(a) Expiration or termination of this Agreement shall not
relieve the Parties of any obligation accruing prior to such expiration or
termination. Except as otherwise specifically set forth in this Section 13 or
elsewhere in this Agreement, the obligations and rights of the Parties under
Sections 7.2, 7.3, 8.4, 11, 12.4, 12.5, 13.5, 15 and 16 shall survive
termination or expiration of this Agreement.
(b) In the event that the Parties terminate this Agreement
under Section 13.2 or Roche Bioscience terminates this Agreement under Section
13.3, without limiting any remedies otherwise available to Roche Bioscience,
(i) all licenses granted by Roche Bioscience to Alanex hereunder shall
terminate and revert to Roche Bioscience, (ii) the licenses set forth in
Section 7.2 shall continue, and (iii) Alanex shall return to Roche Bioscience
all Confidential Information of Roche Bioscience. The royalties owed by Roche
Bioscience to Alanex shall be as set forth in Section 8.4, if Roche Bioscience
terminates this agreement under Section 13.3.
(c) In the event that the Parties terminate this Agreement
under Section 13.2 or Alanex terminates this Agreement under Section 13.3,
without limiting any remedies otherwise available to Alanex, (i) all licenses
granted by Alanex to Roche hereunder shall terminate and revert to Alanex, and
(ii) Roche Bioscience shall return to Alanex all
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Confidential Information of Alanex.
SECTION 14 PUBLICITY
14.1 PUBLICITY REVIEW. Roche Bioscience and Alanex will jointly
discuss and agree, based on the principles of Section 14.2, on any statement to
the public regarding the execution and the subject matter of this Agreement,
the Research to be conducted by the Parties under this Agreement, or any other
aspect of this Agreement, except with respect to disclosures required by law or
regulation. Within 30 days following the Effective Date, the Parties shall
issue a joint press release. Neither party shall use the name of the other
party in any public statement, prospectus, annual report, or press release
without the prior written approval of the other party, which may not be
unreasonably withheld or delayed, provided, however, that both parties shall
endeavor in good faith to give the other party a minimum of five business days
to review such press release, prospectus, annual report, or other public
statement; and provided, further, that either party may use the name of the
other party in any public statement, prospectus, annual report, or press
release without the prior written approval of the other party, if such party is
advised by counsel that such disclosure is required to comply with applicable
law.
14.2 STANDARDS. In the discussion and agreement referred to in
Section 14.1, the principles observed by Roche Bioscience and Alanex will be
accuracy, the requirements for confidentiality under Section 11, the advantage
a competitor of Roche Bioscience or Alanex may gain from any public or Third
Party statements under Section 14.1, 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
Alanex.
SECTION 15 DISPUTE RESOLUTION
15.1 DISPUTES. The Parties recognize that disputes as to certain
matters may from time to time arise during the term of this Agreement which
relate to either Party's rights and/or obligations hereunder or thereunder. It
is the objective of the Parties to establish procedures to facilitate the
resolution of disputes arising under this Agreement in an expedient manner by
mutual cooperation and without resort to litigation. To accomplish this
objective, the Parties agree to follow the procedures set forth in this Section
15 if and when a dispute arises under this Agreement between the Parties or
among the Research Management Committee.
15.2 DISPUTE RESOLUTION PROCEDURES. If the Parties or the Research
Management Committee cannot resolve the dispute within 20 days of formal
request by either Party to the other, any Party may, by written notice to the
other, have such dispute referred to their respective officers designated below
or their successors, for attempted resolution by good faith negotiations within
30 days after such notice is received. Said designated officers are as follows:
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For Roche Bioscience: Head of Neurobiology Business Unit
For Alanex: Chief Executive Officer
15.3 ARBITRATION. Any such dispute arising out of or relating to this
Agreement which is not resolved between the Parties or the Research Management
Committee or the designated officers of the Parties pursuant to the foregoing
shall be resolved by final and binding arbitration conducted in San Diego
County, California under the then current Licensing Agreement Arbitration Rules
of the American Arbitration Association ("AAA"); provided, however, that
depositions shall be permitted as follows: each Party may take no more than
three depositions with a maximum of six hours of examination time per
deposition, and each such deposition shall take place in San Diego County,
California, unless otherwise agreed by the Parties. The arbitration shall be
conducted by one arbitrator who is knowledgeable in the subject matter which is
at issue in the dispute and who is selected by mutual agreement of the Parties
or, failing such agreement, shall be selected according to the AAA rules. In
conducting the arbitration, the arbitrator shall apply the California Evidence
Code, and shall be able to decree any and all relief of an equitable nature,
including but not limited to such relief as a temporary restraining order, a
preliminary injunction, a permanent injunction, or replevin of property. The
arbitrator shall also be able to award actual, general or consequential
damages, but shall not award any other form of damage (e.g., punitive damages).
The Parties shall share equally the arbitrator's fees and expenses pending the
resolution of the arbitration unless the arbitrator, pursuant to its right but
not its obligations, requires the non-prevailing Party to bear all or any
portion of the costs of the prevailing Party. The decision of the arbitrator
shall be final and may be sued on or enforced by the Party in whose favor it
runs in any court of competent jurisdiction at the option of such Party.
SECTION 16 MISCELLANEOUS
16.1 ASSIGNMENT
(a) Notwithstanding any provision of this Agreement to the
contrary, either Party may assign any of its rights or obligations under this
Agreement in any country in any Affiliates; provided, however, that such
assignment shall not relieve the assigning Party of its responsibilities for
performance of its obligations under this Agreement.
(b) Either Party may also assign its rights or obligations under
this Agreement in connection with the sale of all or substantially all of its
assets, or may otherwise assign its rights or obligations under this Agreement
with the prior written consent of the other Party. This Agreement shall survive
any merger of either Party with or into another Party and no consent for a
merger or similar reorganization shall be required hereunder; provided, that in
the event of such merger or in the event of a sale of all assets, no
intellectual property rights of the acquiring corporation shall be included in
the technology licensed hereunder.
(c) 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
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Agreement shall be void.
16.2 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, explosion, flood, strike, lockout, embargo, act of God, or
any other similar cause beyond the control of the defaulting Party, provided
that the Party claiming force majeure has exerted all reasonable efforts to
avoid or remedy such force majeure.
16.3 PAYMENT IN U.S. DOLLARS. All payments due to either Party under
this Agreement shall be paid in U.S. Dollars.
16.4 RETAINED RIGHTS. Nothing in this Agreement shall limit in any
respect the right of either Party to conduct research and development with
respect to and market products outside the Field using such Party's technology
including Know-How and Patent Rights.
16.5 NOTICES. Any notices or communications provided for in this
Agreement to be made by either of the Parties to the other shall be in writing,
in English, and shall be made by prepaid air mail with return receipt addressed
to the other at its address set forth above. Any such notice or communication
may also be given by hand, or facsimile to the appropriate designation. Either
Party may by like notice specify an address to which notices and communications
shall thereafter be sent. Notices sent by mail, facsimile or cable shall be
effective upon receipt and notices given by hand shall be effective when
delivered.
16.6 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.
16.7 WAIVER. Except as specifically provided for herein, the waiver
from time to time by either of the Parties of any of their rights or their
failure to exercise any remedy shall not operate or be construed as a
continuing waiver of same or of any other of such Party's rights or remedies
provided in this Agreement.
16.8 SEVERABILITY. If any term, covenant or condition of this
Agreement or the application thereof to any Party or circumstance shall, to any
extent, be held to be invalid or unenforceable, then (a) the remainder of this
Agreement, or the application of such term, covenant or condition to Parties or
circumstances other than those as to which it is held invalid or unenforceable,
shall not be affected thereby and each term, covenant or condition of this
Agreement shall be valid and be enforced to the fullest extent permitted by
law; and (b) the Parties hereto covenant and agree to renegotiate any such
term, covenant or application thereof in good faith in order to provide a
reasonably acceptable alternative to the term, covenant or condition of this
Agreement or the application thereof that is invalid or unenforceable, it being
the intent of the Parties that the basic purposes of this Agreement are to be
effectuated.
16.9 INDEPENDENT CONTRACTORS. It is expressly agreed that Alanex and
Roche Bioscience shall be independent contractors and that the relationship
between the two Parties
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shall not constitute a partnership or agency of any kind. Neither Alanex nor
Roche Bioscience shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other, without the prior written authorization of such other
Party to do so.
16.10 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.
16.11 ENTIRE AGREEMENT. This Agreement and the Material Transfer
Agreement between the Parties of even date herewith set forth all of the
covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto and supersede and terminate all prior
agreements and understandings between the Parties. There are no covenants,
promises, agreements, warranties, representations conditions or understandings,
either oral or written, between the Parties other than as set forth herein and
therein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties hereto unless reduced to writing
and signed by the respective authorized officers of the Parties.
IN WITNESS WHEREOF, the Parties have executed this Agreement in
duplicate originals by their proper officers as of the date and year first
above written.
ROCHE BIOSCIENCE, A DIVISION OF ALANEX CORPORATION
SYNTEX (U.S.A.) INC.
By: /s/ Xxxxx X. Xxxxx By: /s/ Xxxxxx X. Xxxxx
-------------------------------- ------------------------
Xxxxx X. Xxxxx, M.D., Ph.D. Xxxxxx X. Xxxxx, M.D.
President President and Chief
Executive Officer
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APPENDIX A
Pre-clinical Development Criteria
All of the following criteria must be met to be considered a lead compound:
Affinity pKi of 8 or greater
Selectivity At least 100 fold affinity over other receptor
subtypes of the same receptor family or other
receptors as designated by the Research
Management Committee
Oral Bioavailability Oral bioavailability in rat and one other
species of (greater than or equal to) 25%
Plasma Half-Life Plasma half-life in rat greater than 4 hours
Appendix A - Page 1
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*CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 1
************
*******
Schedule 1 - Page 1
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*CONFIDENTIAL TREATMENT REQUESTED
Exhibit A
******* RESEARCH PLAN
GOAL: To identify and initiate the clinical development of a selective
**************** antagonist.
Phase I: Evaluate relevant pharmacophore information, establish high
throughput assays, and initiate screening of Alanex compound
database. Initiate development of new chemistry methodology for
the synthesis targeted libraries.
Alanex computational chemistry will begin an analysis of the pharmacophore
requirements for binding to the various ************** in order to facilitate
the design of new combinatorial libraries with the goal of creating compounds
that display selectivity for the ****************.
Alanex will obtain from Roche Bioscience cell lines that have been transfected
with the human **************** and the protocol for the binding assay in
order to adapt the assay for high throughput screening at Alanex. If necessary
to expedite the project, Alanex will purchase membrane preparations prepared
from cells that contain the receptor. Alanex will establish the **************
binding assay within six weeks of receiving the appropriate cell line
from Roche Bioscience. Once the high throughput screen for ****************
is established, testing of the Alanex compound database for activity at
**************** will commence.
Alanex will begin development of new synthetic strategies in preparation for
the development of targeted libraries, and in order to extend the range of
exploratory libraries.
Phase II: Complete screening of Alanex database. Design, synthesize and
screen targeted libraries. Initial determination of receptor
selectivity.
Based on the results of screening and the computational modeling of known
compounds, Alanex will design novel targeted libraries, using precursors
synthesized at Alanex as well as those obtained from commercial sources. Active
compounds will be tested for binding activity in a variety of assay systems in
order to determine the selectivity profiles for different chemical series. The
types of assays will be determined by the Research Management Committee.
Modification of active compounds by both combinatorial and medicinal chemistry
methods will proceed.
Phase III: Optimization of active compounds. Detailed pharmacological
analysis of most active compounds. Establish optimization plan
for most active series.
Highly active compounds will be extensively characterized and further optimized
according to a plan established by the Research Management Committee.
Exhibit A - Page 1
28
THE RESEARCH MANAGEMENT COMMITTEE
Based on the Research Drug Discovery Plan, the Research Management Committee
will hold an initial meeting, within 30 days of the signing of the Research
Collaboration Agreement, to define the specific goals for the first 6 months of
the collaboration.
The Initial representatives from Alanex will be:
Xxxx Xxxxxxxx, Ph.D. Vice President, Chemistry
Xxxx Xxx, Ph.D. Director, Pharmacology
Xxxx Xxxxxx, Ph.D. Director, New Lead Discovery
The Initial representatives from Roche Bioscience will be:
Xxxxx Xxxxx, Ph.D. Distinguished Scientist
Xxxxxx Xxxxxx, Ph.D. Department Head, Receptor/Ion Channel Group
Third Member Open
Exhibit A - Page 2
29
EXHIBIT B
Material Transfer Agreement
Submitted as Exhibit 10.16 to this Registration Statement
EXHIBIT B - PAGE 1
30
