Exhibit 10.44
COLLABORATIVE RESEARCH AND LICENSE
AGREEMENT
BETWEEN
THE PHARMACIA & UPJOHN COMPANY
AND
AURORA BIOSCIENCES CORPORATION
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
THIS AGREEMENT is entered into as of the Effective Date by and between THE
PHARMACIA & UPJOHN COMPANY, a company organized and existing under the laws of
the State of Delaware and having offices at 00 Xxxxxxxxx Xxxxx, Xxxxxxxxxxx, Xxx
Xxxxxx, 00000-0000 ("P&U"), and AURORA BIOSCIENCES CORPORATION, a Delaware
corporation having offices at 00000 Xxxxxxxxx Xxxx, Xxx Xxxxx, Xxxxxxxxxx 00000
("Aurora").
RECITALS
WHEREAS, Aurora has expertise in the development of screening systems and
screening biologies/chemistries used therein; and
WHEREAS, Aurora has the scientific expertise and capacity to undertake the
alliance activities described below; and
WHEREAS, P&U desires screen development and screening services and has the
capability to undertake screening and development of drug products for the
prevention and treatment of human diseases and disorders.
NOW, THEREFORE, in consideration of the foregoing premises and of the covenants,
representations and agreements set forth below, the parties agree as follows:
1. DEFINITIONS
As used herein, the following terms shall have the following meanings:
"Affiliate" means any corporation, association or other entity, which directly
or indirectly controls, is controlled by or is under common control with the
party in question. As used herein, the term control shall mean direct or
indirect beneficial ownership of more than *** of the voting or income interest
in such corporation or other business entity.
"Agreement" means this agreement, together with all appendices, exhibits and
schedules hereto, and as the same may be amended or supplemented from time to
time hereafter by a written agreement duly executed by authorized
representatives of each party hereto.
"Aurora Copyrights" means all copyrights throughout the world Controlled by
Aurora.
"Aurora Patent Rights" means the Patent Rights Controlled by Aurora described in
Exhibit 2 attached hereto.
"Aurora Reporter" means any of the reporters described in Exhibit 1.2 attached
hereto.
"Aurora Screen Development Resource" shall have the meaning set forth in Section
2.2.1.
*** Confidential Treated Requested
1
"Aurora Screening Program" shall have the meaning set forth in Section 2.1.5.
"Aurora Technology" means Technology Controlled by Aurora necessary for Aurora
Reporters.
"Collaborative Period" means the period during which the parties are developing
Collaborative Screens and ending on the first anniversary of the Effective Date
unless extended by mutual agreement or concluded earlier in accordance with
Section 9.
"Collaborative Screen" means ***.
"Collaborative Screen Program or CSP" shall have the meanings set forth in
Section 2.1.
"Compound" means ***.
"Compound Supply" shall have the meaning set forth in Section 2.1.6.
"Confidential Information" means all confidential information, data, and
materials received by either party from the other party pursuant to this
Agreement, which if in writing is marked confidential, and all information,
data, and materials developed pursuant to this Agreement which if in writing is
marked confidential, including, without limitation, Technology of each party,
subject to the exceptions set forth in Section 6.1.3.
"Control" or "Controlled" means, with respect to intellectual property,
possession by a party of the ability to grant a license or sublicense in
accordance with the terms of this Agreement, and without violating the terms of
any agreement by such party with any Third Party that is in effect on the
Effective Date.
"Copyrights" means rights that protect expression in a tangible form, such as
the U.S. Copyright Laws.
"CSP Steering Committee" shall have the meaning set forth in Section 2.1.1.
"CSP Work Plan" shall have the meaning set forth in Section 2.1.3.
"Derivative" means ***.
*** Confidential Treated Requested
2
"Development Compound" means ***.
"Effective Date" means the date that this Agreement is signed by the last party
to sign below.
"FDA" shall mean the United States Food and Drug Administration, or any
successor agency having regulatory jurisdiction over the manufacture,
distribution and sale of drugs in the United States or equivalent in any other
jurisdiction.
"Hit" means ***.
"IND" means the first to occur of the following: (i) the filing with and
acceptance by the FDA of an Investigational New Drug application; or (ii) any
corresponding application filed in any country other than the United States; or
(iii) the first administration of a Development Compound into a human subject.
"Internal Research" means ***.
"Invention" means any new and useful process, machine, manufacture, or
composition of matter, or improvement thereto, whether or not patentable.
"Know-How" means information and data which is not generally known to the
public, comprising: designs, concepts, algorithms, formulae, software,
techniques, practices, processes, methods, knowledge, skill, experience,
expertise and technical information.
"Licensee" means a Third Party to whom P&U or its Affiliates grants a license,
sublicense or other right to manufacture, use, sell, offer for sale, distribute
and/or import one or more Products or Development Compounds.
"Licensor" means a Third Party that grants P&U or its Affiliates a license,
sublicense or other right to manufacture, use, sell, offer for sale, distribute
and/or import one or more Products or Development Compounds.
*** Confidential Treated Requested
3
"Manufacturing Cost" means the cost to Aurora and its Affiliates of raw
materials, energy, labor (salary and benefits) and reasonable *** in accordance
with generally accepted accounting methods consistently applied. If an item is
manufactured in whole or in part by a Third Party, the costs to be taken into
account shall be the amount paid to such Third Party plus any costs for raw
materials, energy, labor (salary and benefits) and reasonable overhead charges
that are incurred by Aurora in completing the manufacture and delivery.
"Materials" means any ***.
"NDA" means a new drug application or product license application, as
appropriate in the United States or a foreign equivalent in a foreign country.
"Net Sales" shall mean, with respect to Product(s), the gross amount invoiced to
customers for all Product(s) sold less the following items:
i) trade, quantity and cash discounts or rebates actually
allowed;
ii) credits, rebates, charge-back rebates, reimbursements or
similar payments granted or given to wholesalers and other
distributors, buying groups, health care insurance carriers,
governmental agencies and other institutions, and payments or
rebates granted or given in connection with government
sponsored health insurance programs but only to the extent
actually allowed;
iii) credits or allowances for rejection or return of Products
previously sold;
iv) any tax, tariff, duty or other governmental charge (other than
an income tax) levied on the sale, transportation or delivery
of a Product that is borne by the seller thereof and deducted
from sales under generally accepted accounting principles;
v) ***distribution allowance; and
vi) bad debt expense.
Such amounts shall be determined from the books and records of P&U maintained in
accordance with generally accepted accounting principles ("GAAP") consistently
applied.
"Patent Rights" means all U.S. or foreign (including regional authorities such
as the European Patent Office) regular or provisional patent applications,
including any continuation, continuation-in-part, or division thereof or any
substitute application therefor or equivalent thereof, and any patent issuing
thereon, including any reissue, reexamination or extension thereof and any
confirmation patent or registration patent or patent of additions based on any
such patent, containing one or more claims to an Invention (and in the case of
an issued patent, containing one or more Valid Claims), and for which a party
hereto owns or Controls, individually or jointly, any title thereto or rights
thereunder.
*** Confidential Treated Requested
4
"Phase III Clinical Trial" means that portion of a clinical development program
which provides for the testing of a Development Compound designed to assess the
safety and efficacy of such a product on a sufficient number of human patients
to support an NDA.
"Product" means ***.
"P&U Copyrights" means all copyrights throughout the world Controlled by P&U.
"P&U Patent Rights" means Patent Rights Controlled by P&U.
"P&U Target" shall have the meaning set forth in Section 2.1.1.
"P&U Technology" means Technology Controlled by P&U.
"Royalty Term" means, in the case of any Product and as to any country, the
period of time commencing on the first commercial sale for use or consumption of
such Product in such country and ***: (i) the date that ***, or the Licensors or
Licensees covering the manufacture, use or sale of such ***, or (ii) the
***after the date of such first commercial sale for use or consumption of such
Product in such country.
"Screening Party" means a Third Party with a written contract with P&U to
perform screening services using test chemicals or chemical libraries owned by
such Third Party that are not otherwise accessible to P&U or Aurora.
"Selection Procedure" of ***set forth in Section ***.
"Technology" means Materials and Know-How.
"Term" means the period beginning on the Effective Date and terminating in
accordance with this Agreement, as set forth in Section 9.
"Third Party" means any entity other than Aurora or P&U.
"Tracking Record" shall have the meaning set forth in Section 4.4.2.
"Validation" shall have the meaning set forth in Section 2.1.4.
"Validation Criteria" shall mean the parameters, standards, and results
established by the CSP Steering Committee for each Collaborative Screen.
"Valid Claim" means: (a) an issued claim under an issued patent within the
Patent Rights, which has not (i) expired or been canceled, (ii) been declared
invalid by an unreversed and unappealable decision of a court or other
appropriate body of competent jurisdiction, (iii) been admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise, and/or (iv) been
abandoned; or (b) a claim included in a pending patent application within the
Patent Rights
*** Confidential Treated Requested
5
that is being actively prosecuted in accordance with this Agreement and which
has not been (v) canceled, (vi) withdrawn from consideration, (vii) finally
determined to be unallowable by the applicable governmental authority for
whatever reason (and from which no appeal is or can be taken), or (viii)
abandoned.
2. COLLABORATIVE SCREEN PROGRAM
2.1. COLLABORATIVE SCREEN PROGRAM.
For a period of ***following the Effective Date, the parties will
collaborate in the development and validation of Collaborative Screens
as part of a development program (the "Collaborative Screen Program or
CSP"). P&U and Aurora will collaborate to develop Collaborative Screens
at Aurora for high throughput screening during the Collaborative
Period.
2.1.1. CSP STEERING COMMITTEES. No later than *** after the
Effective Date, the parties shall establish a CSP
Steering Committee (the "CSP Steering Committee").
The mission of the CSP Steering Committee is to
manage the experimental science and all other matters
of the CSP including the selection of targets for
screen development at Aurora (each such target
provided by P&U is a "P&U Target") as provided for
under Section 2.1.2. The CSP Steering Committee shall
consist of ***representatives designated by P&U and
***representatives designated by Aurora. Each
representative to the CSP Steering Committee will
have ***resulting in each party having exactly ***.
The Executive Steering Committee (ESC) shall consist
of the vice president of CNS research of P&U and vice
president research Aurora. Each representative to the
ESC will have *** resulting in each party having
exactly ***.
The CSP Steering Committee will meet no later than
***after the Effective Date and at least *** per year
using mutually agreed upon meeting locations and
formats including tele- and video-conferencing. On an
alternating basis, one party shall promptly prepare
and deliver to the members of the CSP Steering
Committee minutes in respect thereof, for review and
approval of both parties. Decisions in the CSP
Steering Committee will be made by unanimous vote, at
a meeting where all ***voting representatives are
present. Issues that do not reach unanimous agreement
within the CSP Steering Committee and remain
unresolved will be forwarded to the ESC within
***working days. The ESC will meet as soon as
possible and resolve the disagreement no later than
***days from the date of receiving notice from the
CSP Steering Committee of the dispute. Decisions in
the ESC will be made by unanimous vote, at a meeting
where both voting representatives are present. The
absence of a unanimous decision by the ESC, all
scientific matters regarding a CSP Work Plan (defined
below), including those
*** Confidential Treated Requested
6
relating to nomination or priority of molecular
targets for screen development or screening at Aurora
but not contract matters shall be decided by the ESC
representative from P&U.
2.1.2. SCREEN SELECTION. Attached as Exhibit A is a list of
***P&U Targets for Collaborative Screen development.
Additional potential P&U Targets may be presented by
P&U to Aurora during the Collaboration Period.
The ***and those subsequently proposed in writing by
P&U ***that P&U reasonably believes to be amenable
for development for a high throughput screen using
Aurora Technology. Aurora may reasonably request
further information regarding the ***. Within ***days
of first receiving such information, Aurora shall
notify P&U in writing in the event that Aurora
reasonably believes that the development of a
Collaborative Screen ***is not consistent with
Aurora's Third Party obligations or if Aurora
believes that the development of a *** not reasonably
be scientifically ***feasible based on available
information and that information provided by P&U. If
Aurora *** proposed by P&U, Aurora will provide P&U
with reasons for declining to work on the proposed
target, to the extent that Aurora does not have to
reveal confidential information of a Third Party,
waive attorney client privilege ***. Consequently,
***Aurora may not have to provide ***.
2.1.3. SCREEN DEVELOPMENT.
2.1.3.1 CSP WORK PLAN. The CSP Steering Committee
will coordinate the preparation of a work plan (a
"CSP Work Plan"), which shall set forth the
respective responsibilities of the parties for the
development of each Collaborative Screen, and which
must be approved by the CSP Steering Committee. Each
such CSP Work Plan will also contain a description of
the specific deliverables and documentation to be
produced, the Aurora Technology to be used, the dates
by which such activities are expected to be
accomplished by the parties, and *** for each
Collaborative Screen.
*** Confidential Treated Requested
7
2.1.3.2 ***. The CSP Steering Committee will *** CSP
Work Plan, and the design and approval of ***) for
each Collaborative Screen within a time frame set by
the CSP Steering Committee that can satisfy the
objectives of the CSP Steering Committee and the
parties. Promptly following the approval of each CSP
Work Plan, the parties will use reasonable efforts to
commence their respective duties under the CSP Work
Plan for the development of the applicable
Collaborative Screen. All work under a CSP Work Plan
shall be performed in accordance with the provisions
of this Agreement, and each party will *** to
complete its obligations under the CSP Work Plan as
expeditiously as practicable.
2.1.4. ***COLLABORATIVE SCREENS. When Aurora ***the ***, a
written report describing the Collaborative Screen
and the data demonstrating compliance with the CSP
Work Plan including the Validation Criteria shall be
provided by Aurora to the CSP Steering Committee. The
CSP Steering Committee will *** according ***
("Validation") or ***the additional work, if any,
***. Within ***of such ***a Collaborative Screen
developed by Aurora and subject to the availability
of equipment, Aurora will ***accordance with Section
***, and ***of initiating such ***, and when so
directed in writing by P&U and consistent with
Aurora's Third Party obligations, ***.
2.1.5 ***AURORA. During the Collaborative Period,
P&U***Collaborative Screens ***pursuant to Section
***. The Collaborative Screens *** Aurora shall be
indicated in the corresponding CSP Work Plans. For
each Collaborative Screen developed pursuant to a CSP
Work Plan of Section 2.1.3, ***, Aurora will use
reasonable efforts ***pursuant to Section ***. Aurora
shall, with regard to each Collaborative Screen, ***
determined by the CSP Steering Committee and *** CSP
Steering Committee (such ***in each Collaborative
Screen ***an "Aurora ***"), ***the ***, will be
subject to the availability of appropriate equipment
and the feasibility of performing such Collaborative
Screen on that equipment. During the Collaborative
Period, Aurora will use reasonable efforts to provide
P&U with ***. P&U may request that ***Aurora using a
***Collaborative Screen and Aurora will use
reasonable efforts provide *** to P&U which is
dependent on the ***to be used to generate any
***additional ***as provided for in Section *** The
***for any given ***Screen will be ***.
*** Confidential Treated Requested
8
2.1.6 ***. P&U shall, at its expense, supply Aurora with
***by P&U ***. In the event that P&U desires to have
*** a *** (including a ***) owned, accessed or
Controlled by Aurora, the parties agree to negotiate
in good faith the terms and conditions under which
***. Any ***an Aurora ***will be provided in ***in a
standard ***with ***. The *** for each ***in writing
in the CSP Work Plan. Aurora agrees not *** to any
Third Party or to use it for any purpose other than
developing ***. Aurora will ***upon written notice by
P&U.
2.2 AURORA SCREEN DEVELOPMENT RESOURCE, TECHNOLOGY ACCESS AND
PAYMENTS.
Aurora will provide access to Aurora Technology, Aurora
Reporters, Aurora Patent Rights, and the Aurora Screen
Development Resource at Aurora to P&U as follows:
2.2.1 AURORA SCREEN DEVELOPMENT RESOURCE.
During the Collaborative Period, upon payment by P&U
of ***provided for in Section ***, Aurora will commit
the ***full-time Aurora personnel each of whom shall
spend *** (the "Aurora Screen Development Resource")
and who will use reasonable efforts to develop ***.
*** Confidential Treated Requested
9
2.2.2. PAYMENTS FOR TECHNOLOGY ACCESS AND SUPPORT OF THE
SCREEN DEVELOPMENT RESOURCE.
As ***for use of the Aurora Screen Development
Resource under Section 2.2.1 and access and ***Aurora
Technology to use Collaborative Screens ***Section
***, P&U shall pay ***. Such amount shall be payable
within ***of the ***.
2.2.3. PAYMENTS ***AURORA.
As ***for the ***during the Collaborative Period
pursuant ***, P&U will pay Aurora a non-refundable
payment *** *** *** the *** paid within ***and the
***of the Effective Date. For *** in ***, P&U will
pay Aurora, in advance, ***, ***, P&U will pay Aurora
in advance*** and, for ***, P&U will pay Aurora, in
advance, ***. Such payments will be *** related to
***.
2.3 MILESTONES AND ROYALTIES.
In addition to such payments as are made by P&U to Aurora
pursuant to Section 2.2.2 and 2.2.3 hereof, the following
payments shall be made to Aurora for each Collaborative
Screen:
2.3.1 MILESTONES. When ***following milestones, P&U will
*** and within ***of such ***, P&U will pay Aurora
the amount corresponding to such milestone. For each
Collaborative Screen, P&U *** milestone *** of
***that ***the following milestones***of milestones
will be paid ***.
*** Confidential Treated Requested
10
Milestone Amount ($US)
--------- ------------
***
2.3.2. ROYALTIES. With respect to each Product, P&U shall
pay a royalty on *** of such Product during the
Royalty Term for such Product. The royalty applicable
is the product of the worldwide ***summed from each
applicable country multiplied by the royalty rate of
***for each applicable quarter.
2.4 SUPPLY ***.
So long as P&U has made payments in accordance with Section
2.2. and 2.3 as applicable, at P&U's written request, Aurora
will use reasonable efforts to supply within *** after receipt
of a written purchase order therefor, ***use of ***Aurora as
provided for in Section ***. P&U will be charged for all
supplies so delivered at Aurora's Manufacturing Cost ***. P&U
will pay for ***.
***.
2.6. DEVELOPMENT OF PRODUCTS.
P&U will be responsible for all pre-clinical and clinical development,
including all regulatory filings, of Hits and Development Compounds
arising out of this Agreement at no expense to Aurora. P&U shall use
reasonable efforts, consistent with commercial business practices, to
conduct the activities associated with the development of any
Development Compound, all regulatory activities relating to the
manufacture, use or sale of any Development Compound or Product, and
the commercialization and marketing of any Product in any ***.
*** Confidential Treated Requested
11
3. INTELLECTUAL PROPERTY RIGHTS
3.1 GRANT OF RIGHTS FROM AURORA TO P&U.
3.1.1. LICENSE TO COLLABORATIVE SCREENS DEVELOPED BY AURORA.
Aurora, upon payment under Section 2.2, grants to P&U
***.
3.1.2 Except as expressly licensed in Section 3.1.1 P&U
covenants not to use the Aurora Patent Rights, Aurora
Reporters and Aurora Technology.
3.1.3 ***
*** Confidential Treated Requested
12
***.
3.2. GRANT OF RIGHTS FROM P&U TO AURORA.
P&U grants to Aurora a ***.
*** Confidential Treated Requested
13
3.3. OWNERSHIP OF INTELLECTUAL PROPERTY AND PROPERTY.
3.3.1. TRANSFER OF RIGHTS. All rights not expressly licensed
or assigned by P&U are retained by P&U. All rights
not expressly licensed or assigned by Aurora are
retained by Aurora. Except as otherwise expressly
provided in this Agreement, nothing in this Agreement
is intended to convey or transfer ownership by one
party to the other of any rights, title or interest
in any Confidential Information, Technology,
copyrights or Patent Rights owned or Controlled by a
party. Except as expressly provided for in this
Agreement, nothing in this Agreement shall be
construed as a license or sublicense by one party to
the other of any rights in any Technology,
copyrights, or Patent Rights owned or Controlled by a
party.
3.3.2. P&U INVENTIONS. P&U shall own all Inventions and
other Technology made solely by its employees and
agents, and all patent applications and patents
claiming such Inventions and other Technology. If P&U
has a license pursuant to Sections 3.1.1 or 3.1.2,
Aurora shall own such Inventions and other Technology
that consists of improvements relating to an Aurora
Reporter or Aurora Technology and P&U will assign the
same to Aurora.
3.3.3 AURORA INVENTIONS. Aurora shall own all Inventions
and other Technology made solely by its employees and
agents, and all patent applications and patents
claiming such Inventions and other Technology,
provided, however, that P&U will own all Inventions
and other Technology for P&U's Compounds (including
Hits, Derivatives, and Development Compounds from the
Compound Supply) and uses thereof conceived by Aurora
in performance of this Agreement and Aurora will
assign the same to P&U.
3.3.4. JOINT INVENTIONS. During the period from the
Effective Date to three (3) years thereafter, all
Inventions and other Technology conceived jointly by
employees or agents of P&U and employees or agents of
Aurora shall be owned by Aurora and P&U; provided,
however, that if a) P&U has a license pursuant to
Sections 3.1.1 or 3.1.2, Aurora will solely own such
Inventions and other Technology that consist of
improvements relating to an Aurora Reporter or Aurora
Technology and P&U will assign the same to Aurora and
b) P&U will solely own all Inventions and other
Technology relating to P&U's Compounds and
therapeutic uses thereof conceived by Aurora in
performance of this Agreement and Aurora will assign
the same to P&U.
*** Confidential Treated Requested
14
3.3.5 OTHER INVENTIONS. Any Inventions not included in
Sections ***be owned by their inventors.
3.3.6. INVENTORSHIP AND ASSIGNMENT. Inventorship of
patentable inventions shall be determined by U.S.
patent law. P&U and Aurora agree to execute all
documentation necessary to perfect all assignments of
Inventions, Technology and Patent Rights.
4. PAYMENTS OF ROYALTIES, ACCOUNTING FOR ROYALTIES AND RECORDS.
4.1. PAYMENT AND REPORTING.
The royalties due under Article 2 and as follows in this Article 4,
shall be paid within ***after the end of each calendar quarter period
in which such royalties are earned during the Royalty Term for each
Product. With each such quarterly payment, P&U shall furnish Aurora a
royalty statement setting forth on a country-by-country basis the
relevant sales information, including the total number of units of each
such Product sold and other information employed to calculate ***for
such Product.
4.2. CURRENCY OF PAYMENT.
All payments to be made under this Agreement, including the royalties
payable to Aurora by P&U, shall be paid in U.S. dollars by wire
transfer or other mutually acceptable means to a bank account
designated by Aurora. Translation of sales recorded in local currencies
to U.S. dollars will be performed in a manner consistent with P&U's
normal practices used to prepare its audited financial statements for
internal and external reporting purposes, which uses a widely accepted
source of published exchange rate.
4.3. TAXES WITHHELD.
Any income or other tax that P&U or any of its Affiliates, Licensees or
Licensors is required by a government agency to withhold and pay on
behalf of Aurora with respect to the royalties payable under this
Agreement shall be deducted from and offset against said royalties
prior to remittance to Aurora; provided, however, that in regard to any
tax so deducted, P&U shall give or cause to be given to Aurora such
assistance as may reasonably be necessary to enable Aurora to claim
exemption therefrom or credit therefor, and in each case shall furnish
Aurora proper evidence of the taxes paid on Aurora's behalf.
4.4. RECORDS.
4.4.1. ***ROYALTY CALCULATIONS. During the Royalty Term and
for ***from the date of each payment of royalties,
P&U shall keep complete and accurate records of sales
and all other information necessary to calculate
***of each Product in sufficient detail to allow the
accrued royalties to be determined accurately in
accordance with GAAP. Aurora, with reasonable written
notice to P&U, shall have the right to cause Aurora's
*** Confidential Treated Requested
15
nationally recognized independent, certified public
accountant to audit such records at the place or
places of business where such records are customarily
kept in order to verify the accuracy of the reports
of Net Sales and royalty payments. Such accountant
shall execute a confidentiality agreement prior to
entering P&U's premises, obligating such accountant
to keep all information disclosed to it confidential
and shall only be permitted to disclose to Aurora the
extent of any discrepancy between royalty payments
made by P&U hereunder and the actual royalty required
to be so paid. Aurora shall bear the full cost of
such audit unless such audit discloses a variance of
more than *** from the amount of the royalties due
under this Agreement, in which event, P&U shall bear
the full cost of such audit. Aurora agrees not to
disclose Confidential Information concerning royalty
payments and reports, and all information learned in
the course of any audit or inspection, except to the
extent necessary for Aurora to reveal such
information in order to enforce its rights under this
Agreement or if disclosure is required by law.
***
*** Confidential Treated Requested
16
4.4.2.2.Upon ***.
4.5. TRADE SECRET MILESTONES AND ROYALTY.
The parties acknowledge ***, either or both of which the parties
reasonably believe will lessen the time required to bring
pharmaceutical products to market and increase the efficiency of drug
discovery and development processes and technologies. Additionally, the
parties acknowledge that Aurora may not own or Control patent
applications or patents covering the manufacture, sale, use or
importation of a particular Development Compound or Product. ***.
5. INTELLECTUAL PROPERTY ENFORCEMENT AND DEFENSE OF CLAIMS
5.1. INTELLECTUAL PROPERTY ENFORCEMENT.
P&U and Aurora shall have the right, but not the obligation, to bring
proceedings against any Third Party for the inappropriate use,
including patent infringement, of Technology or Patent Rights solely
owned or Controlled by it, and at its own risk and expense. If one
party brings such action such party shall be entitled to control such
action, hire and retain counsel, make decisions, settle on any terms,
and retain any and all awards or damages obtained in any such
proceeding. At the request and expense of either party, the other party
shall give the requesting party all reasonable assistance required to
file and conduct any such proceeding.
5.2. DEFENSE OF INFRINGEMENT CLAIMS FOR P&U HITS, DEVELOPMENT
COMPOUNDS AND PRODUCTS.
Aurora will cooperate with P&U, at P&U's expense, in the defense of any
suit, action or proceeding against P&U and P&U's Affiliates or Aurora
alleging the infringement of the intellectual property rights of a
Third Party by reason of the manufacture, use or sale of a Hit,
Derivative, Compound, Development Compound, Product from a Compound
screened in a Collaborative Screen by P&U or Aurora. Each party shall
give the other party prompt written notice of the commencement of any
such suit, action, proceeding or claim of infringement. Aurora shall
give P&U full and sole authority, information and assistance necessary
to defend, hire counsel, make decisions or settle on any terms any such
suit, action or proceeding and Aurora shall execute all documents,
provide pertinent records, and take all other actions, including
requiring persons within its control to give testimony, which may be
reasonably required in connection with the defense or settlement of
such litigation.
*** Confidential Treated Requested
17
5.3. DEFENSE OF INFRINGEMENT CLAIMS FOR AURORA TECHNOLOGY AND
AURORA PATENT RIGHTS.
P&U will cooperate with Aurora, at Aurora's expense, in the defense of
any suit, action or proceeding against Aurora or P&U alleging the
infringement of the intellectual property rights of a Third Party by
reason of Aurora's or P&U's use of any Aurora Patent Rights and Aurora
Technology licensed to P&U under this Agreement. The parties shall
notify each other promptly in writing of the commencement of any such
suit, action, proceeding or claim of infringement. P&U shall give to
Aurora full and sole authority, information and assistance necessary to
defend, hire counsel, make decisions or settle on any terms any such
suit, action or proceeding and P&U shall execute all documents, provide
pertinent records, and take all other actions, including requiring
persons within its control to give testimony, which may be reasonably
required in connection with the defense or settlement of such
litigation.
6. TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY
6.1. CONFIDENTIALITY.
6.1.1. Subject to the terms and conditions of this
Agreement, P&U and Aurora each agree that, during the
term of this Agreement and for five (5) years
thereafter, it will keep confidential, and will cause
its Affiliates to keep confidential, all Confidential
Information that is disclosed to it or to any of its
Affiliates by the other party in connection with the
performance of this Agreement. Neither P&U nor Aurora
nor any of their respective Affiliates shall use the
other party's Confidential Information except as
expressly permitted in this Agreement.
6.1.2. P&U and Aurora each agree that any disclosure of the
other's Confidential Information to any officer,
employee, contractor, consultant, sublicensee or
agent of the other party or of any of its Affiliates
shall be made only if and to the extent necessary to
carry out its responsibilities under this Agreement
and to exercise the rights granted to it hereunder,
shall be limited to the extent consistent with such
responsibilities and rights, and shall be provided
only to such persons or entities who are bound to
maintain same in confidence in a like manner as the
party receiving same hereunder is so required. Each
party shall use reasonable efforts to take such
action, and to cause its Affiliates to take such
action, to preserve the confidentiality of each
other's Confidential Information, which shall be the
same efforts as it would customarily take to preserve
the confidentiality of its own Confidential
Information.
Either party may be required to disclose some
Confidential Information of the other party in a
patent application filed related to Compounds,
Technology or uses thereof. The disclosing party
shall limit this type of
*** Confidential Treated Requested
18
information to the minimum necessary and the
disclosing party shall inform the non-disclosing
party of exactly what Confidential Information will
be disclosed in the patent application at least two
(2) weeks before such application is filed.
Upon termination of this Agreement, each party, upon
the other's request, will return all the Confidential
Information received from the other party pursuant to
this Agreement, including all copies and extracts of
documents, within sixty (60) days of the request of
the other party. 6.1.3.
Confidential Information shall not include any
information, which the receiving party can prove by
competent evidence:
i) is now, or hereafter becomes, through no act or
failure to act on the part of the receiving party,
generally known or available;
ii) is known by the receiving party at the time of
receiving such information, as evidenced by its
records;
iii) is hereafter furnished to the receiving party
without restriction as to disclosure or use by a
Third Party lawfully entitled to so furnish same;
iv) is independently developed by the employees,
agents or contractors of the receiving party without
the aid, application or use of the disclosing party's
Confidential Information; or
v) is the subject of a written permission to disclose
provided by the disclosing party; or
vi) is provided by the disclosing party to a Third
Party without restriction as to confidentiality.
A party may also disclose Confidential Information of
the other where required to do so by law or legal
process, provided that, in such event, the party
required to so disclose shall give maximum practical
advance written notice of same to the other party and
will cooperate with the other party's efforts to
seek, at the request and expense of the other party,
all confidential treatment and protection for such
disclosure as is permitted by applicable law.
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 in
legal proceedings or as are required to be disclosed
in its financial statements, by law, or under
strictures of confidentiality to bona fide potential
sublicensees.
*** Confidential Treated Requested
19
Either party shall have the further right to disclose
the material financial terms of this Agreement under
strictures of confidentiality to any potential
acquirer, merger partner, bank, venture capital firm,
or other financial institution to obtain financing.
The parties agree that information developed pursuant
to the methods and use of a Collaborative Screen will
be considered Confidential Information of both
parties and shall be subject to the confidentiality
requirements of this Section 6.1. Notwithstanding the
foregoing, either party may disclose and use
information developed pursuant to the methods and use
of a Collaborative Screen that is not specific to a
target proposed by P&U for screen development and
screening under strictures of confidentiality to bona
fide sublicensees.
6.2. PUBLICATION OF RESULTS.
Subject to Section 6.1 hereof, results and data obtained by either
party in the course of a Collaborative Screen Program through use of an
Aurora Reporter may be submitted for publication by P&U in accordance
with P&U's customary practices, provided, however, that P&U shall
credit Aurora in such publication as the developer and/or provider of
the technology that produced, in part, the published results or data.
P&U shall send a copy of the proposed publication and shall allow
Aurora ***from the date of receipt in which to determine whether such
publication contains subject matter for which patent protection should
be sought prior to disclosure, or otherwise contains Aurora
Confidential Information. If no answer is received from Aurora within
***of receipt of the proposed publication, P&U shall be free to submit
such proposed publication.
6.3. PUBLICITY.
Except as required by law and as provided in this Article 6, neither
party may make any public announcement or otherwise disclose the terms
of this Agreement without the prior written consent of the other party,
which consent shall not be unreasonably withheld.
*** Confidential Treated Requested
20
7. PATENT PROSECUTION AND COPYRIGHTS
7.1. PATENTS.
The control and expense of the filing, prosecution (including an
opposition or interference) and maintenance of patents and patent
applications claiming Inventions will be the sole responsibility of the
party filing the patent application and the party not filing the patent
application will cooperate in such filing, prosecution and maintenance
of the validity of such patent position. P&U and Aurora will cooperate
in the filing, prosecution and maintenance of jointly owned patents and
patent applications claiming inventions conceived or made pursuant to
activities under Article 2, and share equally in the expenses incurred
thereto.
7.2. COPYRIGHTS.
The parties agree to treat and handle, to the maximum practical extent,
any copyrights owned or Controlled by a party in the same manner as
Patent Rights owned or Controlled by such party.
8. WARRANTIES AND INDEMNIFICATION
8.1. MUTUAL REPRESENTATIONS AND WARRANTIES.
The parties make the following representations and warranties to each
other:
8.1.1. CORPORATE POWER. Each party hereby represents and
warrants that such party (a) 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; (b) has the requisite
power and authority and the legal right to own and
operate its property and assets, to lease the
property and assets it operates under lease, and to
carry on its business as it is now being conducted;
and (c) is in compliance with all requirements of
applicable law, except to the extent that any
noncompliance would not have a material adverse
effect on the properties, business, financial or
other condition of it and would not materially
adversely affect its ability to perform its
obligations under the Agreement.
8.1.2. DUE AUTHORIZATION. Each party hereby represents and
warrants that such party (a) has the requisite power
and authority and the legal right to enter into the
Agreement and to perform its obligations hereunder;
and (b) has taken all necessary action on its part to
authorize the execution and delivery of the Agreement
and to authorize the performance of its obligations
hereunder and the grant of rights extended by it
hereunder.
*** Confidential Treated Requested
21
8.1.3. BINDING AGREEMENT. Each party hereby represents and
warrants to the other that (a) this Agreement has
been duly executed and delivered on its behalf and is
a legal and valid obligation binding upon it and is
enforceable in accordance with its terms; (b) 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; and (c) all necessary
consents, approvals and authorizations of all
governmental authorities and other persons required
to be obtained by it in connection with the Agreement
have been obtained.
8.1.4. ***.
8.2. WARRANTIES AND AURORA TECHNOLOGY.
Aurora represents and warrants to P&U as of the Effective Date the
following:
8.2.1. To the best knowledge of Aurora: (a) Aurora has the
lawful right to license (or sublicense as the case
maybe) to P&U in accordance with this Agreement
Aurora Patent Rights, Aurora Technology and Aurora
Copyrights; (b) the licensed Patent Rights were
properly filed and prosecuted; and (c) no Third Party
suits exist, to which licensed Patent Rights and
Copyrights are subject.
8.2.2. Except as set forth in Section 8.2.1 above, Aurora
(including its officers, employees and agents)
expressly disclaims any representations and
warranties, whether express or implied, relating to
Aurora Patent Rights, Aurora Copyrights and Aurora
Technology. Aurora further disclaims i) any express
or implied warranty of merchantability or fitness
for a particular purpose of Aurora Technology,
Aurora Copyrights and Aurora Patent Rights, ii) any
express or implied warranty that the practice of
Aurora Copyrights, Aurora Technology or Aurora
Patent Rights will not infringe a patent, copyright,
trademark or other right of a Third Party, and iii)
any express or implied warranty regarding the
patentability of any Aurora Technology, including
Aurora Technology claimed in patent applications as
part of Aurora Patent Rights.
*** Confidential Treated Requested
22
8.3. AURORA INDEMNIFICATION.
Aurora hereby agrees to indemnify, defend ***.
8.4. WARRANTIES AND P&U TECHNOLOGY.
P&U warrants to Aurora as of the Effective Date the following:
8.4.1. To the best knowledge of P&U as of the Effective
Date: (a) P&U has the lawful right to license to
Aurora in accordance with this Agreement P&U Patent
Rights and P&U Technology; (b) the P&U Patent Rights
were properly filed and prosecuted; and (c) no Third
Party suit exists relating to P&U Patent Rights, and
P&U Copyrights.
8.4.2. Except as set forth in Section 8.4.1 above, P&U
(including its officers, employees and agents)
expressly disclaim any representations and
warranties, whether express or implied, relating to
P&U Patent Rights, P&U Copyrights and P&U Technology.
P&U further disclaims: i) any express or implied
warranty of merchantability or fitness for a
particular purpose of P&U Technology or P&U Patent
Rights; ii) practice of P&U Copyrights, P&U
Technology or P&U Patent Rights will not infringe a
patent, copyright, trademark or other right of a
Third Party; and iii) the patentability of any P&U
Technology, including P&U Technology claimed in
patent applications as part of P&U Patent Rights.
*** Confidential Treated Requested
23
8.5. P&U INDEMNIFICATION.
P&U hereby agrees to indemnify, ***.
***.
9. TERM AND TERMINATION
9.1. TERM.
The term of this Agreement will begin on the Effective Date and shall
continue until there is no longer a royalty obligation owed by P&U to
Aurora unless terminated earlier in accordance with the provisions of
Sections 9.2, 9.3 or 9.4 hereof.
9.2. TERMINATION BY MUTUAL AGREEMENT.
The parties may at any time terminate this Agreement, in whole or in
part, by written agreement executed by both Aurora and P&U. In such
event, the document effecting such termination shall specify the
continuation or termination of any license rights granted hereunder, as
well as any other terms agreed to by both parties.
*** Confidential Treated Requested
24
9.3. TERMINATION FOR CAUSE.
Either party shall have the right to terminate this Agreement at any
time for a material breach of this Agreement by the other party,
provided that the non-breaching party shall have given the breaching
party ***written notice of the breach and intention to terminate this
Agreement in the absence of a cure within ***of receipt of such notice
by the breaching party. Upon termination of this Agreement for cause,
all licenses and sublicenses granted in accordance with this Agreement
shall be terminated and all Materials transferred in accordance with
this Agreement shall be returned to the supplying party or destroyed at
the discretion of such party. The non-breaching party, upon termination
of this Agreement may seek actual or general damages and remedies
available to it at law or in equity. NO PUNITIVE OR CONSEQUENTIAL
DAMAGES MAY BE SOUGHT BY EITHER PARTY.
9.4. EFFECT OF EXPIRATION OR TERMINATION.
The obligations and rights of the parties under Sections 2.3, 2.5 and
3.3 Articles 4, 6, 9 and 10, thereof, as well as any provisions, which,
by their intent or meaning are intended to so survive, shall survive
termination or expiration of this Agreement. Except as otherwise
expressly provided in this Agreement, the rights and obligations of the
parties under Article 2 hereof shall terminate and be of no further
force or effect whatsoever upon any termination of this Agreement. Upon
expiration or other termination of the Agreement all licenses granted
will terminate and Materials and Collaborative Screens will be
destroyed or returned, at the sole discretion of the providing party,
to the party providing such Materials and Collaborative Screens within
sixty (60) days.
10. MISCELLANEOUS
10.1. ASSIGNMENT.
Either party may 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; provided, however,
if such assignment is to an Affiliate that is wholly owned by Pharmacia
& UpJohn, Inc. such consent shall not be necessary. This Agreement
shall survive any merger or consolidation of either party with or into
another party and no consent for any such merger, consolidation or
similar reorganization shall be required hereunder. In the event of
such merger, consolidation or similar reorganization or in the event of
a sale of all assets, no intellectual property rights of the acquiring
or acquired company shall be included in the technology licensed
hereunder.
10.2. BINDING EFFECT.
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.
*** Confidential Treated Requested
25
10.3. 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 war, fire, explosion,
flood (e.g. El Nino), earthquake, 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 and thereafter
takes all reasonable steps to mitigate any such delay in performance
hereunder and any damages that may be incurred by the other party
thereby.
10.4. 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 or overnight carrier with return
receipt addressed to the other at its address set forth below. Any such
notice or communication may also be given by hand, or facsimile to the
appropriate designation. Notices shall be sent:
If to P&U, to: Pharmacia & Upjohn
00 Xxxxxxxxx Xxxxx
Xxxxxxxxxxx, XX 00000-0000
Facsimile number: (000) 000-0000
Attention: Xxxxxxx X. Xxxxxx, Ph.D., Group Vice President
Technology Acquisition and Skillbase Development
If to Aurora, to: Aurora Biosciences Corporation
00000 Xxxxxxxxx Xxxx
Xxx Xxxxx, XX 00000
Facsimile number: (000) 000-0000
Attention: Xxxx Xxxxxxx
Senior Vice President, Corporate Development
provided that if such notice or communication relates to an amendment
to this Agreement or to any notice pursuant to Article 9 hereof, a copy
shall also be sent to:
If to P&U, to: General Counsel
If to Aurora, to: Xxxx X. Xxxxxxxx, Ph.D., X.X.
General Counsel, Vice President, Intellectual
Property
*** Confidential Treated Requested
26
Either party may by like notice specify or change 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.
10.5. GOVERNING LAW AND JURISDICTION.
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.
10.6. 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 any of the other of such party's rights or
remedies provided in this Agreement.
10.7. 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 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 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.
10.8. INDEPENDENT CONTRACTORS.
It is expressly agreed that Aurora and P&U shall be independent
contractors and that the relationship between the parties shall not
constitute a partnership or agency of any kind. Neither Aurora nor P&U
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 the other
party to do so.
10.9. COUNTERPARTS.
This Agreement may be executed in two (2) or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
10.10. ENTIRE AGREEMENT.
This Agreement between the parties of even date herewith sets forth all
of the covenants, promises, agreements, warranties, representations,
conditions and understandings between the parties hereto, and
supersedes and terminates all prior agreements and understanding
between the parties, with respect to the subject matter hereof. There
are no covenants, promises, agreements, warranties, representations
conditions or
*** Confidential Treated Requested
27
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. This Agreement shall not be
strictly construed against either party hereto. Any conflict between
the terms set forth in the text of this Agreement and the terms of any
Exhibit hereto shall be resolved in favor of the text of this
Agreement.
10.11. NO THIRD PARTY BENEFICIARIES.
No third party, including any employee of any party to this Agreement,
shall have or acquire any rights by reason of this Agreement. Nothing
contained in this Agreement shall be deemed to constitute the parties
partners with each other or any third party.
10.12. CONSTRUCTION.
The term "Article" or "Section" can refer to any single paragraph level
found herein or any collection of multiple paragraphs thereunder.
10.13. DISPUTE RESOLUTION.
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. 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 arbitration. The parties agree that
prior to any arbitration concerning this Agreement, a member of P&U's
senior management and Aurora's president will meet in person or by
video-conferencing in a good faith effort to resolve any disputes
concerning this Agreement. Within ***of a 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 or their
successors, for attempted resolution by good faith negotiations, such
good faith negotiations to begin within thirty (30) days after such
notice is received. Any dispute arising out of or relating to this
Agreement which is not resolved between the parties or the designated
officers of the parties pursuant to Section 10.13 shall be resolved by
final and binding arbitration conducted in *** (unless the parties
mutually agree to another location) under the then current Licensing
Agreement Arbitration Rules of the American Arbitration Association
("AAA"). The arbitration shall be conducted by ***arbitrators who are
knowledgeable in the subject matter which is at issue in the dispute.
One arbitrator is selected by P&U and one arbitrator is selected Aurora
and the third arbitrator is appointed by the AAA. In conducting the
arbitration, the arbitrators shall determine what discovery will be
permitted, consistent with the goal of limiting the cost and time which
the parties must expend for discovery (and provided that the
arbitrators shall permit such discovery they deem necessary to permit
an equitable resolution of the dispute), ensure that the total time of
the arbitration from filing to a final decision or executed settlement
agreement is less than ***, and 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, specific performance or repletion of property. The
arbitrators
*** Confidential Treated Requested
28
shall also be able to award actual or general damages, but shall not
award any other form of damage (e.g., consequential, punitive or
exemplary 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. Notwithstanding
anything to the contrary in this Section 10.13, either party may seek
immediate injunctive or other interim relief from any court of
competent jurisdiction with respect to any breach of Articles 3 or 6
hereof, or otherwise to enforce and protect the patent rights,
copyrights, trademarks, or other intellectual property rights owned or
Controlled by such party. In addition, arbitration shall not be used to
resolve disputes about patent rights. Patent right disputes including
but not limited to disputes concerning patent ownership, claim
language, claim scope and issues of validity shall be settled in a
court of law. Any arbitration ruling that relies on an interpretation
of patent rights shall have no binding effect in a court of law on any
patent rights related to this Agreement, unless such patent rights have
been adjudicated in a court of law. In no event shall a demand for
arbitration be made after the date when the institution of a legal or
equitable proceeding based on such claim, dispute or other matter in
question would be barred by the applicable statute.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives.
The Pharmacia & Upjohn Company Aurora Biosciences Corporation
By: By:
------------------------------- ----------------------------------
Name: Xxxxxxx X. Xxxxxx, Ph.D. Name: Xxxx X. Xxxxxxx
Title: Group Vice President Title: Senior Vice President
Technology Acquisition Corporate Development
and Skillbase Development
Date: Date:
------------------------------ --------------------------------
*** Confidential Treated Requested
29
LIST OF EXHIBITS
***
*** Confidential Treated Requested
30
EXHIBIT 1.2
***
*** Confidential Treated Requested
31
EXHIBIT 2
***
*** Confidential Treated Requested
32
EXHIBIT A
***
*** Confidential Treated Requested
33
