EXHIBIT 10.8
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
AMENDED AND RESTATED DISTRIBUTOR AGREEMENT
THIS AMENDED AND RESTATED DISTRIBUTOR AGREEMENT (the "Agreement") is made
and entered into effective as of this 22nd day of December, 2000, (the
"Amendment Effective Date") and amends and restates that certain Distributor
Agreement made and entered into as of the 1st day of February, 1999 (the
"Effective Date"), as amended by Amendment No. 1 to Distributor Agreement, made
the 21st day of October, 1999, and Amendment No. 2, made the 28th day of June,
2000, by and between PPGx, Inc., a Delaware corporation whose mailing and notice
address is 00000 X. Xxxxxx Xxxxx Xxxx, Xx Xxxxx, Xxxxxxxxxx 00000, Telephone:
(000) 000-0000 and Facsimile: (000) 000-0000 (hereinafter called the
"Corporation"), and PPD PHARMACO, INC., a Texas corporation (now PPD
Development, LLC, a Texas limited liability company), whose mailing and notice
address is 0000 00xx Xxxxxx Xxxxxxxxx, Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000
Telephone: (000) 000-0000 and Facsimile: (000) 000-0000(hereinafter called
"PPD").
RECITALS
A. PPD desires to acquire the exclusive, worldwide rights to market and
offer for sale certain Designated Services (as hereinafter defined) of the
Corporation upon the terms and conditions set forth hereinafter.
B. PPD further desires to acquire the exclusive, worldwide rights to market
for sublicense and sublicense certain Designated Products (as hereinafter
defined) of the Corporation upon the terms and conditions set forth hereinafter.
C. The Corporation is willing to grant to PPD such rights upon the terms
and conditions set forth hereinafter.
NOW, THEREFORE, in consideration of the foregoing recitals, the mutual
covenants and agreements contained herein, and for other good and valuable
consideration, the sufficiency and receipt of which are hereby acknowledged, the
parties agree as follows:
1. DEFINITIONS. As used throughout this Agreement, the following
definitions shall apply:
a. AFFILIATE. The term "Affiliate" shall mean an entity which
controls, is controlled by or under common control with, directly or
indirectly, PPD. Control for these purposes shall mean ownership of more
than 50% of the voting securities of a corporation or comparable interest
of another entity.
b. CONFIDENTIAL INFORMATION. The term "Confidential Information"
shall mean any and all proprietary and confidential data and information
(including any trade secrets) of the Corporation or relating to the
Corporation Technology, the Designated Services and/or the Designated
Products (i) which is not generally known to the public; and (ii) which
is treated by the Corporation as confidential, and all physical
embodiments of the foregoing. Confidential Information shall not include
any information which was already known to PPD at the time it was first
disclosed to PPD by [*], but shall include confidential information known
to PPD [*]. Confidential Information also shall not include any data or
information which before being divulged, disclosed or used by PPD
(i) has become generally known to the public through no wrongful act of
PPD; (ii) has been rightfully received by PPD from a third
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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party without restriction on disclosure or use and without breach of an
obligation of confidentiality running directly or indirectly to the
Corporation; (iii) has been approved for release to the general public by
written authorization of the Corporation; or (iv) has been disclosed
pursuant to a requirement of a governmental agency or of law without
similar restrictions or other protections against public disclosure, or
disclosure is required by operation of law; provided, however, that PPD
shall have first given written notice of such required disclosure to the
Corporation, made a reasonable effort to obtain a protective order
requiring that the Confidential Information so disclosed be used only for
the purposes for which disclosure is required and taken reasonable steps
to allow the Corporation to seek to protect the confidentiality of the
information required to be disclosed.
c. CONTROLLED. "Controlled" means, with respect to an item of
information or intellectual property, that the Corporation owns, has a
license to or otherwise has lawful access to, such information and
intellectual property and has the ability to grant a license as provided
in this Agreement without violating the terms of an agreement with a
third party.
d. CORPORATION TECHNOLOGY. "Corporation Technology" means and
includes all Patents, data, materials, formulas, know-how, trade secrets,
process information, clinical data, trademarks, copyrights, computer
software and/or program(s), marketing and demographic information,
promotional materials and any and all other information or technology
necessary or useful for Diagnostic Services and/or Diagnostic Products
and Controlled by the Corporation.
e. CUSTOMER. "Customer" means a customer or potential customer of
Designated Services and/or Designated Products sold or licensed hereunder
by PPD or by PPD's sub-distributors and resellers.
f. DESIGNATED SERVICES. "Designated Services" are all existing and
future Pharmacogenomics contract, consulting, research and development,
laboratory, and technical and maintenance support services, including
Enhancements (as hereinafter defined), offered by or available to the
Corporation from time to time. By way of illustration but not limitation,
Designated Services include, to the extent offered by or available from
the Corporation, candidate gene and polymorphism identification,
sequencing, assay development, genotyping, phenotyping, nucleic acid
extraction, storage and archiving, protein and gene expression, sample
collection, clinical trial design, statistical analysis, clinical
diagnostic testing, algorithm development, and software development,
customization, consultation, support and maintenance.
g. DESIGNATED PRODUCTS. "Designated Products" are all existing and
future Pharmacogenomics software programs, documentation, information and
information systems, sequences, sample collections, technology and
methods, including Enhancements, developed or licensed by the Corporation
and which the Corporation makes available for sale or licensing, as the
case may be, from time to time. By way of illustration but not
limitation, Designated Products include, to the extent made available by
the Corporation for sale or licensing, GeneTrials-TM-, allele frequency
database (AFDB), PowerCalculator-TM-, clinical genetics laboratory
information systems, Target Validation System (TVS), LIMS, gene and
polymorphism sequences, allele frequencies, medical and demographic data,
clinical outcomes, DNA panels from reference populations, assay
procedures, turnkey laboratory systems, system specifications and
informatics algorithms.
h. ENHANCEMENTS. "Enhancements" are changes, additions,
improvements or upgrades to the Designated Services or the Designated
Products, as applicable, including but not limited to new products or
services that (i) support new releases of operating systems and devices,
(ii) correct errors or defects, (iii) provide substantial additional
value, (iv) result in
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BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
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downgrading or obsolescence of existing services or products, or
(v) serve as alternative solutions or substitutes to the existing
Designated Services or Designated Products, as applicable.
i. LIMS. "LIMS" is the laboratory information system, including
Enhancements, that integrates and automates the laboratory and
information process components in use in the Corporation's
high-throughput pharmacogenomics laboratory currently located in La
Jolla, California, Morrisville, North Carolina and Cambridge, England. By
way of illustration and not limitation, LIMS includes single nucleotide
polymorphism genotyping, sequencing, nucleic acid extraction, project
definition, and sample management and tracking capabilities.
j. PATENTS. "Patents" means and collectively includes all U.S. and
foreign patents and patent applications, including, without limitation,
any patents issued from such patent applications, reissues, extensions,
substitutions, divisions, continuations, and continuations-in-part.
k. PHARMACOGENOMICS. "Pharmacogenomics" shall have the same meaning
set forth in the Technology Transfer and License Agreement executed by
and between Axys Pharmaceuticals, Inc. and the Corporation effective as
of February 1, 1999.
l. PPD MARGIN. "PPD Margin" means that portion of the Sales Price
which PPD retains for payment for its services and other obligations and
duties under this Agreement, including the amount which PPD retains as
payment for the client contracts [*] (the "[*] Contracts") and including
the amount which PPD retains as payment under the Collateral Contracts as
defined in Section 7 hereof. The PPD Margin (including the PPD Margin on
the [*] Contracts and the Collateral Contracts) shall be determined from
time to time as provided in SCHEDULE 1 attached.
m. SALES PRICE. "Sales Price" means the price charged by PPD to a
Customer for a Designated Product or a Designated Service. With respect
to the [*] Contracts, Sales Price means the fees charged to clients under
the terms of the [*] Contracts. The Sales Price for each Designated
Product and each Designated Service shall be determined from time to time
in accordance with SCHEDULE 1; provided, however, that notwithstanding
anything in this Agreement or SCHEDULE 1 attached, PPD in its sole
discretion shall set the Sales Price charged for each Designated Product
and each Designated Service.
n. TRANSFER PRICE. "Transfer Price" means the price charged to PPD
by the Corporation for a Designated Product or a Designated Service. The
Transfer Price for each Designated Product and each Designated Service
shall be determined from time to time as provided in SCHEDULE 1 attached.
2. APPOINTMENT AND LICENSES.
a. APPOINTMENT. Subject to the terms and conditions herein, the
Corporation hereby appoints PPD as its exclusive, worldwide distributor
and/or reseller, with the right to appoint sub-distributors and/or
resellers, of Designated Services and/or Designated Products and PPD
accepts such appointment.
b. LIMITATION ON APPOINTMENT. Notwithstanding Section 2(a) hereof,
the Corporation (by itself or through agents selected by the Corporation)
shall have the [*] and/or [*], and/or [*] that, with respect to [*] for
the sole purpose of [*].
c. LICENSES. Subject to the terms of this Agreement, the
Corporation hereby grants to PPD an exclusive, worldwide, fully paid
right and license under the Corporation Technology to use, offer for
sale, promote, market, distribute and import the Designated Services and
the
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Designated Products to Customers, except that, the license under the
trademark PPGx shall be non-exclusive.
d. SUBLICENSES. The Corporation hereby grants to PPD the right to
sublicense (i) sub-distributors and resellers appointed by PPD pursuant
to Section 2.a. subject to the same limitations as are imposed upon PPD
herein, and (ii) Customers, to the extent necessary to allow Customers
full use and enjoyment of the Designated Services and/or the Designated
Products. Any sublicenses for the Designated Products granted by PPD to
Customers pursuant to this Agreement shall (i) include such terms and
conditions as may be established from time to time by the Corporation,
after reasonable consultation with PPD, as applicable to end users or
sublicensees, and (ii) certain restrictions, to the extent applicable,
similar to type described in Section 4.1 of that certain Software License
Agreement dated February 1, 1999 as required to be included in
sublicenses granted pursuant to that agreement.
e. NON-COMPETE. PPD agrees that, during the Term, it shall not
re-sell, license or distribute, for any third party, any products or
services owned or controlled by such third party that are substantially
similar to any Designated Products or Designated Services for which PPD
is the distributor on behalf of the Corporation under this Agreement
("Competing Products"), without the written consent of the Corporation.
Notwithstanding the foregoing, PPD shall have the right to sell, license
or otherwise commercialize any products which are [*] and [*], or [*]
("Allowed Products"); provided that PPD's plans for marketing such
Allowed Products are included in the overall marketing plan described in
and subject to the provisions of Section 5.c so as to ensure that PPD is
allocating sufficient marketing effort to the Designated Services and
Designated Products as compared to such Allowed Products.
3. TERM OF LICENSE. Unless sooner terminated or extended as hereinafter
provided, the rights and licenses granted to PPD under this Agreement shall
commence effective as of the Effective Date and shall continue for a period of
ten (10) years ending on the tenth anniversary of the Effective Date. At least
six (6) months prior to the expiration of the initial term and each renewal
term, if any, PPD and the Corporation shall negotiate in good faith for a
renewal of the current term then in effect or such other term as either party
may propose upon such terms and conditions which are mutually acceptable to both
parties. If the parties are unable to agree upon mutually acceptable terms for a
renewal of the current term or any other term, then the Corporation shall have
the right to enter into a new agreement with a third party covering the rights
granted to PPD hereunder, but any such new agreement shall not be on terms which
are more favorable, taken as whole, than those offered to PPD. For purposes of
this Agreement, references to "term" shall mean the initial term and each
renewal term resulting from an extension or renewal as provided above. The
parties agree that for any sublicense or agreement for Designated Services or
Designated Products, or any ancillary agreement in support thereof, which PPD
has entered into with a Customer that has a term which extends beyond the term
of this Agreement, PPD and the Corporation shall continue to fulfill their
obligations under said sublicense, agreement or ancillary agreement until the
expiration or termination thereof, notwithstanding anything in this Agreement to
the contrary.
4. PAYMENT OF TRANSFER PRICE TO THE CORPORATION. PPD shall pay the
Corporation the Transfer Price for the Designated Products and the Designated
Services, as the case may be, purchased by PPD hereunder, during the term of
this Agreement as follows:
a. TIME OF PAYMENT. PPD shall pay the Corporation the Transfer
Price for each Designated Product and each Designated Service within
thirty (30) days after PPD has the contractual right to invoice its
Customer for each such Designated Product and Designated Service. With
respect to the [*] Contracts, the Corporation shall inform PPD at what
time intervals to invoice clients thereunder, and PPD shall be entitled
to retain the PPD Margin at
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BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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such times as it collects fees thereunder and remits payment of the
Transfer Price to the Corporation.
b. RETURNS AND REFUNDS. Within thirty (30) days thereafter each
calendar quarter during the term of this Agreement, PPD shall provide the
Corporation with a report setting forth all refunds made by PPD in the
preceding calendar quarter to Customers in connection with the sale,
license and delivery of the Designated Products and Designated Services
which refunds arise from an uncured material breach of this Agreement by
the Corporation, including but not limited to an uncured material breach
of any warranties made herein by the Corporation, including the portion
of each such refund which includes all or a portion of the Transfer Price
paid by PPD to the Corporation. The Corporation shall reimburse PPD for
all such refunds to the extent of the Transfer Price refunded within
fifteen (15) days after the Corporation's receipt of PPD's report and
supporting documentation. Any disagreements over such refunds shall be
resolved by the appropriate officers of the parties. Refunds, if any,
made by the Corporation under the [*] Contracts for the same reasons
refunds may be made pursuant to this Section 4.b. by PPD with respect to
the Designated Products and the Designated Services shall be handled in a
similar manner, and PPD shall reimburse the Corporation for all refunds
to the extent of the PPD Margin refunded by the Corporation.
c. POST-TERMINATION PAYMENTS. Upon the termination of this
Agreement, PPD shall continue to pay the Corporation, in the manner
described in subsection a. of this Section 4, the Transfer Price for
Designated Products and Designated Services sold or licensed during the
term of this Agreement.
5. DUTIES OF PPD. During the term of this Agreement, PPD agrees to
perform, directly or through one or more of its Affiliates, the following
duties:
a. MARKETING, ADVERTISING, AND PROMOTION. PPD shall use its
reasonable best efforts to promote and market at its sole expense the
Designated Services and the Designated Products to Customers during the
term of this Agreement in accordance with the Marketing Plan described in
Section 5.c below. Such efforts shall include, by way of example,
identification of potential Customers, demonstrations of the Designated
Products to Customers as appropriate and development of sales proposals.
Without limiting the generality of the first sentence of this
Section 5.a., PPD shall be responsible for all costs of advertising,
sales and promotional materials used for these purposes.
b. PERSONNEL. In performing its duties hereunder, PPD shall employ
such persons and/or engage independent contractors at its sole expense as
PPD deems reasonably necessary to perform its duties under this
Agreement. In this regard, PPD, in its discretion, may promote and market
the Designated Services and the Designated Products, and grant
sublicenses related thereto, directly through employees of PPD or its
Affiliates or through an outside sales force, or any combination thereof.
PPD shall be solely responsible for compensating all personnel used by
PPD to accomplish these purposes.
c. MARKETING PLAN AND MANAGEMENT.
(i) MARKETING PLAN PREPARATION AND IMPLEMENTATION. Prior to the
beginning of each calendar year during the term of this Agreement,
PPD shall provide the Corporation with a reasonably detailed
marketing plan generally consistent in form and substance with those
prepared for the marketing of PPD's services and products to the
extent the marketing efforts reflected in such plans is comparable to
the efforts set forth in PPD's marketing plan under this Agreement
for the upcoming calendar year. Such marketing plan shall include,
among other things, performance goals and milestones to be achieved
by PPD during the relevant year. PPD shall provide said plan to the
Corporation at least
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BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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30 days before each calendar year end and the Corporation shall have
30 days in which to discuss or comment on the marketing plan. PPD
shall use all reasonable efforts to either incorporate or respond to
any such comments made by PPGx or to discuss with PPGx its comments
and provide an explanation of why they are not incorporated or
addressed. PPD shall carry out its marketing activities under this
Section 5 in accordance with the marketing plan. To the extent the
parties cannot agree with respect to the nature of, or undertakings
pursuant to, the marketing plan, either party shall have the right to
submit such disputed aspect of the marketing plan to a joint review
committee ("JRC").
(ii) JRC COMPOSITION. The JRC will be composed of at least two,
but no more than four, representatives each from PPD and the
Corporation. The initial members of the JRC will be those
representatives the names of whom will be provided to the other party
within ten days of the Effective Date. Each party will promptly
notify the other party in writing of any change in its appointed
representatives. The chairmanship of the JRC will be one of PPD's
representatives.
(iii) JRC VOTING MECHANISM; DISPUTE RESOLUTION. Each party will
have one vote on the JRC regardless of the number of representatives
of each party on the JRC. All of the decisions of the JRC must be
unanimous in order for a JRC matter to be resolved. In the event of a
deadlocked vote on an issue, the chief executive officers of PPD and
the Corporation will discuss such issue in good faith and will use
their best efforts to find a resolution to the deadlock. In the event
such executive officers are unable to resolve such issue within [*]
of submission of the issue to them by the JRC, either party shall
have the right to submit the matter to binding arbitration before a
single arbitrator ("Arbitrator") selected by the American Arbitration
Association (the "Administrator"), in accordance with its then
existing arbitration rules or procedures regarding commercial or
business disputes. The arbitration shall be held in Chicago,
Illinois. The Arbitrator shall, within [*] days after the conclusion
of the Arbitration hearing, issue a written statement of decision
describing the essential findings and conclusions. Each party shall
bear its own attorney's fees, costs, and disbursements arising out of
the arbitration, and shall pay an equal share of the fees and costs
of the Administrator and the Arbitrator.
(iv) MEETINGS. To accomplish its objectives, the JRC will meet
when needed by teleconference or at a mutually agreed upon site. Each
party will bear its expenses for personnel to attend any meeting. The
chairperson of the JRC will chair the meetings and will be
responsible for preparing agenda, circulating agendas to the other
JRC members prior to the meetings, preparing written minutes of each
such meeting, which minutes will, without limitation, describe each
recommendation and the determination made by the JRC. Such minutes
will be promptly confirmed and unanimously approved in writing by the
JRC.
d. MARKETING MATERIALS. PPD shall provide to the Corporation from
time to time, at no additional charge, reasonable quantities of PPD's
most recent marketing materials, if any, related to the Designated
Services and the Designated Products. In addition, PPD shall provide
drafts of new marketing materials to the Corporation at least thirty
(30) days prior to the scheduled publication date for same and the
Corporation shall have fifteen (15) days in which to comment on said
materials.
e. STRATEGIC PLANNING. During each calendar year of this Agreement,
PPD shall plan and host up to [*] strategic planning meetings at the
Corporation's request which shall focus upon the marketing and promotion
of the Designated Services and the Designated Products. The Corporation
may send a reasonable number of representatives to said meetings. All
strategic
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BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
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planning meetings shall be conducted on dates and at locations mutually
acceptable to the Corporation and PPD.
f. PERIODIC REVIEW. During the term of this Agreement, PPD shall
periodically confer (not less frequently than quarterly) with the
Corporation with respect to monthly, quarterly and annual forecasts for
sales and sublicensing of the Designated Products and the Designated
Services, scheduling delivery of the Designated Products and the
Designated Services and other issues related to Customer satisfaction and
the respective parties' duties hereunder; provided, however, that PPD and
the Corporation shall establish a mutually agreeable process for order
acceptance, scheduling, delivery and performance so that the Corporation
is not committed to specifically perform hereunder without its prior
consent.
g. OTHER ACTIVITIES. PPD shall be responsible for ordering, billing
and accounts receivable activities related to the sale or sublicense of
the Designated Products and the Designated Services to Customers. PPD
shall also be responsible for billing and accounts receivable activities
related to the [*] Contracts.
6. DUTIES OF THE CORPORATION. During the term of this Agreement, the
Corporation shall be responsible for performance of the following duties:
a. PERFORMANCE OF DESIGNATED SERVICES. The Corporation agrees to
perform for PPD or a Customer, as the case may be, any of the Designated
Services undertaken on behalf of a Customer pursuant to this Agreement in
a timely, professional manner and to the best of its ability, consistent
with its agreements pursuant to Section 5.f. The Corporation shall be
responsible for determining the timing, nature and scope of the
Designated Services to be provided to a Customer and it alone shall be
responsible for the performance or nonperformance of such services. The
Corporation shall pay all costs associated with the performance of such
services for a Customer.
b. DELIVERY OF THE DESIGNATED PRODUCTS. The Corporation agrees to
cause delivery of the Designated Products to PPD or to Customers, as the
case may be, in a timely fashion consistent with its agreements pursuant
to Section 5.f. The Corporation shall pay all transportation charges
required for the shipment and delivery of the Designated Products to PPD
or a Customer, as the case may be, unless otherwise agreed with the
Customer.
c. CURRENT VERSIONS AND INFORMATION. The Corporation agrees to
provide PPD in timely fashion (and in any event not less than forty-five
(45) days before PPD is expected to market said release or version) the
most current release or version of the Designated Products available from
time to time and to supply PPD with the Corporation's most current
marketing and technical information concerning the Designated Services
and the Designated Products.
d. STAFFING. The Corporation agrees to hire or retain adequate
trained personnel to meet the good faith demands of Customers for the
Designated Services and the Designated Products projected to be generated
from the marketing and sales efforts of PPD and based upon sales
forecasts to be established jointly by the Corporation and PPD. If the
Corporation acting in good faith determines that it is unable for any
reason to meet the good faith requirements of Customers for the
Designated Services and/or the Designated Products in a timely fashion,
then it shall give advance notice of same to PPD so that PPD and the
Corporation shall have a reasonable time to determine and agree upon
alternatives for delivery of the Designated Services and/or the
Designated Products so as to maximize Customer satisfaction and sales.
e. MARKETING MATERIALS. The Corporation shall provide to PPD and
its Affiliates at no additional charge, copies of the Corporation's most
recent descriptions and/or specifications related to the Designated
Services and the Designated Products and a reasonable number of
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BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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copies (in whatever format reasonably requested) of the Designated
Products for demonstration purposes, as provided for in this Agreement.
f. TRAINING. The Corporation agrees to provide each year during the
term of this Agreement at PPD's reasonable request up to [*] technical
training classes related to the demonstration, marketing, installation
and/or utilization of the Designated Services and the Designated
Products, including specifically any Enhancements, at no charge to PPD or
its Affiliates. Each training class shall not exceed [*] days in
duration. All training shall be conducted on dates and at locations
mutually agreed to by the parties.
g. MARKET AND TECHNICAL SUPPORT. The Corporation agrees to provide
to PPD and its Affiliates market and pre- and post-sale technical
support, by telephone or in some other reasonably appropriate manner, as
reasonably requested from time to time to assist PPD and its Affiliates
in the marketing and promotion of the Designated Services and the
Designated Products. Such market and technical support shall be provided
at no additional charge to PPD or its Affiliates during the term of this
Agreement. In connection with pre-sale technical support, PPD shall pay
all expenses which are approved in advance that are incurred by employees
or agents of the Corporation in traveling to and from customer sites to
assist PPD in the marketing and promotion of the Designated Services and
the Designated Products.
h. DEVELOPMENT PLAN. At each strategic planning meeting hosted by
PPD during the term of this Agreement, the Corporation shall provide a
status report on development plans for the Designated Services and the
Designated Products, including a description of each development project,
target markets, individual development project time lines, and projected
development project costs.
7. COLLATERAL CONTRACTS. From time to time the Corporation may wish to
enter into contracts with third parties for the sole purpose of evaluating the
technology of a third party or because the third party will not agree to
contract with PPD for Designated Services or Designated Products, which contract
may include performance of a Designated Service by the Corporation or delivery
by the Corporation of a Designated Product (a "Collateral Contract"). The
Corporation shall be permitted to enter into such Collateral Contracts in its
name provided that (i) each such Collateral Contract is approved by PPD prior to
its execution and (ii) subject to compliance with applicable confidentiality
provisions, a copy of each fully executed Collateral Contract shall be provided
to PPD in accordance with the notice provisions herein within seven (7) days
after final execution of the Collateral Contract. In cases in which a third
party indicates an unwillingness to contract with PPD for Designated Services or
Designated Products, the Corporation shall use good faith efforts to have such
third party contract with PPD and, if unsuccessful, to use good faith efforts to
include a provision permitting disclosure of such Collateral Contract to PPD in
confidentiality clauses between such third party and the Corporation.
8. CONTRACTS WITH DNA SCIENCES, INC. From time to time the Corporation may
wish to enter into contracts with DNA Sciences, Inc. for the sole purpose of
conducting internal research and development projects at DNA Sciences, Inc. (R&D
Contract) for the sole benefit of DNA Sciences, Inc. and not for any third party
for whom DNA Sciences, Inc. is conducting research and development.
Notwithstanding anything in this Agreement to the contrary, the Corporation
shall be permitted to enter into such R&D Contracts. In the event, however, that
the Corporation desires to enter into contracts with DNA Sciences, Inc. for the
purpose of conducting, on behalf of DNA Sciences, Inc., services for a third
party which are the same as any Designated Services ("DNAS/Third Party
Agreement"), the Corporation shall have the right to enter into any such
DNA/Third Party Agreement in its name provided that (i) each DNAS/Third Party
Contract is approved by PPD prior to its execution and (ii) subject to
compliance with applicable confidentiality provisions, a copy of each
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BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
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fully executed DNAS/Third Party Contract shall be provided to PPD in accordance
with the notice provisions herein within seven (7) days after final execution of
the DNAS/Third Party Contract.
9. REPORTS AND AUDITS. PPD will furnish to the Corporation quarterly
reports of such information as is reasonably requested by the Corporation for
purposes of the activities set forth in SCHEDULE 1. The Corporation shall have
the right, through a certified public accountant mutually acceptable to both
parties, to inspect the books and records of PPD not more than once per quarter,
and to verify the figures provided by PPD to the Corporation. Any such
inspection will be conducted during normal business hours at PPD's office and in
such a manner so as not to interfere with PPD's normal business activities.
10. REPRESENTATIONS AND WARRANTIES OF PPD. PPD makes the following
warranties and representations, each of which shall be deemed a separate
covenant to the Corporation and shall survive the execution and delivery of this
Agreement:
a. ORGANIZATION AND STANDING OF PPD. PPD is duly organized and
validly existing and has complied with all requirements to continue its
existence under the laws of the State of Texas, and has the corporate
power and authority, to own, lease and use its properties and to transact
its business where and as now conducted, and is duly qualified as a
foreign corporation in each jurisdiction where the character of its
properties it owns, leases or licenses or the nature of its business
makes such qualification necessary.
b. EXECUTION AND DELIVERY AUTHORIZED. The execution and delivery of
this Agreement and the consummation of the transactions contemplated by
this Agreement have been duly authorized by the board of directors of
PPD.
c. VALIDITY OF AGREEMENT. The execution and performance of this
Agreement and the actions provided for or contemplated hereunder will not
violate the provisions of any agreement, instrument or obligation to
which PPD is a party or by which it is bound. Assuming due authorization,
execution and delivery hereof by the Corporation, this Agreement
constitutes the valid and binding agreement of PPD, enforceable against
PPD in accordance with its terms, subject as to enforceability to general
equitable principles and to the laws of bankruptcy, insolvency or similar
laws governing the rights of creditors.
d. NO FALSE STATEMENTS. No exhibit, report, document or certificate
furnished or to be furnished by PPD to the Corporation in connection with
this Agreement contains or will contain any false or misleading statement
or representation of a material fact or figure or omit or will omit any
material fact or statement.
e. NO INFRINGEMENT OF LICENSED RIGHTS. PPD acknowledges that any
violation, infringement, unauthorized use or misappropriation of any of
the licensing rights or proprietary rights of the Corporation by PPD is
prohibited, will render PPD liable to the Corporation and constitutes a
breach of this Agreement. The Corporation shall be entitled to take all
necessary action against such unauthorized use, including instituting
proceedings for injunctive and other equitable relief.
f. NOTICE OF INFRINGEMENT. In the event PPD learns of any
third-party violation, infringement, unauthorized use or misappropriation
of the Corporation's licensing or proprietary rights, PPD shall
immediately notify the Corporation giving such details as are available.
Thereafter, the Corporation may take such action and institute such
proceedings as the Corporation deems appropriate, all at the
Corporation's sole expense.
g. COMPLIANCE WITH LAWS. PPD represents and warrants that it has
the resources to perform its duties and obligations under this Agreement,
and that PPD will comply with any applicable laws, rules or regulations
in performance of its duties and obligations hereunder.
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
9
h. PROPRIETARY RIGHTS RETAINED. PPD acknowledges and agrees that
the Corporation has retained all of its proprietary rights (including,
without limitation, trademarks and service marks) with respect to the
Corporation Technology, the Designated Services and the Designated
Products except and unless otherwise provided in this Agreement. PPD
acknowledges and agrees that the Designated Products do not include
diagnostic kits or substantially similar diagnostic products, and small
molecule therapeutic compounds or targets or other intellectual property
relating thereto and that all such matters are outside the scope of this
Agreement. Except as expressly provided herein, this Agreement shall not
be construed to give PPD any vested right, title or interest in any of
the patents (issued or pending), trademarks, service marks, trade names,
copyrights, licenses, licensed rights granted by third parties to the
Corporation or in any of the Corporation's other proprietary rights.
11. REPRESENTATIONS AND WARRANTIES OF THE CORPORATION. The Corporation
makes the following warranties and representations, each of which shall be
deemed a separate covenant to PPD and shall survive the execution and delivery
of this Agreement:
a. ORGANIZATION AND STANDING OF THE CORPORATION. The Corporation is
duly organized and validly existing and has complied with all
requirements to continue its existence under the laws of the State of
Delaware, and has the power and authority, corporate and other, to own,
lease and use its properties and to transact its business where and as
now conducted, and is duly qualified as a foreign corporation in each
jurisdiction where the character of its properties it owns, leases or
licenses or the nature of its business makes such qualification
necessary.
b. EXECUTION AND DELIVERY AUTHORIZED. The execution and delivery of
this Agreement, and the consummation of the transactions contemplated by
this Agreement have been duly authorized and approved by the board of
directors of the Corporation.
c. VALIDITY OF AGREEMENT. The execution and performance of this
Agreement and the actions provided for or contemplated hereunder will not
violate the provisions of any agreement, instrument or obligation to
which the Corporation is a party or by which it is bound. Assuming due
authorization, execution and delivery hereof by PPD, this Agreement
constitutes the valid and binding agreement of the Corporation,
enforceable against the Corporation in accordance with its terms, subject
as to enforceability to general equitable principles and to the laws of
bankruptcy, insolvency or similar laws governing the rights of creditors.
d. NO FALSE STATEMENTS. No exhibit, report, document or certificate
furnished or to be furnished by the Corporation to PPD in connection with
this Agreement contains or will contain any false or misleading statement
or representation of a material fact or figure or omit or will omit any
material fact or statement.
e. OWNERSHIP AND GRANT OF RIGHTS. The Corporation owns or is
licensed or otherwise possesses legally sufficient rights to grant the
rights and licenses granted to PPD this Agreement. All patents,
registered trademarks, service marks and copyrights held by the
Corporation with respect to the Designated Services and the Designated
Products are valid and in full force and effect.
f. NO UNAUTHORIZED USE. To the knowledge of the Corporation, there
is no material unauthorized use, disclosure, infringement or
misappropriation by any third party (including employees and former
employees of the Corporation) of the Designated Products or any
proprietary rights embodied therein or related thereto. Except for the
[*], the Corporation has not entered into any agreement related to the
granting of any rights or licenses with respect to the Designated
Services or the Designated Products.
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
10
g. NO INFRINGEMENT. To the Corporation's knowledge, the Designated
Services and the Designated Products do not infringe any currently issued
patent, copyright, trademark or trade secret or any other intellectual
property rights of any third party, and do not contain any computer virus
which is an undocumented and unauthorized program designed to cause a
loss of, or damages to, data files, or to gain access to and interfere
with the operations, other programs or computer resources, or any other
results not intended by the use of the computer system on which the virus
resides. Except as set forth in SCHEDULE 1.g., the marketing, sublicense
or marketing for sublicense, as applicable, of the Designated Services or
the Designated Products by PPD pursuant to this Agreement does not and
will not infringe any currently issued patent, copyright, trademark or
trade secret or any other intellectual property rights of any third
party.
h. USE; CONFORMITY WITH WRITTEN SPECIFICATIONS. The Designated
Products and the Designated Services shall be fit substantially for the
uses for which they are intended consistent with industry standards and
applicable law. In addition, the Designated Products and the Designated
Services shall materially conform to their written specifications from
time to time and any written representations made by the Corporation to
PPD and, if specifically approved in writing by the Corporation (which
approval shall not be unreasonably withheld), by PPD to Customers. PPD
and the Corporation shall confer periodically (and no less frequently
than semi-annually) in good faith for the purpose of preparing or
revising, as applicable, appropriate written specifications about the
Designated Products and the Designated Services which PPD shall be
permitted to make to Customers. All information supplied by the
Corporation during the term of this Agreement regarding the Designated
Products, including any written marketing materials, shall be at the time
of disclosure accurate in all material respects.
i. COMPLIANCE WITH LAWS. The Corporation represents and warrants
that the Corporation will comply with any applicable laws, rules or
regulations in performance of its duties and obligations hereunder.
j. DISCLAIMER OF CERTAIN WARRANTIES. EXCEPT AS EXPRESSLY SET FORTH
IN THIS SECTION 9 (REPRESENTATIONS AND WARRANTIES OF THE CORPORATION),
THE CORPORATION MAKES NO OTHER WARRANTIES WITH RESPECT TO THE DESIGNATED
PRODUCTS AND THE DESIGNATED SERVICES AND HEREBY EXPRESSLY DISCLAIMS ANY
AND ALL WARRANTIES, EXPRESS, IMPLIED AND STATUTORY, WHETHER ARISING FROM
COURSE OF DEALING OR USAGE OF TRADE, INCLUDING, WITHOUT LIMITATION, THE
IMPLIED WARRANTIES OF MERCHANTABILITY, TITLE, FITNESS FOR A PARTICULAR
PURPOSE AND NON-INFRINGEMENT.
12. CONFIDENTIAL INFORMATION.
a. ACKNOWLEDGMENT OF CONFIDENTIAL INFORMATION. PPD will receive the
Confidential Information and (i) will hold the Confidential Information
in trust and in strictest confidence; (ii) will protect the Confidential
Information from disclosure and in no event take any action causing, or
fail to take any action reasonably necessary in order to prevent, any
Confidential Information to lose its character as Confidential
Information; (iii) will keep such Confidential Information secure; and
(iv) will not use, duplicate, reproduce, distribute, disclose or
otherwise disseminate the Confidential Information except pursuant to the
terms of this Agreement.
b. DISCLOSURES OF CONFIDENTIAL INFORMATION. Disclosures of the
Confidential Information shall be made only to officers, employees,
agents and/or independent contractors of PPD and
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
11
its Affiliates who are directly involved in utilizing the rights granted
to PPD under this Agreement and who have a specific need to know such
information.
13. INDEMNIFICATION.
a. INDEMNIFICATION OF THE CORPORATION. PPD shall indemnify, hold
harmless and defend the Corporation, its respective officers, directors,
employees and agents, from any and all liability, loss, claim, demand,
cost or expense (including reasonable attorneys' fees) based upon or
arising out of: (i) any unauthorized use of the distribution, reseller,
marketing and licensing rights granted to PPD in this Agreement,
(ii) any misrepresentation of a material fact or omission of a material
fact made by PPD, its employees, agents or representatives in connection
with the marketing, promotion, sublicense or sale, as applicable, of the
Designated Services and/or the Designated Products; (iii) any material
breach of any warranty, representation, covenant or agreement of PPD set
forth in this Agreement; or (iv) any failure by PPD to comply in any
material respect with the other terms and conditions of this Agreement.
The foregoing indemnity obligation of PPD shall not extend to any of the
foregoing items to the extent caused by a misrepresentation, act or
omission on the part of the Corporation.
b. INDEMNIFICATION OF PPD. The Corporation shall indemnify, hold
harmless and defend PPD and its Affiliates, their respective officers,
directors, agents and employees, from any and all liability, loss, claim,
demand, cost or expense (including reasonable attorneys' fees) based upon
or arising out of: (i) any infringement claims or actual infringement
arising out of the approved use of the distributor, reseller, marketing
and licensing rights granted to PPD in this Agreement; (ii) any material
breach of any warranty, representation, covenant or agreement of the
Corporation set forth in this Agreement; (iii) any failure by the
Corporation to comply in any material respect with the other terms and
conditions of this Agreement; or (iv) any claims by customers or end
users related to the Corporation's performance of the Designated Services
or related to actions or omissions of the Corporation pertaining to the
Designated Products. The foregoing indemnity obligation of the
Corporation shall not extend to any of the foregoing items to the extent
caused by a misrepresentation, act or omission on the part of PPD or its
Affiliates.
14. TERMINATION. The Corporation, at its sole option, may terminate this
Agreement upon the happening of any of the following events: (i) PPD breaches
any material term or provision of this Agreement, and fails to cure such breach
within sixty (60) days (or twenty (20) days in the case of payment obligations
arising under Section 4 which are not being contested in good faith by PPD) of
notice of such breach from the Corporation; (ii) PPD dissolves and is
liquidated; or (iii) PPD is insolvent, or files for bankruptcy under any
bankruptcy, insolvency or similar laws or in the event that a petition for
bankruptcy or insolvency shall be filed against PPD under applicable law and
such petition is not dismissed or stayed within sixty (60) days. Upon
termination of this Agreement, all rights of PPD (including without limitation,
PPD's distributor, reseller, marketing and licensing rights granted hereunder)
shall immediately cease.
15. MISCELLANEOUS.
a. NOTICES. All notices and other communications hereunder shall be
in writing and shall be deemed given if delivered personally or by
commercial delivery service, or mailed by certified mail (return receipt
requested) or sent via facsimile (with confirmation of receipt) to the
parties at their respective addresses first set forth above (or at such
other address for a party as shall be specified by like notice.
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
12
b. HEADINGS. The headings, titles, and subtitles herein are
inserted for convenience or reference only and shall not control or
affect the meaning or construction of any of the provisions hereof.
c. GOVERNING LAW. This Agreement shall be governed by and construed
in accordance with the laws of the State of Delaware. All references to
"$" shall refer to United States dollars.
d. SEVERABILITY. In the event any provision (or portion thereof) of
this Agreement shall be held invalid or unenforceable according to law,
such holding or action shall not invalidate or render unenforceable any
other provision (or portion thereof) of this Agreement.
e. BINDING EFFECT. This Agreement shall be binding upon and inure
to the benefit of the parties hereto and their respective heirs, personal
and legal representatives, guardians, successors and permitted assigns.
f. ASSIGNMENT. PPD may assign all of its rights under this
Agreement to an Affiliate, without the consent of the Corporation,
provided that such Affiliate assumes, by contract or operation of law,
PPD's duties and obligations under this Agreement; provided that no such
assignment shall release PPD from its secondary liability for its
assignee's performance hereunder without the Corporation's prior written
consent, which shall not be unreasonably withheld. Either party also may
assign all of its rights under this Agreement to a third party
successor-in-interest, with the prior written consent of the other party
(which consent shall not be unreasonably withheld, delayed or
conditioned), provided that such successor-in-interest assumes, by
contract or operation of law, the assigning party's duties and
obligations hereunder.
g. RECITALS, SCHEDULES AND EXHIBITS. Each Recital and each Schedule
and Exhibit attached hereto shall be incorporated into and be a part of
this Agreement.
h. ENTIRE AGREEMENT. This Agreement contains the entire
understanding between the parties and supersedes any prior understandings
or agreements between them affecting the subject matter. No changes,
alterations, amendments, modifications, additions or qualifications to
the terms of this Agreement shall be made or be binding unless made in
writing and signed by each of the parties.
i. COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be an original, but all of which shall
constitute one and the same instrument.
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
13
IN WITNESS WHEREOF, the Corporation and PPD have caused this Agreement to be
executed through their duly authorized officers as of the date first written
above.
PPD DEVELOPMENT, LLC
By: /s/ Xxxx X. Xxxxxxxx
--------------------------------------
Name: Xxxx X. Xxxxxxxx
--------------------------------------
Title: Chief Executive Officer
--------------------------------------
PPGx, Inc.
By: /s/ Xxxxxx X. Xxxxx
--------------------------------------
Name: Xxxxxx X. Xxxxx
--------------------------------------
Title: CEO & President
--------------------------------------
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
14
SCHEDULE 1
TRANSFER PRICING MECHANISM
This schedule outlines the initial procedure for calculating and adjusting
the Transfer Price for Designated Products and Designated Services pursuant to
the Distributor Agreement between the Corporation and PPD dated February 1,
1999, as amended and restated this day of December, 2000 (the "Distributor
Agreement"). Both parties acknowledge that these procedures will be revised from
time to time in order to achieve the objectives of the parties under the
Distributor Agreement. Unless otherwise expressly indicated in this schedule,
all capitalized terms shall have the same meaning set forth in the Distributor
Agreement.
Three relevant prices or costs exist:
1. Direct Costs as hereinafter defined.
2. Transfer Price.
3. Sales Price.
For each Designated Product, the original Transfer Price will be set so that
the PPD Margin on sales of Designated Products will target an "Agreed PPD
Margin." The Agreed PPD Margin upon commencement of the Distributor Agreement
for Designated Products is assumed to be [*] percent. Thereafter, the Transfer
Price for Designated Products will be set from time to time by evaluating PPD's
[*] Sales Prices and [*] Sales Price for each Designated Product. The actual PPD
Margin for each Designated Product is calculated by [*] PPD's [*] Sales Price
and [*] PPD's [*] Sales Price. It is the intention of PPD and PPGx that the
Transfer Price paid to PPGx hereunder for any given Designated Product shall in
all events be [*] PPGx's [*], and that PPGx's [*] does not prevent PPD from
offering Designated Products [*] which also provides PPD [*].
For each Designated Service, the PPD Margin will be the [*] for Designated
Services. The Transfer Price for any given Designated Services will be [*] of
such Designated Services. It is the intention of PPD and PPGx that the Transfer
Price paid to PPGx hereunder with respect to a given Designated Service shall in
all events be [*] PPGx's [*], and that PPGx's [*] does not prevent PPD from
offering Designated Services [*] which also provides PPD [*].
Direct costs will be determined by evaluating [*]. "Direct Costs" means
(i) the cost of [*], (ii) the cost of [*], and (iii) [*] and [*] Direct Costs
will not include the [*].
j. To the extent the parties cannot agree with respect to the Transfer
Price to be paid with respect to a given Designated Product or Designated
Service, or the Direct Costs incurred by the Corporation, the issue shall be
resolved by the JRC in the same manner outlined in Section 5.c of the
Distributor Agreement. In addition, appropriate representatives from the
Corporation and PPD will meet or otherwise confer, pursuant to such procedure
they establish, from time to time (but not less than annually) to review and
analyze [*] for the purpose of adjusting the Transfer Price.
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
1
SCHEDULE 1.g
The performance of the Corporation's proposed business activities (including
the Designated Services) involves the use of equipment, reagents and other items
which [*]. Absent the receipt of appropriate supplemental licenses permitted use
of such [*], which PPGx does [*], the [*]. Accordingly, to the extent that the
[*], the Corporation makes [*].
[*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
2
