Exhibit 10.1

 

AMENDED AND RESTATED

SALES AND MARKETING SERVICES AGREEMENT

 

This Amended and Restated Sales and Marketing Services Agreement(the
“Agreement”) is entered into as of July 9, 2003 (the “Effective Date”) by and
between CV Therapeutics, Inc.,a Delaware corporation (“CVT”), Innovex (North
America) Inc., a New Jersey corporation, as successor to Innovex Inc., a
Delaware corporation (“Innovex Inc.”), Innovex LP, a New Jersey limited
partnership (“Innovex”) and Quintiles Transnational Corp., a North Carolina
corporation (“Quintiles”), each on behalf of itself and its Affiliates (as
defined below). CVT, Innovex Inc., Innovex and Quintiles are sometimes referred
to herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS, CVT, Innovex Inc. and Quintiles (for purposes of Article 8 thereof) are
parties to that certain Sales and Marketing Services Agreement, dated as of May
5, 1999 (the “Services Agreement”), relating to the sale and marketing of the
Product (as defined below);

 

WHEREAS, CVT and Quintiles are parties to that certain Loan Agreement, dated as
of May 5, 1999 (the “Loan Agreement”) and that certain Security Agreement, dated
as of May 5, 1999 (the “Security Agreement”), and together with Fort Know Escrow
Services as the Escrow Agent, are parties to that certain Escrow Agreement,
dated as of May 5, 1999 (the “Escrow Agreement,” and together with the Loan
Agreement and the Security Agreement, the “Ancillary Agreements”);

 

WHEREAS, in connection with the Loan Agreement, CVT has delivered to Quintiles
executed copies of that certain promissory note dated May 5, 1999 in an
aggregate principal amount of $10,000,000 and that certain promissory note dated
May 5, 1999 in an aggregate principal amount of all advances made by Quintiles
to CVT under the Loan Agreement (collectively, the “Notes”);

 

WHEREAS, Innovex Inc. has transferred all of its rights and responsibilities
under the Services Agreement to Innovex, a wholly-owned subsidiary of Quintiles
and Affiliate of Innovex Inc.;

 

WHEREAS, the Parties desire to terminate the Ancillary Agreements and the Notes
and to terminate each Party’s rights and responsibilities under such Ancillary
Agreements and Notes (except as specifically set forth in this Agreement);

 

WHEREAS, it is the intent of the Parties that this Agreement amend and restate
in its entirety the Services Agreement and that, from and after the Effective
Date, the Services Agreement shall be of no further force and effect whatsoever;
and

 

WHEREAS, this Agreement is made in renewal, amendment, restatement, modification
and novation of the obligations under the Services Agreement.

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AGREEMENT

 

NOW, THEREFORE, in consideration of the foregoing recitals, the Parties hereto
agree as follows:

 

1. Definitions.

 

1.1 “Affiliate” means any corporation or business entity controlled by,
controlling, or under common control with a Party to this Agreement. For this
purpose, “control” shall mean direct or indirect beneficial ownership of at
least fifty percent (50%) of the voting stock or income interest in such
corporation or other business entity, or such other relationship as, in fact,
constitutes actual control.

 

1.2 “Approval” means the first approval during the Term of this Agreement by the
FDA authorizing CVT to market the Product in the United States.

 

1.3 “Approval Date” means the date upon which CVT is informed in writing by the
FDA of the Approval.

 

1.4 “FDA” means the U.S. Food and Drug Administration.

 

1.5 “Product” means ranolazine (the pharmaceutical agent described in U.S.
Patent No. 4,567,264) in a sustained release formulation which is the subject of
a new drug application filed by CVT with the FDA, or any other formulation
and/or indication for ranolazine (the pharmaceutical agent described in U.S.
Patent No. 4,567,264).

 

1.6 “Quintiles Services” means (a) any service offered by Innovex, (b) any other
commercialization service offered by Quintiles or its Affiliates, or (c) any
post-approval clinical service offered by Quintiles or its Affiliates.

 

1.7 “Third Party” means any entity or person other than a Party or an Affiliate
of any of them.

 

2. Termination of Ancillary Agreements and Replacement of Services Agreement by
This Agreement.

 

2.1 Confirmation of No Breach or Default. Effective as of the Effective Date,
the Parties hereby confirm that they have no losses, claims, damages,
liabilities, costs or expenses relating to or arising from any default or breach
by the other Party of any representation, warranty, covenant, term or other
provision of any of the Ancillary Agreements, the Notes or the Services
Agreement.

 

2.2 Termination of Ancillary Agreements and the Notes. Effective as of the
Effective Date, each of the Ancillary Agreements and the Notes are hereby
expressly terminated, cancelled and superseded in their entirety by this
Agreement and shall have no further force and effect; and, notwithstanding
anything in such Ancillary Agreements or Notes to the contrary, the Parties
shall have no further rights or obligations under such Ancillary Agreements or
Notes.

 

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2.3 Replacement of Services Agreement by This Agreement. Effective as of the
Effective Date, this Agreement hereby amends, restates and replaces in its
entirety the Services Agreement and the Parties’ respective rights and
obligations thereunder, such that from and after the Effective Date the Services
Agreement is of no further force and effect whatsoever. Without limiting the
generality of the foregoing, the Parties acknowledge and agree that all of the
provisions of the Services Agreement listed in Section 14.10 of the Services
Agreement, which were provided therein as surviving expiration or termination of
the Services Agreement, are as of the Effective Date of no further force and
effect whatsoever.

 

2.4 Release of Security Interests; Filings; Cooperation. Effective as of the
Effective Date, Quintiles hereby acknowledges and agrees that there are no
outstanding obligations of CVT under the Notes and that no Pre-Approval Advances
or any other Advances (each as defined in the Loan Agreement) were made to CVT
at any time, and Quintiles hereby unconditionally and irrevocably releases all
security interests or other claims or rights (the “Security Interests”) granted
or purported to be granted pursuant to the Security Agreement (the “Release”).
Quintiles hereby agrees to promptly (but in any event no later than ten (10)
business days following the Effective Date) make all filings required to
evidence the Release, including, but not limited to, any and all UCC (as defined
in the Security Agreement) filings, and all filings, if any, with the United
States Patent and Trademark Office. Quintiles shall promptly execute and deliver
any further instrument, document or notice as may be necessary, desirable or
which CVT may reasonably require in order to evidence the termination and
Release of the Security Interests.

 

2.5 Return of the Notes Marked Cancelled. Quintiles shall return each of the
Notes to CVT (attn: General Counsel) marked “Cancelled” within ten (10) business
days after the Effective Date. Notwithstanding any failure of Quintiles to
return and/or mark a Note, the Notes will be automatically cancelled at the
Effective Date.

 

2.6 Return of Escrow Property. In connection with the termination of the Escrow
Agreement, the Parties acknowledge and agree that the Escrow Property (as
defined in the Escrow Agreement) shall be returned as follows. Notwithstanding
the Claims Deadline under Section 2.4 of the Escrow Agreement, Quintiles and CVT
each hereby acknowledge and agree that Quintiles shall be entitled to receive
the Borrower NDA Letter (a copy of which is attached as an exhibit to the Escrow
Agreement) from the Escrow Agent (as defined in the Escrow Agreement), and CVT
shall be entitled to receive the Lender NDA Letter (a copy of which is attached
as an exhibit to the Escrow Agreement) from the Escrow Agent. To effectuate the
foregoing, within ten (10) business days following the Effective Date the
Parties agree to send to the Escrow Agent the joint instruction letter set forth
in Exhibit A attached hereto and incorporated herein by this reference,
instructing the Escrow Agent in connection with the mutually agreed-upon
termination of the Escrow Agreement to deliver and return said Borrower NDA
Letter to Quintiles (attn: Thomas C. Perkins) and to deliver and return said
Lender NDA Letter to CVT (attn: Tricia Borga Suvari, General Counsel), in each
case no later than ten (10) business days after the Effective Date.

 

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3. Commercialization Relationship.

 

3.1 Purchase of Quintiles Services. The parties wish to establish the
arrangements set forth in this Section 3 under which CVT will engage Quintiles
and its Affiliates to perform Quintiles Services and Quintiles and its
Affiliates will provide Quintiles Services, and CVT and Quintiles agree to enter
into certain Commercialization Services Agreements referred to below. It is the
intent of CVT and Quintiles that CVT will engage Quintiles and its Affiliates
pursuant to one or more Commercialization Services Agreements to provide
Quintiles Services having an Aggregate Expected Value (as defined below) of Ten
Million Dollars ($10,000,000.00) or more by or before the date that is six (6)
months following the Approval Date (the “CSAs Deadline”). Each engagement for
Quintiles Services will be set forth in a definitive written agreement between
CVT and Quintiles or its applicable Affiliate, containing appropriate terms and
conditions as may be mutually and reasonably acceptable to the parties (each
such agreement, a “Commercialization Services Agreement” or “CSA”). Quintiles
agrees that the prices to be paid by CVT for Quintiles Services pursuant to the
Commercialization Services Agreements shall equal, as nearly as reasonably
practicable, the prices charged by Quintiles or its Affiliates to Third Party
customers buying comparable services on comparable terms and conditions, such as
comparable quantity and scope of services and comparable completion time frames.
Upon such time as CVT notifies Quintiles with respect to a particular engagement
for Quintiles Services, CVT and Quintiles agree to work expeditiously and in
good faith to enter into an applicable Commercialization Services Agreement.
Each CSA shall include a provision setting forth the expected value of the CSA
(the expected value of all CSAs taken together shall be referred to herein as
the “Aggregate Expected Value”). In the event that CVT or Quintiles believes
that the expected value as set forth in a CSA should be modified, such Party may
contact the other Party, and the Parties agree to discuss in good faith such
proposed modification. In the event that CVT and Quintiles initiate working
toward a particular CSA but are unable to reach a definitive agreement, such
proposed CSA shall not in any manner affect the Aggregate Expected Value or
other calculations under this Agreement.

 

3.2 Payment by CVT. In the event that by the CSAs Deadline set forth above the
Aggregate Expected Value of the CSAs does not equal or exceed Ten Million
Dollars ($10,000,000.00), CVT shall be obligated to pay Quintiles a lump-sum
cash payment equal to Ten Percent (10%) of the difference between Ten Million
Dollars ($10,000,000.00) and the Aggregate Expected Value of the CSAs that have
been executed by CVT and Quintiles by the CSAs Deadline. Any and all CSAs
entered into by the Parties under Section 3.1 above, together with the cash
payment (if any is owed hereunder) under the immediately preceding sentence of
this Section 3.2, shall be in full satisfaction of all of the Parties’
respective rights and obligations to each other under this Article 3, including
in the event that the Aggregate Expected Value of the CSAs by the CSAs Deadline
does not equal or exceed Ten Million Dollars ($10,000,000.00). The cash payment
(if any is owed hereunder) shall be paid by CVT to Quintiles no later than
thirty (30) days after the CSAs Deadline.

 

3.3 Miscellaneous. The foregoing provisions of Sections 3.1 and 3.2 shall not
apply, shall have no force or effect, and shall not create any rights or
obligations in the Parties if (a) the Product does not receive Approval during
the Term of this Agreement (as defined below), or (b) CVT does not continue to
hold rights covering the Product on the CSAs Deadline (through ownership,
license or other rights).

 

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4. Preferred Provider Relationship. The Parties wish to preserve, foster and
further develop the working relationship and communications established by the
Parties under the Services Agreement. Accordingly, CVT designates Quintiles
(which for purposes of this Section 4 shall include its Affiliates) as a
“preferred provider,” such that during the Term of this Agreement CVT will give
Quintiles the opportunity to bid on future development and commercialization
projects involving services which (a) Quintiles has demonstrated expertise,
quality and competitive pricing, (b) CVT (which for purposes of this Section 4
shall include its Affiliates) has elected to outsource or otherwise engage a
Third Party to perform, and (c) are expected by CVT to involve payments
individually or in the aggregate of Three Hundred Thousand Dollars ($300,000.00)
or more. The Parties agree that for purposes of the foregoing clause (a), the
Parties initially shall refer to the lists of services described in the
“Business” Section, “Product Development Offerings” and Commercial Services
Offerings” of the Annual Report on Form 10-K (as amended) filed by Quintiles
with the Securities Exchange Commission for the year ended December 31, 2002.
Quintiles shall use its Alliance Manager under Section 5 below to keep CVT
apprised of additional services that may meet the standard under the foregoing
clause (a). CVT shall provide Quintiles with the opportunity to bid on at least
twelve (12) such projects during the Term; provided, however, that if CVT does
not provide Quintiles with the opportunity to bid on at least twelve (12) such
projects during the Term, the respective rights and obligations of the Parties
under Sections 4 and 5 of this Agreement shall automatically be extended for an
additional period of one (1) year. Quintiles agrees that the prices for such
services shall equal, as nearly as reasonably practicable, the prices charged by
Quintiles to Third Party customers buying comparable services on comparable
terms and conditions, such as comparable quantity and scope of services and
comparable completion time frames. The Parties agree to communicate, collaborate
and otherwise endeavor in good faith to fulfill the intent of this Section 4.

 

5. Alliance Managers. For purposes of this Agreement, Quintiles and CVT will
each appoint and maintain an operational Alliance Manager. The Alliance Managers
shall oversee potential and awarded CSAs under Section 3 above and on-going
clinical projects. Additionally, the Alliance Managers shall coordinate
preferred provider arrangements, including the Quintiles services and
opportunities to bid on CVT projects under Section 4 above. Further, the
Alliance Managers shall generally serve to coordinate and facilitate the other
activities of the Parties under this Agreement. The Quintiles Alliance Manager
shall report monthly to Dennis Gillings at Quintiles. For purposes of such CSAs,
projects and arrangements, the PharmaBio Development organization within
Quintiles will interact directly with the Quintiles clinical development team
and Innovex to ensure that pricing and operational delivery meet CVT’s
requirements.

 

6. Common Stock Warrant. Upon the execution and delivery of this Agreement by
each of the Parties, CVT shall issue to Quintiles or its designee a warrant, in
the form attached hereto and incorporated herein by reference as Exhibit B, to
purchase two hundred thousand (200,000) shares of common stock of CVT (the
“Warrant”).

 

7. Representations and Warranties. Each Party represents and warrants to the
other that as of the Effective Date:

 

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7.1 Corporate Power. It is duly organized and validly existing under the laws of
its state or country of incorporation, and has full corporate power and
authority to enter into this Agreement and the Warrant and to carry out the
provisions hereof and thereof.

 

7.2 Due Authorization. It is duly authorized to execute and deliver this
Agreement and the Warrant, and to perform its obligations hereunder and
thereunder, and the person or persons executing this Agreement or the Warrant on
its behalf has been duly authorized to do so by all requisite corporate action.

 

7.3 Binding Agreement. This Agreement and the Warrant are legally binding upon
it and enforceable against it in accordance with their respective terms. The
execution, delivery and performance of this Agreement and the Warrant by it do
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 material
law, regulation or order of any court, governmental body or administrative or
other agency having jurisdiction over it.

 

7.4 Validity. It is aware of no action, suit or inquiry or investigation
instituted by any governmental agency that questions or threatens the validity
of this Agreement or the Warrant, or the consummation of the transactions
contemplated hereby or thereby.

 

8. Confidentiality.

 

8.1 Confidential Information. Each Party agrees that information specifically
relating to the marketing and sales of the Product, or the business affairs or
finances of the other Parties or such other Party’s Affiliates or suppliers,
agents, distributors, licensees or customers, which is or has been disclosed in
writing and marked “confidential”, or disclosed orally or in any other tangible
form and reduced to a written summary marked “confidential”, and which in any
case came into possession of such Party under the Services Agreement or comes
into the possession of such Party under this Agreement, shall be considered
confidential information (“Confidential Information”). Each Party agrees for a
period of five (5) years from the Effective Date to hold Confidential
Information in strict confidence and disclose it only on a need-to-know basis to
Affiliates, subcontractors and employees who are under a written obligation to
maintain the confidentiality of the information. The foregoing obligations of
confidentiality and limited use shall not apply to information:

 

8.1.1 which can be shown by written documentation to have been known by the
recipient Party prior to its receipt from the other Party;

 

8.1.2 which is public or lawfully becomes generally available to the public
through no fault of the recipient Party;

 

8.1.3 which is lawfully acquired by the recipient Party from a Third Party
without being made subject to an obligation of confidence by the Third Party;

 

8.1.4 which by mutual written agreement of the Parties is released from a
confidential status; or

 

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8.1.5 which is required by the recipient Party to be disclosed under any
statutory, regulatory or judicial requirement, including but not limited to any
filing with the Securities Exchange Commission; provided, however, that in any
such event, the recipient Party shall preserve and protect the confidentiality
of the other Party’s Confidential Information to the extent possible, and will
notify the other Party prior to any such disclosure.

 

8.2 Ownership of Data; No License. It is expressly acknowledged and agreed that
no Party transfers or transferred to any other Party by operation of this
Agreement, the Services Agreement or any Ancillary Agreement any patent right,
copyright or other proprietary right. All data and information generated or
derived by Quintiles, Innovex Inc. and/or Innovex as the result of services
performed by Quintiles, Innovex Inc. and/or Innovex under the Services Agreement
or this Agreement shall be and remain the exclusive property of CVT. Any
inventions that may evolve from the data and information as the result of
services performed by Quintiles, Innovex Inc. and/or Innovex under the Services
Agreement or this Agreement shall belong to CVT, and each of Quintiles, Innovex
Inc. and Innovex agree to assign its respective rights in all such inventions
and/or related patents (if any) to CVT. Notwithstanding the foregoing, CVT
acknowledges that Quintiles, Innovex Inc. and Innovex possess certain
inventions, processes, know-how, trade secrets, improvements, other intellectual
properties and other assets, including but not limited to analytical methods,
procedures and techniques, procedure manuals, personnel data, financial
information, computer technical expertise and software, which have been
independently developed by Quintiles, Innovex Inc. and/or Innovex and which
relate to their respective business or operations (collectively, “Quintiles
Property”). The Parties agree that any Quintiles Property or improvement thereto
which is used, improved, modified or developed by Quintiles, Innovex Inc. and/or
Innovex under or during the term of the Services Agreement or this Agreement is
and shall remain the sole and exclusive property of Quintiles, Innovex Inc. or
Innovex, as applicable.

 

8.3 Firewall. In connection with information exchanged under this Agreement
and/or with the provision of any Quintiles Services under any CSA, Quintiles
(for purposes of this Agreement) and Innovex or any Quintiles Affiliate (for
purposes of any CSA to which it is a party) shall keep separate and shall not
share with other parts of its organization that are or may be performing
services for a competing product, the material and information supplied and/or
generated hereunder or thereunder.

 

9. Indemnification.

 

9.1 Indemnification by CVT. CVT shall indemnify, defend, save, protect, and hold
harmless Quintiles, its Affiliates, and its and their respective directors,
officers, employees, and agents (“Quintiles Indemnitees”) against any and all
losses, claims, damages, liabilities, costs and expenses (including reasonable
attorneys fees and expenses and court costs) (collectively, “Losses”) resulting
or arising from any Third Party claims, actions, proceedings, investigations or
litigation relating to or arising from or in connection with: (a) the breach by
CVT of any of its obligations under the Services Agreement prior to the
Effective Date or under this Agreement or (b) the design, development,
manufacture, sale, distribution or use of the Product. Notwithstanding the
foregoing, (i) nothing contained in these indemnification obligations shall
override any indemnification obligations agreed to by the Parties in any

 

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Commercial Services Agreement under Section 3 above or any agreement for
services awarded to Quintiles under Section 4 above, and (ii) CVT shall not be
required to indemnify Quintiles or any of the Quintiles Indemnitees for any
Losses to the extent they arise from the negligent or wrongful acts or omissions
of Quintiles or any of the Quintiles Indemnitees or any breach by Quintiles or
any of the Quintiles Indemnitees of its obligations under the Services Agreement
prior to the Effective Date or under this Agreement.

 

9.2 Indemnification by Innovex. Quintiles, Innovex and Innovex Inc., jointly and
severally, shall indemnify, defend, save, protect, and hold harmless CVT, its
Affiliates, and its and their respective directors, officers, employees, and
agents (the “CVT Indemnitees”) against any and all Losses resulting or arising
from any Third Party claims, actions, proceedings, investigations or litigation
relating to or arising from or in connection with the breach by Quintiles,
Innovex or Innovex Inc. of any of its respective obligations under the Services
Agreement prior to the Effective Date or under this Agreement. Notwithstanding
the foregoing, none of Quintiles, Innovex or Innovex Inc. shall be required to
indemnify CVT or any of the CVT Indemnitees for any Losses to the extent they
arise from the negligent or wrongful acts or omissions of CVT or any of the CVT
Indemnitees or the breach by CVT or any of the CVT Indemnitees of its
obligations under the Services Agreement prior to the Effective Date or under
this Agreement.

 

9.3 Procedure. The Party seeking indemnification hereunder (the “Indemnified
Party”) shall (a) promptly notify the Party obligated to indemnify (the
“Indemnifying Party”) of any Losses for which the Indemnified Party seeks
indemnification; (b) cooperate fully with Indemnifying Party and its legal
representatives in the investigation of any matter the subject of
indemnification; (c) permit the Indemnifying Party full control over the defense
and settlement of any matter the subject of indemnification; and (d) not
unreasonably withhold its approval of the settlement of any claim, liability or
action by Indemnifying Party covered by this indemnification provision.

 

9.4 No Consequential Damages. Notwithstanding the Parties’ rights and remedies
in equity and except with respect to indemnification obligations under Sections
9.1 and 9.2, no Party, nor its Affiliates or their respective directors,
officers, employees or agents shall have any liability to any other for any
special, incidental, indirect or consequential damages, including, but not
limited to the loss of opportunity, use, revenue or profit, in connection with
or arising out of this Agreement even if such damages were foreseeable.

 

10. Dispute Resolution.

 

10.1 Disputes. The Parties recognize that disputes as to certain matters may
from time to time arise during the term of this Agreement which relate to such
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 litigation, as such may be accomplished by good faith negotiations between
the Parties, within thirty (30) days of notice. If such dispute remains
unresolved at that point, it shall promptly be submitted to the Chief Executive
Officer of Quintiles and the Chief Executive Officer of CVT who will meet in
person or by teleconference

 

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at least once within thirty (30) days after such submission and attempt to
resolve the matter or matters in dispute.

 

10.2 Governing Law. Resolution of all disputes arising out of or related to this
Agreement or the performance, enforcement, breach or termination of this
Agreement and any remedies relating thereto, shall be governed by and construed
under the substantive laws of the State of Delaware, as applied to agreements
executed and performed entirely in the State of Delaware by residents of the
State of Delaware, without regard to conflicts of law rules.

 

11. Term and Termination.

 

11.1 Term. The term of this Agreement (“Term”)will begin on the Effective Date
and continue until the third (3rd) anniversary of the Effective Date, unless the
Agreement is terminated earlier in accordance with this Section 11; provided,
however, if the Product receives Approval prior to the third (3rd) anniversary
of the Effective Date, but after thirty (30) months following the Effective
Date, then the Term of this Agreement shall be extended until the date which is
six (6) months following the date of such Approval.

 

11.2 Material Breach. CVT may terminate this Agreement by written notice at any
time if Quintiles, Innovex Inc. or Innovex defaults in the performance of any
material obligations under this Agreement. Quintiles, Innovex Inc. and Innovex
may terminate this Agreement by written notice at any time if CVT defaults in
the performance of any material obligations under this Agreement. In the event
of such default, the Party declaring the default shall provide the defaulting
Party or Parties with written notice setting forth the nature of the default,
and the defaulting Party or Parties shall have thirty (30) days to cure the
default. If the defaulting Party or Parties fail(s) to cure the default within
the foregoing time period, and provided the default is continuing, the other
Party or Parties, as the case may be, may terminate this Agreement by written
notice to the defaulting Party or Parties, which notice shall be effective upon
receipt.

 

11.3 Bankruptcy. CVT may terminate this Agreement by written notice to
Quintiles, Innovex Inc. or Innovex, if Quintiles, Innovex Inc. or Innovex files
a petition for bankruptcy, reorganization or arrangement under any state
statute, or makes an assignment for the benefit of creditors or takes advantage
of any insolvency statute or similar statute, or such filing is made by a Third
Party, and such filing is not withdrawn within sixty (60) days of the filing
date, or if a receiver or trustee is appointed for the property and assets of
Quintiles, Innovex Inc. or Innovex and the receivership proceedings are not
dismissed within sixty (60) days of such appointment. Quintiles, Innovex Inc.
and Innovex may terminate this Agreement by written notice to CVT if CVT files a
petition for bankruptcy, reorganization or arrangement under any state statute,
or makes an assignment for the benefit of creditors or takes advantage of any
insolvency statute or similar statute, or such filing is made by a Third Party,
and such filing is not withdrawn within sixty (60) days of the filing date, or
if a receiver or trustee is appointed for the property and assets of CVT and the
receivership proceedings are not dismissed within sixty (60) days of such
appointment.

 

11.4 Accrued Rights. Termination of this Agreement for whatever reason shall not
affect the accrued rights of any Party arising under or out of this Agreement
and all

 

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provisions which expressly or by implication survive this Agreement shall remain
in full force and effect. Termination of this Agreement shall not relieve the
Parties of any liability which accrued hereunder prior to the effective date of
such termination nor preclude any Party from pursuing all rights and remedies it
may have hereunder or at law or in equity with respect to any breach of this
Agreement nor prejudice any Party’s right to obtain performance of any
obligation.

 

11.5 Survival. The following provisions of this Agreement shall survive any
expiration or termination of this Agreement, and if time periods are specified,
for the period of time specified: Sections 8, 9, 11.5 and 12.4. The Warrant
shall survive any expiration or termination of this Agreement, in accordance
with its terms and conditions.

 

12. Miscellaneous.

 

12.1 Nonsolicitation of Employees. For a period of six (6) months after the
Effective Date, each Party agrees that neither it nor any of its divisions or
operating groups that directly participated in or was directly responsible for
the development or commercialization of the Product pursuant to the Services
Agreement shall, directly or indirectly, recruit, solicit or induce any employee
of the other Party to terminate his or her employment with such other Party.

 

12.2 Publicity. The Parties agree that promptly following the execution of this
Agreement, they will issue a joint press release in the form attached hereto and
incorporated herein by reference as Exhibit C (the “Joint Announcement”).
Subsequent announcements related to this Agreement shall be by mutual consent;
provided, however, that subsequent disclosures (including but not limited to
filings under the Securities and Exchange Act of 1934, as amended) by a Party
that merely restate all or part of the text or substance of the Joint
Announcement shall not require such mutual consent. The Parties acknowledge and
agree that, just as in the Services Agreement, CVT shall continue to be the
Party responsible for disclosure of information related to the sales,
performance, pharmaceutical characteristics and clinical study data of the
Product, and each of Quintiles, Innovex Inc. and Innovex agree not to make any
disclosures, public or private, in that regard. Each Party is otherwise
authorized to make any disclosures as may be required by law, including but not
limited to disclosures as required under the Securities and Exchange Act of
1934, as amended.

 

12.3 Entire Agreement; Amendment. This Agreement and the exhibits attached
hereto (including the Warrant) set forth the complete, final and exclusive
agreement and all the covenants, promises, agreements, warranties,
representations, conditions and understandings between the Parties hereto, and
supersede and terminate all prior agreements and understandings between the
Parties (including the Services Agreement and the Ancillary Agreements). There
are no covenants, promises, agreements, warranties, representations, conditions
or understandings, either oral or written, between the Parties other than as are
set forth herein and therein. No subsequent alteration, amendment, change or
addition to this Agreement shall be binding upon the Parties unless reduced to
writing and signed by an authorized officer of each Party.

 

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12.4 Notices. Any notice required or permitted to be given under this Agreement
shall be in writing, shall specifically refer to this Agreement and shall be
deemed to have been sufficiently given for all purposes five (5) days after
mailed by first class certified or registered mail, postage prepaid, the next
business day after delivery by overnight courier service, or the same business
day as personally delivery or transmission by fax machine (with machine
confirmation of complete delivery), in any case to the proper address of the
Party. Unless otherwise specified in writing in accordance with this Section
12.4, the addresses of the Parties for all notices under this Agreement shall be
as described below:

 

  For CVT:   CV THERAPEUTICS, Inc.

3172 Porter Drive

Palo Alto, California 94304

Attention: Tricia Borga Suvari, General Counsel

Fax: (650) 858-0388

 

  with a copy to:   Latham & Watkins LLP

135 Commonwealth Drive

Menlo Park, California 94025

Attention: Alan C. Mendelson, Esq.

Fax: (650) 463-2600

 

  for Innovex:   Innovex LP

c/o Quintiles Transnational Corp.

4709 Creekstone Drive

Suite 200, Riverbirch Building

Durham, North Carolina 27703

Attention: Thomas C. Perkins

Fax: (919) 998-2090

 

with a copy as provided below;

 

  for Innovex Inc.:   Innovex (North America) Inc.

c/o Quintiles Transnational Corp.

4709 Creekstone Drive

Suite 200, Riverbirch Building

Durham, North Carolina 27703

Attention: Thomas C. Perkins

Fax: (919) 998-2090

 

with a copy as provided below; and

 

  for Quintiles:   Quintiles Transnational Corp.

4709 Creekstone Drive

Suite 200, Riverbirch Building

Durham, North Carolina 27703

Attention: Thomas C. Perkins

Fax: (919) 998-2090

 

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with, in the case of any notice to Innovex, Innovex Inc. or Quintiles hereunder,
a copy to:

 

Smith, Anderson, Blount, Dorsett,

Mitchell & Jernigan, L.L.P.

2500 Wachovia Capitol Center

Raleigh, North Carolina 27601

Attention: Christopher B. Capel

Fax: (919) 821-6800

 

or to such other destination as any Party may hereafter notify the other Party
in accordance with this Section 12.4.

 

12.5 No Strict Construction. This Agreement has been prepared jointly and shall
not be strictly construed against any Party.

 

12.6 Assignment. No Party may assign or transfer this Agreement or any rights or
obligations hereunder without the prior written consent of the other, except
that a Party may make such an assignment without the other Party’s consent to
Affiliates or to a successor to substantially all of the business of such Party,
whether in a merger, sale of stock, sale of assets or other transaction. Any
permitted successor or assignee of rights and/or obligations hereunder shall, in
a writing to the other Parties, expressly assume performance of such rights
and/or obligations. Any permitted assignment shall be binding on the successors
of the assigning Party. Any assignment or attempted assignment by either Party
in violation of the terms of this Section 12.6 shall be null and void and of no
legal effect. If any Party assigns this Agreement to an Affiliate pursuant to
this Section 12.6, the assigning Party shall provide a continuing guarantee of
the performance of this Agreement by such Affiliate.

 

12.7 Performance by Affiliates. Obligations under this Agreement may be
performed by Affiliates of the Parties only with the prior consent of the other
Parties. In the event any such performance is carried out by Affiliates with the
prior consent of the other Parties, each Party guarantees performance of this
Agreement by its Affiliates. No Affiliate of a Party may make decisions
inconsistent with this Agreement, amend the terms of this Agreement or act
contrary to its terms in any way.

 

12.8 Counterparts. This Agreement may be executed in one (1) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

 

12.9 Further Actions. Each Party agrees to execute, acknowledge and deliver such
further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

 

12.10 Severability. If any one or more of the provisions of this Agreement is
held to be invalid or unenforceable by any court of competent jurisdiction from
which no appeal can be or is taken, the provision shall be considered severed
from this Agreement and shall not serve to invalidate any remaining provisions
hereof. The Parties shall make a good faith effort to

 

-12-

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replace any invalid or unenforceable provision with a valid and enforceable one
such that the objectives contemplated by the Parties when entering this
Agreement may be realized.

 

12.11 Ambiguities. Ambiguities, if any, in this Agreement shall not be construed
against any Party, irrespective of which Party may be deemed to have authored
the ambiguous provision.

 

12.12 Headings. The headings for each section in this Agreement have been
inserted for convenience of reference only and are not intended to limit or
expand on the meaning of the language contained in the particular article or
section.

 

12.13 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or
any waiver as to a particular default or other matter shall not constitute a
waiver of such Party’s rights to the future enforcement of its rights under this
Agreement, except with respect to an express written and signed waiver relating
to a particular matter for a particular period of time.

 

(Signature Page Follows)

 

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives as of the date first set forth above.

 

CV THERAPEUTICS, INC.

By:

 

/s/ Louis G. Lange

--------------------------------------------------------------------------------

   

Louis G. Lange, M.D., Ph.D.

Chief Executive Officer

INNOVEX (NORTH AMERICA) INC.

By:

 

/s/ Beverly Rubin

--------------------------------------------------------------------------------

   

Name: Beverly Rubin

Title: Deputy General Counsel

INNOVEX LP

By:

 

/s/ Beverly Rubin

--------------------------------------------------------------------------------

   

Name: Beverly Rubin

Title: Deputy General Counsel

QUINTILES TRANSNATIONAL CORP.

By:

 

/s/ Tom Perkins

--------------------------------------------------------------------------------

   

Name: Tom Perkins

Title: SVP – Corporate Development

 

 

-14-

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EXHIBIT A

 

FORM OF JOINT INSTRUCTION TO ESCROW AGENT

 

July     , 2003

 

Fort Know Escrow Services, Inc.

2100 Norcross Parkway, Suite 150

Norcross, Georgia 30071

Attention: Glen Bryman

 

  Re:   Escrow Agreement dated May 5, 1999

CV Therapeutics, Inc./Quintiles Transnational Corp.

 

Dear Mr. Bryman:

 

We make reference to that certain Escrow Agreement (the “Escrow Agreement”),
dated as of May 5, 1999, by and among Quintiles Transnational Corp., a North
Carolina corporation (“Quintiles”), CV Therapeutics, Inc., a Delaware
corporation (“CVT”) and Fort Knox Escrow Services, Inc., a Georgia corporation
(the “Escrow Agent”). Capitalized terms not defined in this letter shall have
the meanings given to them in the Escrow Agreement.

 

Pursuant to the Escrow Agreement, Quintiles and CVT hereby jointly instruct you
(“Delivery Instruction”) as the Escrow Agent to promptly deliver (i) to
Quintiles (attention: Thomas C. Perkins, with a copy to Quintiles’s outside
counsel as provided below), the Borrower NDA Letter (a copy of which is attached
as an exhibit to the Escrow Agreement) and (ii) to CVT (attention: Tricia Borga
Suvari, General Counsel, with a copy to CVT’s outside counsel as provided
below), the Lender NDA Letter (a copy of which is attached as an exhibit to the
Escrow Agreement), with each such delivery to occur no later than ten (10)
business days after the date set forth above. Quintiles and CVT each hereby (i)
consent to and waive any objections to this Delivery Instruction and (ii)
acknowledge and agree that, after the delivery of the Escrow Property by the
Escrow Agent pursuant to the foregoing Delivery Instruction, the Escrow Property
will be completely distributed in accordance with the terms of the Escrow
Agreement, and immediately thereafter the Escrow Agreement shall be terminated
pursuant to Section 4.9 of the Escrow Agreement.

 

Please note that the required copy to Quintiles’s outside counsel should be
directed to Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P., 2500
Wachovia Capitol Center, Raleigh, North Carolina 27601, Attention: Christopher
B. Capel, Esq.

 

Please note that the required copy to CVT’s outside counsel should be directed
to Latham & Watkins LLP, 135 Commonwealth Drive, Menlo Park, California 94025,
Attention: Alan C. Mendelson, Esq.

 

Should you have any questions, please contact Tricia Borga Suvari of CVT at
(650) 384-8611 or Thomas C. Perkins of Quintiles at (919) 998-2080.

--------------------------------------------------------------------------------

Thank you.

 

CV THERAPEUTICS, INC.       QUINTILES TRANSNATIONAL CORP. By:  

 

--------------------------------------------------------------------------------

      By:  

 

--------------------------------------------------------------------------------

   

Louis G. Lange, M.D., Ph.D.

Chief Executive Officer

         

Name:

Title:

--------------------------------------------------------------------------------

EXHIBIT B

 

FORM OF COMMON STOCK WARRANT

--------------------------------------------------------------------------------

EXHIBIT C

 

FORM OF PRESS RELEASE