Confidential treatment has been
requested for portions of this
document. Brackets indicate portions
of text that have been omitted. A
separate filing of such omitted text
has been made with the Commission as
part of the Company's application
for confidential treatment.
EXHIBIT 10.25
LICENSE AGREEMENT
THIS LICENSE AGREEMENT made and effective as of March 27, 1996 between SYNTEX
(U.S.A.) INC., 0000 Xxxxxxxx Xxxxxx, Xxxx Xxxx, Xxxxxxxxxx 00000 (hereinafter
referred to as "Syntex") and CV THERAPEUTICS, INC., 0000 Xxxxxx Xxxxx, Xxxx
Xxxx, Xxxxxxxxxx 00000 (hereinafter referred to as "CVT").
RECITALS
WHEREAS, Syntex has developed a compound having the generic name of ranolazine,
with the Syntex code number RS-43285-193 (the "Compound" as hereinafter defined)
and is the owner of patent rights and know-how relating to the Compound;
WHEREAS, Syntex desires to have CVT develop and register in specified countries
(the "CVT Territory" as hereinafter defined) pharmaceutical products containing
the Compound for the treatment of angina pectoris, and, at CVT's discretion,
certain other Cardiovascular Indications (as hereinafter defined);
WHEREAS, CVT desires to develop, manufacture, and commercialize Licensed
Products (as hereinafter defined) in the CVT Territory either by itself or with
another party (the "CVT Partner") with whom CVT will collaborate in developing
and/or marketing such products and to receive the right and license under the
Syntex Patents and Know-How (as hereinafter defined) to make, have made, use,
sell, offer for sale and import in the CVT Territory Licensed Products under
CVT's trademark;
WHEREAS, Syntex is willing to grant in the CVT Territory the above- mentioned
rights and license to CVT under Syntex Patents and Know-How relating to the
Licensed Products;
NOW, THEREFORE, the parties hereto agree as follows:
ART. I - DEFINITIONS
The following terms as used in this License Agreement shall have the meanings
respectively set forth in this Article:
1
1.1 "AFFILIATED COMPANY" or "AFFILIATE" shall mean
a) an organization fifty percent (50%) or more of the voting
stock, or comparable ownership interest, of which is owned
and/or controlled directly or indirectly by either party to
this Agreement;
b) an organization that directly or indirectly owns and/or
controls fifty percent (50%) or more of the voting stock, or
comparable ownership interest, of either party of this
Agreement;
c) an organization that is directly or indirectly under common
control with either party to this Agreement through common
share holdings.
1.2 "CARDIOVASCULAR INDICATIONS" shall mean the treatment and prevention of
any disorders of the heart, blood vessels, or kidney and disorders due
to ischemia or hypoxia of any organ or tissue except the brain.
1.3 "COMPOUND" shall mean the chemical substance having the chemical name
( )N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-
piperazine acetamide dihydrochloride. The Compound has the generic name
ranolazine, further identified by Syntex's code number RS-43285-193.
1.4 "CVT KNOW-HOW" shall mean all materials and information developed
relating to the mechanism of action, all preclinical and clinical
research, and processes and inventions useful for the formulation,
development, manufacture, delivery or use of the Licensed Products,
that are owned and/or controlled by CVT.
1.5 "CVT PATENT RIGHTS" shall mean all patents and patent applications,
both foreign and domestic, including without limitation all
provisionals, divisionals, continuations, continuations-in-part,
substitutions, extensions, reissues, renewals, supplementary protection
certificates and inventors' certificates, owned and/or controlled by
CVT that cover inventions or discoveries relating to the Licensed
Products.
1.6 "CVT PATENTS AND KNOW-HOW" shall mean CVT Patent Rights and CVT
Know-How.
2
1.7 "CVT TERRITORY" shall mean all countries in the world, excluding Japan,
Korea, China, Taiwan, Hong Kong, the Philippines, Indonesia, Singapore,
Thailand, Malaysia, Vietnam, Myanmar, Laos, Cambodia and Brunei.
1.8 "LICENSED COMPOUND(S)" shall mean the Compound and any other compound
claimed in U.S. Patent No. 4,567,264 granted January 28, 1986 and in
European Patent No. 126,449, granted December 23, 1987.
1.9 "LICENSED PRODUCT(S)" shall mean human therapeutic product(s)
containing any Licensed Compound as an active ingredient for the
treatment of angina pectoris and, at CVT's discretion, certain other
Cardiovascular Indications, in such formulations and modes of
administration as determined by CVT.
1.10 "NET SALES" shall mean the gross sales of the Licensed Product invoiced
by CVT, its Affiliates, the CVT Partner and other sublicensees, as the
case may be, to non-Affiliated third parties, less [ * ], as computed
on [ * ] (hereinafter referred to as "adjusted gross sales"). From the
adjusted gross sales [ * ].
1.11 "SYNTEX KNOW-HOW" shall mean all materials and information developed
relating to the mechanism of action, all preclinical and clinical
research, and processes and inventions useful for the formulation,
development, manufacture, delivery or use of the Licensed Products,
that are owned and/or controlled by Syntex as of the effective date of
this Agreement and thereafter acquired during and in the course of
performance of the Agreement to the extent that Syntex is free to
disclose without restriction. Information received by Syntex from the
Third Party Licensee will be expressly excluded from Syntex Know-How.
Syntex shall not license such information to another third party in the
CVT Territory for use in Cardiovascular Indications.
1.12 "SYNTEX PATENT RIGHTS" shall mean all patents and patent applications,
both foreign and domestic, including without limitation all
provisionals, divisionals, substitutions, continuations,
continuations-in-part, extensions, reissues, renewals, supplementary
protection certificates and inventors' certificates, that are owned
and/or controlled by Syntex and that cover inventions or discoveries
relating to the Licensed
3
Products. As of the effective date of this Agreement, Syntex Patent
Rights shall mean those patents and applications set out in Appendix A
attached hereto.
1.13 "SYNTEX PATENTS AND KNOW-HOW" shall include Syntex Patent Rights and
Syntex Know-How.
1.14 "THIRD PARTY LICENSEE" shall mean the third party to which Syntex has
granted a license of rights to the Compound in the countries outside
the CVT Territory as of the effective date of this Agreement, or any
future licensee of Syntex of the Compound or other compounds
encompassed by the Licensed Products outside of the CVT Territory.
ART. II - GRANT OF RIGHTS
2.1 Syntex herewith grants to CVT under the Syntex Patent Rights and Syntex
Know-How for the Cardiovascular Indications:
a) an exclusive right and license to develop and register the
Licensed Product(s) in the CVT Territory for angina pectoris
and, at CVT's discretion, certain other Cardiovascular
Indications; and
b) an exclusive right and license to make, have made, use, offer
for sale, sell and import the Licensed Product(s) in the CVT
Territory for angina pectoris and, at CVT's discretion,
certain other Cardiovascular Indications.
No rights are granted pursuant to the foregoing license under the
Syntex Patent Rights and Know-how to any compounds other than the
Licensed Compounds.
2.2 The exclusiveness as per Section 2.1 above shall be valid against
Syntex in the CVT Territory, unless specifically provided for to the
contrary under this Agreement.
2.3 CVT shall be permitted to extend its right and license obtained under
this Agreement to its Affiliates and to grant sublicenses to third
parties in the CVT Territory. Unless expressly stated to the contrary,
all references in this Agreement to sublicensees of CVT shall include
the CVT Partner. CVT shall inform Syntex in writing of the identity of
its
4
sublicensees, including the CVT Partner, and any Affiliates to which it
has extended rights, promptly after such parties have obtained such
rights.
2.4 If at any time CVT or the CVT Partner for reasons of seeking a
marketing partner decides that it desires to sublicense its rights
granted in Section 2.1 to a third party in a given country of the CVT
Territory, CVT or the CVT Partner, as the case may be, shall give
Syntex written notice to such effect identifying the country or
countries. [ * ] as the case may be, by written notice that [ * ]
provided, however, that the foregoing shall not apply to [ * ] [ * ] as
the case may be, [ * ]. Such agreement shall be on commercially
reasonable terms, which may include, without limitation, [ * ] as the
case may be, shall then be [ * ].
2.5 Any registrations, and any other validations, notifications, or like
procedures, and compliance therewith, required by any authority in the
CVT Territory with respect to the right and license granted to CVT
pursuant to this Agreement shall be the sole responsibility of CVT and
shall be at the sole expense of CVT. CVT shall indemnify and hold
Syntex harmless from any claim against Syntex arising from or relating
to CVT's failure to comply with the foregoing.
ART. III - DISCLOSURE
3.1
a) Following execution of this Agreement, Syntex shall provide
CVT all written Syntex Know-How in its possession relevant to
the Compound to the extent available. Syntex shall use
reasonable efforts to arrange for a complete disclosure and
demonstration of all technology and know-how in its possession
worldwide relating to the Compound that is necessary or useful
for the manufacture of Licensed Products (in bulk and finished
form under Good Laboratory Practice ("GLP) and Good
Manufacturing Practice "(GMP") conditions for clinical or
commercial use) by CVT or a CVT sublicensee or subcontractor,
by personnel of
5
Syntex or other knowledgeable ex-Syntex personnel accessible
to Syntex, to the extent such personnel will be available.
b) Upon reasonable notice to Syntex, Syntex shall use reasonable
efforts to make available up to three Syntex employees to
facilitate the transfer of Syntex Know-How relating to bulk
manufacture of the Compound, including a walk-through of a
process batch, and demonstrate the manufacturing process at a
single site, either in North America or Europe, and up to two
Syntex employees to facilitate the transfer of formulation
know-how, including the walk-through of a pilot batch, at a
single manufacturing site designated by CVT as its prime
manufacturing site in the United States or Europe; provided,
however, that Syntex shall not be obligated to make available
more than a total of four (4) employees. In either case,
Syntex shall not be obligated to maintain such employees on
site after successful walk-through and batch preparation, and
in no event longer than three (3) weeks. Travel and related
out-of-pocket expenses of Syntex employees in rendering the
foregoing services at sites remote from the Syntex facilities
shall be paid for by CVT. All Syntex obligations under this
Section 3.1b) shall cease December 31, 1996.
c) Syntex shall grant permission, upon written request and
reasonable notice by CVT, for ex-Syntex personnel and
ex-Syntex consultants, as the case may be, to disclose and
discuss Syntex's proprietary information on the Compound to
CVT or the CVT Partner solely in furtherance of the purposes
of this Agreement. Syntex will pay up to a maximum total of
twenty-five thousand dollars ($25,000) for the reasonable
costs (including consulting fees and reasonable travel
expenses), in the aggregate, of all ex-Syntex personnel and of
the two, ex-Syntex consultants Xx. Xxxx Xxxxxxxxx and Xx. X.X.
Xxxxxxxx when providing the foregoing services to CVT and the
CVT Partner, and CVT shall be solely responsible for payment
of any such costs in excess of that amount and the costs of
any other consultants of CVT.
6
d) Syntex's obligations in accordance with this Article III,
including making employees available for telephone
consultations, with respect to transfer of written information
and associated documentation relating to pre-clinical and
clinical activities and IND matters shall cease four (4)
months from the effective date of this Agreement.
3.2 CVT shall provide periodic progress reports of the significant results
of the development of the Licensed Products and CVT's progress in
meeting the milestone timetable set out in Appendix B, in such form and
detail as Syntex may reasonably require.
3.3 If Syntex has been granted rights under an agreement pursuant to
Section 2.4 above, it is understood that CVT shall then make available
to Syntex any know-how, information, data, etc. (including the
registration file prepared by CVT or the CVT Partner for registration
approval) in CVT's or the CVT Partner's possession for Syntex's
marketing of the Licensed Product in that portion of the CVT Territory
where Syntex has been granted rights to sell Licensed Product(s). In
such case, the provisions of Section 2.5 shall not apply to that
portion of the CVT Territory where Syntex has been granted rights to
sell Licensed Product(s).
ART. IV - DEVELOPMENT, REGISTRATION AND MARKETING
4.1 All development and clinical trials required for regulatory approval in
CVT Territory will be conducted by CVT or the CVT Partner, at the sole
expense of CVT or the CVT Partner. CVT and the CVT Partner will have
the right to subcontract any part of its development and clinical trial
obligations in the CVT Territory.
4.2 Syntex shall, upon execution of this Agreement, exercise reasonable
efforts to introduce CVT to the Third Party Licensee.
4.3 Syntex shall endeavor to provide access by CVT to all consultants who
have been involved in the development of the Compound by Syntex and
whom CVT desires to retain for the purposes of this Agreement, to the
extent such consultants are available and willing to work with CVT.
Subject to Section 3.1c), all costs and expenses associated with
retaining such consultants shall be borne by CVT.
7
4.4 All processes, inventions, formulations, proprietary information,
know-how, and patents resulting from CVT's development program,
including formulation and manufacturing information (the "Results")
developed pursuant to the licenses granted to CVT hereunder shall be
owned by CVT.
4.5 Subject to Section 11.4, CVT shall use commercially reasonable efforts
to develop the Compound for the treatment of angina pectoris within
milestone/time guidelines set out in Appendix B hereto, or as later
mutually agreed to in writing by duly authorized officers of the
parties hereto. CVT shall notify Syntex before the lapse of a time
limit contained in the milestone/time guidelines that the completion of
a particular trial or the filing of a certain document has been
delayed, and if CVT can competently demonstrate that such delay was due
to valid reasons beyond CVT's control and that CVT has undertaken
reasonable efforts to overcome such adverse circumstances, then in such
a case Syntex shall, upon consultation with CVT, extend the respective
time limit for a reasonable period. Notwithstanding the foregoing,
Syntex shall not be obligated to extend any time limit for reaching a
particular milestone set forth under the Milestone Payments more than
once, and failure to meet the milestone in question by such an extended
time limit, unless the amount set forth for payment upon reaching the
milestone is paid on or before expiration of the extended time limit,
shall be deemed a material breach of the Agreement by CVT.
4.6 Subject to Section 11.4, CVT shall use commercially reasonable efforts
consistent with accepted pharmaceutical business practices and legal
requirements to promote, market, distribute and sell the Licensed
Products with the same standard of effort used by CVT in the marketing
of its own products of similar market potential. CVT and any
sublicensee of CVT shall launch Licensed Product(s) in each country of
the CVT Territory within [ * ] of receiving marketing approval, or
pricing approval if required, whichever is later, for the Licensed
Product in question.
4.7 With regard to any countries in the CVT Territory for which CVT is
acting through an Affiliate or sublicensee, CVT's Affiliated Company or
sublicensee of CVT, as the case
8
may be, shall observe commercially reasonable efforts comparable to the
ones set forth above.
4.8 Upon [ * ] prior written notice, but in any event not earlier than one
(1) year after launch of a Licensed Product in a country in question,
Syntex may [ * ] in a given country of the CVT Territory in the event
CVT, or the responsible CVT Affiliate or sublicensee [ * ] in each such
country as set forth above, unless, within such [ * ] period, CVT or
the responsible CVT Affiliate or sublicensee shall have [ * ] or shall
have [ * ] and [ * ] in the country in question, all to the reasonable
satisfaction of Syntex.
4.9 CVT undertakes to inform Syntex of:
a) the date of filing the application for the registration of
each Licensed Product in a given country of the CVT Territory;
b) the date of obtaining product approval (or equivalent
authorization) from the relevant authority in each country of
the CVT Territory;
c) the date of the first sale of the Licensed Product in each
country of the CVT Territory; and
d) any events which might be material to Syntex in connection
with a possible extension of the patent protection term. In
this regard, CVT shall cooperate with Syntex in filing for and
obtaining patent extensions and supplementary or complementary
protection certificates in any country of the Territory, if
and when available, including supplementary protection
certificates in European Union (EU) countries and European
Free Trade Area (EFTA) countries, patent extensions in the
United States of America, and administrative protection, such
as so-called pipeline protection in certain countries of the
CVT Territory. Such cooperation shall include, without
limitation, providing to Syntex, within one (1) month of
receipt by CVT, CVT's Affiliated Companies, recognized
distributors and sublicensees, a copy of every marketing
authorization for a Licensed Product issued by either an EU or
an EFTA country, and in addition, within one (1) month
9
of availability of the document, a copy of the official
journal page from each EU or EFTA country giving the marketing
approval number and date of authorization for each approved
Licensed Product, and a summary of the characteristics of the
Licensed Product for that country, for the purpose of applying
for supplementary protection certificates under EEC (European
Economic Community) Directive 1768/2, which Syntex shall have
the right to do in its sole discretion, and providing
information and signing of documents as required.
4.10 As soon as practicable after execution of this Agreement, but in any
event within [ * ] days of the effective date, Syntex shall initiate
transfer of ownership of and responsibility for all the pending
Investigational New Drug applications, IND 30,205 (oral tablets and
caps) and IND 43,735 (sustained-release tablets) ("INDs"), relating to
the Compound that have been filed with the United States Food and Drug
Administration ("FDA") by sending the appropriate communication to the
FDA. Syntex shall render reasonable assistance with respect to matters
dealing with the transfer of the IND consistent with its obligations in
Article III. After transfer of ownership of the INDs to CVT, CVT shall
be solely responsible for all matters relating to the INDs.
ART. V - PAYMENTS, REPORTS, TIME OF PAYMENTS
5.1 In consideration of the rights and license granted under this
Agreement, CVT shall make the following payments to Syntex:
LICENSE FEE
a) Subject to Section 5.1 c) below, CVT shall pay Seven Hundred
and Fifty Thousand Dollars ($750,000) upon execution of this
Agreement.
MILESTONE PAYMENTS
b) CVT will pay Syntex following additional amounts in milestone
payments upon the first occurrence of each of following six
milestones in the CVT Territory as follows:
10
1) Subject to Section 5.1 c) below, One Million Dollars
($1,000,000) upon the identification of the mechanism of
action of the Compound, but in no event later than twelve (12)
months after the effective date of this Agreement;
2) Two Million Dollars ($2,000,000) upon commencement of Phase
III clinical trials of a Licensed Product in the United
States;
3) Two Million Dollars ($2,000,000) upon commencement of the
first Phase III clinical trial in a country of Europe or the
date of filing of an NDA (or comparable application) in Europe
for a Licensed Product;
4) Two Million Dollars ($2,000,000) upon the date of filing
with the FDA for an NDA in United States for a Licensed
Product;
5) Three Million Dollars ($3,000,000) upon NDA approval by the
FDA of a Licensed Product for sale in the United States; and
6) Three Million Dollars ($3,000,000) upon the first NDA
approval of a Licensed Product for sale by the approval
authority equivalent to the FDA in a major market in Europe or
by the rapporteur in a European country with a rapporteur
system or by the EMEA for EU-wide approval. For the purposes
hereof, "major market" shall mean any of the following
countries: France, Germany, Italy and the United Kingdom; and
"rapporteur" shall mean a country in which a product
registration serves as a basis for obtaining by reference a
registration on the same product in another country.
"Commencement" of a clinical trial shall mean the first date on which a Licensed
Product is shipped to an investigator for the clinical trial.
c) In lieu of payment in cash of the Seven Hundred and Fifty
Thousand Dollars ($750,000) License Fee, or payment in cash of
Seven Hundred and Fifty Thousand Dollars ($750,000) of the One
Million Dollar ($1,000,000) first milestone payment, CVT may
issue Syntex in each instance that number of shares of its
Series E Preferred Stock equally: Seven Hundred Fifty Thousand
11
Dollars ($750,000) divided by the Conversion Price (as that
term is defined in CVT's Restated Certificate of
Incorporation) of the Series E Preferred Stock then in effect.
Any such payment made in Series E Preferred Stock pursuant to
this subsection shall be made on the same terms as, and
pursuant to, that certain Series E Purchase Agreement dated
September 8, 1995 among CVT and the purchases of Series E
Preferred Stock and shall also entitle Syntex to receive
warrants of Series E Preferred Stock, based on the formula
described in the Purchase Agreement, attached hereto as
Exhibit A. The Series E Preferred Stock issued to Syntex shall
be entitled to the rights, preferences and privileges set
forth in CVT's current Restated Certificate of Incorporation
as described to Syntex as of the effective date hereof. The
Series E Preferred Stock issuable upon payment of milestones
(excluding the Warrants) shall be deemed issued and
outstanding for the purpose of obtaining stockholder approval
of any amendment to the Restated Certificate of Incorporation
and CVT shall receive an appropriate number of Series E shares
and warrants for issuance to Syntex as set forth above.
5.2 CVT shall pay the following royalties to Syntex on Net Sales of the
Licensed Products. Such royalties shall be paid on a product-by-product
and country-by-country basis according to the following rates:
a) For Net Sales of a Licensed Product as to which Syntex Patents
and Know-How cover the manufacture, use, sale, offer for sale,
or import of the Licensed Product a rate of [ * ].
b) For sales of a Licensed Product in a country of the CVT
Territory in which competition by products having the same
active compound as the Licensed Product exceeds [ * ] in terms
of unit sales, based on IMS data or equivalent independent
survey, a royalty reduced to [ * ] of the rate shown in
Section 5.2 (a) above for as long as such competition
continues to exceed [ * ].
5.3 The obligation to pay royalties to Syntex hereunder shall be imposed
only once with respect to the same unit of the Licensed Product.
12
5.4 No royalties shall accrue on the sales of CVT to CVT's Affiliated
Companies or sublicensees of CVT on any transactions between such
entities. Royalties shall accrue only on sales of the Licensed Product
from CVT, Affiliated Companies of CVT or sublicensees of CVT to third
parties that are not Affiliates of those entities.
5.5 In the event that CVT shall grant a sublicense to a third party,
including, without limitation, the CVT Partner, all of the terms and
conditions of this Agreement shall apply to such sublicensee to the
same extent as they apply to CVT. CVT guarantees the performance of all
obligations so imposed on its sublicensees under this Agreement and
will itself pay and account to Syntex for all royalties due under this
Agreement which may accrue by reason of the action or operations of any
of CVT's sublicensees.
5.6 CVT shall pay to Syntex the royalties due hereunder, including any
royalties due from the sales of Licensed Product by CVT's Affiliates or
sublicensees on a quarterly basis, within [ * ] of such royalty
computation period, that is to say up to the last working day of the
months of [ * ] respectively of each year. The royalty shall be paid to
Syntex in U.S. Dollars and computed in accordance with Section 5.7 and
Section 5.8, and CVT shall submit to Syntex, together with each royalty
payment, a written royalty statement containing at least the following
information:
a) the quantity of each Licensed Product subject to royalty sold
(by country) by CVT, its Affiliates and sublicensees;
b) total adjusted gross sales for each Product subject to royalty
(by country);
c) total royalties payable to Syntex (by country); and
d) any relevant information related to matters stated in Section
5.9.
Any compensation payment that is not paid on or before the date such
payment is due under this Agreement shall bear interest, to the extent
permitted by applicable law, at the average one month London Interbank
Offered Rate (LIBOR) for the currency and time such a payment is
overdue. The payment of such interest shall not affect the rights
defined in Section 11.3.
13
5.7 With respect to each quarter, monthly adjusted gross sales in the
currency of the country of sale will be converted to U.S. Dollars at an
exchange rate that is the average of the daily exchange rate for the
U.S. Dollar and the currency of the country of sale as quoted by The
Wall Street Journal, or a comparable publication acceptable to the
parties if it ceases to exist, for the corresponding month in which the
adjusted gross sales are made and then aggregated in U.S. Dollars for
the quarter in question. From that quarterly aggregate amount in U.S.
Dollars, a lump sum of [ * ] shall be deducted to obtain the Net Sales
aggregate amount of the quarter in question.
5.8 CVT shall keep accurate books and records setting forth the gross
sales, adjusted gross sales, Net Sales, the amount of royalties payable
to Syntex as provided for herein, for each country with regard to the
Licensed Product sold by CVT, CVT's Affiliated Companies or
sublicensees of CVT. Such books and records shall be retained by CVT at
its principal place of business for at least the three (3) years
immediately following the calendar year to which each shall pertain.
Abstracts thereof shall be made independently from CVT by CVT's public
accountants and shall be made available for audit, all at the request
and expense of Syntex by an independent certified public accountant or
accounting firm appointed by Syntex and acceptable to CVT; provided,
however, that if the audit on behalf Syntex is conducted at the same
time as the regular, annual audit of CVT, the expense of such audit
shall be borne by CVT. CVT shall not unreasonably withhold acceptance
of an independent certified public accountant or accounting firm
appointed by Syntex. In the event that such audit shall indicate that
in any calendar year the royalties which should have been paid by CVT
are at least [ * ] greater than those which were actually paid by CVT,
then CVT shall pay the cost of such audit.
5.9 Any tax required to be withheld by CVT under the laws of any country
for the account of Syntex shall be promptly paid by CVT for and on
behalf of Syntex to the appropriate governmental authority, and CVT
shall furnish Syntex with proof of payment of such tax. Any such tax
actually paid on Syntex's behalf shall be deducted from royalty
payments due Syntex.
ART. VI - SUPPLY OF COMPOUND
14
6.1 Subject to (i) existing quantities of bulk Compound, granulated,
formulated Compound and tableted, formulated Compound in Syntex's
possession and (ii) Syntex's commitment to provide certain quantities
of such materials to Syntex's Third Party Licensee, Syntex shall
provide to CVT (x) at no charge, any combination of free goods
consisting of bulk Compound, granulated, formulated Compound and
tableted, formulated Compound having a total value of [ * ] as
calculated based on the prices listed on Appendix C hereto, and (y) at
CVT's expense, such other agreed to quantities of bulk Compound,
granulated, formulated Compound and tableted, formulated Compound in
Syntex's possession at the prices set forth in Appendix C. CVT shall
order and complete the purchase of the foregoing materials that it
desires to purchase and specify those materials that it wishes to
receive as free goods as soon as practicable, but in no event later
that [ * ] after the effective date, and Syntex shall not be obligated
to supply any material ordered or specified thereafter. The materials
to be provided hereunder are provided "as is", and Syntex hereby
disclaims any representation or warranty that the materials provided
hereunder will be suitable for use in any manner whatsoever or have
adequate dating for use, including, without limitation, for use in
clinical trials, or that such materials will meet the requirements of
any analysis required to establish extended dating for the materials
provided. In the event that the materials provided need to be
reanalyzed to establish extended dating or for any other reason, or
such materials have to reworked or otherwise manipulated, CVT shall be
solely responsible for all of the costs and expenses associated
therewith and relating thereto. Title and risk of loss shall pass to
CVT upon delivery by Syntex to a common carrier, F.C.A. (Incoterms,
1990), Syntex's storage facility. Thereafter, subject to Syntex's
obligations under Article III, CVT and the CVT Partner will be solely
responsible to procure the necessary quantities of Compound for the
development and manufacture of the Licensed Product.
6.2 CVT acknowledges that [ * ] including, without limitation, [ * ]. CVT
shall be responsible for and pay any transportation costs, duties,
fines, taxes, penalties, forfeitures or other charges of any kind
("Costs") associated with the supply by Syntex of any Compound pursuant
to Section 6.1 and shall indemnify and hold harmless Syntex and any
Syntex Affiliates from any such Costs. Any costs, expenses or penalties
15
of any kind associated with the import of any quantity of the Compound
into the United States, [ * ] after the effective date of this
Agreement shall be totally included with the Costs for which the
foregoing indemnity and hold harmless apply.
6.3 Subject to Syntex's obligations under Article III, CVT and the CVT
Partner shall be solely responsible for manufacturing the Compound and
Licensed Products. CVT shall be entitled to procure from any
appropriate source the Compound necessary to develop and manufacture
the Licensed Product for marketing purposes.
ART. VII - LICENSED PRODUCT LIABILITY/DISCLAIMER OF WARRANTIES
7.1 CVT shall indemnify, and holds harmless, Syntex, its Affiliates,
directors, employees and agents from all costs and expenses of any
kind, including reasonable attorneys fees, arising from any claim
relating to the use of the Syntex Know-How and the Syntex Patent
Rights, or the use, manufacture, promotion, marketing and sale of the
Compound or any Licensed Products by CVT, its Affiliates, its
sublicensees, distributors and customers.
7.2 Syntex hereby disclaims any warranties, whether express or implied, of
any kind, including, without limitation, any warranty of
merchantability or fitness for any particular purpose, with respect to
any Compound or other materials in whatever form provided to CVT
hereunder, or that the Compound or a Licensed Product can be
successfully developed by use of the Syntex Know-How, or that clinical
or commercial quantities of the Compound or Licensed Product can be
produced by use of the Syntex Know-How, or that the Syntex Patent
Rights are or will be valid or can be or will be enforceable, or that
the use of the Syntex Know-How or practice of the invention of the
Syntex Patent Rights will not infringe the intellectual property rights
of a third party; provided, however, that as of the effective date of
this Agreement to the best of the knowledge of Syntex there are no
facts that on their face would render the Syntex Patent Rights invalid
or unenforceable and Syntex has received no claims with respect
thereto.
16
ART. VIII - MAINTENANCE AND ENFORCEMENT OF SYNTEX PATENT RIGHTS
8.1 Syntex agrees to prosecute and maintain, at its own cost and expense,
all of the patents and patent applications included within Syntex
Patent Rights. At Syntex's request, CVT shall cooperate, in all
reasonable ways in connection with the prosecution of all patent
applications included within Syntex Patent Rights. Syntex shall advise
CVT promptly of any significant developments in the prosecution of
Syntex Patent Rights in the CVT Territory, in particular of the
issuance of or rejection of or of opposition to or of protest of any
patent or application within Syntex Patent Rights. Should Syntex decide
that it is no longer interested in maintaining or prosecuting Syntex
Patent Rights or part thereof, it shall promptly advise CVT thereof
and, at the request of CVT, Syntex shall assign free of charge such
Syntex Patent Rights or part thereof to CVT. Upon assignment of such
Syntex Patent Rights or part thereof, CVT will thereafter prosecute and
maintain such Syntex Patent Rights at its own cost to the extent that
CVT desires to do so.
8.2 Each party will advise the other promptly upon its becoming aware of
any third party infringement of Syntex Patent Rights. In the event of
an infringement of Syntex Patent Rights by a product that would be or
is competitive with a Licensed Product under active development or
being sold by CVT, the parties agree with the following:
a) to consult with each other to attempt to agree on whether
legal action should be taken against the infringer, and also
to establish the proportion in which they will participate in
the costs and expenses of the action, if taken, and in any
recoveries or awards resulting therefrom; and
b) in the event Syntex does not agree to bring suit or to
participate in a suit against any such infringer, CVT shall
have the right to take such action at its own expense and
deduct up to [ * ] of its reasonable litigation expenses from
future royalties or milestone payments due to Syntex, provided
that such deduction does not reduce the royalties or milestone
payments payable in any quarter below [ * ] of the royalties
or milestone payments otherwise due in such quarter, and, upon
receiving a recovery or award from such suit, such recovery
and award shall be used first to reimburse CVT for its
reasonable litigation expenses actually
17
incurred, then to reimburse Syntex for the amounts of any
unpaid royalties or milestone payments, and any remainder of
the recovery and award shall be retained by CVT for its own
benefit and use; and
c) in any such infringement suit Syntex shall, at the request of
CVT render all reasonable assistance in the prosecution of
such suit.
ART. IX - RETAINED RIGHTS
Syntex retains all rights to make, have made, use, import, offer to
sell, and sell the Licensed Compounds and to use the know-how
encompassed in the Syntex Patents and Know-How in the CVT Territory for
non-Cardiovascular Indications. CVT herewith grants to Syntex a
non-exclusive, royalty-bearing right and license in the CVT Territory
under any CVT Patents and Know-How to exercise such rights. For so long
as Syntex is selling any product covered by a claim of the CVT Patent
Rights, Syntex shall pay CVT a royalty equal to [ * ] of Net Sales, as
defined in Section 1.10, with respect to sales by Syntex, its
Affiliates or sublicensees; provided, however, that if CVT jointly owns
CVT Patent Rights with a third party and payments would be due such
third party upon Syntex's use of the CVT Patent Rights, the parties
shall negotiate in good faith a commercially reasonable royalty rate
that reflects payments due such third party.
ART. X - CONFIDENTIAL INFORMATION
10.1 CVT shall keep the Syntex Know-How in strict confidence and shall not
use Syntex Know-How except for the purposes of this Agreement. Any
information disclosed pursuant to the Confidentiality Agreement between
the parties dated November 7, 1994 shall be considered Syntex Know-How
and governed by the terms of this Agreement.
10.2 Both CVT and Syntex agree to keep in strict confidence all other
know-how as well as other information and data of confidential nature
received from the other party under this Agreement and not to make any
use thereof other than provided under this Agreement.
10.3 The confidentiality obligations as per this Article 10 shall not apply
to the extent that the Syntex Know-How or other know-how or information
and data are required by
18
appropriate authorities to be submitted for purposes of registration of
the Licensed Product; provided, however, that to the extent possible
such submissions shall be made on a confidential basis. The
confidentiality and non-use obligations under this Article 10 shall
extend for the term of this Agreement and five (5) years thereafter.
10.4 The obligation of confidentiality and non-use as set forth in this
Article 10 shall not apply:
a) to information and data which, at the time of disclosure, was
known by the recipient party or an Affiliated Company, or
which after disclosure was independently developed by the
recipient party or an Affiliated Company without use of such
information and data, and which can be so demonstrated by the
records of the recipient party or an Affiliated Company, as
the case may be; and/or
b) are public knowledge at the date of disclosure to the
recipient party; and/or
c) become public knowledge at a later date without any fault of
the recipient party or an Affiliated Company; and/or
d) are disclosed to the recipient party or an Affiliated Company
by a third-party having the right to do so.
10.5 Nothing in this Article 10 or this Agreement shall be construed to
prevent either party from disclosing to its Affiliated Companies
information and data obtained from the other party during this
Agreement, provided that such information is used in a manner
consistent with this Agreement, and further provided that said
Affiliated Companies are bound by a like confidentiality obligation
with respect to such information.
ART. XI - TERM AND TERMINATION
11.1 This Agreement shall be effective as of the date first written above.
11.2 This Agreement shall have a duration on a country-by-country and
product-by-product basis of the later of (i) [ * ] from the date of
first commercial sale of the Licensed
19
Product in a given country of the CVT Territory or (ii) a duration
corresponding to the duration of the Syntex Patent Rights having one or
more claims covering a Licensed Product, or its use or manufacture, in
a given country, whichever is longer. Following expiration of the term
as set forth above, CVT shall retain a non-exclusive, fully-paid
license under the Syntex Know-How to manufacture, use, sell and offer
for sale Licensed Products for Cardiovascular Indications within the
CVT Territory.
11.3 Failures by one party to comply with any of its respective obligations
contained in this Agreement shall entitle the other party to give the
party in default written notice of such default. If such default is not
remedied within [ * ] [ * ] after receipt of such notice (or thirty
(30) days in the event of non-payment), the notifying party shall be
entitled to terminate this Agreement by giving notice with immediate
effect. The right of either party to terminate this Agreement as
provided hereinabove shall not be affected in any way by its waiver of
or failure to take actions with respect to any previous default. In
such cases of breach by CVT, all licenses from CVT to Syntex as set
forth below in Section 11.4 for the case of an early termination shall
be royalty free, and CVT shall provide to Syntex all of the information
required by Section 11.4 in the event of early termination or breach of
this Agreement by CVT. If there is any BONA FIDE dispute between the
parties regarding the right of termination based on failure by CVT to
make a milestone or royalty payment when due, the disputed milestone or
royalty payment, as the case may be, shall be paid into an interest
bearing account by CVT where it shall remain during the pendency of the
dispute, and upon resolution of the dispute, paid, with accumulated
interest, to the prevailing party.
11.4 CVT shall have the right to terminate the Agreement at any time
provided that CVT gives notice to Syntex at least [ * ] prior to such
termination and under the condition that CVT further informs Syntex
together with the notice of termination that, in its reasonable
business judgment based on scientific, medical, economic or other valid
business reasons, CVT has determined not to carry out further
development or marketing of the Licensed Products. In the event of such
an early termination, the licenses granted hereunder by Syntex shall
revert to Syntex. In addition, CVT shall grant Syntex an exclusive
license, with the right to sublicense, to the CVT Patents and Know-How
20
directly related to and solely usable in connection with the Compound
and the Licensed Products to make, have made, use, import, offer to
sell and sell the Compound and the Licensed Products. All other CVT
Patents and Know-How shall be licensed non-exclusively to Syntex solely
for use in connection with the Licensed Products as set forth above.
Licenses under the CVT Patents shall be royalty bearing on commercially
reasonable terms not to exceed, in the aggregate, [ * ] of Net Sales,
as defined in Section 1.10, with respect to sales by Syntex, its
Affiliates or sublicensees, of Licensed Products. All CVT Know-How in
CVT's possession or under its control relating to the Licensed Products
including without limitation the documents necessary to obtain or
maintain the registration authorization of the relevant authorities in
the CVT Territory, shall be made available to Syntex free of charge.
11.5 This Agreement shall survive the acquisition or change of control of
either company, provided that in the case of CVT the acquiring entity
will expressly assume all rights and obligations contained in this
Agreement and such entity further undertakes to use its commercially
reasonable efforts consistent with accepted pharmaceutical business
practices and legal requirements to promote, market, distribute and
sell the Licensed Products with the same standard of effort as used in
the marketing of its own products of similar market potential.
11.6 In the event of a conversion of the exclusive right and license of CVT
into a non-exclusive right and license because of a failure of CVT to
comply with its efforts obligation pursuant to Section 4.3, the
provisions of Section 11.4 for early termination by CVT shall apply
MUTATIS MUTANDIS, with the exception that Syntex shall receive a
royalty-free, non-exclusive license.
11.7 Neither of the undersigned parties shall be liable for failure to
perform its obligations under this Agreement, where such failure was
occasioned by contingencies beyond its control, including without
limitation, strikes or work stoppages, lock-outs, riots, wars, delay of
carriers, Acts of God, including without limitation, fire, floods,
storms, and earthquakes, acts or failures to act by government or
governmental agencies or instrumentalities (Force Majeure). Each party
will notify the other immediately, should
21
any such contingencies occur. Such notice shall set forth the
obligations that the notifying party is unable to perform and shall
also specify the contingencies which it contends provide a basis under
this Section 11.7 for such non-performance. Nothing herein shall
relieve a party from the obligation to pay promptly, in U.S. dollars,
all payments that may be due under this Agreement.
11.8 In the event of termination of the licenses to CVT, any licenses
granted to a CVT Partner shall survive and this Agreement may be
assumed by the CVT Partner for the CVT Partner's portion of the CVT
Territory, subject to adequate assurances to Syntex of such CVT
Partner's ability to perform CVT's obligations hereunder. The agreement
between CVT and the CVT Partner shall provide that if this Agreement is
not assumed by the CVT Partner, then the agreement between CVT and the
CVT Partner shall be terminated and the CVT Partner's patent rights and
know-how relating to the Licensed Products will be licensed to Syntex,
with the right to sublicense, with delivery of the necessary
information to enable Syntex to exercise the license and continue the
development, marketing and sale of Licensed Products in the CVT
Partner's portion of the CVT Territory under the same terms as Syntex's
license to the CVT Patents and Know-How pursuant to Section 11.4 as in
the case of CVT's termination; provided, however, that if the CVT
Partner has acquired technology from a third party that the CVT Partner
is not permitted to transfer to Syntex, then there would not be an
obligation on CVT to obtain agreement to license such technology. In
such event, CVT and the CVT Partner will render reasonable assistance
to Syntex in its attempts to obtain access to that third party
technology. Furthermore, should CVT have acquired licenses from third
parties under technology relating to Licensed Products for which CVT
has the right to sublicense, CVT shall grant sublicenses to Syntex upon
the same financial terms as CVT's licenses, unless the licenses are
available from the third party directly to Syntex on the same or more
favorable financial terms.
11.9 Either party shall have the right to terminate this Agreement if the
other party becomes insolvent or unable to pay its debts or perform its
obligations as they mature, or makes an assignment for the benefit of
creditors, or is the subject of a petition or other document seeking
relief under any bankruptcy law, filed by or against a party, that is
not discharged
22
with prejudice within sixty (60) days thereafter, such termination to
be effective upon the delivery of written notice to the insolvent or
bankruptcy party.
ART. XII - MISCELLANEOUS
12.1 CVT shall not assign or transfer, in whole or in part, this Agreement
or any rights thereunder without the prior written consent of Syntex.
12.2 In the event of the permitted assignment or transfer by CVT of this
Agreement or any part thereof, or in the event of any sublicense
granted by CVT, the assignee, transferee or sublicensee shall agree to
be bound by the terms of this Agreement and CVT shall guarantee the
performance and obligations thereof.
12.3 Syntex shall have the right to assign or transfer, in whole or in part,
this Agreement or any rights thereunder, or delegate any of its
obligations, to any Affiliate of Syntex and such Affiliate shall agree
to be bound by the terms and conditions of this Agreement, and Syntex
shall guarantee the performance and obligations thereof. Promptly after
any such assignment or transfer, Syntex shall provide CVT with written
notice of the assignment or transfer and the identity of the assignee
or transferee.
12.4 This Agreement contains the entire understanding between the parties
relating to the subject matter hereof and supersedes any and all prior
agreements, understandings and arrangements, whether written or oral,
between the parties, including the Confidentiality Agreement dated
November 7, 1994 and the Heads of Agreement dated December 21, 1995. No
amendments, changes, modifications or alterations of the terms and
conditions of this Agreement shall be binding upon either party hereto
unless in writing and signed by both parties.
12.5 All titles and captions in this Agreement are for convenience only and
shall not be interpreted as having any substantive meaning.
12.6 Both parties hereby expressly state that it is the intention of neither
party to violate any rule, law and regulations. If any of the
provisions of this Agreement are held to be void or unenforceable, then
such void or unenforceable provisions shall be replaced by valid
23
and enforceable provisions which will achieve as far as possible the
economic business intentions of the parties.
12.7 Unless required by law or regulation, each party shall refrain from
making any public announcement or disclosure of the terms and
conditions of this Agreement without the prior written consent of the
other party, which consent shall not unreasonably be withheld;
provided, however, CVT may publicize certain aspects of the Agreement
at time of signing, subject to prior written approval by Syntex.
12.8 No failure or delay on the part of a party in exercising any right
hereunder shall operate as a waiver of, or impair, any such right. No
single or partial exercise of any such right shall preclude any other
or further exercise thereof or the exercise of any other right. Any
waiver on the part of either party hereto of any right hereunder shall
be effective only if made in writing and shall not constitute or imply
a waiver of any other right or a subsequent waiver.
12.9 The indemnities of Section 2.5, Section 6.2 and Section 7.1 and the
provisions of Section 5.6, Section 5.7 (for one year), Article X (for
the term set forth in Section 10.3), Section 11.4 and Article XIV shall
survive termination or expiration of this Agreement.
ART. XIII - NOTICES
Any notice required to be given hereunder shall be considered properly
given if sent in English by registered air-mail, telecopier, telex or
by personal courier delivery to the respective address of each party as
follows:
for Syntex: Syntex (U.S.A.) Inc.
X.X.Xxx 10850
0000 Xxxxxxxx Xxxxxx
Xxxx Xxxx, Xxxxxxxxxx X.X.X.
Attention: President
Facsimile: (000) 000-0000
with a copy to: X. Xxxxxxxx-Xx Xxxxx Ltd
X.X.Xxx, XX-0000 Xxxxx
00
Xxxxxxxxxxx
Attention: Corporate Law
Facsimile: 41-61-68-81396
and in the case
of notice regarding
CVT's stock, Attention: Corporate Finance
for CVT: CV Therapeutics, Inc.
0000 Xxxxxx Xxxxx
Xxxx Xxxx, Xxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxxxx
President & COO
Facsimile: (000) 000-0000
or to such other address as a party may designate in a notice given in
accordance with this Article 13.
ART. XIV - GOVERNING LAW AND ARBITRATION
14.1 This Agreement shall be governed by the laws of California (without
regard for the choice of law provisions of California or any other
jurisdiction).
14.2 In the event of any controversy or claim arising out of or relating to
any provision of this Agreement or the breach thereof, the parties
shall try to settle those conflicts amicably between themselves. Should
they fail to agree, any controversy, dispute or claim which may arise
out of or in connection with this Agreement, or the breach, termination
or validity thereof, shall be settled by final and binding arbitration
pursuant to the Rules of the American Arbitration Association as
hereinafter provided:
a) The arbitration tribunal shall consist of three arbitrators.
Each party shall nominate in the request for arbitration and
the answer thereto one arbitrator and the two arbitrators so
named will then jointly appoint the third arbitrator as
chairman of the arbitration tribunal. If one party fails to
nominate its arbitrator or if the parties' arbitrators cannot
agree on the person to be named to be chairman within sixty
(60) days, the American Arbitration Association shall make the
necessary appointments for arbitrator or chairman.
25
b) The place of arbitration shall be in Palo Alto, California and
the arbitration proceedings shall be held in English. The
arbitrators shall apply the law of California as set out in
Section 14.1. The arbitrators shall have no power to award
punitive damages or any multiple of damages assessed.
CV THERAPEUTICS, INC. SYNTEX (U.S.A.) INC.
By: /s/ Xxxxxx X. Xxxxxxxx By: /s/ Xxxxx X. Xxxxxx
-------------------------------- --------------------------------
Xxxxxx X. Xxxxxxxx Xxxxx X. Xxxxxx
President and COO Vice President
Date: 3/27/96 Date: 3/27/96
26
APPENDIX A
APPENDIX A
Case 23550 Cardioselective Aryloxy - And Arylthio - Hydroxypropylene-
Piperazinyl Acetanilides Which Affect Calcium Entry
Case 26720 Novel Methods of Treatment Using Ranolazine and Related
Piperazine Derivatives
Case 27850 High Dose Formulations
PAGE 1 OF 10
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APPLICATION NO: P9503224 APPLICATION DATE: 10MY1994
PATENT NO: GRANT DATE: EXPIRATION DATE:
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APPLICATION NO: P/P00110 APPLICATION DATE: 24AP1995
PATENT NO: 211270 GRANT DATE: 24JL1995 EXPIRATION DATE: 11NY2014
PAGE 9 OF 10
DKT COUNTY CS TP RL TP FL TP FL MO STATUS CLASSIFY
00000 XXXXXX FIL RS61443
APPLICATION NO: 109639 APPLICATION DATE: 12NY1994
PATENT NO: GRANT DATE: EXPIRATION DATE:
00000 XXXXXX FIL RS61443
APPLICATION NO: 943527 APPLICATION DATE: 12MY1994
PATENT NO: GRANT DATE: EXPIRATION DATE:
26720 NORWAY P FIL RS61443
APPLICATION NO: 954546 APPLICATION DATE: 10NY1994
PATENT NO: GRANT DATE: EXPIRATION DATE:
26720 NEW ZEALAND P FIL RS61443
APPLICATION NO: 266683 APPLICATION DATE: 10MY1994
PATENT NO: GRANT DATE: EXPIRATION DATE:
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APPLICATION NO: P311654 APPLICATION DATE: 10MY1994
PATENT NO: GRANT DATE: EXPIRATION DATE:
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APPLICATION NO: 95122420 APPLICATION DATE: 10MY1994
PATENT NO: US94/05196 GRANT DATE: EXPIRATION DATE:
26720 U.S.S.R. P FIL RS61443
APPLICATION NO: US94/05196 APPLICATION DATE: 10NY1994
PATENT NO: GRANT DATE: EXPIRATION DATE:
PAGE 10 OF 10
DKT COUNTY CS TP RL TP FL TP FL MO STATUS CLASSIFY
00000 X.X.X. P 01 GMT RS61443
APPLICATION NO: 08/239,621 APPLICATION DATE: 09MY1994
PATENT NO: 5,427,707 GRANT DATE: 05DE1995 EXPIRATION DATE: 13NY2013
26720 PATENT COOPERAT P FIL RS61443
APPLICATION NO: US94/05196 APPLICATION DATE: 10MY1994
PATENT NO: GRANT DATE: EXPIRATION DATE:
00000 XXXXX XXXXXX GMT RS61443
APPLICATION NO: 943267 APPLICATION DATE: 11MY1994
PATENT NO: 943267 GRANT DATE: 25JA1995 EXPIRATION DATE: 11MY2014
Exhibit A
CV THERAPEUTICS, INC.
SERIES E PREFERRED STOCK AND WARRANT
PURCHASE AGREEMENT
SEPTEMBER 8, 1995
CV THERAPEUTICS, INC.
SERIES E PREFERRED STOCK AND WARRANT PURCHASE AGREEMENT
THIS AGREEMENT is entered into as of September 8, 1995 (the
"Agreement"), by and among CV THERAPEUTICS, INC., a Delaware corporation (the
"Company"), with its principal office at 0000 Xxxxxx Xxxxx, Xxxx Xxxx,
Xxxxxxxxxx 00000, each of the purchasers who are signatories hereto and any
other purchasers who are made a party to this Agreement pursuant to paragraph
2.1 hereof (individually, a "Purchaser" and collectively, the "Purchasers"), as
set forth in the Schedule of Purchasers, attached hereto as EXHIBIT A.
AGREEMENT
In consideration of the mutual promises, representations, warranties
and conditions set forth in the Agreement, the Company and each Purchaser,
severally and not jointly, agrees as follows:
1. AGREEMENT TO SELL AND PURCHASE.
1.1 AUTHORIZATION OF THE SHARES AND WARRANTS. The Company has
authorized, or before the Closing, as defined in paragraph 2.1 hereof, will have
authorized, the issuance and sale of: (a) up to 5,000,000 shares of its Series E
Preferred Stock (the "Shares") and (b) warrants (the "Warrants") to purchase up
to 2,500,000 shares of the Company's Series E Preferred Stock with an exercise
price of $2.00 per share (the "Warrant Shares"), at a purchase price of $2.00
per Share and Warrant Share (a "Unit"). As used herein, a Unit is comprised of
one share of Series E Preferred Stock and one Warrant, in substantially the form
set forth in EXHIBIT B hereto, to purchase one-half of a share of Series E
Preferred Stock.
1.2 SALE OF SHARES AND WARRANTS. In reliance upon the Purchasers'
representations and warranties contained in Section 4 hereof and subject to the
terms and conditions set forth herein, the Company hereby agrees to sell to each
Purchaser, at a price per Unit of $2.00, the aggregate number of Shares and
Warrants set forth below such Purchaser's signature on such Purchaser's
signature page hereto. The total amount of common stock of the Company (the
"Common Stock") and other securities issuable upon conversion of the Shares and
the Warrant Shares is hereinafter referred to as the "Conversion Stock." The
Shares, Warrants, Warrant Shares and the Conversion Stock are hereinafter
collectively referred to as the "Securities."
1.3 PURCHASE OF SHARES AND WARRANTS. In reliance upon the
representations and warranties of the Company contained herein, and subject to
the terms and conditions set forth herein, each Purchaser hereby agrees to
purchase, at a price per Unit of $2.00, the number of Shares and Warrants set
forth below such Purchaser's signature on such Purchaser's signature page
hereto. Each Purchaser shall, severally and not jointly, be liable for only the
purchase of the Shares and the Warrants indicated on such Purchaser's signature
page hereto.
2
1.4 FURTHER ISSUANCE. The Purchasers agree that the Company shall be
entitled to issue and sell any shares of Series E Preferred Stock (or securities
convertible into Series E Preferred Stock) not previously issued and sold at the
Closings (as hereinafter defined), in connection with any corporate partnering,
collaboration, lease financing or similar transaction.
2. CLOSING DATE; DELIVERY.
2.1 CLOSING DATE. The first closing for the purchase and sale of the
Units hereunder will be on September 8, 1995 (the "First Closing") at the
offices of Xxxxxx Godward Xxxxxx Xxxxxxxxx & Xxxxx, Five Xxxx Xxxx Xxxxxx, Xxxx
Xxxx, Xxxxxxxxxx 00000, or at such other time and place as the Company and the
Purchasers shall agree upon (the "First Closing Date"). Additional closings
("Additional Closings") may be held from time to time following the First
Closing and on or before October 31, 1995 at such time (a "Closing Date") and
place as the Company may elect. At or prior to any such Additional Closing, the
Purchaser or Purchasers at such Additional Closing shall execute counterpart
copies of this Agreement and any related agreements or other documents required
to be executed hereunder, dated as of the date of such Additional Closing, and
shall thereupon become parties hereto and thereto for all purposes and be added
to the Schedule of Purchasers. The First Closing and any Additional Closing
shall be referred to collectively as the "Closings" and singularly as a
"Closing."
2.2 DELIVERY. At each Closing, the Company will deliver to each
Purchaser a stock certificate and a Warrant registered in such Purchaser's name
representing the number of Shares and Warrants, respectively, purchased by such
Purchaser as set forth on such Purchaser's signature page hereto. At each
Closing, each Purchaser will pay the purchase price, in an amount equal to $2.00
times the number of Units being purchased by such Purchaser, by check, wire
transfer, cancellation of indebtedness, or a combination thereof, at the option
of the Purchaser. No Warrants will be issued for fractional shares.
2.3 SUBSEQUENT CHANGE IN TERMS. If, after the First Closing, the
Company shall sell any of the Units at any Additional Closing upon terms more
beneficial to the Purchasers than those at any previous Closing, then the
Company shall offer such terms to the Purchasers from any previous Closing and
shall take appropriate actions to amend any document or agreement to carry out
this covenant.
3. REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
Except as set forth on the Schedule of Exceptions attached hereto as
EXHIBIT C, the Company hereby represents and warrants to the Purchasers as
follows:
3.1 ORGANIZATION; GOOD STANDING AND QUALIFICATION. The Company is a
corporation duly organized and validly existing under, and by virtue of, the
laws of Delaware and is in good standing under such laws. The Company has the
requisite corporate power to own and operate its properties and assets, and to
carry on its business as presently conducted and as proposed to be conducted.
The Company is qualified to do business as a foreign corporation in any
jurisdiction where the failure to be so qualified would have a material adverse
impact on the business or financial condition of the Company.
3
3.2 CORPORATE POWER. The Company will have at each Closing Date all
requisite legal and corporate power to execute and deliver this Agreement and
the Amended and Restated Investor Rights Agreement of even date herewith, in
substantially the form attached hereto as EXHIBIT D (the "Investor Rights
Agreement"), to sell and issue the Shares, the Warrants and the Warrant Shares
and Conversion Stock and to carry out and perform its obligations under the
terms of this Agreement and the Investor Rights Agreement, except as
enforceability may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting creditors' and contracting
parties' rights generally and except as enforceability may be subject to general
principles of equity and except as the indemnification agreements of the Company
in Section 3 of the Investor Rights Agreement may be legally unenforceable.
3.3 SUBSIDIARIES. Other than CV Therapeutics International, a
corporation organized under the laws of the Cayman Islands (the "Subsidiary"),
the Company has no subsidiaries or affiliated companies and does not otherwise
own or control, directly or indirectly, any other corporation, association or
business entity. The Company owns all of the outstanding capital stock of the
Subsidiary.
3.4 CAPITALIZATION. The authorized capital stock of the Company,
immediately prior to the First Closing, will consist of 60,000,000 shares of
Common Stock, of which 3,940,497 are issued and outstanding, and 35,000,000
shares of preferred stock (the "Preferred Stock") of which (a) 8,000,000 are
designated Series A Preferred Stock (the "Series A Preferred"), 7,746,973 of
which are issued and outstanding, (b) 1,000,000 are designated Series B
Preferred Stock (the "Series B Preferred"), none of which are issued and
outstanding, (c) 6,000,000 are designated Series C Preferred Stock (the "Series
C Preferred"), 5,505,865 of which are issued and outstanding, (d) 12,500,000 are
designated Series D Preferred Stock (the "Series D Preferred"), 8,296,607 of
which are issued and outstanding, and (e) 7,500,000 are designated Series E
Preferred Stock, none of which are issued and outstanding. The conversion prices
of the Series A Preferred, Series B Preferred, Series C Preferred and Series D
Preferred are $0.80, $1.25, $1.25 and $2.00 per share, respectively. The Company
has reserved (a) 28,125 shares of Common Stock, (b) 250,000 shares of Series A
Preferred, (c) 1,000,000 shares of Series B Preferred, (d) 30,000 shares of
Series C Preferred, and (e) 719,266 shares of Series D Preferred for issuance
upon exercise of outstanding stock purchase warrants. In addition, the Company
has reserved 6,621,327 shares of Common Stock for issuance upon exercise of
outstanding stock options. All of the issued and outstanding shares of Common
Stock and Preferred Stock have been duly authorized and validly issued, are
fully paid and nonassessable and have been issued in compliance with applicable
federal and state securities laws. Except as described herein and in the
Investor Rights Agreement, there are no other options, warrants, conversion
privileges or other rights (including preemptive rights) or agreements presently
outstanding to purchase or otherwise acquire any authorized but unissued shares
of capital stock or other securities of the
Company. The Company is not aware of any voting agreements among its
stockholders. In addition, the total number of shares reserved under the
Company's Non-Employee Director Stock Option Plan, 1992 Stock Option Plan and
1994 Equity Incentive Plan is 200,000, 3,450,000 and 5,000,000, respectively.
4
3.5 AUTHORIZATION. All corporate action on the part the Company, its
directors and stockholders necessary for the authorization, execution, delivery
and performance of this Agreement and the Investor Rights Agreement by the
Company, the authorization, sale, issuance and delivery of the Securities, and
the performance of the Company's obligations hereunder and thereunder has been
taken. The Securities, when issued in compliance with the provisions of this
Agreement, the Warrants and the Certificate (as defined below), will be validly
issued, fully paid and nonassessable, and free of any liens or encumbrances
created by the Company, except for restrictions created by this Agreement, the
Investor Rights Agreement and the Warrants, and will be issued in compliance
with all applicable federal and state securities laws. The issuance of the
Securities, when issued pursuant to this Agreement, the Warrants and the
Certificate, are not subject to any preemptive rights or rights of first refusal
that have not been satisfied or waived, other than rights created by this
Agreement and the Investor Rights Agreement.
3.6 COMPLIANCE WITH OTHER INSTRUMENTS. The Company is not in violation
of any term of its Restated Certificate of Incorporation in the form attached
hereto as EXHIBIT E (the "Certificate") or Bylaws or in any material respect of
any term or provision of any material mortgage, indenture, contract, agreement,
instrument, judgment or decree, and is not in violation of any order, statute,
rule or regulation applicable to the Company, the violation of which would have
a material adverse effect on the Company's business or properties. The
execution, delivery and performance of and compliance with this Agreement and
the Investor Rights Agreement and the issuance of the Securities, will not
result in any such violation, or be in conflict with, or constitute a default
under, or result in the creation of, any mortgage, pledge, lien, encumbrance or
charge upon any of the existing properties or assets of the Company.
3.7 NO CONFLICT WITH LAW OR DOCUMENTS. The execution, delivery and
consummation of this Agreement and the Investor Rights Agreement and the
transactions contemplated hereby and thereby will not: (a) conflict with any
provisions of the Certificate or Bylaws, as amended, of the Company or of the
Subsidiary; (b) result in any violation of or default or loss of a benefit
under, or permit the acceleration of any obligation under (in each case, upon
the giving of notice, the passage of time, or both), any mortgage, indenture,
lease, agreement or other instrument, permit, franchise license, judgement,
order, decree, law, ordinance, rule or regulation applicable to the Company, the
Subsidiary or their respective properties.
3.8 GOVERNMENTAL CONSENT. No consent, approval or authorization of, or
designation, declaration or filing with, any governmental authority on the part
of the Company is required in connection with the valid execution and delivery
of this Agreement and the Investor Rights Agreement or the offer, sale or
issuance of the Securities, or the consummation of any other transaction
contemplated hereby or thereby, except filings as have been made prior to the
Closings, except that any notices of sale required to be filed with the
Securities and Exchange Commission under Regulation D of the Securities Act of
1933, as amended (the "Securities Act"), or such post-closing filings as may be
required under other applicable state or federal securities laws, which filings,
if required, will be accomplished in a timely manner, as required by such laws.
3.9 FINANCIAL STATEMENTS. The Company has provided to each Purchaser
(a) audited financial statements (consisting of a consolidated balance sheet as
at December 31, 1994,
5
and consolidated statement of operations, consolidated statement of
stockholders' equity and consolidated statement of cash flows for the year then
ended, and (b) unaudited financial statements (consisting of a consolidated
balance sheet as at June 30, 1995, and statement of operations and consolidated
statement of cash flows for the six months then ended) (collectively, the
"Financial Statements"). The Financial Statements have been prepared in
accordance with generally accepted accounting principles applied on a consistent
basis throughout the periods indicated.
3.10 CERTAIN TRANSACTIONS. Since June 30, 1995, neither the Company nor
its Subsidiary has (a) mortgaged, pledged or subjected to lien, charge or any
other encumbrance any of its assets, tangible or intangible, (b) sold, assigned
or transferred any of its assets or canceled any debts or obligations except in
the ordinary course of business, consistent with past practices, (c) suffered
any extraordinary losses, or waived any rights of substantial value, (d) entered
into any material transaction other than in the ordinary course of business,
consistent with past practices, or (e) otherwise had any change in its
condition, financial or otherwise, except for changes in the ordinary course of
business, consistent with past practices, none of which individually or in the
aggregate has been materially adverse, and excepted further that the Company
continues to incur losses consistent with its past practices.
3.11 MATERIAL CONTRACTS AND COMMITMENTS.
(a) Except for agreements explicitly contemplated by this Agreement and
the Investor Rights Agreement, there are no agreements, understandings or
proposed transactions between the Company and any of its officers, directors or
holders of ten percent (10%) or more of the outstanding voting securities of the
Company.
(b) Except as set forth in the Financial Statements, there are no
agreements, understandings, instruments, contracts or proposed transactions to
which the Company is a party or by which it is bound, other than contracts with
vendors, suppliers and customers entered into in the ordinary course of
business, that involve (i) obligations (contingent or otherwise) of, or payments
to the Company in excess of $100,000, or (ii) the license of any patent,
copyright, trade secret or other proprietary right to or from the Company, or
(iii) provisions restricting the development, manufacture or distribution of the
Company's products or services.
(c) Except as set forth in the Financial Statements, the Company (i) is
not obligated to repay any indebtedness for money borrowed or incurred any other
liabilities outside the ordinary course of business individually in excess of
$25,000 or, in the case of indebtedness and/or liabilities individually less
than $25,000 in excess of $50,000 in the aggregate, (ii) is not a creditor with
respect to any loans or advances to any person, other than ordinary advances for
travel expenses, or (ii) since June 30, 1995, has not sold, exchanged or
otherwise disposed of any of its assets or rights, other than the sale of its
inventory in the ordinary course of business. For the purposes of this
subsection, all indebtedness, liabilities, agreements, understandings,
instruments, contracts and proposed transactions involving the same person or
entity (including persons or entities the Company has reason to believe are
affiliated therewith) shall be aggregated for the purpose of determining the
individual minimum dollar amounts.
6
(d) The Company is not engaged in any current active discussions (i)
with any representative of any corporation or corporations regarding the merger
of the Company with or into any such corporation or corporations, (ii) with any
corporation, partnership, association or other business entity or any individual
regarding the sale, conveyance or disposition of all or substantially all of the
assets of the Company or a transaction or series of related transactions in
which more than fifty percent (50%) of the voting power of the Company is
disposed of, or (iii) regarding any other form of liquidation, dissolution or
winding up of the Company.
3.12 CHANGES. Since June 30, 1995, there has not been:
(a) any change in the assets, liabilities, financial condition or
operating results of the Company from that reflected in the Financial
Statements, except changes in the ordinary course of business that have not had,
in the aggregate, a materially adverse effect on the Company and other than that
the Company continues to incur losses.
(b) any damage, destruction or loss, whether or not covered by
insurance, materially and adversely affecting the assets, properties, financial
condition, operating results, prospects or business of the Company (as such
business presently is conducted and as it is proposed to be conducted);
(c) any waiver by the Company of a valuable right or of a material debt
owed to it;
(d) any satisfaction or discharge of any lien, claim or encumbrance or
payment of any obligation by the Company, except in the ordinary course of
business and which is not material to the assets, properties, financial
condition, operating results or business of the Company (as such business
presently is conducted and as it is proposed to be conducted);
(e) any material change or amendment to any material contract or
arrangement by which the Company or any of its assets or properties is bound or
subject;
(f) any material change in any compensation arrangement or agreement
with any employee;
(g) any declaration or setting aside for payment or other distribution
in respect of any of the Company's capital stock, or any agreement or obligation
(contingent or otherwise) to repurchase or otherwise acquire or retire shares of
its capital stock; or
(h) to the Company's knowledge, any change in the Company's prospects
or any other event or condition of any character that might materially and
adversely affect the assets, properties, financial condition, operating results
or business of the Company (as such business presently is conducted and as it is
proposed to be conducted).
3.13 TITLE. The Company has good and marketable title to its properties
and assets, and has good title to all its leasehold interests, in each case
subject to no mortgage, pledge, lien, lease, encumbrance or charge, other than
(a) those resulting from taxes not delinquent, (b) minor liens and encumbrances,
which do not in any case, or in the aggregate, materially detract from the value
of the property subject thereto or materially impair the operations of the
Company,
7
when taken as a whole, and (c) those that otherwise have arisen in the ordinary
course of business.
3.14 LITIGATION. There are no material actions, suits, proceedings or
investigations pending or overtly threatened against the Company that question
the validity of this Agreement or the Investor Rights Agreement or the right of
the Company to enter into either of them, or to consummate the transactions
contemplated hereby or thereby, or which could reasonably be expected to result,
either individually or in the aggregate, in any material adverse change in the
assets, condition or prospects of the Company, nor is the Company aware that
there is a basis for any of the foregoing. The Company is not a party to any
order, writ, injunction, judgment, or decree of any court or governmental agency
or instrumentality. There is no action, suit, proceeding, or investigation by
the Company currently pending or that the Company presently intends to initiate.
3.15 REGISTRATION RIGHTS. Except as set forth in the Investor Rights
Agreement, the Company is not under any obligation to register any of its
presently outstanding securities or any of its securities which may hereafter be
issued.
3.16 TAX RETURNS. The Company has filed all federal, state and other
tax returns that are required to be filed. All taxes shown to be due and payable
on such returns, any assessments imposed, and all other taxes due and payable by
the Company on or before the First Closing have been or will be paid prior to
the time they would become delinquent.
3.17 LABOR AGREEMENTS AND ACTIONS. The Company is not bound by or
subject to any written or oral, express or implied, contract, commitment or
arrangement with any labor union, and no labor union has requested or, to the
knowledge of the Company, has sought to represent any of the employees,
representatives or agents of the Company. There is no strike or other labor
dispute involving the Company pending, or to the knowledge of the Company
threatened, which could have a material adverse effect on the assets,
properties, financial condition, operating results, or business of the Company
(as such business is presently conducted and is it is proposed to be conducted),
nor is the Company aware of any labor organization activity involving its
employees. The employment of each officer and employee of the Company is
terminable at the will of the Company and no employee has been granted the right
to any material compensation following the termination of employment with the
Company.
3.18 INSURANCE. The Company has in full force and effect fire, casualty
and liability insurance policies, which to the best of the Company's knowledge
are in such amounts and with such coverage as are carried by companies similar
to the Company.
3.19 PATENTS AND TRADEMARKS. To the best of its knowledge, the Company
owns or possesses sufficient legal rights to all patents, trademarks, service
marks, trade names, copyrights, trade secrets, licenses, information, and
proprietary rights (collectively, "Intellectual Property") necessary for its
business as now conducted and as proposed to be conducted without any conflict
with, or infringement of the rights of, others. There are no outstanding
options, licenses, or agreements of any kind relating to the foregoing, nor is
the Company bound by or a party to any material options, licenses, or agreements
of any kind with respect to the Intellectual Property rights of any other person
or entity, other than such licenses or agreements arising from
8
the purchase of "off the shelf" or standard products. The Company has not
received any communications alleging that the Company has violated or, by
conducting is business as proposed, would violate any of the Intellectual
Property rights of any other person or entity; provided, however, there can be
no assurance that the Company's manufacture and sale of any of its products will
not infringe third-party patents or that patents owned or licensed by the
Company will cover products sold by the Company.
3.20 DISCLOSURE. No statement by the Company contained in this
Agreement and the attached exhibits, and any written statement or certificate
furnished or to be furnished to the Purchasers pursuant to this Agreement or in
connection with the transactions contemplated hereby (when read together)
contains any untrue statement of a material fact or omits to state a material
fact necessary in order to make the statements contained herein or therein not
misleading in light of the circumstances under which they were made. To its
knowledge the Company has provided the Purchasers with all the information they
have reasonably requested in connection with their decision to purchase the
Shares and Warrants hereunder.
3.21 PROPRIETARY INFORMATION AND INVENTIONS AGREEMENT. Each employee of
the Company has executed a Proprietary Information and Inventions Agreement
substantially in the form or forms which have been delivered to special counsel
for the Purchasers.
4. REPRESENTATIONS AND WARRANTIES OF THE PURCHASERS; RESTRICTIONS ON TRANSFER.
4.1 REPRESENTATIONS AND WARRANTIES OF THE PURCHASERS. Each Purchaser,
severally and not jointly, represents and warrants to the Company with respect
to the purchase of the Shares and the Warrants as follows:
(a) DUE AUTHORIZATION, EXECUTION, DELIVERY AND PERFORMANCE. All action
on the part of Purchaser for the authorization, execution, delivery and
performance by Purchaser of this Agreement and the Investor Rights Agreement has
been taken.
(b) INVESTMENT INTENT. Purchaser is acquiring the Shares and the
Warrants for investment for such Purchaser's own account and not with a view to,
or for resale in connection with, any distribution. The Purchaser understands
that the Shares and the Warrants to be purchased have not been registered under
the Act by reason of a specific exemption from the registration provisions of
the Act which depends upon, among other things, the bona fide nature of the
investment intent as expressed herein.
(c) RESTRICTED SECURITIES. Purchaser acknowledges that the Securities
must be held indefinitely unless subsequently registered under the Securities
Act or an exemption from such registration is available. The Purchaser is aware
of the provisions of Rule 144 promulgated under the Securities Act which permits
limited resale of shares purchased in a private placement subject to the
satisfaction of certain conditions, including, in case the Purchaser has held
the Securities for less than three years or is an affiliate of the Company,
among other things: the availability of certain current public information about
the Company, the resale occurring not less than two years after the Securities
were purchased from the Company or
9
an affiliate of the Company, the sale being through a "broker's transaction" or
in transactions directly with a "market maker," and the number of shares being
sold during any three-month period not exceeding specified limitations.
(d) NO PUBLIC MARKET. Purchaser understands that no public market now
exists for any of the securities issued by the Company and there can be no
assurance that a public market will ever exist for the Securities.
(e) RECEIPT OF AND ACCESS TO INFORMATION. Purchaser has been furnished
with such materials and has been given access to such information relating to
the Company as it or its qualified representative has requested and has been
afforded the opportunity to ask questions regarding the Company and the Shares
and Warrants, all as Purchaser has found necessary to make an informed
investment decision.
4.2 LEGENDS. Each certificate representing the Securities shall be
endorsed with the following legend (in addition to any legend required by
applicable state securities laws):
THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED
UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE "SECURITIES ACT"),
AND MAY NOT BE SOLD, TRANSFERRED, ASSIGNED OR HYPOTHECATED UNLESS THERE
IS AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT
COVERING SUCH SECURITIES, THE SALE IS MADE IN ACCORDANCE WITH RULE 144
OR ITS SUCCESSOR RULE UNDER THE SECURITIES ACT, OR THE COMPANY RECEIVES
AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT AN EXEMPTION
FROM SUCH REGISTRATION IS AVAILABLE.
The Company will not register a transfer of the Securities unless the conditions
specified in the foregoing legend are satisfied, and the Company may instruct
its transfer agent not to register the transfer of any of the Securities unless
the conditions specified in the foregoing legend are satisfied. Notwithstanding
the foregoing, the Company shall not require a Purchaser to furnish an opinion
of its counsel in connection with a proposed transfer of Securities to a partner
of the Purchaser unless, in the view of the Company's counsel, such an opinion
is needed to confirm compliance with applicable securities laws.
5. CONDITIONS TO CLOSING.
5.1 CONDITIONS TO PURCHASERS' OBLIGATIONS AT EACH CLOSING. The
Purchasers' obligations to purchase the Shares and the Warrants at each Closing
are subject to the fulfillment on or prior to each Closing of the following
conditions, any of which may be waived in writing in whole or in part by the
Purchasers:
(a) REPRESENTATIONS AND WARRANTIES TRUE; PERFORMANCE OF OBLIGATIONS.
The representations and warranties made by the Company herein shall be true and
correct on the Closing Date with the same force and effect as if they had been
made on and as of the same date; and the Company shall have performed all
obligations and conditions herein required to be performed or observed by it on
or prior to such Closing Date.
10
(b) NECESSARY CONSENTS AND WAIVERS OBTAINED. The Company shall have
obtained all consents and waivers necessary for consummation of the transactions
contemplated by this Agreement which need to be obtained prior to such Closing.
(c) QUALIFICATIONS, LEGAL INVESTMENT. All authorizations, approvals, or
permits, if any, of any governmental authority or regulatory body of the United
States or of any state that are required prior to the Closing in connection with
the lawful sale and issuance of the Shares and the Warrants pursuant to this
Agreement shall have been duly obtained and shall be effective on and as of such
Closing Date.
(d) OFFICER'S CERTIFICATE. The Company shall have delivered to the
Purchasers a certificate or certificates, executed by an officer of the Company,
dated the Closing Date, certifying to the fulfillment of the conditions
specified in subparagraphs (a), (b) and (c) of this Section 5.1.
(e) RESTATED CERTIFICATE OF INCORPORATION. The Restated Certificate of
Incorporation, substantially in the form attached hereto as Exhibit E shall have
been filed with the Secretary of State of the State of Delaware.
(f) INVESTOR RIGHTS AGREEMENT. The Company and the Purchasers shall
have entered into the Investor Rights Agreement, substantially in the form
attached hereto as Exhibit D.
(g) LEGAL OPINION. Purchasers shall have received from Xxxxxx Godward
Xxxxxx Xxxxxxxxx & Xxxxx, counsel to the Company, an opinion letter addressed to
the Purchasers, dated the Closing Date, substantially in form attached hereto as
EXHIBIT F.
5.2 CONDITION TO COMPANY'S OBLIGATIONS AT EACH CLOSING. The Company's
obligation to sell and issue the Shares and the Warrants at each Closing is
subject to the fulfillment to the Company's satisfaction on or prior to each
Closing Date of the following conditions, any of which may be waived in writing
in whole or in part by the Company:
(a) REPRESENTATIONS AND WARRANTIES TRUE. The representations and
warranties made by the Purchasers on the First Closing Date shall be true and
correct when made and shall be true and correct on such Closing Date with the
same force and effect as if they had been made on and as of the same date, and
the Purchasers shall have performed all obligations and conditions herein
required to be performed or observed by them on or prior to such Closing Date.
(b) NECESSARY CONSENTS AND WAIVERS OBTAINED. The Company shall have
obtained all consents and waivers necessary for consummation of the transactions
contemplated by this Agreement which need to be obtained prior to such Closing.
(c) QUALIFICATIONS, LEGAL INVESTMENT. All authorizations, approvals, or
permits, if any, of any governmental authority or regulatory body of the United
States or of any state that are required in connection with the lawful sale and
issuance of the Shares and the Warrants pursuant to this Agreement shall have
been duly obtained and shall be effective on and as of such Closing Date.
11
(d) PERFORMANCE OF OBLIGATIONS. Each Purchaser shall have performed and
complied with all agreements and conditions herein required to be performed or
complied with by such Purchaser on or before such Closing Date, and each
Purchaser shall have delivered payment to the Company in respect of its purchase
of Shares and Warrants.
(e) INVESTOR RIGHTS AGREEMENT. The Company and the Purchasers shall
have entered into the Investor Rights Agreement, substantially in the form
attached hereto as Exhibit D.
6. MISCELLANEOUS.
6.1 WAIVERS AND AMENDMENTS. With the written consent of the record
holders of a majority of the Securities then outstanding, the obligations of the
Company and the rights of the holders of the Securities under this Agreement may
be waived (either generally or in a particular instance, either retroactively or
prospectively, and either for a specified period of time or indefinitely), and
with the same consent of the record holders of a majority of the Securities then
outstanding, the Company, when authorized by resolution of its Board of
Directors, may enter into a supplementary agreement for the purpose of adding
any provision to or changing in any manner or eliminating any provision of this
Agreement. Neither this Agreement nor any provision hereof may be changed,
waived, discharged or terminated orally, but only by a signed statement in
writing. Any such waiver or supplementary agreement shall be binding on all
holders of Securities.
6.2 GOVERNING LAW. This Agreement shall be governed in all respects by
the laws of the State of California as such laws are applied to agreements
between California residents entered into and to be performed entirely within
California.
6.3 SURVIVAL. The representations, warranties, covenants and agreements
made herein shall survive any investigation made by the Purchasers and the
Closings of the transactions contemplated hereby.
6.4 SUCCESSORS AND ASSIGNS. Except as otherwise expressly provided
herein, the provisions hereof shall inure to the benefit of, and be binding
upon, the successors, assigns, heirs, executors and administrators of the
parties hereto.
6.5 ENTIRE AGREEMENT. This Agreement and the other documents delivered
pursuant hereto, including the exhibits, constitute the full and entire
understanding and agreement between the parties with regard to the subjects
hereof and thereof.
6.6 SEVERABILITY OF THIS AGREEMENT. In case any provision of this
Agreement shall be invalid, illegal or unenforceable, the validity, legality and
enforceability of the remaining provisions shall not in any way be affected or
impaired thereby.
6.7 TITLES AND SUBTITLES. The titles of the sections and subsections of
this Agreement are for convenience of reference only and are not to be
considered in construing this Agreement.
12
6.8 DELAYS OR OMISSIONS. It is agreed that no delay or omission to
exercise any right, power or remedy accruing to the Purchasers, upon any breach
or default of the Company under this Agreement, shall impair any such right,
power or remedy, nor shall it be construed to be a waiver of any such breach or
default, or any acquiescence therein, or of or in any similar breach or default
thereafter occurring; nor shall any waiver of any single breach or default be
deemed a waiver of any other breach or default theretofore or thereafter
occurring. It is further agreed that any waiver, permit, consent or approval of
any kind or character by the Purchasers of any breach or default under this
Agreement, or any waiver by the Purchasers of any provisions or conditions of
this Agreement must be in writing and shall be effective only to the extent
specifically set forth in writing and that all remedies, either under this
Agreement, or by law or otherwise afforded to the Purchasers, shall be
cumulative and not alternative.
6.9 PAYMENT OF FEES AND EXPENSES. The Company and each Purchaser shall
bear its own expenses incurred on its behalf with respect to this Agreement and
the transactions contemplated hereby; PROVIDED, HOWEVER, that the Company shall
pay the reasonable fees and expenses of one special counsel to the Purchasers at
the Closing, up to a maximum of $5,000. If any action at law or in equity is
necessary to enforce or interpret the terms of this Agreement or the
Certificate, the prevailing party shall be entitled to reasonable attorney's
fees, costs and necessary disbursements in addition to any other relief to which
such party may be entitled.
6.10 NOTICES. Any notice or report required in this Agreement or
permitted to be given shall be given in writing and shall be deemed effective
upon personal delivery, confirmed facsimile or upon deposit in the United States
mail, first-class, postage prepaid and addressed (a) if to a Purchaser, at such
Purchaser's address set forth on such Purchaser's signature page hereto, or at
such other address as such Purchaser shall have furnished to the Company in
writing, or (b) if to any other holder of any Securities, at such address as
such holder shall have furnished the Company in writing, or, until any such
holder furnishes an address to the Company, then to and at the address of the
last holder of such Securities who has so furnished an address to the Company,
(c) if to the Company, one copy should be sent to its address set forth on the
cover page of this Agreement and addressed to the attention of the Corporate
Secretary, or at such other address as the Company shall have furnished to the
Purchasers.
6.11 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be an original, but all of which together
shall constitute one instrument.
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IN WITNESS WHEREOF, the parties hereto have executed this Series E
Preferred Stock Purchase Agreement as of the date first set forth above.
CV THERAPEUTICS, INC.
By:
-------------------------------------------------
Xxxxx X. Xxxxx, M.D.
Chief Executive Officer
PURCHASERS:
14
EXHIBIT A
SCHEDULE OF PURCHASERS
[OMITTED]
A-1
EXHIBIT B
FORM OF WARRANT
SEE EXHIBIT 10.18
B-1
EXHIBIT C
SCHEDULE OF EXCEPTIONS
[OMITTED]
C-1
EXHIBIT D
FORM OF AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
SEE EXHIBIT 10.11
D-1
EXHIBIT E
FORM OF RESTATED CERTIFICATE OF INCORPORATION
SEE EXHIBIT 3.1
E-1
EXHIBIT F
FORM OF OPINION OF XXXXXX GODWARD XXXXXX XXXXXXXXX & XXXXX
[OMITTED]
F-1
