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.
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);
1.
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:
1. DEFINITIONS.
The following terms as used in this License Agreement shall have the
meanings respectively set forth in this Article:
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;
2.
(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.
3.
1.7 "CVT TERRITORY" shall mean all countries in the world, excluding
Japan, Korea, China, Taiwan, Hong Kong, the Phillipines, 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 [ ]for the [
] (hereinafter referred to as "adjusted gross
sales"). From the adjusted gross sales there shall be [
], computed in accordance with Section 5.7, for [
].
4.
[ ].
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 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.
5.
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.
2. 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.
6.
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 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. Syntex shall have forty-five (45) days
from receipt of such notice to inform CVT, or the CVT Partner, as the case may
be, by written notice that Syntex elects to exercise a right of first
negotiation to obtain such sublicense with respect to the country or
countries in question and provide at the time of such election a proposal of
terms relating to the Licensed Product and country or countries in question.
If the election is in the affirmative, Syntex or any Affiliate of Syntex
shall have a right of first negotiation, such right giving Syntex or its
Affiliate, during the one hundred and twenty (120) day period following
delivery of the notice (the "Negotiation Period"), the exclusive right to
negotiate with CVT or the CVT Partner, before CVT or the CVT Partner
negotiates with any third party, to participate in marketing a Licensed
Product in any portion of the CVT Territory in which CVT or the CVT Partner
plans to seek assistance in marketing the Licensed Product; provided,
however, that the foregoing shall not apply to CVT's selection of a CVT
Partner, or if CVT or the CVT Partner at the time of launch of Licensed
Product has in the relevant portion of the CVT Territory an established and
systematic commercial relationship with a third party for the marketing by
such third party of other products developed by CVT or the CVT Partner, as
the case may be, and CVT or the CVT Partner plans to use such third party to
market the Licensed Product. At Syntex's request, during the Negotiation
Period the parties will negotiate in good faith to enter into an agreement
providing for Syntex or an Affiliate of Syntex being granted rights as a
marketing partner of CVT or the CVT Partner. Such agreement shall be on
commercially reasonable terms, which may include, without limitation,
co-promotion product exchange and other consideration, consistent with
customary business practices in armslength transactions with third parties in
the pharmaceutical industry, it being understood that CVT or the CVT Partner
shall be entitled to reject Syntex's offer at the end of the Negotiation
Period and seek more favorable terms from a third party. If no agreement is
entered into with Syntex or a Syntex Affiliate by the end of the Negotiation
Period, then CVT or the CVT Partner shall be free to enter into an agreement
to sublicense a third party at its sole discretion on terms materially more
favorable to CVT than those last offered by Syntex or its respective
Affiliate. "Terms" shall include, but not be limited to, royalty,
copromotion, product exchange and level of development or marketing support
for the Licensed Product in question. If CVT or the CVT Partner intends to
enter into such an agreement with a third party on terms materially equal or
less favorable to CVT than those last offered by Syntex or its Affiliate, it
shall first offer such terms to Syntex or its Affiliate, as the case may be,
in writing, and Syntex or its Affiliate shall have thirty (30) days from
receipt of such offer to accept or reject the terms of the offer in its
entirety. If Syntex or its Affiliate rejects the offer, CVT or the CVT
Partner, as the case may be, shall then be free to enter into the agreement
with such third party or another party upon the offered terms.
7.
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.
3. 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 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
8.
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
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 [ ]. 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 [ ].
(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
[ ] for the reasonable costs (including consulting fees
and reasonable travel expenses), in the aggregate, of all ex-Syntex personnel
and of the two, [ ]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.
(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
9.
clinical activities and IND matters shall cease [ ] 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).
4. 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.
10.
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.
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
11.
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 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 [ ] after launch of a Licensed Product in a country in
question, Syntex may convert the right and license granted pursuant to
Article II into a non-exclusive right and license in a given country of the
CVT Territory in the event CVT, or the responsible CVT Affiliate or
sublicensee fails to comply with its obligations in each such country as set
forth above, unless, within such [ ] period, CVT or the
responsible CVT Affiliate or sublicensee shall have
12.
cured such default or shall have put a reasonable plan in place and allocated
sufficient resources to meet its efforts - obligation 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
13.
a Licensed Product issued by either an EU or an EFTA country, and in addition,
within one (1) month 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.
5. 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:
14.
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:
(1) Subject to Section 5.1 c) below, [
]
upon [ ], but in no event later
than [
];
(2) [ ] upon commencement of
[ ];
(3) [ ] upon commencement of
[ ] or the date of [ ];
(4) [ ] upon the date of [ ];
(5) [ ] upon [ ];
and
15.
(6) [ ] upon the first [
]. For the purposes hereof, [ ] shall
mean any of the following
[
] and [
] shall
mean [
].
"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 [
] CVT may issue Syntex
[ ]
that number of shares of its Series E Preferred Stock equally: Seven Hundred
Fifty Thousand 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 [ ](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.
16.
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.
17.
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
18.
(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.
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
19.
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.
6. SUPPLY OF COMPOUND.
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
20.
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 it has been informed of the existence,
circumstances and details of a "temporary import bond(s)" put up by Syntex
with respect to the import of existing Counpound into the United States,
including, without limitation, the fact that Syntex has closed out such
bond(s) by shipping the Compound out of the United States, and the potential
consequences of importing any quantity of such Compound into the United
States. 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
21.
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 of any kind associated with the import of any quantity of
the Compound into the United States, whether or not relating to such bond(s),
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.
7. 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
22.
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.
8. MAINTENANCE AND ENFORCEMENT OF SYNTEX PATENT RIGHTS.
8.1 Syntex agrees to prosecute and maintain, [
] 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 [
] to the extent that CVT desires to do so.
23.
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
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.
24.
9. 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.
10. 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
25.
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 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
26.
(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.
11. 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) ten (10) years from the date of
first commercial sale of the Licensed 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 [ ]
27.
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 one hundred and twenty
(120) days 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 directly related to and
solely usable in connection with the Compound and the Licensed Products to
make, have made, use,
28.
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.
29.
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 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
30.
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 with
prejudice within sixty (60) days thereafter, such termination to be effective
upon the delivery of written notice to the insolvent or bankruptcy party.
12. 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.
31.
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 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
32.
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.
13. 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
33.
Facsimile: (000) 000-0000
with a copy to: X. Xxxxxxxx-Xx Xxxxx Ltd
X.X.Xxx, XX-0000 Xxxxx
Xxxxxxxxxxx
Attention: Corporate Law
Facsimile: 41-61-68-81396
and in the case
of notice regarding
CVT's stock, Attention: Corporate Finance
34.
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.
14. 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
35.
person to be named to be chairman within sixty (60) days, the American
Arbitration Association shall make the necessary appointments for arbitrator or
chairman.
(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
------------------------ -------------------------
36.
APPENDIX A
Case [
]
Case [
]
Case [ ]
STATUS OF CASE 23550 APPENDIX A
RUN DATE: 19 MAR 1996 PAGE 1 OF 8
DKT COUNTRY CS TP RL TP FL TP FL MO STATUS CLASSIFY
--- ------- -- -- -- -- -- -- -- -- ------ --------
00000 XXXXXXX E GNT RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: E31533 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
23550 AUSTRALIA GNT RS43285
APPLICATION NO: 28346/84 APPLICATION DATE: 17MY1984
PATENT NO: 566489 GRANT DATE: 220C1987 EXPIRATION DATE: 17MY2004
00000 XXXXXXX E GNT RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: 126449 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
23550 BAHAMAS GNT RS43285
APPLICATION NO: 753 APPLICATION DATE: 17MY1984
PATENT NO: 753 GRANT DATE: 08DE1986 EXPIRATION DATE: 17MY2000
00000 XXXXXX GNT RS43285
APPLICATION NO: 454628 APPLICATION DATE: 17MY1984
PATENT NO: 1256874 GRANT DATE: 04JL1989 EXPIRATION DATE: 04JL2006
00000 XXXXXXXXXXX E GNT RS43285
APPLICATION NO: 84105643.5A APPLICATION DATE: 17MY1984
PATENT NO: 126449 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
23550 CZECH REPUBLIC GNT RS43285
APPLICATION NO: PV3680 APPLICATION DATE: 17MY1984
PATENT NO: 246080 GRANT DATE: 01SE1986 EXPIRATION DATE: 17MY1999
23550 XXXXX XXXXXXXX X 00 XXX XX00000
APPLICATION NO: PV3492 APPLICATION DATE: 15MY1985
PATENT NO: 246099 GRANT DATE: 01SE1986 EXPIRATION DATE: 17MY1999
00000 XXXXXXX E GNT RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: P-3468215.5-08 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
STATUS OF CASE 23550 APPENDIX A
RUN DATE: 19 MAR 1996 PAGE 2 OF 8
DKT COUNTRY CS TP RL TP FL TP FL MO STATUS CLASSIFY
--- ------- -- -- -- -- -- -- -- -- ------ --------
23550 DENMARK GNT RS43285
APPLICATION NO: 2483/84 APPLICATION DATE: 17MY1984
PATENT NO: 168535 GRANT DATE: 18AP1994 EXPIRATION DATE: 17MY2004
23550 EUROPEAN PATENT E INA RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: 126449 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
00000 XXXXX GNT RS43285
APPLICATION NO: 532565 APLICATION DATE: 17MY1984
PATENT NO: 532565 GRANT DATE: 09SE1985 EXPIRATION DATE: 09SE2005
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APPLICATION NO: 841989 APPLICATION DATE: 17MY1984
PATENT NO: 78479 GRANT DATE: 10AU1989 EXPIRATION DATE: 17MY2004
00000 XXXXXX E GNT RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: 126449 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
23550 GREAT BRITAIN E GNT RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: 126449 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
00000 XXXXXX GNT RS43285
APPLICATION NO: 74733 APPLICATION DATE: 16MY1984
PATENT NO: 82400 GRANT DATE: 13DE1984 EXPIRATION DATE: 16MY2004
00000 XXXXXXX GNT RS43285
APPLICATION NO: 1902 APPLICATION DATE: 17MY1984
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23550 IRELAND GNT RS43285
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PATENT NO: 57487 GRANT DATE: 02FE1993 EXPIRATION DATE: 17MY2004
STATUS OF CASE 23550 APPENDIX A
RUN DATE: 19 MAR 1996 PAGE 3 OF 8
DKT COUNTRY CS TP RL TP FL TP FL MO STATUS CLASSIFY
--- ------- -- -- -- -- -- -- -- -- ------ --------
00000 XXXXXX GNT RS43285
APPLICATION NO: 71863 APPLICATION DATE: 17MY1984
PATENT NO: 71863 GRANT DATE: 31JA1988 EXPIRATION DATE: 17MY2004
00000 XXXXX E GNT RS43285
APPLICATION NO: 126449 APPLICATION DATE: 17MY1984
PATENT NO: 67299BE88 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
23550 LIECHTENSTEIN E GNT RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: 126449 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
00000 XXXXXXXXXX E GNT RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: 126449 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
[
]
00000 XXXXXXXXXXX E GNT RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: 126449 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
23550 NORWAY GNT RS43285
APPLICATION NO: 841968 APPLICATION DATE: 16MY1984
PATENT NO: 163618 GRANT DATE: 27JE1990 EXPIRATION DATE: 16MY2004
23550 NEW ZEALAND GNT RS43285
APPLICATION NO: 208188 APPLICATION DATE: 17MY1984
PATENT NO: 208188 GRANT DATE: 13AP1988 EXPIRATION DATE: 17MY2004
STATUS OF CASE 23550 APPENDIX A
RUN DATE: 19 MAR 1996 PAGE 4 OF 8
DKT COUNTRY CS TP RL TP FL TP FL MO STATUS CLASSIFY
--- ------- -- -- -- -- -- -- -- -- ------ --------
00000 XXXXXX GNT RS43285
APPLICATION NO: P247722 APPLICATION DATE: 17MY1984
PATENT NO: 142760 GRANT DATE: 09FE1987 EXPIRATION DATE: 17MY1999
00000 XXXXXX D 01 GNT RS43285
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PATENT NO: 143558 GRANT DATE: 20MR1989 EXPIRATION DATE: 17MY1999
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APPLICATION NO: 78604 APPLICATION DATE: 17MY1984
PATENT NO: 78604 GRANT DATE: 15JL1986 EXPIRATION DATE: 15JL2001
00000 XXXXXX E GNT RS43285
APPLICATION NO: 84105643.5 APPLICATION DATE: 17MY1984
PATENT NO: 84105643.5 GRANT DATE: 23DE1987 EXPIRATION DATE: 17MY2004
00000 XXXXXX XXXXXXXX GNT RS43285
APPLICATION NO: PV3680 APPLICATION DATE: 17MY1984
PATENT NO: 246080 GRANT DATE: 26NO1986 EXPIRATION DATE: 17MY1999
00000 XXXXXX XXXXXXXX D 01 GNT RS43285
APPLICATION NO: PV3492 APPLICATION DATE: 15MY1985
PATENT NO: 246099 GRANT DATE: 26NO1986 EXPIRATION DATE: 17MY1999
[
]
STATUS OF CASE 23550 APPENDIX A
RUN DATE: 19 MAR 1996 PAGE 5 OF 8
DKT COUNTRY CS TP RL TP FL TP FL MO STATUS CLASSIFY
--- ------- -- -- -- -- -- -- -- -- ------ --------
00000 X.X.X. GNT RS43285
APPLICATION NO: 06/495,904 APPLICATION DATE: 18MY1983
PATENT NO: 4,567,264 GRANT DATE: 28JA/1986 EXPIRATION DATE: 18MY2003
00000 XXXXX XXXXXX GNT RS43285
APPLICATION NO: 843746 APPLICATION DATE: 17MY1984
PATENT NO: 843746 GRANT DATE: 29JA1986 EXPIRATION DATE: 17MY2004
26720 AUSTRALIA GNT RS43285
APPLICATION NO: 57618/90 APPLICATION DATE: 21JE1990
PATENT NO: 633589 GRANT DATE: 04FE1993 EXPIRATION DATE: 21JE2010
[
]
STATUS OF CASE 23550 APPENDIX A
RUN DATE: 19 MAR 1996 PAGE 6 OF 8
DKT COUNTRY CS TP RL TP FL TP FL MO STATUS CLASSIFY
--- ------- -- -- -- -- -- -- -- -- ------ --------
[
]
00000 XXXXX XXXXXX GNT RS43285
APPLICATION NO: 904842 APPLICATION DATE: 21JE1990
PATENT NO: 904842 GRANT DATE: 26 FE1992 EXPIRATION DATE: 21JE2010
[
]
27850 BAHAMAS GNT RS61443
APPLICATION NO: 1085 APPLICATION DATE: 12MY1994
PATENT NO: 1085 GRANT DATE: 18MR1995 EXPIRATION DATE: 12MY2010
[
]
STATUS OF CASE 23550 APPENDIX A
RUN DATE: 19 MAR 1996 PAGE 7 OF 8
DKT COUNTRY CS TP RL TP FL TP FL MO STATUS CLASSIFY
--- ------- -- -- -- -- -- -- -- -- ------ --------
[
]
27850 HUNGARY C GNT RS61443
APPLICATION NO: P/P00110 APPLICATION DATE: 24AP1995
PATENT NO: 211270 GRANT DATE: 24JL1995 EXPIRATION DATE: 11MY2014
[
]
STATUS OF CASE 23550 APPENDIX A
RUN DATE: 19 MAR 1996 PAGE 8 OF 8
DKT COUNTRY CS TP RL TP FL TP FL MO STATUS CLASSIFY
--- ------- -- -- -- -- -- -- -- -- ------ --------
00000 X.X.X. P 01 GNT RS61443
APPLICATION NO: 08/239,621 APPLICATION DATE: 09MY1994
PATENT NO: 5,472,707 GRANT DATE: 05DE1995 EXPIRATION DATE: 13MY2013
[
]
00000 XXXXX XXXXXX GNT RS61443
APPLICATION NO: 943267 APPLICATION DATE: 11MY1994
PATENT NO: 943267 GRANT DATE: 25JA1995 EXPIRATION DATE: 11MY2014
APPENDIX B
MILESTONE DATE OF MILESTONE DATE OF MILESTONE
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Satisfied by [ [ [
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Satisfied by [ [ [
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Satisfied by [ [ [
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Satisfied by [ [ [
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Satisfied by [ [ [
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APPENDIX C
Description Unit Price to CVT/Unit
----------- ---- -----------------
Ranolazine [ ] Kg $[ ]/Kg
Ranolazine [ ] Kg $[ ]/Kg
Ranolazine [ ]placebo tablet Tablet $[ ]/Tablet
Ranolazine [ ]blue tablet Tablet $[ ]/Tablet
Ranolazine [ ]tablet Tablet $[ ]/Tablet
Ranolazine [ ]tablet Tablet $[ ]/Tablet
Ranolazine [ ]placebo tablet Tablet $[ ]/Tablet
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.
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
2
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.
3.2 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
3
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.
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
4
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, 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
5
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.
(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
6
(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, 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.
7
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 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
8
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 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
9
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.
(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
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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.
(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.
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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.
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
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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.
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:
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EXHIBIT A
SCHEDULE OF PURCHASERS
[OMITTED]
EXHIBIT B
FORM OF WARRANT
SEE EXHIBIT 10.18
EXHIBIT C
SCHEDULE OF EXCEPTIONS
[OMITTED]
EXHIBIT D
FORM OF AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
SEE EXHIBIT 10.11
EXHIBIT E
FORM OF RESTATED CERTIFICATE OF INCORPORATION
SEE EXHIBIT 3.1
EXHIBIT F
FORM OF OPINION OF XXXXXX GODWARD XXXXXX XXXXXXXXX & XXXXX
[OMITTED]
