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 (the "Agreement") is dated May 07, 1996 by and
between CV THERAPEUTICS, INC., a California corporation, having its principal
place of business at 0000 Xxxxxx Xxxxx, Xxxx Xxxx, Xxxxxxxxxx ("CVT"), and XXXXX
XX, a German corporation having its principal place of business at D 51368
Leverkusen, Germany ("BAYER").
Each of BAYER and CVT are sometimes referred to herein as the "PARTY" or,
collectively, as the "PARTIES".
RECITALS
WHEREAS, CVT has discovered [ ]
([ ] CTX), as the available representative), has performed certain
research, and owns certain proprietary rights thereon.
WHEREAS, BAYER is a leader in the research, development, marketing,
manufacture and distribution of therapeutic pharmaceutic products; and
1.
WHEREAS, CVT and BAYER desire to establish a contractual relationship to
grant an exclusive license to BAYER to research, develop, manufacture and market
CTX, its derivatives and/or modulators of the principle.
NOW, THEREFORE, in consideration of the mutual covenants and promises
contained in this Agreement, the PARTIES agree as follows:
DEFINITIONS
Capitalized words used in this Agreement shall have the meanings ascribed
in the following definitions, unless otherwise stated or defined in the
Agreement.
1. DEFINITIONS
1.1 "AFFILIATE" means any entity controlled by, controlling, or under
common control with a PARTY and shall include without limitation any company
fifty percent (50%) or more of whose voting stock or participating profit
interest is owned or controlled, directly or indirectly, by a PARTY, and any
entity which owns or controls, directly or indirectly, fifty percent (50%) or
more of the voting stock of a PARTY. Where the laws of jurisdiction in which
such entity operates prohibits the ownership by a PARTY of 50%, an AFFILIATE
shall mean an entity that is controlled by, controlling, or under common control
with a PARTY at a maximum level of ownership allowed by such jurisdiction.
1.2 "BAYER PATENT" means all PATENTS that claim or cover COMPOUNDS or
PRODUCTS, the manufacture, use, sale,offer for sale or import of COMPOUNDS, or
methods or materials useful for discovering, identifying, or
2.
assaying for COMPOUNDS, the manufacture, use, sale, offer for sale or import of
PRODUCTS, where such PATENTS cover inventions made solely by employees or agents
of BAYER or an AFFILIATE of BAYER.
1.3 "COMPOUND" means
(a) [ ] (CTX), and/or
(b) modulators [
] of CTX
and/or
(c) any composition of matter that is discovered, identified or
synthesized by or on behalf of BAYER or an AFFILIATE regarding the FIELD and
which is covered by valid claims of the CVT PATENT and/or identified only by
using and applying the CVT KNOW HOW within the FIELD.
1.4 "CONFIDENTIAL INFORMATION" means each PARTY's confidential
information, inventions, additional Know-How or data relating to COMPOUNDS, CTX,
KNOW HOW, including but not limited to identifying, developing, manufacturing
COMPOUNDS and/or PRODUCTS, BAYER's reporting and other business information and
plans, whether in oral, written graphic or electronic form. CONFIDENTIAL
INFORMATION disclosed orally shall be reduced to writing by the disclosing PARTY
and delivered to the other PARTY within thirty (30) days after disclosure.
3.
1.5 "CONTROL" means possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of any agreement,
other arrangement with or any rights of any THIRD PARTY.
1.6 "CTX" means [
] covered by the FIELD and CVT PATENT.
1.7 "CVT KNOW HOW" means all KNOW HOW information, results, procedures
including but not limited to the identification and development of COMPOUNDS and
to the isolation and purification of CTX, [
] and corresponding
information for the use and handling thereof and/or useful for the
identification and development of COMPOUNDS that CVT owns or CONTROLS on the
EFFECTIVE DATE and that will be owned and will be CONTROLLED by CVT. CVT KNOW
HOW shall exclude CVT PATENTS.
1.8 "CVT PATENTS" means all PATENTS owned or CONTROLLED by CVT or an
affiliate of CVT that claim or cover COMPOUNDS, the manufacture or use of
COMPOUNDS and PRODUCTS and/or methods or materials useful for discovering,
identifying, purifying, evaluating or assaying of COMPOUNDS, where such PATENTS
cover inventions made by employees or agents of CVT or made by CVT's cooperation
partners in the FIELD, as identified in Annex 2.
1.9 "EFFECTIVE DATE" means May 07, 1996.
4.
1.10 "FIELD" means the use of the PRINCIPLE for any therapeutic and/or
prophylactic and/or diagnostic use in human or animals.
1.11 "KNOW HOW" means all intangible Know-How, inventions (whether or not
patentable), data, preclinical results, information, and any physical, chemical
or biological material or any replication of any part of such material.
1.12 "NET SALES" shall mean gross sales of PRODUCT sold by BAYER, its
AFFILIATES and sublicensees to THIRD PARTIES (including any unaffiliated THIRD
PARTY's distributors), less, to the extent included in gross sales, the total of
(a) ordinary and customary trade discounts actually allowed,
(b) credits, rebates, returns (including, but not limited to,
wholesaler and retailer returns) actually allowed,
(c) excise taxes, other consumption taxes, customs duties and
compulsory payments to governmental authorities paid, and
(d) amounts equivalent to 5 % of said gross sales as an
allowance for expenses such as transportation, insurance and the like.
1.13 "PATENT" means
(a) valid and enforceable Letters Patent in any and all
countries including without limitation any extension - Supplemental Protection
Certificates
5.
(SPC), registration, confirmation, reissue, continuation-in-part, division, or
renewal thereof, and
(b) pending applications for any of the foregoing.
1.14 "PRINCIPLE" means the [ ]
exemplified as the activities of CTX, and modulators [
].
1.15 "PRODUCT" means any pharmaceutical product identified and developed
under this Agreement covered by the FIELD containing CTX or any other COMPOUND
as active ingredient, representing the PRINCIPLE.
1.16 "PRODUCT DEVELOPMENT" means the performance of the non-clinical and
clinical investigations necessary to and directly in support of obtaining
REGULATORY APPROVAL for marketing a PRODUCT.
1.17 "REGULATORY APPROVAL" means any approvals (including price and
reimbursement approvals), licenses, registrations or authorizations of any
federal, state or local regulatory agency, department, bureau or other
government entity, necessary for the manufacture, use, storage, import,
transport or sale, of PRODUCTS in a country.
1.18 "SUBLICENSE REVENUES" means all revenues from THIRD PARTIES as
consideration for the sale of PRODUCTS.
1.19 "TERRITORY" means the entire world.
6.
1.20 "THIRD PARTY" means any entity other than CVT or BAYER and their
respective AFFILIATES.
1.21 "THIRD PARTY ROYALTIES" means royalties payable to a THIRD PARTY in
respect of the PRINCIPLE, COMPOUND and the manufacture or sale of PRODUCTS.
2. LICENSE GRANT
2.1 CVT hereby grants BAYER a license under CVT PATENTS and CVT KNOW HOW
to identify, have identified and develop, have developed COMPOUNDS and to
develop, have developed, make, have made use, have used, sell, have sold, offer,
have offered for sale, import and have imported COMPOUNDS and/or PRODUCTS
subject to the terms and conditions of this Agreement. Such license shall be
exclusive, unlimited and worldwide. BAYER shall have the right to sublicense
its rights hereunder to its AFFILIATES and to THIRD PARTIES.
2.2 EXCLUSIVITY.
2.2.1 RIGHTS IN USE
Subject to and conditioned upon the provisions of this Agreement, the
rights, licenses and privileges granted pursuant to Article 2.1 shall be
exclusive to
7.
BAYER. Without limiting the generality of the foregoing, CVT covenants that
during the term of this Agreement, neither CVT nor its AFFILIATES shall grant to
any THIRD PARTY any right, license or privilege to identify, develop, make, have
made COMPOUNDS and/or to develop, use or sell PRODUCTS, or to otherwise use or
exploit CVT PATENTS and CVT KNOW HOW.
2.2.2 CONTROL
Regarding CVT PATENTS, CVT KNOW HOW and CTX, CVT herewith expressly
confirms to own and CONTROL exclusively all rights, which will be exclusively
licensed to BAYER. CVT further expressly confirms that CVT. owns and CONTROLS
exclusively all rights, know how experiences, cell lines as defined under CVT
KNOW HOW which was developed at CVT's cooperation partners including but not
limited to the University of Kansas and the Washington University. CVT further
confirms that- to the best of their knowledge - there are not any rights with
any THIRD PARTY regarding the PRINCIPLE.
8.
2.2.3 THIRD PARTY ROYALTIES
If under this Agreement BAYER becomes aware of technology and/or know how
of a THIRD PARTY that at BAYER's discretion would be valuable or necessary to
the discovery, development or commercialization of PRODUCTS, BAYER is free to
acquire such rights at its sole discretion. In the event of an acquisition of
any such THIRD PARTY right or know how which would result in payment of
royalties or other license fee to a THIRD PARTY, the PARTIES will share such
compensation to the offering THIRD PARTY:
Of any such license fee, CVT will pay [ ] out of the milestone payment
foreseen in section 4.3.5., but only up to a maximum of [ ]
of that milestone. The contribution of CVT to this license fee shall be
deducted by BAYER from the milestone foreseen in section 4.3.5. In case of an
obligation by BAYER to pay running royalties to such licensor, CVT will
contribute [ ] out of CVT royalties received from BAYER under
this Agreement, but limited to a maximum of [ ] of CVT's
royalties received from BAYER.
2.3 RIGHTS TO SUBLICENSE
(i) BAYER shall have the sole right to sublicense to THIRD
PARTIES all or any portion of the rights to CVT PATENTS and CVT KNOW HOW and/or
CTX granted to BAYER pursuant to this Agreement;
9.
(ii) BAYER shall have the sole right to sublicense all or any
portion of the rights to the CVT PATENTS, the CVT KNOW HOW and CTX, granted to
BAYER pursuant to this Agreement to any or all of its AFFILIATES.
(iii) BAYER agrees that all sublicenses granted by BAYER hereunder
shall expressly bind sublicensees to the terms of sections 3.2, 4.4, 5.4, 9, and
all other relevant obligations of this Agreement. In the event BAYER grants
sublicenses, BAYER shall pay all royalties to CVT through and under the sole
responsibility of BAYER as if SUBLICENSE REVENUES were NET SALES of BAYER;
(iv) Any sublicenses granted by BAYER shall provide for the
termination of the sublicenses upon termination of this Agreement.
(v) During the term of this Agreement, BAYER shall inform CVT on
all sublicenses granted by BAYER hereunder.
2.4 SUBCONTRACTING
Notwithstanding anything herein provided for to the contrary, BAYER shall
be allowed to (i) sub-contract in whole or in part COMPOUND and PRODUCT
development to THIRD PARTIES, (ii) appoint sales agents and distributors to
market PRODUCT, and (iii) sub-contract the manufacturing of COMPOUND and/or
PRODUCT with THIRD PARTIES on BAYER's discretion or with BAYER's AFFILIATES.
BAYER shall provide for the corresponding confidentiality and restriction-of-use
obligations to apply to those subcontracting THIRD PARTIES according to Article
9.
10.
3. DISCLOSURE OF INFORMATION
3.1 As soon as possible after the EFFECTIVE DATE, CVT shall disclose or
cause its AFFILIATES to disclose and/or deliver to BAYER all CVT PATENTS,
COMPOUND, COMPOUND specifications, CTX, CTX specifications, CVT KNOW HOW, to
enable and support BAYER to identify, develop COMPOUNDS and to manufacture, have
manufactured, and commercialize PRODUCTS in the FIELD on the terms and subject
to the conditions of this Agreement.
3.2 During the term of this AGREEMENT, BAYER shall inform CVT on the
progress of the project under this Agreement, at 6 (six) months intervals
(Summaries, only).
4. PAYMENTS
For the rights granted to BAYER according to Article 2, BAYER will
compensate CVT by the following payments at the following events under the
following conditions:
4.1 DOWN PAYMENT
BAYER shall transfer to CVT a downpayment of U.S. $0.25MM (two hundred
and fifty thousand U.S. Dollars) due on the EFFECTIVE DATE.
4.2 DOWN PAYMENT
11.
If and when the [ ] (CTX) producing cell line is successfully
established at BAYER's labs, [
] and [ ]
efficacy is confirmed by Bayer as being sufficient and qualified for [
] Bayer shall transfer to CVT [
].
4.3 Milestone Payments according to the progress of the first COMPOUND
or PRODUCT to be developed, as follows:
4.3.1 As soon as [
] BAYER shall transfer
to CVT [ ].
4.3.2 At the [
] BAYER shall transfer
to CVT [ ].
4.3.3 At the [
Bayer shall furnish to CVT [
].
12.
4.3.4 At the [
] BAYER will furnish to CVT
[ ].
4.3.5 At the [
BAYER shall furnish to CVT
[ ].
It is understood that all payments identified in Article 4.3 will only
become due [
].
4.4 ROYALTIES
4.4.1 On the NET SALES of each of BAYER's PRODUCTS [
] in the TERRITORY of up to [
]
-accrued during [ ] BAYER shall [
] of [
] for the period according to Art. 10.1.
4.4.2 On the NET SALES of each of BAYER's PRODUCTS [
] in the TERRITORY of more than [
]
- accrued during [ ] BAYER shall [
]
of [ ] for the period according to Art. 10.1.
13.
4.4.3 On the NET SALES of each of BAYER's PRODUCT [
] or [ ] - accrued during [ ] BAYER shall [
]
of [ ] of that identified in Art. 4.4.1 and 4.4.2, respectively, for the
period according to Art. 10.1.
4.5 MARKET EXCLUSIVITY
On a country by country basis, BAYER will pay the royalty rates according
to Art. 4.4 only and as long as the [
] Under all other
circumstances, BAYER will [
] according to Art. 4.4.1
through 4.4.3.
4.6 OFFSET FOR THIRD PARTY ROYALTIES
BAYER may offset, against any amounts owed to CVT as royalties hereunder
the following expenses to the extent incurred in the year for which such royalty
amounts accrued:
(a) [ ] of THIRD PARTY ROYALTIES with respect
to technology acquired and due under Section 2.2.3 to the extent provided
hereunder and as defined and limited according to Section 2.2.3 and,
(b) any amounts paid and/or allocated to be paid by BAYER
pursuant to Art. 8.3 and 8.4.
14.
5. MANNER OF PAYMENTS
5.1 BAYER shall effect each milestone payment under Section 4.3 within
60 (sixty) days after they become due. BAYER shall effect all royalty payments
under Section 4.4 within 90 (ninety) days after each calendar quarter Payment
shall be made to an account designated in writing by CVT.
5.2 BLOCKED CURRENCY
In each country where the local currency is blocked and cannot be removed
from the country, at the election of BAYER, royalties accrued in that country
shall be paid to CVT in the country in local currency by deposit in a local bank
designated in writing by the CVT.
5.3 FOREIGN EXCHANGE
Royalties on U.S. sales shall be calculated and paid in U.S. Dollars.
Royalties on all other sales shall be calculated in local currency and converted
to the US Dollar at the end of each calendar quarter. The exchange rate used
shall be the exchange rate for the US dollar and the currency of the country of
sale as quoted by the Wall Street Journal, or a comparable publication
acceptable to both parties, if the Wall Street Journal ceases to exist, on the
last day of the quarter for which royalties on net sales have been calculated.
15.
5.4 RECORDS
BAYER shall keep or cause to be kept such records as are required to
determine in a manner consistent with generally accepted accounting principles
the sum of royalties due under this Agreement and the sales figures of each
first PRODUCT according to Art. 4.4. At the request (and expense) of CVT, BAYER
and its sublicensees shall permit an independent certified public accountant
appointed by CVT and reasonably acceptable to BAYER, at reasonable times and
upon reasonable notice, to examine those records as may be necessary to:
(a) determine, with respect to any calendar year ending not more than
three years prior to CVT's request, the correctness of any report or payment
made under this Agreement; or
(b) obtain information as to the royalty payable for any calendar year.
Any such examination shall be subject to Article 9. Results of any such
examination shall be made available to both PARTIES. If CVT requests an audit,
CVT shall bear the full cost of the performance of any such audit, unless such
audit discloses a variance of more than [
] from the amount of the original report, royalty or payment calculation. In
such case, BAYER shall bear the full cost of the performance of such audit.
16.
6. DILIGENCE
6.1 DEVELOPMENT
BAYER shall use reasonable diligence in developing and marketing PRODUCTS
and shall endeavor to maximize the economic value of the PRODUCTS.
6.2 COMMERCIAL SUPPLY
BAYER shall be responsible for optimization, scale-up and commercial supply
of PRODUCTS for worldwide sale, directly or through AFFILIATES of BAYER or
through THIRD PARTIES, at BAYER's discretion. BAYER shall manufacture, or have
manufactured, all PRODUCTS for worldwide commercial sales in conformance with
the specifications set forth in the respective applications for REGULATORY
APPROVAL and any amendments or supplements thereto, and any substitutes.
7. TAXES
7.1 CVT shall pay any and all taxes levied on account of the royalties
it receives under this Agreement. If laws or regulations require that taxes be
withheld, BAYER will
(a) deduct those taxes from the remittable royalty,
(b) timely pay the taxes to the proper taxing authorities, and
17.
(c) send proof of payment to CVT within 90 (ninety) days
following that payment.
The PARTIES agree to cooperate to obtain the benefit of any tax treaty with
respect to such royalty payments.
8. OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS
8.1 PATENT PROSECUTION
The PARTIES intend to establish broad patent protection for CTX arid other
patentable inventions developed by or achieved at CVT and CVT's collaboration
partners according to Art. 2.2.2 and other patentable inventions. CVT shall
supervise and direct patenting of all CVT PATENTS. CVT shall file and prosecute
all patent applications covering such CVT PATENTS and collaboration partners'
inventions. For such prosecution, CVT will engage counsel reasonably acceptable
to BAYER, at CVT's expense. CVT shall give BAYER copies of all such
applications and related correspondence, in sufficient time to allow BAYER
reasonably to comment thereon. CVT will seriously consider BAYER's comments.
CVT shall maintain all CVT PATENTS that issue on such applications.
8.2 CONFIDENTIAL TREATMENT
All information disclosed under Sections 8.1 shall be treated as
confidential pursuant to Article 9.
18.
8.3 INFRINGEMENT BY THIRD PARTIES OF CVT PATENT.
If any CVT PATENT is infringed by a THIRD PARTY in any country of the
TERRITORY, regarding the development, manufacture, use, sale, offer for sale or
import of COMPOUND or any PRODUCT in such country, the PARTY first having
knowledge of such infringement shall promptly notify the other in writing. The
notice shall set forth the facts of that infringement in reasonable detail. CVT
shall have the obligation to institute, prosecute, and control any action or
proceeding with respect to such infringement, by counsel of its own choice, and
BAYER shall have the right, at its own expense, to be represented in any action
by counsel of its own choice. If CVT fails to bring an action or proceeding
within a period of ninety (90) days after having knowledge of infringement of a
CVT PATENT, BAYER shall have the right to bring and control any such action by
counsel of its own choice, and CVT shall have the right to be represented in any
such action by counsel of its own choice at its own expense. If one PARTY
brings any such action or proceeding, the other PARTY agrees to be joined as a
party plaintiff if necessary to prosecute the action and to give the first PARTY
reasonable assistance and authority to file and prosecute the suit. No
settlement or consent judgment or other voluntary disposition of a suit brought
by a PARTY under this section may be entered into without the written consent of
the other PARTY if such settlement would adversely affect the other PARTY's
interests, which consent shall not be unreasonably withheld.
[ ]
19.
[ ].
8.4 THIRD PARTY CLAIMS AGAINST CVT PATENTS
If a THIRD PARTY asserts that a patent or other right owned by it is
infringed by the use of CVT KNOW HOW or by the manufacture, use, sale, offer for
sale or import of COMPOUND and/or PRODUCT, the PARTY first obtaining knowledge
of such a claim shall immediately provide the other PARTY notice of such claim
and the related facts in reasonable detail. CVT shall have the primary right
and obligation to control the defense of such claims. BAYER will cooperate in
defending all such actions and shall have the right to be represented separately
by counsel of its own choice. If CVT fails to bring an action or proceeding
within a period of ninety (90) days after having knowledge of infringement of a
CVT PATENT, BAYER shall have the right to bring and control any such action by
counsel of its own choice, and CVT shall have the right to be represented in any
such action by counsel of its own choice at its own expense. If one PARTY
brings any such action or proceeding, the other PARTY agrees to be joined as a
party plaintiff if necessary to prosecute the action and to give the first PARTY
reasonable assistance and authority to file and prosecute the suit. No
settlement or consent judgment or other voluntary disposition of a suit under
this section may be entered into without the written consent of the other PARTY
if such settlement would adversely affect the other PARTY's interests, which
consent shall not be unreasonably withheld.
20.
[
]
9. CONFIDENTIALITY
9.1 CONFIDENTIALITY; EXCEPTIONS.
(a) Except to the extent expressly authorized by this Agreement
or otherwise agreed in writing, the PARTIES agree that, during the term of this
Agreement and five (5) years, thereafter, the receiving PARTY shall keep
confidential and shall not publish or otherwise disclose or use for any purpose,
other than as provided for in this Agreement, any CONFIDENTIAL INFORMATION
furnished to it by the other PARTY.
(b) The restrictions shall not apply to the extent that it can
be established by the receiving PARTY that such CONFIDENTIAL INFORMATION:
(i) was already known to the receiving PARTY, other than under
an obligation of confidentiality, at the time of disclosure by the other PARTY;
(ii) was generally available to the public or otherwise part of
the public domain at the time of its disclosure to the receiving PARTY;
21.
(iii) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act or
omission of the receiving PARTY in breach of this Agreement; or
(iv) was disclosed to the receiving PARTY, other than under
an obligation of confidentiality, by a THIRD PARTY who had no obligation to the
disclosing PARTY not to disclose such information to others.
9.2 AUTHORIZED DISCLOSURE
Each PARTY may disclose CONFIDENTIAL INFORMATION hereunder to the extent
such disclosure is reasonably necessary in filing or prosecuting patent
applications, prosecuting or defending litigation, complying with applicable
governmental regulations or conducting preclinical or clinical trials, provided
that if a PARTY is required by law or regulation to make any such disclosure of
the other PARTY's CONFIDENTIAL INFORMATION it will, except where impracticable
for necessary disclosures, (for example, in the event of medical emergency),
give reasonable advance notice to the other PARTY of such disclosure requirement
and, except to the extent inappropriate in the case of PATENT applications, will
use its reasonable efforts to secure confidential treatment of such CONFIDENTIAL
INFORMATION required to be disclosed and to minimize the extent of such
disclosure. Each PARTY also may disclose to its collaborators according to Art.
2.4, under confidentiality obligations, CONFIDENTIAL INFORMATION developed by
such PARTY during the course of this collaboration.
22.
9.3 PUBLICATIONS BY CVT
Contrary to Art. 9.1 and 9.2, CVT may publish the results developed earlier
than the enforcement of this Agreement so long as such publication will not
disclose confidential information regarding this Agreement. CVT will provide
BAYER with a draft of any intended publication 90 days in advance of such
publication to allow BAYER to identify any such confidential information and
will delete from any proposed publication such relevant confidential:
information as may be identified by BAYER.
If BAYER identifies a strategic interest, not to publish certain results or
the intended publication in total, BAYER will have the right to refuse such
publication, which BAYER confirms not to request unreasonably.
BAYER will be free to publish all results and information it deems
necessary to support the project and to provide COMPOUNDS and PRODUCT.
10. TERM AND TERMINATION
10.1 TERM OF AGREEMENT
This Agreement shall commence as of the EFFECTIVE DATE and, unless sooner
terminated as provided herein, shall continue in effect until the expiration of
the last to expire CVT PATENT licensed under this Agreement or after ten (10)
year's marketing of the first PRODUCT [ ] according to Art. 4.4,
whichever is later.
23.
10.2 TERMINATION AT BAYER'S DISCRETION
Giving 30 (thirty) days written notice to CVT, BAYER may terminate this
Agreement for any reason in its sole discretion, at any time, especially if
there is no exclusivity according to Article 4.5 and/or according to Article
2.2.2.
BAYER may invite CVT to discuss BAYER's reasons for its intent to
terminate the Agreement and to allow CVT to give scientific and/or technical
input to avoid such termination.
Upon termination of the activities by BAYER, CVT would like to have a
royalty-bearing grant-back option. Terms for this would be negotiable in
good faith, at due time, taking into account the relative contribution of
BAYER and CVT. Any such grant-back should also allow BAYER the first right
to negotiate for products based on BAYER's activities under this Agreement
which may subsequently be developed by CVT or a partner of CVT.
24.
10.3 TERMINATION OF BREACH
10.3.1 BREACH BY CVT
If CVT materially breaches this Agreement at any time, and has not cured
such breach within ninety (90) days after written notice thereof from BAYER, or,
if such breach is not curable within such ninety day period, CVT fails to use
diligent and continuing efforts to cure such breach, then [
].
10.3.2 BREACH BY BAYER
If BAYER materially breaches this Agreement at any time, and has not cured
such breach within ninety (90) days after written notice thereof from CVT, or,
if such breach is not curable within such ninety day period, BAYER fails to use
diligent and continuing efforts to cure such breach, then (a) [
] and (b) [
].
25.
10.3.3 The breaching PARTY hereby authorizes, transfers and assigns
to the non-breaching PARTY the right to prosecute, maintain and defend all
PATENTS licensed hereunder in the event of such uncured breach. The breaching
PARTY shall be liable for any damages resulting from its breach, costs and
attorney's fees, and the non-breaching PARTY shall be relieved from its
obligations under this Agreement except as provided in Art. 10.5.
10.4 TERMINATION FOR OTHER REASONS
In the event either PARTY shall:
(a) become insolvent or bankrupt;
(b) make an assignment for the benefit of its creditors;
(c) appoint a trustee or receiver for itself for all or a
substantial part of its property;
(d) have any case of proceeding commenced or other action taken
by or against itself in bankruptcy;
(e) seek liquidation, dissolution, a winding-up arrangement,
composition or readjustment of its debts;
(f) seek any other relief under any bankruptcy, insolvency,
reorganization or other similar or law of any jurisdiction, now or hereafter in
effect; or
26.
(g) have issued against itself a warrant of attachment,
execution, distraint or similar process against any substantial part of its
property of the other PARTY;
then within sixty (60) days of the event, the other PARTY may, at its sole
option, either
(i) terminate this Agreement upon thirty (30) days written
notice to the other PARTY; or
(ii) continue the performance of this Agreement thereafter.
10.5 SURVIVING RIGHTS
The following provisions of this Agreement shall survive termination of
this Agreement, in addition to any provisions which survive by their terms:
Articles 1, 8, 9, 13, 14.
10.6 ACCRUED RIGHTS: SURVIVING OBLIGATIONS
Termination, relinquishment or expiration of the Agreement for any reason
shall be without prejudice to any rights which shall have accrued to the benefit
of either PARTY prior to such termination, relinquishment or expiration,
including damages arising from any breach hereunder. Such termination,
relinquishment or expiration shall not relieve either PARTY from obligations
27.
which are expressly indicated to survive termination or expiration of the
Agreement.
11. DISPUTE RESOLUTION
11.1 DISPUTES
The PARTIES recognize that disputes as to certain matters may from time to
time arise during the term of this Agreement which relate to either PARTY's
rights and/or obligations hereunder. The PARTIES shall follow the procedures
set forth in this Article 11.1 to facilitate the resolution of disputes arising
under this Agreement in an expedient manner by mutual cooperation and to attempt
to avoid litigation between the PARTIES.
In the event the PARTIES are not able to resolve such dispute within such
60-day period, either PARTY may then invoke any other remedies available to it
in law or equity. Any dispute or controversy arising out of or related to this
Agreement which is not resolved between the PARTIES shall be submitted to a
United States federal court located in the County of Santa Clara, California.
The PARTIES hereby consent to the jurisdiction of the State of California.
28.
12. REPRESENTATIONS AND WARRANTIES; EXCLUSIVITY
12.1 REPRESENTATIONS AND WARRANTIES
Each PARTY hereby represents and warrants to the other that this Agreement
is a legal and valid obligation binding upon such PARTY and enforceable in
accordance with its terms. The execution, delivery and performance of and the
rights granted under this Agreement by such PARTY does not conflict with any
agreement, instrument or understanding, written or oral, to which it is a PARTY
or by which it is bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having jurisdiction over it.
12.2 PERFORMANCE BY AFFILIATES
The PARTIES recognize that each may perform some or all of its obligations
under this Agreement through AFFILIATES, provided, however, that each PARTY
shall remain responsible and be guarantor of the performance by such AFFILIATES
and shall cause such AFFILIATES to comply with the provisions of this Agreement
in connection with such performance. Each PARTY waives any obligation on the
other PARTY to seek performance by such PARTY's AFFILIATE before the other PARTY
may enforce the foregoing guaranty.
29.
13. PRODUCTS LIABILITY AND INDEMNIFICATION
13.1 INDEMNIFICATION FOR SALES OF PRODUCTS
With respect to PRODUCTS, BAYER hereby agrees to defend, indemnify, and
hold harmless CVT and its directors, officers, employees, and agents from and
against any and all suits, claims, actions, demands, liabilities, damages,
costs, expenses and/or loss, including reasonable legal expenses and attorney's
fees ("Losses"), resulting directly or indirectly from the manufacture, use,
handling, storage, sale or other disposition of such PRODUCTS by BAYER, or its
agents or sublicensees. In the event that CVT seeks indemnification under this
Section 13.1, it shall inform BAYER of such claim as soon as practicable after
it receives notice of the claim, shall permit BAYER to assume direction and
control of the defense of the claim (including the right to settle the claim
solely for monetary consideration), and shall cooperate as requested in the
defense of the claim.
13.2 INDEMNIFICATION FOR NEGLIGENCE
Each PARTY hereby agrees to defend, indemnify, and hold harmless the other
PARTY and its directors, officers, employees, and agents from and against any
and all losses resulting directly or indirectly from the indemnifying PARTY's
negligence.
30.
14. MISCELLANEOUS
14.1 ASSIGNMENT.
(a) Either PARTY may assign any of its rights or obligations
under this Agreement to any AFFILIATES; provided, however, that such assignment
shall not relieve the assigning PARTY of its responsibilities for performance of
its obligations under this Agreement.
(b) CVT may not assign its rights or obligations under this
Agreement or its ownership interest in CVT PATENTS to a non-AFFILIATE without
the prior written consent of BAYER, which consent shall not be unreasonably
withheld, except that CVT may assign this Agreement and its interests in CVT
PATENTS in connection with any merger, consolidation, or sale of all or
substantially all of its assets.
(c) This Agreement shall be binding upon and inure to the
benefit of the successors and permitted assigns of the PARTIES. Any assignment
not in accordance with this Agreement shall be void.
14.2 CHANGE IN CONTROL OF CVT.
(a) In the event that (i) CVT is acquired by another entity by
reason of merger, consolidation or sale of all or substantially all of its
assets (except for a reorganization transaction in which the persons who held
majority ownership of CVT prior to the transaction continue to hold
31.
majority ownership of CVT, directly or through a parent company, after the
transaction) or (ii) a single entity other than BAYER or an AFFILIATE of BAYER
acquires ownership of a majority of the outstanding voting stock of CVT, this
Agreement shall survive. A change in control shall not be deemed to be an
assignment under Section 14.1.
14.3 CONSENTS NOT UNREASONABLY WITHHELD
Whenever provision is made in this Agreement for either PARTY to secure the
consent or approval of the other, that consent or approval shall not
unreasonably be withheld or delayed, and whenever in this Agreement provision is
made for one PARTY to object to or disapprove a matter, such objection or
disapproval shall not unreasonably be exercised.
14.4 TERMINATION OF PRIOR AGREEMENT
This Agreement supersedes all previous confidentiality agreements between
the PARTIES and their respective AFFILIATES. All confidential information
exchanged between the PARTIES and their respective AFFILIATES under such
agreements shall be deemed CONFIDENTIAL INFORMATION and shall be subject to the
terms of Article 9.
32.
14.5 FORCE MAJEURE
Neither PARTY shall use any rights hereunder or be liable to the other
PARTY for damages or losses on account of failure of performance by the
defaulting PARTY if the failure is occasioned by government action, war, fire,
explosion, flood, strike, lockout, embargo, act of God, or any other similar
cause beyond the control of the defaulting PARTY, provided that the PARTY
claiming force majeure has exerted all reasonable efforts to avoid or remedy
such force majeure; provided, however, that in no event shall a PARTY be
required to settle any labor dispute or disturbance.
14.6 FURTHER ACTIONS
Each PARTY agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be necessary or appropriate
in order to carry out the purposes and intent of this Agreement.
14.7 NOTICES
All notices hereunder shall be in writing and shall be deemed given if
delivered personally or by facsimile transmission (receipt verified), telexed,
mailed by registered or certified mail (return receipt requested), postage
prepaid, or sent by express courier service, to the PARTIES at the following
addresses (or at such other address for a PARTY as shall be specified by like
notice; provided, that notices of a change of address shall be effective only
upon receipt thereof):
33.
If to CVT, addressed to:
CV Therapeutics, Inc.
0000 Xxxxxx Xxxxx
Xxxx Xxxx, XX 00000
Attention: Chief Executive Officer
Telephone: (000) 000-0000
Telecopy: (000) 000-0000
With copy to:
XXXXXX GODWARD XXXXXX XXXXXXXXX & XXXXX
Five Xxxx Xxxx Xxxxxx, 0xx Xxxxx
Xxxx Xxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxxx, Esq.
Telephone: (000) 000-0000
Telecopy: (000) 000-0000
If to BAYER, addressed to:
regarding research aspects
34.
Xxxxx XX
PH-R, Cardiovascular
D-42096 Wuppertal
Federal Republic of Germany
[
]
regarding contractual aspects
Xxxxx XX
Licensing and Technical Cooperation
X-00000 Xxxxxxxxxx
Xxxxxxx Xxxxxxxx of Germany
[
]
and
Xxxxx XX
Pharma-Business Planning
and Administration
International Cooperation and Licensing
X-00000 Xxxxxxxxxx
Xxxxxxx Xxxxxxxx of Germany
[
]
35.
14.8 WAIVER
Except as specifically provided for herein, the waiver from time to time by
either of the PARTIES of any of their rights or their failure to exercise any
remedy shall not operate or be construed as a continuing waiver of same or of
any other of such PARTY's fights or remedies provided in this Agreement.
14.9 SEVERABILITY
If any term, covenant or condition of this Agreement or the application
thereof to any PARTY or circumstance shall, to any extent, be held to be invalid
or unenforceable, then
(i) the remainder of this Agreement, or the application of such term,
covenant or condition to PARTIES or circumstances other than those as to which
it is held invalid or unenforceable, shall not be affected thereby and each
term, covenant or condition of this Agreement shall be valid and be enforced to
the fullest extent permitted by law; and
(ii) the PARTIES hereto covenant and agree to renegotiate any such term,
covenant or application thereof in good faith in order to provide a reasonably
acceptable alternative to the term, covenant or condition of this Agreement or
the application thereof that is invalid or unenforceable, it being the intent of
the PARTIES that the basic purposes of this Agreement are to be effectuated.
36.
14.10 COUNTERPARTS
This Agreement may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and
the same instrument.
14.11 PRESS RELEASES
The PARTIES agree that the specific material economic and specific material
terms of the transaction and the principle shall be kept confidential and shall
not be disclosed without the prior written consent of both PARTIES, subject to
standard exceptions for disclosure of CONFIDENTIAL INFORMATION set forth in the
Agreement and except: (i) as required in financial statements to comply with
generally accepted accounting principles (as determined by the disclosing
PARTY's independent auditors), (ii) by CVT to potential investors in connection
with public and private financing of CVT, and (iii) as mutually agreed.
37.
14.12 ENTIRE AGREEMENT
This Agreement sets forth all the covenants, promises, agreements,
warranties, representations, conditions and understandings between the PARTIES
hereto and supersedes and terminates all prior agreements and understanding
between the PARTIES. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between
the PARTIES other than as set forth herein and therein. No subsequent
alteration, amendment, change or addition to this Agreement shall be binding
upon the PARTIES hereto unless reduced to writing and signed by the respective
authorized officers of the PARTIES.
14.13 GOVERNING LAW
Resolution of all disputes arising out of or related to this Agreement or
the performance, enforcement, breach or termination of this Agreement and any
remedies relating thereto, shall be governed by and construed under the
substantive laws of the State of California, as applied to Agreements executed
and performed entirely in the State of California by residents of the State of
California, without regard to conflicts of law rules and excluding the United
Nations Convention on Sale of Goods.
38.
IN WITNESS WHEREOF, the PARTIES have executed this Agreement in duplicate
originals by their proper officers as of the date and year first above written.
Palo Alto Leverkusen
Date: 5/2/96 Date: 14.05.1996
CVT Therapeutics, Inc. XXXXX XX
/s/ Xxxxx X. Xxxxx /s/
[
]
39.
Annex 1
Preparation and Culture of [ ] Cells Producing [ ]
This protocol reviews the methodology for generating a novel cell line
capable of synthesizing [ ].
The starting cell structure was [ ] cells isolated from [
] the basal media used throughout consists of
Dulbecco's Modified Eagle's Medium (DME/low) mixed [ ] with [
] penicillin, [ ] streptomycin, [ ]
insulin [ ] transferring. [ ] the medium is
supplemented with [ ].
[ ] cell cultures are cultured in [ ] tissue culture
dishes. [ ] is dissolved in [
] to give a final concentration of [ .
] in the laminar flow hood and then [
]. The dishes can be used immediately or stored under sterile
conditions.
The methodology for generating [ ] was derived from the
technique of [
.]
40.
Primary cultures of [ ] were grown to [ ] confluency in
10 cm dishes, detached via [ ] and passed to
[
]. The cells were [
].
[ ]Used:
Classification:[ ]
Agent:[ ]
Strain:[ ]
Original source:[
]
Commercial source: [ ]
The cultures were fed and observed for [ ] at which time colonies of
cells appeared, these were detached and replated after Dilution. Colonies
were then isolated with cloning rings and passaged separately. Cell line
[ ] was found to grow in a monolayer with [ ]. It
is confluent in [ ] at a [ ] subculture. It displays biochemical and
histochemical characteristics of [ ] including positive assays for
[ ] and [ ]. It demonstrates [
].
[ ] is unique for its capacity to specifically produce [
].
41.
[
]:
[
]
As little as [ ] of conditioned medium yields a [ ] fraction
whose [ ] activity for [ ] is equivalent to the maxiumum [
] response to [ ] activity is detected in
the medium by [ ] provides the
best yields. Cells grown in [ ] produce [ ]
constitutively because they [ ] results in
continued, but slower, growth, with no production of [
].
42.
Annex 2
CVT PATENTS means:
patent status + full text of the patent applications.
43.
