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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
EXHIBIT 10.40
OPTION AND LICENSE AGREEMENT
This Agreement ("Agreement") is entered into as of the 6th day of
July, 1998, by and between RIBOGENE, INC., a corporation organized under the
laws of Delaware ("RiboGene"), and XXXXXXX PHARMACEUTICAL CORPORATION
("Xxxxxxx"), a corporation organized under the laws of New Jersey.
RECITALS
WHEREAS, RiboGene has conducted research and development with an
intranasally administered pharmaceutical product containing metoclopramide as an
active ingredient for the treatment of delayed onset emesis and other
indications, and owns certain patents relating thereto; and
WHEREAS, Xxxxxxx is interested in completing the development of
RiboGene's product as a contract research organization for RiboGene, and desires
to obtain an exclusive option for obtaining a license to market said product
after regulatory approvals have been obtained;
WHEREAS, RiboGene and Xxxxxxx have entered into that certain Series A
Preferred Stock Purchase Agreement, dated as of the date hereof, (the "Purchase
Agreement"), pursuant to which Xxxxxxx will purchase 1,428,572 shares of Series
A Convertible Non-voting Preferred Stock of RiboGene (the "Stock Purchase");
NOW, THEREFORE, in consideration of the foregoing and the covenants
and promises contained herein, and subject to the Closing of the Stock Purchase,
the parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "Affiliate" shall mean (i) any corporation or other entity
("Parent") which directly or indirectly owns or controls at least fifty percent
(50%) of the outstanding voting securities of a party, (ii) any corporation or
other entity in which a party owns or controls at least fifty percent (50%)
equity interest, and (iii) any corporation or other entity in which a Parent of
a party owns or controls at least a fifty percent (50%) equity interest.
1.2 "Allowable Expenses" shall mean the pre-existing third party
commitments and any patent and trademark costs in the Territory incurred by
RiboGene relating to the Product, an estimate of which is contained in Exhibit
A.
1.3 "Closing" shall have the meaning specified in the Purchase
Agreement.
1.4 "Collaboration Know-How" shall mean all inventions, discoveries,
materials and information developed by either party relating to the Product
during the term of this Agreement. Collaboration Know-How shall not include
Collaboration Patents.
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1.5 "Collaboration Patents" shall mean any and all patents, including,
without limitation, any substitutions, extensions, reissues, renewals,
supplementary protection certificates and inventors' certificates, which have
not been held invalid or unenforceable by a non-appealable or non-appealed
decision of a court of competent jurisdiction, issuing from patent applications
filed in any jurisdiction, including, without limitation, any provisionals,
divisionals, continuations, and continuations-in-part, which cover inventions or
discoveries made by either party alone or both parties jointly relating to the
Product during the term of this Agreement.
1.6 "Collaboration Technology" shall mean all Collaboration Patents
and Collaboration Know-How.
1.7 "Confidential Information" shall mean a party's confidential
information, including, without limitation, Xxxxxxx Know-How, RiboGene Know-How,
Collaboration Know-How, Development Programs, engineering designs and drawings,
research data, manufacturing processes and techniques, scientific,
manufacturing, marketing, and business plans, financial or personnel matters
relating to the party, its present or future products, sales, suppliers,
customers, employees, investors or business.
1.8 "Development Program" shall mean the program of preclinical and
clinical development activities relating to the Product undertaken by Xxxxxxx
pursuant to this Agreement.
1.9 "Effective Date" shall mean the date on which the Closing occurs,
as defined in the Purchase Agreement.
1.10 "FDA" shall mean the United States Food and Drug Administration.
1.11 "Field" shall mean therapeutic treatment of delayed onset emesis
and any other conditions or diseases in humans.
1.12 "NDA" shall mean the approval required by the FDA or an
equivalent non-U.S. authority required for the marketing and sale of the Product
in the Territory.
1.13 "Net Sales" shall mean the gross invoice price of the Product
sold in the Territory by Xxxxxxx, its Affiliates or sublicensees to an
independent third party after deducting, if not already deducted in the amount
invoiced (a) trade, quantity and cash discounts actually taken, (b) returns,
rebates, chargebacks and allowances made or granted, and (c) transportation and
insurance charges separately billed. With respect to sales of combination
products consisting of metoclopramide combined with one or more additional
active ingredients, the parties will agree on a method of allocation in the
event the situation arises. Sales among Xxxxxxx and its Affiliates or
sublicensees shall not be deemed Net Sales. The Product shall be considered sold
when invoiced by Xxxxxxx.
1.14 "Product" shall mean a pharmaceutical product containing
metoclopramide as an active ingredient formulated for intranasal delivery.
1.15 "RiboGene Know-How" shall mean all inventions, discoveries,
materials and information (i) which RiboGene owns, controls or has a license
(with a right to sublicense) as of
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the Effective Date or which arise outside the Development Program during the
term of this Agreement, and (ii) which are necessary or useful for the conduct
of the Development Program, or the manufacture, use or sale of the Product.
RiboGene Know-How shall not include RiboGene Patents.
1.16 "RiboGene Patents" shall mean the patents listed in Exhibit B and
any and all patents other than Collaboration Patents, including, without
limitation, any substitutions, extensions, reissues, renewals, supplementary
protection certificates and inventors' certificates, which have not been held
invalid or unenforceable by a non-appealable or non-appealed decision of a court
of competent jurisdiction, issuing from patent applications filed in any
jurisdiction, including, without limitation, any provisionals, divisionals,
continuations, continuations-in-part, which (i) RiboGene owns, controls or has a
license to (with the right to sublicense) as of the Effective Date, and (ii)
would be infringed by the conduct of the Development Program, or the
manufacture, use or sale of the Product.
1.17 "RiboGene Technology" shall mean the RiboGene Patents and the
RiboGene Know-How.
1.18 "Regulatory Approval(s)" shall mean shall mean all new drug
approvals, marketing approvals, applications, licenses, permits, and other
authorizations, which are required for manufacturing and selling the Product in
compliance with applicable laws in the Territory.
1.19 "Regulatory Authority" shall mean the competent government
regulatory authority responsible for granting the Regulatory Approvals in a
country of the Territory.
1.20 "Xxxxxxx Know-How" shall mean all inventions, discoveries,
materials and information (i) which Xxxxxxx owns, controls or has a license to
(with a right to sublicense) as of the Effective Date or which arise outside of
the Development Program from time to time during the term of this Agreement, and
(ii) which are necessary or useful for the conduct of the Development Program,
or the manufacture, use or sale of the Product. Xxxxxxx Know-How shall not
include Xxxxxxx Patents.
1.21 "Xxxxxxx Patents" shall mean any and all patents other than
Collaboration Patents, including, without limitation, any substitutions,
extensions, reissues, renewals, supplementary protection certificates and
inventors' certificates, which have not been held invalid or unenforceable by a
non-appealable or non-appealed decision of a court of competent jurisdiction,
issuing from patent applications filed in any jurisdiction, including, without
limitation, any provisionals, divisionals, continuations, continuations-in-part,
which (i) Xxxxxxx owns, controls or has a license to (with the right to
sublicense) as of the Effective Date, and (ii) would be infringed by the conduct
of the Development Program, or the manufacture, use or sale of the Product.
1.22 "Xxxxxxx Technology" shall mean the Xxxxxxx Patents and the
Xxxxxxx Know-How.
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1.23 "Steering Committee" shall mean the committee established by the
parties pursuant to Section 2.1.
1.24 "Territory" shall mean in the United States, its commonwealth and
possessions, Canada and Mexico.
1.25 "Trademark" shall mean Emitasol(R).
ARTICLE 2
PRODUCT DEVELOPMENT
2.1 STEERING COMMITTEE.
(a) Formation of Steering Committee. Promptly after the Effective
Date, the parties shall establish the Steering Committee. The Steering Committee
shall consist of an equal number of members from Xxxxxxx and RiboGene, appointed
and substituted by each party as necessary from time to time. Each member shall
have appropriate technical credentials and knowledge and ongoing familiarity
with the Development Program. All decisions of the Steering Committee shall be
unanimous.
(b) Meetings of Steering Committee. The Steering Committee shall
meet quarterly or at such other intervals as shall be agreed between the
parties, and at such times as shall be mutually agreed upon by the parties and
at a site alternating between RiboGene's and Xxxxxxx'x place of business, or as
otherwise mutually agreed.
(c) Responsibilities of the Steering Committee. The Steering
Committee shall establish the Development Program for the Product aimed at
developing and commercializing the Product in all possible indications in all
countries of the Territory. The Steering Committee shall monitor the progress of
the Development Program and may revise it as necessary to achieve the overall
goal of developing the Product as quickly as commercially feasible, and
maximizing the commercial potential of the Product.
2.2 CONDUCT OF THE DEVELOPMENT PROGRAM.
(a) Xxxxxxx will conduct the Development Program under the
direction of the Steering Committee. Xxxxxxx shall keep the Steering Committee
fully informed on a reasonable basis of the development of the Product,
including but not limited to periodic written updates on the progress of each
filing with a Regulatory Authority.
(b) In performing the Development Program, Xxxxxxx shall devote
the same degree of attention, resources and diligence to the preclinical and
clinical development of the Product as it devotes to its own high priority
compounds and products. In particular, Xxxxxxx undertakes to diligently conduct
clinical trials and to apply for Regulatory Approval of the Product in each
country of the Territory within [ * ] from the Effective Date. If Xxxxxxx has
not filed an NDA or its foreign equivalent in a country of the Territory within
[ * ] from the Effective Date, Xxxxxxx' option granted under Section 4.1 shall
be deemed to
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have expired in such country, and such country shall be excluded from the
Territory. Should an action of a Regulatory Authority outside of Xxxxxxx'
control give rise to a reasonable basis to extend the aforesaid [ * ] period,
meaning that it is reasonable to expect that Xxxxxxx acting with commercially
reasonable diligence shall not have applied for Regulatory Approval as
aforesaid, an extension of time will be provided to enable Xxxxxxx to complete
the Development Plan and the parties shall negotiate in good faith and arrive at
a reasonable period of extension.
(c) All regulatory filings shall be made in the name of RiboGene,
and any Regulatory Approvals granted thereon shall be transferred to Xxxxxxx
upon exercise of the option as set forth in Section 4.2.
2.3 MANUFACTURE FOR DEVELOPMENT. Xxxxxxx shall be responsible for
obtaining supplies of the Product in quantities necessary for performing the
preclinical and clinical development activities under the Development Program.
2.4 ACCESS AND USE OF INFORMATION. RiboGene shall have the right to
use all data obtained in the studies, all filings made, and all Regulatory
Approvals obtained by Xxxxxxx in the Territory, and shall have the right to
reference any such data, any regulatory filings and Regulatory Approvals for
inclusion in regulatory submissions such as filings for Regulatory Approvals for
the Product outside of the Territory.
2.5 DEVELOPMENT FUNDING. RiboGene shall fund the preclinical and
clinical studies conducted by Xxxxxxx under the Development Program, and pay the
Allowable Expenses up to an amount of seven million dollars ($7,000,000)
("Development Funds"). Any costs of activities to be performed under the
Development Program and any Allowable Expenses in excess of the Development
Funds shall be funded by Xxxxxxx. Payments by RiboGene shall be made on a
contract research basis in accordance with a development budget and schedule
established by the Steering Committee in the Development Program.
2.6 [ * ] If at any time during the term of this Agreement and prior
to the exercise of the option by Xxxxxxx pursuant to Section 4.2 below [ * ].
The [ * ] RiboGene at the time when [ * ] or upon the first Regulatory Approval
of the Product. If necessary to pay for the preclinical and clinical studies
under the Development Program or the Allowable Expenses, [ * ] the budget and
payment schedule contained in the Development Program or the due date of the
payments for Allowable Expenses.
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ARTICLE 3
OWNERSHIP OF INTELLECTUAL PROPERTY AND LICENSES
3.1 XXXXXXX TECHNOLOGY. RiboGene acknowledges and agrees that Xxxxxxx
is and shall remain the sole owner of the Xxxxxxx Technology and that RiboGene
has no rights in or to any of it other than the license and rights specifically
granted herein and the licenses granted pursuant to this Agreement.
3.2 RIBOGENE TECHNOLOGY. Xxxxxxx acknowledges and agrees that RiboGene
is and shall remain the sole owner of the RiboGene Technology and that Xxxxxxx
has no rights in or to any of them other than the rights specifically granted
herein and the license to be granted pursuant to this Agreement.
3.3 COLLABORATION TECHNOLOGY. Collaboration Technology shall be owned
by either party alone or jointly with the other party depending on whether such
Collaboration Technology was developed by a party alone or jointly with the
other party. Inventorship shall be determined in accordance with the rules of
inventorship under U.S. patent laws. Neither party shall have rights to such
Collaboration Technology owned solely or jointly except as expressly granted
under this Agreement.
3.4 LICENSE GRANTS.
(a) License Grant to Xxxxxxx. As of the Effective Date, RiboGene
hereby grants to Xxxxxxx a non-royalty bearing, exclusive license under RiboGene
Technology and Collaboration Technology in the Field for the sole purpose of
conducting the Development Program. Xxxxxxx may not grant sublicenses under the
license granted in this subsection (a) except in the context of contract
research or contract development by a third party as part of the Development
Program, and then only after the prior written approval of RiboGene, which
approval shall not be unreasonably withheld. The terms of any sublicense shall
conform to the terms of this Agreement in all respects.
(b) License Grant to RiboGene. As of the Effective Date, Xxxxxxx
hereby grants to RiboGene a non-royalty bearing, non-exclusive license, with the
right to sublicense, under Xxxxxxx Technology, and a non-royalty bearing,
exclusive license, with the right to sublicense, under Collaboration Technology
to research, develop, make, have made, use, import, offer for sale and sell the
Product outside of the Territory.
3.5 TRADEMARK LICENSE. As of the Effective Date, RiboGene hereby
grants to Xxxxxxx a non-royalty bearing, exclusive license, with the right to
sublicense subject to RiboGene's prior written approval, under RiboGene's rights
in and to the Trademark for the sole purpose of developing, marketing, and
selling the Product in the Territory during the term of this Agreement. Xxxxxxx
shall use the Trademark in connection with the development, marketing, promotion
and selling of the Product. RiboGene shall file and maintain the Trademark in
all countries of the Territory. The costs of such filings and maintenance shall
be part of Allowable
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Expenses until Xxxxxxx has exercised its option pursuant to Section 4.2,
whereafter such costs shall be borne by Xxxxxxx.
ARTICLE 4
OPTION GRANT
4.1 OPTION FOR COMMERCIALIZATION LICENSE. Xxxxxxx shall have the
option to obtain an exclusive license, with the right to sublicense subject to
RiboGene's prior written approval, under RiboGene Technology and Collaboration
Technology in the Field to make, have made, use, import, offer for sale and sell
the Product in the Territory. The option shall be in effect in any particular
country of the Territory for a period beginning on the Effective Date and ending
sixty (60) days after first Regulatory Approval of the Product in that
particular country of the Territory ("Option Period").
4.2 OPTION EXERCISE. Xxxxxxx shall exercise the option by giving
RiboGene written notice prior to the expiration of the Option Period.
4.3 EXPIRY OF OPTION. If the option granted under Section 4.1 expires
under the terms of this Agreement, Xxxxxxx shall transfer to RiboGene all
information, including, without limitation, data, reports and documentation
generated by Xxxxxxx in the course of the performance of the Development Program
and all rights of Xxxxxxx in and to such information.
ARTICLE 5
COMMERCIAL TERMS
5.1 LICENSE FEE. Within [ * ] after exercising the option pursuant to
Section 4.2 above, Xxxxxxx shall pay to RiboGene a license fee of ten million
dollars ($10,000,000) ("License Fee") as follows:
(a) [ * ] of the License Fee, i.e. [ * ] if the option is
exercised following FDA Regulatory Approval of the Product for delayed onset
emesis or for an indication which permits the promotion of the Product for
treatment of the symptoms of delayed onset emesis;
(b) [ * ] of the License Fee, i.e. [ * ] if the option is
exercised following FDA Regulatory Approval of the Product for an indication
which does not permit the promotion of the Product for the treatment of the
symptoms of delayed onset emesis;
(c) [ * ] of the License Fee, i.e. [ * ] if the option is
exercised following Regulatory Approval of the Product in Canada or Mexico;
(d) In the event of a partial payment of the License Fee pursuant
to subsections (b) through (c) above, Xxxxxxx shall make additional payments
upon the occurrence of any subsequent Regulatory Approvals for an indication
which permits the promotion of the
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Product for the treatment of the symptoms of delayed onset emesis described in
subsections (a) through (c), up to and until such time as the full amount of the
License Fee has been paid;
(e) Notwithstanding the payment events described in subsections
(b) through (d) above and license fee payments made by Xxxxxxx thereunder, the
balance of the License Fee shall be due and payable (i) if gross sales generated
with the Product in the first year from the date of first commercial sale reach
or exceed [ * ]; or (ii) if the aggregate gross sales generated with the Product
reach or exceed [ * ]
5.2 ROYALTIES.
(a) Royalty Rate. Xxxxxxx shall pay to RiboGene royalties at a
rate of [ * ] of Net Sales of the Product.
(b) Royalty Term.
(i) In any country where the manufacture, use or sale of the
Product is covered by a Collaboration Patent or RiboGene Patent, royalties shall
be payable in such country until the later of (i) [ * ] from the first
commercial sale of the Product in such country and (ii) the expiration of the
last to expire of such Collaboration Patent or RiboGene Patent.
(ii) In any country where the manufacture, use or sale of
the Product is not covered by a Collaboration Patent or RiboGene Patent,
royalties shall be payable in such country until the expiration of [ * ] from
the date of first commercial sale of the Product in such country.
(c) If, due to restrictions or prohibitions imposed by national
or international authority, including but not limited to restrictions on
payments of royalties from the Territory, Xxxxxxx is unable to make the payments
of royalties as aforesaid, the parties shall consult with a view to finding a
prompt and acceptable solution and Xxxxxxx shall not be relieved of the
obligation to make such payments and will from time to time deal with such
monies as RiboGene may lawfully direct.
(d) Any and all taxes payable in connection with the payments to
be made pursuant to this Section 5.2 shall be for the account of RiboGene. In
the event that Xxxxxxx shall be required to withhold or pay any taxes in the
Territory applicable to RiboGene with respect to any such payments, Xxxxxxx
shall promptly furnish RiboGene with the respective tax receipts, or other
evidence of payment.
(e) Upon request by RiboGene, Xxxxxxx shall file on behalf of
RiboGene any tax returns which the law of the Territory may require. Such tax
returns shall be filed in accordance with RiboGene's instructions and Xxxxxxx
shall pay such taxes on RiboGene's behalf, deducting the amounts of such tax
payments from the royalty payments due pursuant to this Section 5.2.
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(f) Xxxxxxx shall reasonably assist RiboGene in obtaining a tax
credit under the applicable taxation treaties and laws, including by providing
appropriate evidence of RiboGene's payment of the withholding tax.
5.3 DUE DILIGENCE.
(a) Xxxxxxx undertakes to launch and sell the Product in each
country of the Territory within [ * ] from the date of Regulatory Approval,
including pricing approval, where applicable, in such country. Xxxxxxx shall
market and promote the Product as it markets and promotes its own products with
similar sales potential.
(b) If Xxxxxxx has not launched the Product within the time
period required under subsection (a) above, Xxxxxxx' license obtained pursuant
to the exercise of the option under Section 4.2 shall be deemed to have expired
in such country, and such country shall be excluded from the Territory. Upon
expiry of the license, Xxxxxxx shall transfer to RiboGene all Regulatory
Approvals in such country, and information, including, without limitation, data,
reports and documentation generated by Xxxxxxx in the course of the performance
of the development of the Product for such country and all rights of Xxxxxxx in
and to such information.
5.4 TERRITORIAL LIMITATION. Xxxxxxx hereby undertakes to practice the
RiboGene Technology and Collaboration Technology licensed hereunder only within
the Territory. Xxxxxxx shall not sell or distribute the Product outside of the
Territory, and shall not sell or supply the Product to any third party of whom
it knows or has reason to believe that such third party sells or supplies the
Product to customers outside of the Territory.
ARTICLE 6
PAYMENTS; RECORDS; AUDIT
6.1 ROYALTY PAYMENT AND REPORTS.
(a) Royalty amounts payable to RiboGene under Section 5.2 shall
be paid in U.S. Dollars within [ * ] of the end of each calendar quarter. Each
payment of royalties shall be accompanied by a statement of the amount of Net
Sales during such period, the amount of aggregate Net Sales to date as of the
end of such period, and the amount of royalties due on such Net Sales.
(b) For the purpose of calculating royalties on Net Sales
generated in currencies other than U.S. dollars, such Net Sales shall be
converted into U.S. dollars at the rate of exchange as quoted in the Wall Street
Journal on the last business day of the relevant calendar quarter. All royalty
payments owed under this Agreement shall be made by means of wire transfer to
RiboGene's account in a bank in the United States to be designated by RiboGene.
6.2 RECORDS AND AUDIT.
(a) During the term of this Agreement and for a period of [ * ]
thereafter, Xxxxxxx shall keep complete and accurate records pertaining to the
sale or other
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disposition of the Product commercialized by it, in sufficient detail to permit
RiboGene to confirm the accuracy of all payments due hereunder.
(b) RiboGene shall have the right to cause an independent,
certified public accountant to audit such records to confirm Xxxxxxx'x Net Sales
and royalty payments; provided, however, that such auditor shall not disclose
Xxxxxxx'x confidential information to RiboGene, except to the extent such
disclosure is necessary to verify the amount of royalties due under this
Agreement.
(c) Such audits may be exercised once a year, within [ * ] after
the royalty period to which such records relate, upon notice to Xxxxxxx and
during normal business hours.
(d) RiboGene shall bear the full cost of such audit unless such
audit discloses a variance of more than [ * ] from the amount of the Net Sales
or royalties previously paid. In such case, Xxxxxxx shall bear the full cost of
such audit. The terms of this Section 6.2 shall survive any termination or
expiration of this Agreement for a period of [ * ]
(e) OVERDUE PAYMENTS. If RiboGene does not receive payment of any
sum payable under this Agreement on the date it is due, simple interest shall
thereafter accrue on the sum due to RiboGene until the date of payment at the
per annum rate of [ * ]
ARTICLE 7
PATENT PROSECUTION AND DEFENSE
7.1 PATENT PROSECUTION AND MAINTENANCE.
(a) RiboGene shall maintain the RiboGene Patents during the term
of this Agreement. The costs of such maintenance shall be part of Allowable
Expenses until Xxxxxxx has exercised its option pursuant to Section 4.2,
whereafter such costs shall be borne by Xxxxxxx.
(b) Xxxxxxx shall be responsible for filing and prosecuting
applications for Collaboration Patents and for maintaining Collaboration Patents
owned solely by either party or jointly by the parties in the Territory. Xxxxxxx
shall consult with RiboGene as to the selection of countries in which to file
applications for such Collaboration Patents. Xxxxxxx shall be responsible for
bearing the cost of filing and prosecuting applications for Collaboration
Patents and of maintaining Collaboration Patents in the Territory. In the event
that Xxxxxxx decides not to proceed with prosecuting an application for a
Collaboration Patent, it shall give RiboGene [ * ] notice before any relevant
deadline, and RiboGene shall have the right to pursue, at its own expense,
prosecution of such patent application or maintenance of such patent, and such
patent shall be excluded from the licenses granted herein or in the License
Agreement.
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(c) Each party agrees to cooperate with the other and take all
reasonable additional actions and execute such agreements, instruments, and
documents as may be reasonably required to prosecute patent applications as
provided in this section, and to perfect the other's ownership interest in
Collaboration Patents as allocated in Article 3, including, without limitation,
the execution of necessary and appropriate instruments of assignment.
7.2 INFRINGEMENT OF PATENTS BY THIRD PARTIES.
(a) Notice. Each party shall promptly notify the other in writing
of any alleged or threatened infringement of RiboGene Patents, Xxxxxxx Patents,
or Collaboration Patents which may adversely impact the rights of the parties
hereunder.
(b) Xxxxxxx Patents and RiboGene Patents.
(i) The party which is the holder of Xxxxxxx Patents or
RiboGene Patents, respectively, shall have the right, but not the obligation, to
bring an appropriate action against any person or entity directly or
contributorily infringing its patents. If the patent holder brings an action
against an alleged infringer, the other party shall cooperate reasonably with
the patent holder in any such efforts.
(ii) Any recovery obtained by the patent holder as a result
of such action, whether obtained by settlement or otherwise, shall be disbursed
as follows: first, each party shall be reimbursed for any reasonable expenses
incurred in bringing or assisting in such action (including counsel fees). If
the infringement was made by a third party product which competed with the
Product in the Territory, the remaining proceeds shall be added to Net Sales. In
the event of any other kind of infringement, the remaining proceeds shall
retained by the patent holder.
(iii) No settlement, compromise or other disposition of any
such action which compromises a party's rights under this Agreement shall be
entered into without such party's prior consent, which shall not be unreasonably
withheld.
(c) Collaboration Patents.
(i) If a Collaboration Patent is infringed in the Territory,
Xxxxxxx shall have the right to bring, at its own expense, an appropriate action
against any person or entity directly or contributorily infringing such
Collaboration Patent. In such event, RiboGene shall cooperate reasonably with
Xxxxxxx in any such action, including if required to bring such action, the
furnishing of a power of attorney.
(ii) In the event Xxxxxxx fails to institute an infringement
suit or take other reasonable action to protect the relevant Collaboration
Patent, RiboGene shall have the right, upon [ * ] of notification of Xxxxxxx, to
institute such suit or take other appropriate action at its own expense in its
own name, the joint owners' name, or both. In such event, Xxxxxxx hereby agrees
to cooperate reasonably with RiboGene in any such effort, including if required
to bring such action, the furnishing of a power of attorney.
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(iii) Regardless of which party brings the action, any
recovery obtained by settlement or otherwise shall be disbursed as follows: the
party bringing such action shall first ensure that any reasonable expenses
incurred in assisting in such action (including counsel fees) by both parties
are reimbursed. Thereafter, the party bringing such action shall ensure that the
net recovery shall be added to Net Sales.
7.3 INFRINGEMENT OF THIRD PARTY RIGHTS.
(i) Joint Strategy. In the event that the Product developed,
manufactured or sold hereunder becomes the subject of a claim for patent,
copyright or other proprietary right infringement in the Territory ("Product
Infringement Claim"), and irrespective of whether Xxxxxxx or RiboGene is charged
with said infringement, and the venue of such claim, the parties shall promptly
confer to discuss the claim. The parties shall agree on how to best defend the
Product Infringement Claim and shall designate the party who shall have primary
responsibility to conduct the defense of any Product Infringement Claim in the
Territory.
(ii) Defense. The party with primary responsibility for the
defense of a Product Infringement Claim shall keep the other party informed on
the progress and shall provide it with copies of all filings made or received in
connection with such claim. The other party shall have the right to participate
in any proceedings and to be represented by counsel of its own choice. The costs
of such defense shall be shared between the parties. Each party shall reasonably
cooperate with the party conducting the defense of the Product Infringement
Claim, including if required to conduct such defense, furnishing a power of
attorney. Neither party shall enter into any settlement that affects the other
party's rights or interests without such other party's written consent, which
consent shall not be unreasonably withheld.
7.4 PATENT MARKING. Xxxxxxx shall xxxx, if necessary, all the Product
manufactured, used or sold under the terms of this Agreement, or its containers,
in accordance with the applicable patent marking laws, as required.
ARTICLE 8
PUBLICATION; PUBLICITY
8.1 PUBLICATION.
(a) Review and Approval. Each party to this Agreement recognizes
that the publication of papers, including oral presentations and abstracts,
regarding the Collaboration Know-How and the Collaboration Patents, subject to
reasonable controls to protect Confidential Information, will be beneficial to
both parties. However, each party shall have the right to review and approve any
paper proposed for publication by the other party, including oral presentations
and abstracts, which utilizes data generated from the Development Program and/or
includes Collaboration Know-How or Confidential Information of the reviewing
party.
(b) Review and Approval Process. At least [ * ] before any such
paper is presented or submitted for publication, the party proposing publication
shall deliver a
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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complete copy to the other party. The receiving party shall review any such
paper and give its comments to the publishing party within [ * ] of the delivery
of such paper to the receiving party. With respect to oral presentation
materials and abstracts, the parties shall make reasonable efforts to expedite
review of such materials and abstracts, and shall return such items as soon as
practicable to the publishing party with appropriate comments, if any, but in no
event later than [ * ] from the delivery date thereof to the receiving party.
The publishing party shall comply with the other party's request to delete
references to such other party's Confidential Information in any such paper and
agrees to withhold publication of same in order to permit the parties to obtain
patent protection, if either of the parties deem it necessary, in accordance
with the terms of this Agreement.
8.2 PUBLICITY. Except as otherwise provided herein or required by law,
no party shall originate any publication, news release or other public
announcement, written or oral, whether in the public press, or stockholders'
reports, or otherwise, relating to the existence of or the performance under
this Agreement, without the prior written approval of the other party, which
approval shall not be unreasonably withheld, [ * ].
8.3 PRESS RELEASE. Notwithstanding any provision of this Agreement to
the contrary, promptly after the date hereof, each party may issue a press
release substantially in the form as agreed to by the parties.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 CORPORATE POWER, DUE AUTHORIZATION, BINDING AGREEMENT. Each party
hereby represents and warrants:
(a) That it is duly organized and validly existing under the laws
of the state or country of its incorporation and has full corporate power and
authority to enter into this Agreement and to carry out the provisions hereof;
(b) That it is duly authorized to execute and deliver this
Agreement and to perform its obligations hereunder;
(c) That this Agreement is a legal and valid obligation binding
upon it and is enforceable in accordance with its terms, and that the execution,
delivery and performance of this Agreement by such party does not conflict with
any agreement, instrument or understanding, oral or written, to which it is a
party or by which it may be bound, nor violate any law or regulation of any
court, governmental body or administrative or other agency having authority over
it.
9.2 INTELLECTUAL PROPERTY. Each party has the full right to grant the
licenses granted by it under this Agreement and is not aware, to the best of its
knowledge, of any claims by third parties to a conflicting ownership interest in
its solely-owned Patents.
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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9.3 RIBOGENE DISCLAIMER. THE RIBOGENE TECHNOLOGY AND COLLABORATION
TECHNOLOGY LICENSED HEREUNDER IS PROVIDED "AS IS" AND RIBOGENE EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN ALL
CASES WITH RESPECT THERETO.
ARTICLE 10
INDEMNIFICATION
10.1 INDEMNIFICATION BY RIBOGENE. RiboGene shall indemnify Xxxxxxx,
its Affiliates, and all their officers, directors, employees and agents, for any
reasonable out-of-pocket costs and expenses (including court and arbitration
costs, witness fees and reasonable attorneys' fees), non-appealed or
non-appealable judicial or arbitration damage awards, and settlement payments,
payable or owed by Xxxxxxx in connection with any demands, law suits and other
legal actions of third parties arising from (i) the performance or breach of
this Agreement by RiboGene, and (ii) any negligent actions or willful misconduct
by RiboGene, its Affiliates, agents or sublicensees.
10.2 INDEMNIFICATION UNDERTAKING BY XXXXXXX. Xxxxxxx shall indemnify
RiboGene, its Affiliates and sublicensees, and all their officers, directors,
employees and agents, for any reasonable out-of-pocket costs and expenses
(including court and arbitration costs and reasonable attorneys' fees),
non-appealed or non-appealable judicial or arbitration damage awards, and
settlement payments agreed with the third party claimants payable or owed by
RiboGene in connection with any demands, law suits and other legal actions of
third parties arising from (i) the performance or breach of this Agreement by
Xxxxxxx, (ii) any negligent actions or willful misconduct by Xxxxxxx, its
Affiliates, or agents, and (iii) the possession, manufacture, use, marketing,
promotion, distribution, sale or administration of the Product.
10.3 CONDITIONS AND LIMITATIONS OF INDEMNIFICATION OBLIGATION.
(a) In order to maintain the right to be indemnified by the other
party ("Indemnitor") for any demands, law suits and other legal actions of third
parties ("Third Party Claims") described in Sections 10.1 and 10.2 above, the
party claiming indemnification ("Indemnitee") must:
(i) notify the Indemnitor promptly after learning of a Third
Party Claim;
(ii) allow the Indemnitor to manage and control (by way of
intervention or otherwise) the defense and/or settlement of the Third Party
Claim against the Indemnitee;
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(iii) cooperate with the Indemnitor in the defense or the
settlement negotiations of any Third Party Claims for which indemnification is
sought, as reasonable required by the Indemnitor;
(iv) abstain from making any statements or taking any
actions which damage the defense against a Third Party Claim (including, without
limitation, any statements against the interest of the Indemnitee or admissions
of causation or guilt).
(b) The Indemnitor shall not agree to any settlement that
adversely affects the Indemnitee's rights or interest without the Indemnitee's
prior written approval (which approval shall not be unreasonably withheld).
(c) The Indemnitor shall have no obligation to indemnify the
Indemnitee to the extent that a Third Party Claim results from the negligence or
willful misconduct of the Indemnitee.
ARTICLE 11
CONFIDENTIALITY
11.1 DISCLOSURE OF CONFIDENTIAL INFORMATION. Confidential Information
disclosed by one party to the other pursuant to and during the term of this
Agreement shall be subject to the confidentiality obligations set forth below:
(a) if disclosed in writing and marked "confidential" or
"proprietary" by the disclosing party prior to or at the time of the disclosure
thereof, or if it would be apparent to a reasonable person, familiar with the
disclosing party's business and the industry, that such information is of a
confidential or proprietary nature; and
(b) if [ * ] after disclosure of Confidential Information, the
disclosing party informs the receiving party in writing of the confidential
nature of the disclosed information, describing such information and referencing
the place and date of the oral, visual or written disclosure and the names of
the employees or officers of the receiving party to whom such disclosure was
made.
11.2 CONFIDENTIALITY AND NON-USE. Except to the extent expressly
authorized by this Agreement or unless otherwise agreed in writing by the
parties, each party agrees that, for the combined term of this Agreement and the
Development Agreement, and for [ * ] thereafter, it shall keep confidential and
shall not publish or otherwise disclose and shall not use for any purpose other
than as provided for in this Agreement any Confidential Information, unless the
receiving party can demonstrate by competent proof that such Confidential
Information:
(a) was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure by the other party;
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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(b) was generally available to the public or otherwise part of
the public domain at the time of its disclosure to the receiving party;
(c) became generally available to the public or otherwise part of
the public domain after it disclosure and other than through any act or omission
of the receiving party in breach of such Agreements;
(d) was disclosed to the receiving party, other than under an
obligation of confidentiality to a third party, by a third party who had no
obligation to the disclosing party not to disclose such information to others;
or
(e) was independently discovered or developed by the receiving
party without the use of Confidential Information belonging to the disclosing
party.
11.3 AUTHORIZED DISCLOSURE.
(a) Each party may disclose Confidential Information belonging to
the other party to Affiliates and sublicensees who agree to be bound by similar
terms of confidentiality. In addition, each party may disclose Confidential
Information of the other party to the extent such disclosure is reasonably
necessary to: (i) comply with applicable securities laws and regulations and
other applicable governmental regulations, (ii) file or prosecute patents
relating to Collaboration Technology, (iii) prosecute or defend litigation, (iv)
file applications for Regulatory Approvals for the Product, and (vi) conduct
pre-clinical or clinical trials with the Product.
(b) Notwithstanding the foregoing, in the event a party is
required to make a disclosure of the other party's Confidential Information
pursuant to subsection (a) above, it will, except where impracticable, give
reasonable advance notice to the other party of such disclosure and use best
efforts to secure confidential treatment of such information. In any event, the
parties agree to take all reasonable action to avoid disclosure of Confidential
Information hereunder.
ARTICLE 00
XXXXXX XXX XXXXXX XXXXXXXX
00.0 XXXXXX XXXXXX LAWS. The parties understand and acknowledge that
each of them is subject to regulation by agencies of the U.S. government,
including the U.S. Department of Commerce, which prohibit export, re-export or
diversion of the Product and technology to certain countries. Any and all
obligations of Xxxxxxx or RiboGene to provide access to or license any
technology pursuant to this Agreement, as well as any technical assistance shall
be subject in all respects to such United States laws and regulations as shall
from time to time govern the license and delivery of technology and the Product
abroad by persons subject to the jurisdiction of the United States, including
the Export Administration Act of 1979, as amended, any successor or interim
controlling legislation, and the Export Administration Regulations issued by the
Department of Commerce, International Trade Administration, Bureau of Export
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Administration. Both parties also agree to comply with the requirements of the
U.S. Foreign Corrupt Practices Act (the "Act") and shall refrain from making any
payments to third parties which would cause Xxxxxxx or RiboGene to violate the
Act.
12.2 NON-UNITED STATES LAWS. Xxxxxxx and RiboGene shall each provide
the other party with such reasonable assistance as may be required for the party
requesting such assistance to comply with all non-United States laws,
ordinances, rules, regulations and the like of all governmental units or
agencies having jurisdiction pertaining to this Agreement, including without
limitation, obtaining all import, export and other permits, certificates,
licenses or the like required by such non-United States laws, ordinances, rules,
regulations and the like, necessary to permit the parties to perform hereunder
and to exercise their respective rights hereunder.
ARTICLE 13
TERM AND TERMINATION
13.1 TERM. Except as provided under Section 13.2 below, the term of
this Agreement shall commence upon the Effective Date and shall expire on the
expiration date of the last to expire royalty obligation.
13.2 TERMINATION ON MATERIAL BREACH. If either party materially
breaches the Agreement, including without limitation its due diligence
obligations under Section 2.2(b) and 5.3, and the breaching party has not cured
the breach or initiated good faith efforts to cure such breach to the reasonable
satisfaction of the non-breaching party within sixty (60) days of notice of
breach from the non-breaching party, the non-breaching party may terminate this
Agreement upon expiration of such sixty (60)-day period.
13.3 LICENSES UPON EXPIRATION OR TERMINATION.
(a) Upon expiration or termination of this Agreement, Xxxxxxx
shall have a fully paid, nonexclusive license under RiboGene Technology and
Collaboration Technology in the Field to make, have made, use, import, offer for
sale and sell the Product in the Territory.
(b) Notwithstanding subsection (a) above, if this Agreement is
terminated by RiboGene based on a material breach by Xxxxxxx, then Xxxxxxx'
license rights shall terminate and RiboGene shall have a perpetual, paid-up,
worldwide license under Xxxxxxx Technology and Xxxxxxx-owned or jointly owned
Collaboration Technology to make, have made, use, import, offer for sale and
sell the Product.
(c) If this Agreement is terminated by Xxxxxxx due to a failure
by RiboGene to pay for the performance of the Development Program conducted
under this Agreement, Xxxxxxx shall have an exclusive license under RiboGene
Technology and Collaboration Technology in the Field to make, have made, use,
import, offer for sale and sell the Product in the Territory, subject only to
the obligation to pay the License Fee (less any amounts of the Development Funds
owed but not paid by RiboGene to Xxxxxxx hereunder) and royalties as provided in
Section 5.2.
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13.4 SURVIVING RIGHTS AND OBLIGATIONS. Termination of this Agreement,
for whatever reason, shall not affect any rights or obligations of either party
which are intended by the parties to survive termination.
13.5 ACCRUED RIGHTS. The 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 any damages arising from any breach
hereunder.
ARTICLE 14
MISCELLANEOUS
14.1 WAIVER. No waiver by either party hereto of any breach or default
of any of the covenants or agreements herein set forth shall be deemed a waiver
as to any subsequent or similar breach or default.
14.2 ASSIGNMENT. This Agreement shall be binding upon and inure to the
benefit of the parties hereto and their permitted successors and assigns;
provided, however, that neither party shall assign any of its rights and
obligations hereunder without the prior written consent of the other; except
that RiboGene may assign this Agreement incident to the merger, consolidations,
reorganization, or acquisition of stock or assets affecting substantially all of
the assets or actual voting control of RiboGene.
14.3 NOTICES. Any notice or other communication required or permitted
to be given to either party hereto shall be in writing and shall be deemed to
have been properly given and to be effective on the date of delivery if
delivered in person or by facsimile or five (5) days after mailing by registered
or certified mail, postage paid, to the other party at the following address:
In the case of RiboGene: RiboGene, Inc.
00000 Xxxxxxxx Xxxx
Xxxxxxx, XX 00000
Fax: (000) 000-0000
Attention: President
with a copy to: Xxxxxx Godward LLP
Five Xxxx Xxxx Xxxxxx
Xxxx Xxxx, XX 00000
Fax: (000) 000-0000
Attention: Xxxxx X. Xxxxxxxxxx, Esq.
In the case of Xxxxxxx: Xxxxxxx Pharmaceutical Corporation
Meridian Center II
0 Xxxxxxxxxx Xxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Fax: (000) 000-0000
Attention: X. X. Xxxxxx, VP and General
Counsel
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Either party may change its address for communications by a notice to the other
party in accordance with this section.
14.4 HEADINGS. The headings of the several sections are inserted for
convenience of reference only and are not intended to be a part of or to affect
the meaning or interpretation of this Agreement.
14.5 AMENDMENT. No amendment or modification hereof shall be valid or
binding upon the parties unless made in writing and signed by both parties.
14.6 CHOICE OF LAW, JURISDICTION AND VENUE.
(a) This Agreement and its terms and conditions shall be governed
exclusively by and construed according to the laws of California, excluding its
choice of law provisions and also excluding the United Nations Convention on
Contracts for the International Sale of Goods.
(b) All disputes which may arise between the parties hereto in
relation to the interpretation or administration of this Agreement shall be
first referred to the Steering Committee for resolution. Any disputes which the
Steering Committee is unable to resolve with a reasonable period of time shall
be resolved by the agreement of the Chief Executive Officers of the respective
parties or their delegates. Any disputes which cannot be resolved in this manner
shall be finally resolved in the courts with jurisdiction and venue at the
domicile of the defendant.
14.7 FORCE MAJEURE. Any delays in performance by any party under this
Agreement shall not be considered a breach of this Agreement if and to the
extent caused by occurrences beyond the reasonable control of the party
affected, including but not limited to acts of God, embargoes, governmental
restrictions, strikes or other concerted acts of workers, fire, flood,
explosion, riots, wars, civil disorder, rebellion or sabotage. The party
suffering such occurrence shall immediately notify the other party as soon as
practicable and any time for performance hereunder shall be extended by the
actual time of delay caused by the occurrence.
14.8 INDEPENDENT CONTRACTORS. In making and performing this Agreement,
Xxxxxxx and RiboGene act and shall act at all times as independent contractors
and nothing contained in this Agreement shall be construed or implied to create
an agency, partnership or employer and employee relationship between RiboGene
and Xxxxxxx. At no time shall one party make commitments or incur any charges or
expenses for or in the name of the other party.
14.9 SEVERABILITY. If any term, condition or provision of this
Agreement is held to be unenforceable for any reason, it shall, if possible, be
interpreted rather than voided, in order to achieve the intent of the parties to
this Agreement to the extent possible. In any event, all other terms, conditions
and provisions of this Agreement shall be deemed valid and enforceable to the
full extent.
14.10 CUMULATIVE RIGHTS. The rights, powers and remedies hereunder
shall be in addition to, and not in limitation of, all rights, powers and
remedies provided at law or in equity,
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or under any other agreement between the parties. All of such rights, powers and
remedies shall be cumulative, and may be exercised successively or cumulatively.
14.11 COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be an original and all of which shall
constitute together the same document.
14.12 ENTIRE AGREEMENT. This Agreement and any and all Schedules and
Appendices referred to herein embodies the entire understanding of the parties
with respect to the subject matter hereof and shall supersede all previous
communications, representations or understandings, either oral or written,
between the parties relating to the subject matter hereof.
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IN WITNESS WHEREOF, both Xxxxxxx and RiboGene have executed this
Agreement, in duplicate originals, by their respective officers hereunto duly
authorized, as of the day and year hereinabove written.
RIBOGENE, INC. XXXXXXX PHARMACEUTICAL CORPORATION
By:_______________________________ By:_________________________________
Name: Xxxxxxx X. Xxxxxx Name:
Title: Vice President Finance & Title:
Administration and
Chief Financial Officer
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EXHIBIT A
ALLOWABLE EXPENSES
[ * ]
[ ] Estimated costs for patent and trademark prosecution, consisting of
approximately [ * ] including the estimated cost of [ * ]
[ ] Estimated patent and trademark maintenance costs (subject to increases due
to litigation or other unforeseen circumstances).
[ ] These expenses shall [ * ] once the Product, [ * ]
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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EXHIBIT B
RIBOGENE PATENTS
[ * ]
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
2.
