EXHIBIT 10.8
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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
LICENSE AGREEMENT
This Agreement is made and entered into this 11th day of July, 2002 (the
"Effective Date") by and between Shionogi & Co., Ltd., a Japanese corporation
having its principal office at 1-8 Xxxxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx 000-0000,
Xxxxx ("Shionogi") and Peninsula Pharmaceuticals, Inc., a Delaware corporation
having its principal office at 0000 Xxxxxx Xxxx, Xxxxxxx, XX 00000, XXX
("Peninsula"). Peninsula and Shionogi may be referred to herein individually as
a "Party", and collectively as the "Parties".
WITNESSETH:
WHEREAS, Shionogi is engaged in the development and manufacturing of the
chemical compound having its internal code number S-4661, and Peninsula has
evaluated S-4661 under the Non-Disclosure Agreement [*] and the Material
Transfer Agreement [*] (collectively, "Secrecy Agreement");
WHEREAS, Peninsula showed its interest in developing, manufacturing and selling
the S-4661 in the Territory (as hereinafter defined), and the Parties negotiated
in good faith major terms and conditions of a possible license agreement on
S-4661;
WHEREAS, through the due diligence investigations concerning S-4661 conducted by
Peninsula under the Letter of Intent dated [*] between the Parties ("Letter of
Intent") to which the list of major terms and conditions of licensing from
Shionogi to Peninsula are attached, Peninsula is interested in pursuing the
development and commercialization of S-4661 in the Territory and desirous of
obtaining from Shionogi certain license necessary therefor; and
WHEREAS, Shionogi is willing to grant such license to Peninsula under the terms
and conditions set forth hereinafter;
NOW, THEREFORE, in consideration of the covenants contained herein, the Parties
hereto hereby agree as follows;
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ARTICLE 1 DEFINITIONS
As used in this Agreement, the following capitalized terms (the singular may
include the plural and vice versa) shall have the following meanings:
1.1 "Affiliates" shall mean any company or organization directly or
indirectly controlling, controlled by, or under common control with
Peninsula or Shionogi, as the case may be. For this purpose,
"control" shall mean the power (whether or not normally exercised),
to direct the management and affairs of the subject corporation or
entity, directly or indirectly, whether through the ownership of
voting securities, by contract, or otherwise. In case of a
corporation, the direct or indirect ownership of fifty percent (50%)
or more of its outstanding voting securities shall in any case be
deemed to confer "control".
1.2 "Controlled" means, with respect to any Information or intellectual
property right, that the Party owns or has a license to such
Information or intellectual property right and has the ability to
grant to the other Party access, a license, or a sublicense to such
Information or intellectual property right as provided for in the
Agreement without violating an agreement with or rights of a third
party.
1.3 "Compound" shall mean a methylcarbapenem antibiotic compound with
the molecular formula of C(15)H(24)N(4)O(6)S(2) and the chemical
name of (+)-(4R,5S,6S)-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-3-
[[(3S,5S)-5-[(sulfamoylamino)methyl]-3-pyrrolidinyl]thio]-1-
azabicyclo[3.2.0.]hept-2-ene-2-carboxylic acid, the chemical
structure of which is shown in Appendix I hereto. The "Compound" may
also be referred to as S-4661 or Doripenem (designated as
International Nonproprietary Names for Pharmaceutical Substances;
INN).
1.4 "FDA" shall mean the United States Food and Drug Administration or
any successor thereto having the administrative authority to
regulate the investigation, development and marketing of human
pharmaceutical products in the United States.
1.5 "GMP" shall mean the current good manufacturing practices required
by the FDA and set forth in the Food, Drug & Cosmetic Act or FDA
regulations, policies or guidelines in effect at a particular time,
for the manufacturing and testing of pharmaceutical materials.
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1.6 "ICH" shall mean the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human
Use.
1.7 "Information" shall mean any confidential or proprietary information
of any kind other than Know-How (as hereinafter defined) that is
communicated by or on behalf of one Party to the other Party,
whether orally, in writing or otherwise, under this Agreement.
1.8 "Know-How" shall mean any scientific or technical information and
data relating to the Compound and/or the Licensed Product (as
hereinafter defined) owned and/or Controlled by Shionogi, including
but not limited to pre-clinical, clinical, manufacturing, and/or
regulatory documentation, data, information, or reports, which is
necessary and/or useful for Peninsula's development or
commercialization of the Licensed Product in the Territory.
1.9 "Licensed Patents" shall mean (a) patents and patent applications
listed in Appendix II hereto, including without limitation United
States Patent Numbers [*] and [*]; (b) any patents issuing on the
patent applications listed in Appendix II, including without
limitation Patent Application Number [*]; (c) any additions,
divisions, continuations, continuations-in-part, extensions,
reissues, renewals, substitutions, and reexaminations of the patents
and patent applications in (a) and (b); and (d) counterparts of the
foregoing patent applications and patents issued by or filed in any
country or other jurisdiction in the Territory.
1.10 "Licensed Product" shall mean any pharmaceutical product intended
for use for the prevention and/or treatment of various bacterial
infectious diseases, or other appropriate uses, in humans that
contains the Compound as an active ingredient. As of the Effective
Date, the Licensed Product shall be considered to be vial-filled
product containing a 250 mg and/or 500 mg strength of the Compound.
1.11 "Registration Approval" shall mean, with respect to a country in the
Territory, all approvals, licenses, registrations, or authorizations
by an applicable Regulatory Authority (as hereinafter defined)
necessary to import, commercialize and market the Licensed Product
in such country, including pricing and reimbursement approval in
such country.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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1.12 "Regulatory Authority" shall mean the FDA in the United States, and
the equivalent regulatory authority or governmental entity having
the responsibility, jurisdiction, and authority to approve the
manufacture, use, importation, packaging, labeling, marketing, and
sale of pharmaceutical products in any country or jurisdiction other
than the United States.
1.13 "Specifications" shall mean the specifications set forth in Appendix
V for the of the Licensed Product, as they may be amended from time
to time by agreement of the Parties.
1.14 "Territory" shall mean the United States of America, Canada and
Mexico.
ARTICLE 2 GRANT OF LICENSE
2.1 License Grant
Shionogi hereby grants to Peninsula, during the term of this Agreement,
the sole and exclusive license under the Licensed Patents and Know-How, to
develop, import, use, market, sell and/or offer for sale Licensed Products
in the Territory. For the purpose of this Article, the license granted to
Peninsula hereunder shall not include any right to manufacture the
Compound. Under the said license, Peninsula shall be permitted to have its
subcontractors (such as contract research organizations and contract sales
organizations), distributors (wholesalers), resellers and retailers
perform the same obligations undertaken by Peninsula under this Agreement.
2.2 Sublicense
Subject to Article 7 hereof, Peninsula shall have the right to grant
sublicenses, under the license granted pursuant to Section 2.1 to any
third parties ("Sublicensees"); provided, however, that in case Peninsula
is desirous of granting a sublicense to a third party, Peninsula shall
obtain Shionogi's prior written consent, which consent shall not be
unreasonably withheld, and shall guarantee that all of its Sublicensees
will comply with all applicable terms and conditions of this Agreement
undertaken by Peninsula.
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2.3 Covenants Regarding Licenses
Subject to Article 7 hereof, Shionogi hereby covenants and agrees that
Shionogi and its Affiliates shall not develop, market or sell, or license
any other party to develop, market or sell, in the Territory any product
containing the Compound for human use.
ARTICLE 3 DEVELOPMENT
3.1 Shionogi's assistance
Shionogi shall disclose to Peninsula all available Know-How, including but
not limited to that set forth in Appendix III hereto, after the Effective
Date without delay. Any additional Know-How developed or acquired by
Shionogi thereafter shall be promptly disclosed to Peninsula. Peninsula
will be free to utilize the Know-How for Peninsula's development and/or
commercialization of the Licensed Product in the Territory.
3.2 Development Committee
(a) Shionogi and Peninsula shall establish a Joint Development Committee
("JDC") which will consist of [*] from Shionogi and Peninsula. The
representatives of each Party may be changed from time to time at
the discretion of the Party making such change upon written notice
by the Party to the other.
(b) The JDC shall meet periodically, in principle semi-annually, in
alternating home office locations or via videoconference or
teleconference, whichever is appropriate. Each Party shall bear its
costs associated with attendance at the JDC meetings.
(c) The JDC shall discuss and decide on the development plan and
strategy for the development in the Territory of the Licensed
Product, including [*]. It is agreed by the Parties that the
underlying concept in establishing such development plan and
strategy shall be reasonably consistent with that employed by
Shionogi for the development of the product containing the Compound
in Japan. Further, the JDC shall review the progress of the
development activities conducted by Peninsula. Shionogi and
Peninsula shall make the minutes of the JDC meetings jointly in
order to confirm the matters discussed and the decision made at the
JDC meetings.
(d) All decisions of the JDC shall be made [*]. In case the JDC cannot
reach [*] because of the difference in opinions between the Parties,
such dispute shall be referred to the President of Peninsula and [*]
of Shionogi, who will meet promptly and use diligent good faith
efforts to seek a resolution. If the matter is not resolved by such
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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executives within [*] days, it shall be resolved according to the
mechanism set forth in Article 21.
3.3 Development activity
(a) Peninsula (or its contractor or Sublicensee) shall use reasonable
efforts to undertake all development work necessary to obtain
Registration Approval for the Licensed Product for the Territory at
its own expense and risk in accordance with the development plan and
strategy decided by the JDC as if the Licensed Product were
Peninsula's own product. Further, Peninsula, when commercially and
financially reasonable, shall conduct development work in accordance
with ICH guidelines.
(b) Promptly after the Effective Date, Peninsula shall prepare a
preliminary development plan, which contains an estimated time-line
for clinical studies, the filing of an Investigational New Drug
("IND") application and New Drug Application ("NDA"), and a target
date for the commercial launch of the Licensed Product in [*].
Within sixty (60) days from the Effective Date, the JDC shall review
and approve a development plan ("Development Plan") based on the
preliminary development plan to be prepared by Peninsula. The
initial Development Plan shall be attached to this Agreement as
Appendix IV. From time to time during the term of this Agreement,
the JDC shall review and modify, as appropriate based on development
results, the Development Plan, and any updates, revisions, or
modifications to the Development Plan shall be attached to this
Agreement as Appendix IV, provided, however, that updates, revisions
or modifications to the Development Plan that are needed due to
delays caused by Peninsula's negligence or willful misconduct in the
development work shall not be made unless Shionogi agrees to such
changes.
(c) Peninsula shall provide Shionogi with any synopses of protocols for
clinical trials relating to the Licensed Product planned by
Peninsula prior to the initiation thereof in order to provide
Shionogi with an opportunity to review and comment thereon.
Peninsula shall reasonably consider Shionogi's comments, provided
that Peninsula receives such comments no later than [*] days after
Shionogi receives such synopses. Peninsula shall provide Shionogi
with copies of all finalized protocols prior to the initiation of
the applicable study.
(d) Peninsula shall inform and report in writing to Shionogi its
development progress from time to time in order for Shionogi to
evaluate the development status. If Peninsula files an IND and/or
NDA with the FDA, Peninsula shall provide Shionogi with a summary of
such filings submitted to the FDA (including any amendments
thereto). If Peninsula foresees or becomes aware of any delay of [*]
months or more in the actual development of the Licensed Product as
compared with the estimated
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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timeline set forth in the then-current Development Plan, Peninsula
shall inform Shionogi of such delay in writing no later than ten
(10) days after becoming aware of such delay. In the event that
Peninsula so informs Shionogi, the JDC shall convene a special
meeting to discuss the reasons and potential countermeasures for
such delay, and to discuss appropriate revisions to the Development
Plan. If necessary, the JDC shall amend the Development Plan. If any
such delay in development is attributable to Peninsula's negligence
or willful misconduct, Shionogi may terminate this Agreement in
accordance with Section 17.2 hereof if Peninsula does not initiate
diligent efforts to address and minimize the delay to Shionogi's
reasonable satisfaction within [*] days after Shionogi determines
such delay is attributable to Peninsula's negligence or willful
misconduct.
(e) Subject to applicable laws in the Territory, Peninsula shall provide
Shionogi with all data, information and documents obtained by
Peninsula promptly after Peninsula obtains final reports of each
pre-clinical or clinical study for a Licensed Product and give
Shionogi reasonable assistance in obtaining registration approval
for the products containing the Compound outside the Territory.
Shionogi will be free to utilize such data, information and
documents to develop and commercialize the products containing the
Compound in countries outside the Territory. At Peninsula's request,
Shionogi shall give Peninsula reasonable assistance in obtaining
Registration Approval in the Territory.
3.4 Shionogi representative(s)' visit
Upon the request of Shionogi, Peninsula shall allow Shionogi
representative(s) to attend Peninsula's meetings concerning development of
the Compound and/or the Licensed Product (including internal meetings and
meetings with investigators and Regulatory Authorities); provided,
however, that Shionogi shall obtain Peninsula's approval in advance with
respect to such attendance of Shionogi representative(s), which approval
shall not be unreasonably withheld, and that any Shionogi
representative(s) shall be bound by obligations of confidentiality
consistent with the obligations contained in Article 16 with respect to
the information disclosed at such meetings.
ARTICLE 4 FIRST REFUSAL RIGHT FOR EUROPEAN TERRITORY
Within [*] years from the Effective Date and in the event Shionogi decides
to seek a partner or grant a license with respect to the Compound and/or
the Licensed Product in
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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one or more countries in the European Union ("European Territory"),
Shionogi shall first provide to Peninsula written notice offering to
Peninsula the opportunity to enter into the negotiation with Shionogi.
Peninsula shall have [*] days in which to provide to Shionogi written
notice that it wishes to enter into negotiations with Shionogi. If
Peninsula provides such written notice to Shionogi within such [*] day
period, the Parties shall promptly enter into good faith negotiations for
reasonable terms and conditions for, and to amend this Agreement to
include, a license with respect to the Licensed Product in such European
Territory, and shall negotiate for up to [*] days from the date of
Peninsula's notice. If Peninsula does not exercise its right of first
negotiation within the [*] day period or if the Parties fail to execute an
amendment of this Agreement within the [*] day period, Shionogi shall be
free to discuss terms and conditions with a third party for the possible
partnership or license in the European Territory; provided, however, that
Shionogi shall not grant to a third party any right to negotiate on terms
and conditions materially more favorable to such third party than the
terms and conditions last offered by Shionogi to Peninsula without first
offering such more favorable terms and conditions to Peninsula for
Peninsula's consideration and possible acceptance.
ARTICLE 5 CONSIDERATION
5.1 Milestone Payment.
In consideration of the license granted by Shionogi to Peninsula herein,
Peninsula shall pay Shionogi the following non-refundable, one-time
payments, which total in the aggregate [*] US dollars (US$ [*]). Such
payments shall be made upon the first occurrence of each milestone
specified below:
i. Within thirty (30) days of the Effective Date, Peninsula shall pay
the non-refundable payment of [*] US dollars (US$ [*]) to Shionogi.
ii. Upon the first dosing of a human subject with a Licensed Product,
regardless of geographical location, Peninsula shall pay the
non-refundable payment of [*] US dollars (US$ [*]) to Shionogi.
iii. Upon the acceptance of the first IND by a Regulatory Authority as to
the Phase II or Phase III clinical study (whichever occurs first) in
the Territory, Peninsula shall pay the non-refundable payment of [*]
US dollars (US$ [*]) to Shionogi.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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iv. Upon submission of the first NDA for a Licensed Product in the
Territory, Peninsula shall pay the non-refundable payment of [*] US
dollars (US$ [*]) to Shionogi.
v. Upon obtaining Registration Approval of the Licensed Product for the
first indication from the FDA, Peninsula shall pay the
non-refundable payment of [*] US dollars (US$ [*]) to Shionogi.
Peninsula shall inform Shionogi of the occurrence of each milestone event
set forth in Subsections (ii) to (v) hereof in writing within [*] business
days after each such occurrence.
For clarity, the foregoing milestone payments will be made only once as to
each milestone under this Agreement.
5.2 Delay
If, due to the negligence or willful misconduct of Peninsula, each
milestone event stipulated in Subsection 5.1 (iii), (iv) and (v) does not
occur within [*] after the target dates set forth for such events in the
then-current Development Plan, the non-refundable milestone payments set
forth in Subsections (iii), (iv) and (v) of Section 5.1, as applicable,
shall become due upon the expiration of the applicable [*] period.
5.3 Bank Account
All milestone payments made by Peninsula to Shionogi under this Article 5
shall be paid in United States dollars and remitted by wire transfer to
the following bank account of Shionogi:
BANK ACCOUNT
------------
Bank Name: [*]
Bank Address: [*]
Account Name: Shionogi & Co., Ltd.
Account No.: [*]
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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5.4 Tax treaty
The payments to be made hereunder by Peninsula to Shionogi shall be net
payments, i.e. without deduction of any bank or transfer charges and any
taxes, levies or duties levied on such payments in the country of
Peninsula by any governmental authority, except that Peninsula shall be
entitled to deduct from the payments to be made to Shionogi the
withholding tax, if applicable, levied on the payments and shall undertake
to pay such withholding tax on behalf of Shionogi and shall provide
Shionogi with a receipt for such payment or other taxation certificate
without delay following the payment.
ARTICLE 6 MARKETING
6.1 Exchange of Information
The Parties shall meet periodically, at least once a year, to exchange any
information and documents each Party possesses or obtains regarding
marketing of products containing the Compound, including but not limited
to the marketing plan and/or strategy of each Party. The initial meeting
shall be held not later than [*] months prior to the anticipated
commercial launch date of the Licensed Product in the United States.
6.2 Diligent efforts
Peninsula shall use its diligent efforts in the promotion, marketing and
sale of the Licensed Product with the goal of maximizing the profit from
sales of the Licensed Products as early as reasonably practical and
maintaining such sales as long as commercially reasonable.
6.3 Package insert and promotional materials
(a) To assist Peninsula's marketing activities, Shionogi shall provide
Peninsula with all information useful for the sale and promotion of
the Licensed Products by Peninsula.
(b) To the extent allowable by law, Peninsula shall ensure that all
Licensed Product packaging, package inserts and significant
promotional materials associated with the Licensed Products include
the logo or company name of "Shionogi & Co., Ltd.". Peninsula agrees
to provide Shionogi with samples of significant written promotional
materials prior to the actual use thereof in order to obtain
Shionogi's approval thereon, which approval shall not be
unreasonably withheld.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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ARTICLE 7 OPTION FOR COLLABORATION
In the event Peninsula decides to seek a partner (including the Sublicensee
stipulated in Section 2.2 hereof) for the development and/or the marketing
of the Compound and/or the Licensed Product for the Territory (a
"Collaboration"), Peninsula shall first provide to Shionogi written notice
offering to Shionogi the opportunity to enter into such Collaboration.
Shionogi shall have [*] days in which to provide to Peninsula written
notice that it wishes to enter into negotiations with Peninsula for such
Collaboration. If Shionogi provides such written notice to Peninsula within
such [*] day period, the Parties shall promptly enter into good faith
negotiations for reasonable terms and conditions for and to execute a
Collaboration Agreement, and shall negotiate for up to [*] days from the
date of Shionogi's notice. If Shionogi does not exercise its right of first
negotiation within the [*] day period or if the Parties fail to execute the
Collaboration Agreement within the [*] day period, Peninsula shall be free
to discuss terms and conditions with a third party for entering into such
Collaboration, provided however that Peninsula shall not grant to a third
party any right or sublicense to enter into such Collaboration on terms and
conditions materially more favorable to such third party than the terms and
conditions last offered by Peninsula to Shionogi without first offering
such more favorable terms and conditions to Shionogi for Shionogi's
consideration and possible acceptance.
ARTICLE 8 CLINICAL SUPPLY
8.1 Supply of the Clinical Sample
Shionogi shall manufacture or have manufactured and supply to Peninsula
Peninsula's entire requirements of the Licensed Products which contain a
250 mg and/or 500 mg strength of the Compound for Phase I, Phase II, and
Phase III clinical studies for and in the Territory ("Clinical Sample").
The Parties hereby acknowledge that, prior to the Effective Date, Peninsula
has placed an initial purchase order for [*], 250 mg strength vials of
Clinical Samples. Shionogi hereby agrees to manufacture or have
manufactured and supply such quantity of Clinical Samples to Peninsula no
later than [*] or such other date as the Parties may mutually agree.
8.2 Quality Control and Quality Control Audits
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Shionogi shall maintain (or cause to be maintained) a quality control and
testing program consistent with then-current [*] ("[*]"), as applicable,
to ensure that the Clinical Samples supplied to Peninsula conform to the
Specifications (the "Quality Control Procedures").
8.3 Records and Samples.
Shionogi shall maintain (or cause to be maintained) complete, accurate,
and authentic accounts, notes, data, and records pertaining to its
manufacture, processing, Quality Control Procedure test results, and
packaging of the Clinical Samples in accordance with [*].
8.4 Delivery
The Clinical Samples ordered shall be delivered [*] (Incoterms 2000). Each
shipment of the Clinical Samples shall be accompanied by a certificate of
analysis (i) confirming that Shionogi (or its contract manufacturer)
followed the Quality Control Procedures (as defined in Section 8.2) for
the testing of such Clinical Samples, (ii) containing the quality control
test results, and (iii) confirming that the Clinical Samples supplied to
Peninsula conform to the Specifications (the "Certificate of Analysis").
8.5 Supply Price
Shionogi shall supply to Peninsula the first [*] vials of 250 mg strength
Clinical Samples [*] to Peninsula ([*]). Each subsequent vial of 250 mg
strength Clinical Samples supplied to Peninsula hereunder shall be at a
price equal to [*] per vial ([*]/vial). The price for 500 mg strength
Clinical Samples supplied to Peninsula hereunder shall be separately
agreed upon by the Parties. All payments for the supply of the Clinical
Samples by Shionogi shall be made in [*] and Shionogi shall deliver to
Peninsula such Clinical Samples after Shionogi confirms the remittance
for each shipment made by Peninsula to the bank account of Shionogi
designated in Section 5.3.
8.6 Acceptance and Rejection of Clinical Samples
(a) All Clinical Samples supplied to Peninsula hereunder shall conform to
the Specifications and shall be manufactured in compliance with [*].
Promptly after Peninsula or its designee receives the Clinical Samples
supplied by Shionogi, Peninsula or its designee shall conduct an
initial acceptance test to detect visible defects (such as broken or
crushed vials) and to discover any shortfalls in the quantity
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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delivered within thirty (30) days after delivery of the Clinical
Samples to the delivery destination set forth in the applicable
purchase order. If as a result of such initial acceptance test,
Peninsula discovers Clinical Samples that are defective or do not
conform to the Specifications ("Defective Products"), or any shortage
of Clinical Samples with respect to the quantity delivered, Peninsula
shall notify Shionogi in writing, which notice shall identify in
reasonable detail the nature of the defect or shortage.
(b) If Peninsula discovers that Clinical Samples are Defective Products and
that the nature of such defect could not have been discovered by
performing the initial acceptance test of the Clinical Samples set
forth in Section 8.6(a) within thirty (30) days after delivery of the
Clinical Samples, Peninsula may revoke its acceptance of such Defective
Products by providing written notice to Shionogi of such revocation.
Such notice shall identify in reasonable detail the nature of the
defect and shall be provided within thirty (30) days of determining the
existence of the defect but no later than [*] months after the delivery
of the Clinical Samples.
(c) If it is determined that any non-conformity with the Specifications
and/or shortage of quantity is attributable to Shionogi after
Shionogi's confirmation of the notice together with relative
information supplied by Peninsula under Section 8.6(a) or 8.6(b),
Shionogi shall, at Peninsula's option and at Shionogi's expense, refund
Peninsula for the amount paid for such Defective Products under Section
8.5, replace such Defective Products or make up the shortage in
quantities of Clinical Samples, as applicable, as soon as reasonably
possible.
(d) If Shionogi disagrees with Peninsula's claim that certain Clinical
Samples are Defective Products, the Parties will first use good faith
efforts to settle such dispute within thirty (30) days of Peninsula's
notice of such defects; if they are unable to do so within such time
period, the dispute will be resolved by a mutually acceptable
independent third party tester after analysis of the relevant Clinical
Samples. Such third party tester shall determine whether such Clinical
Samples are defective, and the Parties agree that such tester's
determination shall be final, binding, and determinative as to whether
such Clinical Samples are Defective Products. The Party against whom
the third party tester rules shall bear all costs of the third party
testing.
ARTICLE 9 COMMERCIAL SUPPLY
9.1 Commercial Supply of the Licensed Products
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(a) It is a common intention of the Parties, as of the Effective Date, that
Shionogi will manufacture or have manufactured and supply to Peninsula,
and Peninsula will purchase exclusively from Shionogi, Peninsula's
entire requirements of the Licensed Products (in final form and in
compliance with GMP) for commercial sale by Peninsula in the Territory.
Promptly after the Effective Date, the Parties shall discuss and
negotiate in good faith the terms and conditions for such supply of the
Licensed Products, which terms shall be commercially reasonable and
typical for transactions of this type; provided, however, that the
price per 250 mg vial of Licensed Product for commercial sale shall be
[*]. Further, the Parties shall discuss an appropriate form of the
Compound (i.e., bulk Compound or nude vial) to be supplied to
Peninsula, if necessary. The Parties shall use diligent efforts to
enter into an agreement governing the terms and conditions of
Shionogi's supply of Peninsula's requirements of Licensed Products for
commercial sale by the Target Date (as hereinafter defined).
(b) [*].
(c) [*].
9.2 [*]
Peninsula and Shionogi agree to discuss in good faith an appropriate
mechanism by which the supply price per 250 mg and/or 500 mg vial of
Licensed Product for commercial sale will be [*] of Licensed Products
purchased by Peninsula.
9.3 Target Date
The Parties shall make their reasonable best efforts to conclude the
agreement setting forth the result of discussions stipulated in
Sections 9.1 and 9.2 by [*] or such other date to be mutually agreed by
the Parties ("Target Date"). If, despite serious and faithful
discussion and good faith efforts, the Parties are unable to enter into
such agreement by the Target Date, such dispute shall be referred to
the President of Peninsula and the [*] of Shionogi or other appropriate
officer of Shionogi who shall meet promptly and use good faith and
diligent efforts for final resolution.
ARTICLE 10 SALES REPORT
Peninsula shall submit to Shionogi a detailed sales report on a
quarterly and country by country basis, including the number of
Licensed Products sold during each month of such quarter to customers,
no later than [*] days after the end of each calendar quarter.
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
- 14 -
ARTICLE 11. SERIOUS ADVERSE DRUG REACTION REPORTING.
Peninsula shall be responsible for receiving, investigating, and
documenting all serious adverse drug reactions relating to the use of
the Licensed Products which require reporting to appropriate Regulatory
Authorities. Peninsula will be solely responsible for filing all
post-marketing reports of such serious adverse drug reactions required
by Regulatory Authorities, or as required by applicable laws or
regulations. During the term of this Agreement, in the event that each
Party receives a report of a serious adverse drug reaction relating to
the use of a Licensed Product anywhere in the world, it shall
immediately notify the other in writing. The Parties shall periodically
exchange a summary of all serious adverse drug reactions of Licensed
Products during the term of this Agreement and shall separately agree
on detailed procedure for exchanging and reporting the information.
ARTICLE 12 INTELLECTUAL PROPERTY RIGHTS
12.1 Representation and Warranty.
UNLESS OTHERWISE PROVIDED HEREIN, SHIONOGI MAKES NO REPRESENTATIONS AND
WARRANTS, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE COMPOUND
AND/OR THE LICENSED PRODUCT, INCLUDING BUT NOT LIMITED TO ANY
WARRANTIES OF VALIDITY OR ENFORCEABILITY OF THE LICENSED PATENTS,
NON-INFRINGEMENT OF ANY THIRD PARTY'S PATENT OR THE NON-EXISTENCE OF
ANY INFRINGEMENT OF THE LICENSED PATENTS IN THE TERRITORY.
12.2 Prosecution and Maintenance.
During the term of this Agreement, Shionogi, [*], shall use diligent,
good faith efforts to file, prosecute and maintain any patent
applications and patents within the Licensed Patents. Shionogi shall
use reasonable best efforts to extend the term of the Licensed Patents
covering the Compound and/or the Licensed Product and Peninsula shall
cooperate with Shionogi in obtaining such extension. Shionogi shall
keep Peninsula continually informed of such prosecution efforts and
shall reasonably consider Peninsula's comments on such prosecution.
12.3 Infringement.
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
- 15 -
(a) In the event that a Party becomes aware of any alleged or threatened
infringement of the Licensed Patents in the Territory, such Party shall
promptly notify the other Party in writing. Shionogi shall have the
right, but not the obligation, at its discretion and expense, to
enforce the Licensed Patents against such infringement, and to defend
the Licensed Patents against any claims of invalidity or
unenforceability in the Territory. Peninsula shall give Shionogi all
reasonable information and assistance with respect to such enforcement.
Except as set forth in Section 12.3(b), any damages or remuneration
received as a result of such action shall be [*] after reimbursing for
the costs and expenses incurred by Peninsula for its assistance.
(b) Peninsula shall have the right, but not the obligation, at its
discretion and expense, to join in such action and seek damages for its
lost profits caused by such infringement. Any damages or remuneration
received as a result of such action shall be applied first to reimburse
each Party for the costs and expenses incurred in such action. Any
remaining amount of such damages or remuneration shall be allocated by
the Parties [*] of the Parties.
(c) If Shionogi does not take any legal action for any reason with respect
to such infringement within one hundred twenty (120) days following
Peninsula's notification, Peninsula shall have the right to bring any
appropriate suit or action against the infringer at Peninsula's
expense. Shionogi shall give Peninsula all reasonable information and
assistance with respect to such infringement. Any damages or
remuneration received as a result of such action shall be [*] after
reimbursing any cost and expenses incurred by Shionogi for its
assistance.
12.4 Generic compound
If any of the patents included within the Licensed Patents are held
invalid or unenforceable, and as a result, a generic version of the
Licensed Product enters the pharmaceutical market in the Territory and
the volume share of such generic version equals or exceeds [*] percent
or more of the total sales of all Licensed Products in a country in the
Territory during the term of this Agreement, Shionogi and Peninsula
will negotiate in good faith a revision of financial conditions to be
agreed by the Parties in accordance with Article 9.
12.5 Inventions.
(a) If any inventions (an "Invention") are made pursuant to work conducted
under this Agreement, such Invention shall belong to the Party making
the Invention and such Party shall have the right to file, prosecute
and maintain patent applications and patents covering Inventions made
solely by that Party.
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
- 16 -
(b) If Shionogi makes an Invention that is necessary or useful for
Peninsula to develop, import, use, market or sell the Licensed Product,
such Invention shall be included in the definition of the Know-How or
the Licensed Patents, as the case may be, and shall be added to
Appendix II hereto promptly after Shionogi files patent applications
relating to such Invention.
(c) If Peninsula makes an Invention that is necessary or useful for
Shionogi to develop, import, use, market or sell the Licensed Product
outside the Territory, Peninsula shall grant to Shionogi [*] license
with a right to grant sublicenses under the patents claiming such
Invention solely for use in using, manufacturing, developing and
commercializing the Licensed Product outside the Territory.
(d) If the Invention is jointly made by the Parties, Shionogi and Peninsula
shall determine in good faith whether or not patent applications should
be filed concerning such jointly-owned Invention and which Party shall
be responsible for filing and prosecuting any patent applications
filed. The Parties shall share the costs in filing any patent
applications, obtaining and maintaining any patents covering the joint
Invention.
ARTICLE 13 TRADEMARK
The Licensed Products sold in the Territory shall bear a trademark
("Trademark") chosen and owned by Peninsula. Peninsula, at its
reasonable discretion, may use the trademark (if any) owned by Shionogi
for the marketing of the Licensed Products (the "Shionogi Trademark")
for so long as Peninsula markets the Licensed Products. If Peninsula
desires to use the Shionogi Trademark, then to the extent legally
permitted, Shionogi shall grant the right to use the Shionogi Trademark
for such purpose free of charge during the term of this Agreement. The
Licensed Products sold in the Territory shall bear the Shionogi name or
logo (the "Marks"), as provided in Subsection 6.3(b), and Shionogi
grants Peninsula the right to use the Marks to the extent necessary for
Peninsula to fulfill the obligations set forth in Subsection 6.3(b)
applicable to the Licensed Products sold in the Territory. Peninsula
will have no obligation to pay royalties for such use of the Marks and
Shionogi Trademark during the term the Agreement. If Shionogi desires
to use the Trademark owned or Controlled by Peninsula to market
products containing the Compound outside the Territory, then to the
extent legally permitted, Peninsula shall grant the right to use the
Trademark for such purpose free of charge for so long as Shionogi (or
its licensee) markets and sells any products containing the Compound
outside the Territory. Shionogi shall not use the
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Trademark outside the scope of this Agreement and shall use the
Trademark in accordance with Peninsula's then-current reasonable
trademark guidelines, if any, as provided to Shionogi in writing in
advance of any such use as they may be updated from time to time by
Peninsula, or alternatively, with Peninsula's prior written approval
for such use.
ARTICLE 14 INDEMNIFICATION
14.1 Indemnification by Shionogi.
Shionogi shall indemnify, defend and hold Peninsula and Peninsula's
Affiliates and Sublicensees harmless from and against any and all
liabilities, demands, damages, losses, costs, expenses or money
judgments (including reasonable attorney's fees and expenses of
litigation) arising or resulting from any claims made or suits which
arise or result from (i) the manufacture and/or supply of the Licensed
Product by or under the control of Shionogi, (ii) the breach of any
obligations or warranties hereunder by Shionogi, (iii) the intentional
act or omission or the negligence of Shionogi, or (iv) the use of the
Trademark in connection with the marketing and/or sale of products
containing the Compound outside the Territory, unless such liabilities,
demands, damages, losses, costs, expenses or money judgments arise or
result from the intentional act or omission or the negligence of
Peninsula. Such indemnity shall not apply to the extent that Peninsula
has an indemnity obligation for such claim pursuant to Section 14.2, or
if Peninsula fails to comply with the indemnification procedures set
forth in Section 14.3.
14.2 Indemnification by Peninsula.
Peninsula shall indemnify and hold Shionogi and its Affiliates harmless
from and against any and all liabilities, demands, damages, losses,
costs, expenses or money judgments (including reasonable attorney's
fees and expenses of litigation) arising or resulting from any claims
made or suits which arise or result from (i) Peninsula's development,
distribution, marketing and promotion of the Licensed Product in and
for the Territory, (ii) Peninsula's exploitation or use of the Licensed
Patents, Know-How or Marks, (iii) the breach of any obligations
hereunder by Peninsula or (iv) the intentional act or omission or the
negligence of Peninsula unless such liabilities, demands, damages,
losses, costs, expenses or money judgments arise or result from the
intentional act or omission or the negligence of Shionogi. Such
indemnity shall not apply to the extent that Shionogi has an indemnity
obligation for such claim pursuant to
- 18 -
Section 14.1, or if Shionogi fails to comply with the indemnification
procedures set forth in Section 14.3.
14.3 Control of Defense.
If either Party is entitled to indemnification under this Article 14
(the "Indemnified Party"), it shall give written notice to the Party
providing indemnification (the "Indemnifying Party") of any claims that
may be subject to indemnification promptly after learning of such
claims, and the Indemnifying Party shall assume the defense of such
claims with counsel reasonably satisfactory to the Indemnified Party.
If such defense is assumed by the Indemnifying Party with counsel so
selected, the Indemnifying Party shall not be subject to any liability
for any settlement of such claims made by the Indemnified Party without
the Indemnifying Party's consent (but such consent shall not be
unreasonably withheld or delayed), and shall not be obligated to pay
the fees and expenses of any separate counsel retained by the
Indemnified Party with respect to such claims.
ARTICLE 15 NON-COMPETITION
Peninsula shall not distribute, sell, market or promote, during the
term of this Agreement, any [*] other than the Licensed Product in the
Territory.
ARTICLE 16 CONFIDENTIALITY AND LIMITATION-ON-USE
16.1 Obligation
Except to the extent expressly authorized by this Agreement, during the
term of this Agreement and for a period of five (5) years after
termination or expiration of this Agreement, each Party agrees to keep
Information and/or Know-How received from the other Party (including
the information received from the other Party under the Secrecy
Agreement or Letter of Intent) (collectively "Confidential
Information") confidential and not to disclose the same to any third
party without the prior written consent of the other Party except as
otherwise permitted in this Article 16, and to use the other Party's
Confidential Information only for the purpose of this Agreement.
The obligations set forth above do not apply to the following
Confidential Information that the receiving Party can demonstrate by
competent written proof:
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(i) is or becomes publicly known through no fault of the receiving
Party,
(ii) is already known to the receiving Party, other than under an
obligation of confidentiality, prior to disclosure by the
disclosing Party as evidenced by the business records of the
receiving Party,
(iii) is learned by the receiving Party from a third party under no
obligations of confidentiality with respect thereto; or
(iv) is developed independently by employees of the receiving Party
who had no access to the Confidential Information.
16.2 Authorized Disclosure.
Each Party may disclose Confidential Information received from the
other Party to the extent such disclosure is reasonably necessary for
the following reasons:
(a) filing or prosecuting the Licensed Patents;
(b) regulatory filings to the Regulatory Authorities;
(c) prosecuting or defending litigation;
(d) complying with applicable governmental regulations;
(e) conducting pre-clinical or clinical trials of the Licensed
Product in the Territory; and
(f) disclosure to Affiliates, Sublicensees, advisors, consultants,
contract research organizations or other persons or entities
who agree to be bound by similar terms of confidentiality and
limitation-on-use obligations set forth in Section 16.1
hereof.
Notwithstanding the foregoing, in the event a Party is required to make
a disclosure of the other Party's Confidential Information pursuant to
this Section 16.2 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, or obtain a protection
order or other similar order for, such information. In any event, the
Parties agree to take all reasonable action to avoid disclosure of
confidential information hereunder.
ARTICLE 17 TERM AND TERMINATION
17.1 Term
This Agreement will become effective as of the Effective Date and
continue to be effective until the later of (a) [*] the last to expire
of the Licensed Patents owned or
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Controlled by Shionogi, or (b) [*] years after the first commercial
launch of the Licensed Product in the Territory on a country-by-country
basis.
17.2 Right to Terminate of Shionogi
Shionogi has the right to terminate this Agreement as follows:
(a) If Peninsula fails to achieve the milestones set forth in the
then-current Development Plan for first [*] for [*] as to the
[*] and/or [*] or [*] for the Licensed Product by [*] months
or more and such delay is attributable to Peninsula's
negligence or willful misconduct, Shionogi shall provide
written notice to Peninsula of such material failure. If
Peninsula does not initiate diligent efforts to address and
minimize the delay to Shionogi's reasonable satisfaction
within [*] days after the date on which it receives notice of
failure, Shionogi shall have the right to terminate on written
notice,
(b) If there occurs a change in control in Peninsula and (i) the
acquiring company elects [*] and/or [*] the Compound and/or
the Licensed Product or (ii) the acquiring company is
developing and/or marketing any [*],
(c) In the event Peninsula materially breaches any of the
provisions of this Agreement and fails to remedy such breach
within [*] days after receiving notice thereof from Shionogi
(except as provided in subsection (a) above), or
(d) On written notice, in the event Peninsula commences
liquidation proceedings, is subject to an assignment for the
benefit of creditors, or ceases to carry on its business in
the normal course.
17.3 Right to Terminate of Peninsula
Peninsula has the right to terminate this Agreement:
(a) In the event Peninsula determines that it is [*] to pursue the
development, launch or sale of the Licensed Product due to
[*], and/or [*], including but not limited to [*] the Compound
and/or the Licensed Product and the [*] of the Licensed
Product, Peninsula may provide written notice to Shionogi of
such determination, together with competent information
thereof (the "Determination Notice") and have serious
discussions with Shionogi. Peninsula may terminate effective
upon written notice [*] days after Shionogi's receipt of the
Determination Notice,
(b) In the event Shionogi materially breaches any of the
provisions of this Agreement and fails to remedy such breach
within [*] days after receiving notice thereof from Peninsula,
or
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(c) Upon [*] days' written notice in the event Shionogi commences
liquidation proceedings, is subject to an assignment for the
benefit of creditors, or ceases to carry on its business in
the normal course.
17.4 Expiration of this Agreement
Upon expiration of this Agreement pursuant to Section 17.1 hereof:
(a) Peninsula's obligation to purchase from Shionogi, and
Shionogi's obligation to sell to Peninsula Licensed Products
will cease; provided, however, that either Party shall not be
relieved from performing any obligations accrued prior to the
date this Agreement terminates. If Peninsula desires to
continue purchasing the Licensed Product from Shionogi after
the expiration of this Agreement, the Parties shall negotiate
in good faith the terms and conditions therefor.
(b) Peninsula's license will revert to a perpetual, irrevocable,
non-exclusive, royalty-free license with regard to the use of
Know-How. If Peninsula has been using the Shionogi Trademark
and desires to continue using such trademark after the
expiration of this Agreement, the Parties will enter into a
trademark license agreement covering use of the Shionogi
Trademark under mutually agreed conditions.
17.5 Early termination of this Agreement
Upon early termination of this Agreement pursuant to Section 17.2 or
Subsection 17.3(a):
(a) Peninsula shall immediately cease to develop, distribute,
market and promote the Licensed Product and shall destroy or
return to Shionogi all Peninsula's inventory stock of the
Licensed Product at the time of termination in accordance with
Shionogi's instruction.
(b) Peninsula shall return any Know-How received from Shionogi
under this Agreement.
(c) Peninsula shall transfer and/or cause to transfer to Shionogi
or Shionogi's designee(s) the [*], with Shionogi [*] Peninsula
for [*] in connection with such transfer.
17.6 Damages
Termination of this Agreement by the non-breaching Party shall in no
way affect or limit such non-breaching Party's right to claim against
the breaching Party for any damages arising out of the breach of this
Agreement.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFITS)
ARISING OUT OF THIS AGREEMENT. NOTWITHSTANDING
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
- 22 -
THE FOREGOING, NOTHING IN THIS SECTION 17.6 IS INTENDED TO LIMIT OR
RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER
ARTICLE 14, OR DAMAGES AVAILABLE FOR BREACH UNDER ARTICLE 16.
17.7 Survival
Any provisions of Article, Sections or Subsections 3.3(e), 12.1, 12.3,
12.5, 14, 16, 17.6, and 17.7 of this Agreement shall survive the
termination or expiration of this Agreement.
ARTICLE 18 FORCE MAJEURE
Each Party shall be excused from the performance of its obligations
under this Agreement to the extent that such performance is prevented
by force majeure, i.e. any events beyond the reasonable control of the
Party which shall include, but not be restricted to, fire, flood,
earthquake, explosion, riot, strike, lockout, war and regulations of
any governmental authority. The affected Party shall promptly provide
notice of such force majeure to the other Party. Such excuse of
performance shall continue for so long as the condition constituting
force majeure continues and solely to the extent the inability to
perform is caused by such condition, and provided that the affected
Party takes reasonable efforts to avoid the affects of such condition
and to perform if possible. Notwithstanding the foregoing, a force
majeure condition shall not excuse Peninsula for making any payments
owed hereunder, unless such force majeure event actually prevents
Peninsula's ability to make such payment. Either Party shall notify the
other Party promptly in the event of any indications of any force
majeure conditions occurring and shall discuss the effect of such
conditions on this Agreement and the measures to be taken. Each Party
shall use its best efforts to reasonably avoid or restrict any
detrimental effects in connection with such incidents.
ARTICLE 19 PUBLIC ANNOUNCEMENT
Either Party shall be free to make a public announcement regarding the
existence of this Agreement but not the terms and conditions hereof. If
a Party wishes to make a public announcement regarding the terms and
conditions of this Agreement, such Party shall provide the other Party
with a copy of any proposed announcement text or other
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relevant information proposed to be published at least sixty (60) days
prior to the scheduled publication date for the other Party to review
and comment.
ARTICLE 20 MISCELLANEOUS
20.1 Notice
Any notice or other communication required or permitted under this
Agreement shall be in writing, in English, addressed to the appropriate
Party at the address given on the first page of this Agreement or to
such other address as may be specified by a Party in accordance with
this Section 20.1, and shall be deemed to have been duly given (a) when
received, if hand-delivered, sent by a reputable overnight service, or
by facsimile (provided that such facsimile is later confirmed in
writing) or, (b) five (5) business days after mailing, if placed in the
mail for delivery by registered or certified mail, return receipt
requested, postage prepaid.
20.2 Entire Agreement/Amendments
This Agreement including the Appendices attached hereto and made a part
hereof embodies the entire agreement between the Parties concerning the
subject matter hereof, and all prior representations, warranties or
agreements relating hereto are hereby terminated and shall be of no
force or effect whatsoever. No amendment, change, modification nor
alteration of the terms and conditions of this Agreement shall be
binding upon either party unless in writing and signed by the Parties.
20.3 Assignment
This Agreement is personal in its nature and neither Party shall assign
any right or obligation hereunder, except those expressly provided
herein, without the prior written consent of the other Party.
Notwithstanding the foregoing, subject to Subsection 17.2 (b), either
Party may assign this Agreement to its successor in interest in
connection with any merger, acquisition, reorganization, consolidation
or sale of all or substantially all of the assets of the business to
which this relates. This Agreement shall be binding upon and, subject
to the terms of the foregoing sentence, inure to the benefit of the
Parties' successors, and permitted assigns.
20.4 Severability
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In case any provision in this Agreement shall be held to be invalid,
illegal, or unenforceable, the validity, legality, and enforceability
of the remaining provision hereof shall not in any way be affected or
impaired thereby.
20.5 Relationship of the Parties.
This Agreement shall not constitute any Party the legal representative
or agent of the other, nor shall any Party have the right or authority
to assume, create, or incur any third-party liability or obligation of
any kind, either express or implied, against, in the name of, or on
behalf of the other except as expressly set forth in this Agreement.
20.6 Headings.
The headings contained in this Agreement have been added for
convenience only and shall not affect the construction, meaning or
interpretation of this Agreement or any of its terms and conditions.
20.7 Counterparts.
This Agreement may be executed in one or more counterparts, each of
which shall be an original and all of which shall constitute together
the same document.
20.8 Export Control.
This Agreement is made subject to any restrictions concerning the
export of products or technical information from the United States of
America or other countries which may be imposed upon or related to
Shionogi or Peninsula from time to time. Each Party agrees that it will
not export, directly or indirectly, any technical information acquired
from the other Party under this Agreement or any products using such
technical information to a location or in a manner that at the time of
export requires an export license or other governmental approval,
without first obtaining the written consent to do so from the
appropriate agency or other governmental entity.
ARTICLE 21 GOVERNING LAW AND DISPUTE RESOLUTION
21.1 Governing Law
This Agreement shall be interpreted and construed in accordance with
the laws of the State of New York, without reference to the principles
of conflict of laws. This Agreement was prepared in the English
language, which language shall govern the interpretation of and any
dispute regarding the terms of the Agreement.
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21.2 Dispute Resolution.
(a) Any controversies, disputes, or claims arising between in the Parties in
connection with this Agreement that the Parties are unable otherwise to
resolve shall be referred to the President of Peninsula and the [*] of
Shionogi or other appropriate officer of Shionogi appointed by Shionogi,
who shall promptly meet and use good faith, diligent efforts to seek to
resolve the matter. If such officers are unable to resolve a matter
presented to them under the preceding sentence within [*] days of
referral, and if such dispute relates to scientific or technical issues,
the Parties shall mutually agree upon an independent third party with an
appropriate scientific background to resolve such dispute. Such
independent third party's decision shall be binding on the Parties. All
other disputes that the officers are unable to resolve shall be referred
to arbitration in accordance with Subsection 21.2(b).
(b) Any controversy or disputes or claims arising between the Parties in
connection with this Agreement which are not scientific or technical and
have not been settled by the officers of the Parties under Subsection
21.2(a) shall be finally settled under the Rules of Arbitration of the
International Chamber of Commerce in Paris, France, by one or more
arbitrators appointed in accordance with said Rules. The arbitration shall
be held in San Francisco (the United States) if requested by Shionogi, or
in Osaka (Japan) if requested by Peninsula. Any award or decision made in
such arbitration shall be final and binding upon the Parties.
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their respective duly authorized officers as of the Effective Date.
For and on behalf of For and on behalf of
Shionogi & Co., Ltd. Peninsula Pharmaceuticals, Inc.
/s/ Xxxxx Xxxxxx /s/ Xxxx X. Xxxxx
------------------------------ ------------------------------
Name: Xxxxx Xxxxxx Name: Xxxx X. Xxxxx
Title: Director and General Manager Title: President
Date: July 11, 2002 Date: July 11, 2002
------------------------- --------------------------
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Appendix I
[Chemical formula of the Compound]
[GRAPHIC]
-28-
Appendix II
[List of Licensed Patents]
UNITED STATES
Patent No. or
Application No. Expiry date*
--------------- ------------
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
CANADA
Patent No. or
Application No. Expiry date*
--------------- ------------
[*] [*]
[*] [*]
[*] [*]
[*] [*]
MEXICO
Patent No. or
Application No. Expiry date*
--------------- ------------
[*] [*]
[*] [*]
* Original term without extension
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Appendix III
I. [*]
II. [*]
III. [*]
IV. [*]
V. [*]
VI. [*]
VII. [*]
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
-30-
Appendix IV
[Development Plan to be separately attached]
-31-
Appendix V
[Specifications of the Licensed Product]
Test Acceptance Limits
---- -----------------
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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