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 dated May 15, 2001 and the
Material Transfer Agreement dated September 18, 2001 (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 March 12, 2002 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;
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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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NOW, THEREFORE, in consideration of the covenants contained herein, the Parties
hereto hereby agree as follows;
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.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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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.
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.
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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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1.11 "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.
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
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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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.
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.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(d) All decisions of the JDC shall be made by unanimous consent. In case the
JDC cannot reach unanimous consent 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
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 the United States of America and Canada. 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.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(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 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
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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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 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 one million eight hundred thousand
US dollars (US$ 1,800,000). Such payments shall be made upon the first
occurrence of each milestone specified below:
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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.
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
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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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.: [*]
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.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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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.
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.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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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 November 1, 2002 or such other date as the Parties may mutually
agree.
8.2 Quality Control and Quality Control Audits
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
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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 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
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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
(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) Based on Peninsula's independent third party inspection of the facilities
at which Shionogi will manufacture Licensed Products, as well as
Peninsula's consultation with experts regarding FDA compliance, Peninsula
agrees that the current manufacturing process for the Licensed Products at
Shionogi's current facilities is sufficient for the manufacture of Clinical
Samples for use in clinical studies of the Licensed Product in
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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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the United States. However, the Parties understand and agree that a [*] to
include the [*] would be beneficial to both Parties. Shionogi agrees that
it [*], in addition to other slight modifications, at [*] in order to
supply Licensed Products in compliance with GMP for commercial sale and/or
for pre-approval inspection by a Regulatory Authority. Accordingly,
Shionogi hereby agrees to use diligent and reasonable efforts to (i) [*] to
its [*], including the [*] to the [*], in order to manufacture the Licensed
Products in compliance with GMP or, in the alternative, (ii) enter into an
agreement with a third party contractor for the manufacture of Licensed
Products in accordance with GMP, no later than [*] years prior to the date
on which Peninsula anticipates launching the first Licensed Product in any
country in the Territory.
(c) If Shionogi foresees that, despite diligent and reasonable efforts, it will
not be able to or otherwise will elect not to manufacture or have
manufactured and supply to Peninsula its requirements of Licensed Products
in compliance with GMP for commercial sale by Peninsula in the Territory,
for any reason, then Shionogi will promptly notify Peninsula in writing of
such situation, but in no event later than [*] years prior to the date on
which Peninsula anticipates launching the first Licensed Product in any
country in the Territory. If Shionogi provides such notice to Peninsula,
Peninsula and Shionogi will immediately convene a meeting to seek all
appropriate means of solution, including without limitation further search
for a possible third party contractor as a source for manufacturing (on
Shionogi's behalf) the Licensed Product to be supplied to Peninsula. In any
event, Shionogi shall manufacture or have manufactured and supply to
Peninsula its requirements of GMP-compliant bulk Compound necessary to
manufacture or have manufactured Licensed Products for commercial sale by
Peninsula in the Territory at a supply price to be negotiated by the
Parties that is appropriate under the circumstances. If the Parties cannot
establish the means of solution within [*] days of convening the first such
meeting, Shionogi is deemed to grant to Peninsula a license in the
Territory with rights to grant sublicenses to third parties, under the
Licensed Patents, Know-How and any other intellectual property Controlled
by Shionogi covering or claiming the manufacture of the Compound and/or the
Licensed Product on commercially reasonable terms and conditions to be
mutually agreed by the Parties, taking into account the circumstances under
which such license is being granted to Peninsula.
9.2 [*]
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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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 September 30, 2002 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.
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.
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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 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.
(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
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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.
(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.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(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 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.
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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 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 Section 14.1, or if
Shionogi fails to comply with the indemnification procedures set forth in
Section 14.3.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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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 injectable carbapenem antibiotics 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:
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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
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This Agreement will become effective as of the Effective Date and continue
to be effective until the later of (a) the expiration of the last to expire
of the Licensed Patents owned or Controlled by Shionogi, or (b) ten (10)
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 dosing for human as to the
Phase II and/or Phase III clinical trials, submitting an NDA or
obtaining Registration Approval 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 not to further develop and/or market the Compound
and/or the Licensed Product or (ii) the acquiring company is
developing and/or marketing any injectable carbapenem antibiotics,
(c) In the event Peninsula materially breaches any of the provisions of
this Agreement and fails to remedy such breach within sixty (60) 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 not feasible to pursue
the development, launch or sale of the Licensed Product due to [*],
and/or [*] reasons, including but not limited to [*] caused by 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
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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effective upon written notice thirty (30) 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 sixty (60) days
after receiving notice thereof from Peninsula, or
(c) Upon thirty (30) 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
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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 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
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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 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
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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
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
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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.
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
[*] = 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 I
[Chemical formula of the Compound]
[*] = 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 II
[List of Licensed Patents]
UNITED STATES
Patent No. or Expiry date*
Application No.
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CANADA
Patent No. or Expiry date*
Application No.
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MEXICO
Patent No. or Expiry date*
Application No.
[*] [*]
[*] [*]
* 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.
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Appendix IV
[Development Plan to be separately attached]
[*] = 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 V
[Specifications of the Licensed Product]
Test Acceptance Limits
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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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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