EXHIBIT 10.13
[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.]
JOINT DEVELOPMENT, LICENSE
AND SUPPLY AGREEMENT
BETWEEN
INSPIRE PHARMACEUTICALS, INC.
AND
KISSEI PHARMACEUTICAL CO., LTD.
DATED AS OF
SEPTEMBER 10, 1998
TABLE OF CONTENTS
-----------------
Page
----
1. DEFINITIONS..............................................................................................1
2. REPRESENTATIONS AND WARRANTIES...........................................................................6
2.1 Representations and Warranties of Both Parties.........................................6
2.2 Representations and Warranties of Inspire..............................................7
2.3 Representations and Warranties of Kissei...............................................7
3. JOINT DEVELOPMENT COMMITTEE..............................................................................8
3.1 Members; Officers. ....................................................................8
3.2 Responsibilities.......................................................................8
3.3 Meetings...............................................................................9
3.4 Decisions.............................................................................10
3.5 Minutes...............................................................................10
3.6 Term. ................................................................................11
3.7 Expenses..............................................................................11
4. JOINT DEVELOPMENT PROGRAM...............................................................................11
4.1 Scope of Joint Development Program....................................................11
4.2 Specific Kissei Responsibilities......................................................11
4.3 Specific Inspire Responsibilities.....................................................12
4.4 Coordinator/Liaison Functions.........................................................13
4.5 Regulatory Matters....................................................................14
4.6 Funding of Joint Development Program. ...............................................15
4.7 Conduct of Joint Development Program..................................................15
4.8 Liability.............................................................................16
5. GRANT OF RIGHTS; COMMERCIALIZATION; MARKETING...........................................................17
5.1 Development Licenses..................................................................17
5.2 Commercialization License. ...........................................................17
5.3 Sublicensing. .......................................................................17
5.4 Grantback Rights. ....................................................................18
5.5 Commercialization Obligations, Rights.................................................19
5.6 Right of First Refusal. ..............................................................19
5.7 Adverse Reaction Reporting. .........................................................19
6. FEES, MILESTONES AND ROYALTIES..........................................................................21
6.1 Up-front Payment. ...................................................................21
6.2 Coordinator/Liaison Fees..............................................................21
6.3 Milestone Payments....................................................................22
(i)
6.4 Transfer Price........................................................................22
6.5 Royalty Payments. ....................................................................23
6.6 Obligation to Pay Royalties...........................................................23
7. PAYMENTS AND REPORTS....................................................................................24
7.1 Payments..............................................................................24
7.2 Mode of Payment. .....................................................................24
7.3 Records Retention.....................................................................24
7.4 Audit Request.........................................................................24
7.5 Cost of Audit.........................................................................25
7.6 No Non-Monetary Consideration for Sales...............................................25
7.7 Taxes.................................................................................26
8. MANUFACTURE AND SUPPLY..................................................................................26
8.1 Commercial Supply Agreement. .........................................................26
9. OWNERSHIP; PATENTS......................................................................................26
9.1 Ownership. ..........................................................................26
9.2 Patent Maintenance....................................................................27
9.3 Patent Enforcement....................................................................28
9.4 Infringement Action by Third Parties. ...............................................28
10. PUBLICATION; CONFIDENTIALITY............................................................................29
10.1 Notification..........................................................................29
10.2 Review................................................................................29
10.3 Exclusions............................................................................30
10.4 Confidentiality; Exceptions...........................................................30
10.5 Exceptions to Obligation. ............................................................30
10.6 Limitations on Use....................................................................31
10.7 Remedies..............................................................................31
11. INDEMNIFICATION.........................................................................................31
11.1 By Kissei.............................................................................31
11.2 By Inspire............................................................................32
11.3 Notice................................................................................32
11.4 Complete Indemnification. ............................................................32
12. TERM; TERMINATION.......................................................................................32
12.1 Term..................................................................................32
(ii)
12.2 Termination for Cause.................................................................33
12.3 Termination by Kissei.................................................................33
12.4 Effect of Expiration or Termination...................................................33
12.5 Accrued Rights; Surviving Obligations.................................................35
13. FORCE MAJEURE...........................................................................................35
13.1 Events of Force Majeure...............................................................35
14. MISCELLANEOUS...........................................................................................36
14.1 Relationship of Parties. ............................................................36
14.2 Assignment............................................................................36
14.3 Books and Records.....................................................................36
14.4 Further Actions.......................................................................36
14.5 Notice. .............................................................................36
14.6 Use of Name. .........................................................................37
14.7 Public Announcements..................................................................37
14.8 Waiver................................................................................38
14.9 Compliance with Law. .................................................................38
14.10 Severability..........................................................................38
14.11 Amendment.............................................................................38
14.12 Governing Law; English Original Controlling...........................................38
14.13 Arbitration. .........................................................................38
14.14 Entire Agreement......................................................................39
14.15 Parties in Interest. ................................................................39
14.16 Descriptive Headings..................................................................39
14.17 Counterparts..........................................................................39
(iii)
TABLE OF CONTENTS - continued
-----------------------------
EXHIBITS
--------
EXHIBIT A INSPIRE'S COSTS
EXHIBIT B INITIAL PATENTS
EXHIBIT C INITIAL MEMBERS OF JOINT DEVELOPMENT
COMMITTEE
EXHIBIT D TERMS AND CONDITIONS OF THE COMMERCIAL
SUPPLY AGREEMENT
(iv)
JOINT DEVELOPMENT, LICENSE
AND SUPPLY AGREEMENT
THIS JOINT DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT (this "Agreement"),
dated as of September 10, 1998, is entered into by and between Inspire
Pharmaceuticals, Inc., a corporation organized and existing under the laws of
the State of Delaware, having offices located at 0000 Xxxxxxx Xxxxxxxxx, Xxxxx
000, Xxxxxx, Xxxxx Xxxxxxxx 00000, XXX ("Inspire"), and Kissei Pharmaceutical
Co., Ltd., a corporation organized under the laws of Japan, having offices
located at 00-00, Xxxxxxx, Xxxxxxxxx-Xxxx, Xxxxxx-Xxxxxxxxxx, 000-0000, Xxxxx
("Kissei").
PRELIMINARY STATEMENTS
----------------------
A. Inspire owns, and/or has exclusive rights to, the Patents and Know-How
in existence as of the Effective Date relating to the Compound. In addition,
Inspire has the expertise necessary to coordinate the worldwide development and
manufacture of the Product.
B. Kissei has the personnel, facilities and expertise necessary for the
development and commercialization of the Product in the Territory.
C. The Parties wish to collaborate to develop, commercialize and market
the Product, upon the terms and conditions set forth in this Agreement. In
connection therewith, Kissei desires to obtain, and Inspire desires to grant to
Kissei, an exclusive license under the Licensed Technology with respect to the
development and commercialization of the Product in the Territory for
applications in the Field, subject to Inspire's right to manufacture and supply
Finished Product and Delivery Systems for Kissei, all on the terms and
conditions set forth below.
D. Simultaneously with the execution of this Agreement, the Parties are
entering in that certain Stock Purchase Agreement (the "Stock Purchase
Agreement") and documents ancillary thereto, all dated of even date herewith,
pursuant to which Kissei is purchasing shares of Series C Preferred Stock of
Inspire.
NOW, THEREFORE, in consideration of the foregoing Preliminary Statements
and the mutual agreements and covenants set forth herein, the Parties hereby
agree as follows:
1. DEFINITIONS.
As used in this Agreement, the following terms shall have the meanings set
forth in this Section 1 unless context dictates otherwise:
1
1.1 "Affiliate," with respect to any Party, shall mean any entity
controlling, controlled by, or under common control with, such Party. For these
purposes, "control" shall refer to (i) the possession, directly or indirectly,
of the power to direct the management or policies of an entity, whether through
the ownership of voting securities, by contract or otherwise, or (ii) the
ownership, directly or indirectly, of at least 50% of the voting securities or
other ownership interest of an entity.
1.2 "Annual Development Plan" shall have the meaning assigned to such term
in Section 4.1(a).
1.3 "Cassette" shall mean a disposable self-contained unit to be filled
with a quantity of Formulated Material sufficient to provide the number of doses
as approved by the Joint Development Committee pursuant to Section 3.2(f) (e.g.,
sufficient for dosing for one week).
1.4 "cGMP" shall mean current Good Manufacturing Practice as defined in
Parts 210 and 211 of Title 21 of the Code of Federal Regulations, as may be
amended from time to time, or any successor thereto.
1.5 "Compound" shall mean the chemical compound designated as INS365,
whose chemical name is P1, P4-Di(uridine 5'-tetraphosphate), and all sodium
salts thereof.
1.6 "Compound Specifications" shall mean the specifications for the
Compound approved by the Joint Development Committee in consideration of the
regulatory requirements in the Territory, as may be amended from time to time.
1.7 "Confidential Information" shall have the meaning assigned to such
term in Section 10.4.
1.8 "Cost of Compound" shall mean Inspire's fully burdened costs
associated with the manufacture of the Compound, as determined pursuant to
Exhibit A.
1.9 "Cost of Delivery Systems" shall mean Inspire's fully burdened costs
associated with the manufacture of the Delivery System, as determined pursuant
to Exhibit A.
1.10 "Cost of Finished Product" shall mean Inspire's fully burdened costs
associated with the manufacture of the Finished Product, including without
limitation, the Cost of Formulated Material and the costs associated with
assembly of the Finished Product, as determined pursuant to Exhibit A.
1.11 "Cost of Formulated Material" shall mean Inspire's fully burdened
costs associated with the manufacture of the Formulated Material, as determined
pursuant to Exhibit A.
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1.12 "Delivery System" shall mean the novel delivery system designed to
deliver Formulated Material contained within a Cassette to the lungs via
inhalation and to be reusable for at least one year, as approved by the Joint
Development Committee pursuant to Section 3.2(f).
1.13 "Delivery System Specifications" shall mean the specifications for
the Delivery System approved by the Joint Development Committee in consideration
of the regulatory requirements in the Territory, as may be amended from time to
time.
1.14 "Development Coordinator/Liaison" shall have the meaning assigned to
such term in Section 4.4(a).
1.15 "Effective Date" shall mean the date of this Agreement.
1.16 "Executive Officers" shall have the meaning assigned to such term in
Section 3.4(b).
1.17 "Field" shall mean the treatment (but not the diagnosis) of
respiratory diseases in humans, excluding otitis media and sinusitis.
1.18 "Finished Product" shall mean the Formulated Material: (i) loaded
into a Cassette, for use with a Delivery System, or (ii) contained in a
vial/nebule for use with standard nebulizers.
1.19 "Finished Product Specifications" shall mean the specifications for
the Finished Product approved by the Joint Development Committee in
consideration of the regulatory requirements in the Territory, and such other
packaging and labeling specifications as are agreed upon by the Joint
Development Committee or the Parties, as the case may be, for the Finished
Product, as may be amended from time to time.
1.20 "First Commercial Sale" shall mean, with respect to any Product, the
first sale for use or consumption by the general public of such Product in the
Territory after all required NDA Approvals have been granted, or, if such sale
is otherwise permitted, by the Regulatory Authority in the Territory.
1.21 "Formulated Material" shall mean any inhalation formulation of any
product containing the Compound as an active ingredient.
1.22 "Formulated Material Specifications" shall mean the specifications
for the Formulated Material approved by the Joint Development Committee in
consideration of the regulatory requirements in the Territory, as may be amended
from time to time.
1.23 "FTE" shall mean a full-time equivalent employee of Inspire assigned
to conduct coordination/liaison activities pursuant to Section 4.4, including
scientists, professionals or the like, but excluding non-technical, non-
professional personnel such as secretarial staff. As used herein,
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a "full-time equivalent" shall mean a full-time person, or in the case of less
than a full- time dedicated person, a full-time, equivalent person year, based
upon a total of 1,880 hours per year of work related to such activities.
1.24 "Improved Analog" shall mean any dinucleotide P2Y2 receptor agonist
which has utility as an inhalation product for use in the Field.
1.25 "IND" shall mean any filing made with the Regulatory Authority in the
Territory for initiating clinical trials in the Territory with respect to the
Product.
1.26 "Invention" shall mean any new or useful process, manufacture,
compound or composition of matter relating to the Compound or the Product
(including, without limitation, the formulation, delivery or use thereof),
whether patentable or unpatentable, or any improvement thereof, that is
conceived or first reduced to practice or demonstrated to have utility during
the term of, and in connection with, the Joint Development Program.
1.27 "Joint Development Committee" shall have the meaning assigned to such
term in Section 3.1.
1.28 "Joint Development Program" shall mean the joint development program
with respect to the Product conducted by Kissei in collaboration with Inspire
pursuant to Section 4.
1.29 "Know-how" shall mean any and all Inventions, improvements,
discoveries, claims, formulae, processes, trade secrets, technologies and know-
how (including confidential data and Confidential Information) which is
generated, owned or controlled by Inspire at any time before or during the term
of this Agreement relating to, derived from or useful for the use or sale of the
Compound or the Product, including, without limitation, synthesis, preparation,
recovery and purification processes and techniques, control methods and assays,
chemical data, toxicological and pharmacological data and techniques, clinical
data, medical uses, product forms and product formulations and specifications.
1.30 "Licensed Claim" shall mean any claim of any Patent that relates to
and is necessary for the use and sale of the Compound or the Product, which
claim has not been held invalid or unenforceable by decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, and which is not admitted to be invalid through
disclaimer or otherwise not admitted by Inspire to be invalid.
1.31 "Licensed Technology" shall mean the Licensed Claims and Know-how,
collectively.
1.32 "Manufacturing Coordinator/Liaison" shall have the meaning assigned
to such term in Section 4.4(b).
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1.33 "Manufacturing Standards" shall mean, with respect to the Finished
Product and Delivery System, cGMP and such additional manufacturing
specifications or standards as may be established by mutual agreement of the
Parties from time to time.
1.34 "NDA" shall mean any filing of a New Drug Application made with the
Regulatory Authority in the Territory for NDA Approval with respect to the
Product.
1.35 "NDA Approval" shall mean approval of the NDA for the Product filed
in the Territory, including pricing or reimbursement, where applicable, by the
Regulatory Authority in the Territory.
1.36 "Net Sales" shall mean, with respect to the Product, the gross amount
invoiced for the Product by Kissei, its Affiliates and Sublicensees, if any, in
arm's length sales to Third Parties, commencing with the First Commercial Sale
of the Product, less deductions for: (i) trade, quantity and/or cash discounts,
allowances and rebates actually allowed or given; (ii) freight, postage,
shipping insurance and other transportation expenses (if separately identified
in such invoice); (iii) credits or refunds actually allowed for rejections,
defects or recalls of such Product, outdated or returned Product, or because of
rebates or retroactive price reductions; and (iv) sales, value-added, excise
taxes, tariffs and duties, and other taxes directly related to the sale, to the
extent that such items are included in the gross invoice price (but not
including taxes assessed against the income derived from such sale). Such
amounts shall be determined from the books and records maintained by Kissei, its
Affiliates or Sublicensees, as applicable.
1.37 "Party" shall mean Inspire or Kissei and, when used in the plural,
shall mean Inspire and Kissei.
1.38 "Patents" shall mean the patents set forth on Exhibit B, and any
other patents or patent applications in the Territory owned or controlled by
Inspire during the term of this Agreement that relate to the Compound or the
Product, together with any patents that may issue therefor in the Territory,
including any and all extensions, renewals, continuations, continuations-in-
part, divisions, patents-of-additions, reissues, supplementary protection
certificates or foreign counterparts of any of the foregoing.
1.39 "Product" shall mean any system which consists of Finished Product
and the Delivery System or Finished Product for use with standard nebulizers,
for use in the Field, the manufacture, use or sale of which either is: (i) based
upon, derived from or related to any of the Know-how; and/or (ii) covered by one
or more Licensed Claims and, but for this Agreement, would constitute an
infringement (whether directly, contributorily or by inducement) thereof.
1.40 "Regulatory Authority" shall mean the authority(ies) in the Territory
with responsibility for granting regulatory approval for the marketing and sale
of the Product in the Territory, and any successor(s) thereto.
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1.41 "Specifications" shall mean the Compound Specifications, the
Formulated Material Specifications, Finished Product Specifications or the
Delivery System Specifications, either respectively or collectively, as context
may dictate.
1.42 "Stock Purchase Agreement" shall have the meaning assigned to such
term in the Preliminary Statements.
1.43 "Strategic Partners" shall have the meaning assigned to such term in
Section 4.4(a).
1.44 "Sublicensee" shall mean a Third Party to which Kissei has granted a
sublicense to develop, use or sell the Product in the Territory, or who acts as
a distributor of Kissei for the resale of any Product to the trade in the
Territory, pursuant to Section 5.3.
1.45 "Supplied Goods" shall have the meaning assigned to such term in
Section 8.1.
1.46 "Supply Agreement" shall have the meaning assigned to such term in
Section 8.1.
1.47 "Territory" shall mean Japan.
1.48 "Testing Methods" shall have the meaning assigned to such term in
Section 5(c) of Exhibit D.
1.49 "Third Party" shall mean any person who or which is neither a Party
nor an Affiliate of a Party.
1.50 "Third Party Manufacturer" shall have the meaning assigned to such
term in Section 7(a) of Exhibit D.
1.51 "Transfer Price" shall have the meaning assigned to such term in
Section 6.4.
1.52 [CONFIDENTIAL TREATMENT REQUESTED].
2. REPRESENTATIONS AND WARRANTIES.
2.1 Representations and Warranties of Both Parties. Each Party
represents and warrants to the other Party, as of the Effective Date, that:
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(a) such Party is duly organized and validly existing under the laws
of the jurisdiction of its incorporation and has full corporate power and
authority to enter into this Agreement and to carry out the provisions hereof;
(b) such Party is free to enter into this Agreement;
(c) in so doing, such Party will not violate any other agreement to
which it is a party;
(d) such Party has taken all corporate action necessary to authorize
the execution and delivery of this Agreement and the performance of its
obligations under this Agreement; and
(e) no person or entity has or will have, as a result of the
transactions contemplated by this Agreement, any right, interest or valid claim
against or upon such Party for any commission, fee or other compensation as a
finder or broker because of any act or omission by such Party or any of its
agents.
2.2 Representations and Warranties of Inspire. Inspire represents and
warrants to Kissei, as of the Effective Date, that:
(a) Inspire is the owner of, or has exclusive rights to, all of the
Patents in existence on the Effective Date, and has the exclusive right to grant
the licenses granted under this Agreement therefor;
(b) to the best of Inspire's knowledge, Inspire has exclusive rights
to all of the Know-how in existence on the Effective Date and the exclusive
right to grant licenses with respect thereto; and
(c) Inspire has not entered into any agreement with any Third Party
which is in conflict with the rights granted to Kissei pursuant to this
Agreement.
2.3 Representations and Warranties of Kissei. Kissei represents and
warrants to Inspire, as of the Effective Date, that:
(a) Kissei has the facilities, personnel and experience sufficient in
quantity and quality to perform its obligations under this Agreement;
(b) All of the personnel assigned to perform such obligations shall be
qualified and properly trained; and
(c) Kissei shall perform such obligations in a manner commensurate
with professional standards generally applicable in its industry.
-7-
3. JOINT DEVELOPMENT COMMITTEE.
3.1 Members; Officers. The Parties shall establish a joint development
committee (the "Joint Development Committee"), which shall consist of six
members, three members from each Party. At least one member from each Party
must be a clinical development professional. The initial members of the Joint
Development Committee are set forth on Exhibit C. Members of the Joint
Development Committee may be represented at any meeting by a designee appointed
by such member for such meeting. The chairperson and secretary of the Joint
Development Committee shall serve coterminous one-year terms, each commencing on
the Effective Date or an anniversary thereof, as the case may be. The right to
name the chairperson and the secretary of the Joint Development Committee shall
alternate between the Parties, and each chairperson and secretary shall be named
no later than 10 days after the commencement of his or her term. The initial
chairperson shall be selected by Kissei and is designated on Exhibit C. The
initial secretary shall be selected by Inspire and is designated on Exhibit C.
Each Party shall be free to change its members, on prior written notice to the
other Party. Each Party may, in its discretion, invite non-member
representatives of such Party to attend meetings of the Joint Development
Committee, provided that the other Party approves such Party's invitee(s) in
advance.
3.2 Responsibilities. Subject to the other terms of this Agreement, the
Joint Development Committee shall oversee the development of the Product
pursuant to this Agreement, from the commencement of any development efforts
through the date on which all NDA Approvals in the Territory for the Product
actively being sought have been obtained. After all such NDA Approvals have
been obtained, the Parties shall continue to collaborate in complying with all
regulatory requirements of maintaining such NDA Approvals (including post-
marketing surveillance and adverse event reporting). Without limiting the
generality of the foregoing, the Joint Development Committee shall:
(a) plan, supervise and coordinate the development of the Product
under this Agreement;
(b) commencing on the Effective Date, discuss and prepare an Annual
Development Plan for the first year of the term of the Joint Development Program
and, not later than 90 days after the Effective Date, finalize an Annual
Development Plan for the first year of the term of the Joint Development
Program;
(c) not later than three months prior to each anniversary of the
Effective Date during the term of the Joint Development Program, discuss and
prepare an Annual Development Plan, and, prior to each anniversary of the
Effective Date during the term of the Joint Development Program, finalize an
Annual Development Plan for the next year of the term of the Joint Development
Program;
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(d) determine whether to approve proposed amendments or modifications
to any Annual Development Plan;
(e) review and determine whether to approve clinical study protocols,
the selection of clinical investigators, clinical study write-ups, regulatory
submissions, NDAs and the like relating to the Joint Development Program;
(f) review and determine whether to approve the final design of the
Cassette and the Delivery System;
(g) evaluate data from the Joint Development Program;
(h) review all proposed publications and presentations of the Parties
pursuant to Section 10.2;
(i) review all studies relating to the Product and any other studies
proposed to be performed in connection with the registration process for the
Product under this Agreement;
(j) allocate responsibilities between the Parties, coordinate the
activities of the Parties, and review and evaluate progress, all under the Joint
Development Program, provided that the Joint Development Committee shall not
have authority to make any determination that either Party is in breach of its
obligations under the Joint Development Program;
(k) determine, review and amend, from time to time, the
Specifications;
(l) provide a mechanism for the exchange of information between the
Parties with regard to Know-how and Inventions;
(m) resolve disputes between the Parties with respect to the
foregoing; and
(n) have such other responsibilities as may be assigned to the Joint
Development Committee pursuant to this Agreement or as may be mutually agreed
upon by the Parties from time to time.
3.3 Meetings. During the term of the Joint Development Program and the
12-month period thereafter, the Joint Development Committee shall meet at least
twice during every calendar year, and more frequently as the Parties deem
appropriate, on such dates, and at such places and times, as the Parties shall
agree. During each calendar year during the term of the Joint Development
Program and the 12-month period thereafter, meetings of the Joint Development
Committee shall be held in Japan, North Carolina or such other place as the
Parties may agree. Thereafter, during the remainder of the term of this
Agreement, the Joint Development Committee shall meet on an as needed basis on
such dates, and at such places and times, as the Parties shall agree. The
chairperson
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shall, if practicable, send notice of all meetings to all members of the Joint
Development Committee no less than 20 days before the date of each meeting. The
Joint Development Committee may also convene or be polled or consulted from time
to time by means of telecommunications, video conferences or correspondence, as
deemed necessary or appropriate; provided, however, that the Joint Development
Committee must meet in person at least twice every calendar year during the term
of the Joint Development Program and the 12-month period thereafter.
3.4 Decisions.
(a) The Joint Development Committee may make decisions with respect to
any subject matter that is subject to the Joint Development Committee's
decision-making authority. All decisions of the Joint Development Committee
shall be made by consensus of the members (or their designees) present at any
meeting.
(b) In the event that consensus cannot be reached by the Joint
Development Committee after good faith discussions with respect to a matter that
is subject to its decision-making authority, the matter shall be referred for
further review and resolution to the Vice Chairman of the Board, currently Xx.
Xxxxx Xxxxx, at Inspire, or such other similar position designated by Inspire
from time to time, and the Managing Director, R&D, currently Dr. Masanori
Iwadare, at Kissei, or such other similar position designated by Kissei from
time to time (such officers collectively, the "Executive Officers"). The
Executive Officers shall use reasonable efforts to resolve the matter within 30
days after the matter is referred to them.
3.5 Minutes. Promptly after each Joint Development Committee meeting,
the chairperson or the secretary of Inspire shall prepare and distribute to all
members of the Joint Development Committee draft minutes of the meeting within
10 days after the meeting. Such minutes shall provide a description, in
reasonable detail, of the discussions had at the meeting and a list of any
actions, decisions or determinations approved by the Joint Development Committee
and a list of any issues to be resolved by the Executive Officers. The
chairperson or the secretary of Kissei shall then have 10 days after receiving
such draft minutes to collect Kissei members= comments thereon and provide them
to the chairperson or the secretary of Inspire. Upon the expiration of such
second 10-day period, the chairperson and the secretary of the Joint Development
Committee shall have an additional 10 days to discuss each other's comments and
finalize the minutes. The secretary and chairperson shall each sign and date
the final minutes. The signature of the chairperson and the secretary upon the
final minutes shall indicate each Party=s assent to the minutes. With the sole
exception of specific items of the meeting minutes to which the chairperson and
the secretary cannot agree and which are escalated as provided below, definitive
minutes of all Joint Development Committee meetings shall be finalized no later
than 30 days after the meeting to which the minutes pertain. If at any time
during the preparation and finalization of Joint Development Committee meeting
minutes the secretary and the chairperson do not agree on any issue with respect
to the minutes, such issue shall be resolved by the escalation process provided
in Section 3.4(b). The decision resulting from the escalation process shall be
recorded by the chairperson or the secretary
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of Inspire in amended finalized minutes for said meeting. All other issues in
the minutes which are not subject to such escalation shall be finalized within
the above-mentioned 30-day period.
3.6 Term. The Joint Development Committee shall exist until the
termination or expiration of the Joint Development Program and for such longer
period as necessary to perform the responsibilities assigned to it under this
Agreement.
3.7 Expenses. Each Party shall be responsible for all travel and
related costs and expenses for its members and approved invitees to attend
meetings of, and otherwise participate on, the Joint Development Committee.
4. JOINT DEVELOPMENT PROGRAM.
4.1 Scope of Joint Development Program.
(a) The Joint Development Committee, acting in accordance with
Sections 3.2(b) and (c), shall prepare and provide to each Party, in form and
substance mutually acceptable to each Party, a detailed description of the
specific actions to be taken under the Joint Development Program during the
upcoming year, which shall include a reasonably detailed description of the
goals and scope of such research, the allocation of responsibilities to the
respective Parties and a research plan (each, an "Annual Development Plan").
(b) If the Joint Development Committee fails to agree on an Annual
Development Plan: (i) the Parties nevertheless shall continue to fund the Joint
Development Program in accordance with Section 4.6; (ii) each Party nevertheless
shall continue to conduct the Joint Development Program in accordance with the
goals and scope of such research as reasonably determined by such Party, within
the scope of the Joint Development Program conducted to date (or, with respect
to the first year of the Joint Development Program, within the scope of this
Agreement); and (iii) Inspire nevertheless shall continue to supply Compound,
Finished Product and Delivery Systems necessary for the conduct of the Joint
Development Program in accordance with this Section 4.
4.2 Specific Kissei Responsibilities. As part of the Joint Development
Program, and pursuant to the Annual Development Plans, Kissei shall:
(a) Conduct, or cause to be conducted, manage and oversee any pre-
clinical studies, or additional pre-clinical studies, required by the Regulatory
Authorities in order to file an NDA for the Product in the Territory; (b)
Conduct, or cause to be conducted, manage and oversee all clinical studies
required by the Regulatory Authorities in order to obtain NDA Approvals for the
Product in the Territory;
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(c) Make all regulatory filings, based on the information and
documentation provided by Inspire, and conduct all analysis and other support
necessary with respect to the manufacture of the Finished Product, Delivery
Systems or Product in the Territory; and
(d) Perform such other obligations with respect to the Joint
Development Program as the Joint Development Committee may assign to it from
time to time.
4.3 Specific Inspire Responsibilities. As part of the Joint Development
Program and pursuant to the Annual Development Plans, Inspire shall:
(a) Immediately after the Effective Date, provide to Kissei copies of
all pre-clinical and clinical data, studies and materials in Inspire's
possession and control that relate to the development and commercialization of
the Product;
(b) Thereafter provide to Kissei copies of all data, studies and
material that come into Inspire's possession and control during the term of this
Agreement that relate to the development and commercialization of the Product
(including, without limitation, such data, studies and materials of Strategic
Partners, to the extent Inspire has the right to provide same to Kissei);
(c) In consultation with Kissei, finalize the design of and the
manufacturing process for the Delivery System and the Finished Product, subject
to review and approval of the Joint Development Committee;
(d) In consultation with Kissei, make all necessary changes to: (i)
the formulation, chemistry, manufacturing process and manufacturing controls
for the Compound, Formulated Material and Finished Product; and (ii) the design
and manufacturing method for the Delivery System and the Finished Product,
subject in each case to review and approval of the Joint Development Committee;
(e) Supply Kissei or its designee(s) with sufficient quantities of
the Compound and/or the Formulated Material to complete all pre-clinical studies
of the Product in which Kissei is required to engage by the applicable
Regulatory Authorities until the filing of, or the affirmative decision of the
Joint Development Committee not to pursue, an IND with respect to the Product in
the Territory. Such Compound and/or Formulated Material shall be supplied in
accordance with quarterly forecasts therefor provided by Kissei at least 180
days prior to the anticipated delivery date for each shipment thereof, provided,
however, in the event that Kissei requires Compound and/or Formulated Material
in fewer than 180 days, Kissei shall notify Inspire of such need and Inspire
will use all reasonable efforts to meet Kissei's delivery request;
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(f) Supply Kissei or its designee(s) with sufficient quantities of
Finished Product and Delivery Systems to complete all clinical studies and all
development, analysis, regulatory support, cGMP and all other NDA Approval-
related activities with respect to the Product in which Kissei is required to
engage by applicable law or regulation until the commercial launch, or the
affirmative decision of the Joint Development Committee not to pursue the
commercial launch, of the Product in the Territory. Such Finished Product and
Delivery Systems shall be supplied in accordance with quarterly forecasts
therefor provided by Kissei at least 180 days prior to the anticipated delivery
date for each shipment of Finished Product or Delivery Systems, provided,
however, in the event that Kissei requires Finished Product and/or Delivery
Systems in fewer than 180 days, Kissei shall notify Inspire of such need and
Inspire will use all reasonable efforts to meet Kissei's delivery request;
(g) As Inspire and its Third Party Manufacturers gain knowledge and
experience in producing the pre-clinical and clinical supplies required pursuant
to Sections 4.3(e) and (f), use reasonable efforts to reduce the lead time
needed to manufacture Compound, Formulated Material, Finished Product and/or
Delivery Systems such that Inspire could be in a position to meet Kissei's
delivery requirements on fewer than 180 days prior notice;
(h) Designate and maintain coordinator/liaisons in accordance with
Section 4.4;
(i) Negotiate in good faith with all relevant Strategic Partners to
obtain the right to: (i) disclose to Kissei all Third Party data or information
owned by such Strategic Partners that this Agreement contemplates will be shared
with Kissei to the extent that Inspire has the right to do so, and (ii) grant
Kissei the right to cross-reference regulatory filings owned by such Strategic
Partners that this Agreement contemplates will be granted to Kissei to the
extent that Inspire has the right to do so; and
(j) Perform such other obligations with respect to the Joint
Development Program as the Joint Development Committee may assign to it from
time to time.
4.4 Coordinator/Liaison Functions. Within 90 days after the Effective
Date, Inspire shall designate two FTEs, to be funded by Kissei pursuant to
Section 6.2, who shall perform the following functions:
(a) One FTE shall serve as a project manager (the "Development
Coordinator/Liaison") who shall be responsible for coordinating, and
facilitating communication regarding, the worldwide development of the Product
among Inspire, Kissei and Inspire's other strategic partners and/or licensees
(collectively, "Strategic Partners"). Inspire shall continue to provide a
Development Coordinator/Liaison until NDA Approval for the Product is received,
or definitively abandoned, in the Territory, whichever occurs first; and
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(b) The second FTE shall serve as a project manager (the "Manufacturing
Coordinator/Liaison") who shall be responsible for coordinating, and
facilitating communication regarding, the design and development of the Delivery
System and the Finished Product, the manufacture of the Compound, the
formulation of the Formulated Material and the manufacture of the Product among
Inspire, Kissei and Inspire's Strategic Partners. Inspire shall continue to
provide a Manufacturing Coordinator/Liaison until Kissei files the NDA for the
Product with the Regulatory Authority in the Territory , or until definitely
abandoned, whichever occurs first. Thereafter Inspire shall continue to provide
a Manufacturing Coordinator/Liaison as and when determined by the Joint
Development Committee.
Each such coordinator/liaison shall maintain regular communication with Kissei
and each of Inspire's Strategic Partners with respect to the matters for which
such coordinator/liaison is responsible. Such communication may include
attendance of meetings and telephone conferences to be held from time to time,
at the request and convenience of the Parties and any Third Parties involved.
4.5 Regulatory Matters.
(a) Kissei shall be responsible for preparing and filing INDs, NDAs
and other regulatory filings for the Product in the Territory up to and
including NDA Approval, and thereafter shall be responsible for maintaining such
NDA Approvals. All such filings shall be in Kissei's name.
(b) Kissei shall own all INDs, NDAs, NDA Approvals and other
regulatory filings for the Product in the Territory.
(c) In order to assist Kissei in the performance of its obligations
under this Section 4.5, Inspire, to the extent it has the right to do so, shall
provide Kissei or its designee(s) with complete copies (or copies of relevant
portions) of, and shall grant Kissei or its designee(s), free of charge, the
right to cross-reference, any INDs, NDAs, NDA Approvals or other regulatory
filings made or held in any country in North America and Europe for the Product.
Inspire shall execute, acknowledge and deliver such further instruments, and
shall do all such other acts, all as promptly as possible after Kissei's request
therefor, that may be necessary or appropriate to effectuate such right in each
such country. Inspire shall not guarantee or warrant that the information and
documents provided to Kissei under this Section shall be useful or effective or
free from any defect.
(d) Kissei shall provide Inspire with complete copies (or copies of
relevant portions) of, and shall grant Inspire free of charge the right to
cross-reference any INDs, NDAs, NDA Approvals or other regulatory filings made
or held in the Territory in the name of Kissei (or that of its Affiliates or
Sublicensees) reasonably necessary or useful to enable Inspire to market
products either within the Territory and outside the Field, or outside the
Territory. Kissei shall execute, acknowledge and deliver such further
instruments, and shall do all such other acts, all as promptly as possible after
Inspire's request therefor, that may be necessary or appropriate to effectuate
such right in the Territory. Kissei also shall provide such copies and such
right to cross-
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reference, free of charge, to any Strategic Partner that grants Kissei or its
designee(s) the right to cross-reference such Strategic Partner's INDs, NDAs,
NDA Approvals or other regulatory filings made or held in any countries in North
America and/or Europe to enable such Strategic Partner to market products
outside the Territory in North America and Europe, and any other countries in
which such Strategic Partners hold such rights. Moreover, Kissei shall provide
such copies and such right to cross-reference, with a reasonable charge, to any
Strategic Partner that does not have rights in any countries in North America
and/or Europe to enable such Strategic Partner to market products outside the
Territory in such countries. Kissei shall not guarantee or warrant that the
information and documents provided to Inspire under this Section shall be useful
or effective or free from any defect.
(e) Kissei shall keep Inspire informed as to the status of all
regulatory filings made pursuant to this Section 4.5, permit Inspire to review
any revisions to any filings or communications with Regulatory Authorities
during their preparation and shall confer with Inspire regarding the preparation
of such filings, communications with Regulatory Authorities and other matters
pertaining to or affecting the registration process.
(f) In connection with any IND or NDA filed by Kissei pursuant to this
Section 4.5, Kissei shall notify Inspire as soon as reasonably possible of any
meeting with the Regulatory Authority in the Territory scheduled by Kissei
(which notification shall describe the subject matter of any such meeting),
shall permit Inspire to assist Kissei in the preparation for any such meeting
and shall promptly advise Inspire in writing of the outcome of any such meeting.
4.6 Funding of Joint Development Program.
(a) Except as otherwise expressly provided in this Agreement, each
Party shall bear the entire cost and expense it incurs in connection with
fulfillment of its obligations under the Joint Development Program.
(b) Kissei shall pay [CONFIDENTIAL TREATMENT REQUESTED], as the case
may be, in connection with the manufacture and supply of Compound, Formulated
Material, Finished Product and Delivery Systems pursuant to Sections 4.3(e) and
(f). Inspire shall be entitled to invoice Kissei therefor following shipment of
such Compound, Formulated Material, Finished Product and Delivery Systems from
time to time. Payment shall be made by Kissei in U.S. Dollars within 30 days
after Kissei's receipt of each invoice therefor, by telegraphic transfer
remittance.
4.7 Conduct of Joint Development Program. The Parties, acting in
accordance with this Section 4 and relevant Annual Development Plans, shall use
all commercially reasonable efforts to develop the Product in the Territory.
Kissei, acting in accordance with this Section 4 and relevant Annual Development
Plans, shall use all commercially reasonable efforts to obtain NDA Approvals
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necessary to market and sell the Product in the Territory. Without limiting the
generality of the foregoing, during the term of the Joint Development Program,
each Party shall:
(a) undertake an interactive, cooperative Joint Development Program
with the other Party as set forth in the applicable Annual Development Plan, and
such other activities that, from time to time, the Joint Development Committee
decides are necessary for the commercial success of the Joint Development
Program;
(b) use all reasonable efforts and proceed diligently to perform the
work set out for such Party to perform in the Annual Development Plan,
including, without limitation, by using personnel with sufficient skills and
experience, together with sufficient equipment and facilities (it being
acknowledged that neither Party shall have an obligation to acquire additional
equipment or to expand its facilities in order to perform its obligations under
the Joint Development Program);
(c) conduct the Joint Development Program in good scientific manner,
and in compliance in all material respects with all requirements of applicable
laws, rules and regulations, and all other requirements of any applicable
current good clinical practice, good laboratory practice and current good
manufacturing practice to attempt to achieve the objectives of the Joint
Development Program efficiently and expeditiously;
(d) within 30 days after the end of each six-month period during the
term of the Joint Development Program and within 30 days following the
expiration or termination of the Joint Development Program, furnish the Joint
Development Committee with reasonably detailed, written reports on all
activities conducted by such Party under the Joint Development Program during
such six-month period or the term of the Joint Development Program, as the case
may be;
(e) maintain records, in sufficient detail and in good scientific
manner, which shall be complete and accurate and shall fully and properly
reflect all work done and results achieved in connection with the Joint
Development Program in the form required under all applicable laws and
regulations. Each Party shall have the right, during normal business hours and
upon reasonable notice, to inspect and copy all such records. Each Party shall
maintain such records and information contained therein in confidence in
accordance with Section 10 and shall not use such records or information except
to the extent otherwise permitted by this Agreement; and
(f) allow representatives of the other Party, upon reasonable notice
and during normal business hours, to visit such Party's facilities where the
Joint Development Program is being conducted, and consult, during such visits
and by telephone, with such Party's personnel performing work on the Joint
Development Program.
4.8 Liability. Each Party shall be responsible for, and hereby assumes,
any and all risks of personal injury or property damage attributable to the
negligent or willful acts or omissions,
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during the term of the Joint Development Program, of such Party or its
Affiliates, and their respective directors, officers, employees and agents.
5. GRANT OF RIGHTS; COMMERCIALIZATION; MARKETING.
5.1 Development Licenses.
(a) Inspire hereby grants to Kissei, during the term of the Joint
Development Program, the exclusive (except as to Inspire), paid-up license, with
the right to grant sublicenses solely to the extent provided in Section 5.3(a),
under the Licensed Technology, to conduct the Joint Development Program.
(b) Kissei hereby grants to Inspire, during the term of the Joint
Development Program, the exclusive (except as to Kissei), paid-up license, with
no right to grant sublicenses (except to the extent necessary to conduct the
Joint Development Program), under Kissei's interest in any Inventions, to
conduct the Joint Development Program.
5.2 Commercialization License. Inspire hereby grants to Kissei an
exclusive (even as to Inspire) license throughout the Territory, with the right
to grant sublicenses in accordance with the terms of this Agreement, under the
Licensed Technology, to develop, use, market and sell Products in the Field.
With respect to any such Patents that may issue in Japan during the term of this
Agreement, a statement referencing the exclusive license granted to Kissei
pursuant to this Section 5.2 shall be registered with the Japanese Patent Office
at Kissei=s cost, as soon as is practically possible after the issuance of the
respective Patents. Inspire hereby agrees that it will execute such documents
and instruments as may be required to effect the registration of such statement
and otherwise cooperate with Kissei in connection with the registration of such
statement with the Japanese Patent Office.
5.3 Sublicensing.
(a) Solely in connection with the grant of a sublicense of the
licenses granted to Kissei under Section 5.2, Kissei shall have the right to
grant a sublicense of the licenses granted to Kissei under Section 5.1(a) for
purposes of such Affiliates' or Sublicensees' performance of Kissei's
obligations under Section 4, provided that, in addition to the requirements set
forth in Section 5.3(b), each Affiliate or Sublicensee agrees in writing to
maintain scientific records and permit Inspire to inspect and copy such records
and visit such facilities pursuant to the relevant provisions of Section 4.7,
and to observe all other applicable terms, of this Agreement.
(b) Kissei shall have the right to grant sublicenses to any of its
Affiliates or Sublicensees of the licenses granted to Kissei under Section 5.2
for purposes of such Affiliates' or Sublicensees' performance of Kissei's
obligations under Section 5.5, provided that: (i) Kissei shall
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submit all proposed sublicenses to Inspire for approval, which approval shall
not be unreasonably withheld; (ii) Kissei shall guarantee and be responsible for
the making of all payments due, and the making of any reports under this
Agreement, with respect to sales of Product by its Affiliates or Sublicensees
and their compliance with all applicable terms of this Agreement; and (iii) each
Affiliate or Sublicensee agrees in writing to maintain books and records and
permit Inspire to review such books and records pursuant to the relevant
provisions, and to observe all other applicable terms, of this Agreement.
Kissei shall promptly provide Inspire with notice of any sublicense granted
pursuant to this Section 5.3, and provide a copy of the sublicense to Inspire
upon its request.
(c) Kissei hereby unconditionally guarantees the performance of any of
its Affiliates and Sublicensees hereunder. In the event of a breach by such an
Affiliate or Sublicensee in the observance of applicable terms of this
Agreement, Inspire shall be entitled to proceed against either such Affiliate or
Sublicensee or directly against Kissei, as Inspire may determine in its sole
discretion, to enforce this Agreement.
5.4 Grantback Rights. Subject to the terms and conditions of this
Agreement, Kissei hereby grants to Inspire:
(a) With respect to any unpatented know-how that embodies or relates
to Inventions and that are owned or controlled by Kissei or its Affiliates, an
exclusive (except as to Kissei), paid-up, perpetual license thereunder: (i) to
develop, make, have made, use, offer to sell, sell and have sold products with
applications outside the Field for all purposes worldwide (including, without
limitation, within the Territory), and (ii) to develop, make, have made, use,
offer to sell, sell and have sold Products with applications within the Field
for all purposes outside the Territory. The foregoing licenses shall include
the right to grant sublicenses.
(b) With respect to any patents or patent applications that embody or
relate to Inventions and that are owned or controlled by Kissei or its
Affiliates, an exclusive (except as to Kissei), paid-up, perpetual license
thereunder, to develop, make, have made, use, offer to sell, sell and have sold
Products with applications within the Field for all purposes outside the
Territory. The foregoing licenses shall include the right to grant sublicenses.
(c) With respect to any patents or patent applications that embody or
relate to Inventions and that are owned or controlled by Kissei or its
Affiliates, an exclusive (except as to Kissei) license, with fees and royalties
as consideration to Kissei, to develop, make, have made, use, offer to sell,
sell and have sold products with applications outside the Field for all purposes
worldwide (including, without limitation, within the Territory); provided that
Inspire shall grant Kissei a right of first offer with respect to co-development
and co-marketing of products covered by such Inventions. The foregoing licenses
shall include the right to grant sublicenses. The Parties shall negotiate the
license fees and royalty rates for the license to such Inventions in good faith
and consistent with customary business practices therefor and the other terms
and conditions set forth in this Agreement.
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5.5 Commercialization Obligations, Rights. Kissei shall use all
commercially reasonable efforts to develop and commercialize the Product in the
Territory. In connection therewith, Kissei shall dedicate resources to the
development and commercialization of the Product consistent with the resources
that Kissei, at all relevant times, would dedicate to products containing
compounds that were generated from Kissei's own research efforts which Kissei
decided to develop commercially and market and that have pricing, volume and
marketing potentials similar to those of the Product. Kissei, either itself
and/or by and through its Affiliates and Sublicensees, shall be responsible for,
and shall have the exclusive right to engage in, all marketing, advertising,
promotional, launch and sales activities in connection with such efforts.
5.6 Right of First Refusal. [CONFIDENTIAL TREATMENT REQUESTED]
5.7 Adverse Reaction Reporting.
(a) Each Party shall record, evaluate, summarize and review all
adverse drug experiences associated with the Compound and the Product. In order
that each Party may be fully informed of the adverse drug experiences associated
therewith that are known to the other Party, each Party shall report:
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(i) In the case of Inspire, to:
Inspire Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxx, Xxxxx Xxxxxxxx 00000
XXX
Attention: Xxxxxxxx Xxxxx, Ph.D., Director, Regulatory
Affairs
Facsimile No.: (000) 000-0000
Telephone No.: (919) 941-9777 ext. 277
(ii) In the case of Kissei, to:
Kissei Pharmaceutical Co., Ltd.
0-0, Xxxxxxxxxx
0-Xxxxx, Xxxxxx-Xx, Xxxxx
000-0000
XXXXX
Attention: Xxxxx Xxxxxx, Ph.D., Director, Member of the
Board, Clinical Development, R & D
Facsimile No.: (00)0000-0000
Telephone No.: (00)0000-0000
all "adverse events," as defined by the then current ICH guidelines, involving
the Compound and/or the Product (all such reports, "AE Reports"). "Serious"
adverse events shall be reported to the other Party within three working days
after a Party's (a "reporting Party") becoming aware of such an event and shall
either be reported by facsimile or telephone. The reporting Party shall report
on a quarterly basis all other adverse events that are known to the reporting
Party through either the receipt of clinical study documentation or post-market
surveillance. In addition, the reporting Party shall report all known instances
of use of the Product during pregnancy. In any event, each Party shall promptly
notify the other of any complaint received by such Party in sufficient detail
and in sufficient time to allow the responsible Party to comply with any and all
regulatory requirements imposed upon it in the Territory. Each Party shall also
advise the other of any regulatory developments (e.g., proposed recalls,
labeling and other registrational dossier changes, etc.) affecting the Compound
or the Product in the Territory.
(b) According to current ICH guidelines, an "adverse event" is any
untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product, which occurrence does not necessarily
have to have a causal relationship with the treatment.
(c) According to current ICH guidelines, a "serious" adverse event is
any untoward medical occurrence that, at any dose, results in death, is life-
threatening (at the time of the
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event), requires inpatient hospitalization or prolongation of existing
hospitalization, results in persistent or significant disability or incapacity,
or is a congenital anomaly or birth defect.
(d) The details of adverse reaction reporting during development stage
and thereafter shall be stipulated in separate agreements to be entered into by
the Parties in due course.
6. FEES, MILESTONES AND ROYALTIES.
6.1 Up-front Payment.
(a) As partial consideration to Inspire for the license and other
rights granted to Kissei under this Agreement, upon the execution of this
Agreement by both Parties, Kissei shall pay to Inspire the sum of [CONFIDENTIAL
TREATMENT REQUESTED] in connection with the license and other rights in the
Territory. Such sum shall be non-refundable.
(b) As further consideration to Inspire for the license and other
rights granted to Kissei under this Agreement, pursuant to the Stock Purchase
Agreement and simultaneously with the execution of this Agreement, Kissei is
purchasing 375,000 shares of Inspire's Series C Preferred Stock for an aggregate
purchase price of US$900,000.
6.2 Coordinator/Liaison Fees. As consideration to Inspire for
designating and maintaining the Development Coordinator/Liaison and the
Manufacturing Coordinator/Liaison:
(a) For every calendar year during which Inspire maintains a
Development Coordinator/Liaison, Kissei shall pay Inspire the sum of
[CONFIDENTIAL TREATMENT REQUESTED], which shall be payable, in advance, on the
first day of each calendar quarter, in equal installments, until NDA Approval
for the Product is received, or definitively abandoned, in the Territory,
whichever occurs first; and
(b) For every calendar year during which Inspire maintains a
Manufacturing Coordinator/Liaison, Kissei shall pay Inspire the sum of
[CONFIDENTIAL TREATMENT REQUESTED], which shall be payable, in advance, on the
first day of each calendar quarter, in equal installments until Kissei files the
NDA for the Product with the Regulatory Authority in the Territory , or until
definitely abandoned, whichever occurs first. Thereafter Kissei shall continue
to make such payments for the Manufacturing Coordinator/Liaison as and when
determined by the Joint Development Committee. In addition, during any period
when Kissei is paying such amount for the Manufacturing Coordinator/Liaison,
Kissei shall also reimburse Inspire for all reasonable travel, lodging, meals
and other necessary out-of-pocket expenses incurred by Inspire in connection
with the Manufacturing Coordinator/Liaison's performance of his or her
obligations under this Xxxxxxxxx.Xx addition, on the Effective Date, Kissei
shall pay Inspire a quarterly installment of each of the Development
Coordinator/Liaison fee and the Manufacturing Coordinator/Liaison fee, pro rated
for
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the number of days remaining after the Effective Date in the calendar quarter in
which the Effective Date falls. Similarly, Inspire shall refund to Kissei such
portion of quarterly installment of each of the Development Coordinator/Liaison
fee and the Manufacturing Coordinator/Liaison fee as prorated for the number of
days remaining after the termination of each of their services in the calendar
quarter in which the termination occurs.
6.3 Milestone Payments. As further consideration to Inspire for the
license and other rights granted to Kissei under this Agreement, Kissei shall
pay to Inspire the following milestone payments upon the first occurrence of
each event set forth below with respect to each Product:
[CONFIDENTIAL TREATMENT REQUESTED]
Each of the payments required pursuant to this Section 6.3 shall be
paid within 30 days after such milestone has been achieved.
6.4 Transfer Price.
(a) The transfer price to Kissei for the Supplied Goods shall be an
amount equal to [CONFIDENTIAL TREATMENT REQUESTED] (the "Transfer Price").
(b) Notwithstanding Section 6.4(a), in the event and to the extent
that Kissei provides Delivery Systems to health care providers and/or patients
at a nominal charge or no charge,
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Inspire and Kissei will negotiation in good faith for [CONFIDENTIAL
TREATMENT REQUESTED].
(c) [CONFIDENTIAL TREATMENT REQUESTED]
6.5 Royalty Payments. As further consideration to Inspire for the
license and other rights granted to Kissei under this Agreement, during the term
of this Agreement, Kissei shall pay to Inspire a royalty on Net Sales of the
Product commencing on the First Commercial Sale of the Product by Kissei, its
Affiliates or its Sublicensees, on a Product-by-Product basis, in an amount
equal to [CONFIDENTIAL TREATMENT REQUESTED] of the aggregate Net Sales of the
Product by Kissei, its Affiliates and its Sublicensees throughout the Territory.
Notwithstanding the foregoing, the royalty rate shall be reduced to
[CONFIDENTIAL TREATMENT REQUESTED] with respect to a Product when such Product
ceases to be covered by any Licensed Claims in the Territory or when one or more
Third Parties markets a generic product. For purposes of this provision,
"generic product" means a Third Party product: (i) having as a pharmaceutically
active ingredient the same Compound or its salt as such Product, AND (ii) where
the manufacture, use or sale of such Third Party product is not covered by a
Licensed Claim. Such reduced royalty rate shall be effective for the first full
calendar quarter commencing after the date of any such event.
6.6 Obligation to Pay Royalties. The obligation to pay royalties to
Inspire under this Section 6 is imposed only once with respect to the same unit
of Product regardless of the number of Patents or quantity of Know-how
pertaining thereto. There shall be no obligation to pay royalties to Inspire
under this Section 6 on sales of Product between Kissei and its Affiliates and
Sublicensees, but in such instances the obligation to pay royalties shall arise
upon the sale by Kissei or its Affiliates or Sublicensees to unrelated Third
Parties. Payments due under this Section 6 shall be deemed to accrue when
Product is billed.
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7. PAYMENTS AND REPORTS.
7.1 Payments.
(a) Inspire shall submit invoices to Kissei for the Transfer Price of
Supplied Goods promptly after each shipment thereof. Each such invoice shall
include any previously uninvoiced adjustments to the Cost of Delivery Systems
pursuant to Section 6.4(b). Payments shall be made by Kissei within 30 days
after Kissei's receipt of each invoice therefor, by telegraphic transfer
remittance.
(b) Beginning with the calendar quarter in which the First Commercial
Sale of Products is made in the Territory and for each calendar quarter
thereafter, Kissei shall submit a statement, Product-by-Product, of the amount
of Net Sales during such quarter and the amount of royalties due on such Net
Sales. Each such statement shall also include information on the number of
Delivery Systems delivered by Kissei during such calendar quarter and the price
Kissei charged therefor. Each such statement shall be accompanied by payment of
the royalties due. The statement, together with the accompanying payment, shall
be submitted quarterly within 30 days after the end of each calendar quarter.
7.2 Mode of Payment. All invoices submitted by Inspire shall be stated
in U.S. Dollars. Kissei shall make all payments required under this Agreement as
directed by Inspire from time to time, net of any out-of-pocket transfer costs
or fees, in U.S. Dollars. All payments due shall be translated at the
Telegraphic Transfer Selling rate (TTS) quoted by Tokyo Mitsubishi Bank, Japan
on the day and time of remittance.
7.3 Records Retention. Kissei and its Affiliates and Sublicensees shall
keep complete and accurate records pertaining to the sale of Products, and
Inspire shall keep complete and accurate records pertaining to Inspire's Cost of
Compound, Formulated Material, Cost of Finished Product and Cost of Delivery
Systems, for a period of three calendar years after the year in which such sales
or costs occurred, and in sufficient detail to permit the other Party to confirm
the accuracy of the aggregate royalty and/or Transfer Price calculations
hereunder.
7.4 Audit Request.
(a) At the request and expense of Inspire, Kissei and its Affiliates
and Sublicensees shall permit an independent, certified public accountant
appointed by Inspire and reasonably acceptable to Kissei, at reasonable times
and upon reasonable notice, to examine such records as may be necessary to: (i)
determine the correctness of any report or payment made under this Agreement; or
(ii) obtain information as to the aggregate Transfer Price and/or royalties
payable for any calendar quarter in the case of Kissei's failure to report or
pay pursuant to this Agreement. Said accountant shall not disclose to Inspire
any information other than information relating to said
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reports, royalties, and payments. Results of any such examination shall be made
available to both Parties.
(b) At the request and expense of Kissei, Inspire shall permit an
independent, certified public accountant appointed by Kissei and reasonably
acceptable to Inspire, at reasonable times and upon reasonable notice, to
examine those records as may be necessary to verify the aggregate Cost of
Compound, Cost of Formulated Material, Cost of Finished Product and/or Cost of
Delivery Systems incurred for any period. Said accountant shall not disclose to
Kissei any information other than information relating to said Cost of Compound,
Cost of Formulated Material, Cost of Products and/or Cost of Delivery Systems.
Results of any such examination shall be made available to both Parties.
7.5 Cost of Audit.
(a) Inspire shall bear the full cost of the performance of any audit
requested by Inspire except as hereinafter set forth. If, as a result of any
inspection of the books and records of Kissei, its Affiliates or its
Sublicensees, it is shown that Kissei's payments under this Agreement were less
than the amount which should have been paid, then Kissei shall make all payments
required to be made to eliminate any discrepancy revealed by said inspection
within 30 days after Inspire's demand therefor. Furthermore, if the payments
made were less than 95% of the amount that should have been paid during the
period in question, Kissei shall also reimburse Inspire for the reasonable costs
of such audit and shall make such payment required to be made to eliminate such
discrepancy.
(b) Kissei shall bear the full cost of the performance of any audit
requested by Kissei except as hereinafter set forth. If, as a result of any
inspection of the books and records of Inspire, it is shown that Inspire
overstated its Cost of Compound, Cost of Formulated Material, Cost of Finished
Product and/or Cost of Delivery Systems under this Agreement for any period,
then Kissei shall be entitled to a credit in the amount necessary to eliminate
any discrepancy revealed by said inspection. Such credit may be applied against
any amounts due and owing to Inspire pursuant to this Agreement (e.g.,
milestones, royalties, Transfer Price). Furthermore, if the amounts for any
period were overstated by more than five percent, Inspire shall also reimburse
Kissei for the reasonable costs of such audit and shall make such payment
required to be made to eliminate such discrepancy.
7.6 No Non-Monetary Consideration for Sales. Without the prior written
consent of Inspire, Kissei and its Affiliates and Sublicensees shall not accept
or solicit any non-monetary consideration of the sale of the Product other than
as would be reflected in Net Sales. The use by Kissei and its Affiliates and
Sublicensees of a commercially reasonable amount of Product for promotional
sampling shall not violate this Section 7.6.
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7.7 Taxes.
(a) In the event that Kissei is required to withhold any tax to the
tax or revenue authorities in the Territory regarding any payment to Inspire due
to the laws of such country, such amount shall be deducted from the payment to
be made by Kissei, and Kissei shall notify Inspire and promptly furnish Inspire
with copies of any tax certificate or other documentation evidencing such
withholding. Each Party agrees to cooperate with the other party in claiming
exemptions from such deductions or withholdings under any agreement or treaty
from time to time in effect.
(b) If Inspire has the legal obligation to collect and/or pay any
sales, use, excise or value added taxes, the appropriate amount shall be added
to Kissei's invoice and paid by Kissei, unless Kissei provides Inspire with a
valid tax exemption certificate authorized by the appropriate taxing authority.
8. MANUFACTURE AND SUPPLY.
8.1 Commercial Supply Agreement. Both Parties recognize the importance
of Inspire establishing and maintaining a reliable and steady source of supply
of Finished Product and Delivery Systems (collectively, "Supplied Goods") for
commercial marketing in the Territory by Kissei so that supply shortages do not
occur. Commencing on the Effective Date, Inspire intends to work toward that
goal with its Third Party Manufacturers, and will keep Kissei informed, through
the Joint Development Committe, of the actions being undertaken by Inspire to do
so. Inspire shall also give Kissei, through the Joint Development Committee or
otherwise, as Kissei may desire, an opportunity to review Inspire's actions and
provide input into other actions deemed appropriate. At such time as the Joint
Development Committee determines is appropriate, the Parties shall negotiate in
good faith the terms of a commerical supply agreement to be entered into by the
Parties (the "Supply Agreement") pursuant to which Inspire shall provide Kissei
with its commercial supply requirements of Supplied Goods. The Supply Agreement
shall contain mutually acceptable terms and conditions, substantially consistent
with the terms and conditions set forth on Exhibit D.
9. OWNERSHIP; PATENTS.
9.1 Ownership.
(a) Except as otherwise provided in Section 9.1(b) or (c), Inspire
shall retain all right, title and interest in and to the Patents and Know-how,
regardless of which Party prepares and prosecutes the applications associated
therewith, or maintains the patents, copyrights or other intellectual property
rights related thereto, subject to the license granted to Kissei pursuant to
Section 5.2. Rights to Inventions made solely by employees of Inspire shall
belong to Inspire.
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Notwithstanding any other provision of this Agreement, Kissei shall not own any
right, title or interest in and to any Inventions relating to the Cassette or
Delivery System.
(b) Rights to Inventions made solely by employees of Kissei shall
belong to Kissei.
(c) Rights to Inventions which were made jointly by employees of
Inspire and by employees of Kissei shall belong jointly to Inspire and to
Kissei. Such joint Inventions shall be subject to the terms and conditions of
this Agreement.
(d) Inspire shall not own any right, title or interest in any
trademark or trade name selected by Kissei or the Joint Development Committee
to appear on any Product label or to be inscribed on any Product or component
part thereof.
9.2 Patent Maintenance.
(a) Inspire shall have full responsibility for, and shall control the
preparation and prosecution of, all patent applications and the maintenance of
all patents relating to the Licensed Technology (including the Patents)
throughout the Territory. Inspire shall pay all costs and expenses of filing,
prosecuting and maintaining the Patents and the patents covering Inventions
owned by Inspire in the Territory.
(b) Inspire shall select qualified independent patent counsel to file
and prosecute all patent applications pursuant to Section 9.2(a). Inspire shall
provide copies to Kissei of any filings made to, and written communications
received from, any patent office relating, in whole or in part, to the Licensed
Claims.
(c) Each Party agrees promptly to provide to the other Party a
complete written disclosure of any Invention made by such Party. Inspire shall
determine whether any Invention owned solely by Inspire or jointly by Inspire
and Kissei is patentable, and if so, shall proceed with the preparation and
prosecution of a patent application covering any such Invention. Kissei shall
determine whether any Invention owned solely by Kissei is patentable, and if so,
shall proceed with the preparation and prosecution of a patent application
covering any such Invention.
(d) Inspire and Kissei shall share all costs and expenses of filing,
prosecuting and maintaining the Patents and the patents covering Inventions
owned jointly by Kissei and Inspire in the Territory. If either Party elects
not to pay for: (i) the filing of a patent application in the Territory on any
such Patent or Invention which the other Party reasonably believes is
patentable, or (ii) the further prosecution or maintenance of any such Patent or
Invention in the Territory, or (iii) the filing of any divisional or continuing
patent application based on any Patent or Invention in the Territory, such Party
shall notify the other Party in a timely manner and the other Party may do so at
its own expense. In such event, such patent or application in the Territory
shall be assigned by such Party
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to the other Party, all of such assigning Party's rights in such patent or
application in the Territory shall cease, and, in the case where Kissei is the
assigning Party, the license granted to Kissei under Section 5.2 with respect
thereto shall terminate.
(e) Each Party agrees to cooperate with the other Party to execute all
lawful papers and instruments, to make all rightful oaths and declarations and
to provide consultation and assistance as may be necessary in the preparation,
prosecution, maintenance, and enforcement of all such patents.
9.3 Patent Enforcement.
(a) If either Party learns of an infringement, unauthorized use,
misappropriation or ownership claim or threatened infringement or other such
claim (an "infringement") by a Third Party with respect to any Licensed
Technology within the Territory, such Party shall promptly notify the other
Party and shall provide such other Party with available evidence of such
infringement. In addition, Inspire shall notify Kissei when Inspire becomes
aware of any infringement action involving the Product in any country outside
the Territory in a timely manner.
(b) Kissei shall have the first right, but not the duty, to institute
patent infringement actions against Third Parties based on any Licensed
Technology in the Territory. If Kissei does not secure actual cessation of such
infringement or institute an infringement proceeding against an offending Third
Party within 180 days of learning of such infringement, Inspire shall have the
right, but not the duty, to institute such an action with respect to any
infringement by such Third Party. The costs and expenses of any such action
(including fees of attorneys and other professionals) shall be borne by the
Party instituting the action, or, if the Parties elect to cooperate in
instituting and maintaining such action, such costs and expenses shall be borne
by the Parties in such proportions as they may agree in writing. Each Party
shall execute all necessary and proper documents and take such actions as shall
be appropriate to allow the other Party to institute and prosecute such
infringement actions. Any award paid by Third Parties as a result of such an
infringement action (whether by way of settlement or otherwise) shall be applied
first to reimburse both Parties for all costs and expenses incurred by the
Parties with respect to such action on a pro rata basis and, if after such
reimbursement any funds shall remain from such award, [CONFIDENTIAL TREATMENT
REQUESTED].
9.4 Infringement Action by Third Parties. In the event of the
institution or threatened institution of any suit by a Third Party against
Kissei for patent infringement involving the sale, distribution or marketing of
any Product in the Territory where such infringement claim is a result of the
use of the Licensed Technology, Kissei shall promptly notify Inspire in writing
of such suit. Unless otherwise covered by Section 11.2(c), Kissei shall have
the right to defend such suit at its own expense,
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and Inspire hereby agrees to assist and cooperate with Kissei, at Inspire's own
expense, to the extent necessary in the defense of such suit. During the
pendency of such action and thereafter, Kissei shall continue to make all
payments due under this Agreement; provided, however, that Kissei shall be
entitled to a credit against royalties otherwise owing on such Product in an
amount equal to [CONFIDENTIAL TREATMENT REQUESTED] of the royalties or other
damages due to such Third Party in any calendar quarter, except that in no event
shall any such credit reduce the royalty rate to less than [CONFIDENTIAL
TREATMENT REQUESTED]. Further, if Kissei finally prevails and receives an award
from such Third Party as a result of such action (whether by way of judgment,
award, decree, settlement or otherwise), such award shall be allocated in the
manner provided in Section 9.3(b).
10. PUBLICATION; CONFIDENTIALITY.
10.1 Notification.
(a) Both Parties recognize that each may wish to publish the results
of their work relating to the subject matter of this Agreement. However, both
Parties also recognize the importance of acquiring patent protection.
Consequently, subject to any applicable laws or regulations obligating either
Party to do otherwise, any proposed publication by either Party shall comply
with this Section 10.1(a). At least 30 days before a manuscript is to be
submitted to a publisher, the publishing Party will provide the Joint
Development Committee with a copy of the manuscript. Any such manuscript, if
not in English, shall be accompanied by an English language summary thereof,
which shall include a translation of all data tables to be included in such
manuscript. In such event, the publishing Party shall provide an English
translation of such manuscript, in whole or in part, as requested by any member
of the Joint Development Committee, at least 10 days prior to submission of such
manuscript to the publisher. If the publishing Party wishes to make an oral
presentation, it will provide the Joint Development Committee with a copy of the
abstract (if one is submitted) at least 30 days before it is to be submitted.
(b) In addition, Inspire shall provide Kissei with a copy of any
publications relating to the Compound or the Product published by any of
Inspire's Strategic Partners in a timely manner after such publication.
10.2 Review. The Joint Development Committee will review the
manuscript, abstract, text or any other material provided under Section 10.1(a)
to determine whether patentable subject matter is disclosed. The Joint
Development Committee will notify the publishing Party within 30 days of receipt
of the proposed publication if the Joint Development Committee, in good faith,
determines that patentable subject matter is or may be disclosed, or if the
Joint Development Committee, in good faith, believes Confidential Information
(as defined in Section 10.4) is or may be disclosed. If it is determined by the
Joint Development Committee that patent applications should be filed, the
publishing Party shall delay its publication or presentation for a period not to
exceed 90 days from the Joint Development Committee's receipt of the proposed
publication or presentation to allow time for the filing of patent applications
covering patentable subject matter. In the event that the delay
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needed to complete the filing of any necessary patent application will exceed
the 90 day period, the Joint Development Committee will discuss the need for
obtaining an extension of the publication delay beyond the 90 day period. If it
is determined in good faith by the Joint Development Committee that Confidential
Information or proprietary information is being disclosed, the Parties will
consult in good faith to arrive at an agreement on mutually acceptable
modifications to the proposed publication or presentation to avoid such
disclosure.
10.3 Exclusions. Nothing in Sections 10.1 and 10.2 shall prevent either
Party: (i) in connection with efforts to secure financing at any time during the
term of this Agreement, from issuing statements as to achievements made, and the
status of the work being done by the Parties, under this Agreement, so long as
such statements do not jeopardize the ability to obtain patent protection on
Inventions or disclose non-public technical or scientific Confidential
Information; or (ii) from issuing statements that such Party determines to be
necessary to comply with applicable law (including the disclosure requirements
of the U.S. Securities and Exchange Commission, Nasdaq or any other stock
exchange on which securities issued by such Party are traded); provided that, to
the extent practicable under the circumstances, such Party shall provide the
other Party with a copy of the proposed text of such statements sufficiently in
advance of the scheduled release thereof to afford such other Party a reasonable
opportunity to review and comment upon the proposed text.
10.4 Confidentiality; Exceptions. Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing, the Parties agree
that, during the term of this Agreement and for five years thereafter, the
receiving Party, its Affiliates, its licensees and its sublicensees shall keep,
and shall ensure that its employees, officers and directors keep, completely
confidential and shall not publish or otherwise disclose and shall not use for
any purpose any information furnished to it by the other Party, its Affiliates,
its licensees or its sublicensees or developed under or in connection with this
Agreement, except to the extent that it can be established by the receiving
Party by competent proof that such information: (i) was already known to the
receiving Party, other than under an obligation of confidentiality, at the time
of disclosure by the other Party; (ii) was generally available to the public or
otherwise part of the public domain at the time of its disclosure to the
receiving Party; (iii) became generally available to the public or was otherwise
part of the public domain after its disclosure and other than through any act or
omission of the receiving Party in breach of this Agreement; or (iv) was
disclosed to the receiving Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the disclosing Party
not to disclose such information to others (all such information to which none
of the foregoing exceptions applies, "Confidential Information").
10.5 Exceptions to Obligation. The restrictions contained in Section
10.4 shall not apply to Confidential Information that: (i) is submitted by the
recipient to governmental authorities to facilitate the issuance of NDA
Approvals for the Product, provided that reasonable measures shall be taken to
assure confidential treatment of such information; (ii) is provided by the
recipient to Third Parties under confidentiality provisions at least as
stringent as those in this Agreement, for consulting, manufacturing development,
manufacturing, external testing, marketing trials and, with
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respect to Kissei, to Third Parties who are Sublicensees or other
development/marketing partners of Kissei with respect to any of the subject
matter of this Agreement; or (iii) is otherwise required to be disclosed in
compliance with applicable laws or regulations or order by a court or other
regulatory body having competent jurisdiction; provided that if a Party is
required to make any such disclosure of the other Party's Confidential
Information such Party will, except where impracticable for necessary
disclosures, for example to physicians conducting studies or to health
authorities, give reasonable advance notice to the other Party of such
disclosure requirement and, except to the extent inappropriate in the case of
patent applications, will use its best efforts to secure confidential treatment
of such Confidential Information required to be disclosed.
10.6 Limitations on Use. Each Party shall use, and cause each of its
Affiliates, its licensees and its sublicensees to use, any Confidential
Information obtained by such Party from the other Party, its Affiliates, its
licensees or its sublicensees, pursuant to this Agreement or otherwise, solely
in connection with the activities or transactions contemplated hereby.
10.7 Remedies. Each Party shall be entitled, in addition to any other
right or remedy it may have, at law or in equity, to an injunction, without the
posting of any bond or other security, enjoining or restraining the other Party,
its Affiliates, its licensees and/or its sublicensees from any violation or
threatened violation of this Section 10.
11. INDEMNIFICATION.
11.1 By Kissei. Kissei shall indemnify, defend and hold harmless
Inspire and its Affiliates, and their respective directors, officers, employees
and agents, from and against any and all liabilities, damages, losses, costs and
expenses (including the reasonable fees of attorneys and other professionals)
arising out of or resulting from:
(a) negligence, recklessness or wrongful intentional acts or
omissions of Kissei, its Affiliates or its Sublicensees, if any, and their
respective directors, officers, employees and agents, in connection with the
work performed by Kissei under the Joint Development Program;
(b) any warranty claims, Product recalls or any tort claims of
personal injury (including death) or property damage relating to or arising out
of any manufacture, use, distribution or sale of any Product by Kissei, its
Affiliates or its Sublicensees due to any negligence, recklessness or wrongful
intentional acts or omissions by, or strict liability of, Kissei, its Affiliates
or its Sublicensees, and their respective directors, officers, employees and
agents, except, in each case, to the comparative extent such claim arose out of
or resulted from the negligence, recklessness or wrongful intentional acts or
omissions of Inspire and its Affiliates, and their respective directors,
officers, employees and agents; or
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(c) any breach of any representation or warranty made by Kissei
pursuant to Section 2.
11.2 By Inspire. Inspire shall indemnify, defend and hold harmless
Kissei, its Affiliates and its Sublicensees, and their respective directors,
officers, employees and agents, from and against any and all liabilities,
damages, losses, costs and expenses (including the reasonable fees of attorneys
and other professionals) arising out of or resulting from:
(a) negligence, recklessness or wrongful intentional acts or
omissions of Inspire or its Affiliates, and their respective directors,
officers, employees and agents, in connection with the work performed by Inspire
under the Joint Development Program;
(b) any warranty claims, Product recalls or any tort claims of
personal injury (including death) or property damage relating to or arising out
of any manufacture, use, distribution or sale of any Supplied Goods by Inspire
or its Affiliates due to any negligence, recklessness or wrongful intentional
acts or omissions by, or strict liability of, Inspire or its Affiliates, and
their respective directors, officers, employees and agents, except, in each
case, to the comparative extent such claim arose out of or resulted from the
negligence, recklessness or wrongful intentional acts or omissions of Kissei,
its Affiliates or its Sublicensees, and their respective directors, officers,
employees and agents; or
(c) any breach of any representation or warranty made by Inspire
pursuant to Section 2.
11.3 Notice. In the event that any person (an "indemnitee") entitled to
indemnification under Section 11.1 or 11.2 is seeking such indemnification, such
indemnitee shall inform the indemnifying Party of the claim as soon as
reasonably practicable after such indemnitee receives notice of such claim,
shall permit the indemnifying Party to assume direction and control of the
defense of the claim (including the sole right to settle it at the sole
discretion of the indemnifying Party, provided that such settlement does not
impose any obligation on the indemnitee or the other Party) and shall cooperate
as requested (at the expense of the indemnifying Party) in the defense of the
claim.
11.4 Complete Indemnification. As the Parties intend complete
indemnification, all costs and expenses incurred by an indemnitee in connection
with enforcement of this Section 11 shall also be reimbursed by the indemnifying
Party.
12. TERM; TERMINATION.
12.1 Term. This Agreement shall become effective as of the Effective
Date and, unless earlier terminated pursuant to the other provisions of this
Section 12, shall expire as follows:
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(a) As to each Product in the Territory, this Agreement shall expire
on the later of (i) the tenth anniversary of the First Commercial Sale of such
Product in the Territory, or (ii) the date on which the sale of such Product
ceases to be covered by a Licensed Claim in the Territory.
(b) This Agreement shall expire in its entirety upon the expiration
of this Agreement with respect to all Products in the Territory.
12.2 Termination for Cause. Either Party (the "non-breaching Party")
may, without prejudice to any other remedies available to it at law or in
equity, terminate this Agreement in the event the other Party (the "breaching
Party") shall have materially breached or defaulted in the performance of any of
its material obligations hereunder (but excluding any such breach or default
under the Supply Agreement, which shall be addressed in such separate Supply
Agreement), and such default shall have continued for 60 days after written
notice thereof was provided to the breaching party by the non-breaching party
(or, if such default cannot be cured within such 60-day period, if the breaching
party does not commence and diligently continue actions to cure such default
during such 60-day period). Any such termination shall become effective at the
end of such 60-day period unless the breaching party has cured any such breach
or default prior to the expiration of such 60-day period (or, if such default
cannot be cured within such 60-day period, if the breaching party has commenced
and diligently continued actions to cure such default). The right of either
party to terminate this Agreement as provided in this Section 12.2 shall not be
affected in any way by its waiver or failure to take action with respect to any
previous default.
12.3 Termination by Kissei. In the event that Kissei, in its sole good
faith discretion, determines that continued development or marketing of the
Product pursuant to this Agreement is scientifically or economically infeasible,
Kissei shall have the right to terminate this Agreement in its entirety upon
three months' prior written notice.
12.4 Effect of Expiration or Termination.
(a) Following the expiration of the term of this Agreement with
respect to a Product in the Territory pursuant to Section 12.1(a):
(i) Kissei shall have a non-exclusive, royalty-free, perpetual right
to continue to use, market, distribute, sell, manufacture and have manufactured
any Product in the Territory, and the non-exclusive, perpetual and paid-up right
to use the Licensed Technology in connection therewith. To that end, Kissei may
continue to hold and use all data, reports, records and materials that relate to
or are prepared in the course of the Joint Development Program, and may hold all
INDs, NDAs, NDA Approvals and other regulatory filings made or filed by Kissei
for such Product, pursuant to this Agreement, and may in its sole discretion
continue any sublicense granted by Kissei under this Agreement; and
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(ii) Inspire shall have the fully-paid non-exclusive right to
continue to cross-reference and otherwise exercise its rights as set forth in
Section 4.5(d) under the NDA Approval(s) and other regulatory filings for such
Product in the Territory.
(b) Following expiration of the term of this Agreement in its
entirety pursuant to Section 12.1(b):
(i) Kissei shall have a non-exclusive, royalty-free, perpetual right
to continue to use, market, distribute, sell manufacture and have manufactured
all Products in the Territory, and the non-exclusive, perpetual and paid-up
right to use the Licensed Technology in connection therewith. To that end,
Kissei may continue to hold and use all data, reports, records and materials
that relate to or are prepared in the course of the Joint Development Program,
and may hold all INDs, NDAs, NDA Approvals and other regulatory filings made or
filed by Kissei for all Products, pursuant to this Agreement, and may in its
sole discretion continue any sublicense granted by Kissei under this Agreement;
(ii) Inspire shall have: (A) the fully-paid non-exclusive right to
continue to cross-reference and otherwise exercise its rights as set forth in
Section 4.5(d) under the NDA Approvals and other regulatory filings for Products
in such countries; and (B) the fully-paid, non-exclusive, perpetual right to
continue to use patents or know-how that embody or relate to Inventions and that
are owned or controlled by Kissei or its Affiliates as set forth in Section 5.4.
(c) If this Agreement is terminated by Inspire pursuant to Section
12.2 by reason of a breach or default by Kissei, in addition to any other
remedies available to Inspire at law or in equity, or by Kissei pursuant to
Section 12.3: (i) Kissei shall promptly transfer to Inspire copies of all data,
reports, records and materials in Kissei's possession or control that relate to
the Joint Development Program and return to Inspire all relevant records and
materials in Kissei's possession or control containing Confidential Information
of Inspire (provided that Kissei may keep one copy of such Confidential
Information of Inspire for archival purposes only); (ii) all licenses granted by
Inspire to Kissei under Sections 5.1 and 5.2 shall terminate; (iii) ownership of
all INDs, NDAs, NDA Approvals and other regulatory filings made or filed for the
Product shall be transferred promptly to Inspire; and (iv) all sublicenses
granted by Kissei under this Agreement shall terminate. Furthermore, Inspire
shall have the fully-paid, non-exclusive, perpetual right to continue to use
patents or know-how that embody or relate to Inventions and that are owned or
controlled by Kissei or its Affiliates as set forth in Section 5.4.
(d) If this Agreement is terminated by Kissei pursuant to Section
12.2 by reason of a breach or default by Inspire, in addition to any other
remedies available to Kissei at law or in equity,: (i) the license granted to
Inspire by Kissei under Section 5.4 shall terminate; (ii) Kissei shall have an
exclusive, royalty-free, perpetual right to continue to use, market, distribute,
sell, manufacture and have manufactured any Product in the Territory, and the
exclusive, perpetual and paid-up right to use the Licensed Technology in
connection therewith. To that end, Kissei may
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continue to hold and use all data, reports, records and materials that relate to
or are prepared in the course of the Joint Development Program, and may hold all
INDs, NDAs, NDA Approvals and other regulatory filings made or filed by Kissei
for the Products, pursuant to this Agreement, and may in its sole discretion
continue any sublicenses granted by Kissei under this Agreement; and (iii) in
order to secure the right of Kissei in clause (ii) of this Section 12.4(d),
Inspire hereby grants Kissei the Manufacturing License as provided in the Supply
Agreement, and will use all reasonable efforts to enable Kissei to manufacture,
or have manufactured Finished Product and Delivery Systems, including working
with Kissei to establish arrangements with the Third Party Manufacturers.
12.5 Accrued Rights; Surviving Obligations.
(a) Termination, relinquishment or expiration of this Agreement for
any reason shall be without prejudice to any rights which shall have accrued to
the benefit of either Party prior to such termination, relinquishment or
expiration. Such termination, relinquishment or expiration shall not relieve
either Party from obligations which are expressly indicated to survive
termination or expiration of this Agreement.
(b) All of the Parties' rights and obligations under Sections 3.7,
4.7(d), 4.7(e), 4.8, 5.7, 7, 9.1, 9.3 (solely with respect to actions commenced
before the effective date of termination of this Agreement), 9.4 (solely with
respect to actions commenced before the effective date of termination of this
Agreement), 10.4, 10.5, 10.6, 10.7, 11, 12.4, 12.5, 14.12 and 14.13 shall
survive termination, relinquishment or expiration of this Agreement.
13. FORCE MAJEURE.
13.1 Events of Force Majeure. Neither Party shall be held liable or
responsible to the other Party nor be deemed to be in default under, or in
breach of any provision of, this Agreement for failure or delay in fulfilling or
performing any obligation of this Agreement when such failure or delay is due to
force majeure, and without the fault or negligence of the Party so failing or
delaying. For purposes of this Agreement, force majeure is defined as causes
beyond the control of the Party, including, without limitation, acts of God;
acts, regulations, or laws of any government; war; civil commotion; destruction
of production facilities or materials by fire, flood, earthquake, explosion or
storm; labor disturbances; epidemic; and failure of public utilities or common
carriers. In such event Inspire or Kissei, as the case may be, shall
immediately notify the other Party of such inability and of the period for which
such inability is expected to continue. The Party giving such notice shall
thereupon be excused from such of its obligations under this Agreement as it is
thereby disabled from performing for so long as it is so disabled and the 30
days thereafter. To the extent possible, each Party shall use reasonable
efforts to minimize the duration of any force majeure.
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14. MISCELLANEOUS.
14.1 Relationship of Parties. Nothing in this Agreement is intended or
shall be deemed to constitute a partnership, agency, employer-employee or joint
venture relationship between the Parties. No Party shall incur any debts or
make any commitments for the other, except to the extent, if at all,
specifically provided herein.
14.2 Assignment. Neither Party shall be entitled to assign its rights
hereunder without the express written consent of the other Party hereto, except
that each Party may assign its rights and transfer its duties hereunder to any
assignee of all or substantially all of its business (or that portion thereof to
which this Agreement relates) or in the event of such Party's merger,
consolidation or involvement in a similar transaction. No assignment and
transfer shall be valid or effective unless done in accordance with this Section
14.2 and unless and until the assignee/transferee shall agree in writing to be
bound by the provisions of this Agreement.
14.3 Books and Records. Any books and records to be maintained under
this Agreement by a Party or its Affiliates or Sublicensees shall be maintained
in accordance with generally accepted accounting principles, consistently
applied.
14.4 Further Actions. Each Party shall execute, acknowledge and deliver
such further instruments, and do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.
14.5 Notice.
(a) Any notice or request required or permitted to be given under or
in connection with this Agreement shall be deemed to have been sufficiently
given if in writing and personally delivered or sent by certified mail (return
receipt requested), facsimile transmission (receipt verified), or overnight
express courier service (signature required), prepaid, to the Party for which
such notice is intended, at the address set forth for such Party below:
(i) In the case of Inspire, to:
Inspire Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxx, Xxxxx Xxxxxxxx 00000
XXX
Attention: Xxxxxxx X. Xxxxxxx, Ph.D.
Facsimile No.: (000) 000-0000
-36-
(ii) In the case of Kissei, to:
Kissei Pharmaceutical Co., Ltd.
00-00, Xxxxxxx
Xxxxxxxxx-Xxxx, Xxxxxx-Xxxxxxxxxx
000-0000
XXXXX
Attention: Masanori Iwadare, Ph.D.
Facsimile No.: (263) 28-2174
or to such other address for such Party as it shall have specified by like
notice to the other Party, provided that notices of a change of address shall be
effective only upon receipt thereof. If delivered personally or by facsimile
transmission, the date of delivery shall be deemed to be the date on which such
notice or request was given. If sent by overnight express courier service, the
date of delivery shall be deemed to be the next business day after such notice
or request was deposited with such service. If sent by certified mail, the date
of delivery shall be deemed to be the third business day after such notice or
request was deposited with the U.S. or Japanese Postal Service, as the case may
be.
(b) All correspondence, notices and other communications shall be
promptly provided to the other Party in English. If any data, information and
document or literature which relate to Joint Development Program or any
regulatory filings is written in non-English language, an appropriate summary in
English shall be attached to it, and an English translation will follow in a
timely manner if requested.
14.6 Use of Name. Except as otherwise provided herein, neither Party
shall have any right, express or implied, to use in any manner the name or other
designation of the other Party or any other trade name or trademark of the other
Party for any purpose in connection with the performance of this Agreement.
14.7 Public Announcements. Except as required by law (including,
without limitation, disclosure requirements of the U.S. Securities and Exchange
Commission, Nasdaq or any other stock exchange on which securities issued by a
Party are traded) and as permitted by Section 10.3, neither Party shall make any
public announcement concerning this Agreement or the subject matter hereof
without the prior written consent of the other, which shall not be unreasonably
withheld, provided that it shall not be unreasonable for a Party to withhold
consent with respect to any public announcement containing any of such Party's
Confidential Information. In the event of a required public announcement, to
the extent practicable under the circumstances, the Party making such
announcement shall provide the other Party with a copy of the proposed text
prior to such announcement sufficiently in advance of the scheduled release of
such announcement to afford such other Party a reasonable opportunity to review
and comment upon the proposed text.
-37-
14.8 Waiver. A waiver by either Party of any of the terms and
conditions of this Agreement in any instance shall not be deemed or construed to
be a waiver of such term or condition for the future, or of any subsequent
breach hereof. All rights, remedies, undertakings, obligations and agreements
contained in this Agreement shall be cumulative and none of them shall be in
limitation of any other remedy, right, undertaking, obligation or agreement of
either Party.
14.9 Compliance with Law. Nothing in this Agreement shall be deemed to
permit a Party to export, reexport or otherwise transfer any Product sold under
this Agreement without compliance with applicable laws.
14.10 Severability. When possible, each provision of this Agreement
will be interpreted in such manner as to be effective and valid under applicable
law, but if any provision of this Agreement is held to be prohibited by or
invalid under applicable law, such provision will be ineffective only to the
extent of such prohibition or invalidity, without invalidating the remainder of
this Agreement.
14.11 Amendment. No amendment, modification or supplement of any
provisions of this Agreement shall be valid or effective unless made in writing
and signed by a duly authorized officer of each Party.
14.12 Governing Law; English Original Controlling. This Agreement shall
be governed by and interpreted in accordance with the laws of Delaware without
regard to its choice of law principles; provided, however, that any arbitration
proceeding conducted pursuant to Section 14.13 shall be governed by the
Convention on the Recognition and Enforcement of Foreign Arbitral Awards of June
10, 1958. The English original of this Agreement shall prevail over any
translation hereof.
14.13 Arbitration.
(a) Except as expressly otherwise provided in this Agreement, any
dispute arising out of or relating to any provisions of this Agreement shall be
finally settled by arbitration to be held in San Francisco, California, under
the auspices and then current commercial arbitration rules of the International
Chamber of Commerce. Such arbitration shall be conducted by three arbitrators
appointed according to said rules and in the English language. The Parties
shall instruct such arbitrators to render a determination of any such dispute
within 30 days after their appointment.
(b) Any award rendered by the arbitrator(s) shall be final and
binding upon the Parties. Judgment upon any award rendered may be entered in
any court having jurisdiction, or application may be made to such court for a
judicial acceptance of the award and an order of enforcement, as the case may
be. Each Party shall pay its own expenses of arbitration, and the expenses of
the arbitrator(s) shall be equally shared unless the arbitrator(s) assesses as
part of his or
-38-
her award all or any part of the arbitration expenses of one Party (including
reasonable attorneys' fees) against the other Party.
(c) This Section 14.13 shall not prohibit a Party from seeking
injunctive relief from a court of competent jurisdiction in the event of a
breach or prospective breach of this Agreement by the other Party which would
cause irreparable harm to the first Party.
14.14 Entire Agreement. This Agreement, together with the Exhibits
hereto and every Annual Development Plan approved by the Joint Development
Committee, sets forth the entire agreement and understanding between the Parties
as to the subject matter hereof and merges all prior discussions and
negotiations between them, and neither of the Parties shall be bound by any
conditions, definitions, warranties, understandings or representations with
respect to such subject matter other than as expressly provided herein or as
duly set forth on or subsequent to the date hereof in writing and signed by a
proper and duly authorized officer or representative of the Party to be bound
thereby.
14.15 Parties in Interest. All of the terms and provisions of this
Agreement shall be binding upon, inure to the benefit of and be enforceable by
the Parties hereto and their respective permitted successors and assigns.
14.16 Descriptive Headings. The descriptive headings of this Agreement
are for convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.
14.17 Counterparts. This Agreement may be executed simultaneously in
any number of counterparts, any one of which need not contain the signature of
more than one Party but all such counterparts taken together shall constitute
one and the same agreement.
* * *
-39-
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be
executed by its duly authorized representative as of the day and year first
above written.
INSPIRE PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. Xxxxx
-----------------------------------
Xxxxx X. Xxxxx, M.D., Vice Chairman
KISSEI PHARMACEUTICALS CO., LTD.
By:/s/ Xxxxxx Xxxxxxx
-------------------------------
Xxxxxx Xxxxxxx, President and
Chief Executive Officer
EXHIBIT A
---------
INSPIRE'S COSTS
---------------
[CONFIDENTIAL TREATMENT REQUESTED]
EXHIBIT B
---------
INITIAL PATENTS
---------------
1. US Patent No. 5,635,160 " Dinucleotides Useful for the Treatment of Cystic
Fibrosis and for Hydrating Mucus Secretions", X. X. Xxxxxx, III, X. X.
Xxxxxxx, Xx., X. X. Xxxxxxxxxx, and C. A. Xxxxx. Assignee: The University
of North Carolina at Xxxxxx Xxxx, Xxxxxx Xxxx, X.X. Issued: June 3, 1997.
2. [CONFIDENTIAL TREATMENT REQUESTED]
3. [CONFIDENTIAL TREATMENT REQUESTED]
4. US Patent No. 5,763,447 "Method of Preventing or Treating Pneumonia in
Immobilized Patients with Uridine Triphosphates and Related Compounds", X.
X. Xxxxxxx and X. X. Xxxxxxxx. Assignee: Inspire Pharmaceuticals, Inc.,
0000 Xxxxxxx Xxxx., Xxxxxx, X.X. Issued: June 9, 1998.
5. [CONFIDENTIAL TREATMENT REQUESTED].
EXHIBIT C
---------
INITIAL MEMBERS OF
------------------
JOINT DEVELOPMENT COMMITTEE
---------------------------
A. Initial Designees of Inspire:
1. Xxxxxxx Xxxxxxx, Ph.D., Initial Secretary
2. Xxxxxxx Xxxxx, Ph.D.
3. Xxxxxxxx Xxxxx, Ph.D.
B. Initial Designees of Kissei:
1. Xxxxxxx Xxxxxxxxx, Initial Chairperson
2. Xxxxx Xxxxx, Ph.D.
3. Xxxxx Xxxxxx, Ph.D.
EXHIBIT D
---------
TERMS AND CONDITIONS OF
-----------------------
THE COMMERCIAL SUPPLY AGREEMENT
-------------------------------
Defined terms used in the Exhibit shall have the meaning assigned to such terms
in the Joint Development, License and Supply Agreement dated as of September 10,
1998 between the Parties (the "License Agreement").
1. Supply. Commencing on the commercial launch of the Product and
thereafter during the term of the Supply Agreement, Inspire shall have, or have
obtained, all rights necessary to make, or have made, Finished Product and
Delivery Systems. Commencing on the commercial launch of the Product and
thereafter during the term of the Supply Agreement, subject to the terms and
conditions of this agreement, Inspire shall supply Kissei with all of Kissei's
requirements for Supplied Goods for commercial use in the Territory (which shall
be deemed to include all of the requirements of Kissei's Affiliates and
Sublicensees), and Kissei shall purchase from Inspire all of such requirements
for the Supplied Goods. Kissei may place orders for the requirements of its
Affiliates and Sublicensees, and either have Inspire ship directly to such
Affiliates or Sublicensees or to Kissei for its reshipment to such Affiliates
and Sublicensees. Inspire shall prepare all Supplied Goods in bulk containers
for shipment to Kissei. Kissei shall be responsible for putting the Supplied
Goods in final packaged form, including, without limitation, all product
labeling and other package inserts and materials required by the applicable
Regulatory Authorities.
2. Forecasts. Commencing 24 months prior to the anticipated commercial
launch of the first Product in the Territory, no later than 180 days prior to
the first day of each calendar quarter ("Q1"), Kissei shall provide Inspire with
a non-binding, good faith rolling forecast of estimated quantities in trade
units and anticipated delivery schedules for the Supplied Goods for the
following 12-month period (i.e., Q1 and the next three calendar quarters ("Q2,"
"Q3," etc., respectively)), by calendar quarters. The quantity indicated for Q1
shall be considered a firm order. Such forecasts shall be revised and updated
quarterly, including firm orders for the next succeeding quarter.
3. Orders.
(a) Together with each forecast provided under Section 2 (the "Current
Forecast"), Kissei shall place its firm order on a quarterly basis with Inspire,
setting forth trade units, delivery dates and shipping instructions with respect
to each shipment of Supplied Goods for delivery in Q1. Inspire shall accept
such orders from Kissei, subject to the other terms and conditions of the Supply
Agreement, to the extent such quantity of Finished Product or Delivery Systems,
as the case may be, is: (i) no more than the least of: (A) the quantity thereof
reflected in the Current Forecast for Q1; (B) [CONFIDENTIAL TREATMENT REQUESTED]
of the quantity thereof reflected for Q2 in the forecast that next preceded the
Current Forecast; and (C) [CONFIDENTIAL TREATMENT REQUESTED] of the quantity
thereof reflected for Q3 in the forecast that next preceded the forecast
referred to in clause (i)(B); and (ii) no less than the greatest
D-1
of: (A) the quantity thereof reflected in the Current Forecast for Q1; (B)
[CONFIDENTIAL TREATMENT REQUESTED] of the quantity thereof reflected for Q2 in
the forecast that next preceded the Current Forecast; and (C) [CONFIDENTIAL
TREATMENT REQUESTED] of the quantity thereof reflected for Q3 in the forecast
that next preceded the forecast referred to in clause (ii)(B). Kissei's orders
shall be made pursuant to purchase orders which are in a form mutually
acceptable to the Parties, to the extent that such form is not inconsistent with
the terms of the Supply Agreement.
(b) Inspire shall not be obligated to accept orders for Q1 to the
extent the quantity of Supplied Goods ordered exceeds the foregoing limitations,
but shall use good faith efforts to fill such orders for such excess quantities
from available supplies. In the event that Inspire, despite the use of good
faith efforts, is unable to supply such excess quantities to Kissei, such
inability to supply shall not be deemed to be a breach of Inspire's obligations
under this Supply Agreement. Inspire shall use all reasonable efforts to notify
Kissei within 10 days after receipt of an order of Inspire's ability to fill any
amounts of such orders in excess of the quantities that Inspire is obligated to
supply.
(c) In the event that Kissei submits orders of Supplied Goods with
respect to any Q1 for less than the minimum quantity of Product that Kissei is
required to purchase under this Supply Agreement, Inspire nevertheless shall
have the right to supply and ship to Kissei, and Kissei shall have the
obligation to purchase and accept from Inspire, such minimum quantity of
Supplied Goods.
(d) By way of illustration, examples of the maximum quantities of
Finished Product or Delivery Systems that Inspire is required to supply, and the
minimum quantities of Finished Product or Delivery Systems that Kissei is
required to order (and that Inspire is entitled to supply), are set forth on
Schedule 1.
4. Delivery. With respect to exact shipping dates, Inspire shall use all
reasonable commercial efforts to ship quantities of Supplied Goods that Inspire
is obligated to supply pursuant to Section 3 on the dates specified in Kissei's
purchase orders submitted and accepted in accordance with Section 3. All
Supplied Goods delivered pursuant to the terms of the Supply Agreement shall be
suitably packed for shipment by Inspire, marked for shipment to the destination
point indicated in Kissei's purchase order. All Supplied Goods will be
delivered CIF the arrival point designated by Kissei. The shipping packaging
shall be in accordance with the package specifications which shall be approved
by both Parties from time to time.
5. Conformity; Specifications; Quality Control.
(a) All quantities of Supplied Goods supplied by Inspire pursuant to
the Supply Agreement will comply with all applicable Specifications and
applicable Manufacturing Standards and shall adhere to all applicable
governmental laws and regulations relating to the manufacture, sale
D-2
and shipment of the respective Supplied Goods at the time they arrive at the
point designated by Kissei.
(b) Kissei shall have the right to change the Specifications, from
time to time, to accommodate the demands or requests of any Regulatory
Authority at any time during the term of the Supply Agreement on not less than
12 months' prior written notice to Inspire. Any costs or expenses incurred by
Inspire in connection with such changes shall be borne by Kissei, and Inspire
shall be entitled to include such costs and expenses in invoices submitted to
Kissei pursuant to Section 7.1(a) of the License Agreement, from time to time.
In addition, other changes to the Specifications shall be made only upon the
mutual consent of the Parties. In this case, any costs or expenses derived from
such changes shall be paid by the Party which demands or requests such changes.
In any such event, Inspire shall use reasonable commercial efforts to meet any
of the foregoing changes.
(c) Inspire shall conduct, or cause to be conducted, quality control
testing of Supplied Goods prior to shipment in accordance with the applicable
Specifications and applicable Manufacturing Standards as are in effect from time
to time and such other quality control testing procedures agreed to by the
Parties from time to time (collectively, the "Testing Methods"). Inspire or its
designee shall retain records pertaining to such testing. Each shipment of
Supplied Goods hereunder shall be accompanied by a certified quality control
protocol and certificate of analysis for each lot of Supplied Goods therein as
well as such customs and other documentation as is necessary or appropriate.
6. Acceptance/Rejection; Interim Replacement.
(a) Kissei may test or cause to be tested Supplied Goods in accordance
with Kissei's customary procedures within 30 days of its receipt at Kissei's
plant or that of its designee. Kissei or its designee shall have the right to
reject any shipment of Supplied Goods made to it under this Agreement that does
not meet the applicable Specifications and applicable Manufacturing Standards
when received by it at such destination when tested in accordance with the
Testing Methods. All claims by Kissei of non-conforming Supplied Goods shall be
deemed waived unless made by Kissei in writing and received by Inspire within
such 30-day period.
(b) All claims of non-conforming Supplied Goods shall be accompanied
by a report of analysis (including a sample of the Supplied Goods from the batch
analyzed) of the allegedly non-conforming Supplied Goods that shall have been
made by Kissei or its designee, using the Testing Methods. If, after its own
analysis of such sample, Inspire confirms such non-conformity, then Inspire
shall replace such shipment at its expense, including charges incurred by Kissei
for shipping and/or storage, if applicable. If, after its own analysis, Inspire
does not confirm such non-conformity, the Parties shall agree to retest the
shipment or otherwise in good faith attempt to agree upon a settlement of the
issue. In the event that the Parties cannot resolve the issue, the Parties
shall submit the disputed Supplied Goods to an independent testing laboratory,
to be agreed
D-3
upon by the Parties, for testing in accordance with the Testing Methods.
Notwithstanding Section 14.13 of the License Agreement, the findings of such
laboratory shall be binding on the Parties, absent manifest error. Expenses of
such testing shall be borne by the Party adversely affected by such findings.
In the event that any such shipment or batch thereof is ultimately agreed or
found not to meet the applicable Specifications or Manufacturing Standards,
Inspire agrees to replace such shipment at its expense, including charges
incurred by Kissei for shipping and/or storage, if applicable. Kissei shall
return any such rejected shipment to Inspire if so instructed by Inspire, at
Inspire's expense.
(c) During the pendency of any dispute concerning the conformity of a
shipment of Supplied Goods to the applicable Specifications and applicable
Manufacturing Standards, Inspire shall replace the shipment under dispute, at
the request of Kissei. Such replacement Supplied Goods shall be ordered in
accordance with Section 3.
(d) Notwithstanding any other provision of the License Agreement or
the Supply Agreement, Kissei shall not be required to pay for any shipment of
Supplied Goods that fails to meet the applicable Specifications, but Kissei
shall be obligated to pay in full for any rejected shipment of Supplied Goods
that is subsequently determined to meet the applicable Specifications. In the
event that Kissei pays for a shipment of Supplied Goods and subsequently rejects
such shipment in accordance with the terms of the Supply Agreement, Kissei shall
be entitled to a refund or credit equal to the amount paid with respect to such
rejected shipment. Any such refund or credit shall be reflected in the
statements submitted by Kissei pursuant to Section 7.1(b) of the License
Agreement.
(e) Based on the information currently available regarding the
Finished Product, Inspire anticipates that the commercial shelf-life of Finished
Product will be at least 24 months. The targeted commercial shelf-life of
Finished Product is 36 months.
7. Third Party Manufacturers.
(a) The Parties acknowledge and agree that Inspire shall satisfy its
supply obligations to Kissei hereunder through arrangements with Third Parties
engaged to perform services or supply facilities or goods (including Compound,
Formulated Material, Finished Product and Delivery Systems) in connection with
the manufacture, testing, and/or packaging of Supplied Goods (each, a "Third
Party Manufacturer"). Inspire shall ensure that all such facilities comply with
the applicable Manufacturing Standards in effect from time to time, and such
Third Party Manufacturers shall permit Kissei to inspect such facilities, at
Kissei=s request at any time during the term of the Supply Agreement or the
License Agreement.
(b) Inspire acknowledges and agrees that such Third Party
Manufacturers shall be subject to Section 5(a) and that use of a Third Party
Manufacturer shall not relieve Inspire of its obligations under Section 5(a).
D-4
8. Manufacturing Plan. At least 12 months prior to the anticipated launch
of the Product, Inspire shall prepare a proposed manufacturing plan for Supplied
Goods, including, without limitation, plans and timing for establishing Third
Party Manufacturers and back-up and/or secondary Third Party Manufacturers (to
the extent feasible and practicable) for review and approval by the Joint
Development Committee (the "Manufacturing Plan"). Upon approval of the
Manufacturing Plan by the Joint Development Committee, Inspire shall use
commercially reasonable efforts to comply with the Manufacturing Plan.
9. Shortage of Supply. Inspire shall notify Kissei: (i) within 30 days
of Inspire's receipt of a firm order from Kissei as provided in Section 3, or
(ii) immediately upon becoming aware of an event of force majeure under Section
13 of the License Agreement or any other event that would render Inspire unable
to supply the quantity of Supplied Goods to Kissei that Inspire is required to
supply hereunder, if Inspire is unable to supply such quantities of Supplied
Goods. In such event, Inspire shall implement all reasonable measures to remedy
the shortage.
10. Inability to Supply.
(a) In the event of any Inability to Supply (as defined herein) with
respect to any Supplied Goods, Kissei shall have the option, exercisable by
providing Inspire written notice thereof, to manufacture (or have manufactured)
such Supplied Goods for sufficient supply thereof in the Territory in order to
settle the Inability to Supply. In such event: (i) Inspire shall provide to
Kissei copies of all documentation within Inspire's possession and control that
is reasonably necessary to enable Kissei to manufacture (or have manufactured)
Supplied Goods with respect to which an Inability to Supply has occurred; (ii)
Inspire shall provide such technical assistance to Kissei as is reasonably
necessary to enable Kissei to manufacture (or have manufactured) such Supplied
Goods pursuant to the applicable Specifications and Manufacturing Standards; and
(iii) Inspire shall reasonably cooperate with Kissei to establish an alternative
supply, including sources of materials. Notwithstanding the foregoing, Inspire
shall continue to resolve the Inability to Supply as provided in Section 9.
Once Inspire has resolved the Inability to Supply, Inspire shall notify Kissei
and shall resume manufacturing of such Supplied Good to meet Kissei's
requirements as soon as practicable.
(b) For purposes of this Section 10, an "Inability to Supply" shall
mean, with respect to any Supplied Goods, Inspire's failure to supply Kissei
with quantities of such Supplied Goods meeting the applicable Specifications and
Manufacturing Standards: (i) in any two consecutive calendar quarters, equal to
at least 70%, or (ii) in any 12-month period, equal to at least 80%, of the
lesser of (i) the quantity of such Supplied Goods ordered by Kissei for the
applicable period, and (ii) the maximum quantity of such Supplied Goods that
Inspire is obligated to supply under Section 3 for the applicable period.
(c) The remedy provided in this Section 10 shall be Kissei's sole
remedy for Inability to Supply unless such Inability to Supply results from a
material breach of Inspire's material obligations contained in the Supply
Agreement. However, in the event that such Inability to Supply
D-5
results from a material breach of Inspire=s material obligations contained in
the Supply Agreement, the remedy provided in this Section 10 shall be in
addition to any other remedies available to Kissei at equity or in law.
11. Right to Manufacture. In the event that Kissei exercised the option
referred to in Section 10(a), Inspire hereby grants to Kissei, and Kissei hereby
accepts, a royalty-free license (the "Manufacturing License") under the Licensed
Technology necessary to make, have made, use and sell such Supplied Goods in the
Territory for use in applications within the Field. Such Manufacturing License
shall be subject to all other terms and conditions of the Supply Agreement. In
such event, Kissei shall be relieved of its obligation to purchase the
quantities of Supplied Goods from Inspire, to the extent that Kissei has elected
to exercise the Manufacturing License.
12. Investigation; Recall. In the event that the Supplied Product
supplied hereunder, or any portion thereof, should be alleged or proven not to
meet the applicable Specifications, applicable Manufacturing Standards or other
applicable mandatory standards for same, Kissei shall notify Inspire
immediately, and both Parties shall cooperate fully regarding the investigation
and disposition of any such matter. Each Party shall bear all costs and
expenses associated with any Product recall that is due to or arises from an act
or omission with respect to which such Party has an obligation to provide
indemnification under Section 11 of the License Agreement.
13. Supply Following Expiration of the License Agreement. Following the
expiration of the term of the License Agreement in its entirety pursuant to
Section 12.1(b) of the License Agreement, the Parties shall hold discussions
concerning the desirability and feasibility of Inspire's continued supply of
Supplied Goods to Kissei. If the Parties agree that such an arrangement would
be desirable and feasible, then they shall negotiate in good faith the terms
upon which such supply shall be made.
D-6
Schedule 1 - Maximum/minimum Orders under Section 3
----------
The following examples are intended to illustrate the operation of Section 3
regarding the maximum quantity of Supplied Goods that Inspire is required to
accept orders for, and the minimum quantity of Supplied Goods that Kissei is
required to purchase (and Inspire is entitled to supply), with respect to any
particular Q1.
Assumptions
1. The following examples are restricted to the supply of Finished Product.
Identical calculations would be made with respect to Inspire's supply of
Delivery Systems but are omitted for purposes of clarity.
2. "Forecast 1" refers to the quarterly forecast for Finished Product to be
supplied by Inspire during the fourth calendar quarter of 2001 (the
"Subject Quarter") which forecast is delivered to Inspire by Kissei on or
before the first day of the fourth calendar quarter of 2000.
3. "Forecast 2" refers to the quarterly forecast for Finished Product to be
supplied by Inspire during the Subject Quarter which forecast is delivered
to Inspire by Kissei on or before the first day of the first calendar
quarter of 2001.
4. "Forecast 3" refers to the quarterly forecast for Finished Product to be
supplied by Inspire during the Subject Quarter which forecast is delivered
to Inspire by Kissei on or before the first day of the second calendar
quarter of 2001.
Example 1
Kissei's forecasts for Finished Product for the Subject Quarter, as provided
over a three-quarter period, are as follows:
====================================================================
Forecast 1 Forecast 2 Forecast 3
====================================================================
* * *
====================================================================
The first forecast (Forecast 1), provided to Inspire before the start of the
fourth quarter 2000, forecasts * of Finished Product. The second
forecast (Forecast 2), provided to Inspire before the start of the first quarter
2001, forecasts * of Finished Product. The third forecast (Forecast 3),
provided to Inspire before the start of the second quarter 2001, forecasts *
units of Finished Product.
*[CONFIDENTIAL TREATMENT REQUESTED]
D-7
Kissei's forecasts for Finished Product have increased over this three-quarter
period. Pursuant to clause (i) of Section 3(a), Kissei is entitled to purchase,
and Inspire is obligated to deliver no more Finished Product than the least of:
(A) [*] of the quantity of Finished Product reflected in Forecast 1
(*);
(B) [*] of the quantity of Finished Product reflected in Forecast 2
(*); or
(C) the quantity of Finished Product reflected in Forecast 3 (*).
Therefore, Inspire will not be obligated to accept orders for, or supply, more
than * of Finished Product during the Subject Quarter.
Example 2
Kissei's forecasts for Finished Product for the Subject Quarter, as provided
over a three-quarter period, are as follows:
====================================================================
Forecast 1 Forecast 2 Forecast 3
====================================================================
* * *
====================================================================
Kissei's forecasts for Finished Product have decreased over this three-quarter
period. Pursuant to clause (ii) of Section 3(a), Kissei is required to
purchase, and Inspire is entitled to supply, no less Finished Product than the
greatest of:
(A) [*] of the quantity of Finished Product reflected in Forecast 1 (*);
(B) [*] of the quantity of Finished Product reflected in Forecast 2 (*);
or
(C) the quantity of Finished Product reflected in Forecast 3 (*).
Therefore, Kissei is obligated to purchase, and Inspire is entitled to supply, *
of Finished Product during the Subject Quarter.
Example 3
Kissei's forecasts for Finished Product for the Subject Quarter, as provided
over a three-quarter period, are as follows:
*[CONFIDENTIAL TREATMENT REQUESTED]
D-8
====================================================================
Forecast 1 Forecast 2 Forecast 3
====================================================================
* * *
====================================================================
Kissei's forecasts for Finished Product have decreased between the two most
recent forecasts. Pursuant to clause (ii) of Section 3(a), Kissei is required
to purchase, and Inspire is entitled to supply, no less Finished Product than
the greatest of:
(A) * of the quantity of Finished Product
reflected in Forecast 1 (*);
(B) [CONFIDENTIAL TREATMENT REQUESTED] of the quantity of Finished Product
reflected in Forecast 2 (*); or
(C) the quantity of Finished Product reflected in Forecast 3 (*).
Therefore, Kissei is obligated to purchase, and Inspire is entitled to supply,
* of Finished Product during the Subject Quarter.
Example 4
Kissei's forecasts for Finished Product for the Subject Quarter, as provided
over a three quarter period, are as follows:
====================================================================
Forecast 1 Forecast 2 Forecast 3
====================================================================
* * *
====================================================================
Kissei's forecasts for Finished Product have increased between the two most
recent forecasts. Pursuant to clause (i) of Section 3(a), Kissei is entitled to
purchase, and Inspire is obligated to deliver no more Finished Product than the
least of:
(A) * of the quantity of Finished Product
reflected in Forecast 3 (*);
(B) * of the quantity of Finished Product
reflected in Forecast 2 (*); or
(C) the quantity of Finished Product reflected in Forecast 3 (*).
Therefore, Inspire will not be obligated to accept orders for, or supply, more
than * of Finished Product during the Subject Quarter.
* [CONFIDENTIAL TREATMENT REQUESTED]
D-9
