REDACTED VERSION
EXHIBIT 10.18
TO
LIGHT SCIENCES ONCOLOGY, INC.'S
REGISTRATION STATEMENT ON FORM S-1
INITIALLY FILED
APRIL 21, 2006
REGISTRATION NO. 333-133474
"[*]" = omitted, confidential material, which material has been
separately filed with the Securities and Exchange Commission pursuant to a
request for confidential treatment.
LICENSE AND SUPPLY AGREEMENT
DATED AS OF APRIL 28, 2000
BY AND AMONG
NIPPON PETROCHEMICALS CO., LTD
AND
MEIJI SEIKA KAISHA, LTD.
AND
LIGHT SCIENCES CORPORATION
TABLE OF CONTENTS
ARTICLE 1. DEFINITIONS........................................................
1.1 Affiliate...................................................
1.2 Bulk........................................................
1.3 CMC Section.................................................
1.4 Compound....................................................
1.5 Confidential Information....................................
1.6 Device......................................................
1.7 Disease Area................................................
1.8 DMF or Drug Master File.....................................
1.9 Effective Date..............................................
1.10 Europe......................................................
1.11 FDA.........................................................
1.12 Field.......................................................
1.13 First Commercial Sale.......................................
1.14 IND.........................................................
1.15 Indication..................................................
1.16 Kit.........................................................
1.17 Licensed Know-How...........................................
1.18 Licensed Patents............................................
1.19 Licensed Technology.........................................
1.20 Licensee Information........................................
1.21 Licensor....................................................
1.22 Manufacturing Know-How......................................
1.23 Market Exclusivity..........................................
1.24 NDA.........................................................
1.25 Net Sales...................................................
1.26 Other Commercial Application................................
1.27 PDT or Photodynamic Therapy.................................
1.28 Phase I Clinical Studies....................................
1.29 Phase II Clinical Studies...................................
1.30 Phase III Clinical Studies..................................
1.31 Pivotal Clinical Studies....................................
1.32 [ * ].......................................................
1.33 Product.....................................................
1.34 Regulatory Approval.........................................
1.35 Territory...................................................
1.36 Valid Claim.................................................
ARTICLE 2. GRANT OF LICENSE..................................................
2.1 License Grant...............................................
2.2 Sublicense..................................................
ARTICLE 3. SUPPLY OF LICENSED KNOW-HOW, LICENSED PATENTS AND EXCHANGE OF DATA
3.1 Supply by Licensor..........................................
3.2 Translation Cost............................................
----------
[ * ] Confidential Treatment Requested
-2-
3.3 Supply by Licensee............................................
ARTICLE 4. TRANSFER OF MANUFACTURING KNOW-HOW...................................
4.1 Third-Party Manufacturer(s)...................................
4.2 Transfer of Manufacturing Know-How............................
ARTICLE 5. UPFRONT LICENSE FEE, MILESTONE PAYMENTS AND ROYALTIES
5.1 Upfront License Fee...........................................
5.2 Milestone Payments............................................
5.3 Royalty Payments..............................................
5.3.1 Royalty in Countries Without Market Exclusivity......
5.3.2 Royalty in Countries Covered by Market Exclusivity...
5.3.3 Royalties on Net Sales of Product for Other than
Therapeutic Application to Human Disease Areas.......
5.3.4 Extension of Market Exclusivity......................
5.3.5 Reduction of Royalties...............................
5.3.6 Quarterly Payments in U.S. Dollars...................
5.3.7 Royalty Statement....................................
5.3.8 [ * ] Product and Kit................................
5.3.9 Sales to Affiliates and Sublicensees.................
5.3.10 Records..............................................
----------
[ * ] Confidential Treatment Requested
-3-
5.4 Bank Remittance...............................................
5.5 Late Payments.................................................
5.6 Taxes and Withholdings........................................
ARTICLE 6. DEVELOPMENT.........................................................
6.1 Due Diligence.................................................
6.2 Compliance with Regulations...................................
6.3 Progress Report...............................................
6.4 Failure of Due Diligence......................................
6.5 Licensee Information..........................................
6.6 Transfer of IND...............................................
ARTICLE 7. REPORTS OF ADVERSE EVENTS...........................................
ARTICLE 8. SUPPLY OF THE BULK AND PRODUCT BY MEIJI.............................
8.1 Bulk Supply...................................................
8.2 Product Supply................................................
8.3 Room Temperature Stability Studies............................
8.4 Compliance With Specifications................................
8.4.1 Audit................................................
8.4.2 Meiji Responsibility for Compliance
With Specifications, Including cGMP..................
8.5 Forecasting, Orders, Delivery and Acceptance..................
8.5.1 Forecasting and Ordering of Supply for Development...
8.5.2 Shipment of Bulk and Product for Development.........
8.5.3 Payment..............................................
-4-
8.5.4 Acceptance...........................................
8.6 Term of Supply Obligation.....................................
ARTICLE 9. SALES AND PROMOTION.................................................
9.1 Commercial Sale...............................................
9.2 Sales Promotion...............................................
9.3 Supply of Promotional Materials...............................
9.4 Packaging Reference...........................................
ARTICLE 10. ANTI-INFECTIVES: MEIJI RIGHT OF FIRST NEGOTIATION.................
ARTICLE 11. LICENSEE'S DEVICE..................................................
ARTICLE 12. PRODUCT LIABILITY AND INDEMNIFICATION..............................
12.1 Licensor's Indemnification of Licensee........................
12.2 Licensee's Indemnification of Licensor........................
12.3 Indemnification Obligations with respect to Bulk and Product
Supplied by Xxxxx.............................................
ARTICLE 13. TRADEMARKS.........................................................
ARTICLE 14. PATENTS............................................................
14.1 Patent Maintenance............................................
14.2 Extension of Licensed Patent Term.............................
14.3 Third-Party Infringement of Licensed Patents..................
14.4 Alleged Infringement of Third-Party Patents...................
ARTICLE 15. INVENTIONS.........................................................
15.1 Licensee's Inventions.........................................
15.2 Licensor's Inventions.........................................
-5-
15.3 Joint Inventions..............................................
ARTICLE 16. TERM AND TERMINATION...............................................
16.1 Term..........................................................
16.2 Termination by Mutual Agreement...............................
16.3 Breach........................................................
16.4 Insolvency or Bankruptcy......................................
16.5 Serious Events................................................
16.6 Effect of Termination.........................................
16.7 Survival of Liability and Other Obligations...................
ARTICLE 17. FORCE MAJEURE......................................................
ARTICLE 18. CONFIDENTIALITY AND DISCLOSURE.....................................
18.1 Confidentiality...............................................
18.2 Disclosure....................................................
18.3 Prior Confidentiality Agreement...............................
ARTICLE 19. REPRESENTATIONS AND WARRANTIES.....................................
19.1 By Licensor...................................................
19.2 By Licensee...................................................
ARTICLE 20. MISCELLANEOUS......................................................
20.1 Assignment....................................................
20.2 Severability..................................................
20.3 Notices.......................................................
20.4 Applicable Law................................................
20.5 Entire Agreement..............................................
-6-
20.6 Headings......................................................
20.7 Independent Contractors.......................................
20.8 Waiver........................................................
20.9 Dispute Resolution............................................
20.10 Arbitration...................................................
20.11 Public Announcements..........................................
20.12 Limitations of Liability......................................
20.13 Counterparts..................................................
20.14 Official Language.............................................
20.15 Further Documents.............................................
EXHIBITS
Exhibit A - Licensed Patents (1)
Exhibit B - Development Plan
Exhibit C - IND Transfer to Light Sciences
Exhibit D - List of Documents to be Translated
-7-
LICENSE AND SUPPLY AGREEMENT
THIS LICENSE AND SUPPLY AGREEMENT (the "Agreement") is made as of the 28th
day of April, 2000 (the "Effective Date"), by and among:
Nippon Petrochemicals Co., Ltd., a Japanese corporation having its
principal place of business at 0-0, Xxxxxxxxxx-xxx 0-xxxxx, Xxxxxxx-xx, Xxxxx
000-0000, Xxxxx (hereinafter referred to as "NPC");
Meiji Seika Kaisha, Ltd., a Japanese corporation having its principal place
of business at 0-00, Xxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx 000-0000, Xxxxx
(hereinafter referred to as "Meiji");
(Meiji and NPC shall hereinafter be individually referred to as such and
collectively referred to as "Licensor", as further provided in Section 1.21
below); and
Light Sciences Limited Partnership, a Washington State limited partnership
having its principal place of business at 0000-00xx Xxxxxx XX, Xxxxx X-0,
Xxxxxxxx, Xxxxxxxxxx 00000, X.X.X. (hereinafter referred to as "Licensee").
WITNESSETH
WHEREAS, either NPC or Xxxxx is the owner of the Licensed Patents (as
hereinafter defined) covering a photosensitizing agent coded NPe6 (also known as
ME2906), which is potentially useful in photodynamic therapy, and is also the
owner of the Licensed Know-How (as hereinafter defined) relating thereto; and
WHEREAS, Licensee wishes to obtain a worldwide (except in Japan) exclusive
license to develop, make, have made and commercialize the Product (as
hereinafter defined); and
WHEREAS, Licensor is willing to grant Licensee such license under the terms
and conditions set forth in this Agreement;
NOW, THEREFORE, in consideration of the obligations and promises as set
forth herein, the parties do hereby agree as follows:
ARTICLE 1. DEFINITIONS
As used in this Agreement, the following terms shall have the following
respective meanings:
1.1 AFFILIATE means any corporation or other entity which controls, is
controlled by, or is under common control with a party to this Agreement. A
corporation or other entity shall be regarded as in control of another
corporation or entity if it owns or controls directly or indirectly fifty
percent (50%) or more of the voting power of the other corporation or entity or
otherwise has the power to control its general activities, but in each case only
so long as such ownership or control shall continue.
1.2 BULK means the Compound in bulk form.
1.3 CMC SECTION means the Section on chemistry, manufacture and control
defined in 21 C.F.R. 312.23 (a) (7) or any successor to such provision, or a
foreign equivalent thereof, and submitted by or on behalf of Meiji or Licensee
to the FDA, or a foreign equivalent thereof, with respect to the Bulk or the
Product, as applicable.
1.4 COMPOUND means a photosensitizing compound coded NPe6 or ME2906 with
the chemical name of (+)-tetrasodium(2S, 3S)-18-carboxylato-20-[N-(S)-1,
2-dicarboxylatoethyl]carbamoylmethyl-l3-ethyl-3, 7, 12,
17-tetramethyl-8-vinylchlorin-2-propanoate (its JAN is "taporfin sodium"), any
isomers, salts and analogs thereof and all compounds derived from NPe6 or ME2906
and covered by the Licensed Patents.
1.5 CONFIDENTIAL INFORMATION means the Licensed Know-How, the Licensee
Information and any information, data, improvements, inventions, development,
commercialization or business plans or development or royalty reports relating
to the Compound, the Bulk, the Product, the Kit and/or the Device which a party
discloses to the other party, except any portion thereof which:
(i) was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure, as documented by
written records;
(ii) is or was disclosed to the receiving party, other than under an
obligation of confidentiality, by a third person with a right to make such
disclosure;
(iii) was or becomes part of the public domain through no fault or
breach of the receiving party; or
(iv) is or was independently developed by personnel of the receiving
party and without access or reference to the information disclosed by the
other party, as evidenced by the receiving party's written records.
1.6 DEVICE means any light generation and/or light delivery device(s)
acquired, developed, produced and/or manufactured by or on behalf of Licensee
for use with the Product in the Field.
1.7 DISEASE AREA means any generic type of disease, such as cancer,
ophthalmologic disease, cardiovascular disease, etc., as opposed to a specific
Indication within a Disease Area, such as lung cancer, stomach cancer, etc.
1.8 DMF or DRUG MASTER FILE means the information defined in 21 C.F.R.
314.420 or any successor to such provision, or any foreign counterpart thereof,
and filed with the FDA, or any foreign equivalent thereof, by or on behalf of
Meiji, [*] or Licensee with respect to the manufacture of the Bulk or the
Product, as applicable, in support of an IND or NDA for the Product.
1.9 EFFECTIVE DATE means the date first written above.
1.10 EUROPE means the European Union and any country that is a member of
the European Union.
1.11 FDA means the United States (U.S.) Food and Drug Administration or any
successor entity thereto.
1.12 FIELD means any treatment, diagnosis or monitoring of any Disease Area
in humans or animals and all Other Commercial Applications of the Product.
1.13 FIRST COMMERCIAL SALE means, on a country-by-country basis and an
Indication-by-Indication basis, the first sale of the Product or the Kit in a
country in the Territory by Licensee, its Affiliates or sublicensees to any
unaffiliated third party.
1.14 IND means an Investigational New Drug Application filed with the FDA
to commence human clinical testing of a drug, or any foreign counterpart
thereof.
1.15 INDICATION means a specific type of disease within a Disease Area; for
the avoidance of doubt, a Regulatory Approval to expand the use of Product in
----------
[*] Confidential Treatment Requested
connection with a particular Indication shall not be deemed a new Indication
(for example, if the FDA approves the use of Product for lung cancer -- one
Indication in the oncology Disease Area -- with certain restrictions, and the
FDA subsequently removes some or all of such restrictions on the approved use of
Product with lung cancer, such removal of restrictions shall not be deemed a new
Indication for the Product, but rather an expansion of the authorized use of
Product in connection with a previously approved Indication).
1.16 KIT means a combination of the Product and a consumable light delivery
apparatus when sold collectively for a single price on a unit-treatment basis.
1.17 LICENSED KNOW-HOW means any and all proprietary data, information,
trade secrets, formulations, inventions (including new formulations),
improvements, know-how and technology (other than the Licensed Patents) owned or
controlled by Licensor, their Affiliates or licensees (excluding Licensee), as
of the Effective Date or thereafter during the term of this Agreement relating
to the Compound, the Bulk and/or the Product, including but not limited to, all
pharmacological and toxicological data, all non-clinical, clinical and
regulatory data, results and reports (including, without limitation, all data,
results and reports submitted by, or in the possession or control of, all third
parties generating such data, results and reports on behalf of Licensor, their
Affiliates or licensees (excluding Licensee), including [*] and [*], to the
extent Licensor has the right, or can reasonably obtain the right at no cost, to
disclose such information to Licensee), formulation data, the CMC Section(s)
submitted by Xxxxx, the Drug Master File filed by or on behalf of Meiji, the
Manufacturing Know-How, copies of all written communications and submissions to
and from regulatory authorities and pricing authorities in the United States and
Japan, and a detailed written summary of all substantive oral communications and
discussion with such authorities; provided that Licensed Know-How excludes
Manufacturing Know-How not existing on the Effective Date but to be owned or
controlled by Licensor after the Effective Date and also excludes Licensor's
proprietary data, information, trade secrets, formulations, inventions,
improvements, know-how and technology pertaining only to Other Commercial
Applications of the Product.
1.18 LICENSED PATENTS means (i) all patents and patent applications in the
Territory set forth in Exhibit A attached hereto and incorporated by reference
herein, and any patents which may issue from the patent applications listed in
Exhibit A, in each case together with any substitutions, extensions, additions,
reissues, reexaminations, renewals, divisionals, continuations,
continuations-in-part and supplementary patent certificates thereof or therefor,
owned or controlled by Licensor
----------
[*] Confidential Treatment Requested
as of the Effective Date or thereafter during the term of this Agreement
relating to the Compound and/or the Product and/or Manufacturing Know-How
(Manufacturing Know-How existing as of the Effective Date), and (ii) to the
extent of Meiji's or NPC's interest therein and subject to Section 5.3.4, all
other patents and applications in the Territory owned or controlled by Licensor,
or any of their Affiliates, during the term of this Agreement relating to the
Compound and/or Product or methods of use for the Compound or Product, together
with any substitutions, extensions, additions, reissues, reexaminations,
renewals, divisionals, continuations-in-part and supplementary patent
certificates thereof or therefor, excluding such other patents to be owned or
controlled by Licensor or any of their Affiliates after the Effective Date
pertaining to inventions for the manufacture of the Compound, Bulk and Product
invented after the Effective Date and such other patents pertaining only to
Other Commercial Applications of the Product.
1.19 LICENSED TECHNOLOGY means the Licensed Know-How and the Licensed
Patents.
1.20 LICENSEE INFORMATION means any and all proprietary data, information
and know-how arising out of all development activities hereunder with respect to
the Compound, the Bulk and the Product conducted by or on behalf of Licensee,
its Affiliates or sublicensees during the term of this Agreement, including,
without limitation, all pharmacological, toxicological, non-clinical, clinical
and regulatory data, results and reports (including, without limitation, all
data, results and reports submitted by, or in the possession or control of all
third parties generating such data, results and reports on behalf of Licensee,
its Affiliates or sublicensees, all to the extent Licensee has the right, or can
reasonably obtain the right at no cost, to disclose such information to
Licensor; provided that, Licensee's patentable inventions (including
proprietary, new processes and formulations and new uses of the Compound) and
patentable improvements pertaining to the Compound, the Bulk and the Product are
excluded from Licensee Information and, instead, are addressed in Section 15.1
below; provided further that Licensee Information excludes Licensee's
proprietary data, information and know-how pertaining to the manufacture of the
Compound, the Bulk and the Product, and also excludes Licensee's proprietary
data, information and know-how pertaining only to Other Commercial Applications
of the Product. For the sake of clarification, Licensee Information excludes
Licensee's proprietary data, information, and know-how related to its Device(s),
rights to which are as set forth in Article 11;
1.21 LICENSOR means Meiji and NPC; the rights and obligations of Licensor
are and shall be the joint and several rights and obligations of Meiji and NPC;
except where this Agreement expressly provides otherwise, Meiji shall be
authorized to act for and on behalf of Licensor for all purposes in connection
with this Agreement;
Licensee's notices and communications to Meiji shall be deemed notices and
communications to Licensor; Xxxxx's notices and communications to Licensee shall
be deemed notices and communications from Licensor; and Licensee shall be
entitled to rely on the actions of Meiji as being the actions of Licensor.
1.22 MANUFACTURING KNOW-HOW means all data, know-how, technical
information, processes, trade secrets, inventions and improvements relating to
the manufacture of the Bulk and/or the Product, including all Drug Master Files,
which is owned or controlled by, or filed on behalf of, Meiji.
1.23 MARKET EXCLUSIVITY means, on a country-by-country basis and an
Indication-by-Indication basis, the status in which, and the period during
which, either (x) the manufacture, use or sale of the Product would infringe a
Valid Claim of the Licensed Patents enforceable in such country in the absence
of the license granted herein, or (y) the Product is otherwise legally protected
with market exclusivity conferred by the governing authorities of such country
(including, but not limited to, the U.S. Xxxxxx-Xxxxx Act or Drug Price
Competition and Patent Term Restoration Act or EC Directive 65/65/EEC or
87/21/EEC), provided such legal protection is granted for and based on the
Licensed Technology and/or data generated therefrom, as opposed to other
intellectual property rights or data covering the Product independent of the
Licensed Technology.
1.24 NDA means a New Drug Application and all supplements filed pursuant to
the requirements of FDA, and any foreign counterparts thereof, to commence
commercial sale of a drug, including all documents, data and other information
concerning the Compound, the Product and/or the Kit which are necessary for
approval of such application.
1.25 NET SALES means the gross amounts invoiced by Licensee, its Affiliates
or sublicensees for sales of the Product and/or the Kit, as applicable, to
unrelated third parties (distributors, agents, wholesalers, customers or
reimbursement organizations, as the case may be) less [*] of such gross amounts.
For the sake of clarification, amounts invoiced for transfers between and among
Licensee, its Affiliates and sublicensees shall not be included in the
calculation of Net Sales. Section 5.3.2(a)(ii) sets forth the calculation of Net
Sales of the Product component of a Kit.
In the event any Product or Kit contains, in addition to the Compound, one
or more other active ingredients, the gross selling price for purposes of
determining Net
----------
[*] Confidential Treatment Requested
Sales on such combination shall be calculated by [*]. In the event that no
separate sale of either such above-designated Product or Kit or such
above-designated other active ingredient(s) is made by Licensee, its Affiliates
or sublicensees during the royalty reporting period in which the sale was made,
the parties shall, for purposes of determining Net Sales, discuss in good faith
and agree upon a reasonable apportionment of the gross selling price of such
combination of the Product or Kit with other active ingredient(s).
1.26 OTHER COMMERCIAL APPLICATION means any application of the Product not
related to the treatment, diagnosis or monitoring of any Disease Area in humans
or animals.
1.27 PDT or PHOTODYNAMIC THERAPY means the treatment, diagnosis and
monitoring of diseases or Other Commercial Applications by application of light
with a photosensitizing active agent.
1.28 PHASE I CLINICAL STUDIES means the type of studies defined in 21
C.F.R. 312.21(a) or any successor to such provision and the foreign equivalent
thereof.
1.29 PHASE II CLINICAL STUDIES means the type of studies defined in 21
C.F.R. 312.21(b) or any successor to such provision and the foreign equivalent
thereof.
1.30 PHASE III CLINICAL STUDIES means the type of studies defined in 21
C.F.R. 312.21(c) or any successor to such provision and the foreign equivalent
thereof.
1.31 PIVOTAL CLINICAL STUDIES means that portion of the clinical
development program which is the last clinical trial step required to be
completed prior to the filing of an NDA.
1.32 [*].
1.33 PRODUCT means any formulation containing the Compound as an active
ingredient in the finished form packaged and labeled and suitable for use by the
ultimate customer. A Kit is not a Product but contains a Product.
1.34 REGULATORY APPROVAL means all governmental approvals, registrations,
licenses and authorizations necessary for the commercial sale of the Product in
a country in the Territory, including but not limited to marketing
authorization, pricing
----------
[*] Confidential Treatment Requested
approval and pricing reimbursement, as applicable.
1.35 TERRITORY means all countries in the world except for Japan.
1.36 VALID CLAIM means any claim of an issued and unexpired patent in the
Licensed Patents which has not been held unenforceable, unpatentable or invalid
by a decision of a court or government agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, or which has not
been admitted by the holder of the patent to be invalid or unenforceable through
reissue, disclaimer or otherwise.
ARTICLE 2. GRANT OF LICENSE
2.1 License Grant. Licensor hereby grants to Licensee an exclusive (even as
to Licensor) license, with the right to grant sublicenses, to research and
develop, use, make, have made, distribute, offer for sale, sell, import and
export the Bulk, Compound, Product and Kit in the Field in the Territory under
the Licensed Technology. Notwithstanding the foregoing, Licensor reserves the
non-exclusive right, with the right to grant licenses, only to conduct research
in the Territory regarding Other Commercial Applications of the Product.
2.2 Sublicense. In the event that Licensee grants a sublicense hereunder to
any entity, Licensee shall inform Licensor, subject to the confidentiality
provisions of this Agreement, of the name(s) of such sublicensee(s) in advance
(except that Licensee need not inform Licensor in advance if Licensee's license
rights become semi-exclusive as provided in Article 6). Such sublicensees shall
be subject to applicable provisions of this Agreement, and Licensee shall
incorporate into the agreements with such sublicensees all the obligations of
Licensee contained in this Agreement to the extent that such obligations are
relevant to and applicable to such sublicensees. In the event that Licensee
sublicenses to any entity for the sale of Product in the Territory or any part
of the Territory, Licensee shall continue to be responsible for paying any
royalties due and payable on Net Sales in the Territory.
ARTICLE 3. SUPPLY OF LICENSED KNOW-HOW, LICENSED PATENTS AND EXCHANGE OF DATA
3.1 Supply by Licensor. Promptly after Licensor's receipt of the Upfront
License Fee provided in Section 5.1, Licensor shall furnish Licensee without
charge with all the Licensed Know-How then available to Licensor that is
reasonably necessary or useful to Licensee, its Affiliates and sublicensees for
the development of the Product and/or Kit, the conduct of pre-clinical and
clinical studies, the preparation and submission of filings for Regulatory
Approval of the Product and/or the Kit and the maintenance of Regulatory
Approvals, and the manufacture of Bulk and/or
Product (as specified in Article 4.2). Further, during the term of this
Agreement, Licensor shall promptly furnish Licensee with any and all Licensed
Know-How which hereafter becomes available to Licensor that is reasonably
necessary or useful to Licensee, its Affiliates and sublicensees for the
development of the Product and/or Kit, the conduct of pre-clinical and clinical
studies, the preparation and submission of filings for Regulatory Approval of
the Product and/or Kit and the maintenance of Regulatory Approvals. In addition,
promptly after Licensor's receipt of the Upfront License Fee provided in Section
5.1, and on an ongoing basis thereafter during the term of this Agreement as
additional documentation becomes available, Licensor shall provide to Licensee,
without charge to Licensee, all copies of all the Licensed Patents (including
copies of all communications and correspondence by or on behalf of Licensor and
the relevant patent offices related to patent applications included in the
Licensed Patents). Consistent with Licensee's obligation under Section 6.3,
Meiji shall report semi-annually to Licensee on the progress status of its
development and commercialization of the Product in Japan.
3.2 Translation Cost. Licensor shall, as soon as reasonably possible, [*],
translate into English the Licensed Know-How written in Japanese which is
described on Exhibit D. Licensor shall provide such Licensed Know-How to
Licensee in such translated form (and shall also provide the Japanese form to
Licensee at Licensee's request). With respect to Licensed Know-How existing as
of the Effective Date that is not translated into English and Licensed Know-How
that first comes into existence during the term of this Agreement after the
Effective Date, if Licensee requests translation into English of such Licensed
Know-How that is written in Japanese, Licensor shall, at Licensee's request,
make arrangements for having outside translators prepare English translations,
and Licensee shall bear the cost of such translation work.
3.3 Supply by Licensee. From time to time during the term of this
Agreement, so long as Meiji, its Affiliates or licensees are developing and
commercializing the Product in Japan, Licensee shall furnish Meiji without
charge, for use solely in Japan in connection with the Product by Meiji, its
Affiliates and licensees in Japan, with the Licensee Information which hereafter
becomes available to Licensee that is necessary or useful to Meiji, its
Affiliates and its licensees for the development of Product, the conduct of
pre-clinical and clinical studies, the preparation and submission of filings for
Regulatory Approval of the Product in Japan and the maintenance of such
Regulatory Approvals.
ARTICLE 4. TRANSFER OF MANUFACTURING KNOW-HOW
----------
[*] Confidential Treatment Requested
4.1 Third-Party Manufacturer(s). As soon as practically possible after the
Effective Date, Licensee shall identify a third-party manufacturer or
manufacturers of choice who will undertake to manufacture the Bulk and the
Product for Licensee (hereinafter referred to as "Third-Party Manufacturer(s)").
In the process of evaluating candidates to be the Third-Party Manufacturer(s)
and retaining consultants to assist Licensee in such process, and in the
agreement(s) with the selected Third-Party Manufacturer(s), Licensee shall
obtain appropriate non-disclosure agreements from such candidates, consultants
and Third-Party Manufacturer(s) to whom Licensee discloses the Manufacturing
Know-How in order to protect the Manufacturing Know-How.
4.2 Transfer of Manufacturing Know-How. During a period ending [*] months
following the Effective Date, such period to be extended up to an additional [*]
months by mutual agreement of Meiji and Licensee if reasonably necessary (such
agreement not to be unreasonably withheld), Meiji shall, upon request by
Licensee, and [*] except for the reimbursement of expenses as provided in
subsection (c) below, transfer and furnish the Manufacturing Know-How existing
as of the Effective Date to Licensee and the Third-Party Manufacturer(s)
selected by Licensee, in a manner to be mutually agreed upon, and shall provide
all necessary and useful technical assistance and training to facilitate the
Third-Party Manufacturer(s)' use of such Manufacturing Know-How and their
effective and efficient manufacture of Bulk and/or Product. The transfer of such
Manufacturing Know-How will occur by means of (i) qualified technical personnel
of the Third-Party Manufacturer(s) (and, in Licensee's discretion, its
representatives and consultants) visiting Meiji's facilities and/or, (ii) at
Licensee's request, by Xxxxx dispatching qualified technical personnel to the
facilities of the Third-Party Manufacturer(s), subject to the following
conditions in subsections (a) - (c) below. In addition to such visits, qualified
Meiji personnel shall, via telephone or e-mail, provide consultation with
respect to such Manufacturing Know-How from time to time in response to
reasonable requests from the Third-Party Manufacturer(s) or Licensee:
(a) With respect to the dispatch of technical personnel by both Xxxxx
and the Third-Party Manufacturer(s) to the facilities of the other, the timing
of dispatch, the number of personnel to be dispatched (subject to (c) (i) below
in the case of Xxxxx's dispatch of its personnel) and the duration of their stay
shall be mutually and reasonably agreed upon by the parties in advance.
(b) With respect to the dispatch of technical personnel of the Third-
----------
[*] Confidential Treatment Requested
Party Manufacturer(s) to Meiji (and in Licensee's discretion, its personnel and
consultants), all expenses incurred in connection with the dispatch of such
personnel shall be borne by Licensee or the Third-Party Manufacturer(s).
(c) With respect to the dispatch of Xxxxx's technical personnel to the
Third-Party Manufacturer(s) (if requested by Licensee):
(i) The number of Meiji personnel to be dispatched in one trip shall
not exceed [*] of whom shall be qualified to transfer the
Manufacturing Know-How and provide technical assistance and training to the
Third-Party Manufacturer(s); and
(ii) The total number of days of each Meiji employee's stay at the
facilities of the Third-Party Manufacturer(s), including his/her traveling
days (but excluding holidays and weekends), shall not exceed [*] days per
person; and
(iii) Licensee or the Third-Party Manufacturer(s) shall reimburse
Meiji for round-trip business class air fares, in-land traveling expenses,
first class hotel expenses and reasonable living expenses actually incurred
By the Meiji personnel during their visit(s) to the facilities of the
Third-Party Manufacturer(s). In addition, if Meiji personnel stay more than
[*] days per person at the facilities of the Third-Party Manufacturer(s)
(e.g., two (2) Meiji personnel each staying a total of more than [*] days
in one or more trips; not, e.g., two (2) Meiji personnel staying [*] days
each), then Licensee shall also reimburse and pay Meiji for the actual
salaries (excluding overhead) of such Meiji personnel for the days in
excess of [*] days that each such person is at the facilities of the
Third-Party Manufacturer(s), including traveling days, holidays and
weekends.
Should Licensee reasonably require further assistance with respect to the
transfer of Manufacturing Know-How existing as of the Effective Date, Meiji
shall provide such assistance subject to the terms to be reasonably agreed upon
by the parties.
ARTICLE 5. UPFRONT LICENSE FEE, MILESTONE PAYMENTS AND ROYALTIES
----------
[*] Confidential Treatment Requested
5.1 Upfront License Fee. In consideration of the license granted under
Article 2 and Licensor's fulfillment of its other obligations and undertakings
under this Agreement, Licensee shall pay to Licensor a non-refundable upfront
license fee in the amount of [*] within [*] days after the Effective Date.
5.2 Milestone Payments. In consideration of the license granted under
Article 2 and Licensor's fulfillment of its other obligations and undertakings
under this Agreement, Licensee shall make the following (and only the following)
non-refundable milestone payments to Licensor within [*] days after the event
specified below. Such milestones refer only to the therapeutic application of
the Product or Kit to human Disease Areas.
(a) With respect to Oncology (Up to US$15 million in total):
(i) [*] upon the first NDA filing for approval of Product or Kit
for the first Oncology Indication in the U.S. or Europe;
(ii) [*] upon the first NDA approval of Product or Kit for the
first Oncology Indication in the U.S. or Europe;
(iii) [*] upon the second NDA approval of Product or Kit for the
first Oncology Indication in the U.S. or Europe (whichever of those two
regions was not the subject of the NDA approval referenced in subsection
(a)(ii) above);
(iv) [*] upon the first NDA approval of Product or Kit for the
second Oncology Indication in the U.S. or Europe; and
(v) [*] upon the second NDA approval of Product or Kit for the
second Oncology Indication in the U.S. or Europe (whichever of those two
regions was not the subject of the NDA approval referenced in subsection
(a)(iv) above).
For the sake of clarification with respect to the above milestone payments,
should Licensee file an NDA for approval of Product for the first Indication in
the Oncology Disease Area (e.g., lung cancer) and pay the milestone payment
related thereto, but should the FDA not approve such NDA, then, when Licensee
files an NDA for a second Oncology Indication (e.g., breast cancer) Licensee
shall owe no additional milestone payment for such second filing, but if the FDA
approves such second NDA,
----------
[*] Confidential Treatment Requested
Licensee shall owe Licensor the milestone payment specified in Section
5.2(a)(ii), since that will be the first NDA approval in the Oncology Disease
Area. Should Licensee file an amended NDA for the first Indication, Licensee
shall owe no additional milestone payment relating to the filing of such
amendment.
(b) With respect to Ophthalmology (Up to [*] in total):
(i) [*] upon the first initiation (meaning enrollment of the
first patient following protocol clearance) of the Phase III Clinical
Studies of the use of Product or Kit for the first Indication in the
Ophthalmology Disease Area in the U.S. or Europe, or upon the first NDA
filing for approval of Product or Kit where the FDA, or its foreign
equivalent in Europe, grants "Fast Track" status for the Product, whichever
is earlier;
(ii) [*] upon the first NDA approval of Product or Kit for the
first Ophthalmology Indication in the U.S. or Europe; and
(iii) [*] upon the second NDA approval of Product or Kit for the
first Ophthalmology Indication in the U.S. or Europe (whichever of those
two regions was not the subject of the NDA approval referenced in
subsection (b)(ii) above).
(c) With respect to Third Disease Area (excluding Oncology and
Ophthalmology) (Up to [*] in total):
(i) [*] upon the first NDA approval of Product or Kit for the
first Indication in a Disease Area other than Oncology and Ophthalmology in
the U.S. or Europe; and
(ii) [*] upon the second NDA approval of Product or Kit for the
first Indication in a Disease Area other than Oncology and Ophthalmology in
the U.S. or-Europe (whichever of those two regions was not the subject of
the NDA approval referenced in subsection (c)(i) above).
(d) With respect to Fourth Disease Area (excluding Oncology,
Ophthalmology and the Third Disease Area) (Up to [*] in total):
(i) [*] upon the first NDA approval in the U.S. or
----------
[*] Confidential Treatment Requested
Europe of Product or Kit for the first Indication in a Disease Area other
than Oncology, Ophthalmology and the Third Disease Area referenced in
subsection (c) above; and
(ii) [*] upon the second NDA approval in the U.S. or Europe of
Product or Kit for the first Indication in a Disease Area other than
Oncology, Ophthalmology and the Third Disease Area (whichever of those two
regions was not the subject of the NDA approval referenced in subsection
(d)(i) above).
5.3 Royalty Payments. In consideration of the license granted under Article
2 and Licensor's fulfillment of its other obligations and undertakings under
this Agreement, Licensee shall pay to Licensor a non-refundable royalty, on a
country-by-country basis and (subject to Section 5.3.8) an
Indication-by-Indication basis, on the Net Sales of the Product and the Kit sold
by Licensee, its Affiliates and sublicensees in the Territory.
5.3.1 Royalty in Countries Without Market Exclusivity. With respect to all
countries in which no Market Exclusivity exists for a given Indication (i.e., in
contrast to countries in which Market Exclusivity exists for a period of time,
but then expires), Licensee (subject to Sections 5.3.5, 5.3.8 and 5.3.9 below)
shall pay the following royalty on Net Sales of the Product or the Kit (as the
case may be) sold in such country for such Indication for therapeutic
application to human Disease Areas from the date of the First Commercial Sale in
such country until the earlier of (x) the date of expiration of the Market
Exclusivity for such Indication in the U.S. or (y) the tenth anniversary of the
date of the First Commercial Sale in such country for such Indication:
(i) If Licensee, its Affiliates or sublicensees market and sell the
Product alone, [*]of the Net Sales of the Product; and
(ii) If Licensee, its Affiliates or sublicensees market and sell the
Product as part of a Kit, [*] of the Net Sales of the Kit.
(iii) Following the termination of the royalty period set forth above
(i.e., upon the earlier of (x) or (y) above), if (a) any of the
composition-of-matter patents in Japan covering the Compound [*]
is still enforceable in Japan, and such patent(s) were issued and
effective as of the Effective Date and remain subject
----------
[*] Confidential Treatment Requested
to royalty obligations under the Research Agreement and the
Assignment described in clause (b) below, and the sale of the
Product in Japan would infringe a Valid Claim of such patent(s)
absent a license, and (b) if at such time NPC continues to have
royalty obligations to [*], based on gross sales of the Product
in such countries in the Territory, then, in countries without
Market Exclusivity, Licensee shall pay Licensor a royalty of [*]
of the gross sales of the Product if Licensee, its Affiliates or
sublicensees sell the Product alone in countries without Market
Exclusivity, or (subject to the last sentence of this Paragraph
(iii)) [*] of gross sales of the Kit if Licensee, its Affiliates
or sublicensees sell the Product as part of a Kit in countries
without Market Exclusivity, but only until the earlier of (a) or
(b) above is no longer the case. Notwithstanding the foregoing,
if during the royalty period in which Net Sales of the Kit are
calculated under this Paragraph (iii), Licensee, its Affiliates
or sublicensees also sell the Product separately in the same
country where they sell the Kit for the same Indication, then
Licensee shall (when royalties are payable under this Paragraph
(iii)) pay royalties on all Product sold as part of Kits in such
country at the rate of [*] of gross sales during such period (for
example, if Licensee sells the Product as part of the Kit in
Country A for $X per Kit per dose for lung cancer and, in the
same royalty period, Licensee also sells the Product separately
for $Y per dose in Country A for lung cancer, Licensee shall
(with respect to sales of Kits) pay a royalty equal to [*] times
gross sales based on $Y times the number of Kits sold in Country
A during that royalty period).
5.3.2 Royalty in Countries Covered by Market Exclusivity. With respect to
all countries in which Market Exclusivity exists for the Product for a given
Indication, Licensee shall pay the following royalty in respect to the Product
and the Kit sold in such country for such Indication for therapeutic application
to human Disease Areas from the date of the First Commercial Sale in such
country:
(a) Until expiration of such Market Exclusivity:
(i) If Licensee or its Affiliates market and sell the Product alone
(not as part of a Kit), [*] of the Net Sales of the Product; if
----------
[*] Confidential Treatment Requested
sublicensees market and sell the Product alone (not as part of a
Kit) for therapeutic application in the Oncology Disease Area in
humans, [*] of the Net Sales of the Product; if sublicensees
market and sell the Product alone for therapeutic application in
the Ophthalmology Disease Area in humans, [*] of the Net Sales of
the Product; and if sublicensees market and sell the Product
alone for therapeutic application in other Disease Areas in
humans other than Oncology and Ophthalmology, the royalty
percentage set forth in the table at the end of this Section
5.3.2(a).
(ii) If Licensee or its Affiliates market and sell the Product as part
of a Kit, [*] of the Net Sales of the Kit; if sublicensees market
and sell the Product as part of a Kit for therapeutic application
in the Oncology Disease Area in humans, [*] of the Net Sales of
the Kit; if sublicensees market and sell the Product for
therapeutic application in the Ophthalmology Disease Area in
humans, [*] of the Net Sales of the Kit; and if sublicensees
market and sell the Kit for therapeutic application in other
Disease Areas in humans other than Oncology and Ophthalmology,
the royalty percentage set forth in the table at the end of this
Section 5.3.2(a); provided that, if during the royalty period for
which Net Sales of the Kit are calculated, Licensee, its
Affiliates or sublicensees also sell the Product separately in
the same country where they sell the Kit for the same Indication,
then Licensee shall pay royalties on all Product sold as part of
Kits in such country at the rates set forth in subsection (a)(i)
above during such period (for example, if Licensee sells the
Product as part of the Kit in the United States for $X per Kit
per dose for lung cancer and, in the same royalty period,
Licensee also sells the Product separately for $Y per dose in the
United States for lung cancer, Licensee shall (with respect to
sales of Kits) pay a royalty equal to [*] times Net Sales based
on $Y times the number of Kits sold in the United States during
that royalty period).
----------
[*] Confidential Treatment Requested
Royalty Percentages Applicable to Sublicensee Net Sales
of Product for Therapeutic Application in Human Disease
Areas Other Than Oncology and Ophthalmology:
If the gross selling price Royalty on Net Royalty on
per dose of the Product is: Sales of Product Net Sales of Kit
--------------------------- ---------------- ----------------
- $1,000 or less [*] [*]
- $1,001 to $1,500 [*] [*]
- $1,501 to $2,000 [*] [*]
- $2,001 to $3,000 [*] [*]
- $3,001 or higher [*] [*]
(b) On and after the date of expiration of such Market Exclusivity and
until the tenth anniversary of the date of the First Commercial Sale in such
country for such Indication:
(i) If Licensee, its Affiliates or sublicensees market and sell the
Product alone, [*] of the Net Sales of the Product; and
(ii) If Licensee, its Affiliates or sublicensees market and sell the
Product as part of a Kit, [*] of the Net Sales of the Kit.
5.3.3 Royalties on Net Sales of Product for Other than Therapeutic
Application to Human Disease Areas. Licensee shall pay a royalty on Net Sales of
the Product or the Kit sold for uses other than human therapeutic uses (e.g.,
diagnostic and monitoring uses for human Disease Areas, veterinary uses and
Other Commercial Applications); the amount of such royalty shall be [*] of the
royalty rates specified above except for the royalty payable under Section
5.3.1(iii) (such royalty only being due if owed by NPC to PPI's former
shareholders on such Product sales under the Research Agreement and Assignment
described in Section 5.3.1(iii)).
5.3.4 Extension of Market Exclusivity. If during the term of this
Agreement, (i) Licensor obtains a new patent right covering an invention that,
if used for the Product, would extend Market Exclusivity or create new Market
Exclusivity for the
----------
[*] Confidential Treatment Requested
Product in a given Indication in a given country, and (ii) Licensee notifies
Licensor that Licensee elects, in its discretion, to use such invention for the
Product, such patent right shall automatically, upon such election by Licensee,
be included in the Licensed Patents. In such event, Licensee shall (subject to
Sections 5.3.5, 5.3.8 and 5.3.9 below) pay the royalty on Net Sales of such
Product (or a Kit including such Product, as the case may be) in the Indication
and country in which Market Exclusivity is created or extended by such new
patent right at the rate(s) set forth in Section 5.3.2(a) above during the
period of such Market Exclusivity (if such Indication is for therapeutic
application to a human Disease Area; otherwise, in accordance with Section
5.3.3, the royalty shall be [*] of such rates during the period of Market
Exclusivity). Unless and until Licensee notifies Licensor that it elects to use
a new patent right as aforesaid, such new patent right shall be excluded from
the Licensed Patents.
5.3.5 Reduction of Royalties. Royalties payable by Licensee to Licensor
under this Section 5.3 shall be reduced or abated, as the case may be, as
follows:
(a) In the event of, and only during the pendency of, any third-party
infringement of Licensed Patents, royalties due in the country(ies) of such
infringement shall be reduced to [*] of the then currently applicable levels,
provided that the recovery obtained in any action or suit against a third-party
infringer shall be subject to Section 14.3(b).
(b) In the event the development, manufacture, use, distribution,
marketing or sale of the Product or the Product as part of the Kit in the
Territory allegedly infringes a third party's patent rights, where the alleged
infringement is based on Licensee's or its Affiliates' or sublicensees' practice
in the Territory of the Licensed Technology, amounts otherwise payable to
Licensor shall be reduced as provided in Section 14.4.
(c) If a third party obtains, by order, decree or grant from a
competent governmental authority in any country in the Territory, a compulsory
license under Licensed Patents authorizing such third party to manufacture, use
or sell any Product or the Product as part of the Kit in such country, with a
royalty rate lower than the applicable royalty rate set forth in this Article 5,
Licensor or Licensee, as the case may be, shall give the other party prompt
notice of such compulsory license. During the period of sales of such Product
and/or the Product as part of the Kit by said third party under such compulsory
license, Licensee's obligations to pay royalties
----------
[*] Confidential Treatment Requested
under Section 5.3 hereof with respect to sales in such country for such Product
and/or the Product as part of the Kit shall be reduced to the rate payable by
said third party under such compulsory license.
5.3.6 Quarterly Payments in U.S. Dollars. Royalty payments due under this
Agreement shall accrue on a calendar quarter basis (each calendar quarter being
a "royalty period") and shall be made in U.S. Dollars within [*], with respect
to sales by Licensee and its Affiliates, and within [*], with respect to sales
by sublicensees, after the last day of March, June, September and December for
royalties accruing on the Net Sales during the preceding royalty period.
5.3.7 Royalty Statement. Each quarterly royalty payment shall be
accompanied by a statement which sets forth, on a country-by-country basis and
an Indication-by-Indication basis (to the extent such information is readily
available), the gross sales and the Net Sales expressed in U.S. Dollars, the
quantity of the Product and/or the Kit sold, and the royalty rates and royalties
payable. For those Net Sales occurring in currencies other than United States
Dollars, the exchange conversion of foreign payments into U.S. Dollars shall be
calculated at the average of the rate of exchange existing in the U.S. for a
given foreign currency as reported in the Wall Street Journal (New York Edition)
on each banking day of each of the three (3) months during the royalty period as
provided for in Section 5.3.6.
5.3.8 [*] Product and Kit. [*] shall be payable in respect of the Net Sales
of a given Product or Kit (e.g., if a Product or Kit sold to a customer is
approved for multiple Indications or multiple Disease Areas, [*] shall be due on
the Net Sales of that Product or Kit to that customer, [*] for the multiple
Indications or Disease Areas).
In the event that one formulation of the Product is approved for use with
more than one (1) Indication within a Disease Area or for use with more than one
(1) Disease Area, then the royalty rate and the term of royalty payments shall
be determined in accordance with the following example: If, for example, the
Product is approved for lung cancer in Year [*] and the same Product with the
same formulation is approved for pancreatic cancer in Year [*] in a country with
Market Exclusivity, and the Product loses Market Exclusivity in Year [*], then
the royalty rate beginning in Year [*] for all such Product sales (for both lung
and pancreatic cancer) shall be as specified in Section [*]. The obligation to
pay royalties on such Product for sales in connection with lung cancer shall
terminate
----------
[*] Confidential Treatment Requested
in Year [*], and the obligation to pay royalties on such Product for sales in
connection with pancreatic cancer shall terminate in Year [*]. During Year [*]
and Year [*], Net Sales on which royalties shall be paid shall be calculated as
follows: Total Net Sales of Product shall be [*]. Notwithstanding the foregoing,
the parties may mutually agree, on a case-by-case basis, to calculate Net Sales
differently than as provided above, taking into account the contribution to Net
Sales from particular Indications.
In addition, if a Product is sold as a part of a Kit, [*] shall be due --
on Net Sales of the Kit -- and [*] shall be due in respect of the Product that
is a component of such Kit.
5.3.9 Sales to Affiliates and Sublicensees. No royalties shall be payable
on sales between and among Licensee, its Affiliates and sublicensees, but shall
become payable upon the first sale by Licensee, its Affiliates and/or
sublicensees to an unrelated third party.
5.3.10 Records. Licensee shall keep, and cause its Affiliates and
sublicensees to keep, accurate records of sales of Products and Kits made
pursuant to the license granted hereunder so that the royalty payable and the
royalty statement may be verified. Such records shall be open to inspection at
any reasonable time -- but there shall not be more than [*] -- within [*] years
after the royalty period to which such records relate. Such inspection shall be
by an independent certified public accounting firm selected by Licensor and
approved by Licensee, which approval shall not be unreasonably withheld, and
shall be at Licensor's expense. Such accounting firm shall execute and deliver
to Licensee a confidentiality agreement in a form reasonably acceptable to
Licensee. In no event shall any information, except for the information
necessary for Licensor to confirm the accuracy of the royalty payments, be
disclosed by such accounting firm to Licensor. Such accounting firm shall
disclose the same information to Licensee. If said examination of the records
reveals more than a [*] underpayment of the royalty payable during the royalty
period(s) under inspection, expenses for said accounting firm shall be borne by
Licensee.
5.4 Bank Remittance. All payments under Sections 5.1, 5.2 and 5.3 shall be
made by wire transfer to the bank and to the account designated by NPC on behalf
of Licensor. The allocation of payments between NPC and Meiji shall be solely in
their discretion and solely their responsibility.
----------
[*] Confidential Treatment Requested
5.5 Late Payments. In the event that any payment under Sections 5.1, 5.2 or
5.3 is not made when due, including any underpayment of royalties determined in
accordance with Section 5.3.10, the payment shall accrue interest at the prime
rate prevailing at the Bank of Tokyo-Mitsubishi in Tokyo (or its successor) on
the date when such payment is due.
5.6 Taxes and Withholdings. All taxes required to be withheld from any
payments under Article 5 shall be deducted from the amounts payable and shall be
paid to the appropriate fiscal or tax authorities on behalf of Licensor. Such
payments shall be withheld and paid on behalf of NPC unless NPC notifies
Licensee in writing that some or all of such payments should be withheld and
paid on behalf of Meiji. Licensee shall promptly furnish to Licensor (care of
NPC unless Licensee is notified otherwise) tax receipts issued by the
appropriate fiscal or tax authorities evidencing payment of such taxes. Licensor
may seek applicable tax credits in Japan for the amount of such withholdings.
ARTICLE 6. DEVELOPMENT
6.1 Due Diligence. Licensee shall use commercially reasonable
diligence--consistent with accepted business practices and legal requirements
(which diligence may, but not necessarily will, include application of
scientific, technical, clinical and regulatory personnel, equipment, and time
and resources towards the development of the Product and/or the Product as part
of the Kit to meet Licensee's obligations under this Agreement), and taking into
account issues of commercial viability, safety and efficacy -- to develop,
obtain Regulatory Approval of, and commercialize the Product (and/or, in
Licensee's discretion, the Product as part of a Kit). Licensee's development
efforts with respect to the Oncology and Ophthalmology Disease Areas shall be
guided by the development plan attached hereto as Exhibit B (hereinafter
referred to as the "Development Plan"), but the failure to comply with such
Development Plan shall not be deemed a failure of required diligence if
Licensee's efforts reflect commercially reasonable diligence as described above.
Licensee shall notify Meiji of any material amendment or modification of the
Development Plan and the reasons therefor, and Meiji shall have the right to
offer input and suggestions to Licensee regarding such amendment(s) and
modifications(s); Licensee shall give due consideration to such input and
suggestions, provided that such consideration shall be in accordance with
commercially reasonable diligence as described above. In addition, Licensee
shall use commercially reasonable diligence to achieve the [*]. Licensor
recognizes, however, that commercial, safety or efficacy issues may not make it
commercially reasonable to achieve such targets, and that many
----------
[*] Confidential Treatment Requested
aspects of achieving such targets are beyond Licensee's reasonable control.
Licensor further agrees that Licensee's exercise of commercially reasonable
diligence with respect to a Product or a Product as part of a Kit for any one
Indication in a Disease Area shall be deemed to satisfy Licensee's diligence
obligations in such Disease Area. Licensor further agrees that, during the first
[*] months following the Effective Date of this Agreement, Licensee's exercise
of commercially reasonable diligence in the development of a Product or a
Product as part of a Kit in any one Disease Area shall be deemed to satisfy
Licensee's diligence obligations under this Agreement.
Provided that it is reasonable to do so on grounds of commercial
non-viability, toxicity or non-efficacy, Licensee shall have the right,
exercised by giving notice in writing to Licensor, either not to commence
development of a Product (including a Product as part of a Kit), or to cease
development of a Product, or not to pursue Regulatory Approval or
commercialization of a Product in one or more Disease Area(s) in a particular
country or countries. In such case, at Licensee's option as indicated in its
notice to Licensor, either (i) the scope of Licensee's rights under the license
granted in this Agreement shall be reduced commensurate with the Disease Area(s)
or countries Licensee elects to relinquish in such notice, or (ii) Licensee may
elect to reduce its license rights in respect to a specified country or
countries or a specified Disease Area or Disease Areas to a "semi-exclusive
license" as described, and on the terms provided, in Section 6.4 below.
6.2 Compliance with Regulations. Licensee shall undertake development of
the Product and/or the Product as part of the Kit hereunder in accordance with
all applicable regulatory requirements including, but not limited to, the
then-current Good Laboratory Practices, Good Clinical Practices and Good
Manufacturing Practices promulgated by any regulatory authorities in any country
of the Territory.
6.3 Progress Report. Licensee shall report semi-annually to Licensor on the
progress status of the development work and activities with respect to the
Product and/or the Product as part of the Kit. In addition, at the request of
either Meiji or Licensee, the parties shall meet every six (6) months to discuss
the status of development, at a mutually agreeable time and place.
6.4 Failure of Due Diligence. In the event that Licensor believes Licensee
has failed to perform in accordance with the diligence obligations with respect
to the development and commercialization of the Product as set forth in this
Agreement, Licensor may, in its discretion, acting through Meiji, give detailed
written notice of such alleged failure to Licensee, such notice to specify the
countries and Disease
----------
[*] Confidential Treatment Requested
Area(s) (collectively, the "areas") in which Licensor believes Licensee has
failed to proceed with commercially reasonable diligence. Licensee and Xxxxx
shall then discuss the situation in good faith. If Licensee agrees it has not
acted with the requisite diligence in the areas indicated in Licensor's notice,
but is willing to do so, it shall immediately commence diligent efforts in the
areas indicated. Alternatively, Licensee may, in its discretion, agree to
relinquish certain rights under the license granted in this Agreement, as
provided in Section 6.1 above. Alternatively, Licensee may disagree with
Licensor and claim that its efforts reflect commercially reasonable diligence as
required in Section 6.1. In such case, Licensor may agree with Licensee
following their discussion or may disagree with Licensee. If Licensor disagrees
with Licensee, Licensor may, in its discretion (acting through Meiji) initiate a
dispute resolution process in accordance with Section 20.9 and an arbitration
proceeding in accordance with Section 20.10 to resolve the issue.
If the arbitrators issue a final decision in favor of Licensor on the issue
of diligence, then the following shall be the sole options and remedies
available to the parties:
(a) Licensee has the option (to be exercised in writing not later than
[*] days following Licensee's receipt of the arbitrators' final decision), in
its discretion, of terminating its rights under the license granted in this
Agreement in areas in which the arbitrators found it failed to exercise
commercially reasonable diligence; or
(b) If Licensee elects, in its discretion, to retain its full,
exclusive rights under this Agreement, Licensee shall (either before or after
the arbitration proceeding, but not later than [*] following its receipt of the
arbitrators' final decision) pay [*] in the Disease Area in which it is found
not to have exercised the required diligence (such payment to be credited
against such milestone payment when it becomes due). If Licensee continues to
elect to retain its full rights under this Agreement, it shall pay [*] from the
date of its payment of [*] (which payment shall also be credited against the
milestone payment when it becomes due) or when the actual milestone is achieved,
whichever is earlier. Upon Licensee's payment of the total first milestone
payment due in a given Disease Area, Licensee shall be deemed to have satisfied
its diligence obligations under this Agreement in such Disease Area, and
Licensor shall thereafter have no right or ability to allege or contest
Licensee's lack of diligence in such Disease Area.
(c) If Licensee elects not to avail itself of either option described
in
----------
[*] Confidential Treatment Requested
Paragraph (a) or Paragraph (b) above, then Licensor shall have, as its sole
remedy for Licensee's failure to exercise the requisite diligence, the option
(to be exercised in writing between [*] and [*] days following Xxxxx's receipt
of the arbitrators' final decision, if Licensee did not elect either of its
options above) to convert the exclusive license granted to Licensee under this
Agreement into a semi-exclusive one in respect to a country or countries and a
Disease Area or Disease Areas with respect to which the arbitrators concluded
Licensee's failure of commercially reasonable diligence occurred; provided that
if the arbitrators conclude both (a) that Licensee is not diligently developing
the Product at all, in any Disease Area, and (b) that Licensee is at that time
developing a competing product in a given Disease Area, then Licensor, acting
through Meiji, may in its discretion (to be exercised in writing between [*] and
[*] days following Xxxxx's receipt of the arbitrators' final decision if
Licensee did not elect either of its options above) terminate (rather than
merely convert to semi-exclusive) Licensee's license rights under this Agreement
in the Disease Area in which Licensee is developing a competing product. (For
the avoidance of doubt, and without limiting the above, this Agreement does not
prohibit Licensee from developing and commercializing other products in the
Field.)
The term "semi-exclusive license" shall mean that Licensee shall retain the
exclusive license granted to it under this Agreement, with the right to
sublicense, subject to the reservation of the same right by Licensor (including
the right to manufacture Compound and Bulk and make, use and sell Product), but
only in the country(ies) and Disease Area(s) in which Licensee failed to
exercise the required diligence, with the right to license (subject to
Licensee's semi-exclusive license). In such case, Licensee's right to sublicense
and Licensor's right to license, as applicable, means only the right to
sublicense or license, as the case may be, all of the granted rights under
Article 2 or the reserved rights under this Section 6.4 to one third party each
(for a total of two) in a particular country relating to the Disease Area(s) in
question. In the event of such sublicense or license, Licensee and Licensor
shall each have no right itself to exercise the right granted under Article 2 or
reserved under this Section 6.4 in such particular country for the Disease
Area(s) in question, as the case may be (for the sake of clarification, this
means that, in the event of a semi-exclusive license, each party will have the
right itself, or through an Affiliate or one sublicensee (in the case of
Licensee) or through an Affiliate or one licensee (in the case of Licensor), to
make, use and sell the Product relating to the Disease Area in question in a
given country). If Licensee's exclusive license is converted into a
semi-exclusive one as to a Disease Area in a country, then the royalty rates set
forth in Section 5.3 shall be [*] in respect to Net Sales of Product in such
Disease Area in such
----------
[*] Confidential Treatment Requested
country for which the option is exercised, except in those country(ies) where
Licensor elects never to undertake the development, Regulatory Approval or
commercialization of the Product (itself or through an Affiliate or a licensee).
In the event Licensee's license is converted to semi-exclusive in a Disease Area
in a country, Licensee shall consent to Licensor cross-referencing Licensee's
IND for such Disease Area in such country, free of charge.
6.5 Licensee Information. Licensee shall own all resulting Licensee
Information, data, reports and other information and all rights arising from its
research, development, regulatory and commercialization activities and efforts
including, but not limited, to all data, reports, information and rights arising
out of any NDA for a Product or Kit, any FDA approval thereof or any
corresponding application or approval in any country in the Territory.
6.6 Transfer of IND. NPC has an IND with the FDA for the Product (IND No.
[*]. Promptly after Licensor's receipt of the Upfront License Fee specified in
Section 5.1 (unless due to unavoidable translation problems), Licensor shall
complete the tasks assigned to it and submit the specified materials to Licensee
in accordance with Exhibit C (IND Transfer to Light Sciences). NPC shall
transfer the IND and all of NPC's rights and responsibilities in such IND to
Licensee. Such transfer shall be substantially in the form as set forth in
Exhibit C. Provided Licensor complies with its obligations in accordance with
Exhibit C, all subsequent work necessary to make such IND fully compliant with
applicable laws and regulations, and to enable Licensee to conduct further
development thereon, shall be at Licensee's sole responsibility and cost.
ARTICLE 7. REPORTS OF ADVERSE EVENTS
Promptly after the Effective Date, and from time to time thereafter at
either party's request, the parties hereto shall discuss and establish standard
operating procedures for the prompt exchange -- in compliance with all
applicable laws and regulations -- of any and all information on serious and
other adverse drug experiences, as defined and required by the FDA and other
applicable regulatory authorities, which the parties are obligated to report to
any regulatory authorities in accordance with applicable regulations or
requirements in connection with any use of the Compound and/or the Product. Each
party shall comply with such agreed procedures. Without limiting the foregoing,
each party shall immediately provide to the other party a copy of any adverse
event report(s) of which it becomes aware
----------
[*] Confidential Treatment Requested
during the term of this Agreement, so long as the other party is developing or
marketing the Product.
ARTICLE 8. SUPPLY OF THE BULK AND PRODUCT BY XXXXX
8.1 Bulk Supply.
(a) Development Phase
(i) In order to enable Licensee to proceed with development of
the Product without disruption, Meiji shall, as requested by Licensee,
supply Licensee with up to [*] of the Bulk in the year 2000 and [*] of the
Bulk in the year 2001 for the development of the Product. Should the
Third-Party Manufacturer(s) fail to supply Licensee with its requirements
of the Bulk in the development phase, Meiji shall further serve as a
back-up supplier to Licensee and shall, as requested by Licensee, supply
the Bulk to Licensee for development use during the Phase I and Phase II
Clinical Studies for the first two Disease Areas of the Product (for the
avoidance of doubt, Phase II Clinical Studies are not Pivotal Clinical
Studies). In addition, if reasonably necessary to avoid disruption of
Product development and testing, Meiji shall also supply the Bulk to
Licensee for the Pivotal Clinical Studies of the Product for the said first
two Disease Areas, provided that (x) Licensee provides Meiji with
reasonably sufficient lead time to fill Licensee's request for such supply
and (y) at such time Meiji has sufficient manufacturing capacity to supply
the quantities requested by Licensee. Licensee (and its collaborators)
shall use the Bulk supplied by Meiji hereunder solely for the purpose of
the development specified herein and shall not use the same for any other
purposes.
(ii) The procedures and time periods for forecasting, ordering,
delivery and acceptance of the Bulk to be supplied for the development use
under (i) above are set forth in Section 8.5 below. It is understood and
agreed that there shall be no minimum batch size for orders of the Bulk.
(iii) Price of the Bulk to be supplied for the development use
under (i) above shall be [*]; provided that Meiji shall supply the [*].
(b) Commercialization Phase. If Licensee requests Meiji to supply the
Bulk during the period of Product commercialization, Meiji shall do so, subject
to
----------
[*] Confidential Treatment Requested
the terms and conditions of a separate supply agreement to be negotiated in good
faith and executed at the time of such request by Licensee. Such separate
agreement shall be consistent with the applicable terms of the Agreement, will
contain commercially reasonable terms and conditions as are necessary and
appropriate for such a supply agreement, and shall incorporate the following
terms among others: (x) Licensee shall pay not less than [*] for the first [*]
of the Bulk supplied each year for commercial use, and (y) if Licensee requests
more than [*] per year, the separate agreement shall assure the price of the
Bulk not less than [*] and compensation to Meiji for its capital investment (if
any) necessary to increase its manufacturing capacity to supply Licensee's
requirements. Unless such separate agreement is executed by the date of the
First Commercial Sale of Product in the United States or Europe, whichever is
earlier, Meiji shall have no subsequent obligations to supply the Bulk for
commercial use.
8.2 Product Supply. If requested by Licensee, Meiji shall supply the
Product for the development use during the Phase I Clinical Studies for the
first Product and - but only if reasonably necessary to prevent disruption of
Product development - the Phase II Clinical Studies for the first Product (for
the avoidance of doubt, Phase II Clinical Studies are not Pivotal Clinical
Studies). Meiji shall not supply the Product to Licensee thereafter. Licensee
shall use the Product supplied by Meiji hereunder solely for the purpose of the
development specified herein and shall not use the same for any other purposes.
Price of the Product per vial of 100 mg active Compound to be supplied for the
development use hereunder shall be [*] and all orders for the Product (except
for the [*]) shall call for each shipment to be in quantities of [*] as a unit;
provided that Meiji shall supply the [*] of Product to Licensee [*]. The
procedures and time periods for forecasting, ordering, delivery and acceptance
of the Product are set forth in Section 8.5 below.
8.3 Room Temperature Stability Studies. Promptly after receipt of the
Upfront License Fee specified in Section 5.1, [*] Meiji shall initiate room
temperature stability studies on the current formulation of the Product, in
accordance with protocols to be reasonably agreed upon between the parties.
Meiji may, in its discretion, conduct such studies in the Territory.
8.4 Compliance With Specifications.
8.4.1 Audit. Prior to commencement of supply of the Bulk and/or the
Product by Xxxxx to Licensee as provided hereunder, Licensee shall audit Meiji's
----------
[*] Confidential Treatment Requested
manufacturing facilities during reasonable business hours to verify that Meiji's
facilities, equipment and procedures are acceptable to Licensee in its quality
assurance and production standards.
8.4.2 Meiji Responsibility for Compliance With Specifications,
Including cGMP. In the event that, as the result of such audit under 8.4.1
above, Licensee accepts and requires Meiji to supply the Bulk and/or the
Product, Meiji shall supply the Bulk and/or the Product in accordance with this
Article 8. Meiji shall use its best efforts promptly to remedy any plant
deficiencies or manufacturing problems brought to Meiji's attention by Licensee,
the FDA or any foreign counterparts of the FDA in Europe and to maintain all of
its manufacturing facilities for supply of the Bulk and the Product to Licensee
in compliance with the then-current U.S. Good Manufacturing Practices (cGMP) and
any other comparable regulations or guidelines in Europe. The Bulk and Product
Meiji supplies to Licensee (or its designees) shall conform in all respects to
the then-current agreed Specifications for such Bulk and Product, including
cGMP, and Meiji will manufacture such Bulk without negligence or fault,
including without contamination or adulteration. As used in this Section 8.4.2,
"Bulk" means NPe6 or ME2906 itself in bulk form, and "Product" means any
formulation containing NPe6 or ME2906 itself as an active ingredient in finished
form.
8.5 Forecasting, Orders, Delivery and Acceptance.
8.5.1 Forecasting and Ordering of Supply for Development. Subject to
the limitations in Sections 8.1(a) and 8.2 above, Meiji shall supply Licensee
with such quantities of the Bulk and/or Product as Licensee may order pursuant
to this Agreement. Promptly after the Effective Date and thereafter, no later
than [*] days before the start of each Half-Year Period, Licensee shall provide
Meiji with a rolling [*] quarter forecast of its expected requirements of the
Bulk and/or Product, including forecast quantities and delivery dates. Licensee
shall update such forecast at the beginning of each calendar quarter thereafter
during the development phase. No later than [*] days before the first day of any
calendar month in which delivery is required (a "Delivery Month"), Licensee
shall provide to Meiji its firm purchase orders for Bulk and/or Product for
development use, including quantities and delivery dates. Such orders shall not
deviate by more than [*] percent from the amount forecasted for such delivery
dates in the most recent forecast. Meiji shall use its best efforts to deliver
the ordered quantities to Licensee during the specified Delivery Month, at
facilities designated by Licensee, no later than
----------
[*] Confidential Treatment Requested
[*] days after receipt by Meiji of Licensee's firm order for a specified
quantity of the Bulk and/or Product. The actual date of delivery to Licensee
within each specified Delivery Month shall be within the discretion of Meiji,
and Licensee shall undertake to accept delivery on such delivery date.
Notwithstanding the foregoing, Meiji shall delivery to Licensee the first [*] of
Bulk (referenced in Section 8.1(a)(iii)) within [*] days after Licensee pays the
Upfront License Fee (unless Licensee and Meiji agree on a different delivery
date), and Meiji shall deliver to Licensee the first [*] of Product (referenced
in Section 8.2) in [*] (unless Licensee and Meiji agree on a different delivery
date, in order to enable Product development to proceed without disruption. As
used herein, Half-Year Period shall mean the period from April 1 to September 30
in any year or the period from October 1 in one year to March 31 in the
following year, as the case may require.
8.5.2 Shipment of Bulk and Product for Development. Meiji shall ship
all Bulk and Product ordered by Licensee to a U.S. port designated by Licensee,
with all expenses associated with shipping, delivery and insurance to be paid by
Licensee.
8.5.3 Payment. Licensee shall pay Meiji for the Bulk and/or Product it
orders from Meiji within the later of [*] days following (i) Licensee's receipt
of Meiji's invoice therefor or (ii) Licensee's receipt of the ordered Bulk
and/or Product at its facilities. Any payment not made when due [*].
8.5.4 Acceptance. Licensee and Meiji shall reasonably agree upon
applicable written specifications, including production criteria in compliance
with cGMP (collectively, "Specifications") for the Bulk and Product. Meiji shall
manufacture and supply all Bulk and Product in accordance with such
Specifications and shall deliver a Certificate of Analysis (in a mutually
agreeable form) with each shipment, which certificate shall confirm that the
Bulk and Product are in compliance with the Specifications on the date of
shipment. Licensee shall inspect all shipments of the Bulk and Product supplied
by Meiji promptly upon receipt, and Licensee may, by giving written notice to
Meiji, reject any shipment (i) which does not conform to the applicable
Specifications or (ii) which otherwise is deficient with respect to the quantity
or quality of material provided or due to contamination by materials not listed
in the Specifications or which is adulterated or misbranded (collectively, is
"Deficient"). Any such notice shall be in writing and shall indicate the reasons
for such rejection. In order to reject delivery of a shipment of the Bulk or
Product, Licensee shall give written notice to Meiji of Licensee's rejection of
any delivery within [*] days after receipt of such delivery at Licensee's
designated facilities
----------
[*] Confidential Treatment Requested
(arrival at the port designated by Licensee shall not constitute delivery to the
facilities designated by Licensee). If Meiji is satisfied that the relevant
shipment does not comply with the Specifications or is Deficient, Licensee shall
dispose of the noncomplying shipment as Meiji shall lawfully direct and, at
Xxxxx's sole cost and expense, Meiji shall replace the shipment or remedy the
deficiency as soon as practically possible, at its sole cost and expense. If
Meiji disputes Licensee's rejection of such Bulk or Product, the parties shall
submit such Bulk or Product to a mutually agreed third-party laboratory in the
U.S. for testing. Such laboratory's determination shall be final. The party
against whom the third-party laboratory rules shall bear all costs of the
third-party testing. In the event that the third-party laboratory determines
that such Bulk or Product fails to meet the Specifications or is Deficient,
Meiji shall replace such Bulk or Product or remedy the deficiency as soon as
practically possible after receiving the third-party laboratory's notice of such
determination. If the third-party laboratory rules that the rejected Bulk or
Product meets the Specifications and is not Deficient, Licensee shall purchase
such Bulk or Product at the agreed-upon price. If Licensee sends no such notice
of rejection to Meiji, Licensee shall be deemed to have accepted such delivery
[*] days after receipt of the shipment at its facilities. Once Licensee accepts
shipment of the Bulk or Product, Licensee shall have no recourse against Meiji
if such Bulk or Product is subsequently deemed unsuitable for use, unless
Licensee proves that the aforementioned qualitative faults could not have been
detected within such period using mutually agreed quality control and acceptance
procedures.
8.6 Term of Supply Obligation. Meiji's obligation to supply the Bulk and
the Product under this Article 8 shall expire [*], whichever is earlier, unless
by such time, negotiating in good faith, the parties have executed an agreement
for the supply of Bulk during the commercialization phase, as provided in
Section 8.1 (b) above, which agreement shall continue in full force and effect.
ARTICLE 9. SALES AND PROMOTION
9.1 Commercial Sale. Subject to the acknowledgement in Section 9.2 below,
Licensee (including its Affiliates, sublicensees and distributors) shall
commence marketing and sale of the Product and/or Kit in each country of the
Territory as soon as commercially reasonable following the date when all the
necessary Regulatory Approvals to market and sell the Product and/or Kit are
obtained from the regulatory authorities in such country. Licensee shall
promptly notify Licensor of the respective dates when the Regulatory Approvals
are obtained
----------
[*] Confidential Treatment Requested
and the commercial sale of the Product and/or Kit is commenced in each country
of the Territory.
9.2 Sales Promotion. Licensee (including its Affiliates, sublicensees and
distributors) shall use commercially reasonable efforts to promote and
commercialize the Product and/or the Kit in the Territory; provided that
Licensor acknowledges that potential market size or financial, pricing or
regulatory conditions in certain countries may make it commercially unreasonable
to commercialize Product in such countries, and that it will be commercially
reasonable for Licensee to promote and commercialize Product in certain
countries before other countries.
Licensee shall promote, at its own expense, sales of the Product and/or the
Kit efficiently and in commercially reasonable fashion by distributing
scientific literature and samples, by advertising in professional publications,
etc., by detailing doctors, hospitals, etc. and by other commercially reasonable
means.
9.3 Supply of Promotional Materials. Licensee shall furnish Licensor with
copies of its representative promotional materials and packages used for the
Product and/or the Kit for Licensor's reference.
9.4 Packaging Reference. Where commercially appropriate and in compliance
with applicable laws and regulations, Licensee shall indicate in writing on the
secondary Product packaging (i.e. the unit carton), labels, packages, package
inserts, and promotional materials for the Product, in wording previously
approved in writing by Licensor, that the Product contains Compound developed
and sold under license from Meiji and NPC.
ARTICLE 10. ANTI-INFECTIVES: MEIJI RIGHT OF FIRST NEGOTIATION
In the event that Licensee or its Affiliates desire to develop the Product for
use in the field of anti-infectives, Licensee shall, prior to implementing a
plan for such development, present a proposal to Meiji for a worldwide
relationship in such field (exclusive of Japan). Meiji shall have a period of
[*] days from its receipt of such proposal in which to accept or decline such
proposal. If Meiji declines (or fails to accept) such proposal within such [*]
day period, Licensee, its Affiliates or sublicensees (by themselves or in
collaboration with one or more third parties) shall be free to develop and
commercialize the Product throughout the Territory for use in the field of
anti-infectives, free of any obligations to Meiji under this Article 10, subject
only to the terms and conditions set forth elsewhere in this Agreement,
----------
[*] Confidential Treatment Requested
including payment of the applicable milestone and royalty payments to Licensor
set forth in Sections 5.2 and 5.3 hereof. If Meiji accepts such proposal within
the [*] day period, Licensee and Meiji shall promptly negotiate an appropriate
agreement setting forth detailed terms and conditions to implement such
proposal. If the parties fail to execute such agreement within [*] days
thereafter, Licensee, its Affiliates or sublicensees shall be free to develop
and commercialize the Product throughout the Territory for use in the field of
anti-infectives, with no obligation to Meiji under this Article 10, subject only
to the terms and conditions set forth elsewhere in this Agreement.
ARTICLE 11. LICENSEE'S DEVICE
If Licensee develops or acquires rights to the Device, and if Licensee has the
right and authority to grant the following rights in the Device to Meiji, Meiji
shall have the right, subject to mutual agreement on the terms and conditions
thereof, to develop and customize the Device, and to be the exclusive
distributor (with the right to use subdistributors) of the Device, solely in
Japan and solely in conjunction with the Product. Such terms and conditions,
including Meiji's payment obligation to Licensee in connection therewith and its
obligation to disclose improvements to the Device to Licensee, shall be subject
to discussion and mutual agreement by the parties. When Licensee has developed
or obtained rights to the Device, by itself or through its Affiliates, licensees
or sublicensees, Licensee shall inform Meiji thereof so that Meiji may, in its
discretion, notify Licensee whether Meiji is interested in obtaining rights to
the Device for use with the Product in Japan. If so, Xxxxx shall present a
written proposal to Licensee, which the parties shall then promptly discuss. If
the parties do not execute an agreement within [*] days after Licensee invites
Meiji to present such a proposal, Licensee shall have no further obligation to
Meiji under this Section or otherwise with respect to the Device (except for
royalty obligations under this Agreement based on Net Sales of the Kit). Xxxxx
recognizes that in the course of developing the Device, obtaining rights to the
Device (or components thereof) from others or contracting with others for the
development of the Device, Licensee may not have, or may lose, the right to
xxxxx Xxxxx the rights contemplated in this Section, in which case Meiji shall
have no rights hereunder, provided that Licensee shall use reasonable efforts,
at no cost to Licensee, to obtain the right to xxxxx Xxxxx the rights
contemplated in this Section. For the avoidance of doubt, this Section
contemplates Licensee's grant to Meiji of rights to the Device solely in Japan
and solely in conjunction with the Product; Licensee is free to grant rights to
the Device to others for use in Japan in conjunction with products other than
----------
[*] Confidential Treatment Requested
the Product.
ARTICLE 12. PRODUCT LIABILITY AND INDEMNIFICATION
12.1 Licensor's Indemnification of Licensee. In addition to, and without
limiting, Xxxxx's indemnification obligations under Section 12.3 and Licensor's
obligations under Section 14.4, Licensor shall at all times during and after the
term of this Agreement be responsible for, and shall defend, indemnify and hold
Licensee, its Affiliates and sublicensees, and their respective directors,
officers, employees, agents and representatives harmless from and against any
and all third-party claims, actions, lawsuits, proceedings, fines, penalties,
damages, costs, fees and expenses, including reasonable legal expenses, costs
and attorneys' fees incurred in the defense thereof (collectively, "Claims"),
resulting from, arising out of or attributable to any breach of any
representation or warranty in Section 19.1 by Licensor, except to the extent
such Claim is attributable to Licensee's breach of any of its representations
and warranties provided in Section 19.2; provided, however, that (a) Licensee
gives Licensor prompt notice of any such Claim; (b) Licensor has the right, in
consultation with Licensee to compromise, settle or defend such Claim; and (c)
Licensee, at Licensor's expense, cooperates with Licensor in the defense of such
Claim.
12.2 Licensee's Indemnification of Licensor. In addition to, and
without limiting, Licensee's indemnification obligations under Section 12.3 and
Licensee's obligations under Section 14.4, Licensee shall at all times during
and after the term of this Agreement be responsible for, and shall defend,
indemnify and hold Licensor, their directors, officers, employees, agents and
representatives harmless from and against, any and all third-party claims,
actions, lawsuits, proceedings, fines, penalties, damages, costs, fees and
expenses, including reasonable legal expenses, costs and attorneys fees incurred
in the defense thereof (collectively, "Claims") resulting from, arising out of
or attributable to (i) any breach of any representation or warranty in Section
19.2 by Licensee, or (ii) the research, development, use, manufacture, sale and
distribution by Licensee, its Affiliates and sublicensees of the Compound, Bulk,
Product and Kit or (iii) the use of the Licensed Technology by Licensee, its
Affiliates, sublicensees and collaborators (including, without limitation, the
Third-Party Manufacturer(s)), except to the extent such Claim is attributable to
Meiji's or Licensor's breach of any of its or their representations and
warranties provided in Section 19.1 or is subject to Meiji's or Licensor's
indemnification or other obligations under Sections 12.1, 12.3 or 14.4;
provided, however, that (a) Licensor gives Licensee prompt notice of any such
Claim; (b) Licensee, its Affiliates or sublicensees have the right, in
consultation with Licensor, to compromise, settle or defend such Claim; and (c)
Licensor, at the expense of Licensee, cooperates with Licensee, its Affiliates
or sublicensees in the defense of such Claim.
12.3 Indemnification Obligations with respect to Bulk and Product Supplied
by Xxxxx. Subject to, and without limiting, Licensor's obligations under
Sections 12.1 and 14.4, during and after the term of this Agreement, Licensee
shall be responsible for, and shall indemnify, defend and hold harmless Meiji,
and its directors, officers, employees, agents and representatives from and
against, any and all third-party claims, actions, lawsuits, proceedings, fines,
penalties, damages, costs, fees and expenses, including reasonable legal
expenses, costs and attorneys' fees incurred in the defense thereof
(collectively, "Claims") resulting from any use by Licensee, its Affiliates,
sublicensees and collaborators of the Bulk and the Product supplied by Xxxxx,
except for Claims resulting from, arising out of or attributable to (i) the
failure of the Bulk or the Product supplied by Meiji to meet the then-current
Specifications; or (ii) any negligence or fault in the manufacture of the Bulk
so supplied, including any contamination or adulteration of the Bulk so
supplied; for which Claims Meiji shall, during and after the term of this
Agreement, be responsible for and shall indemnify, defend and hold harmless
Licensee, its Affiliates, sublicensees and collaborators, and their respective
directors, officers, employees, agents and representatives.
ARTICLE 13. TRADEMARKS
Licensee and its Affiliates and sublicensees may use any trademark(s) owned
or controlled by Licensee or any of its Affiliates or sublicensees in connection
with the Product and/or Kit to be distributed in the Territory, and shall notify
Licensor in writing of the same. Licensor shall have no ownership or other right
in or to such trademark(s).
ARTICLE 14. PATENTS
14.1 Patent Maintenance. Licensor shall, at its sole cost and expense, use
diligent efforts to prosecute, obtain and maintain all Licensed Patents in the
Territory. Licensor shall promptly notify Licensee in writing of the filing or
issuance of any Licensed Patents. In addition, on an ongoing basis during the
term of this Agreement, Licensor shall provide to Licensee copies of all
actions, amendments and correspondence with Patent Offices in countries in the
Territory relating to such Licensed Patents, and shall otherwise keep Licensee
up to date on the status of all such Licensed Patents. Without limiting the
foregoing, Licensor shall provide Licensee with semi-annual reports, as
requested by Licensee, on the status of the Licensed Patents.
14.2 Extension of Licensed Patent Term. Upon the written request of
Licensee, and with Licensee's reasonable cooperation, Licensor shall execute and
file
any appropriate application and related documents to extend the term of any
Licensed Patent.
14.3 Third-Party Infringement of Licensed Patents.
(a) Each party shall promptly notify the other party if it becomes
aware of the activities of any third party which are believed to infringe any of
the Licensed Patents.
The parties, including their Affiliates and sublicensees as appropriate, shall
consult as to a potential litigation strategy or strategies against the alleged
infringer and shall use reasonable efforts to terminate such alleged
infringement without litigation.
(b) If the efforts of the parties are not successful in abating the
alleged infringement, Licensee shall have the first right, but not the
obligation, to bring an appropriate suit or action against such infringement, in
its own name, in the name of its Affiliates or sublicensees, and in the name(s)
of Licensor, as Licensee reasonably deems appropriate [*], to restrain any
infringement, threatened infringement or suspected infringement of any Licensed
Patent in the Territory and to [*]. Licensor shall cooperate in any such
infringement action, shall make available to Licensee copies of any and all
relevant records, papers, documents, information and specimens and shall execute
all such papers and perform such other acts as may be reasonably requested by
Licensee (including consent to be joined as nominal party plaintiff in such
action). [*] if any, for taking any action at the written request of Licensee.
Licensee shall have full right and authority to settle or otherwise consent to
an adverse judgment in any such action or suit. If Licensee does not elect to
bring suit against the alleged infringement, Licensor shall have the right, but
not the obligation, to bring an appropriate suit or action against such
infringement, [*]. Any amount recovered in any action or suit against a
third-party infringer shall [*]; provided that, if Licensee is the party
bringing such action, any recovery [*].
14.4 Alleged Infringement of Third-Party Patents.
(a) Resolution of Alleged Infringement Through Third-Party License. In
the event either Licensor or Licensee learns of any third party's patents which
may cover the development, manufacture, use, distribution, marketing or sale of
the Product and/or the Product as part of the Kit in the Territory, and such
coverage arises out of Licensee's practice, in the Field and in the Territory,
of its rights granted
----------
[*] Confidential Treatment Requested
by Licensor hereunder, such party shall notify the other. The parties shall
confer in good faith regarding such potential infringement risk and shall
explore reasonable alternatives for avoiding such risk. Unless the parties
mutually agree on a different strategy to avoid the risk, and if Licensee
believes in good faith that the manufacture, use or sale of the Product would
create an unjustified risk of infringement liability, Licensee may negotiate and
enter into a license for such third party's patents. Licensee shall pay any
royalties that may be due by Licensee under such third-party license. Provided
that Licensee has obtained Licensor's prior written consent to such third-party
license, which consent Licensor shall not unreasonably withhold or delay,
Licensee may credit and offset [*] of the amount of royalties due for such
third-party license against any subsequent royalty payments owed to Licensor
hereunder (for the sake of clarification, such credit and offset shall not be
applicable to royalties paid to Licensor prior to such third-party license);
provided that, in no event may Licensee reduce the amount owed to Licensor by
more than [*] of any royalty payment owed to Licensor in any calendar quarter,
and any unused credit may carry forward to be used as a credit against future
royalty payments due to Licensor hereunder so long as any portion of such credit
remains unused.
(b) Defense of Action for Alleged Infringement. Additionally, if a
third party files a claim, suit or action (collectively, an "Infringement
Claim") against Licensee or any of its Affiliates or sublicensees claiming that
any patent owned or controlled by a third party is infringed by the development,
manufacture, use, marketing, distribution or sale of the Product and/or the
Product as part of the Kit, and any such Infringement Claim arises out of
Licensee's or any of its Affiliates' or sublicensees' practice in the Field in
the Territory of any Licensed Technology licensed hereunder, Licensee, its
Affiliates and sublicensees shall have the right, but not the obligation, to
defend against or to settle any such Infringement Claim. If Licensee, its
Affiliates or sublicensees undertake such defense, Licensor will assist in the
defense of any such Infringement Claim as reasonably requested by Licensee, its
Affiliate or sublicensee. Licensee, its Affiliate or sublicensee may settle any
such Infringement Claim, but if such settlement would result in a reduction (in
accordance with this Section 14.4) of royalties paid to Licensor under this
Agreement, Licensee, its Affiliate or sublicensee shall not settle such claim
without the prior express written consent of Licensor, which consent Licensor
shall not unreasonably withhold or delay.
(c) Where Licensee Is Unable to Continue Product Sales Because of
Infringement Claim. In the event Licensee, its Affiliates or sublicensees shall
not be
----------
[*] Confidential Treatment Requested
able to continue to sell the Product any longer in the country(ies) or Disease
Areas that were the subject of the Infringement Claim due to such Infringement
Claim, Licensor shall have no obligation (except only for Licensor's obligations
under Section 12.1 and 19.1, which remain unaffected by this Section) [*].
(d) Licensor's Obligations Where Licensee is Able to Continue Product
Sales. In the event Licensee, its Affiliates and sublicensees shall be able to
continue to sell the Product despite such Infringement Claim, Licensee shall
[*].
(e) Licensor's Sole and Exclusive Obligations. Except for, and without
limiting, Licensor's obligations under Sections 12.1 and 19.1, Licensor's
obligations to Licensee set forth in this Section 14.4, and Licensee's rights
under this Section 14.4 (including its rights [*] as provided herein), shall
be the sole and exclusive obligations and rights with respect to the alleged
infringement of third-party patents by Licensee, its Affiliates and
sublicensees.
ARTICLE 15. INVENTIONS
15.1 Licensee's Inventions. All improvements and inventions made by
Licensee pertaining to the Compound, the Product and/or the Kit shall be owned
solely by it, and Licensee shall have the right to control the filing,
prosecution and maintenance of all patents on such inventions worldwide at its
own expense. So long as Meiji is developing and commercializing the Product in
Japan, and provided that Licensee at such time has the right and authority to
make the following disclosures to Meiji and to grant the following rights to
Meiji, Licensee shall promptly disclose to Meiji in writing all improvements and
inventions relating to the Compound, the Product and the Product part of the Kit
in sufficient detail to allow Meiji to evaluate them (excluding any improvements
and inventions relating to the manufacture of the Compound, the Bulk and/or the
Product). Meiji shall have the right to use non-patentable improvements
(excluding those relating to (i) the manufacture of the Compound, the Bulk
and/or the Product and (ii) Other Commercial Applications), [*], solely in
connection with Meiji's development and sale of the Product in Japan in the
Field. Meiji shall have the right of first negotiation to obtain an exclusive
license, with the right to sublicense, to exercise (a) patentable improvements
and inventions relating to the Compound, the Product and the Product part of the
Kit (excluding those relating to the manufacture of the Compound, the Bulk
and/or the Product), and (b) patentable and non-patentable inventions and
improvements relating to Other Commercial Applications during the term of this
Agreement in Japan in
----------
[*] Confidential Treatment Requested
connection with Meiji's development and sale of the Product in Japan in the
Field. In the event that Licensee has filed patent application(s) on such
inventions and improvements, Licensee shall notify Meiji of the identity of such
patent application(s) and a summary of the inventions and improvements claimed
therein. Thereafter, Licensee shall, if requested by Xxxxx, inform Xxxxx of the
prosecution status of such patent application(s). If Meiji expresses an interest
in any such improvement or invention, Meiji shall present the proposed terms and
conditions of an exclusive license to Licensee to practice such improvement or
invention in connection with the Product in Japan during the term of this
Agreement. If Licensee accepts such proposal within [*] days of its receipt of
such proposal, Meiji and Licensee shall promptly negotiate an appropriate
agreement setting forth detailed terms and conditions to implement such
proposal. If the parties fail to execute such agreement within [*] days
thereafter, Licensee shall have no further obligation to Meiji with respect to
such invention or improvement.
15.2 Licensor's Inventions. All improvements and inventions made by
Licensor pertaining to the Compound or Product shall be owned solely by
Licensor, subject to this Agreement. Licensor shall have the right to control
the filing, prosecution and maintenance of all patents on such inventions
worldwide at its own expense. Licensor shall promptly disclose to Licensee in
writing all improvements and inventions pertaining to the Compound or Product in
sufficient detail to allow Licensee to evaluate them (excluding any improvements
and inventions relating to the manufacture of the Compound, the Bulk and/or the
Product that Licensor develops during the term of this Agreement, after the
Effective Date). Except as provided below in this Section 15.2, such
improvements and inventions developed by Licensor (excluding any improvements
and inventions relating to the manufacture of the Compound, the Bulk and/or the
Product) shall, if desired by Licensee in its discretion, be included within the
scope of Licensed Technology under this Agreement and are and shall be
automatically included within the scope of the exclusive license granted by
Licensor to Licensee in this Agreement, [*], but subject to the terms and
conditions of this Agreement. In the event that Licensor has filed patent
application(s) on such inventions and improvements, Licensor shall notify
Licensee of the identity of such patent application(s) and a summary of the
inventions and improvements claimed therein. Thereafter, Licensor shall, if
requested by Licensee, inform Licensee of the prosecution status of such patent
application(s).
Notwithstanding the above, if Licensor's improvement or invention does not
pertain to the treatment, monitoring or diagnosis of a Disease Area (human or
animal)
----------
[*] Confidential Treatment Requested
but, instead, pertains to an Other Commercial Application, then Licensee shall
not be entitled automatically to include such improvement or invention within
the scope of Licensed Technology licensed under this Agreement; instead,
Licensee shall have a right of first negotiation to obtain an exclusive license
to such improvement or invention in the Territory. After Licensor has disclosed
such improvement or invention to Licensee in sufficient detail to allow Licensee
to evaluate it, and Licensee has had [*] days to evaluate such improvement or
invention, Licensee shall notify Licensor whether Licensee is interested in
obtaining license rights to such improvement or invention in connection with the
development and sale of the Product and/or Kit in the Territory in the field
during the term of this Agreement. If so, Licensee shall present a written
proposal to Licensor, which the parties shall then promptly discuss. If the
parties do not execute an agreement for such improvement or invention within [*]
days after Licensor receives Licensee's proposal, Licensee shall have no further
rights to such improvement or invention.
15.3 Joint Inventions. All Inventions made jointly by employees or agents
of each party pertaining to the Compound or the Product shall be jointly owned
(the "Joint Inventions), all as determined in accordance with U.S. laws of
inventorship. With respect to all Joint Inventions relating to the treatment,
diagnosis or monitoring of any Disease Area in humans or animals: (i) Licensee
shall have the exclusive right (with the right to license and sublicense), and
Licensor hereby grants such right to Licensee, without any additional payment to
Licensor, to practice and use the Joint Inventions in the Territory, and shall
have the right to file, prosecute, maintain and control, at its expense, any
patent applications on the Joint Inventions in the Territory; and (ii) Licensor
shall have the exclusive right, with the right to license and sublicense, and
Licensee hereby grants such right to Licensor, without any payment to Licensee,
to practice and use the Joint Inventions in Japan, and shall have the right to
file and control, at its expense, any patent applications on such Joint
Inventions in Japan. With respect to Joint Inventions related to Other
Commercial Applications, the parties shall discuss in good faith the
development, intellectual property protection and commercialization of such
inventions, and their rights and responsibilities with respect thereto. Each
party shall execute such further documents and take such further steps as the
other party reasonably determines may be necessary or desirable to effectuate
the purposes of this Section.
ARTICLE 16. TERM AND TERMINATION
16.1 Term. The term of this Agreement shall commence on the Effective Date
and shall extend until, and expire upon, the later of (a) the sixteenth (16th)
----------
[*] Confidential Treatment Requested
anniversary of the Effective Date or (b), on a country-by-country basis in the
Territory, the expiration, lapse, cancellation, abandonment or invalidation of
the last to expire of the Licensed Patents covering the Product; provided that
if, but for such expiration of the Agreement, Licensee would remain obligated,
on a country-by-country basis, to pay royalties under Section 5.3, then the
Agreement shall continue in effect in such countries until Licensee no longer
remains obligated to pay such royalties, and shall expire in such countries at
such time. Upon the expiration of this Agreement on a country-by-country basis,
Licensee shall have a fully paid up, irrevocable exclusive license, with the
right to sublicense, to make, have made, develop, use, distribute, offer for
sale, sell, import and export the Product in a given country for a given
Indication for which such royalty obligations under Section 5.3 have so expired.
16.2 Termination by Mutual Agreement. The parties may at any time terminate
this Agreement by mutual written agreement executed by Xxxxxxxx and Licensee.
16.3 Breach. Either Licensor or Licensee may, in addition to any other
remedies available to it at law or in equity (subject to the terms and
conditions of this Agreement), terminate this Agreement based on the other
party's unremedied breach of a material provision of this Agreement, as provided
in, and in accordance with the procedures set forth in, this Section 16.3. In
the event Licensor or Licensee alleges that the other party has breached a
material provision of this Agreement, it shall give detailed written notice
specifying the alleged breach to the other party, which notice shall, if it is
intended to be a basis for termination, state such intention to the alleged
breaching party if the breach is not cured. If the alleged breaching party fails
to cure its breach of a material provision of this Agreement within ninety (90)
days of its receipt of such notice, or if such breach is incapable of cure
within such 90-day period and the alleged breaching party fails to commence
diligent and reasonable steps to cure such breach within such 90-day period and
to continue such steps diligently thereafter until the breach is cured, then the
other party shall have the right to terminate this Agreement in full upon a
further thirty (30) days written notice; provided, that should the alleged
breaching party dispute in writing the alleged breach or allege that it has
cured the breach or commenced diligent and reasonable steps to cure such breach
within such 90-day period, the dispute shall be resolved through the dispute
resolution and arbitration process as provided in Sections 20.9 and 20.10. In
the case of such a dispute, the termination of this Agreement shall not take
effect unless and until the Agreement is terminated by mutual agreement pursuant
to Section 16.2 or by a final decision of the arbitrators pursuant to Section
20.10, which decision finds that the alleged breaching party has breached a
material provision of this Agreement and failed to cure, and to take reasonable
steps to cure, such breach. Such arbitration proceeding shall be deemed
commenced by the party alleging the breach
and seeking to terminate this Agreement. This Section 16.3 shall not apply to
the alleged failure of Licensee to proceed with diligence in the development and
commercialization of the Product; the process and remedy for dealing with such
alleged failure is set forth in Section 6.4.
16.4 Insolvency or Bankruptcy. Either of Licensor (as to Licensee) and
Licensee (as to Meiji or NPC) may, in addition to any other remedies available
to it at law or in equity (subject to the terms and conditions of this
Agreement), terminate this Agreement by written notice to the other party in the
event (where Licensee is the other party) of the commencement of a bankruptcy
proceeding by or against Licensee under the United States Bankruptcy Code, or
(where Meiji or NPC is the other party) of the commencement of an equivalent
proceeding by or against Meiji or NPC under Japanese law, which proceeding seeks
the liquidation, dissolution or winding-up of Licensee, Meiji or NPC, as the
case may be; provided that such proceeding continues unabated for at least one
hundred twenty (120) days following its commencement; and provided further that
the continuation and success of such proceeding will render the affected party
unable to fulfill its obligations under this Agreement.
16.5 Serious Events. Should there occur serious or unexpected events or
circumstances which, from a reasonable pharmaceutical company's point of view,
would make it impossible, impracticable or commercially unreasonable to pursue
the development and commercialization of the Product, such as (without
limitation) safety issues, efficacy issues, regulatory issues or other
justifiable reasons which would have a material adverse effect on the
development and commercialization of the Product, Licensee may, in its sole
discretion, but in consultation with Licensor, terminate this Agreement by
written notice to Licensor, such notice to be effective on its receipt.
16.6 Effect of Termination.
(a) Upon termination of this Agreement in accordance with Sections
16.2 or 16.5 or by Licensor in accordance with Sections 16.3 or 16.4:
(i) All rights and licenses granted to Licensee hereunder,
including the license to develop, use, manufacture and sell the Compound,
the Bulk and the Product, shall immediately terminate and shall revert to
Licensor, provided, however, that Licensee may, in its discretion, continue
to sell its remaining inventory of the Bulk and the Product for twelve (12)
from the effective date of such termination, subject to the royalty payment
on the Net Sales generated by such sales in accordance with Section 5.3;
and;
(ii) Licensee shall, in accordance with Licensor's instruction,
return to Licensor, or destroy, all the Licensed Know-How and any other
Confidential Information supplied by Licensor in tangible form and copies
thereof then possessed by Licensee, its Affiliates and sublicensees and the
Third-Party Manufacturer(s); and cease all use of the Licensed Know-How and
any other Confidential Information disclosed by Licensor, except to the
extent, at the time of such termination, the Licensed Know-How and any
other Confidential Information disclosed by Licensor, is no longer
Confidential Information (other than due to a breach of Article 18 by
Licensee); and
(iii) In the event of termination by Licensor under Section 16.3
based on Licensee's unremedied breach of a material provision hereunder, or
termination by Licensor under Section 16.4, Licensee shall transfer to
Meiji or NPC, as Licensor directs (at no charge), any Regulatory Approvals
(including IND's) or applications for Regulatory Approvals (including
IND's) for the Product in the Territory, together with the Licensee
Information and the full dossier and all data submitted in support of such
Regulatory Approvals (including, IND's), excluding any Regulatory Approvals
pertaining to the Device, applications therefor, and data and information
related thereto.
(b) Upon termination of this Agreement by Licensee pursuant to Section
16.3 or 16.4:
(i) All rights of Licensor to use or reference any Licensee
Information, or any Licensee invention, improvement or Device, and any
other Confidential Information disclosed by Licensee hereunder, shall
immediately terminate; and
(ii) Licensor shall, in accordance with Licensee's instruction,
return to Licensee, or destroy, all such Licensee Information, information
related to Licensee inventions, improvements or the Device, and any other
Confidential Information disclosed by Licensee, except to the extent, at
the time of such termination, such information is no longer Confidential
Information (other than due to a breach of Article 18 by Licensor); and
(iii) Licensee shall have a fully paid up, irrevocable, exclusive
license under the Licensed Technology, with the right to sublicense, to
make, have made, develop, use, distribute, offer for sale, sell, import and
export the Product in the Territory; and
(iv) If at the time of such termination Licensor has not yet
transferred the Manufacturing Know-How to Licensee and the Third-Party
Manufacturer(s) as provided in Article 4, it shall do so promptly in
accordance with the provisions of Article 4.
(c) Upon termination of Licensee's rights under the license granted in
this Agreement in a particular Disease Area in a particular country due to
failure of Due Diligence by Licensee as set forth in Section 6.4(a) or 6.4(c):
(i) All rights and license granted to Licensee hereunder with
respect to such particular Disease Area in such country, including the
license to develop, use, manufacture and sell the Compound, Bulk and
Product in such particular Disease Area in such country, shall immediately
terminate and shall revert to Licensor;
(ii) Licensee shall cease all use of the Licensed Know-How and
any other Confidential Information disclosed by Licensor with respect to
such particular Disease Area in such country, except to the extent, at the
time of such termination, the Licensed Know-How and any other Confidential
Information disclosed by Licensor is no longer Confidential Information
(other than due to a breach of Article 18 by Licensee);
(iii) Licensee shall transfer to Meiji or NPC, as Licensor
directs (at no charge), any Regulatory Approvals (including IND's) and
applications for Regulatory Approvals (including IND's) for the Product in
such particular Disease Area in such country, together with the related
Licensee Information and the full dossier and all data submitted in support
of such Regulatory Approvals (including IND's), excluding any Regulatory
Approvals pertaining to the Device, applications therefor, and data and
information related thereto; and
(iv) Licensee's rights under this Agreement in all Disease Areas
and in all countries not the subject of termination under Section 6.4(a) or
6.4(c) shall remain unaffected and in full force.
16.7 Survival of Liability and Other Obligations. Expiration or termination
of this Agreement through any means and for any reason shall not affect any
accrued obligations, rights and remedies prior thereto and shall be without
prejudice to the rights and remedies of either party with respect to any
antecedent breach of any provision of this Agreement, which rights and remedies
shall be subject to the terms and conditions of this Agreement. The rights and
obligations described in the following Articles of this Agreement shall survive
its expiration or termination: Articles 7, 12, 16, 18, 19 and 20 plus such other
provisions of the Agreement which by their express terms or their context are
intended to survive expiration or termination of this Agreement.
ARTICLE 17. FORCE MAJEURE
None of the parties shall be held liable or responsible to the other
parties nor be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any obligations under this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party, including but not limited to fire,
floods, embargoes, wars, acts of war (whether war is declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other parties; provided, however, that the party
so affected shall use reasonable efforts to avoid or remove such causes of delay
or nonperformance, and shall continue to perform hereunder with reasonable
dispatch whenever such causes are removed. Any party shall provide the other
parties with prompt written notice of any delay or failure to perform that
occurs by reason of force majeure.
ARTICLE 18. CONFIDENTIALITY AND DISCLOSURE
18.1 Confidentiality. Each party shall maintain in confidence, and neither
party shall disclose to any third party, any Confidential Information received
by it from the other party pursuant to this Agreement, or pursuant to the
Confidential Disclosure Agreement described in Section 18.3, nor use any such
Confidential Information for any purpose other than the purpose of this
Agreement without the prior written consent of the other party. Neither party
shall use, disclose, transfer or grant use of such Confidential Information
except as expressly authorized by this Agreement or as reasonably necessary to
perform acts permitted by this Agreement. This obligation shall continue for a
period of ten (10) years after expiration or termination of this Agreement.
18.2 Disclosure. Nothing contained in this Article shall be construed to
restrict the parties from disclosing or using Confidential Information as
reasonably necessary: (i) in prosecuting or defending litigation; (ii) in
responding to court order or other government order or request; or (iii) to
perform acts permitted by this Agreement, including developing the Product,
seeking and maintaining Regulatory Approval of the Product, marketing, sale or
use of the Product, and filing and prosecuting patent applications; provided
that, if any party is required or finds it reasonably necessary to make any such
disclosure of Confidential Information, it will to the extent practicable and
appropriate use reasonable efforts to secure confidential treatment of such
disclosed information.
18.3 Prior Confidentiality Agreement. Information disclosed under the
Confidential Disclosure Agreement (the "CDA") between Meiji and Licensee dated
July 28, 1999, information and data generated by or on behalf of Licensee under
the Statement of Investigator dated September 10, 1999, and information
disclosed under the CDA between NPC and Licensee dated January 20, 2000, shall
be covered by the terms of this Article 18.
ARTICLE 19. REPRESENTATIONS AND WARRANTIES
19.1 By Licensor. Licensor represents and warrants that:
(a) Licensor has the right, power and authority to grant to Licensee
the exclusive licenses and rights to the Licensed Technology in the Territory
set forth in this Agreement and to enter into this Agreement and perform
Licensor's obligations hereunder;
(b) This Agreement has been duly executed and delivered by Licensor
and is a legal, valid and binding obligation enforceable against Licensor in
accordance with its terms, subject to applicable bankruptcy, insolvency,
reorganization, arrangement, moratorium and other laws relating to or affecting
creditors' rights generally and equitable principles;
(c) The execution, delivery and performance of this Agreement, and the
rights and licenses granted hereunder, do not conflict with, violate or breach
any agreement to which Licensor is a party, and there are no agreements,
assignments or encumbrances in existence inconsistent with the provisions of
this Agreement. Licensor has not granted and will not grant any license or other
right in any of the Licensed Technology that interferes with or conflicts with
any of the licenses or rights granted to Licensee under this Agreement;
(d) The License Agreement dated as of [*] between NPC and Meiji
relating to NPe6 (the "NPC-Meiji Agreement") remains in effect, without breach
by either party. This Agreement is not a sublicense of the NPC-Meiji Agreement.
[*] respective rights and obligations hereunder. Meiji has granted no
sublicense or other rights under the NPC-Meiji Agreement in the Territory;
(e) As of the Effective Date of this Agreement, Licensor is the sole
and exclusive owner of, or controls the sole and exclusive rights to, the
Licensed Technology including the Compound (including, without limitation, all
versions of the Drug Master File filed by Xxxxx);
----------
[*] Confidential Treatment Requested
(f) To the best knowledge of Licensor as of the Effective Date, no
third party has any right, title or interest in or to the Licensed Technology in
the Territory; [*].
(g) As of the Effective Date, Licensor has not received any notice
from any third party claiming any ownership interest or control in the Licensed
Technology, including the Compound;
(h) The Licensed Technology has not knowingly been obtained through
any activity, omission or representation that would limit or destroy the
validity or enforceability of the Licensed Technology, and Licensor has, as of
the Effective Date, no knowledge or information that would have a material
adverse impact on the validity and/or enforceability of the Licensed Technology;
(i) As of the Effective Date, there are no actions pending, or, to the
best of Licensor's knowledge as of the Effective Date, threatened before any
court or tribunal relating to the Licensed Technology, and no Licensed Patent
has been involved in any reissue, reexamination, interference, opposition or
equivalent or similar proceeding or in any litigation, [*];
(j) To the best knowledge of Licensor as of the Effective Date, the
issued Licensed Patents are valid and enforceable and are not being infringed by
any third party in the Territory or Japan. Licensor has, as of the Effective
Date, no knowledge or information that would materially affect the validity
and/or enforceability of the Licensed Patents. However, Licensor does not
represent and warrant that any of the Licensed Patents is valid and enforceable;
(k) As of the Effective Date, Licensor has not received any notice
from any third party claiming that the development, manufacture, use,
importation, exportation or sale of NPe6 or ME2906 will infringe any patent of
any third party;
(l) No other license for currently existing patents or patent
applications of Licensor or Affiliates of Licensor is required to develop, make,
have made, use, import, export, offer for sale or sell the Compound in the
Territory;
(m) Licensor has not knowingly misstated any material fact with
respect to the Compound, including its manufacture, safety and efficacy, or the
Licensed Patents or with respect to the information related thereto provided by
Licensor to Licensee, nor has Licensor knowingly omitted to state any material
fact or
----------
[*] Confidential Treatment Requested
provide any material information required to make such information not
misleading;
(n) As of the Effective Date, Licensor neither owns nor controls any
compound, other than the Compound, for use with PDT, or any intellectual
property rights related to any such compound, and is not, as of the Effective
Date, developing or negotiating to obtain any such compound or intellectual
property rights; and
(o) The execution and delivery by Licensor of this Agreement require
no governmental approvals to be obtained on the part of Licensor, or, if
required, Licensor has obtained such approvals.
(p) Without limiting Licensor's obligations regarding the Licensed
Know-How under Section 2.1, Article 3, Article 4, Section 6.6, Article 7 and
Article 15 of this Agreement, and except for and subject to Licensor's
representations and warranties set forth above, LICENSOR MAKES NO OTHER WARRANTY
WITH RESPECT TO THE ACCURACY, COMPLETENESS, APPLICABILITY, FITNESS OR
MERCHANTABILITY OF THE LICENSED KNOW-HOW, INCLUDING THE ENGLISH TRANSLATION
THEREOF.
19.2 By Licensee. Licensee represents and warrants that:
(a) Licensee has the right, power and authority to enter into this
Agreement and to perform Licensee's obligations hereunder.
(b) This Agreement has been duly executed and delivered by Licensee
and is a legal, valid and binding obligation enforceable against Licensee in
accordance with its terms, subject to applicable bankruptcy, insolvency,
reorganization, arrangement, moratorium and other laws relating to or affecting
creditors' rights generally and equitable principles;
(c) The execution, delivery and performance of this Agreement, and the
rights and licenses granted hereunder, do not conflict with, violate or breach
any agreement to which Licensee is a party, and there are no agreements,
assignments or encumbrances in existence inconsistent with the provisions of
this Agreement;
(d) The execution and delivery by Licensee of this Agreement require
no governmental approvals to be obtained on the part of Licensee, or, if
required, Licensee has obtained such approvals.
ARTICLE 20. MISCELLANEOUS
20.1 Assignment. Neither party may assign any right or obligation hereunder
without the prior written consent of the other party, except if such assignment
arises
under a transaction in which the assigning party is selling or transferring
substantially all of its business or is being acquired by or merging with a
third party (which assignment shall be permitted without the consent of the
other party but shall require prompt written notice to the other party). This
Agreement shall be binding upon and inure to the benefit of the parties'
respective successors and permitted assigns. Any attempted assignment in
violation of this provision shall be void and of no effect. Licensor
acknowledges that Licensee plans to convert from a limited partnership form to a
corporate form, that Licensee then plans to merge with and assign its rights,
interests and obligations in this Agreement to such corporation, and that this
shall be a permitted assignment under this Agreement.
20.2 Severability. Each party intends not to violate any public policy,
statutory or common law, rule, regulation, treaty or decision of any government
agency or executive body thereof of any country or community or association of
countries. If any term or provision of this Agreement is held to be invalid,
illegal or unenforceable by a court or other governmental authority of competent
jurisdiction, such invalidity, illegality or unenforceability shall not affect
any other term or provision of this Agreement, which shall remain in full force
and effect. To the extent possible, the parties shall revise such invalid,
illegal or unenforceable term or provision in a manner that will render such
term or provision valid without impairing the parties' original intent. The
holding of a term or provision to be invalid, illegal or unenforceable in one
jurisdiction shall not have any effect on the enforceability of the term or
provision in any other jurisdiction.
20.3 Notices. Any consent, notice or approval required or permitted to be
given or made under this Agreement by one of the parties hereto to the other
shall be in writing, delivered personally or by facsimile (and promptly
confirmed by personal delivery, first-class mail or commercial courier),
first-class mail or commercial courier (e.g., Fed Ex, DHL), postage prepaid
(where applicable), addressed to such other party at its address indicated
below, or to such other address as the addressee shall have last furnished in
writing to the addressor, and shall be effective upon the earlier of its
documented receipt by the addressee or [*] business days after dispatch of such
notice in accordance with this Section.
----------
[*] Confidential Treatment Requested
If to NPC: Nippon Petrochemicals Co., Ltd.
0-0, Xxxxxxxxxx-xxx 0-xxxxx
Xxxxxxx-xx, Xxxxx 000-0000
Xxxxx
Attention: Director, General Manager of
New Business Development Department
If to Meiji: Meiji Seika Kaisha, Ltd.
0-00, Xxxxxxxx 0-Xxxxx
Xxxx-xx, Xxxxx 000-0000
Xxxxx
Attention: President, Pharmaceuticals
If to Licensor: To Meiji (at the above-specified address)
on behalf of NPC and Meiji
If to Licensee: Light Sciences Limited Partnership
0000-00xx Xxxxxx XX, Xxxxx X-0
Xxxxxxxx, Xxxxxxxxxx 00000
U.S.A.
Attention: Both the President and
the V.P., Product Development
20.4 Applicable Law. This Agreement is deemed to have been entered into in
the State of New York, United States of America, and it shall be governed by,
construed, and enforced in accordance with the laws of the State of New York,
United States of America, excluding its conflict-of-laws provision.
20.5 Entire Agreement. This Agreement, including the exhibits hereto,
contains the entire understanding of the parties with respect to the subject
matter hereof. All express or implied agreements and understandings, either oral
or written, heretofore made are expressly merged in and made a part of this
Agreement. There are no understandings, obligations, indemnifications,
warranties and representations except as expressly set forth herein, and no
rights or licenses are granted except as expressly set forth herein. This
Agreement may be amended, or any term hereof modified, only by a written
instrument duly executed by all the parties hereto.
20.6 Headings. The captions to the Articles and Sections hereof are not a
part of this Agreement, but are merely guides or labels to assist in locating
and reading the Articles and Sections hereof.
20.7 Independent Contractors. It is expressly understood and agreed that
Licensor and Licensee are and shall be independent contractors and that the
relationship between the parties shall not constitute a partnership, joint
venture or agency. None of the parties hereto shall have the authority to make
any statements, representations or commitments of any kind, or to take any
action, which shall be binding on the other parties, without the prior written
consent of the parties to do so, except as expressly provided in this Agreement.
20.8 Waiver. The waiver by either party hereto of any right hereunder or of
a failure to perform or breach by the other party shall not be deemed a waiver
of any other right hereunder or of any other failure or breach, whether of a
similar nature or otherwise.
20.9 Dispute Resolution. In the event a dispute arises between the parties
relating to this Agreement, or any alleged breach of this Agreement or the
grounds for the termination thereof (the "Dispute"), the aggrieved party shall
notify the other party in writing of such Dispute, and the parties shall attempt
to resolve such Dispute in good faith. If, within [*] days of such written
notice, the parties have not succeeded in resolving the Dispute, the matter
shall be referred by the aggrieved party for review and resolution by the CEOs
of Licensor and Licensee. The CEOs shall attempt in good faith to resolve the
Dispute for a period of [*] days and shall, if they mutually agree, submit the
dispute to voluntary mediation at such place and following such procedures as
the parties shall reasonably agree. If no successful resolution of the Dispute
has been mutually agreed to at the end of this period, either party shall be
free to seek legal or equitable relief under Section 20.10 of this Agreement.
20.10 Arbitration. Licensor and Licensee agree that any Dispute that arises
between them in connection with this Agreement, which cannot be amicably
resolved by the parties pursuant to Section 20.9, shall be finally resolved by
binding arbitration to be conducted by a single arbitrator or a panel of three
(3) arbitrators. If arbitration is initiated by Xxxxx and/or NPC against
Licensee, the arbitration shall be conducted in Seattle, Washington, U.S., in
the English language pursuant to the Rules of the American Arbitration
Association. If arbitration is initiated by Licensee against Meiji and/or NPC,
arbitration shall be conducted in Tokyo, Japan, in the Japanese language,
pursuant to the Rules of the Japan Commercial Arbitration Association. Such
arbitrator(s) shall be lawyers or business executives or experts in the
pharmaceutical business, having no business relationship with any of the
parties, who are experienced in the subject matter that is the basis of the
dispute. The parties shall mutually agree
----------
[*] Confidential Treatment Requested
on such arbitrator(s) within [*] days after one party's receipt of notice
initiating the arbitration proceeding from the other party. If the parties do
not mutually agree on such arbitrator(s) within such period, the arbitration
shall be conducted by a panel of three (3) arbitrators, one to be selected by
Licensor and one to be selected by Licensee within [*] days after the end of the
initial [*] period. Those two arbitrators shall then mutually agree on the third
arbitrator within [*] days thereafter. If they do not reach such agreement, the
Director of the Arbitration Association office in the city where the arbitration
will be conducted shall select such third arbitrator, as well as any other
arbitrator(s) the parties were entitled to select but did not select within the
allotted time period. The arbitration award at the conclusion of the proceeding,
which shall be the final decision of the majority of the arbitrators, may
include legal and equitable relief and shall be final and binding upon both
parties. Judgment upon the award rendered through arbitration may be entered in
any court having jurisdiction, or application may be made to such court for a
judicial acceptance of the award, an order of enforcement or such other
appropriate remedy as may be available.
20.11 Public Announcements. Except as may otherwise be required by law or
regulation (including as may be required by the Securities and Exchange
Commission or by the disclosure policies of a major Stock Exchange), neither
party shall make any public announcement concerning this Agreement or the
subject matter hereof without the prior written consent of the other party. If
any party determines that notification is required by law or regulation, such
party shall submit a copy of the proposed announcement to the other party for
review. The other party shall have [*] business days to review such announcement
and provide its comments and suggestions. The party issuing such announcement,
subject to legal requirements, shall use its every effort to accommodate the
other party's comments and suggestions.
20.12 Limitations of Liability. Without limiting the parties'
indemnification obligations for third-party Claims under Article 12 or their
obligations under Section 14.4, IN NO EVENT SHALL EITHER PARTY OR ITS
AFFILIATES, OR THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR
REPRESENTATIVES BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL,
SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A CLAIM OR
ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT OR
LEGAL THEORY, OR ARISING OUT OF THIS AGREEMENT.
20.13 Counterparts. This Agreement may be executed in three or more
----------
[*] Confidential Treatment Requested
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
20.14 Official Language. The official text of this Agreement and any
appendices, exhibits and schedules hereto, or any notice or consent given or
reports, accounts or statements required by this Agreement, shall be in English.
In the event of any dispute concerning the construction or meaning of this
Agreement, reference shall be made only to this Agreement as written in English
and not to any other translation into any other language.
20.15 Further Documents. Each party hereto agrees to execute such further
documents and take such further steps as the other party reasonably determines
may be necessary or desirable to effectuate the purposes of this Agreement.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
the Effective Date.
NIPPON PETROCHEMICALS CO., LTD. MEIJI SEIKA KAISHA, LTD.
By: /s/ Xxxxx Xxxxxxx By: /s/ Xxxxxx Xxxxx
--------------------------------- ------------------------------------
Xxxxx Xxxxxxx Xxxxxx Xxxxx
President President, Pharmaceuticals
LIGHT SCIENCES LIMITED PARTNERSHIP
By: /s/ Xxxxxx Xxxxxxx
---------------------------------
Xxxxxx Xxxxxxx
President, Light Sciences II Co.,
General Partner
EXHIBIT A
LICENSED PATENTS (1)
Priority Expiration
No No. Applicant Title Country Application No. Status date
-- ----------- -------------- ------------------------------------- ------- ---------------- ------------------------ -------------
1 US84-631925 Nippon (1) Tetrapyrrole Therapeutic Agents AU 45158-85 registered 579387 Jul.18, 2005
US85-728784 Petrochemicals (2) Tetrapyrrole Therapeutic Agents 45159-85 registered 592058 Jul.18, 2005
CA 487040 registered 1262862 Nov.14, 2006
487041 registered 1264740 Jan.23, 2007
DK 3267-85 registered 167768 Jul.18, 2005
3268-85 registered 167769 Jul.18, 2005
EP(1) 85108987 registered 168832 Jul.18, 2005
85108981 registered 168831 Jul.18, 2005
NO 852871 registered 169290 Jul.18, 2005
852872 registered 169291 Jul.18, 2005
US 631925 registered 4675338 Jul.18, 2004
728784 registered 4693885 Jul.18, 2004*
SG 941031 Confirmation of EP(UK) Jul.18, 2005
9401031
941032 Confirmation of EP(UK) Jul.18, 2005
9401032
HK 908 Confirmation of EP(UK) Jul.18, 2005
9400908
1359 Confirmation of EP(UK) Jul.18, 2005
9401359
2 US85-728752 Nippon Tetrapyrrole AU 56889-86 registered 583373 Apr.30, 2006
Petrochemicals Polyaminomonocarboxylic Acid CA 507943 registered 1314042 Mar.2, 2010
Therapeutic Agents DK 1973-86 registered 168512 Apr.30, 2006
EP(2) 86105955 registered 213272 Apr.30, 2006
NO 861722 registered 169292 Apr.30, 2006
US 728752 registered 4977177 Apr.30, 2005*
3 US85-728786 Nippon Tetrapyrrole Therapeutic Agents AU 56891-86 registered 589957 Apr.30, 2006
Petrochemicals CA 507944 registered 1291710 Nov.5, 2008
DK 1972-86 registered 168690 Apr.30, 2006
EP(1) 86105954 registered 210351 Apr.30, 2006
NO 861724 registered 173319 Apr.30, 2006
US 351770 registered 5066274 Jul.18, 2004*
EXHIBIT A
LICENSED PATENTS (2)
Expiration
No Priority No. Applicant Title Country Application No. Status date
-- ------------ ------------- ------------------------------------- ------- --------------- ---------------------- -----------
4 US85-728785 Nippon Tetrapyrrole Therapeutic Agents AU 56890-86 registered 589176 Apr.30, 2006
Petrochemicals CA 507945 registered 1290753 Oct.15, 2008
DK 1971-86 registered 168296 Apr.30, 2006
EP' 86105953 registered 200218 Apr.30, 2006
NO 861723 registered 169293 Apr.30, 2006
US 728785 registered 4656186 Apr.30, 2006
5 US87-137750 Nippon Novel Tetrapyrrole Aminocarboxlic AU 27687-89 registered 618054 Jan.3, 2009
Petrochemicals Acids EP(3) 88121593 registered 322795 Dec.23, 2008
US 137750 registered 5004811 Apr.2, 2008
CA 586634 registered 1340023 Sep.1, 2015
6 US89-441303 Nippon Method for Detecting Cholesterol US 441303 registered 4997639 Nov.27, 2009
Petrochemicals Deposited in Bodies of Mammals
7 JP91-126608 Nippon Therapeutic Agent for Treating US 875367 registered 5308861 Apr.29, 2012
Petrochemicals Atherosclerosis of Mammals
8 JP93-120977 Nippon Method and Medical Agent for CA 2121716 publication No.2121716
Petrochemicals Diagnosis and/or Therapy of Arthritis EP(4) 94106083 publication No.629409
US 229940 registered 5430051 Apr.19, 2014
353882 registered 5567409 Dec.12, 2014
TW 94-106082 registered 259706 Jul.3, 2014
CN 94104956 publication 1099613
PH 48111 filing (Apr.18, 1994)
49204 filing (Oct.18, 1994)
KR 94-8364 allowance
(Oct.28, 1999)
9 JP95-228760 Meiji Seika Photochemotherapeutical Obstruction US 616177 registered 5633275 Mar.15, 2016
Kaisha of Newly-formed Blood Vessels 301320 reissue application
10 JP96-293061 Meiji Seika Treatment of autoimmune diseases by US 297810 filing
JP97-204711 Kaisha photochemotherapy International filing
date: Oct. 17, 1997
CA 2270558 filing
International filing
date: Oct. 17, 1997
EXHIBIT A
LICENSED PATENTS (3)
Expiration
No Priority No. Applicant Title Country Application No. Status date
-- ------------ ------------- ------------------------------------- ------- --------------- ----------------------- ----------
11 JP97-210395 Meiji Seika Immunosuppression by US Unknown Filing
Kaisha photochemotherapy (PCT/JP98/03492) International filing
date: Aug.5, 1998
CA Unknown Filing
(PCT/JP98/03492) International filing
date: Aug.5, 1998
AU Unknown Filing
(PCT/JP98/03492) International filing
date: Aug.5, 1998
EP(5) Unknown Filing
(PCT/JP98/03492) International filing
date: Aug.5, 1998
12 JP98-195717 Meiji Seika Novel X-ray intercepting metal PCT(6) PCT/JP99/03752 International filing
date: Jul.12, 1999
Kaisha Complexes of chlorine derivatives Publication
No.WO00/02882
13 Meiji Seika Photodynamic therapy for selective PCT(7) PCT/JP00/00901 International filing
date: Feb.17, 2000
Xxxxxx Xxxxxxxxx of neovascular vessel in
Ocular fundus tissue
* Terminal disclaimer
----------
US:USA, EP:EPO, AU: Australia, CA: Canada, CN: China, DK: Denmark, HK: Hong
Kong, JP: Japan, NO: Norway, SG: Singapore, TW: Taiwan, PH: Philippine, KR:
Korea
1): Austria, Belgium, Switzerland, Germany, France, United Kingdom, Italy,
Liechtenstein, Luxembourg, Netherlands, Sweden
2): Belgium, Switzerland, Germany, France, United Kingdom, Italy,
Liechtenstein, Luxembourg, Netherlands, Sweden
3): Switzerland, Germany, France, United Kingdom, Italy, Liechtenstein
4): Switzerland, Germany, France, United Kingdom, Italy, Liechtenstein, Sweden
5): EPO (Austria, Belgium, Switzerland, Cyprus, Germany, Denmark, Spain,
Finland, France, United Kingdom, Greece, Ireland, Italy, Liechtenstein,
Luxembourg, Monaco, Netherlands, Portugal, Sweden)
6): All designated countries (100 countries)
7): Japan, USA, EPO (Austria, Belgium, Switzerland, Cyprus, Germany, Denmark,
Spain, Finland, France, United Kingdom, Greece, Ireland, Italy,
Liechtenstein, Luxembourg, Monaco, Netherlands, Portugal, Sweden)
EXHIBIT B
DEVELOPMENT PLAN
i)
Task Name 2000 2001 2002 2003 2004 2005
----------- ----------- ----------- ----------- ----------- -----------
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
------------------ -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- --
[1] ONCOLOGY #
Transfer IND +
Meeting with FDA *
Phase I
Phase IIa
Phase IIb
Phase III
NDA Filing
[2] OPTHAMOLOGY #
Meeting with FDA *
Phase I
Phase II
Phase III
NDA Filing
EXHIBIT C
TRANSFER OF IND TO LIGHT SCIENCES
1. Tasks that NPC and Meiji shall complete before transfer of the IND [*]:
1) NPC to complete the amendment of U.S. clinical reports and submit it
to the FDA.
2) NPC to request and confirm with [*] to provide a letter to the FDA
authorizing the FDA to refer to the [*] after the transfer of NPC
IND to Light Sciences.
3) NPC to submit a letter notifying the FDA that it is transferring the
IND to Light Sciences and indicating the effective date of the
transfer. (cc: Light Sciences)
4) Meiji to submit and file its new DMF for the drug substance to the
FDA.
2. Materials that NPC and Meiji shall submit to Light Sciences
1) Original NPC IND (Vol. 1 to 4)
2) All IND amendments and correspondences, annual reports etc., submitted
to the FDA by NPC (Serial No. 1 to 22)
3) All FDA correspondence files
4) U.S. clinical report amendments
5) U.S. clinical study files and case report forms for each site
6) English translations of Xxxxx's preclinical study full reports
including the certified translation of toxicology studies
7) English translation of abstracts of Xxxxx's clinical study and
Certified English translations of all Adverse Event Reports and
pertinent Efficacy data of Xxxxx's clinical studies
8) CMC Section of Meiji's Drug Product and Meiji's new DMF for Drug
Substance
3. Light Sciences' tasks after transfer of the IND
1) Light Sciences to request Meiji to provide a letter to the FDA
authorizing the FDA to refer to the Meiji DMF as necessary for the
Light Sciences' IND.
----------
[*] Confidential Treatment Requested
EXHIBIT D
LIST OF DOCUMENTS TO BE TRANSLATED
1) Antitumor Effects of PDT Using ME2906 on Human Lung Cancer (LC-6-JCK)
Transplanted to Nude Mice. Meiji Seika Kaisha, Ltd.
2) Antitumor Effects of PDT Using ME2906 on Human Uterine Cervical Cancer
(HeLa S3) Transplanted to Nude Mice. Meiji Seika Kaisha, Ltd.
3) Antitumor Effects of PDT Using ME2906 on Fibrosarcoma (Meth-A) Transplanted
to Mice -Effects of ME2906 Dose-. Meiji Seika Kaisha, Ltd.
4) Antitumor Effects of PDT Using ME2906 on Fibrosarcoma (Meth-A) Transplanted
to Mice -Effects of Laser Dose-. Meiji Seika Kaisha, Ltd.
5) Antitumor Effects of PDT Using ME2906 on Fibrosarcoma (Meth-A) Transplanted
to Mice -Effects of Interval from Drug Administration to Laser
Irradiation-. Meiji Seika Kaisha, Ltd.
6) Antitumor Effects of PDT Using ME2906 on Colon Cancer (colon26)
Transplanted to Mice. Meiji Seika Kaisha, Ltd.
7) In Vitro Cytotoxic Effects of PDT Using ME2906 on Cultured Tumor Cells.
Meiji Seika Kaisha, Ltd.
8) In Vitro Cytotoxic Effects of PDT Using ME2906 on Cultured Tumor Cells
- Cytotoxic Effects on Multidrug-resistant Cell-. Meiji Seika Kaisha, Ltd.
9) In Vitro Cytotoxic Effects of PDT Using ME2906 on Cultured Tumor Cells
- Cytotoxic Effects Immediately after Addition of ME2906-. Meiji Seika
Kaisha, Ltd.
10) Antitumor Effects of PDT Using ME2906 on Fibrosarcoma (Meth-A) Transplanted
to Mice -Relationship between Plasma and Tumor Drug Concentrations and
Antitumor Effects-. Meiji Seika Kaisha, Ltd.
11) Effects of PDT Using ME2906 on Tumor Vessel Occlusion -Time-Course Change
after PDT-. Meiji Seika Kaisha, Ltd.
12) Effects of PDT Using ME2906 on Tumor Vessel Occlusion -Changes at Various
PDT Conditions-. Meiji Seika Kaisha, Ltd.
13) Histopathological Analysis on Tumor Vascular Changes of Fibrosarcoma
(Meth-A) Transplanted to Mice after PDT Using ME2906. Meiji Seika Kaisha,
Ltd. (BOZO Research Center Inc.)
14) Effects of ME2906 on the Central Nervous System in Mice and Rats. Meiji
Seika Kaisha, Ltd.
15) Effects of ME2906 on the Respiratory and Cardiovascular Systems in Dogs.
Meiji Seika Kaisha, Ltd.
16) Effects of ME2906 on the Isolated Guinea Pig Ileum. Meiji Seika Kaisha,
Ltd.
17) Study for Safety Pharmacology of ME2906 on Isolated Guinea Pig Ileum. JBC,
Inc.
18) Pharmacology Study of ME2906 in Human Blood. Preclinical Medicinal Research
Laboratory, Inc.
19) Effects of Laser Irradiation on Trachea and Xxxxxxxx in Dogs Injected with
ME2906 (1). Meiji Seika Kaisha, Ltd.
20) Effects of Laser Irradiation on Trachea and Xxxxxxxx in Dogs Injected with
ME2906 (2). Meiji Seika Kaisha, Ltd.
21) Effects of Laser-Irradiation on the Uterus Cervix and Trachea in ME2906
Treated Monkeys. Shin Nippon Biomedical Laboratories, Ltd.
22) The Effects of Laser-Irradiation on the Uterine Cervix and Trachea in
ME2906 Treated Monkeys -IL Shin Nippon Biomedical Laboratories, Ltd.
23) Study for the Injury of the Rat Oral Mucosa by Laser Irradiation after a
Single Intravenous Administration of ME2906. JBC, Inc.
24) Preparative Details of [aspartic acid-U-i4C] ME2906. Amersham Pharmacia
Biotech
25) Assay Method Validation for ME2906 Protein Binding. Meiji Seika Kaisha,
Ltd.
26) Assay Method Validation for ME2906 (HPLC) in Phase I Plasma. SRL
27) Assay Method Validation for ME2906 (HPLC) in Phase I Urine 2. SRL
28) Assay Method Validation for ME2906 (Total Chlorin) in Phase I Urine. SRL
29) Assay Method Validation for ME2906 (Total Chlorin) in Phase I Plasma. SRL
30) Pharmacokinetic Study of ME2906 [I] Establishment of Experimental System in
Rats. Daiichi Pure Chemicals Co., Ltd.
31) Pharmacokinetic Study of ME2906 [II] Absorption, Distribution and Excretion
in Rats. Daiichi Pure Chemicals Co., Ltd.
32) Plasma ME2906 Concentrations after ME2906 Administration in Mice, Rats and
Dogs. Meiji Seika Kaisha, Ltd.
33) Dose-Linearity of ME2906 in Mice and Rats. Meiji Seika Kaisha, Ltd.
34) A Preliminary Pharmacokinetic Study of ME2906 in Cynomolgus Monkeys. Shin
Nippon Biomedical Laboratories, Ltd.
35) Plasma and Tumor Concentrations of ME2906 in Tumor-bearing Mice under
Various Conditions. Daiichi Pure Chemicals Co., Ltd.
36) Concentration for Total Chlorin in Plasma of Animals after ME2906
Administration. Meiji Seika Kaisha, Ltd.
37) Pharmacokinetic Study of ME2906 [III] Distribution in Rats. Daiichi Pure
Chemicals Co., Ltd.
38) Pharmacokinetic Study of ME2906 [V] Placenta Transfer and Transfer into
Milk in Rats. Daiichi Pure Chemicals Co., Ltd.
39) Pharmacokinetic Study of ME2906 [IV] Distribution and Excretion in Rats.
Daiichi Pure Chemicals Co., Ltd.
40) Protein Binding Ratio of ME2906. Meiji Seika Kaisha, Ltd.
41) Tissue Distribution of 14C-ME2906 in Tumor-bearing Mice. Meiji Seika
Kaisha, Ltd. (Daiichi Pure Chemicals Co., Ltd.)
42) Plasma and Tissue Concentrations of ME2906 in Cynomolgus Monkeys. Shin
Nippon Biomedical Laboratories, Ltd.
43) Metabolites of ME2906 in Plasma and Urine in Rats. Meiji Seika Kaisha, Ltd.
44) Metabolites of ME2906 in Bile in Rats. Meiji Seika Kaisha, Ltd.
45) Pharmacokinetic Study of ME2906 [VI] In Vitro Metabolism of ME2906 Human
and Rat Hepatocytes (3). Daiichi Pure Chemicals Co., Ltd.
46) Pharmacokinetic Study of ME2906 [VI] In Vitro Metabolism of ME2906 Human
and Rat Hepatocytes (4). Daiichi Pure Chemicals Co., Ltd.
47) Single Intravenous Dose Toxicity Study of ME2906 in Male and Female Rats.
Meiji Seika Kaisha, Ltd.
48) Single Intravenous Dose Toxicity Study of ME2906 in Male and Female Dogs.
Meiji Seika Kaisha, Ltd.
49) 28-Day Repeated Intravenous Dose Toxicity Study of ME2906 in Male Rats
(Preliminary Study). Meiji Seika Kaisha, Ltd.
50) 28-Day Repeated Intravenous Dose Toxicity Study of ME2906 in Male and
Female Rats. Meiji Seika Kaisha, Ltd.
51) 28-Day Repeated Intravenous Dose Toxicity Study of ME2906 in Male Dogs.
Meiji Seika Kaisha, Ltd.
52) 28-Day Repeated Intravenous Dose Toxicity Study of ME2906 in Male Dogs with
a 28-Day Recovery Period. Meiji Seika Kaisha, Ltd.
53) 28-Day Repeated Intravenous Dose Toxicity Study of ME2906 in Female Dogs
with a 28-Day Recovery Period. Meiji Seika Kaisha, Ltd.
54) Chromosomal Aberration Study of ME2906 in Cultured Mammalian Cells.
Mitsubishi Chemical Safety Institute Ltd.
55) Micronucleus Study of ME2906 in Mice. Mitsubishi Chemical Safety Institute
Ltd:
56) Dominant Lethal Test of ME2906 with Mice. Meiji Seika Kaisha, Ltd.
57) Study of Rat Fertility and Early Embryonic Development to Implantation with
ME2906. New Drug Development Research Center, Inc.
58) Study for Effects of ME2906 on Embryo-Fetal Development in Rats
-Dose-Finding Study-. New Drug Development Research Center, Inc.
59) Study for Effects of ME2906 on Embryo-Fetal Development in Rats. New Drug
Development Research Center, Inc.
60) Study for Effects of ME2906 on Embryo-Fetal Development in Rabbits
-Dose-Finding Study-. New Drug Development Research Center, Inc.
61) Study for Effects of ME2906 on Embryo-Fetal Development in Rabbits. New
Drug Development Research Center, Inc.
62) Study for Effects of ME2906 on Pre- and Postnatal Development and Maternal
Functions in Rats -Dose-Finding Study-. New Drug Development Research
Center, Inc.
63) Study for Effects of ME2906 on Pre- and Postnatal Development and Maternal
Functions in Rats. New Drug Development Research Center, Inc.
64) Primary Skin Irritation Study of NPe6 in Rabbits. Meiji Seika Kaisha, Ltd.
65) Effects of ME2906 in Rabbit-Skin Irritation Study under the Sunlight. Meiji
Seika Kaisha, Ltd.
66) Antigenicity Study of ME2906 in Guinea Pigs. Meiji Seika Kaisha, Ltd.
67) Single Intravenous Dose Toxicity Study of Related Substances of ME2906 in
Male Mice. Meiji Seika Kaisha, Ltd.
68) Skin Photosensitivity Study of ME2906 in Rats. JBC, Inc.
69) Pharmacokinetics of ME2906 in Phase I Clinical Study in Japan. Meiji Seika
Kaisha, Ltd.
70) Urinary Excretion of ME2906 in Phase II Clinical Study in Japan. Meiji
Seika Kaisha, Ltd.
71) (Clinical Study Report) Phase I Clinical Trial of PDT Using ME2906 and
Diode Laser in the Treatment of Superficial Malignant Tumors.
72) (Clinical Study Report) Phase II Clinical Trial of PDT Using ME2906 and
Diode Laser in the Treatment of Early Stage Lung Cancers.
73) Investigation on Description of ME2906 Drug Substance. Meiji Seika Kaisha,
Ltd.
74) Study on the Solubilities of ME2906 Drug Substance in Various Solvents.
Meiji Seika Kaisha, Ltd.
75) Investigation on Hygroscopicity of ME2906 Drug Substance. Meiji Seika
Kaisha, Ltd.
76) Investigation on Melting Point and Thermal Analysis of ME2906 Drug
Substance. Meiji Seika Kaisha, Ltd.
77) Investigation on pH of ME2906 Drug Substance. Meiji Seika Kaisha, Ltd.
78) Investigation on Dissociation Constant of ME2906 Drug Substance. Meiji
Seika Kaisha, Ltd.
79) Investigation on Partition Coefficient of ME2906 Drug Substance. Meiji
Seika Kaisha, Ltd.
80) Study on Stability of Aqueous Solution of ME2906 Drug Substance. Meiji
Seika Kaisha, Ltd.
81) Investigation on Rationale for Setting Laser Irradiation Wavelength to
ME2906 Drug Substance. Meiji Seika Kaisha, Ltd.
82) Study on Detection of Singlet Oxygen Produced by Laser Irradiation to
ME2906. Meiji Seika Kaisha, Ltd. (Toray Research Center)
83) Study on the Elementary Analysis of ME2906 Drug Substance. Meiji Seika
Kaisha, Ltd. (Sumika Chemical Analysis Service, TORAY Research Center)
84) Study on Structure Determination of ME2906. Meiji Seika Kaisha, Ltd.
85) Investigation on UV/Visible Absorption Spectra of ME2906 Drug Substance.
Meiji Seika Kaisha, Ltd.
86) Investigation on Infrared Absorption Spectra of ME2906 Drug Substance.
Meiji Seika Kaisha, Ltd.
87) Details of the Correction of the Structure of ME2906. Meiji Seika Kaisha,
Ltd.
88) Investigation on Isomers of ME2906 Drug Substance. Meiji Seika Kaisha, Ltd.
89) Investigation on Optical Rotation of ME2906 Drug Substance. Meiji Seika
Kaisha, Ltd.
90) Isolation and Identification of Chlorin e4. Meiji Seika Kaisha, Ltd.
91) Study on By-product I of ME2906 (Aspartic Acid Dimer Substance). Meiji
Seika Kaisha, Ltd.
92) Study on By-product II of ME2906 (23-Asp Substance). Meiji Seika Kaisha,
Ltd.
93) Study on By-product of ME2906 (32-Asp Substance). Meiji Seika Kaisha, Ltd.
94) Study on New By-product N of ME2906. Meiji Seika Kaisha, Ltd.
95) Study on New By-product V of ME2906. Meiji Seika Kaisha, Ltd.
96) Study on Related Substances (Ring Cleavage Product). Meiji Seika Kaisha,
Ltd.
97) Isolation and Structure Determination of a By-product of ME2906 (unk-2).
Meiji Seika Kaisha, Ltd.
98) Revision of the Structures of By-products and Degradation Products of
ME2906. Meiji Seika Kaisha, Ltd.
99) The Investigation on Quantitative Method of ME2906 Drug Substance. Meiji
Seika Kaisha, Ltd.
100) Study of Degradation Product of ME2906 Drug Substance. Meiji Seika Kaisha,
Ltd. 101)Isolation and Identification of Thermal Degradation Product I
ME2906 (Water Adduct). Meiji Seika Kaisha, Ltd.
102) Isolation and Identification of Thermal Degradation Product II ME2906
(Decarboxylated Substance). Meiji Seika Kaisha, Ltd.
103) Isolation and Identification of New Thermal Degradation Products ME2906
(Thermal Degradation Product III, IV). Meiji Seika Kaisha, Ltd.
104) Specifications and Test Procedures for Taporfin Sodium Reference Standard.
Meiji Seika Kaisha, Ltd.
105) Validation of Analytical Procedures on Heavy Metals and Arsenic Test for
Taporfin Sodium Drug Substance. Toray Research Center
106) Validation of Analytical Procedures for Taporfin Sodium Related Substances.
Meiji Seika Kaisha, Ltd.
107) Validation of Analytical Procedures on Residual Solvents for Taporfin
Sodium Drug Substance. Toray Research Center
108) Validation of Analytical Procedures on Bacterial Endotoxins Test for
Taporfin Sodium Drug Substance. Meiji Seika Kaisha, Ltd.
109) Validation of Analytical Procedures on Assay for Taporfm Sodium Drug
Substance. Meiji Seika Kaisha, Ltd.
110) Specifications and Test Procedures for Taporfin Sodium Drug Substance.
Meiji Seika Kaisha, Ltd.
111) Validation of Analytical Procedures on Sodium Contents for Taporfin Sodium
Reference Standard. Toray Research Center
112) Stress Testing for Taporfin Sodium Drug Substance. Meiji Seika Kaisha, Ltd.
113) Photostability Testing for Taporfin Sodium Drug Substance. Meiji Seika
Kaisha, Ltd.
114) Accelerated Testing for Taporfin Sodium Drug Substance. Meiji Seika Kaisha,
Ltd.
115) Long-term Testing of Taporfin Sodium Drug Substance at Cold Place. Meiji
Seika Kaisha, Ltd.
116) Study on Impurities in ME2906 Drug Product. Meiji Seika Kaisha, Ltd.
117) Study on Forced Degradation Products of ME2906. Meiji Seika Kaisha, Ltd.
118) Establishment of Specifications and Test Procedures for Taporfin Sodium
Drug Product. Meiji Seika Kaisha, Ltd.
119) Validation of Analytical Method for Taporfin Sodium Drug Product. Meiji
Seika Kaisha, Ltd.
120) Stress Testing for Taporfin Sodium Drug Product. Meiji Seika Kaisha, Ltd.
121) Photostability Testing for Taporfin Sodium Drug Product. Meiji Seika
Kaisha, Ltd.
122) Accelerated Testing for Taporfin Sodium Drug Product. Meiji Seika Kaisha,
Ltd.
123) Long-term Testing of Taporfin Sodium Drug Product at Cold Place. Meiji
Seika Kaisha, Ltd.
