CONFIDENTIAL TREATMENT REQUESTED EXHIBIT 10.80
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24(b)(2) OF THE SECURITIES AND
EXCHANGE ACT OF 1934. CONFIDENTIAL TREATMENT REQUESTED IS REQUESTED AND IS NOTED
WITH "[CONFIDENTIAL TREATMENT REQUESTED]." AN UNREDACTED VERSION OF THIS
DOCUMENT HAS BEEN PREVIOUSLY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
DEVELOPMENT, LICENSE
AND
SUPPLY AGREEMENT
BETWEEN
PFC THERAPEUTICS, LLC
AND
BEIJING DOUBLE-CRANE PHARMACEUTICAL CO., LTD.
CONFIDENTIAL TREATMENT REQUESTED
1. DEFINITIONS...........................................................3
2. GRANT OF RIGHTS.......................................................8
3. LICENSEE'S MAIN OBLIGATIONS..........................................10
4. LICENSOR'S MAIN OBLIGATIONS..........................................10
5. DEVELOPMENT..........................................................11
6. MARKETING AUTHORIZATIONS.............................................15
7. LICENSE FEE AND ROYALTY..............................................16
8. PRODUCT PRICE; PAYMENT; AUDIT REPORT.................................17
9. TECHNOLOGY, MANUFACTURE AND SUPPLY OF PRODUCT FOR CLINICAL TRIALS....18
10. INTELLECTUAL PROPERTY................................................20
11. REPRESENTATIONS AND WARRANTIES.......................................23
12. INDEMNIFICATION......................................................25
13. TERM AND TERMINATION.................................................26
14. CONSEQUENCES OF TERMINATION..........................................27
15. CONFIDENTIALITY, PUBLICATIONS, PUBLICITY.............................29
16. PERFORMANCE BY AFFILIATES............................................31
17. DISPUTE RESOLUTION...................................................31
18. MISCELLANEOUS........................................................32
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CONFIDENTIAL TREATMENT REQUESTED
This Development, License and Supply Agreement (the "Agreement") is
made and entered into as of May___, 2005 (the "Effective Date"), , by and
between PFC Therapeutics, LLC, a Delaware limited liability company
("Licensor"), with a business address of 0000 Xx Xxxxx Xxxxxxx, Xxxxx, Xxxxx
000, Xxx Xxxxx, Xxxxxxxxxx 00000 and Beijing Double-Crane Pharmaceutical Co.,
Ltd., ("Licensee") a corporation organized under the laws of the People's
Republic of China with a business address of Xx. 0, Xxxx xxxxxx Xxxx, Xxxxxxxx,
Xxxxxxxx Xxxxxxxx, Xxxxxxx, 000000, Xxxxx. Licensor and Licensee will be
referred to throughout the Agreement as "Parties" collectively and "Party"
singularly.
RECITALS
A. Whereas Licensor is a pharmaceutical company currently
specializing in the development of blood substitute products and exclusively
owns complete Know-How (as defined in this Agreement) and Intellectual Property
(as defined in this Agreement) for development and manufacturing of the Product
(as defined below);
B. Whereas Licensee is a pharmaceutical company possessing
expertise and qualification in the research, development and commercialization
of pharmaceutical products as well as marketing pharmaceutical products of other
countries as the sales agents in the Territory;
C. Whereas both Licensor and Licensee desire to cooperate
within the scope of this Agreement to complete the Clinical Trials of the
Product in China with the purpose of achieving Marketing Authorization within
the Territory (as defined below). Therefore, the Licensor wishes to transfer,
and the Licensee wishes to accept the transfer of all "Licensed Know How"
according to the terms and conditions of this Agreement for the Clinical Trials,
and further development, manufacturing and marketing of the Product within the
Territory;
In consideration of the mutual covenants contained in this Agreement
and other good and valuable consideration, the receipt and sufficiency of which
is hereby acknowledged, the Parties agree as follows:
1. DEFINITIONS
The capitalized terms used in this Agreement will have the meanings
given to them in this Section 1 and throughout this Agreement.
1.1. "AFFILIATE" means a corporation or other business entity
which, directly or indirectly, through one or more intermediaries, controls, is
controlled by or is under common control with a Party. For purposes of this
definition only, "control" and, with corresponding meanings, the terms
"controlled by" and "under common control with" means (a) the possession,
directly or indirectly, of the power to direct the management or policies of a
legal entity, whether through the ownership of voting securities or by contract
relating to voting rights or corporate governance, or (b) the ownership,
directly or indirectly, of more than 50% of the voting securities or other
ownership interest of a legal entity; provided, however, that if local law
restricts foreign ownership, control will be established by direct or indirect
ownership of the maximum ownership percentage that may, under such local law, be
owned by foreign interests.
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CONFIDENTIAL TREATMENT REQUESTED
1.2. "BUSINESS DAY" means a day other than a Saturday, Sunday,
Bank Holiday or other public holiday in the People's Republic of China or the
State of New York.
1.3. "CLINICAL TRIALS" means planned experiments which involve
subjects or patients and are designed to elucidate the most appropriate
treatment of future patients with a given medical condition. A Clinical Trial
uses results based on a limited sample of patients to make inferences about how
treatment should be conducted in the general population of patients who require
treatment in the future.
1.4. "CMC DATA" means the qualitative and quantitative
particulars of the constituents, the description of the manufacturing method and
the controls and tests carried out at all relevant stages of the manufacturing
process.
1.5. "COMPETING PRODUCT" means any fluorochemical emulsion or
other oxygen carrying blood substitute with approved indications comparable to
the Product.
1.6. "CONFIDENTIAL INFORMATION" means and includes all
Know-How, patent applications, formulas, designs, drawings, specifications,
catalogs, data sheets, sales and technical bulletins, service manuals,
mechanical diagrams, and all other information, whether or not reduced to
writing, relating to the formula, design, manufacture, use, and service of the
Product, as well as to any other information relating to the Licensor's business
or the Licensee's Business, as the case may be, that may be divulged to the
Licensor or the Licensee, in written or non-written forms, as the case may be,
in the course of its performance of this Agreement.
1.7. "DEVELOPMENT PLAN" means a plan or plans prepared by
Licensee describing all activities in the development program for Product,
including the information necessary for application and obtaining approval of
the Clinical Trials, to conduct Clinical Trials and application for and
obtaining application permit.
1.8. "DMF" means a drug master file to be maintained with the
applicable regulatory authorities in each country of the Territory.
1.9. "DOSSIER" means the master regulatory dossier relating to
the Product for obtaining Marketing Authorization for such Product in the
Territory with the relevant authorities, including relevant Product and
Scientific Data, pre-clinical data, CMC Data.
1.10. "FIRST COMMERCIAL SALE" means, the first sale to a Third
Party of a Product in the Territory after all necessary regulatory approval and
Marketing Authorization has been achieved for distribution and sale of Product.
1.11. "IMPROVEMENT" means any invention, discovery or
Know-How, whether or not patentable, relating to Product that is developed
solely or jointly by Licensor, Licensee, their Affiliates or their Third Party
contractors after the Effective Date in the course of performing the Development
Plan or commercializing a Product in the Territory or through independent
development activities by Licensor.
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CONFIDENTIAL TREATMENT REQUESTED
1.12. "INSPECTION ON RECEIPT" means the procedures relating to
the inspection of Product on receipt to ensure compliance with Specifications to
be carried out by or on behalf of Licensee upon delivery, in accordance with the
Quality Agreement.
1.13. "INTELLECTUAL PROPERTY" means all Patents, trademarks
and trade names, service marks, registered designs, applications for any of the
foregoing and the right to apply for any of the foregoing in any part of the
world, copyright, design right, data rights, inventions, confidential
information (including Know-How) and any other similar right situated in any
country in the world.
1.14. "JOINT INVENTIONS" means any invention or discovery in
connection with the Product made or conceived jointly by an employee(s),
consultant(s) or agent(s) of Licensor or its Affiliates and employee(s),
consultant(s) or agent(s) of Licensee or its Affiliates, as determined in
accordance with applicable patent laws. Joint Inventions expressly exclude
jointly invented Improvements.
1.15. "KNOW-HOW" means information, results and data of any
type whatsoever, in any tangible or intangible form whatsoever, including
databases, practices, methods, techniques, specifications, formulations,
formulae, knowledge, know-how, skill, experience, test data including
pharmacological, medicinal chemistry, biological, chemical, biochemical,
toxicological and clinical test data, analytical and quality control data,
stability data, studies and procedures, and manufacturing process and
development information, results and data.
1.16. "LICENSED KNOW-HOW" means (a) any non-public or
confidential sections of the Licensor's NDA, and (b) all right, title and
interest in the Territory to any other non-public or confidential Know-How owned
or under the control of Licensor during the Term that is useful or necessary for
the performance of pre-clinical or clinical development of the Product in the
Territory, for the filing and maintenance of Marketing Authorizations in the
Territory, or the commercialization, marketing or manufacture of the Product in
the Territory.
1.17. "LICENSED PATENTS" means the patents or patent
applications listed in Exhibit 1, any other Patents owned or under the control
of Licensor during the Term that would be infringed, in the absence of an
assignment, by the manufacture, use, sale, offer for sale or importation of a
Product and Patents on Improvements, in the Territory.
1.18. "LICENSED TECHNOLOGY" means the Licensed Patents,
Licensed Know-How and any Improvements (exclusive of Licensee's part of any
Joint Inventions in any such Improvements).
1.19. "LICENSEE TRADEMARKS" means any trademarks or trade
names used or registered by Licensee as of the Effective Date or during the
Term.
1.20. "LICENSOR TRADEMARKS" means any trademarks or trade
names used or registered by Licensor as of the Effective Date or during the
Term.
1.21. "MARKETING AUTHORIZATION(S)" means any approvals
(including Price & Reimbursement Approvals) and any master files, DMFs,
establishment licenses, registrations or authorizations of any national,
supranational or local regulatory agency, department, bureau or other
governmental entity, necessary for the manufacture, use, storage, importation,
export, transport, distribution or sale of a Product (including the approval of
an NDA) in or outside the Territory.
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CONFIDENTIAL TREATMENT REQUESTED
1.22. "NDA" means a New Drug Application submitted by Licensee
to the appropriate regulatory body in the Territory for the purposes of
obtaining approval for the marketing of a Product in such country.
1.23. "NET SALES" Net Sales means the total amount actually
received by Licensee or its Affiliate in connection with sales of Product to any
person or entity that is not an Affiliate of Licensee, after deduction of all
the following to the extent applicable to such sales:
1.23.1 all trade credits, discounts, refunds or rebates,
including without limitation rebates accrued, incurred or paid to assistance
program and any other price reductions required by a governmental agency;
1.23.2 allowances or credits for returns, including without
limitation amounts received for sales which become the subject of a subsequent
temporary or partial recall by a regulatory agency for safety or efficacy
reasons outside the control of Licensee, and retroactive price reductions
(including managed care and similar types of rebates);
1.23.3 cost of freight, postage, and freight insurance;
1.23.4 sales taxes, value added taxes, excise taxes, and
customs duties; and
1.23.5 cost of export licenses (if applicable) and any taxes
(excluding income taxes or similar taxes), fees or other charges associated with
the exportation or importation of Product.
1.23.6 A sale or transfer by Licensee to an Affiliate of
Licensee for resale by such Affiliate shall not be considered a sale for the
purpose of this provision but the resale by such Affiliate shall be a sale for
such purposes. Transfers for pre-Clinical Trials and Clinical Trials, testing or
market research or promotional purposes shall not be a sale of Product for the
purpose of calculating Net Sales.
1.23.7 If a Product is sold in conjunction with a product or
service (e.g. as a bundled or combination therapy) that is not a Product, the
Net Sales of such combination product for purposes of determining royalties
payable on sales thereof shall be calculated by first determining the Net Sales
of such combination product as above, and then multiplying such number by the
applicable fraction from the following three options:
1.23.8 If the Product(s) and other component(s) in such
combination product all are sold separately, then such fraction shall be
A/(A+B),
i) where, for the combination product:
ii) "A" is the listed sale price(s) of the Product(s)
in such combination product when sold separately; and
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CONFIDENTIAL TREATMENT REQUESTED
iii) "B" is the listed sale price(s) of the product
component(s) in such combination product when sold separately.
1.23.9 If the product component(s) in the combination product
is not sold separately, then such fraction shall be A/C, where "A" is as above,
and C is the average listed sale price of the combination product.
1.23.10 If neither the Product(s) nor the product component(s)
in the combination product are sold separately, then such fraction shall be a
fraction reasonably reflecting the relative value contributed by the Product(s)
to the total value of the combination product, with such fraction to be
established by mutual agreement of the Parties based on good faith and
reasonable negotiation. If the Parties cannot reach such agreement within sixty
(60) days of Licensee or Licensor submitting the matter for agreement, the
Parties shall resolve such issue by having the fraction determined by binding
arbitration under Section 17.
1.24. "PATENTS" means patents, letters patent, applications
(provisional and non-provisional) for patents, and any patents issuing therefrom
and from any patent application claiming, or entitled to claim; priority from
any such application for patent; any divisions, continuations, continued
prosecution applications, continuations-in-part, utility models and any
equivalents, substitutions, confirmations, registrations, revalidations,
additions, reexamination certificates of any of the foregoing and any patents
issuing on any of the foregoing; and any reissue patents, patent extensions and
patent term restorations of any of the foregoing.
1.25. "PRICE & REIMBURSEMENT APPROVALS" means approval or
listing on official price lists, reimbursement schedules or hospital
recommendation lists as appropriate for the individual markets in the Territory.
1.26. "PRODUCT" means the injectable fluorochemical emulsion
known as OXYGENT or [CONFIDENTIAL TREATMENT REQUESTED], capable of transporting
oxygen in therapeutic effective amounts in the bloodstream for all medical uses,
including without limitation, the Product existing and produced in batch as of
the Effective Date having a composition agreed upon by the Parties and set out
in the Specifications.
1.27. "PRODUCT PRICE" means the price payable from Licensee to
Licensor for Product used for Clinical Trials upon delivery and shall include
the entire cost to Licensor of the manufacturing of the Product by a third party
contract manufacturer and any costs to Licensor of shipping the Product
including freight, customs, taxes and any other associated costs. Licensee shall
pay Licensor the actual cost as documented which shall not exceed [CONFIDENTIAL
TREATMENT REQUESTED] per unit.
1.28. "PRODUCT AND SCIENTIFIC DATA" means data related to the
Product and all other documentation or correspondence obtained in the use of or
in connection with the Product in development of the Product in the Territory,
in pre-Clinical Trials or in Clinical Trials, (such as pharmacokinetics,
metabolism, pharma-codynamics, dose response, safety, efficacy and other
pharmacological data).
1.29. "PRODUCT TRADEMARKS" means any trademarks, trade dress,
logos, slogans, and designs, whether or not registered by Licensee in the
Territory, used to identify or promote a Product in the Territory, but excluding
any Licensee Trademarks or Licensor Trademarks.
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CONFIDENTIAL TREATMENT REQUESTED
1.30. "QUALITY AGREEMENT" means a technical manufacturing
agreement in connection with raw materials, suppliers, production,
manufacturing, storage, shipment and final testing of the product for Clinical
Trials. .
1.31. "SPECIFICATIONS" means the specification for Product as
specified from time to time in the Licensee Marketing Authorization(s), and may
be attached as a schedule to the Quality Agreement.
1.32. "TERM" has the meaning set forth in Section 13.1 of this
Agreement.
1.33. "TERRITORY" means the People's Republic of China
("China") including Taiwan, Hong Kong and Macao and other countries to which the
Parties may agree upon in the future.
1.34. "THIRD PARTY" means any individual or entity other than
Licensor, Licensee and their respective Affiliates.
1.35 "TRIGGERING PATIENT(S)" means a patient in Clinical
Trials in either the treatment group or in the control group who has met the
protocol specified conditions for transfusion of red blood cells and has been
treated with the Product or allogeneic blood (or other control substance),
respectively.
1.36 "UNIT" means, with respect to each Product, of 110 ml,
with composition of [CONFIDENTIAL TREATMENT REQUESTED]
2. GRANT OF RIGHTS
2.1. GRANTS TO LICENSEE.
2.1.1 LICENSE TO LICENSEE. Subject to the terms and conditions
of this Agreement, Licensor hereby grants to Licensee an exclusive license to
the Licensed Technology in the Territory. As of the Effective Date, Licensor and
Licensee will have signed and executed a license agreement exclusively licensing
all rights to the Intellectual Property in the Territory to Licensee (Exhibit
2).
2.1.2 OPTION. Licensee shall have the right of first refusal,
to add the following countries: CIS countries (Armenia, Azerbaijan, Belarus,
Georgia, Kazakhstan, Kyrgyz Republic, Moldovia, Russia, Tajikstan, Turkmenistan,
Ukraine, Uzbekistan), South Africa and certain Asian countries (Afghanistan,
Bangladesh, Bhutan, Brunei, Burma [Myanmar Republic], Cambodia, India,
Indonesia, Laos, Malaysia, Mongolia, Nepal, Pakistan, Philippines, Singapore,
Sri Lanka, Thailand, Timor-Leste and Viet Nam). The Licensor will make a
proposal of terms for each of the countries listed above on a country-by-country
basis and Licensee will have thirty (30) days to either reject, accept or make a
counterproposal of such proposal of terms on a country-by-country basis. The
Licensor and Licensee may extend the time period for negotiation upon mutual
agreement.
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CONFIDENTIAL TREATMENT REQUESTED
2.1.3 RIGHTS OF LICENSEE. Subject to the terms and conditions
of the Agreement, Licensor acknowledges that during the Term, Licensee shall
have the exclusive rights under the Licensed Technology to manufacture, market,
sell, offer to sell, use, import and export, distribute and sub-license Product
in the Territory, and submit on Licensee's behalf for approval legally required
for Marketing Authorization for the Product in the Territory.
2.1.4 LICENSEE'S MANUFACTURING RIGHT. Following the State Food
and Drug Administration's ("SFDA") approval and registration of the Product in
the Territory, Licensee will have the exclusive right to manufacture and market
the Product for use in the Territory. Upon initiation of enrollment of patients
in Phase III Clinical Trials, Licensor agrees to transfer all the Know-How
information that Licensor owns related to all existing manufacturing technology
of Product, the complete technical documents as well as the necessary training
and training materials at written request of Licensee and upon agreement with
request to the time schedule, contents, standards and compensation of the
training. Licensee will pay for the translation of all necessary information
from English to Mandarin and will supply translators, with an appropriate
technical background, during any visit to facilitate the transfer of information
from Licensor's engineers to Licensee. Licensor shall pay the expenses to
include salary, airfare and local expenses, excluding local transportation for a
total of 2 employees, engineers and/or consultants for two 1-week trips to come
to China to assist Licensee in manufacturing the Product. If Licensee requests
additional support from Licensor's employees, engineers and/or consultants, all
costs associated with this support including, salary of $500 per day per person,
airfare and all local expenses will be paid by the Licensee.
2.1.5 REFERENCE TO LICENSOR MARKETING AUTHORIZATIONS. Subject
to the terms and conditions set forth in this Agreement, Licensor hereby grants
to Licensee a fully paid, non-exclusive right and license to reference any
Marketing Authorizations under the control of Licensor for Product outside the
Territory for the purpose of obtaining Marketing Authorization of Product in one
or more countries in the Territory.
2.1.6 OWNERSHIP. Subject to the rights of reference and use
granted to Licensor in Section 2.2 below, Licensee shall own all rights in
Dossiers, Marketing Authorizations in the Territory, Product and Scientific
Data, and the information and data contained therein.
2.2. GRANTS TO LICENSOR.
2.2.1 Except as to Licensee as set out in subsection 2.3,
Licensee hereby grants to Licensor the exclusive right (a) to use, outside the
Territory, any clinical and non-clinical data generated by or on behalf of
Licensee in the course of developing Product, and (b) to reference any Marketing
Authorizations or Product and Scientific Data obtained for Product in the
Territory, for the purpose of developing and pursuing Marketing Authorizations
for Product outside the Territory.
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CONFIDENTIAL TREATMENT REQUESTED
2.2.2 All Product and Scientific Data shall belong to Licensee
and except as to Licensee, as set out in subsection 2.3, Licensee hereby grants
an exclusive, irrevocable, free license to Licensor to use the Product and
Scientific Data outside the Territory. Licensee shall throughout the Term
provide copies of all Product and Scientific Data to Licensor, or as it may
direct, as soon as practicable after such Product and Scientific Data is
generated or comes into the possession and control of Licensee.
2.3. JOINT INVENTIONS.
2.3.1 In relation to use of Joint Inventions with other
products, the Parties shall negotiate in good faith the scope of each other's
uses of any such Joint Inventions, and the distribution of proceeds from sales,
licensing, assignment or other transfer of rights under Joint Inventions to each
other and/or Third Parties. Neither of the Parties shall grant any rights under
Joint Inventions to Third Parties explicitly or implicitly before agreement
concerning distribution of proceeds has been reached.
3. LICENSEE'S MAIN OBLIGATIONS
3.1. Under the terms of this Agreement, Licensee shall:
3.1.1 Under the direction of the Development Committee, be
responsible for the development of the Product in the Territory, including the
preparation and execution of a Development Plan, conduct Clinical Trials in the
Territory pursuant to the Development Plan, and communication with the
authorities and investigators in the Territory as set out in Section 5;
3.1.2 prepare and submit the Dossier with the relevant
regulatory authorities for obtaining a Marketing Authorization for the Territory
as set out in Section 6;
3.1.3 at its option, pursuant to subsection 10.2, register,
maintain, defend and enforce the Licensed Technology in the Territory as set out
in Section 10;
3.1.4 launch and commercialize the Product throughout the
Territory;
3.1.5 obtain any and all import licenses and governmental
approvals that may be necessary in the Territory necessary for the Clinical
Trials of the Product; and,
3.1.6 comply with any and all governmental laws, regulations,
and orders that may be applicable to Licensee by reason of its execution of this
Agreement.
3.2. Except as otherwise indicated herein, Licensee shall bear
all costs and expenses related to the activities listed in subsection 3.1.
4. LICENSOR'S MAIN OBLIGATIONS
4.1. Under the terms of this Agreement, Licensor shall:
4.1.1 simultaneously with the execution of this Agreement,
license the Intellectual Property in the Territory to Licensee as set out in the
license agreement.
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CONFIDENTIAL TREATMENT REQUESTED
4.1.2 deliver all information related to the Product and the
development hereof available to Licensor as set out in Sections 2, 5, 6 and 10
to the Licensee including but not limited to all existing information necessary
for SFDA's approval of Clinical Trials and marketing authorization;
4.1.3 transfer the Licensed Technology and transfer Licensed
Know-How as set out in Sections 2, 5, 6 and 10 and provide necessary training,
subject to Section 2.1.4, enabling the Licensee to manufacture the Product that
can meet the criteria;
4.1.4 provide adequate documents to Licensee proving its
exclusive and transferable ownership of Know-How;
4.1.5 manufacture and supply or have manufactured and supplied
Product to Licensee for clinical development;
4.1.6 participate in the preparation of protocols for Clinical
Trials; and,
4.2. Except as otherwise indicated herein, Licensor shall bear
all costs related to the activities listed in subsection 4.1.
5. DEVELOPMENT
5.1. JOINT DEVELOPMENT COMMITTEE.
5.1.1 The Parties shall establish a joint development
committee ("Development Committee") consisting of at least two (2)
representatives of each of the Parties. The initial members of the Development
Committee shall be the persons listed under "Development Committee Members" in
Exhibit 3.
5.1.2 The Development Committee will perform the following
functions (a) monitor the progress of, and provide input to, Licensee's efforts
in seeking approval of the Product in the Territory as stated in Sections 5.3.2
and 5.3.5, and any further development of the Product, and Licensor's
corresponding efforts outside the Territory; (b) oversee and monitor the
development and scale-up of the manufacturing process for Product pursuant to
any Development Program; (c) confirm agreed upon specifications for the Product,
(d) notify the Parties of Improvements, and (e) address and attempt to resolve
conflicts or disputes between the Parties that may arise during the course of
performing this Agreement.
5.1.3 The respective Development Committee members of each of
the Parties shall appoint the persons ("appointed persons") necessary for the
performance of the activities listed in this Section 5. The appointed persons
shall be made available to the extent reasonably necessary for the performance
of the tasks to which they are appointed.
5.1.4 Licensor shall, if reasonably necessary, allow Licensee
to contract, if required, with any appointed persons on a consultancy basis.
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5.1.5 Each Party will select one of the representatives to the
Development Committee as such Party's primary contact person for communication
between the Parties relating to any development, technical and patent aspects of
this Agreement. An alternate member designated by a Party may serve on the
Development Committee temporarily in the absence of a permanent member, and may
replace such permanent member on a permanent basis, if necessary. Each Party
will bear its own costs of participation in the Development Committee.
5.1.6 The Development Committee will have only such authority
as are specifically stipulated in this Agreement, and will have no power to
amend this Agreement or waive a Party's rights or obligations under this
Agreement. Delegation of powers to the Development Committee will not relieve
either Party from its obligations under this Agreement.
5.1.7 The Development Committee will hold meetings (in person,
by telephone or videoconference) at such times and places as will be determined
by the members of the Development Committee of both Parties. The first meeting
of the Development Committee will take place within sixty (60) days after the
Effective Date. The contact persons will establish an agenda for each such
meeting and will designate representatives of the Parties who will have
management responsibility for the issues on the agenda for such meeting.
Documents made by the committee may be executed through signing on electronic
version, and any decision by the Development Committee shall be made
unanimously.
5.1.8 Licensee shall have the ultimate authority in relation
to activities in the Development Plan performed on behalf of Licensee. Licensor
shall have the ultimate authority in relation to activities in the Development
Plan performed on behalf of Licensor.
5.2. DELIVERY OF KNOW-HOW DOCUMENTS.
5.2.1 The Licensor will deliver to Licensee within one month
of the Effective Date, all documents (in electronic form) necessary for SFDA
submission for Clinical Trial initiation by Licensee. If additional information
is required by SFDA, Licensor shall make reasonable efforts to provide Licensee
with requested information. At the commencement of Phase II Clinical Trials and
at Licensee's request, Licensor shall start to prepare the transfer of
information that Licensor owns relating to existing manufacturing technology of
Product and delivery shall be made upon initiation of enrollment of patients in
Phase III Clinical Trials.
5.2.2 All Know-How documents shall be copies of existing
documents in existing form and the copies will be made and delivered to the
Licensee to the address designated by the Licensee;
5.2.3 Upon request of the Licensee, the Licensor shall provide
correction or replacement of any missing or damaged documents promptly without
charge.
5.3. CLINICAL TRIALS.
5.3.1 Licensee shall as soon as reasonably practicable
following the Effective Date, but in any event no later than forty five (45)
days from the Effective Date, present to the Development Committee a draft
Development Plan containing a plan for Clinical Trials. A Development Plan shall
include a time schedule for interaction with the relevant authorities, a
Clinical Trial program together with a timetable for all required actions for
the completion of the Dossier in respect of the initial indication of Product.
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CONFIDENTIAL TREATMENT REQUESTED
It is currently contemplated by the Parties that the Phase III Clinical Trials
will have no fewer than [CONFIDENTIAL TREATMENT REQUESTED] patients. The
Development Plan shall be amended taking into consideration the advice taken
from such authorities. The Development Committee shall discuss and amend the
Development Plan within fifteen (15) days of its submission.
5.3.2 Licensee shall conduct and pay for all costs and
expenses associated with all Clinical Trials (including Xxxxx 0, Xxxxx XX xxx
Xxxxx XXX) needed to obtain Product approval from the SFDA for registration and
marketing. Licensee agrees to conduct all Clinical Trials in accordance with ICH
guidelines and current Good Clinical Practice ("cGCP") guidelines per the
current version of the Guideline for Good Clinical Practice, ICH Harmonized
Tripartite Guideline (this is very important and is per the Memorandum of
Understanding and discussions). Phase III Clinical Trials will have no fewer
than [CONFIDENTIAL TREATMENT REQUESTED] Triggering Patients and shall not exceed
[CONFIDENTIAL TREATMENT REQUESTED] patients unless required by the SFDA. If the
SFDA requires more than [CONFIDENTIAL TREATMENT REQUESTED] patients, Licensee
shall pay any additional costs. If Licensor requires that a Phase III Clinical
Trial have more than [CONFIDENTIAL TREATMENT REQUESTED] patients, Licensor shall
pay for any additional cost.
5.3.3 Licensor shall notify the Development Committee of
development activities outside the Territory.
5.3.4 Licensee shall have the ultimate authority in relation
to activities related to the Clinical Trials performed on behalf of Licensee.
Licensor shall have the ultimate authority in relation to activities related to
Clinical Trials performed on behalf of Licensor.
5.3.5 Licensor shall notify Licensee from time to time of all
requirements applicable outside the Territory in connection with the conduct of
Clinical Trials outside the Territory, and Licensee will comply with such
requirements in the conduct of the Clinical Trials inside the Territory in
compliance with ICH guidelines and current Good Clinical Practice ("cGCP")
guidelines per the current version of the Guideline for Good Clinical Practice,
ICH Harmonized Tripartite Guideline (this is very important and is per the
Memorandum of Understanding and discussions) and legal rules in the Territory to
enable Licensor to use any data derived from such Clinical Trials in the
Territory to support or undertake Clinical Trials outside the Territory or for
any other purpose in connection with the development and/or commercialization of
Product outside the Territory. Licensee acknowledges and agrees that Licensor
will use the data obtained by Licensee outside the Territory.
5.4. DRUG ADVERSE EVENTS REPORTING.
5.4.1 The Parties shall establish and maintain a system for
exchanging safety information on the preparations of the Product. This system
shall enable both parties to meet the safety regulatory requirements imposed by
authorities both locally and internationally and to follow current international
guidelines and standards in pharmacovigilance.
5.4.2 With Licensee being the holder of the Marketing
Authorization in the Territory, Licensee will provide a full system for
pharmacovigilance fulfilling all legal requirements in the Territory. Licensee
will also prepare Periodic Safety Updates (ICH format) and maintain a Company
Core Safety Information Sheet ("CCSI").
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CONFIDENTIAL TREATMENT REQUESTED
5.4.3 During the Development Plan, Licensee will hold the
database for reporting of Suspected Serious Unexpected Adverse Reactions and
prepare Annual Safety Reports for submission to regulatory authorities.
5.4.4 Any clinical and pre-clinical safety data (Investigator
Brochures, clinical protocols and clinical and pre-clinical reports on the
preparations of Product) held by Licensor should be provided to Licensee as
reference documents to evaluate the safety data to be collected in the
pre-marketing development program. Once in Licensee's possession, the
Investigator Brochures and clinical protocols and any similar documents may only
be updated after consultation with the Licensor.
5.4.5 A copy of all expedited Individual Case Safety Reports
("ICSRs"), annual safety reports, Serious Adverse Event Reports, Periodic Safety
Update Reports, Regulatory Agency Safety Reports and any communications or
reports of communications with the SFDA, or other regulatory agencies will be
translated into English and forwarded together with the copies in Chinese to the
Licensor. Licensee will immediately translate into English and forward to the
Licensor any Serious Adverse Event Reports within five (5) business days of
their receipt from the clinical investigator so that Licensor can report such
events to any relevant clinical authority outside of the Territory. A detailed
pharmacovigilance agreement between Licensee and Licensor shall be established
at least three (3) months prior to Licensor or any Partner of Licensor requiring
information on pre- or post marketing safety data for regulatory reasons.
5.5. SUPPLY OF CLINICAL TRIAL PRODUCT AND PREPARATION OF
COMMERCIAL SUPPLY.
5.5.1 Licensor shall enter into a development and manufacture
agreement with a Third Party manufacturer. Licensor shall take all reasonable
steps to ensure that the contract manufacturer conducts scale-up of the Product
to ensure Clinical Trial supply. Licensor will supply necessary quantities of
Product at the actual cost of manufacturing and shipping, proved by
documentation, to be reimbursed by Licensee as stated in Section 9. Licensor is
not responsible for events outside of Licensor's control concerning Third Party
Manufacturers but will take all reasonable steps to ensure an adequate supply of
Product to Licensee.
5.5.2 At the commencement of Phase II Clinical Trials and at
Licensee's request, Licensor shall start to prepare the transfer all Know-How
owned by Licensor to Licensee relating to manufacture of Product to ensure the
scale-up of the Product to level of production volume for marketing in the
Territory as soon as possible upon initiation of enrollment of patients in Phase
III Clinical Trials
5.5.3 The Parties shall mutually set out a project plan
describing each step of transfer of technology related to the manufacture and
the cost thereof.
5.5.4 Licensor shall supply the total requirement of Product
for performance of Clinical Trials in the Territory to Licensee. The Product for
Clinical Trials shall be supplied at a rate of [CONFIDENTIAL TREATMENT
REQUESTED] for such Product when acquired from the Third Party contract
manufacturer plus handling fees (e.g. shipping, insurance) under the terms set
forth in Section 9.
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CONFIDENTIAL TREATMENT REQUESTED
5.5.5 Licensor warrants that all Product delivered for
Clinical Trial supply upon delivery have been manufactured in accordance with
current good manufacturing practices ("cGMPs") or other relevant standard,
conforms with the Specifications, and has a remaining shelf life of at least
[CONFIDENTIAL TREATMENT REQUESTED].
5.5.6 [CONFIDENTIAL TREATMENT REQUESTED].
6. MARKETING AUTHORIZATIONS
6.1. Licensee shall as soon as reasonably practicable, after
completion and evaluation of the results of the Clinical Trials, compile and
submit the Dossier in respect of the Product with the relevant authorities and
shall use all reasonable endeavors to conduct the approval process in order to
obtain a Marketing Authorization for the Product in the Territory. Upon the
Licensee's request, the Licensor shall provide necessary assistance for this
purpose. Licensee will reimburse Licensor for any cost and expense of its
employees, engineers and consultants traveling to China or any other country in
the Territory for this purpose.
6.1.1 To the extent either Party receives any written or oral
communications relating to the Product from any regulatory authority inside or
outside the Territory, such Party will promptly inform the other Party thereof
(including by providing a copy of any written communication or a written account
of any oral communication), but in no event later than ten (10) Business Days
after receipt of such communication.
6.1.2 Each Party will promptly notify the other Party, and
provide such other Party with a copy, of any correspondence or other reports or
complaints submitted to or received by the first Party from any regulatory
authority in the Territory or from any other Third Party claiming that any
product promotional materials (including advertising and other promotional
materials used in connection with the marketing, promotion and sale of the
Product) are inconsistent with a Product's labeling or are otherwise in
violation of applicable law or regulation.
6.1.3 Each Party will provide the other Party upon request
with a copy of any documents or reports filed with any regulatory authority
during the Term with respect to the Product.
6.2. DATA EXCLUSIVITY. Each of Licensee and Licensor shall use
all reasonable endeavors to procure and maintain the maximum period of data
exclusivity according to the law as stated inside the Territory.
6.3. PRICE & REIMBURSEMENT APPROVALS. To the extent
applicable, Licensee shall apply for Price & Reimbursement Approvals with the
relevant authorities at the appropriate time relative to grant of Marketing
Authorization. The Licensee shall have sole discretion, after consultation with
Licensor, to decide the prices at which the Product is to be sold to Third Party
customers.
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CONFIDENTIAL TREATMENT REQUESTED
6.4. OWNERSHIP AND MAINTENANCE OF MARKETING AUTHORIZATIONS.
Licensee shall be the exclusive Marketing Authorization holder in respect of all
Product in each country of the Territory and shall assume all responsibilities
towards the regulatory authorities. Licensee shall maintain the Marketing
Authorizations at its cost in the Territory for the Term. Licensor will,
throughout the Term, provide reasonable technical and scientific support, at
Licensee's cost, to enable Licensee to maintain Marketing Authorizations in the
Territory.
7. LICENSE FEE AND ROYALTY
7.1 Licensee will pay Licensor [CONFIDENTIAL TREATMENT
REQUESTED] as soon as possible but no later than [CONFIDENTIAL TREATMENT
REQUESTED] from the Effective Date of this Agreement.
7.2 Licensee will pay Licensor [CONFIDENTIAL TREATMENT
REQUESTED] upon delivery of Product to Licensee for use in Clinical Trials and
upon SFDA approval to conduct Clinical Trials of the Product in humans in the
Territory.
7.3 Licensee will pay Licensor [CONFIDENTIAL TREATMENT
REQUESTED] upon SFDA approval to market the Product in the Territory.
7.4 ROYALTIES
7.4.1 ROYALTY AMOUNT. Licensee will pay to Licensor a royalty
based upon the sales of Product in the Territory. The first [CONFIDENTIAL
TREATMENT REQUESTED] of cumulative sales of Product (as calculated per Section
8) in the Territory shall be [CONFIDENTIAL TREATMENT REQUESTED]. Thereafter,
Licensee will pay a royalty of [CONFIDENTIAL TREATMENT REQUESTED].
7.4.2 ROYALTY TERM. Royalties due under the preceding
subsection 7.3.1 will continue on a country to country basis in the Territory
until the later of (a) the expiration of an issued Licensed Patent covering the
Product in a given country in the Territory, or (b) the date [CONFIDENTIAL
TREATMENT REQUESTED] after the date of First Commercial Sale of a Product in
such country in the Territory under this Agreement.
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CONFIDENTIAL TREATMENT REQUESTED
8. PRODUCT PRICE; PAYMENT; AUDIT REPORT.
8.1. PRODUCT PRICE. Licensee shall pay to Licensor the price
of Product for Clinical Trials in the Territory which shall be agreed upon
between the Parties no later than three months prior to the expected first
shipment. The Product Price shall be Licensor's cost of manufacturing and
shipping of each Unit of Product. The Product Price shall be stated in U.S.
Dollars per Unit and shall be the actual cost as documented not exceeding
[CONFIDENTIAL TREATMENT REQUESTED] per unit.
8.2. The product price is payable 30 Business Days from
receipt of delivery. The payment will be wired in US dollar to the account
designated by Licensor.
8.3. After the First Commercial Sale in the Territory,
Licensee will provide Licensor within thirty (30) Business Days after the end of
each calendar quarter with a report stating the volume of Product sold or
otherwise disposed of in each country of the Territory and provide the
calculations for the Net Sales and royalties due. Within sixty (60) Business
Days after the end of each calendar quarter, Licensee will transfer, by wire,
the amount of royalties and cost of goods due to such bank account as Licensor
may indicate from time to time. All such amounts shall first be calculated in
the domestic currency of the sale and then converted into, and paid, in U.S.
Dollars. For the purpose of the above calculation, the Net Sales shall be
converted into U.S. Dollars using the average rate of exchange for such calendar
quarter published by the People's Bank of China.
8.4. TAXES.
8.4.1 If Licensee is required by law or a governmental body
charged with the administration thereof to withhold or deduct any taxes from or
in respect of any amount payable by Licensee to the Licensor hereunder then (i)
Licensee shall make such withholdings or deductions; (ii) Licensee shall pay the
full amount withheld or deducted to the relevant taxation or other authority in
accordance with applicable laws; and(iii) Licensee shall promptly deliver to the
Licensor a receipt or similar documentation of the relevant authority evidencing
the payment of such taxes.
8.5. AUDIT RIGHTS; ADJUSTMENTS.
8.5.1 Licensee will permit an independent certified public
accountant designated by Licensor and reasonably acceptable to Licensee (the
"Auditor"), to have access to Licensee's records and books during regular
business hours for the sole purpose of determining the accuracy of the amounts
reported and actually paid or otherwise payable to Licensor under the terms of
this Agreement (the "Audit"). Any Audit will cover a period not to exceed 3
years immediately preceding such audit. Licensor will bear all costs and
expenses in connection with the Audit; PROVIDED, HOWEVER, that if any Audit
reveals an understatement of Net Sales greater than 10% of the stated amount,
then Licensee will bear all costs and expenses in connection with such Audit.
Any such Audit will be performed upon at least thirty (30) Business Days prior
written notice during regular business hours, and not more than once in each
calendar year during the term of this Agreement and during each calendar year in
the 3-year period following expiration or termination of this Agreement.
8.5.2 The Auditor will execute a written confidentiality
agreement with Licensee and will disclose to Licensor only the amount and
accuracy of payments reported and actually paid or otherwise payable under this
Agreement. The Auditor will send a copy of the report to Licensee at the same
time it is sent to Licensor. The report sent to Licensee will also include the
methodology and calculations used to determine the results.
8.5.3 If the Audit results in a determination that Net Sales
have been understated, then any resulting underpayment will be paid to Licensor
within thirty (30) Business Days after receipt of the Auditor's report including
an annual interest rate of 5% of the outstanding amount calculated from the
period when the amount was originally due until the actual payment of the
amount.
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CONFIDENTIAL TREATMENT REQUESTED
9. TECHNOLOGY, MANUFACTURE AND SUPPLY OF PRODUCT FOR CLINICAL
TRIALS
9.1. DELIVERY OF KNOW-HOW DOCUMENTS
9.1.1 Upon commencement of Phase II Clinical Trials and at
Licensee's request, Licensor shall start to prepare the transfer of information
related to the existing manufacturing technology and delivery shall be made upon
initiation of enrollment of patients in Phase III Clinical Trials, and Licensor
will:
(a) Provide Licensee with reasonable access to any
relevant Know-How and other information relating to the manufacture of Product
owned or controlled by Licensor no sooner than the initiation of enrollment of
patients in Phase III Clinical Trials; and
(b) Deliver the Know-How documents, training and
necessary consulting, subject to Section 2.1.4, in the following manners:
(i) Subject to this Sections 9.1.1 and
2.1.4, Licensor will deliver all technical documents in connection with
manufacturing, test, use of the Product in their existing condition and forms by
air mail.
(ii) Licensor will make correction or
replacement of any document missing or damaged promptly without charge;
(iii) Upon Licensee's request and written
agreement between the Parties and subject to Section 2.1.4, Licensor will
provide training to Licensee, either via dispatching experts to Licensee's
premises or hosting training in its own premises.
(iv) When necessary that Licensee wants to
import equipment or materials for manufacturing of the Product, the Licensor
shall provide advice and assistance to facilitate the purchase in favorable
terms.
9.2. SUPPLY OF PRODUCT FOR CLINICAL TRIALS.
9.2.1 Licensor undertakes to manufacture and supply Product to
Licensee and Licensee undertakes to purchase Product from Licensor for the
Clinical Trials in Territory, in accordance with the terms and conditions of
this Agreement.
9.2.2 Licensor shall deliver Product to Licensee in accordance
with delivery dates specified in Binding Orders as defined in Section 9.3. The
Product shall be labeled as specified by Licensee as advised by Licensor and in
accordance with US regulations.
9.2.3 The Licensee shall pay to Licensor the documented cost
of clinical product as well as costs associated with the shipping of product.
The delivery of the product shall be in accordance with regulations of the SFDA
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CONFIDENTIAL TREATMENT REQUESTED
9.2.4 Licensor acknowledges that, when delivered, all Product
supplied under this Agreement shall have a remaining shelf life of at least
[CONFIDENTIAL TREATMENT REQUESTED] under specified storage conditions.
9.2.5 The Parties shall enter into the Quality Agreement
concerning the supply of Product for Clinical Trials.
9.2.6 AUDITS. In order to ensure that the requirements set out
in this Agreement are complied with, Licensee shall be entitled to carry out
audits as specified in the Quality Agreement at the Licensor or its designated
supplier at any time with prior notification.
9.2.7 COMMERCIAL SUPPLY. If applicable, the Parties agree to
negotiate in good faith to reach terms as the to commercial supply of Product
from Licensor to Licensee for sale in the Territory.
9.3. FORECASTS, DELIVERY AND ORDERS.
9.3.1 Licensor will use best efforts to provide approximately
[CONFIDENTIAL TREATMENT REQUESTED] vials of Product for the SFDA submission
before the end of October 2005. Licensee shall submit to Licensor each calendar
quarter a rolling forecast for each Product for the following twelve (12) months
showing its best estimate of quantities of the Product needed for such
12-month-period and required delivery dates for such quantities in each month
("Rolling Forecast"). Licensee undertakes to place orders to Licensor for the
quantities specified for the first three months of such Rolling Forecast
("Binding Orders"). Licensor shall acknowledge and accept each Binding Order in
writing ("Acceptance") to Licensee and undertakes to issue within ten (10)
Business Days an Acceptance in respect of each Binding Order placed by Licensee
in accordance with the first three months of such Rolling Forecast and to
fulfill all such Binding Orders in accordance with the required delivery dates
specified therein.
9.3.2 Licensor shall notify Licensee within ten (10) Business
Days after receiving from Licensee a forecast if Licensor anticipates that it
will not have the capacity required to produce the amounts set out in such
Rolling Forecast. In such situation, the Parties shall discuss in good faith to
find possibilities to accommodate Licensee's anticipated requirements. For the
avoidance of doubt, the above provision by no means relieves Licensor from its
obligation according subsection 9.3.1.
9.4. QUALITY - DEFECTIVE PRODUCT.
9.4.1 As soon as reasonably practicable upon the receipt of
Product from Licensor, Licensee (or its designated nominee) shall test such
batch in accordance with Inspection on Receipt.
9.4.2 Licensee shall notify Licensor in writing in the event
that it becomes aware by reason of the Inspection on Receipt or otherwise that
all or any part of any batch of Product delivered to it fails to comply with the
warranty given under Section 11.4.1 Within ninety (90) Business Days from the
date of receipt of such batch of Product by Licensee (or its designee) where
such failure to comply is apparent from the Inspection on Receipt; or (b) Where
such failure is not so apparent, within twenty five (25) Business Days after
Licensee becomes aware of such failure.
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CONFIDENTIAL TREATMENT REQUESTED
9.4.3 In the event of notification under Section 9.4.2,
Licensee (or its designee) shall give full details in such notification of such
claim and shall give Licensor reasonable access to such batch to investigate the
matter before the remainder of the Product in the same consignment is used or
returned to Licensor.
9.4.4 Licensee's sole and exclusive remedy for breach of the
warranty set forth in 11.4.1 shall be (a) withdraw of all defective Product in
Clinical Trials immediately; (b) Licensor shall promptly replace all such
defective Product within thirty (30) Business Days of receipt of notice under
Section 9.4.2 and shall make arrangements for the return or disposal, at
Licensor option, of all such non-complying Product. Licensor shall pay all
shipping and related charges in connection with the shipment of replacement
Product; or (c)If Licensee at its discretion informs Licensor that Licensee does
not want replacement of the defective Product, Licensor shall promptly issue a
credit note for any invoice issued in respect of any returned batch.
9.4.5 In the event of a conflict between the test results of
Licensee and Licensor with respect to any shipment of Product hereunder, a
sample of such Product shall be submitted to an independent laboratory for
testing using the criteria set out in the Quality Agreement. Such independent
laboratory shall be as agreed between the parties or in the absence of agreement
(at the request of either party) each Party shall select an independent
laboratory, and such independent laboratories shall select a third independent
laboratory to conduct the testing. Such laboratory shall act as an expert, not
as an arbitrator. The test results obtained by such laboratory shall be reported
to Licensee and Licensor and shall in the absence of manifest error be final and
binding on the parties. The fees and expenses of such laboratory testing shall
be borne entirely by the party against whom such laboratory's findings are made.
10. INTELLECTUAL PROPERTY
10.1. LICENSOR'S OBLIGATION TO INFORM. During the Term,
Licensor will disclose to Licensee the complete text of all patent applications
included in the Licensed Patents that are filed after the Effective Date, as
well as copies of all correspondence concerning the prosecution thereof made or
received by or on behalf of Licensor to or from patent offices and any
information or correspondence received by or on behalf of Licensor from patent
offices concerning the institution of any interference, opposition,
re-examination, reissue, revocation, nullification or any official proceeding
involving any Licensed Patents after the Effective Date, and if possible
transmit such information electronically to Licensee or, at the expense of
Licensee, ship such materials to a place of destination to be named by Licensee.
Licensor shall promptly inform Licensee of the issuance of any Licensed Patents.
Licensor shall provide prompt written notice to Licensee of each Improvement
made by or on behalf of Licensor.
10.2. PATENT FILING, PROSECUTION AND MAINTENANCE. Subject to
the terms and conditions set forth in this Section 10.2, being a Licensee,
Licensee has the exclusive right to prosecute and maintain all Licensed Patents
in the Territory at its own cost. However, Licensee acknowledges and agrees that
per the terms of this Agreement, Licensor will own all Licensed Patents in the
Territory.
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CONFIDENTIAL TREATMENT REQUESTED
10.2.1 Licensor shall consent to and execute the necessary
documents in order to have Licensee registered as Licensee of the Licensed
Patents in the Territory if required.
10.2.2 With respect to Improvements, Licensee may apply for
patent protection in all countries of the Territory for any Improvement that in
Licensee's reasonable opinion is patentable. If Licensee elects not to file a
patent application claiming or covering an Improvement in a particular country,
then Licensee will give prompt written notice to Licensor of such decision, but
in any event within sixty (60) Business Days before the time limit, if any, set
forth in the appropriate laws and regulations for the filing of such
application. In such case, Licensor may elect at its sole discretion to
undertake the preparation, filing, prosecution or maintenance of a patent
application claiming or covering such Improvement in such country at its sole
expense. However, during the Term, Licensor shall not use its ownership of any
such patent application and patents issuing therefrom to limit or restrict
Licensee's sales of a Product in the Territory. This obligation of non
enforcement against Licensee shall extend to all third parties to whom any
rights are transferred. Licensee will execute such documents and perform such
acts as may be reasonably necessary for Licensor to commence such prosecution.
10.3. ENFORCEMENT RIGHTS.
10.3.1 NOTIFICATION OF INFRINGEMENT. If either Party learns of
any misappropriation of any proprietary Product information such as trade
secrets, Know-How, trademarks or any infringement or threatened infringement by
a Third Party of the Licensed Patents in the Territory, such Party will promptly
notify the other Party and will provide such other Party with all available
evidence of such misappropriation or infringement.
10.3.2 Enforcement of Patents and Product Rights in the
Territory:
(a) Licensee will have the right, but not the
obligation, at its cost, to institute, prosecute and control any action or
proceeding with respect to infringement in the Territory of the Licensed
Technology or any misappropriation of rights in the Territory, by counsel of its
own choice, and will consult with Licensor on any actions that Licensee proposes
to take in such action or proceeding. Licensor will have the right, at its own
expense, to be represented in such action by its own consultation counsel.
Licensee agrees that its counsel will keep Licensor's consultation counsel fully
informed.
(b) If Licensee fails to bring an action or
proceeding or otherwise take appropriate action in Licensee's discretion to
xxxxx such infringement or misappropriation in the Territory within a period of
ninety (90) Business Days of written notice by Licensor to Licensee requesting
such action, Licensor will have the right, but not the obligation, to bring and
control, by counsel of its own choice, any such infringement or misappropriation
action or proceeding. Licensee will cooperate with Licensor in any such action
or proceeding brought by Licensor against a Third Party, and will have the right
to consult with Licensor and to participate in and be represented by independent
counsel in such litigation at its own expense.
(c) If a Party brings any action or proceeding under
this subsection 10.3.2, the other Party agrees, at the request of the first
Party, to be joined as a party plaintiff if necessary to prosecute the action or
proceeding and to give the first Party reasonable assistance and authority to
file and prosecute the suit, including without limitation providing commercial,
clinical or manufacturing data available to the Parties, executing necessary
documents, and providing expert support.
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CONFIDENTIAL TREATMENT REQUESTED
10.3.3 SETTLEMENT WITH A THIRD PARTY. The Party that controls
the prosecution of a given action under subsection 10.3.2. will also have the
right to control settlement of such action; provided, however, that no
settlement will be entered into which would limit the scope or enforceability of
any Licensed Patents without the written consent of Licensor, such consent not
to be unreasonably withheld. However, if any settlement reached by Licensee, in
an action brought by a Third Party against Licensee due to infringement of Third
Party patent rights in the Territory due to the sale or manufacture of the
Product in the Territory, causes overall loss to the Licensee, the Licensee
shall have the right to be reasonably compensated by the Licensor including a
credit against future amounts owed under the Agreement if applicable. However,
for any settlement that causes loss to Licensee and requires reimbursement by
Licensor, Licensee will obtain Licensor's consent to such settlement.
10.3.4 ENFORCEMENT COSTS AND AWARDS. Any costs and attorneys'
fees incurred in connection with an action or proceeding brought by a Party
pursuant to this Section 10 of this Agreement shall be borne by the Party
bringing the action. Any damage award resulting from any such action, will be
retained by the Party covering the costs of the action.
10.4. DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS. Subject to
Section 10.5 below, if a Third Party asserts that a Patent, trade secret, or
other intangible right owned or exclusively licensed by it is infringed or
misappropriated by the manufacture, use, sale, or offer for sale of Product in
the Territory, the Licensee shall duly consult with Licensor and shall at
Licensee's discretion defend such right. Licensor shall duly assist Licensee at
Licensee's cost. Licensor shall compensate any loss or cost incurred by
Licensee, including a credit against future amounts owed under the Agreement if
applicable, if Licensee is found to infringe the patent, trade secret or other
intangible right of a Third Party by a court of competent jurisdiction in the
Territory due to the manufacture or sale of the Product in the Territory.
However, Licensee is solely responsible for any trademark infringement of a
Third Party of any trademark or trade dress Licensee chooses to market the
Product under in any country in the Territory. Licensor shall not compensate
Licensee for any loss or cost of infringement of a Third Party trademark or
trade dress in the Territory.
10.5. WITHDRAWAL DUE TO ALLEGED INFRINGEMENT. In the event
Licensee receives notice from a Third Party alleging that the manufacture, use
or sale of the Product in a country in the Territory infringes such Third
Party's patent rights, Licensee shall provide Licensor with prompt written
notice thereof and the Parties shall consult with each other in good faith
regarding such allegation. Licensee shall consider Licensor's suggestions and
comments regarding such alleged infringement; provided, however, that Licensee
shall have the right, after such consultation with Licensor, at its own
discretion to withdraw the Product from the country in the Territory and keep it
off the market in that country until the issue is resolved through
acknowledgment of non-infringement by the Third Party or through a court ruling
in the relevant part of the Territory. Such withdrawal shall not constitute a
breach of any of Licensee's obligations set out in this Agreement. As Licensor
and Licensee expand the numbers of countries under the definition of Territory,
Licensor and Licensee shall reexamine the rights and obligations of the Licensor
and Licensee under Section 10 as they pertain to each additional country.
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CONFIDENTIAL TREATMENT REQUESTED
11. REPRESENTATIONS AND WARRANTIES
11.1. MUTUAL REPRESENTATIONS AND WARRANTIES. Each of the
Parties hereby represents and warrants to the other Party that:
11.1.1 such Party is an entity duly organized, validly
existing and in good standing under the laws of the state or country in which it
was formed;
11.1.2 this Agreement is a legal and valid obligation binding
upon such Party and enforceable against such Party in accordance with its terms;
11.1.3 the execution, delivery and performance of this
Agreement by such Party does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a Party or by which it is bound;
11.1.4 to the best of such Party's knowledge, the execution,
delivery and performance of this Agreement by such Party does not violate any
law or regulation of any court, governmental body or administrative or other
agency having jurisdiction over such Party;
11.1.5 such Party has the full power and authority to enter
into this Agreement and to carry out the obligations contemplated hereby;
11.1.6 such Party has not, and during the Term will not, grant
any right to any Third Party relating to its respective Patents and Know-How
which would conflict with the rights granted to the other Party hereunder; and,
11.1.7 such Party has taken all necessary corporate action on
its part to authorize the execution and delivery of this Agreement.
11.2. LICENSOR'S ADDITIONAL REPRESENTATIONS, WARRANTIES AND
COVENANTS. Licensor hereby represents and warrants to Licensee that:
11.2.1 To the best of Licensor's knowledge, neither the
Product nor the manufacture, use or sale of the Product infringe the
Intellectual Property rights of any Third Party in the Territory or constitute a
misappropriation of the trade secrets in the Territory or other Intellectual
Property rights of any person or entity within the Territory.
11.2.2 Licensor has not, and during the term of the Agreement
will not, grant any right to any Third Party relating to the Product in the
Territory which would conflict with the rights granted to Licensee hereunder.
11.2.3 To the best of Licensor's knowledge, no Third Party in
the Territory is infringing any of the Licensed Patents claiming any part of the
Product or using any of the Licensed Know-How.
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CONFIDENTIAL TREATMENT REQUESTED
11.2.4 Licensor has obtained the assignment of all interests
and all rights of any and all Third Parties (including, but not limited to
employees) with respect to any Licensed Patents.
11.2.5 As of the Effective Date, Licensor has not been served
with any interference action or litigation with respect to any Licensed Patents
claiming any part of the Product or related to the Product or the manufacture
hereof, and Licensor has not received any written communication which expressly
threatens interference actions or other litigation before any patent and
trademark office, court, or any other governmental entity in any jurisdiction in
regard to any such Patents.
11.2.6 Licensor owns all rights related to the Product and may
grant to Licensee the rights set forth in this Agreement without breaching any
agreement with any Third Party.
11.2.7 Licensor warrants and represents that it has perfected
its ownership interest in the Licensed Patents and any and all maintenance and
annuity fees have been paid.
11.2.8 The Licensor warrants and represents that prior to the
Effective Date, it has used its best efforts to maintain the Licensed Technology
in confidence and has not disclosed, distributed, or disseminated such
information to anyone who is not in turn under an obligation to the Licensor to
maintain this information in confidence.
11.2.9 As of the Effective Date, there are no inquiries,
actions or other proceedings pending before or, to the best of Licensor's
knowledge, threatened by any regulatory authority or other government agency
with respect to the Product or any facility where the Product is manufactured,
and Licensor has not received written notice threatening any such inquiry,
action or other proceeding. As of the Effective Date, there are no
investigations pending before or, to the best of Licensor's knowledge,
threatened by any regulatory authority or other government agency with respect
to the Product or any facility where the Product is manufactured, and Licensor
has not received written notice threatening any such investigation. Licensor
shall promptly notify Licensee in writing upon learning of any such actual or
threatened investigation, inquiry or proceeding.
11.3 LICENSEE'S ADDITIONAL REPRESENTATIONS, WARRANTIES AND
COVENANTS.
11.3.1 As of the Effective Date, Licensee warrants and
represents that neither the Licensee nor any of its Affiliates markets or plans
to market any Competing Product.
11.3.2 Licensee covenants and agrees that neither the Licensee
nor its Affiliates will market a Competing Product during the Term of this
Agreement or for three years after termination of the Agreement, if termination
of the Agreement occurs for any reason other than those stated in 13.2(a), 13.3
or 13.4. However, the definition of Competing Product after termination of the
Agreement shall be limited to a fluorocarbon emulsion with an indication
comparable to the Product.
11.3.3 Licensee covenants and agrees that it will not pursue
filing of any patent application covering the Product, its method of
manufacturing or its method of use inside the Territory without the express
consent of the Licensor. Licensee covenants and agrees that it will not pursue
filing of any patent application covering the Product, its method of
manufacturing or its method of use outside the Territory.
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CONFIDENTIAL TREATMENT REQUESTED
11.4 PRODUCT WARRANTY.
11.4.1 Licensor hereby warrants and undertakes that upon
delivery of each batch of Product, all Product in such batch shall comply in all
material respects with the Specifications, including without limitation, having
been manufactured in accordance with cGMPs or other relevant standard.
11.4.2 THE FOREGOING WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL
OTHER EXPRESS AND IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PARTICULAR PURPOSE, RELATED TO
THIS AGREEMENT, AND THE WARRANTIES IN THE 1980 U.N. CONVENTION ON AGREEMENTS FOR
THE INTERNATIONAL SALES OF GOODS, THE UNIFORM COMMERCIAL CODE AND OTHER RELEVANT
LAWS SHALL NOT APPLY. WITH THE EXCLUSION OF GROSS NEGLIGENCE AND WILLFUL
MISCONDUCT, NEITHER OF THE PARTIES SHALL BE SUBJECT TO ANY CONSEQUENTIAL OR
INDIRECT DAMAGES WITH RESPECT TO CLAIMS MADE HEREUNDER OR BY ANY PURCHASER OR
USER OF THE PRODUCT.
12. INDEMNIFICATION
12.1. INDEMNIFICATION BY LICENSEE. Licensee will indemnify,
defend and hold Licensor and its directors, officers, employees, agents and
Affiliates harmless from and against any liabilities, damages, costs or
expenses, including reasonable attorneys' fees (collectively, "Losses"), which
arise out of, relate to or result from the breach by Licensee of any of its
representations, warranties or obligations contained within this Agreement or
any claim or action arising from, relating to or in connection with the
manufacture of the Product delivered from or on behalf of the Licensee.
Notwithstanding the foregoing, Licensee will not indemnify Licensor for any
Losses to the extent that Licensee is entitled to seek indemnification from
Licensor for such Losses under Section 12.2 of this Agreement.
12.2. INDEMNIFICATION BY LICENSOR. Licensor will indemnify,
defend and hold Licensee and its directors, officers, employees, agents and
Affiliates harmless from and against any Losses which arise from any claim,
lawsuit or other action to the extent such Losses arise out of, relate to or
result from the breach by Licensor of any of its representations, warranties or
obligations contained within this Agreement or any claim or action arising from
or relating in connection with the manufacture of the Product delivered from or
on behalf of Licensor. Notwithstanding the foregoing, Licensor will not
indemnify Licensee for any Losses to the extent that Licensor is entitled to
seek indemnification from Licensee for such Losses under Section 12.1 of this
Agreement.
12.3. INDEMNIFICATION PROCEDURES. A Party which intends to
claim indemnification under Section 12.1 or 12.2 of this Agreement (the
"Indemnitee") will promptly notify the other Party (the "Indemnitor") in writing
of any claim, lawsuit or other action in respect of which the Indemnitee or any
of its directors, officers, employees, and Affiliates intend to claim such
indemnification within a reasonable period of time after the assertion of such
claim; provided, however, that the failure to provide written notice of such
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CONFIDENTIAL TREATMENT REQUESTED
claim within a reasonable period of time will not relieve the Indemnitor of any
of its obligations hereunder, except to the extent that the Indemnitor is
prejudiced by such failure to provide prompt notice. The Indemnitor will have
the right to assume the complete control of the defense, compromise or
settlement of any such claim with the prior written consent of such Indemnitee,
which such consent will not be unreasonably withheld; provided, however, that
Indemnitee will have the right to withhold such consent in its sole discretion
if such defense, compromise or settlement includes any admission of wrongdoing
on the part of an Indemnitee, or limits the scope of any claims in or
enforceability of any Patents owned by or licensed to the Indemnitee. The
Indemnitor may at its own expense, employ legal counsel to defend the claim at
issue. At any time after Indemnitor has assumed defense of a claim, the
Indemnitor may exercise, on behalf of the Indemnitee, any rights which may
mitigate the extent or amount of such claim; provided, however, the Indemnitee:
(a) may, in its sole discretion and at its own expense, employ legal counsel to
represent it (in addition to the legal counsel employed by the Indemnitor) in
any such matter, and in such event legal counsel selected by the Indemnitee will
be required to confer and cooperate with such counsel of the Indemnitor in such
defense, compromise or settlement for the purpose of informing and sharing
information with the Indemnitor; (b) will, at its own expense, make available to
Indemnitor those employees, officers and directors of Indemnitee whose
assistance, testimony or presence is necessary, useful or appropriate to assist
the Indemnitor in evaluating and in defending any such claim; provided, however,
that any such access will be conducted in such a manner as not to interfere
unreasonably with the operations of the businesses of Indemnitee; and (c) will
otherwise fully cooperate with the Indemnitor and its legal counsel in the
investigation and defense of such claim. The rights and remedies provided
pursuant to this Section 12 are the sole and exclusive remedies of the Parties
hereto with respect to Losses.
12.4. INSURANCE. Each Party will make best efforts, assuming
its availability, to maintain commercially reasonable insurance coverage
commensurate with its obligations under this Agreement. Such commercially
reasonable insurance coverage will include comprehensive general liability
insurance coverage, including product liability, preferably with a minimum limit
of not less than [CONFIDENTIAL TREATMENT REQUESTED], or the highest available
limit, which shall be in effect at initiation of any Clinical Trials in the
Territory.
13. TERM AND TERMINATION
13.1. TERM OF THE AGREEMENT. The term of this Agreement (the
"Term") will commence on the Effective Date and, unless terminated earlier
pursuant to this Section 13, will expire on a country-by-country basis upon the
later of (a) the expiration of an issued Licensed Patent covering the Product in
a given country in the Territory, or (b) the date 10 years after the date of
First Commercial Sale of a Product in such country in the Territory under this
Agreement.
13.2. LICENSEE'S RIGHT TO TERMINATE. Licensee may terminate
the Agreement (a) in any country within the Territory with service of thirty
(30) Business Days written notice if: 1) the Product is considered unsafe by the
SFDA, or other applicable regulatory authorities, to administer to patients; or
2) Licensor is unable to manufacture and supply the Product to Licensee to meet
Licensee's demand after Licensor receives notice from Licensee to that effect
and after a 30 day opportunity to cure its failure to meet Licensee's
manufacture and supply demands; and (b) after the First Commercial Sale of the
Product in any country within the Territory with service of 3 months written
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CONFIDENTIAL TREATMENT REQUESTED
notice. In the case of termination pursuant to 13.2 (a), the Parties will make
all reasonable attempts to solve any safety or supply problems before Licensee
terminates the Agreement. If Licensee terminates the Agreement for any reason
other than those stated in 13.2(a), 13.3 or 13.4 (i.e. change of control or
strategy), the Parties agree to negotiate in good faith to find a solution which
will allow product development to continue in the Territory.
13.3. TERMINATION FOR MATERIAL BREACH. In the event of a
material breach of this Agreement by either Party, which is not cured within
sixty (60) Business Days following receipt of written notice of the such breach
from the non-breaching Party, the non-breaching Party will have the right to
terminate this Agreement by written notification to the other Party, effective
immediately upon receipt.
13.4. TERMINATION FOR BANKRUPTCY. Either Party may immediately
terminate this Agreement upon the occurrence of either of the following: (a) the
entry of a decree or order for relief by a court having jurisdiction in the
premises in respect of the other Party in an involuntary case under any
applicable national, federal, or state insolvency or other similar law, and the
continuance of any such decree or order unstayed and in effect for a period of
sixty (60) consecutive days; or (b) the filing by the other Party of a petition
for relief under any applicable national, federal, or state insolvency or other
similar law.
14. CONSEQUENCES OF TERMINATION
14.1. GENERAL. No termination of this Agreement will relieve
any Party hereto from any liability which, at the time of such termination, has
already accrued to the other Party or which is attributable to a period prior to
such termination, nor preclude either Party from pursuing any rights and
remedies it may have under this Agreement or at law or in equity which accrued
or are based upon any event occurring prior to such termination.
14.2. TERMINATION UNDER 13.2. In the event of termination by
Licensee of this Agreement under Section 13.2, Licensee shall forthwith after
the effective date of termination:
14.2.1 provide to Licensor the Dossier, all Product and
Scientific Data and any other documents, materials, data or information within
Licensee's possession or control containing or evidencing any Intellectual
Property of Licensor and all Licensor Confidential Information and:
14.2.2 cease all exploitation, manufacturing and marketing of
Product provided always that Licensee shall be entitled to continue to sell
Product for a period of six calendar months thereafter in order to fulfill
existing orders only (subject always to payment of Royalties) and provided that
Licensee shall not sell such inventory in a manner detrimental to the market for
Product in the Territory;
14.2.3 upon termination under sub section 13.2(b), give or
procure for Licensor access to all data filed in connection with the Marketing
Authorizations for the Product in the Territory;
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CONFIDENTIAL TREATMENT REQUESTED
14.2.4 upon termination under sub section 13.2(b), allow
Licensor to cross-reference the file relating to the Product held by each
relevant Regulatory Authority for the purpose of transferring the Marketing
Authorization for the Product in the Territory to Licensor or as it may
nominate;
14.2.5 subject to Licensee's right to sell its inventory of
Product pursuant to Section 14.2.2, transfer the adverse event database for the
Product relating to the Territory to Licensor; and
14.2.6 in the event of termination during the development, use
all reasonable endeavors to effect an orderly transfer to Licensor of the
management and conduct of the Clinical Trials performed by or on behalf of
Licensee and to fulfill Third Party obligations related to the Clinical Trials,
including requirements of authorities, ethical committees etc.
14.3. LICENSOR'S TERMINATION UNDER 13.3. In the event of
Licensor's termination under subsection 13.3 of this Agreement due to Licensee's
material breach, Licensee shall perform the acts set out in subsection 14.2
above.
14.4. LICENSEE'S TERMINATION UNDER 13.4. In the event of
Licensee's termination under subsection 13.4 of this Agreement due to Licensor's
bankruptcy, Licensee's rights shall continue in full force in the Territory and
shall not be affected by any proceedings. If Licensor is responsible for
manufacture and supply of Product to Licensee, Licensee shall have the right to
obtain its supply of Product from Licensor's Third Party contract manufacturer
with no obligation to Licensor. Licensor shall immediately transfer to Licensee
any necessary manufacturing technology and Know-How. All Licensed Patents shall
become automatically assigned to Licensee and Licensor agrees to effect such
assignment. Licensee will have no further obligations to make royalty and
milestone payments due under the Agreement except for royalties and other
payments due prior to the date of Licensor's petition for bankruptcy.
14.5. LICENSOR'S TERMINATION UNDER 13.4. In the event of
Licensor's termination under subsection 13.4 of this Agreement to Licensee's
bankruptcy, Licensee shall perform the acts set out in subsection 14.2 above.
14.6. LICENSES UPON EXPIRATION. Upon expiration of this
Agreement pursuant to Section 13.1 of this Agreement with respect to a country
in the Territory, Licensee's rights in the Licensed Technology shall become
irrevocable and Licensee shall have no further obligation to Licensor with
respect to such Licensed Technology.
14.7. SURVIVAL. In the event of expiration or termination of
this Agreement pursuant to Section 13 of this Agreement, except as may otherwise
be expressly set forth herein, the following sections will survive, together
with the definitions of any defined terms used therein: Sections 12, 14, 15, 17
and 18. All other provisions, including all rights and obligations thereunder,
will terminate and be of no further force and effect.
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CONFIDENTIAL TREATMENT REQUESTED
15. CONFIDENTIALITY, PUBLICATIONS, PUBLICITY
15.1. CONFIDENTIAL INFORMATION. Each Party acknowledges that
the other Party's Confidential Information comprises valuable trade secrets and
is proprietary. Each Party will hold in strict confidence the other Party's
Confidential Information and will not disclose the same to any other person,
firm or corporation, except as allowed hereunder. Notwithstanding the foregoing,
the obligation of confidentiality contained in this Agreement will not apply to
the extent that the receiving Party can demonstrate, by competent written proof,
that such Confidential Information:
15.1.1 was, at the time of disclosure, published, publicly
known or otherwise in the public domain, other than through any act or omission
by the receiving Party;
15.1.2 was already known to the receiving Party, other than
under an obligation of confidentiality or non-use, prior to the time of
disclosure;
15.1.3 was disclosed to the receiving Party in good faith,
without an obligation of confidentiality, by a Third Party not under any
obligation of confidence with respect to such information; or
15.1.4 was independently developed by the receiving Party
without use of or reference to the disclosing Party's Confidential Information.
15.2. TREATMENT OF CONFIDENTIAL INFORMATION. The Parties agree
that during the term of this Agreement and for ten (10) years after its
expiration or termination for any reason whatsoever, a Party receiving
Confidential Information of the other Party will: (a) treat any such
Confidential Information disclosed to it by the other Party as strictly
confidential; (b) except as necessary in the performance of this Agreement, not
disclose such Confidential Information to Third Parties without the prior
written consent of the other Party, other than to its Affiliates, sublicensees,
collaborators or any consultants, provided that such disclosure be under
confidentiality agreements with provisions comparable to those contained in this
Agreement; (c) not use such Confidential Information for purposes other than
those authorized expressly herein; and (d) use reasonable efforts to prevent
inadvertent disclosure of such Confidential Information, provided however, that
the obligations under this Section 15.2 shall continue in force and effect with
respect to each item of Confidential Information that is identified as a trade
secret by the disclosing party at the time of or within thirty (30 ) days after
its initial disclosure hereunder, until such time as such item of Confidential
Information is no longer susceptible of being kept a trade secret.
15.3. ACCESS. Access to Confidential Information will be
limited to those employees or consultants of the Party designated to receive
such information or of such Party's Affiliates who reasonably require such
information in order to carry out activities authorized pursuant to this
Agreement. Such employees or consultants will be advised of the confidential
nature of the Confidential Information and the related confidentiality
undertaking and each Party will assure that its employees, consultants and
Affiliates are bound by the terms of this Agreement relating to confidentiality.
15.4. PERMITTED DISCLOSURES. Notwithstanding any other
provision in this Agreement, a receiving Party may disclose Confidential
Information of the disclosing Party to the extent such disclosure is required by
law or court order, provided that the receiving Party gives the disclosing Party
prompt written notice of the requirement to disclose and reasonably cooperates
with the disclosing Party to seek a protective order or other restrictions on
the disclosure of such Confidential Information of the disclosing Party. Any
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CONFIDENTIAL TREATMENT REQUESTED
such required disclosure will be limited only to that Confidential Information
that is required to be disclosed and such disclosed Confidential Information
will remain Confidential Information hereunder despite the required disclosure.
A receiving Party may also disclose Confidential Information of the disclosing
Party in connection with filing, prosecuting, defending and/or enforcing
Patents, seeking or maintaining Marketing Authorizations and developing Product.
15.5. RETURN OF CONFIDENTIAL INFORMATION. Upon termination or
expiration of this Agreement, each Party hereto and its Affiliates will return
all Confidential Information of the other Party in their possession to the other
Party; provided, however, that each Party may retain: (a) a single archival copy
of the Confidential Information of the other Party solely for the purpose of
determining the extent of disclosure of Confidential Information hereunder and
assuring compliance with the surviving provisions of this Agreement; (b) any
portion of the Confidential Information of the other Party which is contained in
laboratory notebooks; and (c) any portion of the Confidential Information of the
other Party which a Party is required by mandatory applicable law to retain.
15.6. CONFIDENTIALITY OF THE AGREEMENT TERMS. Neither Party
will disclose the terms of this Agreement to any Third Party without the prior
written consent of the other Party; provided, however, that either Party may
disclose the terms of this Agreement to actual or prospective investors and
corporate partners (including sublicensees), to a Party's accountants, attorneys
and other professional advisors, and as required by applicable laws and
regulations of the U.S. Securities and Exchange Commission and any stock
exchange on which a Party's (or any Affiliate of any Party) stock is traded.
15.7. PUBLICATIONS. Any proposed written publication of
research results arising from this Agreement will be submitted to the other
Party at least twenty five (25) Business Days prior to submission for
publication, and at least ten (10) Business Days prior to oral, or other
non-written format, disclosure or the submission of an abstract. During this
twenty five (25) Business Day period for publication submissions and ten (10)
Business Day period for abstracts or oral, or other non-written format,
disclosures, the reviewing Party shall identify information that in the
reasonable judgment of such Party (a) will interfere with such Party's rights
hereunder (including any effect on patentability of disclosed information)
and/or (b) constitutes such Party's Confidential Information. Should the
reviewing Party require additional time to conduct its review the submitting
Party agrees to postpone the oral disclosure and submission of the manuscript or
the abstract for up to an additional sixty (60) days. Each Party agrees to
delete from any proposed manuscript, abstract or oral disclosure, information
identified by the other Party as its Confidential Information.
15.8. PUBLICITY. Neither Party will make any public
announcement concerning the existence, or the terms, of this Agreement, without
the prior written approval of the other Party with regard to the form, content
and precise timing of such announcement, except such as may be required to be
made by either Party in order to comply with applicable law, regulations, court
order, or tax or securities filings. A Party disclosing under the above
provision according to law shall provide the other Party with a copy of the
disclosed information. Such consent will not be unreasonably withheld or delayed
by such other Party. Prior to any such public announcement, the Party wishing to
make the announcement will submit a draft of the proposed announcement to the
other Party as soon as possible and in no event less than five (5) Business Days
in advance to enable the other Party to consider and comment thereon.
Notwithstanding anything to the contrary in this Agreement, nothing in this
Section 15.8 is intended to prohibit either Party from republishing or restating
information relating to this Agreement that has already been approved by the
other Party for use in a prior press release or public announcement.
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CONFIDENTIAL TREATMENT REQUESTED
16. PERFORMANCE BY AFFILIATES
The Parties recognize that each Party may perform some or all of its
obligations under this Agreement through Affiliates, provided, however, that
each Party will remain responsible for the performance by its Affiliates and
will cause its Affiliates to comply with the provisions of this Agreement in
connection with such performance and any act or omission committed by an
Affiliate shall be deemed to have been conducted by the Party itself.
17. DISPUTE RESOLUTION
17.1. The Parties will try to settle their differences
amicably between themselves. In the event of any controversy or claim arising
out of or relating to any provision of this Agreement or the performance or
alleged non-performance of a Party of its obligations under this Agreement
("Dispute"), a Party may notify the other Party in writing of such Dispute. If
the Parties are unable to resolve the Dispute within twenty (20) Business Days
of receipt of the written notice by the other Party, such dispute will be
referred to the Chief Executive Officers of each of the Parties (or their
respective designees) who will use their good faith efforts to resolve the
Dispute within fifteen (15) Business Days after it was referred to the Chief
Executive Officers.
17.2. Subject to subsection 17.1 of this Agreement, any
Dispute that is not resolved as provided in the preceding Section 17.1, whether
before or after termination of this Agreement, that in any way relates to the
Agreement, will be arbitrated pursuant to the Singapore Arbitration Act of 2001
(the "Rules") by three (3) independent and impartial arbitrators in accordance
with said Rules, but the Parties may agree on just one arbitrator. The
arbitration will be conducted in English and will be held in Singapore and each
Party will pay for their own costs and the cost of the arbitrators will be
divided equally among the Parties. The award in the arbitration will be final
and enforceable in any court of competent jurisdiction.
17.3. During the arbitration proceedings, parties shall
continue to perform their obligations under this Agreement except those under
arbitration.
18. MISCELLANEOUS
18.1. FURTHER ASSURANCES. At any time during the term of this
Agreement, Licensee and Licensor each will, at the request of the other Party,
use reasonable efforts to (a) deliver to the other Party such records, data or
other documents consistent with the provisions of this Agreement, (b) execute,
and deliver or cause to be delivered, all such assignments, consents, documents
or further instruments of transfer or license, and (c) take or cause to be taken
all such other actions, as a Party may reasonably deem necessary or desirable in
order for such Party to obtain the full benefits of this Agreement and the
transactions contemplated hereby.
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CONFIDENTIAL TREATMENT REQUESTED
18.2. ASSIGNMENT. Neither Party will assign its rights or
obligations under this Agreement to any Third Party without the prior written
consent of the other Party (which consent shall not be unreasonably withheld),
except that either Party may assign such rights and obligations, without
consent, to the surviving entity pursuant to a merger, acquisition or
consolidation, or to a Third Party acquiring all or substantially all assets of
a Party. In the event of such a transaction, however, intellectual property of
the acquiring entity shall not be included in the Licensed Technology. All
permitted assignments by either Party of any of its rights under this Agreement
will be subject to all of the terms and conditions of this Agreement. All
successors, permitted Licensees of either Party will be subject to, and will be
bound in writing by, all the terms and conditions of this Agreement. Any
purported assignment not permitted under the terms of this Agreement will be
null, void, and of no effect.
18.3. INDEPENDENT CONTRACTORS. The Parties hereto are
independent contractors. Nothing contained herein will constitute either Party
the agent of the other Party for any purpose whatsoever, or constitute the
Parties as partners or joint ventures. Employees of each Party remain employees
of said Party and will be considered at no time agents of or owing a fiduciary
duty to the other Party. Neither Party hereto will have any implied right or
authority to assume or create any obligations on behalf of or in the name of the
other Party or to bind the other Party to any other contract, agreement or
undertaking with any Third Party.
18.4. WAIVER. The failure of either Party to enforce any
provision of this Agreement at any time will not be construed as a present or
future waiver of such or any other provision of this Agreement. The express
waiver by either Party of any provision or requirement hereunder will not
operate as a future waiver of such or any other provision or requirement and
will be effective only if set forth in a written instrument signed by a duly
authorized representative of the Party waiving such provision or requirement.
18.5. AMENDMENT. The Parties hereto may amend, modify or alter
any of the provisions of this Agreement, but such amendment, modification or
alteration will be valid and binding on either Party only if made by a written
instrument that explicitly refers to this Agreement and that is signed by a duly
authorized representative of each Party.
18.6. SEVERABILITY. In the event that any provision in this
Agreement is held to be unlawful or invalid in any jurisdiction, the meaning of
such provision will be construed to the greatest extent possible so as to render
it enforceable. If no such construction can render such provision enforceable,
it will be severed. The remainder of this Agreement will remain in full force
and effect, and the Parties will negotiate in good faith a reasonable substitute
provision that is valid and enforceable in such jurisdiction. If the Parties are
unable to agree on a substitute provision, and if the unlawful or invalid
provision was an essential element of this Agreement without which one of the
Parties would not have entered into this Agreement, as evidenced by this
Agreement as a whole, then such Party may terminate this Agreement by written
notice to the other Party effective upon receipt.
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CONFIDENTIAL TREATMENT REQUESTED
18.7. NOTICE. All notices hereunder must be given in writing
and will be deemed given if delivered personally or by facsimile transmission
(receipt confirmed), mailed by registered or certified mail (return receipt
requested) with postage prepaid, or sent by express courier service (FedEx or
other reputable, internationally recognized courier service), to the Parties at
the following addresses (or at such other address for a Party as will be
specified by like notice; provided that notices of a change of address will be
effective only upon receipt thereof).
If to Licensor: PFC THERAPEUTICS, LLC
0000 Xx Xxxxx Xxxxxxx Xxxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxxx X. Xxxx, Manager
Facsimile: (000) 000-0000
With copies to: XXXXX & LARDNER LLP
000 X. Xxxxxxxx, 00xx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxxx X. Xxxxx
Facsimile: (000) 000-0000
If to Licensee: Beijing Double-Crane Pharmaceutical Corp., Ltd.
No 1, Lize donger Road, Wangjing
Xxxxxxxx Xxxxxxxx, Xxxxxxx 000000
Xxxxx
Attention: General Manager
Facsimile: 10 64 39 8090
With copies to: Beijing Double-Crane Pharmaceutical Corp., Ltd.
No 1, Lize donger Road, Wangjing
Xxxxxxxx Xxxxxxxx, Xxxxxxx 000000
Xxxxx
Attention: Legal Department
Facsimile: 10 64 39 8090
18.8. FORCE MAJEURE. Neither Party will be deemed to be in
breach of this Agreement as a result of default, delay or failure to perform by
such Party which is due to any cause beyond the reasonable control of such
Party, including without limitation, fire, earthquake, acts of God, severe
weather, acts of war, strikes, lockouts or other labor disputes, riots, civil
disturbances, actions or inactions of governmental authorities (except actions
in response to a breach of applicable laws by such Party), or epidemics. In the
event of any such force majeure, the Party affected will promptly notify the
other Party, will use commercially reasonable efforts to overcome such force
majeure, and will keep the other Party informed with respect thereto. If such
force majeure continues for a period of more than one hundred and eighty (180)
Business Days, the Party not subject to such force majeure may terminate this
Agreement by written notice to the other Party.
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CONFIDENTIAL TREATMENT REQUESTED
18.9. COUNTERPARTS. This Agreement may be executed by the
Parties in one or more identical counterparts, all of which together will
constitute this Agreement. If this Agreement is executed in counterparts, no
signatory hereto will be bound until both Parties have duly executed a
counterpart of this Agreement.
18.10. GOVERNING LAW. This Agreement will be governed by, and
construed an interpreted in accordance with, the laws of the State of New York
without giving effect to any choice of law rule that would cause the application
of the laws of any jurisdiction other than the internal laws of the State of New
York to the rights and duties of the Parties.
18.11. CONSTRUCTION. Unless used in combination with the word
"either," the word "or" is used throughout this Agreement in the inclusive sense
(and/or). The captions of this Agreement are for convenience of reference only
and in no way define, describe, extend or limit the scope or intent of this
Agreement or the intent of any provision contained in this Agreement. The term
"including" as used herein will mean including, without limiting the generality
of any description preceding such term. No rule of strict construction will be
applied against either Party hereto.
18.12. ENGLISH LANGUAGE. This Agreement has been written and
executed in English and Chinese. Both versions shall have the same legal force
and effect.
18.13. ENTIRE AGREEMENT. This Agreement, including any
Exhibits attached hereto, constitutes the entire agreement of the Parties with
respect to the subject matter hereof, and supersedes all prior and
contemporaneous agreements, understandings and negotiations, whether oral or
written, with respect to such subject matter, including, without limitation, the
Confidential Disclosure Agreement; PROVIDED, HOWEVER, that no agreement between
the Parties executed contemporaneously with this Agreement will be so superseded
by this Agreement.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK. SIGNATURE PAGE FOLLOWS.]
34
The Parties have caused this Agreement to be executed as of the
Effective Date by signature of their duly authorized representatives.
PFC THERAPEUTICS LLC
/s/ Xxxxx X. Xxxx
-----------------
By: Xxxxx X. Xxxx
Title: Chief Executive Officer
BEIJING DOUBLE-CRANE PHARMACEUTICAL CO., LTD.
/s/ Xx Xxx
----------
By: Xx Xxx
Title: President
35
EXHIBIT 1
1. Chinese patent application [CONFIDENTIAL TREATMENT REQUESTED]
entitled [CONFIDENTIAL TREATMENT REQUESTED].
2. Chinese patent application, divisional of [CONFIDENTIAL TREATMENT
REQUESTED] entitled [CONFIDENTIAL TREATMENT REQUESTED] (still waiting for
assignment of application number).
3. [CONFIDENTIAL TREATMENT REQUESTED] composition patent application
which will cover the precise formulation of OXYGENT, which is currently being
drafted and will be filed as a PCT application.
4. Various manufacturing and emulsion testing patent applications to be
filed, which currently are trade secrets.
EXHIBIT 2
This License Agreement, effective this 13th day of May, 2005 (the
"Effective Date"), upon the execution of the Development, License and Supply
Agreement, is made by and between PFC THERAPEUTICS, LLC ("PFC"), a Delaware
limited liability company, and BEIJING DOUBLE-CRANE PHARMACEUTICAL CO., LTD.
("Double-Crane"), a corporation organized under the laws of the People's
Republic of China.
WHEREAS:
A. PFC represents that it is the owner of pending patent applications
and patent applications to be filed listed in Exhibit 1 of this Development,
License and Supply Agreement, which relate to the Product as defined in this
Development, License and Supply Agreement.
B. PFC and Double-Crane intend to enter into or have entered into this
Development, License and Supply Agreement, upon the closing of which, PFC
intends to license to Double-Crane, among other things, the patent applications
listed in Exhibit 1.
C. Double-Crane wishes to obtain, and PFC wishes to grant, an exclusive
license in the Territory as defined in the Development, License and Supply
Agreement under each of the patent applications listed in Exhibit 1 under the
terms and conditions set forth in the Development, License and Supply Agreement.
NOW, THEREFORE, in consideration of the promises and the mutual
covenants hereinafter set forth, the receipt and adequacy of which are hereby
acknowledged, the Parties agree as follows:
LICENSE GRANT:
--------------
Subject to the terms and conditions of this Development, License and
Supply Agreement, PFC hereby grants to Double-Crane an exclusive license to the
patent applications listed in Exhibit 1 and any divisional, continuation,
continuation-in-part, reissue or reexamination (or their foreign equivalents) or
utility model which claims priority to any of the patents or patent applications
listed on Exhibit 1.
IN WITNESS WHEREOF, the undersigned have executed this Development,
License and Supply Agreement, which shall be effective as of the date last
listed below and set forth above.
PFC THERAPEUTICS, LLC
By /S/ Xxxxx Xxxx
------------------------------
Xxxxx Xxxx, Manager
Dated: _____________________, 2005
BEIJING DOUBLE-CRANE PHARMACEUTICAL CO., LTD.
By /S/ Xx Xxx
------------------------------
Xx Xxx, President
Dated: ______________________, 2005
EXHIBIT 3
DEVELOPMENT COMMITTEE MEMBERS
-----------------------------
PFC Therapeutics, LLC
(a) [CONFIDENTIAL TREATMENT REQUESTED]
(b) [CONFIDENTIAL TREATMENT REQUESTED]
BEIJING DOUBLE-CRANE PHARMACEUTICAL CO., LTD.
---------------------------------------------
(a) [CONFIDENTIAL TREATMENT REQUESTED]
(b) [CONFIDENTIAL TREATMENT REQUESTED]
