Exhibit 10.48
LICENSE AND SUPPLY AGREEMENT
between
BUMIMEDIC (MALAYSIA) SDN. BHD.
and
AMARILLO BIOSCIENCES, INC.
January 18th, 2006
CONFIDENTIAL
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with the Commission.
TABLE OF CONTENTS
ARTICLE I: DEFINITIONS.......................................................5
ARTICLE II: RESEARCH AND DEVELOPMENT........................................11
Section 2.01. ABI Obligations........................................11
Section 2.03. Availability of Resources; Cooperation.................13
Section 2.04. Reporting Obligations of BME...........................13
ARTICLE III: LICENSE........................................................13
Section 3.01. License and Supply Grant...............................13
Section 3.02. Restrictions...........................................14
Section 3.03. Retained Rights........................................14
Section 3.04. First Right of Refusal.................................14
ARTICLE IV: PAYMENTS AND ROYALTIES..........................................14
Section 4.01. Initial Fee............................................14
Section 4.02. Royalty Payments.......................................15
Section 4.03. Milestone Payments.....................................15
Section 4.04. Minimum Payment........................................15
Section 4.05. Reports................................................15
Section 4.06. Records and Audits.....................................15
Section 4.07. Exchange Rate; Manner and Place of Payment.............16
Section 4.08. Late Payments..........................................16
Section 4.09. Taxes..................................................16
ARTICLE V: TERM AND TERMINATION.............................................17
Section 5.01. Term...................................................17
Section 5.02. Termination By BME.....................................17
Section 5.03. Termination by ABI.....................................17
Section 5.04. Termination Upon Certain Events........................18
Section 5.05. Remedies...............................................18
Section 5.06. Effect of Termination..................................18
Section 5.07. Bankruptcy.............................................19
Section 5.08. Continuing Obligations.................................19
Section 5.09. Return of Confidential Information.....................19
ARTICLE VI: SUPPLY, MANUFACTURE AND PURCHASE OF PRODUCT.....................19
Section 6.01. Supply of Product......................................19
Section 6.02. Supply and Manufacturing Rights........................20
Section 6.03. Quality Assurance......................................20
Section 6.04. ABI's Duties...........................................20
Section 6.05. BME's Duties if Manufacturing..........................21
Section 6.06. Failure to Supply......................................22
Section 6.07. Allocation.............................................22
Section 6.08. Records and Audits.....................................22
ARTICLE VII: PURCHASE AND SALE..............................................23
Section 7.01. Purchase Price and Payment.............................23
Section 7.02. Labeling and Artwork...................................23
Section 7.03. Purchase Forms.........................................23
Section 7.04. Confirmation...........................................23
Section 7.05. Delivery...............................................24
Section 7.06. Forecasts and Orders...................................24
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ARTICLE VIII: WARRANTY, REJECTION AND INSPECTIONS...........................25
Section 8.01. ABI Warranty...........................................25
Section 8.03. BME Inspections........................................26
ARTICLE IX: REGULATORY COMPLIANCE...........................................26
Section 9.01. Maintenance of Marketing Authorizations................26
Section 9.02. Adverse Drug Event Reporting and Phase IV Surveillance.26
Section 9.03. Commercial Sale Testing and Reporting..................27
Section 9.04. Assistance.............................................27
Section 9.05. Compliance.............................................28
ARTICLE X: REPRESENTATIONS, WARRANTIES AND COVENANTS........................28
Section 10.01. Corporate Power........................................28
Section 10.02. Due Authorization......................................28
Section 10.03. Binding Obligation.....................................28
Section 10.04. Ownership of ABI Rights................................28
Section 10.05. Material Agreements....................................29
Section 10.06. Adverse Properties.....................................29
Section 10.07. Preservation of Name and Reputation....................29
Section 10.08. Debarment..............................................29
Section 10.09. Limitation on Warranties...............................30
Section 10.10. Limitation of Liability................................30
ARTICLE XI: PATENTS AND TRADEMARK...........................................30
Section 11.01. Filing, Maintenance and Protection of Patents.........30
Section 11.02. Cooperation...........................................30
Section 11.03. ABI to Prosecute Infringement.........................30
Section 11.04. Infringement Claimed by Third Parties.................31
Section 11.05. Trademark.............................................31
ARTICLE XII: COVENANTS OF BME AND ABI.......................................31
Section 12.01. Access to Books and Records............................31
Section 12.02. Further Actions........................................31
Section 12.03. Equitable Relief.......................................32
ARTICLE XIII: INDEMNIFICATION...............................................32
Section 13.01. BME Indemnified by ABI.................................32
Section 13.02. ABI Indemnified by BME.................................33
Section 13.03. Prompt Notice Required.................................33
Section 13.04. Indemnitor May Settle..................................33
ARTICLE XIV: DISPUTE RESOLUTION.............................................34
Section 14.01. Disputes...............................................34
Section 14.02. Trial Without Jury.....................................34
Section 14.03. Performance to Continue................................34
Section 14.04. Provisional Remedies...................................34
Section 14.05. Determination of Patents and Other Intellectual Property.34
ARTICLE XV: CONFIDENTIALITY.................................................35
Section 15.01. Confidentiality........................................35
Section 15.02. Publicity Review.......................................35
ARTICLE XVI: MISCELLANEOUS..................................................36
Section 16.01. Commercially Reasonable Efforts........................36
Section 16.02. Notices................................................36
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Section 16.03. Severability...........................................37
Section 16.04. Entire Agreement/Merger................................37
Section 16.05. Amendment..............................................37
Section 16.06. Counterparts...........................................37
Section 16.07. No Waiver of Rights....................................37
Section 16.08. Force Majeure..........................................38
Section 16.09. Further Assurances.....................................38
Section 16.10. Assignment and Sublicense..............................38
Section 16.11. Expenses...............................................38
Section 16.12. Binding Effect.........................................38
Section 16.13. Governing Law..........................................38
Section 16.14. Survival of Representations and Warranties.............39
Section 16.15. No Strict Construction.................................39
Section 16.16. Independent Contractors................................39
Exhibit A - Specifications............................................A-1
Exhibit B - Certificate of Compliance.................................B-1
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LICENSE AND SUPPLY AGREEMENT
This License and Supply Agreement ("Agreement") is made as of January 18th
2006 (the "Effective Date"), by and between Bumimedic (Malaysia) SDN. BHD, a
Malaysian corporation ("BME"), with its principal place of business located at
▇▇. ▇ ▇▇▇▇▇ ▇▇/▇, ▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇ Darul Ehsan,
MALAYSIA, and Amarillo Biosciences, Inc., a Texas corporation ("ABI"), with its
principal place of business located at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇
▇▇▇▇▇, ▇▇▇. ABI and BME are sometimes referred to collectively herein as the
"Parties" and individually as a "Party."
WHEREAS, ABI and its contract supplier, Hayashibara Biochemical
Laboratories, Inc. ("HBL") have substantial expertise in the production and oral
use of human interferon alpha ("IFN") and have proprietary rights and Know-How
in the field of production, purification and formulation of IFN;
WHEREAS, ABI is willing to disclose to BME the ABI Know-How consisting of
human clinical data and all other data, including safety, bioavailability, and
clinical trial data necessary for BME to obtain regulatory approval for a
product for the treatment of human diseases in the Territory; and
WHEREAS, ABI has an exclusive worldwide license (except Japan) to market
and distribute the oral formulation of HBL IFN, and desires to provide HBL IFN
to BME on the terms and conditions herein set forth, and BME desires to obtain
the right to perform clinical trials on, distribute and market HBL IFN on the
terms and conditions herein set forth;
WHEREAS, ABI owns certain proprietary information, intellectual property,
Patents and ABI Know-How, and other rights relating to the use of low dose IFN
for the treatment or prevention of human diseases;
WHEREAS, subject to the terms of this Agreement, ABI desires to grant to
BME, and BME wishes to obtain from ABI, an exclusive supply agreement license,
subject to existing rights, to such Know-How and related intellectual property
rights in the Territory in connection with the Product; and
WHEREAS, ABI is willing to grant such rights and licenses to BME under the
terms and conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth, the Parties mutually agree as follows:
ARTICLE I:
DEFINITIONS
(a) The following terms as used in the Agreement shall, unless the context
clearly indicates to the contrary, have the meaning set forth below:
CONFIDENTIAL
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with the Commission.
"ABI Know-How" means all Know-How under the Control of ABI as of the
Effective Date and at any time during the Term related to (but not claimed
under) the ABI Patent Rights and which is necessary or useful to develop,
Manufacture and/or commercialize the Product, including all information,
reports, results, inventions, materials, and any other technical and scientific
data, specifications and formulae directly related to the development,
regulatory approval, Manufacture, testing, use, marketing and/or sale of
Product, including non-patentable Improvements, and any nonpublic information
relevant to the ABI Patent Rights, including preclinical and clinical data from
ABI's past, current or future studies, relating to safety or bioavailability, or
preclinical or clinical data relating to the use of HBL IFN and/or IFN for the
treatment or prevention of human diseases.
"ABI Patent Rights" means all Patent Rights that are under the Control of
ABI as of the Effective Date and at any time during the Term that are necessary
or useful to the use, development, Manufacture, marketing, promotion,
distribution, sale and/or commercialization of the Product for use in the
treatment of the Licensed Indication, and Improvements thereto developed by or
on behalf of ABI during the Term.
"ABI Technology" means the ABI Patent Rights and the ABI Know-How.
"Affiliate" means any entity, which directly or indirectly controls, is
controlled by or is under common control with either BME or ABI. The term
"control" as used in the preceding sentence means the power to direct or control
the affairs of such entity, and control shall be presumed where BME or ABI or
their Affiliates (as the case may be) own ten percent (10%) or more of the
voting stock or other equity interests of such entity.
"Applicable Laws" means all applicable laws, rules, regulations and
guidelines within or without the Territory that may apply to the marketing or
sale of the Product in the Territory or the performance of either Party's
obligations under this Agreement including laws, regulations and guidelines
governing the marketing, distribution and sale of the Product in the Territory,
to the extent applicable and relevant, and including all cGMP or current Good
Clinical Practices standards or guidelines promulgated by the FDA or the
Governmental Authorities and including trade association guidelines.
"Bulk IFN" means concentrated liquid HBL IFN which can be used to
Manufacture Product.
"Certificate of Compliance" means the certificate of compliance in the
form attached hereto as Exhibit B.
"CFR" means the United States Code of Federal Regulations.
"cGMP" means current good manufacturing practices as defined in 21 CFR ss.
110 et seq. and established under the Act and applicable Regulations.
"Confidential Information" means any confidential information (including
Know-How) of a Party relating to any human interferon use, process, method,
compound, research project, work in process, future development, scientific,
engineering, Manufacturing, marketing, business plan, financial or personnel
matter relating to the disclosing Party, its present or future product, sales,
suppliers, customers, employees, investors or business, whether in oral,
written, graphic or electronic form. Confidential Information shall not include
any information, which the receiving Party can prove by competent evidence:
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(a) is now, or hereafter becomes, through no act or failure to act on the part
of the receiving Party, generally known or available;
(b) is known by the receiving Party at the time of receiving such information,
as evidenced by its written records maintained in the ordinary course of
business;
(c) is hereafter furnished to the receiving Party by a Third Party, as a
matter of right and without restriction on disclosure;
(d) is independently developed by the receiving Party, as evidenced by its
written records, without knowledge of, and without the aid, application or
use of, the disclosing Party's Confidential Information; or
(e) is the subject of a written permission to disclose provided by the
disclosing Party.
"Control" means the possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of any agreement
or other arrangement with any Third Party.
"Existing Licensees" means, as applicable, Pharma Pacific Management Pty,
Ltd. (PPM), HBL and Interferon Sciences, Inc. (ISI), their successors,
transferees and licensees.
"Existing Licenses" means, as applicable, the HBL Agreement, the PPM
Agreement and the ISI Agreement.
"FDA" means the United States Food and Drug Administration.
"First Commercial Sale" means the first sale for use, consumption or
resale of a Product by BME, its Affiliates or its sublicensees in the Territory
(excluding any sales for clinical trials). A sale to an Affiliate shall not
constitute a First Commercial Sale unless the Affiliate is the end user of the
Product.
"GAAP" means United States generally accepted accounting principles,
consistently applied in accordance with past practice.
"Good Clinical Practices" means good clinical practices as defined in
21 CFR ss. 50 et. seq. and ss. 312 et. seq.
"Governmental Approval" means all permits, licenses and authorizations,
including Marketing Authorizations, required by the FDA or any other
Governmental Authority as a prerequisite to the Manufacturing, packaging,
marketing and selling of the Product.
"Governmental Authority" means any federal, state, local or other
government, administrative or regulatory agency, authority, body, commission,
court, tribunal or similar entity, including the FDA and other entities in each
country in the Territory responsible for the regulation of medicinal products
intended for human use.
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"HBL" means Hayashibara Biochemical Laboratories, Inc. of Okayama,
Japan.
"HBL Agreement" means the Joint Development and Manufacturing/Supply
Agreement by and between HBL and ABI dated as of March 13, 1992, as amended by
the First Amendment to Joint Development and Manufacturing/Supply Agreement
dated as of January 17, 1996 and the Addendum to Manufacturing/Supply Agreements
dated as of May 10, 1996 and September 7, 2001.
"HBL IFN" means the cell culture derived human lymphoblastoid IFN produced
by HBL.
"Improvements" means any and all developments, inventions or discoveries
in the Licensed Indication relating to the ABI Patent Rights developed, or
acquired by ABI at any time during the Term and shall include developments
intended to enhance the safety and/or efficacy of the Product.
"IFN" means human interferon alpha.
"ISI Agreement" means the License Agreement dated October 20, 1989 by and
between Interferon Sciences, Inc. and ABI, as successor-in-interest to Amarillo
Cell Culture Company, Incorporated.
"Know-How" means all know-how, trade secrets, inventions, data, processes,
techniques, procedures, compositions, devices, methods, formulas, protocols and
information, whether or not patentable, which are not generally publicly known,
including, without limitation, all chemical, biochemical, toxicological, and
scientific research information, whether in written, graphic or video form or
any other form or format, related to human interferon alpha.
"Licensed Indications" means influenza and one other human indication
treated or treatable by the oral administration of IFN.
"Manufacture" or "Manufacturing Process" means the storage, handling,
production, processing and packaging of the Product, in accordance with this
Agreement and Applicable Laws.
"Marketing Authorization" means all necessary and appropriate regulatory
approvals, including Pricing and Reimbursement Approvals, where applicable, to
put the Product on the market in the Territory.
"Material Agreements" means the Existing Licenses, and the TAMU License
Agreement.
"NDA" means a new drug application, biological license application or
establishment license application, as applicable, and all amendments and
supplements thereto, filed or to be filed, with the FDA seeking authorization
and approval to Manufacture, package, ship and sell the Product as more fully
described in the Regulations.
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"Net Sales" means the invoice amounts actually received for sales of the
Product by BME, its Affiliates or sub-licensees in a bona fide arm's length
transaction, less the following items, provided that they are bona fide
transactions designed to optimize the sales of Product (a) cash discounts and
trade allowances actually granted, (b) rebates and charge backs required by
Applicable Laws or made pursuant to agreements with customers, (c) credits or
allowances actually granted upon claims, damaged goods, outdated goods,
rejections or returns of such Product, including recalls, (d) taxes, tariffs and
similar obligations, duties or other governmental charges (other than income
taxes) levied on, absorbed or otherwise imposed on sales of such Product in the
Territory and shown separately on the invoice, (e) shipping charges and (f)
insurance costs related to shipping.
Components of Net Sales shall be determined in the ordinary course of
business in accordance with historical practice and using the accrual method of
accounting in accordance with GAAP, but shall not include any sales of the
Product for pre-clinical or clinical testing or for other than commercial
purposes.
In the event BME transfers the Product to a Third Party in a bona fide
arm's length transaction, for consideration, in whole or in part, other than
cash or to a Third Party in other than a bona fide arm's length transaction, the
Net Sales price for such Product shall be deemed to be the standard invoice
price then being invoiced by BME in an arms length transaction with similar
customers for similar amounts less the items set forth in (a) through (f) above.
"Patent Rights" means all rights related to human interferon alpha under
patents and patent applications, and any and all patents issuing there from
(including utility, model and design patents and certificates of invention),
together with any and all substitutions, extensions (including supplemental
protection certificates), registrations, confirmations, reissues, divisional,
continuations, continuations-in-part, re-examinations, renewals and foreign
counterparts of the foregoing and all improvements, supplements, modifications
or additions.
"Phase III Study" means a well-controlled study of sufficient size and
appropriate design to demonstrate the safety and efficacy of the Product for its
intended use.
"Phase IV" means, as applicable, a study or program designed to obtain
additional safety or efficacy data, detect new uses for a drug, or to determine
effectiveness for labeled indications under conditions of widespread usage,
which is commenced after Government Approval of the Product in the applicable
country in the Territory or any such study or program required by the FDA or
other applicable Governmental Authority.
"PPM Agreement" means the PPM/ACC Sublicense Agreement dated April 27,
1995 by and between Pharma Pacific Management Pty, Ltd. and ABI.
"Pricing and Reimbursement Approvals" means any pricing and reimbursement
approval that must be obtained before placing the Product on the market in the
Territory in which such approval is required.
"Prime Rate of Interest" means the prime rate of interest published from
time to time in The Wall Street Journal as the prime rate; provided, however
that if The Wall Street Journal does not publish the prime rate of interest,
then the term "Prime Rate of Interest" shall mean the rate of interest publicly
announced by Bank of America, N.A., as its prime rate, base rate, reference rate
or the equivalent of such rate, whether or not such bank makes loans to
customers at, above, or below said rate.
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"Product" means a formulation or composition containing IFN and
designated, detailed, or labeled for oral use in the treatment of the Licensed
Indications.
"Regulations" means regulations, statutes, rules, guidelines and
procedures promulgated by the FDA or other governmental agency pursuant to the
Act or other law, including without limitation, those regulations currently
contained in Title 21 of the CFR.
"Shipment" or "Shipped" means each individual group of Product received by
BME from ABI or its agent.
"Specifications" means the specifications for the Product as may be
amended from time to time by BME on notice to ABI or in compliance with
Applicable Laws. The initial Specifications are attached hereto as Exhibit A.
"TAMU License Agreement" means the License Agreement between The Texas A&M
University System and ABI dated March 22, 1988, as amended by Amendment No. 1
dated September 17, 1998.
"Territory" means the country of Malaysia.
"Third Party" means any entity other than ABI or BME or an Affiliate of
ABI or BME.
"Unit" means a single finished dosage form of Product in the form
designated by BME, which initially, for clinical supplies, shall consist of a
200 mg by weight, with 150 international units by activity, tablet or lozenge.
Clinical testing may result in a change in the optimal dose and require a new
definition of "Unit."
(b) Each of the following terms is defined in the Section or under the defined
term set forth opposite such term below:
ABI.............................................................Preamble
ADE.........................................................Section 9.02
Agreement.......................................................Preamble
Clinical Records.........................................Section 2.01(c)
Disputed Amount..........................................Section 5.03(a)
DMF......................................................Section 2.02(b)
Effective Date..................................................Preamble
Force Majeure..............................................Section 16.08
BME.............................................................Preamble
Indemnitee.................................................Section 13.03
Indemnitor.................................................Section 13.03
Interferon......................................................Recitals
Loss.......................................................Section 13.01
Parties.........................................................Preamble
Party...........................................................Preamble
Patent Rights .............................................Section 10.01
Purchase Price..............................................Section 7.01
Representatives............................................Section 15.01
Royalty Payment Date........................................Section 4.02
Milestone Payments..........................................Section 4.03
SEC........................................................Section 15.02
SOP.........................................................Section 9.02
Term........................................................Section 5.01
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(c) Interpretation. The section headings contained in this Agreement are for
reference purposes only and shall not affect the meaning or interpretation of
this Agreement. Except where the context clearly requires to the contrary: (i)
each reference in this Agreement to a designated "Section" or "Exhibit" is to
the corresponding Section or Exhibit of or to this Agreement; (ii) instances of
gender or entity-specific usage (e.g., "his" "her" "its" "person" or
"individual") shall not be interpreted to preclude the application of any
provision of this Agreement to any individual or entity; (iii) the word "or"
shall not be applied in its exclusive sense; (iv) "including" shall mean
"including, without limitation"; (v) references to laws, regulations and other
governmental rules, as well as to contracts, agreements and other instruments,
shall mean such rules and instruments as in effect at the time of determination
(taking into account any amendments thereto effective at such time without
regard to whether such amendments were enacted or adopted after the effective
date of this Agreement) and shall include all successor rules and instruments
thereto; (vi) references to "$" or "dollars" shall mean the lawful currency of
the United States; (vii) references to "Federal" or "federal" shall be to laws,
agencies or other attributes of the United States (and not to any State or
locality thereof); (viii) the meaning of the terms "domestic" and "foreign"
shall be determined by reference to the United States; (ix) references to "days"
shall mean calendar days; (x) references to months or years shall be to the
actual calendar months or years at issue (taking into account the actual number
of days in any such month or year); (xi) days, business days and times of day
shall be determined by reference to local time in Amarillo, Texas; and (xii) the
English language version of this Agreement shall govern all questions of
interpretation relating to this Agreement, notwithstanding that this Agreement
may have been translated into, and executed in, other languages.
ARTICLE II:
RESEARCH AND DEVELOPMENT
Section 2.01. ABI Obligations.
(a) As soon as reasonably practicable after the Effective Date, ABI will make
available all ABI Know-How to BME for BME's inspection and at BME's request will
provide BME with a copy of all ABI Know-How in tangible form and a written
summary of all ABI Know-How not in tangible form. In the event BME requests that
more than 1,000 pages be copied in connection with the foregoing, BME shall
reimburse ABI for ABI's actual out-of-pocket costs for making copies in excess
of 1,000 pages. BME shall pay ABI such amounts within 30 days following BME's
receipt of an invoice therefor accompanied by documentation reasonably
supporting such invoice.
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(b) ABI hereby grants to BME reference rights to ABI's, and agrees to cause HBL
to grant to BME rights of reference to HBL's, as the case may be, FDA Drug
Master File ("DMF"), when filed, and FDA Investigational New Drug Application,
when filed, for HBL IFN and agrees to execute or cause HBL to execute any
necessary authorization letters in this regard.
(c) ABI agrees to maintain, or cause HBL to maintain, the DMF for HBL IFN
up-to-date at all times during the Term. ABI shall cooperate fully with BME in
order to obtain all the Marketing Authorizations which now are or later become
necessary to develop, Manufacture, use, market or sell any Product. Such
cooperation shall include, but not be limited to, ABI providing BME with the ABI
Know-How and ABI appearing at and participating in meetings with regulatory
agencies at the reasonable request of BME to assist BME in obtaining such
Marketing Authorizations as are now required, or may in the future be required
to Manufacture, use, market or sell any Product. ABI shall execute, or cause
third parties to execute, upon request by BME, any and all documents reasonably
necessary to obtain such Marketing Authorizations. BME shall reimburse ABI for
any reasonable out-of-pocket costs, including reasonable attorney's fees and
travel expenses incurred by ABI in connection with such cooperation.
(d) ABI shall provide to BME or any sub-licensee of BME, at BME's request and,
unless otherwise set forth in this Agreement, sole expense, with ABI Technology
reasonably necessary to enable BME or such sub-licensee to exercise fully its
rights and fulfill its obligations under this Agreement
Section 2.02. BME Obligations.
(a) BME will use commercially reasonable efforts to timely complete at the sole
cost and expense of BME (i) clinical trials and development of Product for the
treatment of the Licensed Indications, (ii) animal toxicology and other
pre-clinical studies required for commercial launch of the Product, (iii) Phase
III Studies, and (iv) other tasks supporting commercialization of the final
formulation of the Product.
(b) BME shall use commercially reasonable efforts to timely secure any and all
Governmental Approvals in the Territory and shall own and maintain all
Governmental Approvals and related information as provided herein. The Parties
agree and acknowledge that Governmental Approval for the Product will be sought
in Malaysia.
(c) BME shall maintain records in sufficient detail and in good scientific
manner appropriate for patent and regulatory purposes and shall properly reflect
all work done and results achieved in the performance of its duties hereunder
(including all data in the form required to be maintained under any Applicable
Laws), and any subsequent pre-clinical or clinical studies (the "Clinical
Records"). The Clinical Records shall be jointly owned by BME and ABI, shall be
considered Confidential Information of both BME and ABI, and shall include
books, records, reports, research notes, charts, graphs, comments, computations,
analyses, compilations, recordings, photographs, computer programs and
documentation thereof, computer information storage means, samples of materials
and other graphic or written data generated in connection with BME's research
and development activities with respect to the Product.
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(d) ABI has the right, upon five business days prior written notice to BME, to
inspect the Clinical Records upon request and during normal business hours, and
BME shall, subject to Applicable Laws, provide ABI upon request with a copy of
all requested Clinical Records, to the extent reasonably required for the
exercise of ABI's rights under this Agreement. ABI may use the Clinical Records
and the summaries thereof for commercial purposes. If ABI wants to provide a
Third Party with the Clinical Records or a summary thereof or use information
contained in such records for a commercial purpose, ABI may do so.
Section 2.03. Availability of Resources; Cooperation.
Each Party shall maintain laboratories, offices and/or other facilities
reasonably necessary to carry out the activities to be performed by such Party
hereunder. Upon reasonable advance notice, each Party agrees to make its
employees and non-employee consultants reasonably available at their respective
work locations to consult with the other Party on issues arising during the
collaboration and in connection with any request from any Governmental
Authority, including regulatory, scientific, technical and clinical testing
issues.
Section 2.04. Reporting Obligations of BME.
On or prior to December 31st of each year during the Term of this
Agreement BME shall provide ABI with a report of ongoing development efforts,
including a report of efforts by BME with respect to clinical testing,
regulatory approval efforts, marketing/sales strategy, and any other areas into
which BME's reasonable business efforts in accordance with this paragraph may
reasonably be categorized. Such report shall be provided in English and shall be
accompanied by samples of labeling, instructions, promotional and other support
materials, if any, developed for BME's sales force, patients, physicians, or
other outside parties.
ARTICLE III:
LICENSE
Section 3.01. License and Supply Grant.
Subject to the terms of this Agreement and the Existing Licenses, ABI
hereby grants to BME:
(a) an exclusive sublicense, with rights to sublicense, under the ABI Technology
to use the ABI Technology to market, advertise, promote, Manufacture, offer for
sale, sell, and distribute the Product in the Territory; and
(b) an exclusive sublicense, with rights to sublicense, under all rights granted
to ABI pursuant to the HBL Agreement to market, advertise, promote, Manufacture,
offer for sale, sell, and distribute the Product in the Territory.
In addition to the transfer fees and Royalty, ABI shall receive fifty
percent (50%) of any license fee, option fee, or other payment, which BME may
receive for the sublicense of rights under this Agreement to the sale and/or use
of Product.
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Section 3.02. Restrictions.
BME shall have the right to use and sell Product only in the Territory and
only for use in the treatment of the Licensed Indications. BME shall not seek
customers, establish any branch or maintain any distribution depot for Product
in any country outside the Territory. BME shall not sell Product to any customer
in any country outside the Territory or to any customer in the Territory if, to
the knowledge of BME, such customer intends to resell such Product in any
country outside the Territory.
Section 3.03. Retained Rights.
ABI retains all rights other than as set forth in this Agreement to HBL
IFN and IFN, including without limitation, the right to test, develop, license,
sublicense, market, distribute or otherwise use IFN and HBL IFN for treatment of
the Licensed Indications outside the Territory.
Section 3.04. First Right of Refusal.
BME shall have a first right of refusal to add to this Agreement as
Licensed Indications, in the Territory, other clinical indications treated or
treatable by the oral administration of IFN, as such may become available from
ABI from time to time in the future, within the term of this Agreement. In the
event ABI should determine to license such an indication or indications in the
Territory, ABI shall provide written notice of such intention to BME. If ABI
proposes to license such indication or indications to any person or entity other
than BME, ABI shall provide to BME, along with such written notice, a complete
outline of the substantive terms of such proposed license; BME shall thereupon
have a period of thirty (30) days to notify ABI, in writing, that it elects to
enter into the license, on the terms and conditions set forth in such notice
from ABI to BME. If BME does not so notify ABI of its election to license, then
ABI shall be free to license such indication or indications to the party or
parties identified in such notice, or to any other party or parties, during a
period of ninety (90) days after the expiration of the aforesaid thirty (30)
days, and if ABI does not so license the indication or indications within said
ninety (90) day period, BME's first right of refusal shall be reinstituted, with
respect to any future license by ABI of such indication or indications, in the
Territory. The first right of refusal contained in this Section 3.04 shall not
constitute an obligation on the part of ABI to license any further indication or
indications in the Territory and ABI may elect not to develop treatments for any
further indications, or if it does develop such, ABI may elect not to license
them in the Territory.
ARTICLE IV:
PAYMENTS AND ROYALTIES
Section 4.01. Initial Fee.
On the Effective Date as an initial license fee BME shall pay to ABI a fee
equal to **** US Dollars ($****) which fee shall be applied by ABI toward patent
filings, prosecution and maintenance outside Malaysia.
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Section 4.02. Royalty Payments.
During the Term, BME will pay ABI a royalty on Product equal to **** of
the aggregate Net Sales of Product in each calendar year; Royalties shall be due
and payable thirty (30) days after the end of each calendar quarter (each a
"Royalty Payment Date"). BME may prepay, in whole or in part, any royalties
prior to the applicable Royalty Payment Date.
Section 4.03. Milestone Payments.
BME shall pay to ABI, as licensing fees, the following milestone payments
within 30 calendar days after the occurrence of the specified milestone event
with respect to the Product:
(a) **** US Dollars ($****) upon BME's receipt of the Governmental Approval
to market Product for human use from the applicable Governmental
Authority in Malaysia and upon BME's completion of all required Product
registration procedures.
(b) **** US Dollars ($****) upon BME's first commercial sale of the Product
in Malaysia.
Section 4.04. Minimum Payment.
BME shall pay to ABI a Minimum Payment which shall be the greater of ****
dollars ($****) per calendar year, or **** dollars ($****) per fifteen (15)
lozenges, of Product sales by BME, its affiliates or sub-licensees in bonafide
arm's length, transactions per calendar year, starting from the date of
completion of product registration procedures. Failure to make this minimum
payment shall be a reason for Termination pursuant to Section 5.03(e). Minimum
Payments made under this Section 4.04 shall be applied toward the royalty
payable under Section 4.02, above.
Section 4.05. Reports.
BME shall furnish to ABI a quarterly written report (in sufficient detail
to determine the relevant amounts and dates specified in this Section 4.05),
which report shall contain at a minimum (a) the Minimum Payment provided in
Section 4.04, including the number of lozenges sold; (b) the calculation of Net
Sales; (c) royalties payable in U.S. dollars, if any, which shall have accrued
hereunder based upon Net Sales; (d) withholding taxes, if any, required by law
to be deducted with respect to such sales; (e) the dates of the First Commercial
Sale of any Product; and (f) the exchange rates, if any, used to determine the
amount of United States dollars (collectively, the "Royalty Statement"). Reports
shall be due on the 30th day following the close of each quarter.
Section 4.06. Records and Audits.
During the Term and for a period of two years thereafter or upon written
notice to BME received prior to the expiration of such two year period as
otherwise required in order for ABI to comply with Applicable Law, BME shall
keep complete and accurate records in sufficient detail to permit ABI to confirm
the completeness and accuracy of the information presented in each Royalty
Statement and all payments due hereunder. BME shall permit an independent,
certified public accountant reasonably acceptable to BME to audit and/or inspect
those records of BME (including financial records) that relate to number of
lozenges sold and Net Sales for the sole purpose of verifying the completeness
and accuracy of the Royalty Statements and the calculation of Minimum Payments,
Net Sales and confirming royalty payments for the Product, during the preceding
calendar year. Such inspection shall be conducted during BME's normal business
hours, no more than once in any 12-month period and upon at least ten days'
prior written notice by ABI to BME. If such accounting firm concludes that such
payments were underpaid during the periods reviewed by such accountants, BME
shall pay ABI the amount of any such underpayments, plus interest at a rate
equal to the Prime Rate of Interest, within 30 days of the date ABI delivers to
BME such accounting firm's report so concluding that such payments were
underpaid. If such accounting firm concludes that such payments were overpaid
during such period, ABI shall pay to BME the amount of any such overpayments,
without interest, within 30 days of the date ABI delivers to BME such accounting
firm's report so concluding that such payments were overpaid. ABI shall bear the
full cost of such audit unless such audit discloses an underpayment by more than
5% of the amount due during such period. In such case, BME shall bear the full
cost of such audit.
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Section 4.07. Exchange Rate; Manner and Place of Payment.
All payments hereunder shall be payable in United States dollars. With
respect to each calendar quarter, whenever conversion of payments from any
foreign currency shall be required, such conversion shall be made at the rate of
exchange reported in The Wall Street Journal on the last business day of the
applicable calendar quarter. All payments owed under this Agreement shall be
made by wire transfer to a bank account designated in writing by ABI, unless
otherwise specified in writing by ABI.
Section 4.08. Late Payments.
Unless otherwise provided in this Agreement, upon the failure of BME to
pay any amount due under this Agreement within five days after receipt of notice
by ABI that such amount has become due and payable and has not been paid, BME
shall pay interest to ABI on such amount from the date such amount is due under
this Agreement at the rate of 8% per annum calculated on the number of days such
payment is delinquent, unless such payment is being disputed by BME in good
faith pursuant to Section 5.03(a). Nothing in this Section 4.06 shall relieve
BME of BME's obligation to make payments, risk Termination pursuant to Section
5.03(a), or provide a Royalty Statement pursuant to Section 5.03(b).
Section 4.09. Taxes.
All taxes levied on account of the payments accruing to ABI under this
Agreement shall be paid by ABI for its own account, including taxes levied
thereon as income to ABI. If provision is made in law or regulation for
withholding, such tax shall be deducted from the payment made by BME, paid to
the proper taxing authority and a receipt of payment of the tax secured and
promptly delivered to ABI.
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ARTICLE V:
TERM AND TERMINATION
Section 5.01. Term.
This Agreement will take effect on the Effective Date and will remain in
force through December 31, 2015 (the "Term") after which it shall automatically
be renewed for successive periods of one year each, unless terminated earlier
under provisions of this Article V or if notice of termination is given by
either Party at least one hundred twenty (120) days prior to the December 31st
anniversary each year after 2015.
Section 5.02. Termination By BME.
BME may terminate this Agreement by notice to ABI as follows:
(a) at any time with or without cause upon three months' prior written notice to
ABI;
(b) immediately, if the HBL Agreement is terminated; or
(c) immediately, if BME reasonably determines based upon the clinical trials and
after consultation with ABI that receipt of Governmental Approval for a Product
is unlikely.
Section 5.03. Termination by ABI.
ABI may terminate this Agreement by notice to BME, upon any of the
following conditions:
(a) if BME shall fail to make any payments to ABI on the date on which such
payments are due hereunder and such failure continues for more than 30 days
after BME's receipt of notice of such failure to pay; provided, however, that
this subsection (a) shall not apply to any payment, or portion thereof, under
this Agreement, which is the subject of a good faith dispute (a "Disputed
Amount") between BME and ABI. Any Disputed Amount shall be resolved by the
Parties within 30 days from the date BME notifies ABI of a good faith dispute;
provided, however, if the Disputed Amount cannot be resolved to the mutual
satisfaction of the Parties within such 30-day period then either Party may
request that the dispute be submitted to the Chief Executive Officers of ABI and
BME, respectively, or their designees, for joint resolution. If the Disputed
Amount is not jointly resolved by the Parties' Chief Executive Officers, or
their designees, within ten days after the submission thereto, then ABI shall be
entitled to pursue any and all remedies at law available to it. In no event will
the dispute resolution period for the activities set forth above exceed a
maximum of 60 days unless otherwise agreed in writing by the Parties. Further,
BME may in its discretion elect to pay any such Disputed Amount and in the event
such amount is finally determined not to have been payable by BME, ABI shall
reimburse BME for such amount, without interest; or
(b) if BME shall fail to deliver to ABI a Royalty Statement by the Royalty
Payment Date and shall fail to cure such default within 30 days after notice
from ABI with respect thereto; or
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(c) if BME shall commit any material breach of the provisions of this Agreement
other than a breach set forth in subsections (a) or (b) above, provided that ABI
has first given BME notice specifying the details of the material breach, and
BME has not cured such material breach, if such breach is capable of being cured
within such time period, within 45 days of the effective date of such notice; or
(d) if BME fails to market product in the Territory within six (6) months of the
Effective Date, provided all such product registration, governmental approvals,
manufacturing process etc. have been completed and BME has had reasonably
sufficient time to market the product; or
(e) immediately, if the HBL Agreement is terminated.
Section 5.04. Termination Upon Certain Events.
This Agreement may be terminated by the Party specified below immediately
upon written notice to the other Party of the occurrence of either of the
following events:
(a) by either Party upon a cessation of operations in the ordinary course of the
other Party or the institution by or against such Party as debtor of any
proceeding (whether voluntary or involuntary) in bankruptcy or for dissolution,
liquidation, reorganization, arrangement or the appointment of a receiver,
trustee or judicial administrator (or the equivalent thereof in the jurisdiction
in question) or any other proceeding under the law for the relief of debtors,
if, in the case of an involuntary proceeding, the same shall not have been
dismissed or stayed within 45 days after its institution; or
(b) by either Party if the other Party makes an assignment for the benefit of,
or arrangement with, its creditors or becomes unable to pay its debts as they
become due.
(c) A Party's failure to terminate this Agreement for any of the reasons
specified in this Section 5.04 shall not in any way be deemed a waiver of such
Party's rights in respect thereof or otherwise limit its rights to enforce the
obligations hereunder.
Section 5.05. Remedies.
All of the non-breaching Party's remedies shall be cumulative, and the
exercise of one remedy hereunder by the non-defaulting Party shall not be deemed
to be an election of remedies. These remedies shall include the non-breaching
Party's right to ▇▇▇ for damages for such breach without terminating this
Agreement.
Section 5.06. Effect of Termination.
In the event of termination of this Agreement:
(a) Neither Party shall be discharged from any liability or obligation to the
other Party that became due or payable prior to the effective date of such
termination;
(b) BME shall discontinue, and shall cause its Affiliates and sublicensees to
discontinue, the sale of the Product; and
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(c) In the event of termination by ABI under Section 5.03, all duties of ABI
(other than under Section 5.08) and all rights (but not duties) of BME (other
than under Section 5.08) under this Agreement shall immediately terminate
without the necessity of any action being taken either by ABI or by BME, and
BME shall have a period of six months to sell off its inventory of Product
existing on the date of termination and shall pay royalties to ABI with respect
to such Product sales within 30 days after the expiration of such six-month
period.
Section 5.07. Bankruptcy.
In the event that ABI as a debtor in possession, or a trustee in
bankruptcy under the U.S. Bankruptcy Code, rejects this Agreement or BME's right
to continue the licenses under this Agreement, BME may elect to retain its
license rights under the Agreement by paying all applicable fees, and otherwise
acting in accordance with Section 365(n) of the U.S. Bankruptcy Code.
Thereafter, neither ABI as debtor in possession, nor a trustee in bankruptcy,
shall interfere with the rights of BME to use the ABI Technology under this
Agreement.
Section 5.08. Continuing Obligations.
Expiration or termination of this Agreement shall not relieve the Parties
of any obligation accruing prior to such expiration or termination. Except as
otherwise set forth in this Agreement, the obligations and rights of the Parties
under Articles X, XII, XIII (other than Section 13.03), XV and Sections
5.06-5.09, 11.04 and 14.01 (for the period set forth therein) shall survive
expiration or termination of this Agreement.
Section 5.09. Return of Confidential Information.
Except to the extent necessary for BME to exercise its rights to the ABI
Technology under Sections 5.08 and 5.09, within 30 days following the expiration
or termination of this Agreement, each Party shall return to the other Party, or
destroy, upon the written request of the other Party, any and all Confidential
Information of the other Party in its possession and upon a Party's request,
such destruction (or delivery) shall be confirmed in writing to such Party by a
responsible officer of the other Party. Notwithstanding the provisions of this
Section 5.09, either Party may retain one (1) copy of such Confidential
Information for the sole purpose of determining its continuing confidentiality
obligation to the other Party under this Agreement.
ARTICLE VI:
SUPPLY, MANUFACTURE AND PURCHASE OF PRODUCT
Section 6.01. Supply of Product.
Subject to the terms of this Agreement, ABI agrees to Manufacture or cause
to be Manufactured for, and sell exclusively to BME in the Territory, BME's
total requirements for the Product in the Territory on the terms and conditions
set forth herein. ABI shall provide Product or Bulk IFN as directed in a
forecast by BME, at BME's sole discretion. Subject to notice to and prior
written approval of BME, which approval shall not be unreasonably withheld,
conditioned or delayed, ABI may, at BME's sole expense, subcontract any part of
the Manufacturing Process for the Product to Third Parties provided the Product
and the facilities used to Manufacture the Product continue to meet the
requirements set forth in this Agreement. If subcontracting is initiated by ABI,
BME will bear the cost of validation and necessary stability testing.
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Section 6.02. Supply and Manufacturing Rights.
During the Term, BME shall have the right to purchase Product or Bulk IFN
from ABI in accordance with the terms of this Agreement. BME shall have the
right to Manufacture Product from Bulk IFN.
Section 6.03. Quality Assurance.
ABI shall Manufacture or cause to be Manufactured the Product in
accordance with the Specifications and this Agreement. ABI shall promptly notify
BME in writing of any changes required by a Governmental Authority in the
Specifications or BME's quality assurance procedures that would render ABI or
its supplier unable to supply the Product in accordance with the terms of this
Agreement. The Parties agree to develop and execute an appropriate action plan
in such situation. Any additional costs or expenses shall be shared between the
Parties in such proportion as is equal to each Party's relative fault in causing
such change or changes to occur; provided, however, that if the Parties cannot
reach an agreement in good faith as to the relative fault of each Party or if
neither Party is at fault, such additional costs and expenses shall be born
equally by the Parties.
Section 6.04. ABI's Duties.
ABI agrees to furnish to BME with every Shipment a written certificate of
analysis and Certificate of Compliance that confirms conformity of the Product
to the Specifications and this Agreement. BME shall analyze each Shipment
promptly upon receipt in accordance with Section 8.02. In addition, ABI shall:
(a) provide BME with written sampling and testing procedures used by ABI or its
manufacturer to assure that the Product conforms to the Specifications;
(b) retain a sample of each batch of Product for a period equal to the greater
of (i) one year after the date of Manufacture of such batch of Product or (ii)
such period as required by Applicable Laws. Upon the request of BME, ABI shall
make such samples available to BME for inspection. The retained sample shall be
sufficient in size to allow BME to perform tests to determine whether the
Product meets the Specifications. ABI shall store the retained sample in
accordance with the Specifications and Applicable Law,
(c) maintain records to ensure BME's ability to perform a complete lot history
via lot tracing of the Product,
(d) keep on file all manufacturing records and analytical results pertaining to
the Manufacture of each batch of Product for a period expiring not earlier than
one year after the expiration date of the last lot of the last batch of Product
Manufactured and Shipped to BME. ABI shall make, and shall cause any Third Party
manufacturer to make, such records available to BME upon request,
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(e) provide BME with notice within 48 hours following ABI's receipt of
notification of any scheduled inspection, and as soon as possible following
ABI's receipt of notification of any unscheduled inspection, by any Governmental
Authority of ABI's facilities, books or records, or of the facilities, books or
records of any subcontractor being utilized by ABI to perform any portion or all
of the Manufacture or development of the Product. ABI shall inform such
Governmental Authority that BME may desire to be present at such inspection;
provided that BME's right to be present is subject to approval by such
Governmental Authority and subject to BME being available at the time and date
established by such Governmental Authority and, with respect to any inspection
of HBL's facilities, HBL's consent to the presence of BME at such inspection.
ABI shall use reasonable efforts to secure a time and date for such inspection
that is reasonably acceptable to BME; provided, however, that ABI alone shall
have the right to make the final decision on all such matters;
(f) maintain at its expense any and all licenses, permits and consents necessary
or required to perform its obligations under this Agreement; and
(g) ensure that all Products delivered, have a remaining shelf life from the
time of manufacture of not less than five years if refrigerated to at least 2-8
degrees Centigrade or two years, if maintained below 25 degrees centigrade.
Section 6.05. BME's Duties if Manufacturing.
BME agrees to furnish to ABI with every Shipment a written certificate of
analysis and Certificate of Compliance that confirms conformity of the Product
to the Specifications and this Agreement. ABI shall analyze each Shipment
promptly upon receipt in accordance with Section 8.02. In addition, BME shall:
(a) provide ABI with written sampling and testing procedures used by BME or its
manufacturer to assure that the Product conforms to the Specifications;
(b) retain a sample of each batch of Product for a period equal to the greater
of (i) one year after the date of Manufacture of such batch of Product or (ii)
such period as required by Applicable Laws. Upon the request of ABI, BME shall
make such samples available to ABI for inspection. The retained sample shall be
sufficient in size to allow ABI to perform tests to determine whether the
Product meets the Specifications. BME shall store the retained sample in
accordance with the Specifications and Applicable Law,
(c) maintain records to ensure ABI's ability to perform a complete lot history
via lot tracing of the Product,
(d) keep on file all manufacturing records and analytical results pertaining to
the Manufacture of each batch of Product for a period expiring not earlier than
one year after the expiration date of the last lot of the last batch of Product
Manufactured by BME. BME shall make, and shall cause any Third Party
manufacturer to make, such records available to ABI upon request.
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Section 6.06. Failure to Supply.
ABI shall immediately notify BME if ABI is unable to fill any purchase
order placed by BME pursuant to Section 7.06, and advise BME of the revised
delivery date. BME shall then have the option of terminating the purchase order
without obligation of payment or of accepting the revised delivery date. If ABI
is unable to cure to BME's reasonable satisfaction the circumstances giving rise
to such failure within 15 business days after such notice, BME shall not be
obligated to purchase any further Product from ABI under the then existing
forecasts.
Notwithstanding the foregoing, ABI shall not be deemed to be unable to
fill any order placed by BME if ABI's inability to fill any order arises as a
result of a 50% or greater increase in BME's order over BME's immediately prior
forecast. For example, if BME's forecast for the initial three-month period was
for 100 Units and BME's forecast for the second three-month period was for 200
Units, then, if after the time the second three-month forecast becomes firm
pursuant to Section 7.06(a), BME changed its forecast by the maximum amount
allowed of 100 Units (i.e., 50% times 200 Units), ABI would not be deemed to be
unable to supply Product for any amount in excess of 300 Units for such
three-month period
Section 6.07. Allocation.
If ABI is unable to supply all of the requirements of the Product, and
quantities ordered by BME in accordance with Section 7.06, then ABI shall
allocate the resources available to it so that BME receives at least its
proportional share of available supplies as determined based on reasonable
forecasts (taking into consideration past sales and sales performance against
forecast) of BME.
Section 6.08. Records and Audits.
During the Term and for a period of two years thereafter or such longer
period as is required in order for BME to comply with Applicable Law, ABI shall
keep complete and accurate records in sufficient detail to permit BME to confirm
the completeness and accuracy of the information presented in each invoice sent
to BME pursuant to this Agreement and all payments made by BME relying on such
invoices hereunder. ABI shall permit an independent, certified public accountant
reasonably acceptable to ABI to audit and/or inspect those records of ABI
(including financial records) that relate to such invoices for the sole purpose
of verifying the completeness and accuracy of such invoices during the preceding
calendar year. Such inspection shall be conducted during ABI's normal business
hours, no more than once in any 12-month period and upon at least ten days prior
written notice by BME to ABI. If such accounting firm concludes that such
payments were overpaid during the periods reviewed by such accountants, ABI
shall pay BME the amount of any such overpayments, plus interest at a rate equal
to the Prime Rate of Interest, within 30 days of the date BME delivers to ABI
such accounting firm's report so concluding that such payments were overpaid.
BME shall bear the full cost of such audit unless such audit discloses an
overpayment by more than 5% of the amount due during such period. In such case,
ABI shall bear the full cost of such audit.
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ARTICLE VII:
PURCHASE AND SALE
Section 7.01. Purchase Price and Payment.
ABI shall sell, and BME shall purchase, Product at a purchase price equal
to, the actual amount (exclusive of the Royalties as defined in the HBL
Agreement) paid to HBL under the HBL Agreement as in effect at the time of such
sale and purchase, plus ten percent (10%), and all other reasonable costs of
Manufacture actually paid by ABI with respect to such Product, plus ten percent
(10%), for all Product supplied by ABI to BME pursuant to this Agreement (the
"Purchase Price"). ABI shall invoice BME for all Product manufactured by ABI for
BME, which invoice shall be accompanied by reasonable documentation, i.e.,
invoices for amounts paid by ABI, supporting the amounts set forth in the
invoice, and payment shall be made to ABI before BME takes physical possession
of Product.
Section 7.02. Labeling and Artwork.
After execution of this Agreement, ABI shall review and comment on any
labeling and proposed changes to the labeling of the Product and shall be
entitled to participate in discussions with the Governmental Authorities
concerning any labeling or proposed labeling change so long as BME is purchasing
the Product from ABI. Notwithstanding the above, BME shall make the final
decision with regard to any labeling or labeling revisions
Both Parties will approve all artwork developed for inclusion in the
Product packaging, including carton labels, package inserts, etc., which
approval will not be unreasonably withheld, conditioned or delayed by either
Party. If BME wishes to institute changes in labeling artwork, both Parties will
develop a mutually acceptable implementation schedule. The actual cost of
implementing such change will be at BME's sole cost and expense, including any
materials made obsolete by BME's changes to the artwork. Neither Party shall
alter, change or in any way modify the artwork, which has previously been
approved, for any reason, without prior written authorization from the other
Party, which approval will not be unreasonably withheld, conditioned or delayed,
and provided that such approved artwork shall conform to all Applicable Laws.
Section 7.03. Purchase Forms.
Purchase orders, purchase order releases, confirmations, acceptances and
similar documents submitted by a Party in conducting the activities contemplated
under this Agreement are for administrative purposes only and shall not add to
or modify the terms of the Agreement. To the extent of any conflict or
inconsistency between this Agreement and any such document, the terms of this
Agreement shall govern.
Section 7.04. Confirmation.
ABI shall confirm each purchase order within ten business days from the
date of receipt of a purchase order and shall supply the Product within a
maximum of 30 days from the date of acceptance of a purchase order, or later if
so specified in the purchase order. Failure of ABI to confirm any purchase order
shall not relieve ABI of its obligation to supply Product ordered by BME in
conformity with this Agreement.
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Section 7.05. Delivery.
Delivery for Product shall be at ABI's or its subcontractor's facility,
which is currently located in Okayama, Japan, or Canada or such other location
designated by ABI as BME may agree to in writing. Product shall be delivered,
not cleared for export, to the carrier nominated by BME at the designated
location, and BME, or its designated carrier, shall be responsible for loading.
ABI shall ship Product in accordance with BME's purchase order form or as
otherwise directed by BME in writing. Title to any Product purchased by BME
shall pass to BME upon the earlier of (a) a common carrier accepting possession
or control of such Product, or (b) passage of such Product from the loading dock
of ABI's or its subcontractor's facilities to BME or its agent.
Section 7.06. Forecasts and Orders.
Not later than six months after submission of the NDA for a Product or
other applicable regulatory filing on a country-by-country basis, BME will
provide ABI with a 12-month forecast of BME's requirement of each Product, which
forecast will include designation of whether such Product shall be provided in
bulk or Unit form, for which an NDA, or other applicable regulatory filing, has
been submitted, on a Product basis, as follows:
(a) During the period commencing six months after submission of an NDA, or other
applicable regulatory filing, for a Product through the end of the fourth full
calendar quarter following the First Commercial Sale of that Product, the
forecasts shall be provided quarterly, no less than 45 days prior to the
beginning of each quarter. Said requirements will be based on standard
production planning parameters, including sales forecasts, sales demand
forecasts, promotional forecasts, inventory requirements, and the like. The
first two quarters of the 12-month forecast will be stated in monthly
requirements. The second two quarters of the 12-month forecast will be total
requirement by stock keeping unit and will be stated as quarterly requirements.
The first three months of the 12-month forecast will be firm orders to purchase.
The second three months will be allowed to be flexed from the previous forecast
by plus or minus 25% per month until fixed by the subsequent forecast; provided
that the aggregate adjustment from the quantity set forth in the previous
forecast for such three-month period shall not exceed 50% in aggregate during
that three-month period. For example, if BME's forecast for the first three
months was for 100 Units and its forecast for the second three months was for
200 Units, the maximum number of Units BME could order at the time the second
three-month period becomes fixed would be 300 Units (i.e., 50% of 200 Units plus
the 200 Units originally forecast). The last two quarters of any 12-month
forecast will be an estimate and not binding.
(b) Following the end of the fourth full calendar quarter following the First
Commercial Sale of a Product, BME will provide to ABI a rolling 12-month
forecast for each Product with the first three months of the rolling 12-month
forecast a firm order to purchase. Each forecast under this subsection (ii)
shall be provided monthly, no less than 20 days prior to the beginning of each
month. All orders will be for full batch quantities.
CONFIDENTIAL
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with the Commission.
It is understood that ABI will not maintain Product inventory in excess of
the applicable forecast, but will produce Product upon receipt of that portion
of BME's forecasts that constitute firm orders to purchase. Nothing in this
Agreement shall obligate ABI to deliver Product if HBL is unable for any reason
to provide Product.
BME agrees to purchase a sufficient amount of Product to enable BME to
carry sufficient inventory to allow for fluctuations in sales demand so as to
allow ABI reasonable lead-time to meet increased demand. ABI will use
commercially reasonable efforts to meet any increase in demand in excess of the
allowed adjustment, but will not be obligated to do so. All forecasts will be
made by BME to ABI in good faith based upon standard commercial parameters. From
time to time after the Effective Date, the Parties shall consider whether, in
light of market demand, manufacturing capacity, inventory levels and other
pertinent factors, to revise the schedule for delivery of forecasts and, if
appropriate, negotiate in good faith to revise such schedule.
ARTICLE VIII:
WARRANTY, REJECTION AND INSPECTIONS
Section 8.01. ABI Warranty
ABI represents and warrants to BME that the Product delivered pursuant to
this Agreement (a) shall comply with the Specifications and this Agreement and
conform to the certificate of analysis for each such Product; (b) are not
adulterated or misbranded under Applicable Laws; and (c) at the time of
Manufacture and Shipment to BME, will be and are free from any failure or
defects.
EXCEPT AS OTHERWISE SET FORTH HEREIN, ABI MAKES NO OTHER WARRANTIES OF ANY
OTHER KIND, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY OR
FITNESS OF THE PRODUCT FOR ANY PURPOSE, AND ABI EXPRESSLY DISCLAIMS ANY SUCH
OTHER WARRANTIES WITH RESPECT TO THE PRODUCT, EITHER EXPRESSED OR IMPLIED.
Section 8.02. Rejection of Product for Failure to Conform to Specifications.
BME shall have 45 days after the receipt of any Shipment to determine
conformity of the Shipment to the Specifications and/or Applicable Laws, except
for hidden defects. A "hidden defect" shall mean a defect in the Product not
discovered by BME during its testing of the Product in accordance with generally
accepted industry testing procedures and which would not be a defect normally
expected to be discovered in accordance with such testing. If testing of such
Shipment shows a failure of the Shipment to meet the Specifications and/or
Applicable Laws, BME may return the entire Shipment, or any portion thereof, to
ABI at ABI's expense within a reasonable time following the above described
testing, provided that notice of non-conformity is received by ABI from BME
within 45 days of BME's receipt of said Shipment. BME shall have the right to
request that ABI provide to BME, within 30 days after such notice is received by
it, Product that meets the Specifications and Applicable Laws or to promptly
provide BME with full credit for the Purchase Price paid by BME for the returned
Product. In the case of a hidden defect, BME shall have the right to request
that ABI provide to BME, within thirty (30) days after a notice concerning a
hidden defect is received by BME, Product that meets the Specifications and
Applicable Laws or to promptly provide BME with full credit for the Purchase
Price paid by BME for the returned Product. In either case, the cost of freight
and handling to return or replace Product or shall be at the expense of ABI. If
BME does not notify ABI of the non-conformity of the Product within 45 days of
receipt of said Shipment, the Product shall be deemed to meet the Specifications
(including those related to packaging of the Product) and Applicable Laws,
except with respect to hidden defects. Notwithstanding anything in this
Agreement to the contrary, the Parties may agree to a return of the Product or
an adjustment in the Purchase Price in the event of any failure or defect in the
Product. Should there be a discrepancy between BME's test results and the
results of testing performed by ABI, such discrepancies shall be finally
resolved by testing performed by an independent Third Party mutually agreed upon
by BME and ABI. The costs of such testing shall be borne by the Party against
whom the discrepancy is resolved. In the event Product have been previously
returned to ABI and such independent Third Party determines that the Product
meets the Specifications, BME shall be responsible for all costs associated with
the return.
CONFIDENTIAL
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with the Commission.
Section 8.03. BME Inspections.
ABI shall, and shall cause HBL or other subcontractors of ABI used to
Manufacture the Product to, upon reasonable (but not less than fifteen (15)
days) prior written notice by BME and during normal business hours, allow BME to
inspect and audit ABI's facilities and the facilities of HBL or other
subcontractors of ABI used to Manufacture the Product, twice annually, to
confirm that the such facilities and the equipment, personnel and operating and
testing procedures used by ABI or such subcontractors in the Manufacture,
testing, storage and distribution of the Product are in compliance with
Applicable Laws and the Governmental Approvals; provided that such inspection
does not interfere with ABI's or such subcontractor's normal operations or cause
ABI or such subcontractor's to violate or be in breach of any confidentiality
agreements with any Third Parties.
ARTICLE IX:
REGULATORY COMPLIANCE
Section 9.01. Maintenance of Marketing Authorizations.
BME will own all Marketing Authorizations. BME agrees, at its sole cost
and expense, to maintain the Marketing Authorizations including obtaining any
variations or renewals thereof, including all fees and licenses, including user
fees, related to the Manufacture of the Product by BME. Each Party agrees that
neither it nor its Affiliates or permitted sublicensees will do anything to
adversely affect a Marketing Authorization.
Section 9.02. Adverse Drug Event Reporting and Phase IV Surveillance.
Each Party, including its permitted sublicensees, shall advise the other
Party, by telephone or facsimile, immediately but in no event later than 24
hours after a Party, or its sublicensees, becomes aware of any potentially
serious or unexpected adverse event (including adverse drug experiences, as
defined in Applicable Laws) involving the Product (each, an "ADE"). Such
advising Party shall provide the other Party with a written report delivered by
confirmed facsimile of any adverse reaction, stating the full facts known to
such Party, including customer name, address, telephone number, batch, lot and
serial numbers, and other information as required by Applicable Laws. During the
Term, BME shall have full responsibility for (i) monitoring such adverse
reactions; and (ii) data collection activities that occur between BME and the
patient or medical professional, as appropriate, including any follow-up
inquiries which BME or ▇▇▇ ▇▇▇▇ necessary or appropriate.
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with the Commission.
In the event either Party requires information, regarding adverse drug
events with respect to reports required to be filed by it in order to comply
with Applicable Laws, including obligations to report ADEs to the Governmental
Authorities, each Party agrees to provide such information to the other on a
timely basis.
The Parties agree to follow BME's standard operating procedure for
reporting and identifying adverse drug reactions (the "SOP") in effect from time
to time, a copy of which BME will provide to ABI. In the event the SOP is
modified or amended during the Term, BME shall provide ABI with copies of any
such modification or amendment to the SOP for ABI's prior approval, which will
not be unreasonably withheld, conditioned or delayed, at least five business
days prior to such amendment taking effect. BME shall designate a qualified
person under Applicable Laws to be responsible for ADE reporting in each country
in the Territory.
If the report of an ADE causes a Governmental Authority to request a
labeling revision as a result of an ADE or that a Phase IV surveillance program
be conducted, then the Parties shall promptly enter into discussions and shall
mutually agree on all of the material terms and conditions of such labeling
revision or Phase IV surveillance program; provided, however the costs of such
labeling revision or Phase IV surveillance program shall be paid by BME. BME
shall have the authority to make the final decision with regard to any labeling
revisions provided that BME will consider, in making its decision, the effect
any such labeling revisions will have on the marketing and sale of the Product
outside the Territory. BME agrees that should Applicable Laws require that any
such interim data and results from such Phase IV surveillance programs be
prepared in written form, BME shall comply with such requirements and provide
all such information in writing to ABI and the Governmental Authorities in
accordance with Applicable Laws. BME further agrees that ABI shall have the
right to incorporate, refer to and cross-reference such results and underlying
data in any regulatory filing or any other filing or requirement ABI is required
to undertake with respect to the Product, if any.
Section 9.03. Commercial Sale Testing and Reporting.
If, after the date of First Commercial Sale in any country in the
Territory, a Governmental Authority requires (a) additional testing,
modification or communication related to approved indications of the Product or
(b) BME to conduct a Phase IV study as a condition to receiving a Marketing
Authorization, then BME shall design and implement any such testing,
modification or communication and the costs shall be paid by BME.
Section 9.04. Assistance.
Each Party shall provide reasonable assistance to the other at the other's
request, in connection with their obligations pursuant to this Article IX,
subject to reimbursement of all of its out-of-pocket costs by the requesting
Party.
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with the Commission.
Section 9.05. Compliance.
BME shall be responsible for compliance with Applicable Laws and the
Governmental Approvals relating to the design, possession, promotion, marketing,
sale, advertising and distribution of the Product and Units, including obtaining
all necessary permits, licenses and any other requirements relating to the
import, sale and distribution of the Product. ABI shall be responsible for
compliance with Applicable Laws and Governmental Approvals relating to the
Manufacture of the Product, as applicable, and with cGMP relating to the
Manufacture and testing of the Product, as applicable. BME and ABI shall comply
with all Applicable Laws within the Territory as set forth in this Agreement,
including the provision of information by BME and ABI to each other necessary
for ABI and BME to comply with any applicable reporting requirements. Each Party
shall promptly notify the other Party of any comments, responses or notices
received from, or inspections by, the FDA, or other Governmental Authority,
which relate to or may impact the Product or the Manufacture of the Product or
the sales and marketing of the Product, and shall promptly inform the other
Party of any responses to such comments, responses, notices or inspections and
the resolution of any issue raised by the FDA or other Governmental Authority.
ARTICLE X:
REPRESENTATIONS, WARRANTIES AND COVENANTS
Section 10.01. Corporate Power.
Each Party hereby represents and warrants that such Party is duly
organized and validly existing under the laws of the state of its incorporation
and has full corporate power and authority to enter into this Agreement and to
carry out the provisions hereof.
Section 10.02. Due Authorization.
Each Party hereby represents and warrants that such Party is duly
authorized to execute and deliver this Agreement and to perform its obligations
hereunder.
Section 10.03. Binding Obligation.
Each Party hereby represents and warrants that this Agreement is a legal
and valid obligation binding upon it and is enforceable in accordance with its
terms. 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 may be bound, nor violate any law
or regulation of any court, governmental body or administrative or other agency
having authority over it.
Section 10.04. Ownership of ABI Rights.
As of the Effective Date, ABI represents and warrants that (a) it has all
right, title and interest in and to HBL IFN and the ABI Technology necessary to
grant BME the licenses hereunder, (b) except for those rights granted to
Existing Licensees under the Existing Licenses and except with respect to BME,
it has not granted any license to any Third Party under the ABI Technology (or
any component thereof) and is under no obligation to grant any such license, (c)
there are no outstanding liens, encumbrances, agreements or understanding of any
kind, either written, oral or implied, regarding either the ABI Technology, any
component thereof or the rights of ABI in and to HBL IFN pursuant to the HBL
Agreement.
CONFIDENTIAL
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with the Commission.
Section 10.05. Material Agreements.
ABI represents and warrants that:
(a) each Material Agreement is valid, binding, and enforceable in accordance
with its terms against ABI and, to the knowledge of ABI, each other party
thereto, and is in full force and effect.
(b) ABI has performed in all material respects all obligations imposed on it
under each Material Agreement and neither ABI nor to the knowledge of ABI, any
other party to a Material Agreement is in material default under any Material
Agreement nor is there any event that with notice or lapse of time, or both,
would constitute a material default by ABI, or, to the knowledge of ABI, any
other party thereunder;
(c) true and complete copies of each Material Agreement, including any
amendments thereto, have been delivered to BME or its counsel by ABI,
(d) each of the HBL Agreement and the TAMU Agreement were duly and validly
executed in accordance with Applicable Law and no Person is materially
renegotiating any amount paid or payable under either agreement or any material
term or provision of the HBL Agreement or the TAMU Agreement.
Section 10.06. Adverse Properties.
ABI represents and warrants that it knows of no adverse effects or other
properties that may raise objections from the FDA or other Governmental
Authorities or may affect the use, effectiveness or merchantability of the
Product.
Section 10.07. Preservation of Name and Reputation.
During the Term, each of the Parties shall endeavor to preserve the good
name and reputation of the other Party and shall conduct itself in a manner as
to maintain the good name and reputation of the other Party.
Section 10.08. Debarment.
During the Term, neither of the Parties shall utilize any employee,
representative, agent, assistant or associate who has been debarred pursuant to
the Act in connection with any of the activities to be carried out under this
Agreement.
CONFIDENTIAL
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Section 10.09. Limitation on Warranties.
Neither Party makes any warranties, express or implied, concerning the
success or commercial utility of the Product.
Section 10.10. Limitation of Liability.
EXCEPT FOR WILLFUL MISCONDUCT, GROSS NEGLIGENCE, BREACHES BY A PARTY OF
SECTION 15.01 OR INFRINGEMENT OF THIRD PARTY PROPRIETARY RIGHTS, NEITHER PARTY
SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL,
CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY
LICENSE GRANTED HEREUNDER.
ARTICLE XI:
PATENTS AND TRADEMARK
Section 11.01. Filing, Maintenance and Protection of Patents.
ABI shall, at BME's expense, file, maintain and protect the ABI Patent
Rights, if any, in the Territory during the Term; provided however, that upon
written request by ABI, BME shall, at BME's cost or expense, provide such
assistance as may be necessary to enable ABI to comply with the administrative
formalities necessary to maintain any ABI Patent Rights.
Section 11.02. Cooperation.
BME shall, at BME's cost or expense, make available to ABI or its
authorized attorneys, agents or representatives, its employees, agents or
consultants necessary or appropriate to enable ABI to file, prosecute and
maintain patent applications for a period of time sufficient for ABI to obtain
the assistance needed from such personnel.
Section 11.03. ABI to Prosecute Infringement.
During the Term, each Party shall give prompt notice to the other of any
Third Party act that may infringe the ABI Patent Rights and shall cooperate with
each other to terminate such infringement without litigation. ABI shall, at its
sole expense, prosecute the judicial or administrative proceedings against such
Third Party infringement. BME shall provide such assistance and cooperation to
ABI as may be necessary to successfully prosecute any action against Third Party
infringement at ABI's expense and may deduct the expenses thereof from any
amounts payable to ABI under this Agreement.
In the event ABI fails to institute proceedings and terminate any Third
Party infringement of the ABI Patent Rights within 45 days after the later of
(i) receiving notice from BME of any such infringement or (ii) sending notice to
ABI of such infringement, BME may take (but shall have no obligation to do so)
such action as it deems appropriate, including without limitation, the filing of
a lawsuit against such Third Party. In such event ABI will provide such
assistance and cooperation to BME as may be necessary, at ABI's expense, and BME
may deduct all costs and expenses incurred in connection with such action, not
otherwise recovered in connection with such action or paid or reimbursed to BME,
from any amount payable to ABI under this Agreement and retain all amounts
awarded in such action. BME may settle any such claim so long as the terms of
such settlement do not impair ABI's rights hereunder or ABI's rights in the ABI
Technology.
CONFIDENTIAL
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Section 11.04. Infringement Claimed by Third Parties.
In the event a Third Party commences, or threatens to commence, a judicial
or administrative proceeding against a Party to this Agreement and such
proceeding claims that the ABI Technology infringes such Third Party's
intellectual property rights, the Party against whom such proceeding is
threatened or commenced shall give prompt notice to the other Party. ABI shall,
at its sole expense, defend such claims or proceedings and BME shall provide
such assistance and cooperation to ABI as may be necessary to successfully
defend any such claim or proceeding at ABI's expense. ABI may settle any such
claim so long as the terms of such settlement contains a complete release of BME
and do not impair BME's rights hereunder, increase the costs to BME hereunder or
require any relief other than monetary damages. Notwithstanding the above, if
such claim or proceeding relates to or arises from the actions, activities or
omissions of BME other than the use by BME of the ABI Technology, then BME shall
defend such claims or proceedings, at BME's sole expense, and BME shall
indemnify ABI for any liabilities, costs and expenses, including, without
limitation, attorneys' fees, incurred with respect to such claim or proceeding.
Section 11.05. Trademark.
If BME uses a trademark in Malaysia provided by ABI, then BME will
compensate ABI with an additional **** percent (****%) royalty on Net Sales.
ARTICLE XII:
COVENANTS OF BME AND ABI
Section 12.01. Access to Books and Records.
BME shall permit ABI, at ABI's expense and during normal business hours,
to exercise the inspection rights granted to ABI by BME under Section 4.06.
Section 12.02. Further Actions.
Upon the terms and subject to the conditions hereof, each of the Parties
hereto shall use its commercially reasonable efforts to (a) take, or cause to be
taken, all appropriate action and do, or cause to be done, all things necessary,
proper or advisable under Applicable Law or otherwise to consummate and make
effective the transactions contemplated by this Agreement, (b) obtain from
Governmental Authorities any consents, licenses, permits, waivers, approvals,
authorizations or orders required to be obtained or made by the Parties in
connection with the authorization, execution and delivery of this Agreement and
the consummation of the transactions contemplated by this Agreement and (c) make
all necessary filings, and thereafter make any other required submissions, with
respect to this transaction under (i) the Securities Exchange Act of 1934, as
amended and the Securities Act of 1933, as amended, and the rules and
regulations thereunder and any other applicable federal or state securities laws
and (ii) any other Applicable Law. The Parties hereto shall cooperate with each
other in connection with the making of all such filings, including by providing
copies of all such documents to the other Party's counsel (subject to
appropriate confidentiality restrictions) prior to filing and, if requested, by
accepting all reasonable additions, deletions or changes suggested in connection
therewith. Without limiting the generality of the foregoing, each Party shall
take or omit to take such action as the other Party shall reasonably request to
cause the Parties to obtain any material Governmental Approvals and/or the
expiration of applicable waiting periods, provided that the foregoing shall not
obligate either Party to take or to omit to take any action (including, without
limitation, the expenditure of funds or any holding separate and agreeing to
sell or otherwise dispose of assets, categories of assets or businesses) as in
the good faith opinion of such Party, would cause a material adverse effect on a
Party.
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Section 12.03. Equitable Relief.
The Parties understand and agree that because of the difficulty of
measuring economic losses to the non-breaching Party as a result of a breach of
the covenants set forth in this Article XII or Section 15.01, and because of the
immediate and irreparable damage that may be caused to the non-breaching Party
for which monetary damages would not be a sufficient remedy, the Parties agree
that the non-breaching Party will be entitled to seek specific performance,
temporary and permanent injunctive relief, and such other equitable remedies to
which it may then be entitled against the breaching Party. This Section 12.03
shall not limit any other legal or equitable remedies that the non-breaching
Party may have against the breaching Party for violation of the covenants set
forth in this Article XII or Section 15.01. The Parties agree that the
non-breaching Party shall have the right to seek relief for any violation or
threatened violation of this Article XII or Section 15.01 by the breaching Party
from any court of competent jurisdiction in any jurisdiction authorized to grant
the relief necessary to prohibit the violation or threatened violation of this
Article XII or Section 15.01. This Article XII shall apply with equal force to
the breaching Party's Affiliates.
ARTICLE XIII:
INDEMNIFICATION
Section 13.01. BME Indemnified by ABI.
ABI shall indemnify and hold BME harmless from and against any liabilities
or obligations, damages, losses, claims, encumbrances, costs or expenses
(including attorneys' fees) (any or all of the foregoing herein referred to as
"Loss") insofar as a Loss or actions in respect thereof, whether existing or
occurring prior to, on or subsequent to the Effective Date, arises out of or is
based upon (a) any misrepresentation or breach of any of the warranties,
covenants or agreements made by ABI in this Agreement; (b) the Manufacture of
any Product that is identifiable as having been Manufactured by or on behalf of
ABI; (c) any claims that a Product (as a result of the use of the ABI Technology
therein) or its Manufacture (as a result of the use of ABI Technology therein),
use or sale infringes the patent, trademark or other intellectual property right
of a Third Party.
CONFIDENTIAL
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Section 13.02. ABI Indemnified by BME.
BME shall indemnify and hold harmless ABI from and against any Loss
insofar as such Loss or actions in respect thereof occurs subsequent to the
Effective Date, whether existing or occurring prior to, on or subsequent to the
date hereof, arises out of or is based upon (a) any misrepresentation or breach
of any of the warranties, covenants or agreements made by BME in this Agreement
or (b) BME's material violation of any Applicable Law.
Section 13.03. Prompt Notice Required.
No claim for indemnification hereunder shall be valid unless notice of the
matter which may give rise to such claim is given in writing by the persons
seeking indemnification (the "Indemnitee") to the persons against whom
indemnification may be sought (the "Indemnitor") as soon as reasonably
practicable after such Indemnitee becomes aware of such claim; provided that the
failure to notify the Indemnitor shall not relieve it from any liability which
it may have to the Indemnitee otherwise than under this Article XII. Such notice
shall state that the Indemnitor is required to indemnify the Indemnitee for a
Loss and shall specify the amount of Loss and relevant details thereof. The
Indemnitor shall notify Indemnitee no later than 60 days from such notice of its
intention to assume the defense of any such claim. In the event the Indemnitor
fails to give such notice within that time, the Indemnitor shall no longer be
entitled to assume such defense.
Section 13.04. Indemnitor May Settle.
The Indemnitor shall at its expense, have the right to settle and defend,
through counsel reasonably satisfactory to the Indemnitee, any action which may
be brought in connection with all matters for which indemnification is
available. In such event, the Indemnitee of the Loss in question and any
successor thereto shall permit the Indemnitor full and free access to its books
and records and otherwise fully cooperate with the Indemnitor in connection with
such action; provided that this Indemnitee shall have the right fully to
participate in such defense at its own expense. The defense by the Indemnitor of
any such actions shall not be deemed a waiver by the Indemnitor of its right to
assert a claim with respect to the responsibility of the Indemnitor with respect
to the Loss in question. The Indemnitor shall have the right to settle or
compromise any claim against the Indemnitee without the consent of the
Indemnitee provided that the terms thereof: (a) provide for the unconditional
release of the Indemnitee; (b) require the payment of compensatory monetary
damages by Indemnitor only; and (c) expressly state that neither the fact of
settlement nor the settlement agreement shall constitute, or be construed or
interpreted as, an admission by the Indemnitee of any issue, fact, allegation or
any other aspect of the claim being settled. No Indemnitee shall pay or
voluntarily permit the determination of any liability, which is subject to any
such action while the Indemnitor is negotiating the settlement thereof or
contesting the matter, except with the prior written consent of the Indemnitor,
which consent shall not be unreasonably withheld or delayed. If the Indemnitor
fails to give Indemnitee notice of its intention to defend any such action as
provided herein, the Indemnitee involved shall have the right to assume the
defense thereof with counsel of its choice, at the Indemnitor's expense, and
defend, settle or otherwise dispose of such action. With respect to any such
action, which the Indemnitor shall fail to promptly defend, the Indemnitor shall
not thereafter question the liability of the Indemnitor hereunder to the
Indemnitee for any Loss (including counsel fees and other expenses of defense).
CONFIDENTIAL
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ARTICLE XIV:
DISPUTE RESOLUTION
Section 14.01. Disputes.
The Parties recognize that disputes as to certain matters may from time to
time arise during the Term, which relate to either Party's rights and/or
obligations hereunder. It is the objective of the Parties to establish
procedures to facilitate the resolution of disputes arising under this Agreement
in an expedient manner by mutual cooperation and without resort to litigation.
To accomplish this objective, the Parties agree to follow the procedures set
forth in this Article XIV if and when a dispute arises under this Agreement.
Unless otherwise specifically recited in this Agreement, disputes among
the Parties will be resolved as recited in this Article XIV. Disputes among the
Parties first shall be presented to the chief executive officers of ABI and BME,
or their respective designees, for resolution. In the event that the chief
executive officers of ABI and BME, or their respective designees, cannot resolve
the dispute within ten days of being requested by a Party to resolve a dispute,
either Party may, by written notice to the other, invoke the provisions of
Section 14.02.
Section 14.02. Trial Without Jury.
If the Parties fail to resolve the dispute through negotiation in
accordance with Section 14.01, each Party shall have the right to pursue any of
the remedies legally available to resolve the dispute; provided, however, that
the Parties expressly waive any right to a jury trial in any legal proceedings
under this Section 14.02.
Section 14.03. Performance to Continue.
Each Party shall continue to perform its obligations under this Agreement
pending final resolution of any dispute arising out of or related to this
Agreement; provided, however, that a Party may suspend performance of its
obligations during any period in which the other Party fails or refuses to
perform its obligations.
Section 14.04. Provisional Remedies.
Although the procedures specified in this Article XIV are the sole and
exclusive procedures for the resolution of disputes arising out of or related to
this Agreement, either Party may seek a preliminary injunction or other
provisional equitable relief, if, in its reasonable judgment, such action is
necessary to avoid irreparable harm to itself or to preserve its rights under
this Agreement.
Section 14.05. Determination of Patents and Other Intellectual Property.
Notwithstanding the foregoing, any dispute relating to the determination
of validity of claims, infringement or claim interpretation relating to a
Party's patents shall be submitted exclusively to federal court.
CONFIDENTIAL
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with the Commission.
ARTICLE XV:
CONFIDENTIALITY
Section 15.01. Confidentiality.
During the Term and for a period of five years thereafter, each Party
shall maintain all Confidential Information of the other Party as confidential
and shall not disclose any such Confidential Information to any Third Party or
use any such Confidential Information for any purpose, except (a) as expressly
authorized by this Agreement, (b) as required by law, rule, regulation or court
order (provided that the disclosing Party shall first notify the other Party and
shall use commercially reasonable efforts to obtain confidential treatment of
any such information required to be disclosed), or (c) to its Affiliates and its
employees, agents, consultants and other representatives ("Representatives") to
accomplish the purposes of this Agreement, so long as such persons are under an
obligation of confidentiality no less stringent than as set forth herein. Each
Party may use such Confidential Information only to the extent required to
accomplish the purposes of this Agreement. Each Party shall use at least the
same standard of care as it uses to protect its own Confidential Information to
ensure that it and its Affiliates and Representatives do not disclose or make
any unauthorized use of the other Party's Confidential Information. Each Party
shall be responsible for any breach of this Agreement by its Representatives.
Each Party shall promptly notify the other Party upon discovery of any
unauthorized use or disclosure of the other Party's Confidential Information.
Section 15.02. Publicity Review.
The Parties agree that the public announcement of the execution of this
Agreement shall be in the form of press releases issued by each of the Parties
on or before the Effective Date and thereafter each Party shall be entitled to
make or publish any public statement consistent with the contents thereof. The
Parties acknowledge the importance of supporting each other's efforts to
publicly disclose results and significant developments regarding the Product.
The principles to be observed by ABI and BME in such public disclosures will be:
accuracy, compliance with FDA regulations and other FDA guidance documents and
other Applicable Laws, the advantage a competitor of ABI or BME may gain from
any public statements under this Section 15.02, and the standards and customs in
the biotechnology and pharmaceutical industries for such disclosures by
companies comparable to ABI and BME. The terms of this Agreement may also be
disclosed by a Party to: (a) government agencies where required by law,
including filings required to be made by law with the United States Securities
and Exchange Commission ("SEC"), (b) Third Parties with the prior written
consent of the other Party, which consent shall not be unreasonably withheld, or
(c) lenders, investment bankers and other financial institutions solely for
purposes of financing the business operations of such Party, so long as such
disclosure in (b) and (c) above is made under an agreement of confidentiality at
least as restrictive as the confidentiality provisions in Section 15.01, to the
extent possible highly sensitive terms and conditions such as financial terms
are extracted from the Agreement (including in any disclosure required by law or
the SEC) or deleted upon the request of the other Party, and as the disclosing
Party gives reasonable advance notice of the disclosure under the circumstances
requiring the disclosure.
CONFIDENTIAL
**** Indicates that a portion of the text has been omitted and filed separately
with the Commission.
ARTICLE XVI:
MISCELLANEOUS
Section 16.01. Commercially Reasonable Efforts.
Each Party shall use commercially reasonable and diligent efforts to
perform its responsibilities under this Agreement. As used herein, the term
"commercially reasonable and diligent efforts" means, unless the Parties agree
otherwise, those efforts consistent with the exercise of prudent scientific and
business judgment, as applied to other products of similar scientific and
commercial potential within the relevant product lines of the Parties.
Section 16.02. Notices.
All notices, requests and other communications to any party hereunder
shall be in writing and shall be deemed to have been given if delivered
personally, mailed by certified mail (return receipt requested) or sent by
cable, telegram or recognized overnight delivery service to the parties at the
following addresses or at such other addresses as, specified by the parties by
like notice:
If to ABI : ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Chairman & CEO
Amarillo Biosciences, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
With a copy to:▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, Legal Counsel
SandersBaker, PC
▇▇▇ ▇. ▇▇▇▇, ▇▇▇. ▇▇▇
▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
If to BME: ▇▇▇▇▇ ▇▇▇▇, Chief Executive Officer
Bumimedic (Malaysia) Sdn. Bhd.
▇▇. ▇, ▇▇▇▇▇ ▇▇/▇, ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇
Facsimile: ▇▇▇-▇▇▇▇-▇▇▇▇
Telephone: ▇▇▇-▇▇▇▇-▇▇▇▇
Notice so given shall be deemed given and received (i) if by mail on the
15th day after posting; (ii) by cable, telegram, telex or personal delivery on
the date of actual transmission, with evidence of transmission acceptance, or
(as the case may be) personal or other delivery; and (iii) if by overnight
delivery courier, on the next business day following the day such notice is
delivered to the courier service.
CONFIDENTIAL
**** Indicates that a portion of the text has been omitted and filed separately
with the Commission.
Section 16.03. Severability.
Whenever possible, each clause, subclause, provision or condition of this
Agreement shall be interpreted in such manner as to be effective and valid under
applicable law, but if any clause, subclause, provision or condition of this
Agreement should be prohibited or invalid under applicable law, such clause,
subclause, provision or condition shall be considered separate and severable
from this Agreement to the extent of such prohibition or invalidity without
invalidating the remaining clauses, subclauses, provisions and conditions of
this Agreement.
Section 16.04. Entire Agreement/Merger.
This Agreement sets forth the entire agreement between the Parties hereto
pertaining to the subject matter hereof and supersedes all negotiations,
preliminary agreements, memoranda or letters of proposal or intent, discussions
and understandings of the Parties hereto in connection with the subject matter
hereof. All discussions between the Parties have been merged into this
Agreement, and neither Party shall be bound by any definition, condition,
understanding, representation, warranty, covenant or provision other than as
expressly stated in or contemplated by this Agreement or as subsequently shall
be set forth in writing and executed by a duly authorized representative of the
Party to be bound thereby.
Section 16.05. Amendment.
No amendment, change or modification of any of the terms, provisions or
conditions of this Agreement shall be effective unless made in writing and
signed on behalf of the Parties hereto by their duly authorized representatives.
Section 16.06. Counterparts.
This Agreement may be executed in one or more counterparts, each of which
shall be deemed to be an original document, but all such separate counterparts
shall constitute only one and the same instrument. This Agreement may be signed
and delivered to the other Party by facsimile signature; such transmission shall
be deemed a valid signature.
Section 16.07. No Waiver of Rights.
No waiver of any term, provision, or condition of this Agreement, whether
by conduct or otherwise, in any one or more instances, shall be deemed to be or
construed as a further or continuing waiver of any such term, provision, or
condition of this Agreement.
CONFIDENTIAL
**** Indicates that a portion of the text has been omitted and filed separately
with the Commission.
Section 16.08. Force Majeure.
Neither Party shall be liable hereunder to the other Party nor shall be in
breach for failure to deliver, provided failure to deliver is no greater than
the delay in time caused by circumstances beyond the control for either Party,
including acts of God, fires, floods, riots, wars, civil disturbances, sabotage,
accidents, labor disputes, shortages, government actions (including priorities,
requisitions, allocations and price adjustment restrictions) and inability to
obtain material, equipment, labor or transportation (collectively, "Force
Majeure").
Section 16.09. Further Assurances.
The Parties hereto shall each perform such acts, execute and deliver such
instruments and documents and do all such other things as may be reasonably
necessary to accomplish the transactions contemplated in this Agreement.
Section 16.10. Assignment and Sublicense.
Neither this Agreement nor any of the rights, interests, options or
obligations hereunder may be assigned, sublicensed or delegated by either of the
Parties without the prior written consent of the other Party, provided, however,
that either BME or ABI may, without such consent, assign this Agreement and its
rights and obligations hereunder in connection with the transfer or sale of all
or substantially all of its business pertaining to this Agreement, or in the
event of its merger or consolidation or change in control or similar
transaction. Any permitted assignee shall assume all obligations of its assignor
under this Agreement. Further, a Party may assign or sublicense any and all of
its rights, interests, options, and delegate all obligations hereunder, to any
Affiliate of such Party (and such Affiliate may further assign or sublicense
this Agreement to such Party or any other Affiliate of such Party) without the
consent of the other Party. In the event of an assignment or sublicense to an
Affiliate, the assigning Party shall guarantee the performance of such assignee
or sublicensee. The assignment or sublicense to an Affiliate shall not operate
to discharge the assignor or sublicensor from any obligation under this
Agreement. Any assignment that contravenes this Section 16.10 shall be void ab
initio.
Section 16.11. Expenses.
The Parties hereto shall each bear their own costs and expenses (including
attorneys' fees) incurred in connection with the negotiation and preparation of
this Agreement and consummation of the transactions contemplated hereby.
Section 16.12. Binding Effect.
This Agreement, and all of the terms, provisions and conditions hereof,
shall be binding upon and shall inure to the benefit of the Parties hereto and
their respective permitted successors and assigns.
Section 16.13. Governing Law.
This Agreement shall be construed and interpreted in accordance with the
laws of Malaysia if a lawsuit against BME is initiated by ABI , and any such
suit shall be brought in Malaysia; this Agreement shall be construed and
interpreted in accordance with the laws of Texas , USA, if a lawsuit against ABI
is initiated by BME , and any such suit shall be brought in Texas, USA.
CONFIDENTIAL
**** Indicates that a portion of the text has been omitted and filed separately
with the Commission.
Section 16.14. Survival of Representations and Warranties.
All statements contained herein, or in any schedule hereto, shall be
considered a representation, warranty or covenant of the Party making such
statement. All representations, warranties, covenants contained herein, or in
any schedule hereto, shall survive the closing of this transaction.
Section 16.15. No Strict Construction.
This Agreement has been prepared jointly and shall not be strictly
construed against either Party.
Section 16.16. Independent Contractors.
The status of the Parties under this Agreement shall be that of
independent contractor. No Party shall have the right to enter into any
agreements on behalf of the other Party nor shall it represent to any Person
that it has such right or authority.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
duly executed by their respective authorized officers as of the Effective Date.
AMARILLO BIOSCIENCES, INC.
By: /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
-------------------------
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇,
President and Chief Executive Officer
BUMIMEDIC (MALAYSIA) SDN. BHD.
By: /s/ ▇▇▇▇▇ ▇▇▇▇
------------------
▇▇▇▇▇ ▇▇▇▇
Chief Executive Officer
CONFIDENTIAL
**** Indicates that a portion of the text has been omitted and filed separately
with the Commission.
EXHIBIT A
SPECIFICATIONS
Lozenges
Test Item and Specification
Appearance
Color: White
Shape: Cylindrical cut squarish
No cracked and no foreign matter
Identification
No IFN activity after neutralization by anti-IFN antibody
Moisture Content
<2.0%
Weight Variation
Not more than 2 of 20 lozenges tested may deviate by more than 7.5% from
200 mg.
Disintegration
No residue nor spongy substance after 30 min.; if 1 or 2 lozenges failed,
repeat the test on 12 additional lozenges; all the 12 tested lozenges should
disintegrate completely.
Content Uniformity
IFN activity of all 10 lozenges tested should be in the range of 100+/-30%
of the labeled activity. Results given as the single lozenge furthest from 100%.
If the activity of 1 lozenge is in the range of 80-140% of the labeled
activity, repeat the test with additional 20 lozenges: The IFN activity of all
the 20 lozenges should be in the range of 70-130% of the labeled activity.
IFN Activity
The average IFN activity of the 10 lozenges should be from 70-130% of the
labeled activity.
Test Item Specification
Sterility
Bacteria, Fungi Negative
Mycoplasma Negative
Specific activity Not less than 5 x 10(7) U/mg protein
DNA Not more than 10 pg/5 x 10(6) IU
Endotoxin Negative/1 x 10(6) IU
Subtype ratio (alpha)2: 74+/-9%, (alpha)8: 26+/-9%
Foreign proteins Total not more than 0.1 ug/1 x 10(6) IU
Hamster protein Not more than 0.1 ug/1 x 10(6) IU
CAF Not more than 0.1 ug/1 x 10(6) IU
Sendai virus protein Not more than 0.1 ug/1 x 10(6) IU
Mouse IgG Not more than 0.1 ug/1 x 10(6) IU
Inducing virus Negative/5 x 10(6) IU
Adventitious virus Negative
Pyrogen Negative/6 x 10(5) IU
Molecular weight 17+/-4 kDa
IFN activity Not less than 1 x 10(7) IU/Ml
Physical characteristics Colorless and clear solution,
no smell, a little salty
Identification
Neutralization Neutralized by anti-IFN antibody
Antiviral activity Positive
pH 6.0-7.5
Purity
Heavy metal Not more than 1 ppm
Arsenic Not more than 0.2 ppm
Abnormal Toxicity Negative/5 x 10(6) IU
Histamine Negative/1 x 10(6) IU
Residue on Ignition Not more than 2.5 mg/1 x 10(6) IU
Antigenicity Negative
EXHIBIT B
FORM OF CERTIFICATE OF COMPLIANCE
Issue Date: __________________
CERTIFICATE OF COMPLIANCE
FOR
CUSTOMER
LOT NUMBER
FILL DATE PREP/EX DATE
DOSAGE
QUANTITY
The batch production record for this Product has been reviewed for
accuracy, completeness, and compliance with the Specifications set forth in the
License and Supply Agreement between Amarillo Biosciences, Inc. and BME
Pharmaceuticals dated March ___, 2005 (the "Agreement") and the Agreement, and
in accordance with cGMP requirements. Any deviations/abnormal occurrences from
the aforementioned requirements have been appropriately documented, reviewed,
and approved.
Reviewed By:_________________________
Batch Record Auditor
Date:_________________________
Amarillo Biosciences, Inc.
Approved By:_________________________
Acting Supervisor Manager, Documentation
Date:_________________________
cc: All Customers