Exhibit 10.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
LICENSE AGREEMENT
BY AND BETWEEN
BOSTON LIFE SCIENCES, INC.
AND
BIOAXONE THERAPEUTIC INC.
TABLE OF CONTENTS
PAGE
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Article I
Definitions.............................................................. 1
Section 1.1 "AAA"................................................... 1
Section 1.2 "Affiliate"............................................. 1
Section 1.3 "Agreement"............................................. 1
Section 1.4 "BA".................................................... 1
Section 1.5 "BA Indemnitee"......................................... 1
Section 1.6 "Bankruptcy Code"....................................... 1
Section 1.7 "BLA"................................................... 2
Section 1.8 "BLSI".................................................. 2
Section 1.9 "BLSI Indemnitee"....................................... 2
Section 1.10 "Calendar Year"......................................... 2
Section 1.11 "Claim"................................................. 2
Section 1.12 "Clinical Product"...................................... 2
Section 1.13 "Combination Product"................................... 2
Section 1.14 "Commercialization" or "Commercialize".................. 2
Section 1.15 "Commercially Reasonable Efforts"....................... 2
Section 1.16 "Compound".............................................. 2
Section 1.17 "Confidential Information".............................. 2
Section 1.18 "Control" or "Controlled" or "Controls"................. 3
Section 1.19 "Cover" or "Covering" or "Covered"...................... 3
Section 1.20 "Develop" or "Development".............................. 3
Section 1.21 "Development Plan"...................................... 3
Section 1.22 "Diligence Milestones".................................. 3
Section 1.23 "Effective Date"........................................ 3
Section 1.24 "Field"................................................. 3
Section 1.25 "GAAP".................................................. 3
Section 1.26 "IND"................................................... 3
Section 1.27 "Indemnified Party"..................................... 3
Section 1.28 "Indemnifying Party".................................... 3
Section 1.29 "Key European Countries"................................ 3
Section 1.30 "Know-How".............................................. 3
Section 1.31 "Launch"................................................ 4
Section 1.32 "Licensed Intellectual Property"........................ 4
Section 1.33 "Licensed Know-How"..................................... 4
Section 1.34 "Licensed Patent Rights"................................ 4
Section 1.35 "Licensed Product"...................................... 4
Section 1.36 "Licensed Trademarks"................................... 4
Section 1.37 "Marketing Approval".................................... 4
Section 1.38 "Master Cell Bank"...................................... 4
Section 1.39 "Net Sales"............................................. 4
Section 1.40 "Party"................................................. 6
Section 1.41 "Patent Rights"......................................... 6
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TABLE OF CONTENTS (CONTINUED)
PAGE
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Section 1.42 "Person"................................................ 6
Section 1.43 "Phase II Clinical Trial"............................... 6
Section 1.44 "Phase III Clinical Trial".............................. 6
Section 1.45 "Phase IV Clinical Trial"............................... 6
Section 1.46 "Regulatory Approval"................................... 6
Section 1.47 "Regulatory Authority".................................. 7
Section 1.48 "Regulatory Materials".................................. 7
Section 1.49 "Royalty Expiration Date"............................... 7
Section 1.50 "Severed Clause"........................................ 7
Section 1.51 "Territory"............................................. 7
Section 1.52 "Third Party"........................................... 7
Section 1.53 "University Restated License Agreement"................. 7
Section 1.54 "Valid Claim"........................................... 7
Article II
Grant of License......................................................... 8
Section 2.1 License Grants; Sublicensing............................ 8
Section 2.2 Retained Rights......................................... 8
Section 2.3 Section 365(n) of the Bankruptcy Code................... 8
Section 2.4 Fully Paid-Up License................................... 8
Section 2.5 Trademark............................................... 9
Section 2.6 Limitation.............................................. 9
Section 2.7 Waiver.................................................. 9
Article III
Reports and Diligence.................................................... 9
Section 3.1 Responsibility for Development and Commercialization.... 9
Section 3.2 Diligence............................................... 11
Section 3.3 Records................................................. 11
Section 3.4 Development Reports..................................... 11
Section 3.5 Technology Transfer..................................... 11
Section 3.6 Transfer of Regulatory Materials........................ 12
Section 3.7 Transfer of Clinical Product............................ 12
Section 3.8 Master Cell Bank........................................ 12
Article IV
Financial Provisions..................................................... 12
Section 4.1 License Payment......................................... 12
Section 4.2 Milestone Payments...................................... 13
Section 4.3 Royalties............................................... 13
Section 4.4 Duration of Payments.................................... 13
Section 4.5 Minimum Royalties....................................... 13
Section 4.6 Reports and Accounting.................................. 14
Section 4.7 Currency and Method of Payments......................... 14
Section 4.8 Late Payments........................................... 15
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TABLE OF CONTENTS (CONTINUED)
PAGE
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Section 4.9 Payments to BA Licensors................................ 15
Article V
Intellectual Property Protection and Related Matters..................... 15
Section 5.1 Prosecution and Maintenance of Licensed Patent Rights... 15
Section 5.2 Infringement by a Third Party........................... 16
Section 5.3 Infringement of Third Party's Rights.................... 17
Section 5.4 Maintenance of Trademarks............................... 17
Article VI
Confidentiality.......................................................... 17
Section 6.1 Confidential Information................................ 17
Section 6.2 Employee, Consultant and Advisor Obligations............ 18
Section 6.3 Term.................................................... 18
Article VII
Representations and Warranties........................................... 19
Section 7.1 Representations of Authority............................ 19
Section 7.2 Consents................................................ 19
Section 7.3 No Conflict............................................. 19
Section 7.4 Employee, Consultant and Advisor Obligations............ 19
Section 7.5 Intellectual Property................................... 19
Section 7.6 No Warranties........................................... 19
Article VIII
Term and Termination..................................................... 19
Section 8.1 Term.................................................... 19
Section 8.2 Breach of Material Obligation by BLSI................... 20
Section 8.3 Default by BA........................................... 20
Section 8.4 Insolvency.............................................. 21
Section 8.5 Termination for Failure to Launch....................... 21
Section 8.6 Post Termination........................................ 22
Section 8.7 Survival................................................ 23
Article IX
Dispute Resolution....................................................... 23
Section 9.1 Alternative Dispute Resolution.......................... 23
Section 9.2 No Limitation........................................... 24
Article X
Miscellaneous Provisions................................................. 24
Section 10.1 Indemnification and Insurance........................... 24
Section 10.2 Governing Law........................................... 25
Section 10.3 Assignment.............................................. 26
Section 10.4 Entire Agreement; Amendments............................ 26
Section 10.5 Notices................................................. 26
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TABLE OF CONTENTS (CONTINUED)
PAGE
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Section 10.6 Force Majeure........................................... 27
Section 10.7 Public Announcements.................................... 27
Section 10.8 Independent Contractors................................. 27
Section 10.9 Headings................................................ 27
Section 10.10 No Implied Waivers; Rights Cumulative................... 27
Section 10.11 Severability............................................ 27
Section 10.12 Execution in Counterparts............................... 27
Section 10.13 No Third Party Beneficiaries............................ 28
Section 10.14 No Consequential Damages................................ 28
Schedule 3.7 Clinical Product
Exhibit A Compounds
Exhibit B Licensed Patent Rights
Exhibit C Trademarks
Exhibit D University Restated License Agreement
Exhibit E Development Plan
Exhibit F Annual Sales Forecast and Minimum Royalties
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LICENSE AGREEMENT
This license agreement (the "AGREEMENT"), dated as of this 28th day of
December, 2006 (the "EFFECTIVE DATE"), is by and between Boston Life Sciences,
Inc., a Delaware corporation ("BLSI"), and BioAxone Therapeutic Inc., a Canadian
corporation ("BA").
INTRODUCTION
1. BLSI is in the business of developing and marketing pharmaceutical
products.
2. BA owns or controls patents and know-how relating to the fusion
proteins, including without limitation the protein referred to as BA-210 or
Cethrin(R).
3. BLSI desires to obtain, and BA desires to grant to BLSI, an exclusive
license to use such patents and know-how to Develop (as defined below) the
Compounds (as defined below) and the Licensed Products (as defined below) and an
exclusive license to Commercialize (as defined below) such Licensed Products
under the Licensed Trademarks (as defined below) in the Territory (as defined
below).
NOW, THEREFORE, BLSI and BA agree as follows:
Article I
Definitions
When used in this Agreement, each of the following terms shall have the
meanings set forth in this Article I:
Section 1.1 "AAA" has the meaning set forth in Section 9.1.
Section 1.2 "Affiliate" means, with respect to a Party, any Person that
controls, is controlled by, or is under common control with such Party. For
purposes of this Section 1.2, "control" shall refer to (a) in the case of a
Person that is a corporate entity, direct or indirect ownership of more than
fifty percent (50%) of the stock or shares having the right to vote for the
election of directors of such Person; and (b) in the case of a Person that is
not a corporate entity, the possession, directly or indirectly, of the power to
direct, or cause the direction of, the management or policies of such Person,
whether through the ownership of voting securities, by contract or otherwise.
Section 1.3 "Agreement" has the meaning set forth in the preamble.
Section 1.4 "BA" has the meaning set forth in the preamble.
Section 1.5 "BA Indemnitee" has the meaning set forth in Section 10.1(a).
Section 1.6 "Bankruptcy Code" means 11 U.S.C. Sections 101-1330, as
amended.
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Section 1.7 "BLA" means a biologics license application filed with the FDA
and/or any other application required for the purpose of marketing or selling or
using a therapeutic or prophylactic product to be filed with a governmental
agency in a non-U.S. country or group of countries, including, without
limitation, a product license application or marketing authorization application
in the European Union.
Section 1.8 "BLSI" has the meaning set forth in the preamble.
Section 1.9 "BLSI Indemnitee" has the meaning set forth in Section 10.1(b).
Section 1.10."Calendar Year" means a period of twelve (12) months in the
Gregorian calendar beginning on January 1 and ending on December 31.
Section 1.11. "Claim" has the meaning set forth in Section 10.1(a).
Section 1.12. "Clinical Product" means BA-210 formulated in a buffer
solution and combined with an active or inactive ingredient or excepient,
resulting in a dosage form that can be applied onto the dura mater of the spinal
cord using a suitable device.
Section 1.13. "Combination Product" has the meaning set forth in Section
1.39.
Section 1.14. "Commercialization" or "Commercialize" means any activities
directed to producing, manufacturing, marketing, promoting,
pricing/reimbursement, distributing, importing or selling a product.
Section 1.15. "Commercially Reasonable Efforts" means the commitment of
resources and efforts in accordance with reasonable business, legal, medical,
and scientific judgment that are consistent with the efforts, resources and
judgment that a development stage biotechnology company of similar size and
position of BLSI in the marketplace would use in Developing and Commercializing
its other pharmaceutical products and compounds which are of similar market
potential and at a similar stage in their life cycle, taking into account
product labeling or anticipated labeling, market potential, past performance (if
any), economic return potential, medical and clinical considerations, the
regulatory environment, and competitive market conditions in the therapeutic
area, including the global impact of regional marketing, launch and pricing
decisions, all as measured by the facts and circumstances at the time such
efforts are due; provided, however, that BLSI shall not be entitled pursuant to
the foregoing to take into account the fact that it is or may be in the future
Developing or Commercializing a product that competes with the Licensed
Products.
Section 1.16. "Compound" means any fusion protein the composition of matter
for which is owned or Controlled by BA or its Affiliates as of the Effective
Date, including without limitation those proteins listed on Exhibit A, and any
derivatives, metabolites, prodrugs, isomers or polymorphs thereof.
Section 1.17. "Confidential Information" means any and all verbal, written,
pictorially or electronically transmitted and/or machine reproduced confidential
or proprietary information, including the Master Cell Bank, supplied, provided
or disclosed or which will be supplied, provided or disclosed by one Party to
the other prior to the Effective Date or under this
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Agreement and such Confidential Information that may be generated by BLSI during
the Development and the Commercialization.
Section 1.18. "Control" or "Controlled" or "Controls" means the possession
by the applicable Party of the ability to grant a license or sublicense, in each
case as provided for in this Agreement, without violating the terms of any
agreement or other arrangement with any Third Party.
Section 1.19. "Cover" or "Covering" or "Covered" means, with respect to a
product, that, but for a license granted to a Party under a Valid Claim, the
Development or Commercialization of such product would infringe such Valid
Claim.
Section 1.20. "Develop" or "Development" means research, discovery and
preclinical and clinical drug development activities, including without
limitation test method development and stability testing, toxicology,
formulation, manufacturing process or method, quality assurance/quality control
development, statistical analysis, clinical studies, regulatory affairs, product
approval and registration or any other activity that may be required by a
Regulatory Authority for the obtaining of the Regulatory Approval of a Licensed
Product.
Section 1.21. "Development Plan" has the meaning set forth in Section
3.1(b).
Section 1.22. "Diligence Milestones" has the meaning set forth in Section
3.2.
Section 1.23. "Effective Date" has the meaning set forth in the preamble.
Section 1.24. "Field" means the treatment of disease in humans.
Section 1.25. "GAAP" means United States generally accepted accounting
principles.
Section 1.26. "IND" means an investigational new drug application and/or
any other similar application to be filed with the US FDA a or foreign
Regulatory Authority in a country or group of countries of the Territory.
Section 1.27. "Indemnified Party" has the meaning set forth in Section
10.1(c).
Section 1.28. "Indemnifying Party" has the meaning set forth in Section
10.1(c).
Section 1.29. "Key European Countries" means German, France, Italy, Spain
and the United Kingdom.
Section 1.30. "Know-How" means any technical, scientific and business
information, including all biological, chemical, pharmacological, toxicological,
clinical, and assay information, data, analyses, discoveries, inventions,
methods, techniques, improvements, concepts, designs, processes, formulae,
specifications and trade secrets, data, whether or not patentable, including
documents (which shall include paper, notebooks, books, files, ledgers, records,
tapes, discs, diskettes, CD-ROM and any other media on which the foregoing
information can be stored) containing any of the foregoing information.
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Section 1.31. "Launch" means, for each Licensed Product in each country,
the first arm's-length sale to a Third Party for use or consumption by the
public of such Licensed Product in such country after Regulatory Approval of
such Licensed Product in such country. A Launch shall not include any Licensed
Product sold for use in clinical trials (including Phase IV Clinical Trials),
for research or for other non-commercial uses, or that is supplied as part of a
compassionate use or similar program.
Section 1.32. "Licensed Intellectual Property" means the Licensed Know-How,
the Master Cell Bank, the Licensed Trademarks and the Licensed Patent Rights.
Section 1.33. "Licensed Know-How" means any Know-How that is owned or
Controlled by BA or any Affiliate of BA and disclosed or required to be
disclosed by BA or any Affiliate of BA to BLSI that is necessary, used or useful
for the Development or Commercialization of any Compound or Licensed Product.
Section 1.34. "Licensed Patent Rights" means all Patent Rights owned or
Controlled by BA and its Affiliates as of the Effective Date and during the term
of this Agreement that, but for this Agreement, would be infringed by the
Development or Commercialization of a Compound or Licensed Product, including
without limitation those Patent Rights listed on Exhibit B.
Section 1.35. "Licensed Product" means a pharmaceutical product (whether
prescription or over-the-counter) for use in the Field containing a Compound,
including without limitation a Combination Product.
Section 1.36. "Licensed Trademarks" means the trademarks listed in Exhibit
C.
Section 1.37. "Marketing Approval" means Regulatory Approval together with
any applicable governmental price and reimbursement approvals of Regulatory
Authorities necessary for the Commercialization of a product in a country or
territory.
Section 1.38. "Master Cell Bank" means the master cell bank provided by BA
to BLSI that expresses the Compound.
Section 1.39. "Net Sales" means, with respect to a Licensed Product, the
gross amounts billed by BLSI, its Affiliates and sublicensees in respect of
sales of such Licensed Product by BLSI, its Affiliates and sublicensees to Third
Parties, in each case less the following deductions:
(a) the total of ordinary and customary trade discounts earned and
actually taken or granted;
(b) any statutory or contractual rebates paid to any governmental or
any other public authority, agency or entity or to other health maintenance
organizations;
(c) cash and quantity discounts actually allowed;
(d) allowances and adjustments actually credited or paid to customers
for recalled, rejected, spoiled, damaged, outdated and/or returned Licensed
Products;
-4-
(e) chargebacks and other amounts due from BLSI, its Affiliate or its
sublicensee, as applicable, on sale to customers, or on sale by customers to
Third Parties (including without limitation end users), or on dispensing of the
Licensed Product;
(f) freight, insurance, transportation costs and handling charges
identified by BLSI, its Affiliate or its sublicensee, as applicable, in its
invoices to independent Third Parties;
(g) excise, sales and value added taxes included by BLSI, its
Affiliate or its sublicensee, as applicable, in its invoices to independent
Third Parties;
(h) customs duties, tariffs, and other compulsory payments made by
BLSI, its Affiliate or its sublicensee, as applicable, to national provincial
and local government authorities; and
(i) amounts written off as uncollectible in accordance with the
accounting policies of BLSI, its Affiliate or its sublicensee, as applicable.
Such amounts shall be determined from the books and records of BLSI and its
Affiliates, maintained in accordance with generally accepted accounting
principles, consistently applied.
In the event the Licensed Product is sold as part of a Combination Product (as
defined below), the Net Sales from the Combination Product, for the purposes of
determining royalty payments, shall be determined by multiplying the Net Sales
(as determined above) of the Combination Product, during the applicable royalty
reporting period, by the fraction, A/A+B, where A is the average sale price of
the Licensed Product when sold separately in finished form and B is the average
sale price of the other active ingredient(s) included in the Combination Product
when sold separately in finished form, in each case during the applicable
royalty reporting period or, if sales of both the Licensed Product and the other
active ingredient(s) did not occur in such period, then in the most recent
royalty reporting period in which sales of both occurred. In the event that such
average sale price cannot be determined for both the Licensed Product and all
other active ingredient(s) included in such Combination Product, Net Sales for
the purposes of determining royalty payments shall be calculated by multiplying
the Net Sales of the Combination Product by the fraction of C/C+D where C is the
fair market value of the Licensed Product and D is the fair market value of all
other active ingredient(s) included in the Combination Product. In such event,
BLSI shall in good faith make a determination of the respective fair market
values of the Licensed Product and all other active ingredient(s) included in
the Combination Product, and shall notify BA of such determination and provide
BA with data to support such determination. BA shall have the right to review
such determination of fair market values and, if BA disagrees with such
determination, to notify BLSI of such disagreement within sixty (60) days after
BLSI notifies BA of such determination. If BA notifies BLSI that BA disagrees
with such determination within such sixty (60) day period and if thereafter the
Parties are unable to agree in good faith as to such respective fair market
values, then such matter shall be resolved as provided in Article IX. If BA does
not notify BLSI that BA disagrees with such determination within such sixty (60)
day period, such determination shall be conclusive and binding on the Parties.
-5-
As used above, the term "Combination Product" means any pharmaceutical product
that includes both (x) a Licensed Product and (y) other active ingredient(s).
Section 1.40. "Party" means BLSI or BA; "Parties" means BLSI and BA.
Section 1.41. "Patent Rights" means all patents and patent applications
(including provisional patent applications and any continuations of any such
patent applications, claims in continuations-in-part to the extent such claims
are entirely supported by the specifications of any such patent applications,
and any divisionals, provisionals or substitute applications with respect to any
such patent applications), any patent issued with respect to any such patent
applications, any reissue, reexamination, renewal or extension (including any
supplemental patent certificate) of any such patent, and any confirmation
patent, registration patent, patent of addition, or inventor's certificate based
on or directed to the same invention as any such patent, and all patents and
patent applications anywhere in the world that at any time, directly or
indirectly, claim priority from, support a claim of priority of or contain
substantially identical disclosure as any of the foregoing.
Section 1.42. "Person" means any natural person or any corporation,
company, partnership, joint venture, pool, syndicate, governmental authority,
firm or other entity not listed herein.
Section 1.43. "Phase II Clinical Trial" means a controlled human clinical
trial conducted in accordance with GCP, anywhere in the world, of a product that
utilizes the pharmacokinetic and pharmacodynamic information obtained from one
or more previous Phase I Clinical Trial(s) to assess clinical efficacy of the
therapy; as well as to continue Phase I assessments in a larger group of
volunteers and subjects to establish the optimal manner of use of the product
(dose and dose regimen) prior to initiation of a Phase III Clinical Trial.
Section 1.44. "Phase III Clinical Trial" means a controlled human clinical
trial conducted in accordance with GCP, anywhere in the world, on large subjects
group that is designed to establish that the product is safe and efficacious in
a statistically significant form and optimum dosage, for its intended use, and
to define warnings, precautions, and adverse reactions that are associated with
such product in the dosage range to be prescribed, and to support Regulatory
Approval of such product or label expansion of such product.
Section 1.45. "Phase IV Clinical Trial" means a controlled human clinical
trial of a product conducted in accordance with GCP, or other test or study of
the product, commenced after receipt of initial Regulatory Approval for an
indication in a country that is conducted within the parameters of the labeling
approved for the product. Phase IV Clinical Trials may include clinical trials,
or other tests and studies, conducted in support of pricing/reimbursement for an
initial Regulatory Approval, epidemiological studies, modeling and
pharmacoeconomic studies, post-marketing surveillance studies, health economics
studies, and investigator-sponsored clinical trials.
Section 1.46. "Regulatory Approval" means the approvals (excluding any
applicable governmental price and reimbursement approvals), licenses,
registrations or authorizations of
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Regulatory Authorities necessary for the Commercialization of a product in a
country or territory.
Section 1.47. "Regulatory Authority" means a federal, national,
multinational, state, provincial or local regulatory authority, court,
commission, administrative or other agency, department, bureau or governmental
entity which regulates the Development or Commercialization of a product in a
country.
Section 1.48. "Regulatory Materials" means the technical, medical and
scientific registrations, authorizations and approvals (including, without
limitation, approvals of BLAs or foreign equivalents, supplements and
amendments, pre- and post- approvals, pricing and Third Party reimbursement
approvals, and labeling approvals) of any Regulatory Authority necessary for the
Development or Commercialization of a Licensed Product in a regulatory
jurisdiction, together with all related correspondence to or from any Regulatory
Authority and all documents referenced in the complete regulatory chronology for
each BLA or foreign equivalent, including the Drug Master File (if any), IND and
BLA, or foreign equivalents.
Section 1.49. "Royalty Expiration Date" has the meaning set forth in
Section 2.4.
Section 1.50. "Severed Clause" has the meaning set forth in Section 10.11.
Section 1.51. "Territory" means all countries of the world.
Section 1.52. "Third Party" means any Person or entity other than a Party
or any of its Affiliates.
Section 1.53. "University Restated License Agreement" means the Restated
Patent License Agreement and I.P Agreement agreed upon between Universite de
Montreal ("UNIVERSITY") and BA on August 2nd, 2006 which agreement is attached
hereto as Exhibit D.
Section 1.54. "Valid Claim" means any claim of (i) an issued and
non-expired Patent Right within the Licensed Patent Rights or (ii) an issued and
non-expired Patent Right of BLSI or any of its Affiliates that Covers in whole
or in part a Licensed Product and is based on or arising from exposure to the
Licensed Intellectual Property ("BLSI Improvement Patent"), in each case which
has not been revoked, held unenforceable, non-patentable, or invalid by a court
or governmental agency of competent jurisdiction, unappealed or unappealable
within the time allowed for appeal, or has not been specifically admitted by the
holder of the patent to be unenforceable, non-patentable, or invalid through
reissue, disclaimer, or otherwise in writing. Notwithstanding the foregoing, in
the event that payment by BLSI of a royalty on the Net Sales of Licensed
Products Covered by a BLSI Improvement Patent and not also Covered by a Licensed
Patent Right is held by a court or governmental agency of competent jurisdiction
to be patent misuse or otherwise a violation of applicable law in a proceeding
initiated by a Third Party, unappealed or unappealable within the time allowed
for appeal, the claims of such BLSI Improvement Patents shall not constitute
Valid Claims.
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Article II
Grant of License
Section 2.1 License Grants; Sublicensing.
(a) Licenses Granted to BLSI.
(i) Research and Development. Subject to the terms of this
Agreement, BA hereby grants BLSI an exclusive, royalty-free license (with the
right to grant sublicenses in accordance with Section 2.1(b), under Licensed
Intellectual Property to Develop the Compounds and Licensed Products in the
Field in the Territory.
(ii) Commercialization. Subject to the terms of this Agreement,
BA hereby grants BLSI an exclusive, royalty-bearing license (with the right to
grant sublicenses in accordance with Section 2.1(b)) under Licensed Intellectual
Property to Commercialize Licensed Products in the Field in the Territory.
(b) Sublicenses. BLSI may grant and authorize sublicenses under the
license granted pursuant to Section 2.1(a) of this Agreement under terms and
conditions that are not less stringent than those set forth herein. Within
thirty (30) days of entering into any such sublicense, BLSI shall provide BA
with a copy of the sublicense agreement, which copy may be redacted to exclude
confidential financial information (except to the extent such information
relates to the calculation of Net Sales, in which case such information shall be
made available to BA). BLSI shall require BLSI's sublicensees to comply with the
provisions of this Agreement as such provisions are applicable to the exercise
by sublicensees of rights licensed to BLSI hereunder. BLSI hereby guarantees,
and shall remain primarily liable for, the performance of its permitted
sublicensees under this Agreement. Any such sublicenses by BLSI shall include an
obligation for the sublicensee to account for and report its Net Sales, and BLSI
shall pay to BA (or arrange for the sublicensee to pay to BA, with BLSI
remaining responsible for any failure of the sublicensee to pay amounts when due
under this Agreement) royalties on such Net Sales as if such Net Sales of the
sublicensee were Net Sales of BLSI.
Section 2.2 Retained Rights. BA hereby reserves the right to Develop the
Compounds and Licensed Products for the sole purpose of conducting Development
activities in accordance with Section 3.1(d).
Section 2.3 Section 365(n) of the Bankruptcy Code. All rights and licenses
granted under or pursuant to this Agreement are, and shall otherwise be, deemed
to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights
to "intellectual property" as defined under Section 101(35A) of the Bankruptcy
Code. The Parties shall retain and may fully exercise all of their respective
rights and elections under the Bankruptcy Code.
Section 2.4 Fully Paid-Up License. On a country-by-country and Licensed
Product-by-Licensed Product basis, from and after the date of (1) with respect
to those countries where there is a Valid Claim Covering a Licensed Product, the
later of the expiration of the last-to-expire Valid Claim Covering such Licensed
Product in such country or the date that is ten (10) years after the Launch of
such Licensed Product in such country; or (2) with respect to those countries
where there is no Valid Claim Covering a Licensed Product, the date that is ten
(10)
-8-
years after the Launch of such Licensed Product in such country (in each case
such date referred to as the "ROYALTY EXPIRATION DATE" for such Licensed Product
in such country), BLSI shall have a nonexclusive, fully paid, irrevocable,
perpetual license in such country, with the right to grant sublicenses, under
the Licensed Intellectual Property.
Section 2.5 Trademark. BLSI agrees to Commercialize any Licensed Products
related to the BA-210 protein for the treatment of acute spinal cord injury
solely under the trademark Cethrin(R). BLSI shall ensure that each reference to
and use of the Cethrin(R) trademark by BLSI in any marketing material related to
the BA-210 related Licensed Products is made in accordance with applicable law
and is accompanied by an acknowledgement that the Cethrin(R) trademark is a
trademark or registered trademark owned by BA and used by BLSI under license.
Section 2.6 Limitation. BLSI hereby acknowledges and agrees that all rights
granted to BLSI under this Agreement are subject to the terms, conditions,
limitations and obligations of BA set forth in the University Restated License
Agreement. Furthermore, the Parties agree that should there be any inconsistency
between this Agreement and the University Restated License Agreement, the terms
and conditions of the University Restated License Agreement shall prevail.
Section 2.7 Waiver. BLSI hereby acknowledges and agrees that shortly after
the Effective Date, BA will terminate all of its employees. Accordingly, BLSI
acknowledges that notwithstanding any provisions contained herein, BA shall have
no obligation to support or provide assistance to BLSI in the Development or
Commercialization of a Compound or Licensed Product, provided that BA or its
designee or successor shall fulfill its obligations under Section 3.1(d),
Section 3.1(f), Section 3.5, Section 3.6 and Section 3.7 regardless of BA's
then-current staffing or operational capacity.
Article III
Reports and Diligence
Section 3.1 Responsibility for Development and Commercialization.
(a) Generally. During the term of this Agreement, except as provided
in Section 3.1(d) below, BLSI (or its Affiliates or sublicensees) shall have
sole authority to conduct Development and Commercialization activities,
including all regulatory activities, with respect to any Compounds and/or
Licensed Products throughout the Territory in accordance with the Development
Plan. All regulatory submissions made after the Effective Date with respect to
the Licensed Products in the Territory shall be owned by BLSI and/or its
Affiliates or sublicensee(s), as applicable. Upon BLSI's reasonable written
request and subject to Section 2.7, (i) BA shall use commercially reasonable
efforts pursuant to Section 3.5 to provide BLSI with any Licensed Know-How that
is reasonably useful for BLSI to conduct the activities set forth in this
Section 3.1(a); and (ii) BA, at BLSI cost and expense, shall make reasonable
efforts to cooperate with BLSI in connection with regulatory submissions related
to any Licensed Product.
(b) Development Plan. All Development activities performed under this
Agreement shall be in accordance with the Development Plan set forth on Exhibit
E (the "DEVELOPMENT PLAN"). Any amendment to the Development Plan shall be by
written approval of both Parties.
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(c) Joint Management Committee. Within thirty (30) days of the
Effective Date, the Parties shall establish a Joint Management Committee to
oversee Development activities hereunder. The Joint Management Committee will be
comprised of at least two (2) senior representatives from each of BLSI and BA
and shall be chaired by one of the representatives from BLSI. Either Party may
substitute in its sole discretion its designated members of the Joint Management
Committee from time to time. The Joint Management Committee shall operate by
consensus and in accordance with the Development Plan. Meetings of the Joint
Management Committee shall be held monthly and shall alternate between the
offices of BLSI and BA unless BLSI and BA otherwise agree. Meetings may not
necessarily be face-to-face meetings, but upon the agreement of the Parties may
be via other methods of communication such as teleconferences and/or
videoconferences. Each Party shall bear its own costs associated with its
participation on the Joint Management Committee, including all travel and living
expenses. Upon BLSI's payment to BA of the license fee set forth in Section
4.1(b), the Joint Management Committee shall dissolve and thereafter BLSI shall
be solely responsible for Development activities, subject to the Development
Plan.
(d) BA Transitional Development Activities. During the period from the
Effective Date through the date on which BLSI pays to BA the license fee as set
forth in Section 4.1(b) (the "TRANSITION PERIOD"), BA shall manage Development
of Compounds and/or Licensed Products in accordance with the Development Plan
and under the guidance of the Joint Management Committee.
(e) Development Costs. During the term of this Agreement, including
the Transition Period, BLSI shall be responsible for all costs related to the
Development of Compounds and/or Licensed Products. Accordingly, BLSI hereby
agrees to promptly reimburse BA for all costs and expenses incurred by BA
related to the Development of Compounds and/or Licensed Products during the
Transition Period.
(f) Regulatory Matters During Transition Period. During the Transition
Period, and subject to the provisions of this Section 3.1(f), BA will be solely
responsible for maintaining, at BLSI's cost and expense, the Regulatory
Materials for BA-210 or Cethrin(R) and Compounds and Licensed Products
containing BA-210 or Cethrin(R), including but not limited to the IND therfor
and any foreign equivalents. Upon request by BA, BLSI shall assist BA in
maintaining the IND. Prior to the transfer set forth in Section 3.6, BA will be
the sole owner of the IND. During the Transition Period, BA shall be responsible
for all communications with the FDA and other Regulatory Authorities related to
Compounds and/or Licensed Products in the Territory. Notwithstanding the
forgoing, BA will not (i) file any document with the FDA or any other Regulatory
Authority relating to Compounds or Licensed Products without the prior consent
of BLSI or (ii) attend any meetings with a Regulatory Authority related to
Compounds or Licensed Products at which a representative of BLSI will not be
present, unless otherwise agreed by BLSI. If contacted by the FDA or any other
Regulatory Authority regarding any matter related to a Compound or Licensed
Product, BA shall inform BLSI of such contact as soon as practicable, and shall
use commercially reasonable efforts to postpone any discussions with such
Regulatory Authority regarding such matters until such time as BLSI is available
to participate.
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Section 3.2 Diligence. BLSI shall use Commercially Reasonable Efforts to
Develop and Commercialize at least one Licensed Product in the Territory during
the term of this Agreement in accordance with the Development Plan; provided
that BLSI may satisfy such obligation, subject to the terms of this Agreement,
by sublicensing the Development and Commercialization of a Compound or Licensed
Product to a sublicensee that shall be obligated to adhere to the Commercially
Reasonable Efforts obligations in this Agreement. BLSI shall be deemed to have
satisfied its diligence obligations under this Section 3.2 with respect to a
Compound or Licensed Product so long as BLSI has met the milestones for
Development and Commercialization set forth in Section II of the Development
Plan ("DILIGENCE MILESTONES") on or before the Outside Completion Date. BLSI
shall be deemed to have failed its diligence obligations under this Section 3.2
should BLSI fail to meet any Diligence Milestone on or before the Outside
Completion Date, except to the extent such failure is caused by (i) demonstrated
toxicity or drug safety issues with the Compounds and/or Licensed Products
determined in accordance with industry standards or (ii) a failure to
demonstrate statistically significant efficacy of the Compounds and/or Licensed
Products in a well-designed, well-controlled clinical trial as measured by
appropriate industry standards.
Section 3.3 Records. BLSI shall maintain complete and accurate records of
all Regulatory Materials and material related to Development and
Commercialization conducted by it or on its behalf related to each Compound and
Licensed Product, and all material information generated by it or on its behalf
in connection with Development and Commercialization under this Agreement with
respect to each Compound and Licensed Product. BLSI shall, unless otherwise
required by any applicable law or regulation, maintain such records at least
until the later of: (a) [**] years after such records are created, or (b) [**]
years after either the Launch of the Licensed Product to which such records
pertain or the abandonment of Development of the Compound or Licensed Product to
which such records pertain.
Section 3.4 Development Reports. Within [**] days after June 30 and
December 31 of each Calendar Year ending prior to the first Launch of a Licensed
Product by BLSI, a BLSI Affiliate or a BLSI sublicensee, BLSI shall provide to
BA a written report (a) summarizing the activities undertaken by BLSI, its
Affiliates and sublicensees during the immediately preceding Calendar Year in
connection with the Development of Compounds and Licensed Products, including
progress toward the development activities outlined in Section I of the
Development Plan; (b) identifying any Development Plan activities BLSI, its
Affiliates and sublicensees anticipate will not be met by within at least [**]
months of the Target Completion Date set forth in the Development Plan; (c)
identifying the Compounds and Licensed Products being Developed by BLSI, its
Affiliates and sublicensees, including Compounds that are being clinically
developed or that BLSI, its Affiliates and sublicensees have identified as lead
compounds for which future clinical development is reasonably likely; and (d)
describing the Development activities planned to be undertaken by BLSI, its
Affiliates and sublicensees during the then current Calendar Year. Furthermore,
BLSI shall promptly provide written notice of any significant positive or
negative event related to the Development of Compounds and Licensed Products.
Section 3.5 Technology Transfer. During the Transition Period, BA shall
provide BLSI with full access to the Licensed Know-How including Regulatory
Materials as necessary to carry out Development activities under the Development
Plan, including access (by
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teleconference or in person at BA's facilities or the facilities of any Third
Party manufacturer involved in the manufacture of Compounds or Licensed
Products) to BA personnel directly involved in the manufacture of Compounds or
Licensed Products for reasonable consultation on the Licensed Know-How and the
manufacturing processes for any Compounds or Licensed Products. Promptly after
the completion of the Transition Period, BA shall use commercially reasonable
efforts to transfer to BLSI the Licensed Know-How, including without limitation
the Master Cell Bank, which Master Cell Bank BLSI shall maintain during the term
of this Agreement in accordance with generally accepted industry standards for
the same kind of proprietary material. Thereafter during the term of this
Agreement, BA or its designee or successor shall provide BLSI with any
additional Licensed Know-How that BA comes to own or Control after the Effective
Date upon the request of BLSI.
Section 3.6 Transfer of Regulatory Materials. Subject to and upon BLSI's
payment to BA of the license fee set forth in Section 4.1(b), BA hereby agrees
to assign to BLSI BA's rights in any Regulatory Materials for BA-210 or
Cethrin(R) and Compounds and Licensed Products containing BA-210 or Cethrin(R),
including but not limited to the IND therefore and any foreign equivalents.
Thereafter, BLSI or its sublicensees shall hold title to such IND (and foreign
equivalents), and shall assume full responsibility for such IND (and foreign
equivalents). In addition, BA promptly shall execute any and all other
instruments, forms of assignment or other documents and take such further
actions as BLSI may reasonably request in order to give effect to or evidence
the foregoing assignment.
Section 3.7 Transfer of Clinical Product. Subject to and upon BLSI's
payment to BA of the license fee set forth in Section 4.1(b), BA shall transfer
its existing stock of Clinical Product, as more fully described in Schedule 3.7
hereto and including all related assays and cell lines, to BLSI at no cost. BLSI
shall be responsible at its costs and expenses to import and receive any such
Clinical Product.
Section 3.8 Master Cell Bank. BLSI hereby acknowledges the proprietary and
highly confidential nature of the Master Cell Bank. At all times during the term
of this Agreement BLSI shall ensure that the Master Cell Bank (i) is maintained
in accordance with applicable laws and generally prevailing industry standards
and (ii) is not transferred or provided to any Third Party, provided that BLSI
may (x) transfer the Master Cell Bank to a Third Party to store and maintain the
Master Cell Bank on BLSI's behalf in accordance with this Section 3.8 and (y)
provide access to the Master Cell Bank to a Third Party manufacturer solely for
the purpose of manufacturing the Licensed Product, and provided further that
each such Third Party be under strict confidentiality obligations.
Article IV
Financial Provisions
Section 4.1 License Payment. BLSI shall make a non-refundable license
payment to BA of Ten Million Dollars ($10,000,000), payable as follows:
(a) Two and a Half Million Dollars ($2,500,000) shall be paid
concurrently with the execution of this Agreement; and
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(b) Seven and a Half Million Dollars ($7,500,000) shall be payable on
or before March 31, 2007.
Section 4.2 Milestone Payments. BLSI shall make the following
non-refundable milestone payments to BA within [**] days after each of the
following events:
MILESTONE EVENTS PAYMENT
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Completion of the first Phase III Clinical Trial of any Licensed Product $[**]
First Regulatory Approval of a Licensed Product in the United States $[**]
First Regulatory Approval of a Licensed Product in the European Union $[**]
First Regulatory Approval of a Licensed Product in Japan $[**]
[**] days after the calendar month during which cumulative Net Sales of
Licensed Products reach [**] $[**]
[**] days after the calendar month during which cumulative Net Sales of
Licensed Products reach [**] $[**]
The milestone payments payable pursuant to this Section 4.2 shall each only be
payable one time, irrespective of how many Licensed Products BLSI, its
Affiliates and sublicensees Develop or Commercialize.
Section 4.3 Royalties. BLSI shall pay BA royalties on Calendar Year Net
Sales in the Territory at the royalty rates stated below.
(a) [**] percent ([**]%) of such Net Sales in any Calendar Year that
are less than or equal to [**] Dollars ($[**]); and
(b) [**] percent ([**]%) of such Net Sales in any Calendar Year that
are greater than [**] Dollars ($[**]).
Notwithstanding the foregoing, with respect to Net Sales in any country where
there is no Valid Claim Covering the Licensed Product sold, BLSI shall pay BA
royalties of [**] percent ([**]%) of such Net Sales in lieu of the royalty rates
set forth above. The obligation to pay royalties is imposed only once with
respect to Net Sales of the same unit of a Licensed Product.
Section 4.4 Duration of Payments. The amounts payable under Section 4.3
shall be paid on a Licensed Product-by-Licensed Product and country-by-country
basis until the Royalty Expiration Date applicable to each Licensed Product in
each country.
Section 4.5 Minimum Royalties. Exhibit F attached hereto and incorporated
herein by reference sets out, for the first [**] years after Marketing Approval
of the Licensed Product in the United States and one of the Key European
Countries, the minimum royalties to be paid to BA during such [**] years
("MINIMUM ROYALTIES"). For [**] years thereafter (or until the expiration of the
last-to-expire Valid Claim of a Patent Right owned or Controlled by BA Covering
the Licensed Product, if earlier, in which case the Minimum Royalty shall be pro
rated for the Calendar Year in which such expiration occurs), Minimum Royalties
shall be [**] Dollars ($[**]) annually on a world-wide basis. In the event that
royalty payments under Section 4.3 for a Calendar Year for which Minimum
Royalties are owed fall below the Minimum Royalty
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amounts for territories in which a Licensed Product has obtained Marketing
Approval, BLSI shall remit to BA the amount of the shortfall within [**] days of
the end of such Calendar Year. If Marketing Approval of the first Licensed
Product in a territory occurs during the first six (6) months of a Calendar
Year, then the payable Minimum Royalty for such territory for the first Calendar
Year shall be pro-rated in accordance with the number of days remaining in such
Calendar Year. If Marketing Approval of the first Licensed Product in a
territory occurs during the last six (6) months of a Calendar Year, then the
Minimum Royalty for such territory for the first Calendar Year shall be shifted
one year forward and no Minimum Royalty shall be due for that first Calendar
Year. Minimum Royalties for the United States and the Key European Countries
shall be due for only the first ten (10) Calendar Years after the first
Marketing Approval of the first Licensed Product in either the United States or
one of the Key European Countries (or until the expiration of the last-to-expire
Valid Claim of a Patent Right owned or Controlled by BA Covering the Licensed
Product, if earlier), but shall be due irrespective of whether or when a Launch
of the Licensed Product occurs in the described territories.
Section 4.6 Reports and Accounting.
(a) Reports; Payments. BLSI shall deliver to BA, within [**] days
after the end of each calendar quarter, reasonably detailed written accountings
of Net Sales of the Licensed Product that are subject to payment obligations to
BA for such calendar quarter. Such quarterly reports shall indicate (i) gross
sales and Net Sales on a Licensed Product-by-Licensed Product and
country-by-country basis; (ii) details relating to the calculation of deductions
made pursuant to Section 1.39; and (ii) details relating to the calculation of
payment amounts owed to BA from such gross sales and Net Sales. When BLSI
delivers such accounting to BA, BLSI shall also deliver all amounts due under
Section 4.3 to BA for the calendar quarter.
(b) Audits by BA. BLSI shall keep, and shall require its Affiliates
and sublicensees to keep, in accordance with GAAP consistently applied, records
of the latest five (5) years relating to gross sales and Net Sales. For the sole
purpose of verifying amounts payable to BA, BA shall have the right no more than
once each Calendar Year, at BA's expense, to review, together with BA's
accountants, such records in the location(s) where such records are maintained
by BLSI and its Affiliates and sublicensees upon reasonable notice and during
regular business hours. Results of such review shall be made available to BLSI.
If the review reflects an underpayment to BA, such underpayment shall be
promptly remitted to BA, together with interest calculated in the manner
provided in Section 4.8. If the underpayment is equal to or greater than five
percent (5%) of the amount that was otherwise due, BA shall be entitled to have
BLSI pay all of the costs of such review.
Section 4.7 Currency and Method of Payments. All payments under this
Agreement shall be made in United States Dollars by wire transfer to such bank
account as BA may designate in writing from time to time. Any royalties due
hereunder with respect to amounts in currencies other than United States dollars
shall be payable in their United States dollar equivalents, calculated using the
average applicable interbank transfer rate determined by reference to the
currency trading rates published by The Wall Street Journal (Eastern U.S.
edition) over all business days of the calendar quarter to which the report
under Section 4.6(a) relates.
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Section 4.8 Late Payments. BLSI shall pay interest to BA on the aggregate
amount of any payment that is not paid on or before the date such payment is due
under this Agreement at a rate per annum equal to the prime rate of interest of
Citibank, NA as announced on the date such payment is due plus two percent (2%),
or at the maximum rate permitted by applicable law, whichever is lower, for the
period during which such payment remains overdue.
Section 4.9 Payments to BA Licensors. BA shall remain solely responsible
and liable for any and all fees and payments owing to any Third Party from whom
BA licenses Licensed Intellectual Property, including without limitation the
University, arising as a result of this Agreement.
Article V
Intellectual Property Protection and Related Matters
Section 5.1 Prosecution and Maintenance of Licensed Patent Rights.
(a) Right to Prosecute and Maintain. Subject to and upon BLSI's
payment to BA of the license fee set forth in Section 4.1(b), and subject to the
rights of University under the University Restated License Agreement, BLSI shall
have the first right and option to file and prosecute any patent applications
and to maintain any patents included in the Licensed Patent Rights. If BLSI
declines the option or fails to file and/or prosecute any such patent
applications or maintain any such patents it shall give BA and the University
reasonable notice to this effect, sufficiently in advance to permit BA or the
University to undertake, BA or the University having the right but not the
obligation, to pay all reasonable costs in order for such filing, prosecution
and/or maintenance in order to maintain the said Licensed Patent Rights. In the
event BA, or the University pursuant to the University Restated License
Agreement, pays such costs for maintenance of the Licensed Patent Rights, BLSI
agrees to reimburse BA, or the University on behalf of BA, as applicable, for
same within ninety (90) days of receiving notice from BA or the University
stating the maintenance fees related to the Licensed Patents have been paid,
such reimbursements to be made in U.S. Dollars.
(b) Costs and Expenses. Beginning on the Effective Date of this
Agreement, BLSI shall (i) be responsible for the payment of all maintenance and
other fees relating to the filing, prosecution, and maintenance of the Licensed
Patents Rights; and (ii) on behalf of BA, provide the University with copies of
correspondences evidencing such payments. BLSI shall be entitled to deduct from
its payment obligations under Section 4.2 and Section 4.3 any such costs and
expenses incurred by BLSI pursuant to Section 5.1(a) in preparing, filing,
prosecuting and maintaining Licensed Patent Rights.
(c) Cooperation. Each Party agrees to cooperate with the other with
respect to the filing, prosecution and maintenance of patents and patent
applications pursuant to this Section 5.1. In furtherance of the foregoing, BA
shall use commercially reasonable efforts under the circumstances (which efforts
may include without limitation the exercise of all contractual rights and
remedies available to BA under the University Restated License Agreement) to
cause the University (subject to any limitations set forth in the University
Restated License Agreement) to cooperate with BLSI as follows:
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(i) the execution of all such documents and instruments and the
performance of such acts as may be reasonably necessary in order to permit the
other Party to file, prosecute or maintain patents and patent applications as
provided for in Section 5.1(a);
(ii) making its employees, agents and consultants reasonably
available to the other Party (or to the other Party's authorized attorneys,
agents or representatives), to the extent reasonably necessary to enable the
prosecuting Party to file, prosecute or maintain patents and patent applications
as provided for in Section 5.1(a); and
(iii) to provide the other Party with copies of all material
correspondence with the United States Patent and Trademark Office or its foreign
counterparts pertaining to the filing, prosecution or maintenance of patents and
patent applications as provided for in Section 5.1(a).
Section 5.2 Infringement by a Third Party.
(a) Should either Party become aware of any infringement or potential
infringement of the Licensed Patents Rights, they shall give the other written
notice detailing the facts concerning such infringement or potential
infringement.
(b) In the event of infringement or potential infringement of the
Licensed Patent Rights, BLSI shall have the first right, within six (6) months
of receiving notice, to either: (i) take the appropriate steps to stop the
infringement; (ii) file suit against the infringer; or (iii) provide BA (or the
University on behalf of BA) with reasonable evidence showing that the infringer
intends to enter into a settlement agreement in which future infringement will
be halted and any damages, profits or awards which might be obtained shall be
recovered by BLSI for its own and sole benefit, subject to Section 5.2(d).
Should BLSI decide not to enforce the Licensed Patent Rights against such
infringement, it shall so advise BA (or the University on behalf of BA) in
writing, the said writing stating why BLSI has made, in its sole discretion,
such a decision, and BA (or the University if the University elects to exercise
its rights under the University Restricted License Agreement) shall have the
right, at its own expense, to bring any action it deems necessary to stop the
infringement and recover any damages, profits, and awards which might be
obtained, subject to Section 5.2(d).
(c) During the term of this Agreement, BLSI at its own expense, shall
be deemed to have the right, as authorized pursuant to the appropriate statutes:
(i) to bring suit in its own name or, if required by law, BA and/or the
University in which case BA grants and shall use commercially reasonable efforts
under the circumstances (which efforts may include without limitation the
exercise of all contractual rights and remedies available to BA under the
University Restated License Agreement) to cause the University to grant, if
necessary, a full power of attorney to BLSI, at BLSI's expense and on its own
behalf for infringement of the Licensed Patents Rights; (ii) in any such suit,
to enjoin infringement, and for infringing the Licensed Patents Rights, to
collect damages, profits, and awards of whatever nature recoverable for such
infringement for its own and sole benefit; and (iii) to settle any claim or suit
for infringement of the Licensed Patents Rights by granting the infringing Party
a sub-license as authorized by this Agreement.
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(d) In the event either Party takes action under this Section 5.2, the
other Party shall cooperate (and in the case of an action taken by BLSI, BA
shall use commercially reasonable efforts under the circumstances (which efforts
may include without limitation the exercise of all contractual rights and
remedies available to BA under the University Restated License Agreement) to
cause the University to cooperate) with the Party so acting to the extent
reasonably possible, including joining the suit if necessary or desirable. Any
recovery obtained by any Party as a result of any proceeding described in this
Section 5.2, by settlement or otherwise, shall be applied first to reimburse
each Party for all litigation costs in connection with such proceeding paid by
that Party and not otherwise recovered (on a pro rata basis based on each
Party's respective litigation costs, to the extent the recovery was less than
all such litigation costs).
Section 5.3 Infringement of Third Party's Rights. Without prejudice to any
other right they may have, should a claim that the Licensed Products (as it
relates to the Licensed Patents Rights) or any material part thereof, infringe a
Third Party's intellectual property rights be threatened or made against BA,
BLSI, or any party receiving rights to the Licensed Patents Rights through BLSI,
each of BA and BLSI agree that it shall give the other Party prompt written
notice detailing as many facts as possible concerning such claim and shall
cooperate fully with the other in the defense of such claim. The reasonable
expenses incurred by BLSI, in the defense of such claim, shall be first deducted
from any royalty owing and then any balance shall be held in trust by BLSI until
such time that the potential infringement case is terminated or settled and BA
shall only have a right to such royalties held in trust if the Third Party
claiming is unsuccessful in obtaining a judgment against BLSI or any of its
sublicensees. If the Third Party claiming the infringement is successful in
obtaining a judgment against BLSI or any of its Sublicensees or if the Parties
agree (BLSI acting reasonably) to amicably settle the matter, any amount held in
trust and any future royalty shall first serve to pay the Third Party 's
indemnity or damages awarded pursuant to a judgment of a court of competent
jurisdiction or pursuant to any settlement, including any Third Party license
fees occurring as a result of a judgment or settlement requiring that BLSI or
any of its sublicensees obtain a license from the Third Party, and the balance,
if any, shall be payable to BA pursuant to the provisions of Article IV.
Section 5.4 Maintenance of Trademarks. Subject to and upon BLSI's payment
to BA of the license fee set forth in Section 4.1(b), and subject to the
provisions of Section 2.5, BLSI shall have the first right and option to file
and maintain any trademarks included in the Licensed Trademarks. If BLSI
declines the option or fails to file and/or maintain any such trademark it shall
give BA reasonable notice to this effect, sufficiently in advance to permit BA
to undertake, BA having the right but not the obligation, to pay all reasonable
costs in order for such filing and/or maintenance in order to maintain the said
Licensed Trademark. Beginning on the Effective Date of this Agreement, BLSI
shall reimburse BA for all maintenance and other fees BA incurs with respect to
the Licensed Trademarks within ninety (90) days of receiving evidence from BA
that such fees have been paid by BA.
Article VI
Confidentiality
Section 6.1 Confidential Information. Each Party shall keep in confidence
Confidential Information of the other Party. The Party receiving such
information agrees not to
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reproduce or disclose same to any Third Party or to use it for any purpose not
authorized in writing by the disclosing Party (except to the extent reasonably
necessary for Regulatory Approval of Licensed Products, for the filing,
prosecution and maintenance of Patent Rights or to Develop and Commercialize
Licensed Products in accordance with this Agreement). The receiving Party agrees
to hold the disclosing Party's information in confidence and to protect it with
the same degree of care used in protecting its own information of same
importance and in any case with not less than reasonable care and shall not
otherwise be disclosed by the receiving Party to any other Person (except
consultants, advisors and Affiliates in accordance with Section 6.2), without
the prior written consent of the disclosing Party, except to the extent that the
Confidential Information:
(a) was known or used by the receiving Party prior to its date of
disclosure to the receiving Party; or
(b) either before or after the date of the disclosure to the receiving
Party is lawfully disclosed to the receiving Party by sources other than the
disclosing Party rightfully in possession of the Confidential Information; or
(c) either before or after the date of the disclosure to the receiving
Party becomes published or generally known to the public through no fault or
omission on the part of the receiving Party; or
(d) as evidenced by written records, is independently developed by or
for the receiving Party without reference to or reliance upon the Confidential
Information.
Notwithstanding the foregoing, the receiving Party shall be entitled to
disclose the Confidential Information that is, in the receiving Party's
reasonable judgment after consultation with counsel (which counsel may be
in-house counsel), required to be disclosed by the receiving Party to comply
with applicable laws or regulations, to defend or prosecute litigation or to
comply with legal process, provided that the receiving Party provides prior
written notice of such disclosure to the disclosing Party to the extent
reasonably practicable under the circumstances and only discloses Confidential
Information of the other Party to the extent necessary for such legal compliance
or litigation purpose.
Section 6.2 Employee, Consultant and Advisor Obligations. BLSI and BA each
agrees that it and its Affiliates shall provide Confidential Information
received from the other Party only to the receiving Party's respective
employees, consultants and advisors, and to the employees, consultants and
advisors of the receiving Party's Affiliates, who have a need to know such
Confidential Information to assist the receiving Party in fulfilling its
obligations under this Agreement; provided that in any case, a receiving Party
shall be responsible for any violation of the terms hereof by any of its
employees, consultants, advisors and Affiliates.
Section 6.3 Term. All obligations of confidentiality imposed under this
Article VI shall remain until the Confidential Obligation falls under one of the
exceptions set forth in paragraphs (a) through (d) of Section 6.1.
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Article VII
Representations and Warranties
Section 7.1 Representations of Authority. BLSI and BA each represents and
warrants to the other that as of the Effective Date it has full right, power and
authority to enter into this Agreement and to perform its respective obligations
under this Agreement.
Section 7.2 Consents. BLSI and BA each represents and warrants that as of
the Effective Date all necessary consents, approvals and authorizations of all
government authorities and other persons required to be obtained by such Party
in connection with execution, delivery and performance of this Agreement have
been obtained.
Section 7.3 No Conflict. BLSI and BA each represents and warrants that, as
of the Effective Date, the execution and delivery of this Agreement and the
performance of such Party's obligations hereunder (a) do not conflict with or
violate any requirement of applicable laws or regulations and (b) do not
conflict with, violate or breach or constitute a default of, or require any
consent under, any contractual obligations of such Party, except such consents
as have been obtained as of the Effective Date.
Section 7.4 Employee, Consultant and Advisor Obligations. BLSI and BA each
represents and warrants that, as of the Effective Date, each of its and its
Affiliates' employees, consultants and advisors has executed an agreement or has
an existing obligation under law obligating such employee, consultant or advisor
to maintain the confidentiality of Confidential Information to the extent
required under Article VI.
Section 7.5 Intellectual Property. BA represents and warrants to BLSI that
(a) BA owns or Controls, subject to the University's rights under the University
Restated License Agreement, the entire right, title and interest in and to the
Licensed Patent Rights; (b) BA has the right, subject to the University's rights
under the University Restated License Agreement, to grant to BLSI the rights and
licenses under the Licensed Patent Rights granted in this Agreement; (c) as of
the Effective Date, to the knowledge of BA without due enquiry, there is no
claim or demand of any Person pertaining to, or any proceeding which is pending
or threatened, that asserts the invalidity, misuse or unenforceability of the
Licensed Patent Rights or challenges BA's ownership of the Licensed Patent
Rights or makes any adverse claim with respect thereto, and, to the knowledge of
BA, there is no basis for any such claim, demand or proceeding; and (d) to the
knowledge of BA without due enquiry, as of the Effective Date, the Licensed
Patent Rights are valid and enforceable and are not being infringed by any Third
Party.
Section 7.6 No Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN,
THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED.
Article VIII
Term and Termination
Section 8.1 Term. This Agreement shall become effective as of the Effective
Date, may be terminated as set forth in this Article VIII, and otherwise remains
in effect until the expiration of all of the obligations to pay royalties set
forth in Article IV.
-19-
Section 8.2 Breach of Material Obligation by BLSI.
(a) Diligence Milestones - U.S. In the event that BLSI fails to
satisfy the Outside Completion Date for any of the first nine (9) Diligence
Milestones described in Section II of Exhibit E (unless such failure is caused
by (i) demonstrated toxicity or drug safety issues with the Compounds and/or
Licensed Products determined in accordance with industry standards or (ii) a
failure to demonstrate statistically significant efficacy of the Compounds
and/or Licensed Products in a well-designed, well-controlled clinical trial as
measured by appropriate industry standards), then, at its option, BA may
terminate BLSI's rights under this Agreement in whole or in part by written
notice to BLSI within thirty (30) days of the Outside Completion Date for the
failed Diligence Milestone as such date is defined in Exhibit E. BLSI will,
within thirty (30) days after such termination by BA, make the appropriate
payment to BA as set out in Section II of Exhibit E; provided, however, that in
the event of multiple failed Diligence Milestones only the amount allocable to
the most recent failed Diligence Milestone shall be payable to BA.
(b) Diligence Milestones - Key European Countries and Japan. In the
event that BLSI fails to satisfy the Outside Completion Date for a Diligence
Milestone described in Exhibit E related to Regulatory Approval in the European
Union or Japan (unless such failure is caused by (i) demonstrated toxicity or
drug safety issues with the Compounds and/or Licensed Products determined in
accordance with industry standards or (ii) a failure to demonstrate
statistically significant efficacy of the Compounds and/or Licensed Products in
a well-designed, well-controlled clinical trial as measured by appropriate
industry standards), then, at its option, BA may terminate BLSI's rights under
this Agreement with respect to the European Union or Japan, as applicable, by
written notice to BLSI within thirty (30) days of the Outside Completion Date
for the failed Diligence Milestone as such date is defined in Exhibit E. BLSI
will, within thirty (30) days after such termination by BA, make the appropriate
payment to BA as set out in Section II of Exhibit E.
(c) Material Breach other than Diligence Milestones or Failure to
Launch. In case BLSI is in material breach of its material obligations or breach
or misstatement of its representations and warranties hereunder other than those
expressly covered in subsections (a) and (b) of this Section 8.2 or in Section
8.5 below (but including for greater certainty failure to use Commercially
Reasonable Efforts), BA shall give BLSI written notice stating the default of
BLSI. BLSI shall have sixty (60) days from the date of the notice to remedy the
stated default, failing which BA shall have the option, without limiting any
recourse it may have, by written notice, to (i) terminate the Agreement and all
rights granted to BLSI; or (ii) terminate the exclusivity granted herein to
BLSI, provided that in such case, BLSI shall not be entitled to claim damages
from BA unless after arbitration pursuant to Article IX, the arbitrator finds
that BLSI was not in material breach.
(d) Failure to Pay License Payment. In the event BLSI fails to make
the payment described in Section 4.1(b) on or before March 31, 2007, this
Agreement shall terminate automatically.
Section 8.3 Default by BA. BLSI may terminate this Agreement, if BA is in
material breach of its material obligations or breach or misstatement of its
representations and warranties
-20-
hereunder. BLSI shall give BA written notice of termination prior to terminating
this Agreement. Such notice shall state the causes for termination. BA shall
have sixty (60) days from the date of the notice to remedy the stated cause(s)
for termination, failing which BLSI shall have the option to terminate the
present Agreement and all rights granted to BLSI hereunder.
Section 8.4 Insolvency. Either Party may terminate this Agreement, on
written notice to the other Party and to the extent permitted by law, if the
other Party shall become insolvent, or shall make or seek to make or arrange an
assignment for the benefit of creditors, or if proceedings in voluntary or
involuntary bankruptcy shall be initiated by, on behalf of or against such Party
(and, in the case of any such involuntary proceeding, not dismissed within
ninety (90) days), or if a receiver or trustee of such Party's property shall be
appointed and not discharged within ninety (90) days.
Section 8.5 Termination for Failure to Launch.
(a) United States. Should BLSI, its Affiliates or its sublicensee or
partner fail to Launch a Licensed Product within twelve (12) months of obtaining
Marketing Approval for such Licensed Product in the U.S., any or all of the
following remedies may, at the option of BA, be invoked on thirty (30) days
written notice:
(i) BA may terminate BLSI's rights under this Agreement in whole
or in part at the end of the twelve (12) months after receipt of such Marketing
Approval by BLSI and all Licensed Intellectual Property, Confidential
Information and Regulatory Material shall be returned and assigned to BA or its
designee by BLSI at BLSI's cost and expense;
(ii) All then unpaid milestones described in Section 4.2 will
become immediately payable to BA; and
(iii) An amount equal to two times the Minimum Royalties set
forth on Exhibit F for the United States through the third Calendar Year after
Marketing Approval shall be payable to BA within thirty (30) days of
termination, notwithstanding termination of BLSI's rights under this Agreement.
(b) Key European Countries. Should BLSI, its Affiliates or its
sublicensee or partner fail to launch a Licensed Product in at least two (2) of
the Key European Countries within twelve (12) months of obtaining Marketing
Approval for such Licensed Product in two (2) of the Key European Countries, any
or all of the following remedies may, at the option of BA, be invoked:
(i) BA may terminate BLSI's rights under this Agreement solely
with respect to the European Union at the end of the twelfth (12th) month after
receipt of such Marketing Approval by BLSI and all Licensed Intellectual
Property, Confidential Information and Regulatory Material related to the
European Union shall be returned and assigned to BA or its designee by BLSI at
BLSI's cost and expense; and
(ii) Minimum Royalties set forth on Exhibit F for the Key
European Countries through the third Calendar Year after Regulatory Approval
shall be payable to BA
-21-
within thirty (30) days of termination, notwithstanding termination of BLSI's
rights under this Agreement.
(c) Japan. Should BLSI, its Affiliates or its sublicensee or partner
fail to launch a Licensed Product in Japan within twelve (12) months of
obtaining Marketing Approval for such Licensed Product in Japan, the following
remedies may, at the option of BA, be invoked:
(i) BA may terminate BLSI's rights under this Agreement solely
with respect to Japan at the end of the twelfth (12th) month after receipt of
such Marketing Approval by BLSI and all Licensed Intellectual Property,
Confidential Information and Regulatory Material related to the Japan shall be
returned and assigned to BA or its designee by BLSI at BLSI's cost and expense.
Section 8.6 Post Termination.
(a) In any case of termination other than a termination pursuant to
Section 8.2(b), Section 8.5(b) or Section 8.5(c), BLSI shall promptly transfer
and assign to BA, at BLSI's cost and expense, the Master Cell Bank, all Licensed
Intellectual Property and Confidential Information related to the terminated
Compounds and/or Licensed Products, and all rights, titles and interests in any
Regulatory Materials related to a Licensed Product or a Compound and all
non-clinical, clinical and other reports, records, data and other information
developed or generated by the Development and Commercialization of a Compound or
Licensed Product that are reasonably required for BA or its future licensees to
continue Development, Commercialization and to satisfy requirements imposed by
applicable Regulatory Authorities, and cooperate with BA and its future
licensees, at BLSI's expense, to effect an orderly transfer of Development and
regulatory responsibilities, including the transition of existing clinical
studies, to BA as promptly as practicable. If BA decides to continue to Develop
and/or Commercialize the Compounds and/or the Licensed Products, BA may do so
under the same trademark as those used by BLSI and BLSI will assign any and all
trademarks associated with any Licensed Product or Compound.
(b) In the case of a termination pursuant to Section 8.2(b), Section
8.5(b) or Section 8.5(c), BLSI shall promptly transfer and assign to BA, at
BLSI's cost and expense, a replica of the Master Cell Bank, all Licensed
Intellectual Property and Confidential Information related to the terminated
Compounds and/or Licensed Products, and all rights, titles and interests in any
Regulatory Materials issuing from a Regulatory Authority in the European Union
and/or Japan, as applicable, related to a Licensed Product or a Compound and all
non-clinical, clinical and other reports, records, data and other information
developed or generated by the Development and Commercialization of a Compound or
Licensed Product that are reasonably required for BA or its future licensees to
continue Development and Commercialization in the European Union and/or Japan,
as applicable, and to satisfy requirements imposed by applicable Regulatory
Authorities in the European Union and/or Japan, as applicable, and cooperate
with BA and its future licensees, at BLSI's expense, to effect an orderly
transfer of Development and regulatory responsibilities in the European Union
and/or Japan, as applicable, including the transition of existing clinical
studies, to BA as promptly as practicable. If BA decides to continue to Develop
and/or Commercialize the Compounds and/or the Licensed Products in the
-22-
European Union and/or Japan, as applicable, BA may do so under the same
trademark as those used by BLSI and BLSI will provide BA a license to use any
and all trademarks associated with any Licensed Product or Compound for
Commercialization of Licensed Products in the European Union and/or Japan, as
applicable.
Section 8.7 Survival. Upon expiration or termination of this Agreement for
any reason, nothing in this Agreement shall be construed to release either Party
from any obligations that matured prior to the effective date of expiration or
termination; and the following provisions shall expressly survive any such
expiration or termination: Section 3.3, Section 3.4, Section 4.5, Section 4.6,
Section 4.7, Section 4.8, Section 4.9, Section 8.6, this Section 8.7, Article
VI, Article IX, and Article X.
Article IX
Dispute Resolution
Section 9.1 Alternative Dispute Resolution. Any dispute arising out of or
relating to this Agreement shall be resolved through binding arbitration as
follows:
(a) A Party may submit such dispute to arbitration by notifying the
other Party, in writing, of such dispute. Within thirty (30) days after receipt
of such notice, the Parties shall designate in writing a single arbitrator to
resolve the dispute; provided, however, that if the Parties cannot agree on an
arbitrator within such 30-day period, the arbitrator shall be selected by the
New York, New York office of the American Arbitration Association (the "AAA").
The arbitrator shall be a lawyer with biotechnology and/or pharmaceutical
industry legal experience, and shall not be an Affiliate, employee, consultant,
officer, director or stockholder of any Party.
(b) Within thirty (30) days after the designation of the arbitrator,
the arbitrator and the Parties shall meet, at which time the Parties shall be
required to set forth in writing all disputed issues and a proposed ruling on
the merits of each such issue.
(c) The arbitrator shall set a date for a hearing, which shall be
completed no later than forty-five (45) days after the submission of written
proposals pursuant to Section 9.1(b), to discuss each of the issues identified
by the Parties. The Parties shall have the right to be represented by counsel.
Except as provided herein, the arbitration shall be governed by the Commercial
Arbitration Rules of the AAA; provided, however, that the Federal Rules of
Evidence shall apply with regard to the admissibility of evidence and the
arbitration shall be conducted by a single arbitrator.
(d) The arbitrator shall use his or her best efforts to rule on each
disputed issue within thirty (30) days after the completion of the hearings
described in Section 9.1(c). The determination of the arbitrator as to the
resolution of any dispute shall be binding and conclusive upon all Parties. All
rulings of the arbitrator shall be in writing and shall be delivered to the
Parties.
(e) The (i) attorneys' fees of the Parties in any arbitration, (ii)
fees of the arbitrator and (iii) costs and expenses of the arbitration shall be
borne by the Parties as determined by the arbitrator.
-23-
(f) Any arbitration pursuant to this Section 9.1 shall be conducted in
New York, New York. Any arbitration award may be entered in and enforced by any
court of competent jurisdiction.
Section 9.2 No Limitation. Nothing in Section 9.1 shall be construed as
limiting in any way the right of a Party to seek an injunction or other
equitable relief with respect to any actual or threatened breach of this
Agreement or to bring an action in aid of arbitration. Should any Party seek an
injunction or other equitable relief, or bring an action in aid of arbitration,
then for purposes of determining whether to grant such injunction or other
equitable relief, or whether to issue any order in aid of arbitration, the
dispute underlying the request for such injunction or other equitable relief, or
action in aid of arbitration, may be heard by the court in which such action or
proceeding is brought.
Article X
Miscellaneous Provisions
Section 10.1. Indemnification and Insurance.
(a) BLSI. BLSI agrees to defend, indemnify and hold harmless BA, its
Affiliates, and their respective directors, officers, employees and agents ("BA
INDEMNITEE") from and against any liability, damage, loss, or expense (including
reasonable attorneys fees and expenses of litigation) incurred by or imposed
upon any of the BA Indemnitees in connection with any Third Party claims, suits,
actions, demands or judgments ("CLAIM") resulting from or relating to (i) any
breach by BLSI of any of its representations or warranties hereunder or breach
of its obligations pursuant to this Agreement; or (ii) personal injury, property
damage or other damage resulting from the Development or Commercialization of a
Compound or Licensed Product by BLSI or its Affiliates or sublicensees; or (ii)
the use by BLSI of the Licensed Intellectual Property; provided, however, that
such indemnification shall not apply to any liability, damage, loss, or expense
to the extent attributable to (a) the act, omission, negligent activities or
intentional misconduct of BA Indemnitees; (b) the settlement of a claim, suit,
action, or demand by BA Indemnitees without the prior written approval of BLSI;
or (c) the breach or misstatement by BA of any of its obligations,
representations and warranties hereunder.
(b) BA. BA agrees to defend, indemnify and hold harmless BLSI, its
Affiliates, and their respective directors, officers, employees and agents
("BLSI INDEMNITEE") at BA's cost and expense, from and against any Claim arising
out of or relating to any breach by BA of any of its representations, warranties
or breach of its obligations pursuant to this Agreement; provided, however, that
such indemnification shall not apply to any liability, damage, loss, or expense
to the extent attributable to (a) the act, omission, negligent activities or
intentional misconduct of the BLSI Indemnitees; (b) the settlement of a Claim by
BLSI Indemnitees without the prior written approval of BA; or (c) the breach or
misstatement by BLSI of any of its obligations, representations and warranties
hereunder.
(c) Claims for Indemnification. A person entitled to indemnification
under this Section 10.1 (an "INDEMNIFIED PARTY") shall give prompt written
notification to the person from whom indemnification is sought (the
"INDEMNIFYING PARTY") of the commencement of any action, suit or proceeding
relating to a Third Party claim for which indemnification may be
-24-
sought or, if earlier, upon the assertion of any such claim by a Third Party (it
being understood and agreed, however, that the failure by an Indemnified Party
to give notice of a third-party claim as provided in this Section 10.1(c) shall
not relieve the Indemnifying Party of its indemnification obligation under this
Agreement except and only to the extent that such Indemnifying Party is actually
damaged as a result of such failure to give notice). Within thirty (30) days
after delivery of such notification, the Indemnifying Party may, upon written
notice thereof to the Indemnified Party, assume control of the defense of such
action, suit, proceeding or claim with counsel reasonably satisfactory to the
Indemnified Party. If the Indemnifying Party does not assume control of such
defense, the Indemnified Party shall control such defense. The Party not
controlling such defense may participate therein at its own expense; provided
that, if the Indemnifying Party assumes control of such defense and the
Indemnified Party reasonably concludes, based on advice from counsel, that the
Indemnifying Party and the Indemnified Party have conflicting interests with
respect to such action, suit, proceeding or claim, the Indemnifying Party shall
be responsible for the reasonable fees and expenses of counsel to the
Indemnified Party solely in connection therewith; provided, however, that in no
event shall the Indemnifying Party be responsible for the fees and expenses of
more than one counsel for all Indemnified Parties. The Party controlling such
defense shall keep the other Party advised of the status of such action, suit,
proceeding or claim and the defense thereof and shall consider recommendations
made by the other Party with respect thereto. The Indemnified Party shall not
agree to any settlement of such action, suit, proceeding or claim without the
prior written consent of the Indemnifying Party, which shall not be unreasonably
withheld, delayed or conditioned. The Indemnifying Party shall not agree to any
settlement of such action, suit, proceeding or claim or consent to any judgment
in respect thereof that does not include a complete and unconditional release of
the Indemnified Party from all liability with respect thereto or that imposes
any liability or obligation on the Indemnified Party without the prior written
consent of the Indemnified Party.
(d) All Risk Insurance. BLSI agrees to maintain all risk and general
liability and Products Liability insurance covering the transportation,
Development and Commercialization of the Compound and Licensed Products as is
normal and customary in the pharmaceutical industry generally for Persons
similarly situated and in such form, amount and effect so as to fulfill its
obligations hereunder. If such insurance is written on a claim made basis,
policy will provide an extended discovery period of three (3) years from the
termination date of this Agreement. Under any such insurance policy, BA shall be
mentioned as an additional insured and the certificate evidencing the insurance
shall mention that BA will be provided with a thirty (30) day prior written
notice wherever there be any termination, cancellation or material change in
coverage. Upon BA's request, a copy of the certificate will be provided to BA.
BLSI shall, once a year, provide BA with certificates of insurance attesting the
existence of such insurance.
Section 10.2. Governing Law. This Agreement shall be construed and the
respective rights of the Parties determined (including the validity and
applicability of the arbitration provision set forth in Section 9.1, and the
conduct of any arbitration, enforcement of any arbitral award and any other
questions of arbitration law or procedure arising thereunder) according to the
substantive laws of New York, notwithstanding the provisions governing conflict
of laws under such New York law to the contrary.
-25-
Section 10.3. Assignment. Neither BA nor BLSI may assign this Agreement in
whole or in part without the consent of the other, except if such assignment
occurs in connection with the sale or transfer of all or substantially all of
the business and assets of BA, on the one hand, or BLSI, on the other, to which
the subject matter of this Agreement pertains. Notwithstanding the foregoing,
any Party may assign its rights (but not its obligations) pursuant to this
Agreement in whole or in part to an Affiliate of such Party. This Agreement
shall be binding upon and inure to the benefit of the Parties and their
respective successors and permitted assigns.
Section 10.4. Entire Agreement; Amendments. This Agreement, together with
the Exhibits and Schedules, constitutes the entire agreement between the Parties
with respect to the subject matter hereof, and supersedes all previous
arrangements with respect to the subject matter hereof, whether written or oral,
including the Heads of Agreement dated December 1st, 2006. Any amendment or
modification to this Agreement shall be made in writing signed by both Parties.
Section 10.5. Notices.
Notices to BA shall be addressed to:
BioAxone Therapeutic Inc.
0000, xxx Xxxxxxxxx-Xxxxxxx, Suite 200
St. Laurent (Quebec) Canada
H4S 2A1
Attention: President
Facsimile No.: x0 (000) 000-0000
Notices to BLSI shall be addressed to:
Boston Life Sciences, Inc.
00 Xxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: Chief Financial Officer
Facsimile No.: x0 (000) 000-0000
with a copy to:
Xxxxxx Xxxxxx Xxxxxxxxx Xxxx and Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Xxxxxx X. Xxxxxx, Esq.
Facsimile No.: x0 (000) 000-0000
Any Party may change its address by giving notice to the other Party in the
manner herein provided. Any notice required or provided for by the terms of this
Agreement shall be in writing and shall be (a) sent by registered or certified
mail, return receipt requested, postage prepaid, (b) sent via a reputable
overnight or international express courier service, (c) sent by facsimile
transmission, or (d) personally delivered, in each case properly addressed in
accordance with the
-26-
paragraph above. The effective date of notice shall be the actual date of
receipt by the Party receiving the same.
Section 10.6. Force Majeure. No failure or omission by the Parties hereto
in the performance of any obligation of this Agreement shall be deemed a breach
of this Agreement or create any liability if the same shall arise from any cause
or causes beyond the control of the Parties, including, but not limited to, the
following: acts of God; acts or omissions of any government; any rules,
regulations or orders issued by any governmental authority or by any officer,
department, agency or instrumentality thereof; fire; storm; flood; earthquake;
war; rebellion; insurrection; riot; and invasion. The Party claiming force
majeure shall notify the other Party with notice of the force majeure event as
soon as practicable, but in no event longer than ten (10) business days after
its occurrence, which notice shall reasonably identify such obligations under
this Agreement and the extent to which performance thereof will be affected.
Section 10.7. Public Announcements. Any public announcements or publicity
with respect to the execution of this Agreement shall be agreed upon in writing
by the Parties in advance of such announcement.
Section 10.8. Independent Contractors. It is understood and agreed that the
relationship between the Parties hereunder is that of independent contractors
and that nothing in this Agreement shall be construed as authorization for
either BA or BLSI to act as agent for the other.
Section 10.9. Headings. The captions or headings of the sections or other
subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions hereof.
Section 10.10. No Implied Waivers; Rights Cumulative. No failure on the
part of BA or BLSI to exercise, and no delay in exercising, any right, power,
remedy or privilege under this Agreement, or provided by statute or at law or in
equity or otherwise, shall impair, prejudice or constitute a waiver of any such
right, power, remedy or privilege or be construed as a waiver of any breach of
this Agreement or as an acquiescence therein, nor shall any single or partial
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege.
Section 10.11. Severability. If, under applicable law or regulation, any
provision of this Agreement is invalid or unenforceable, or otherwise directly
or indirectly affects the validity of any other material provision(s) of this
Agreement (such invalid or unenforceable provision, a "SEVERED CLAUSE"), this
Agreement shall endure except for the Severed Clause. The Parties shall consult
one another and use reasonable efforts to agree upon a valid and enforceable
provision that is a reasonable substitute for the Severed Clause in view of the
intent of this Agreement.
Section 10.12. Execution in Counterparts. This Agreement may be executed in
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument.
-27-
Section 10.13. No Third Party Beneficiaries. No person or entity other than
BA, BLSI and their respective Affiliates and permitted assignees hereunder shall
be deemed an intended beneficiary hereunder or have any right to enforce any
obligation of this Agreement.
Section 10.14. No Consequential Damages. NEITHER PARTY HERETO WILL BE
LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE
DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER,
OR FOR LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT,
REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 10.14 IS
INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF
EITHER PARTY WITH RESPECT TO THIRD PARTY CLAIMS.
[Remainder of page intentionally left blank]
-28-
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first set forth above.
BOSTON LIFE SCIENCES, INC.
By: /s/ Xxxxx X. Xxxxx
------------------------------------
Title: Chairman and CEO
BIOAXONE THERAPEUTIC INC.
By: /s/ Xxxxx Xxxx
------------------------------------
Title: President and CEO
SCHEDULE 3.7
CLINICAL PRODUCT
[**]
EXHIBIT A
COMPOUNDS
BA DESIGNATION DESCRIPTION
-------------- -----------
BA-205 [**]
BA-207 [**]
BA-209 [**]
BA-210 [**]
BA-301 [**]
BA-302 [**]
BA-303 [**]
BA-304 [**]
BA-250-285 SERIES [**]
BA-290-320 SERIES [**]
EXHIBIT B
LICENSED PATENT RIGHTS
TABLE 1. FUSION PROTEINS (B300)
COUNTRY APPLICATION NUMBER FILING DATE PATENT/PUBLICATION NUMBER STATUS TITLE
------- ------------------ ----------- ------------------------- ------ -----
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
TABLE 2. COMPOSITIONS AND METHODS FOR TREATING TUMOR SPREADING (B300/B500)
COUNTRY APPLICATION NUMBER FILING DATE PATENT/PUBLICATION NUMBER STATUS TITLE
------- ------------------ ----------- ------------------------- ------ -----
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
TABLE 3. TREATMENT OF MACULAR DEGENERATION (B300)
COUNTRY APPLICATION NUMBER FILING DATE PATENT/PUBLICATION NUMBER STATUS TITLE
------- ------------------ ----------- ------------------------- ------ -----
[**] [**] [**] [**] [**] [**]
TABLE 4. RHO ANTAGONIST FORMULATIONS (B200)
COUNTRY APPLICATION NUMBER FILING DATE PATENT/PUBLICATION NUMBER STATUS TITLE
------- ------------------ ----------- ------------------------- ------ -----
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
TABLE 5. USE OF RHO ANTAGONISTS (B100)
COUNTRY APPLICATION NUMBER FILING DATE PATENT/PUBLICATION NUMBER STATUS TITLE
------- ------------------ ----------- ------------------------- ------ -----
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
EXHIBIT C
TRADEMARKS
REGISTRATION/
TRADE-MARKS APPLICATION NO.
----------- ---------------
CETHRIN 2,818,761
EXHIBIT D
UNIVERSITY RESTATED LICENSE AGREEMENT
RESTATED PATENT LICENSE AGREEMENT
(re B100, B200, B400)
AND I.P. AGREEMENT
(re B600 and others)
BY AND BETWEEN
UNIVERSITE DE MONTREAL
AND
BIOAXONE THERAPEUTIC INC.
AUGUST 2006
Table of Contents
Page
----
1. INTERPRETATION....................................................... 2
1.1 Definitions.................................................... 2
1.2 Schedules...................................................... 5
1.3 Currency....................................................... 5
1.4 Choice of Law and Attornment................................... 5
1.5 Interpretation Not Affected by Headings of Party Drafting...... 5
1.6 Number and Gender.............................................. 6
1.7 Time of Essence................................................ 6
2. RESTATEMENT OF THE PATENT LICENSE AGREEMENT.......................... 6
3. GRANT FOR THE LICENSED PATENTS....................................... 6
3.1 Grant of Rights................................................ 6
3.2 Rights to Sub-License.......................................... 6
3.3 Exclusivity.................................................... 7
4. OTHER INTELLECTUAL PROPERTY RIGHTS AGREEMENT......................... 7
4.1 Improvements by BioAxone and Ownership of B600................. 7
4.2 Right of First Refusal on Other Intellectual Property of
University.................................................. 8
5. TERM AND TERMINATION................................................. 9
5.1 Term........................................................... 9
5.2 Surviving Terms................................................ 9
5.3 BioAxone's Rights to Termination............................... 9
5.4 The University's Rights to Termination......................... 10
5.5 Results and Obligations of Expiry or Termination............... 10
6. LICENSING AND OTHER RIGHTS CONSIDERATIONS............................ 11
6.1 Reimbursement of Patent Costs.................................. 11
6.2 Financing...................................................... 11
7. ROYALTIES............................................................ 12
8. PAYMENTS AND REPORTS................................................. 12
8.1 Payments....................................................... 12
8.2 Payments in Canadian dollars................................... 12
8.3 Reports........................................................ 12
9. CONFIDENTIAL INFORMATION RESTRICTIONS................................ 13
9.1 Protection Requirements........................................ 13
9.2 Publicity, Press Releases and Announcements.................... 13
9.3 Survival....................................................... 14
10. PATENT MAINTENANCE................................................... 14
10.1 Patent Applications............................................ 14
i
10.2 BioAxone to Maintain Licensed Patents.......................... 14
11. INFRINGEMENT......................................................... 15
11.1 Obligation to Notify........................................... 15
11.2 Right to Enforce............................................... 15
11.3 Prosecution of Infringement.................................... 15
11.4 Infringement of Third Party's Rights........................... 15
12. REPRESENTATIONS, WARRANTIES AND COVENANTS............................ 16
12.1 Joint Representations.......................................... 16
12.2 Representations of University.................................. 16
12.3 Representations and Undertakings of BioAxone................... 18
13. GENERAL PROVISIONS................................................... 18
13.1 Effective Date................................................. 18
13.2 Assignment..................................................... 18
13.3 Alternative Dispute Resolution................................. 18
13.4 Further Assurances............................................. 19
13.5 Entire Agreement............................................... 19
13.6 Notices........................................................ 19
13.7 Waiver of Rights............................................... 20
13.8 Extended Operation............................................. 20
13.9 Partial Invalidity............................................. 20
13.10 Execution in Counterparts...................................... 21
13.11 Language....................................................... 21
ii
RESTATED PATENT LICENSE AGREEMENT AND I.P. AGREEMENT
THIS AGREEMENT is executed on this 2nd day of August, 2006.
BY AND BETWEEN: UNIVERSITE DE MONTREAL, a corporation incorporated pursuant to
the Charte de l'Universite de Montreal, 1967, 15-16 Eliz. 2
ch, 129, having its head office at 2900 Xxxxxxx-Xxxxxxxxx,
Montreal, Province of Xxxxxx, X0X 0X0;
(hereinafter referred to as: the "UNIVERSITY")
AND: BIOAXONE THERAPEUTIC INC., a corporation duly constituted
under the Canada Business Corporations Act ("CBCA"), having
its head office at 0000, Xxxxxxxxx-Xxxxxxx, xxxxx 000,
Xxxxx-Xxxxxxx, Xxxxxx, X0X 0X0;
(hereinafter referred to as: "BIOAXONE")
(University and BioAxone are hereinafter collectively referred
to as the "PARTIES" or individually as a "PARTY")
PREAMBLE
WHEREAS pursuant to an Agreement in Principle dated January 26, 2001 between the
University, Xxxx XxXxxxxxxxx and BioAxone as amended pursuant to the Avenant No.
1 dated May 29, 2001 and a Letter Agreement dated December 14, 2001 between the
same Parties (collectively referred to as the "AGREEMENT IN PRINCIPLE"), the
University granted BioAxone an exclusive option (the "OPTION") to acquire an
exclusive license to the Licensed Patents.
WHEREAS following the execution of the Agreement in Principle, BioAxone has: (i)
disbursed the totality of the costs and expenses relating to the prosecution of
the Licensed Patents, (ii) has obtained financing of at least two million
dollars ($2,000,000) enabling it to pursue research on any of the Licensed
Patents (hereinafter referred to as the "FINANCING"), and (iii) has exercised
its Option by its execution of a Patent License Agreement on June 10, 2002
thereafter modified on June 14, 2004 by an Amendment To The Patent License
Agreement (both these agreements hereinafter collectively referred to as the
"ORIGINAL AGREEMENT").
WHEREAS pursuant to the University policy on intellectual property (the
"UNIVERSITY POLICY"), the innovations covered by the Licensed Patents before the
assignment to the University were either jointly owned by Xxxx XxXxxxxxxxx and
Xxxxxx Xxxxxx or solely owned by Xxxx XxXxxxxxxxx, the original inventors of the
invention embodied in the Licensed Patents (Xxxx XxXxxxxxxxx and Xxxxxx Xxxxxx
being hereinafter referred to collectively as "INVENTORS" or individually as
"INVENTOR").
WHEREAS, pursuant to the University Policy, the University (i) has obtained,
from the Inventors, formal assignments of the Licensed Patents and (ii) has the
management responsibility for negotiating licenses and for taking any other step
deemed necessary for the commercialisation of the innovations covered by the
Licensed Patents, on its behalf and on behalf of the Inventors.
WHEREAS the University had and still has the exclusive right to issue the
Original Agreement and this Restated Patent License Agreement and I.P. Agreement
(the "RESTATED AGREEMENT") granting BioAxone rights to the Licensed Patents.
WHEREAS with this Restated Agreement, the Parties now wish to restate the terms
and conditions of the Original Agreement in order to clarify some undesirable
ambiguities and complexities found therein.
WHEREAS the Parties also wish to clarify the ownership of a certain product
known as B600, as well as to provide a right of first refusal to BioAxone on
some intellectual property of University.
NOW THEREFORE, in consideration of the foregoing premises forming an integral
part of this Restated Agreement, the mutual covenants and obligations
hereinafter contained, and other good and valuable consideration, the University
and BioAxone agree as follows:
1. INTERPRETATION
1.1 DEFINITIONS
All words, terms and phrases used in this Restated Agreement shall have meanings
ascribed to them in standard English language dictionaries. However, where this
Restated Agreement specifically defines a term, that definition shall be used in
this Restated Agreement. That definition shall govern, whether the term is used
in the singular or plural, and shall apply regardless of the gender of the
object or person to which it is applied.
In addition to capitalized terms defined above, the following terms shall have
the meanings set forth below:
1.1.1 "AFFILIATE" means, with respect to a Party to this Restated Agreement
or to a Sub-licensee, any individual or entity, which directly or
indirectly Controls, is Controlled by, or is under common Control with
such Party or Sub-Licensee. The term "CONTROL" means possession,
direct or indirect, of the powers to direct or cause the direction of
the management or policies of a Person; whether through ownership of
equity participation, voting securities, or beneficial interests by
contract, by agreement or otherwise. "AFFILIATE" shall specifically
exclude Sub-licensees of rights granted by BioAxone pursuant to the
authority granted by this Restated Agreement, where BioAxone has no
relationship to the Sub-licensee other than commonly defined as
licensor-licensee relationship.
1.1.2 "CALENDAR YEAR" means a period of twelve (12) months in the Gregorian
calendar beginning on January 1 and ending on December 31.
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1.1.3 "CONFIDENTIAL INFORMATION" means any information relating to a Party
(the "DISCLOSING PARTY"), whether written, graphic, electronic or
communicated orally by the Disclosing Party to the receiving Party, or
its agents, which, at the time of disclosure, is reasonably
understood, as being confidential or proprietary to the Disclosing
Party. Such "Confidential Information" shall specifically include, but
not be limited to, any disclosure, independent of the physical medium
through which the information is disclosed, made by the Disclosing
Party to the receiving Party which, at the time of disclosure, is
physically marked or verbally qualified as confidential or
proprietary. But such "Confidential Information" shall exclude such
information which: (i) prior to the 10th of June 2002 was already in
the possession of the recipient, as demonstrated by written records;
(ii) is generally available to the public, other than as a result of a
disclosure by the receiving Party; (iii) is made available to the
receiving Party on a non-confidential basis from a source other than
the Disclosing Party or its representatives; or (iv) is required by
law to be disclosed to a competent court, tribunal, governmental or
regulatory authority.
1.1.4 "DISTRIBUTOR" means any Person engaged by BioAxone or by a
Sub-Licensee to distribute any Licensed Products to any End User,
either directly or indirectly through other distributors.
1.1.5 "EARLY TERMINATION" has the meaning ascribed to such terms pursuant
to the provisions of Sections 5.3 or 5.4 herein as the case may be.
1.1.6 "EFFECTIVE DATE" means the date of closing of the Financing being
June 21, 2002.
1.1.7 "END USER" means any Person who or which is neither a Party nor, with
respect to a Party, an Affiliate, a Sub-Licensee or a Distributor of
that Party.
1.1.8 "EXPIRY" has the meaning ascribed to such term pursuant to the
provisions of Section 5.1 herein.
1.1.9 "GROSS REVENUES" (i) when referring to "GROSS REVENUES TYPE 1", means
all sales, revenues (including revenues generated from sub-licenses in
the form of lump sums), receipts and monies, received by BioAxone or
its Affiliates during the term of the Licensed Patents from the use,
sale, lease, or other transfer, other than royalties received from
Sub-licensees, of one or some Licensed Products and (ii) when
referring to "GROSS REVENUES TYPE 2", means all royalty revenues
received by BioAxone or its Affiliates during the term of the Licensed
Patents from their Sub-licensees of one or some Licensed Products.
"Gross Revenues" type 1 and type 2 shall however exclude: (a) all
equity compensation received by BioAxone; (b) all revenues from
research and development agreements; (c) all grants, credits or
financial support of any sort related to the research and development;
and (d) all revenues from material transfer agreements, provided that
such agreements do not include license grants or commercialisation
rights with respect to the Licensed Patents.
-3-
1.1.10 "IMPROVEMENTS" means innovations, inventions, ideas, designs,
concepts, discoveries, techniques, works, processes, formulas, new
derived material and modifications related to the Licensed Patents;
whether or not patentable, copyrightable, or otherwise protectable as
trade secrets or under any other intellectual property regime.
1.1.11 "LICENSED PATENTS" means the patent applications listed in Schedule
1.1.11 hereto as amended by the Parties from time to time, and any
foreign patent application based thereon and all patents granted on
said applications as well as any continuation, continuation-in-part,
division, patent of addition, reissue, re-examination or extension of
any of the foregoing and any and all patents granted anywhere in the
world with respect thereto.
1.1.12 "LICENSED PRODUCT" means any product, the production or manufacture
of which incorporates the Licensed Patents.
1.1.13 "MARKET EXCLUSIVITY" means for a given country within the Territory,
the fact, in the said country, there are valid and enforceable
Licensed Patents that exist to protect the relevant Licensed Product
against infringement.
1.1.14 "MATERIAL BREACH NOTICE" means the written notice required to
terminate this Restated Agreement pursuant to the provisions of
Subsections 5.3.2 or 5.4.1 as the case may be.
1.1.15 "NET SALES" means Gross Revenues type 1 less the following related
qualifying costs borne by BioAxone:
(a) Credits, refunds, or uncollected amounts;
(b) Discounts, in amounts customary in the trade, for quantity
purchases, cash payments, prompt payments, wholesalers, and
Distributors;
(c) Packaging;
(d) Prepaid transportation insurance premiums;
(e) Prepaid outbound transportation expenses;
(f) Handling charges;
(g) Taxes; including without limitation, sales, use, turnover,
excise, import, export, and other taxes or duties imposed by a
government agency on such sales, lease, or transfer; and
(h) Allowances for defective Licensed Products.
Specifically excluded from the calculation of "Net Sales" is any
consideration received for the use, sale, lease or transfer of any Licensed
Product made for the purpose of
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obtaining regulatory approval including, without limitation, providing
samples for clinical trials.
1.1.16 "PERSON" means a corporation, an association, a joint venture, a
partnership, a trust, a business, an individual, a government or
political subdivision thereof, including an agency, or any other
organisation, which can exercise independent legal standing.
1.1.17 "SUB-LICENSEE" means any Person, not an Affiliate of BioAxone, which
is licensed by BioAxone pursuant to the authority granted in this
Restated Agreement.
1.1.18 "TERRITORY" means the world.
1.2 SCHEDULES
The following are the "SCHEDULES" annexed hereto and incorporated by reference
and deemed to be part hereof:
Schedule Description
-------- -----------
1.1.11 Description of Patent Applications
6.1 Patenting costs to-be reimbursed
13.3.2 Arbitration
1.3 CURRENCY
Unless otherwise indicated, all dollar amounts referred to in this Restated
Agreement are in lawful money of Canada.
1.4 CHOICE OF LAW AND ATTORNMENT
This Restated Agreement shall be governed by and construed in accordance with
the laws of the Province of Quebec and the laws of Canada applicable therein,
without regard to the principle of conflict of laws.
1.5 INTERPRETATION NOT AFFECTED BY HEADINGS OF PARTY DRAFTING
The division of this Restated Agreement into articles, sections, subsections and
clauses and the insertion of headings are for convenience of reference only and
shall not affect the construction or interpretation of this Restated Agreement.
The terms "THIS RESTATED AGREEMENT", "HEREOF", "HEREIN", "HEREUNDER" and similar
expressions refer to this Restated Agreement and the schedules hereto and not to
any particular article, section, subsection, clause or other portion hereof and
include any agreement or instrument supplementary or ancillary hereto. Each
Party hereto acknowledges that it and its legal counsel have reviewed and
participated in settling the terms of this Restated Agreement, and the Parties
hereby agree that any rule of construction to
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the effect that any ambiguity is to be resolved against the drafting Party shall
not be applicable in the interpretation of this Restated Agreement.
1.6 NUMBER AND GENDER
In this Restated Agreement, unless there is something in the subject-matter or
context inconsistent therewith, (i) words (including without restriction the
defined terms herein) in the singular number include the plural and such words
shall be construed as if the plural had been used, (ii) words (including without
restriction the defined terms herein) in the plural include the singular and
such words shall be construed as if the singular had been used, and (iii) words
(including without restriction the defined terms herein) importing the use of
any gender shall include all genders where the context or party referred to so
requires, and the rest of the sentence shall be construed as if the necessary
grammatical and terminological changes have been made.
1.7 TIME OF ESSENCE
Time shall be of the essence hereof.
2. RESTATEMENT OF THE PATENT LICENSE AGREEMENT
The Original Agreement is hereby terminated and replaced by this Restated
Agreement.
3. GRANT FOR THE LICENSED PATENTS
3.1 GRANT OF RIGHTS
3.1.1 Subject to the terms and conditions of this Restated Agreement, the
University hereby grants to BioAxone and its Affiliates, with the
right to grant sublicenses, an exclusive license to use the Licensed
Patents in the Territory for the term of this Restated Agreement to
commercialize the Licensed Products.
3.1.2 Without limiting the generality of Subsection 3.1.1, the right to use
granted therein extend to and authorise, without limitation, the right
to (a) conduct research and development and related activities
including, without limitation, compassionate access programs, and (b)
make, have made, use, reproduce, lease or to proceed to other
transfer, distribute for sale, promote, market, offer for sale, sell,
have sold, import and export, the Licensed Products.
3.2 RIGHTS TO SUB-LICENSE
3.2.1 Should a sub-license be granted for the purposes of developing and
marketing Licensed Products, then BioAxone agrees that such a
sub-license shall only be granted to third parties that can reasonably
demonstrate to BioAxone, at BioAxone's sole discretion, capabilities
for the effective development and marketing of the Licensed Products.
3.2.2 Each sub-license granted by BioAxone shall impose obligations;
responsibilities and standards upon any Sub-Licensees that, in all
material respects, are not less
-6-
than those imposed on BioAxone hereunder. Each Sub-Licensee shall
specifically refer to this Restated Agreement and all rights retained
by University. Notwithstanding the foregoing, the Parties understand
and agree that BioAxone shall not be in breach of this Restated
Agreement if any agreement with a Sub-Licensee provides that royalties
will not be paid by the Sub-Licensee to BioAxone if: (i) a Licensed
Patent expires, whether by statute or otherwise; (ii) is invalidated
by a final decision of a court or other judicial or administrative
body of competent jurisdiction for any reason; or (iii) a Licensed
Patent is not issued or granted.
3.2.3 No sub-license agreement shall relieve BioAxone of any of its
obligation under this Restated Agreement, including the obligation to
pay royalties to the University in accordance with its Article 7.
3.2.4 BioAxone shall provide the University with copies of every
sub-license granted by BioAxone pursuant to the terms and conditions
of this Restated Agreement.
3.3 EXCLUSIVITY
The exclusivity granted to BioAxone hereunder shall be total in all respects,
except that the University specifically reserves the right to use the Licensed
Patents for teaching and continuing research only. For the sake of clarity, the
University confirms that its reserved right under this section shall not include
the right to use the Licensed Patents for any commercial purposes and shall not
include the right to grant other licenses of the Licensed Patents to any other
Person.
4. OTHER INTELLECTUAL PROPERTY RIGHTS AGREEMENT
4.1 IMPROVEMENTS BY BIOAXONE AND OWNERSHIP OF B600
4.1.1 Unless otherwise agreed to between the Parties, BioAxone shall retain
title to and Control of any Improvement it may produce, develop, make
or achieve.
4.1.2 As of the date of this Restated Agreement, each of the Parties
confirms that the product known as the B600 (also known as
4-substituted piperidine derivatives) is to be herein considered
Improvements and therefore, that B600 is exclusively owned by BioAxone
since its creation.
4.1.3 Without limiting the preceding subsection, University hereby assigns,
conveys and transfers any and all intellectual property rights, titles
and interests that it has or may have in and to the invention known as
B600 and the patents and patents applications related thereto,
including without limiting the generality of the foregoing, the right
to xxx for past infringement, the whole without restrictions of any
kind, unto BioAxone and the University recognises and agrees that
BioAxone is the sole and absolute assignee of patents related to B600
wherever granted throughout the world. BioAxone accepts the present
assignment, conveyance and transfer of rights.
-7-
4.2 RIGHT OF FIRST REFUSAL ON OTHER INTELLECTUAL PROPERTY OF UNIVERSITY
4.2.1 Subject to Section 4.1, the University hereby grants BioAxone a right
of first refusal with respect to, as the case may be, any improvement
to the Licensed Patents not covered by the definition of Licensed
Patents and that is dominated by the Licensed Patents and that:
(a) is assigned to the University or otherwise owned by it; and
(b) arises out of work carried out by Xxxx XxXxxxxxxxx within her
laboratory situated within the premises of the University or any
scientist working in Xxxx XxXxxxxxxxx'x laboratory situated on
the premises of the University.
(c) Notwithstanding the foregoing, the Parties understand and agree
that the present section does not apply to innovations which
arise out of work carried out within the premises leased from
time to time under separate agreements to BioAxone by the
University; notwithstanding anything to the contrary that could
be stated in another agreement, the said innovations being the
exclusive property of BioAxone.
4.2.2 Should BioAxone decide that one or more patent applications covering
the innovation mentioned hereinabove have to be filed anywhere in the
world, then BioAxone shall send a written notice to the University
advising the University of same. Upon filing of the said patent
application(s), the Parties shall immediately amend this Restated
Agreement by adding the said patent application(s) to Schedule 1.1.11.
Should the Parties fail to make the aforementioned amendment in
writing, then this Restated Agreement shall be deemed to have been
amended by adding the said patent application(s) to Schedule 1.1.11
upon filing thereof.
4.2.3 Should the University decide that one or more patent applications
covering the aforementioned innovation have to be filed anywhere in
the world, the University shall send a written notice to BioAxone
advising it of same, BioAxone having sixty (60) days from the date it
receives the said notice to advise the University in writing that it
wishes to add the aforementioned patent application(s) to this
Restated Agreement. If BioAxone so advises the University, then, upon
filing of the said patent application(s), the Parties shall
immediately amend this Restated Agreement by adding the said patent
application(s) to Schedule 1.1.11. Should the Parties fail to make the
aforementioned amendment in writing, then this Restated Agreement
shall be deemed to have been amended by adding the said patent
application(s) to Schedule 1.1.11 upon filing thereof.
4.2.4 If BioAxone advises the University in writing that it does not wish
to add the patent application(s) referred to in Section 4.2.3 to this
Restated Agreement or if BioAxone fails to provide the University with
the aforementioned notice within the aforementioned sixty (60) day
delay, then the University shall have the right, at its own expense,
to file whatever patent applications with respect to the
aforementioned innovation it deems appropriate and to negotiate with
third parties
-8-
whatever licensing or other contractual arrangement with respect
thereto that the University deems appropriate, BioAxone having
forfeited any right in and to the said innovation.
5. TERM AND TERMINATION
5.1 TERM
The term of this Restated Agreement shall from Effective Date be infinite or
perpetual except that with respect to the Licensed Patents the term shall expire
("EXPIRY") at the earlier of (i) the date upon which the last of the Licensed
Patent expires, whether by statute or otherwise, (ii) the date upon which the
last of the Licensed Patents is invalidated by a final decision of a court or
other judicial or administrative body of competent jurisdiction for any reason,
(iii) if no valid patent may issue for the Licensed Patents, the date upon which
the last and final refusal is issued by a court or other judicial or
administrative body of competent jurisdiction for any reason, and (iv) by the
operation of law.
5.2 SURVIVING TERMS
The Parties understand and agree that Articles or Sections 2, 4, 5.2, 5.3.1,
5.4.3, 5.5, 6.1, 7, 8, 9, 13.3, 13.5, 13.6, 13.7 and 13.9 shall survive Expiry.
5.3 BIOAXONE'S RIGHTS TO TERMINATION
5.3.1 BioAxone may terminate this Restated Agreement without justification
after it has been in effect for six (6) months ("EARLY TERMINATION").
In order to terminate, BioAxone must give written notice of its intent
to terminate at least sixty (60) days prior to actual termination.
Upon such Early Termination, it is understood that BioAxone shall lose
all of its rights and interests in the said Restated Agreement but
shall still be bound to all obligations including those of payments.
5.3.2 Upon any material breach of this Restated Agreement by the University
limited to:
(a) The assignment of the University's rights in and to the Licensed
Patents to a third party, or
(b) The grant of a license in and to the Licensed Patents to a third
party within the Territory and during the Term, or
(c) The grant of hypothecs or other liens or encumbrances with
respect to the Licensed Patents,
(d) which is not cured by the University pursuant to the provisions
of this Subsection 5.3.2, BioAxone may terminate this Restated
Agreement upon giving the University a formal notice of
termination ("Early Termination"), the whole subject to the
provisions of Subsection 5.5.3. Prior to such formal notice of
termination, BioAxone shall give the
-9-
University a Material Breach Notice. The Material Breach Notice
shall state the causes for such material breach and the
procedures, if any, the University must follow to prevent such
termination. The University shall have sixty (60) days after the
date of the Material Breach Notice to remedy the stated causes
for termination, according to the procedures stated, otherwise
this Restated Agreement and all rights of the University, may be
terminated by BioAxone at any time after the end of the sixtieth
(60th) day by giving the University the formal notice of
termination contemplated in this Subsection 5.3.2.
5.4 THE UNIVERSITY'S RIGHTS TO TERMINATION
5.4.1 Upon any material breach of this Restated Agreement by BioAxone,
which is not cured by BioAxone pursuant to the provisions of this
Subsection 5.4.1, the University may terminate this Restated Agreement
upon giving BioAxone a formal notice of termination ("EARLY
TERMINATION"). Prior to the formal notice of termination, the
University shall give BioAxone a Material Breach Notice. The Material
Breach Notice shall state the causes for such material breach and the
procedures, if any, BioAxone must follow to prevent such termination.
BioAxone shall have sixty (60) days after receipt of the Material
Breach Notice to remedy the stated causes for termination, according
to the procedures stated, otherwise this Restated Agreement and all
rights granted to BioAxone herein, may be terminated by the University
at any time after the end of the sixtieth (60th) day by giving
BioAxone the formal notice of termination contemplated in this
Subsection 5.4.1.
5.4.2 If BioAxone (i) becomes insolvent or technically bankrupt, (ii) makes
a general assignment for the benefit of creditors, (iii) suffers or
permits the appointment of a receiver for its business or assets, or
(iv) avails itself of, or becomes subject to, any proceeding under the
Federal Bankruptcy Act or any other statute of any province, state or
country relating to insolvency or the protection of creditor rights,
and any such proceedings remain undismissed for a period of one
hundred and twenty (120) days (the "Events"), this Restated Agreement
may be automatically terminated at the occurrence of the Events, such
termination to be effective upon receipt by BioAxone of a notice of
termination ("EARLY TERMINATION") from the University.
5.4.3 BioAxone shall lose all of its rights contemplated herein upon the
Early Termination described in Section 5.4 but shall still be bound to
all obligations including those of payments.
5.5 RESULTS AND OBLIGATIONS OF EXPIRY OR TERMINATION
5.5.1 Expiry of any portion of this Restated Agreement or Early Termination
of this Restated Agreement shall not release the University or
BioAxone from any obligation or liability to the other which shall
have matured prior to Expiry or Early Termination, nor shall Expiry or
Early Termination rescind or require
-10-
repayment of any payment or consideration made or given by either
Party, except as otherwise provided herein. If the terms of this
Restated Agreement expressly state that a right or obligation shall
survive termination of this Restated Agreement, such right or
obligation shall survive any Expiry or Early Termination to the degree
necessary to allow complete fulfillment or discharge of the right or
obligation.
5.5.2 Notwithstanding anything to the contrary herein, upon Early
Termination of this Restated Agreement by BioAxone in accordance with
the provisions of Subsection 5.3.2 (Early Termination), this Restated
Agreement shall become fully paid-up, the provisions of articles 7 and
8 shall cease to take effect forthwith and all other provisions of
this Restated Agreement shall continue to be in force until Expiry.
5.5.3 Except for the Early Termination right of BioAxone pursuant to
Subsection 5.3.1 and the Early Termination right of the University
pursuant to Subsection 5.4.2 and notwithstanding anything to the
contrary herein, neither Party shall have the right to terminate this
Restated Agreement if the procedure of arbitration as provided for in
Subsection 13.3.2 has been initiated by either one of the Parties and
any notice of termination, other than (i) a notice of BioAxone
pursuant to the provisions of Subsection 5.3.1, or (ii) a notice of
the University pursuant to the provisions of Subsection 5.4.2, given
after the aforementioned procedure of arbitration has been initiated
shall only become effective if the decision of the arbitrator confirms
such termination.
6. LICENSING AND OTHER RIGHTS CONSIDERATIONS
6.1 REIMBURSEMENT OF PATENT COSTS
In consideration of the license granted herein, the agreements herein related to
other intellectual property of University and the out-of-pocket patenting costs
incurred by the University for the Licensed Patents up to January 26, 2001
(being the date of the Option), BioAxone has within a period of [**] days, from
the Effective Date reimbursed to the University the sum of [**], such amounts
representing together the aggregate costs related to the Licensed Patents
anywhere in the Territory that are required to be reimbursed by BioAxone to any
Person, as such costs are more fully described in Schedule 6.1 attached hereto.
The payment of these patent costs by BioAxone in accordance with this Section
6.1 shall, subject to Section 6.2 and Article 7, constitute full and final
payment of any amounts owed to the University or any other Person by BioAxone
with regard to the Licensed Patents.
6.2 FINANCING
At the closing of the Financing, being June 21, 2002 as herein above specified,
in accordance with the Parties' agreement, BioAxone has issued to the
University, whom had subscribed to, [**] Common Shares for a total subscription
price of [**] in the capital stock of BioAxone, and as required the University
has signed the Unanimous shareholders agreement with all the other shareholders
of BioAxone.
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7. ROYALTIES
In consideration for the license granted in this Restated Agreement, BioAxone
shall make payments to the University, in the manner designated in this Restated
Agreement, included in Section 8 below, of an earned royalty of: (i) [**]
percent ([**]%) of Net Sales in the countries where BioAxone has Market
Exclusivity; and (ii) [**] percent ([**]%) of Gross Revenues type 2 received by
BioAxone in the countries where BioAxone has Market Exclusivity.
In no event shall there be a duplication of royalties on Net Sales payable by
BioAxone to University under this Restated Agreement with royalties on same net
sales payable by BioAxone to University under a Restated Product Royalty
Agreement executed by the Parties concurrently with this Restated Agreement.
8. PAYMENTS AND REPORTS
8.1 PAYMENTS
8.1.1 Any amount due to the University as a result of each Licensed Product
being used, sold, leased, or transferred pursuant to this Restated
Agreement shall accrue only from the time BioAxone receives payment
for such Licensed Product or receives the payment of royalties from
any and all Sub-Licensees.
8.1.2 Unless otherwise specified in this Restated Agreement, all payments
amounts due to the University under this Restated Agreement shall be
paid within [**] days following the end of the Calendar Year in which
such payment accrues or BioAxone otherwise incurs the obligation to
pay such amounts.
8.1.3 All such payments shall be remitted to the University's address given
in the notification provision of this Restated Agreement or to such
other address, as the University shall direct provided that BioAxone
has received sufficient prior written notice of such other address.
8.2 PAYMENTS IN CANADIAN DOLLARS
BioAxone shall make payment of any amounts due to the University under this
Restated Agreement in Canadian dollars. All amounts due to the University but
received by BioAxone in a currency other than the Canadian dollar shall be
converted into Canadian dollars based on the currency rate listed in the Wall
Street Journal on the last business day of each Calendar Year.
8.3 REPORTS
8.3.1 BioAxone shall keep, at its own expense, during the term of this
Restated Agreement and for two (2) years after Expiry, accurate books
of account, detailing the data necessary to calculate any payments due
to the University from BioAxone under this Restated Agreement. No more
than once per Calendar Year, records shall be open, during normal
business hours during the term of this Restated Agreement, for
inspection and audit by a duly authorized independent and of good
reputation chartered accountant hired by the University to ascertain
-12-
the accuracy of the royalty payments, provided that a fifteen (15)
business day notice shall be given to BioAxone.
8.3.2 Each payment made to the University shall be accompanied by a written
report summarising the data used to calculate the amounts paid,
including Gross Revenues type 2. Each report pertaining to royalty
payments for the applicable accounting period shall specifically
include the following, as applicable:
(a) Net Sales amounts and details relating to how they were
calculated; and
(b) Royalties due.
9. CONFIDENTIAL INFORMATION RESTRICTIONS
9.1 PROTECTION REQUIREMENTS
Each Party shall keep in confidence Confidential Information of the other Party.
The Party receiving such information agrees not to reproduce or disclose same to
any third party or to use it for any purpose not authorized by the Disclosing
Party. The receiving Party agrees to restrict access of such information to
employees or agents who have a need to know such information for purposes hereof
and further agrees to instruct its employees having access to such information
of receiving Party's confidentiality obligations. In any case, a receiving Party
shall be responsible for any violation of the terms hereof by any of its
employees or agents. The receiving Party agrees to hold the Disclosing Party's
information in confidence and to protect it with the same degree of care used in
protecting its own information and in any case with not less than reasonable
care.
9.2 PUBLICITY, PRESS RELEASES AND ANNOUNCEMENTS
Except as otherwise required by law, the Parties shall not issue a press release
or make any other public disclosure with regard to the existence of this
Restated Agreement or the terms thereof without the prior approval of the other
Party of such press release or public disclosure. Each Party shall submit any
such press release or public disclosure to the other Party, and the receiving
Party shall expeditiously review and approve any such press release or public
disclosure, which approval shall not be unreasonably withheld. If the receiving
Party does not respond within five (5) days, the press release or public
disclosure shall be deemed approved. In the event that for any reason the press
release or public disclosure is required on an urgent basis, the Parties shall
work together and use commercially reasonable efforts to disclose such release
sooner. In addition, if a public disclosure is required by law, including
without limitation in a filing with any securities and exchange commission, the
Disclosing Party shall use commercially reasonable efforts to secure
confidential treatment of any Confidential Information of the other Party
contained in such release, prior to its disclosure. BioAxone may disclose the
terms of this Restated Agreement to its actual or prospective investors or
corporate partners or to such Party's accountants, attorneys and other
professional or financial advisors provided that nothing in this Section 9.2
shall permit BioAxone or any such investor, corporate partner, accountant,
attorney or advisor to release the Confidential Information or to jeopardize any
trade secret of the other Party.
-13-
9.3 SURVIVAL
Notwithstanding anything to the contrary herein, the obligations under this
article 9 shall survive the termination or expiry of this Restated Agreement as
long as the Confidential Information remains confidential.
10. PATENT MAINTENANCE
10.1 PATENT APPLICATIONS
BioAxone will consult with the University but will have the ultimate final
decision on the choice of countries where any of the patent applications that
are included in the definition of Licensed Patents are to be filed, prosecuted
and maintained at the cost of BioAxone provided that such patent applications
will be filed, prosecuted and maintained in Canada and the United States except
that if, in the opinion of the patent counsels of BioAxone, such patent
application will not reasonably issue in any one of the aforementioned
countries, BioAxone will not be obliged to include such country or countries in
its filing for a patent.
10.2 BIOAXONE TO MAINTAIN LICENSED PATENTS
10.2.1 Subject to Section 10.1, BioAxone shall prosecute and maintain the
Licensed Patents during the term of this Restated Agreement. Matters
related to the prosecution, filing and maintenance of all Licensed
Patents shall be the sole responsibility and at the sole discretion of
BioAxone provided however that the University shall provide assistance
to BioAxone concerning such matters, and the University agrees to
cooperate with BioAxone in such matters. In the event where BioAxone
fails to maintain a Licensed Patent during the term of this Restated
Agreement, the University will have the right but not the obligation
to pay all reasonable costs in order to maintain the said Licensed
Patent and BioAxone shall reimburse the University for same.
10.2.2 Subject to Section 10.1, beginning on the Effective Date of this
Restated Agreement, BioAxone shall be responsible for the payment of
all maintenance and other fees relating to the filing, prosecution,
and maintenance of the Licensed Patents. BioAxone undertakes to
provide the University with copies of correspondences evidencing such
payments. It is understood and agreed that this Subsection 10.2.2 does
not apply to the situation contemplated by Subsection 4.2.4.
10.2.3 Within ninety (90) days of receiving notice from the University
stating patent maintenance fees related to the Licensed Patents have
been paid, BioAxone shall reimburse the University for such fees.
-14-
11. INFRINGEMENT
11.1 OBLIGATION TO NOTIFY
Should either Party become aware of any infringement or potential infringement
of the Licensed Patents, they shall give the other written notice detailing the
facts concerning such infringement or potential infringement.
11.2 RIGHT TO ENFORCE
In the event of such infringement or potential infringement, BioAxone shall have
the first right, within six (6) months of receiving notice, to either: (i) take
the appropriate steps to stop the infringement; (ii) file suit against the
infringer; or (iii) provide the University with reasonable evidence showing that
the infringer intends to enter into a settlement agreement in which future
infringement will be halted and any damages, profits or awards which might be
obtained shall be recovered by BioAxone for its own and sole benefit. Should
BioAxone decide not to enforce the Licensed Patents against such infringement,
pursuant to Section 11.3, it shall so advise the University in-writing, the said
writing stating why BioAxone has made, in its sole discretion, such a decision,
and the University shall have the right, at its own expense and for its own and
sole benefit, to bring any action it deems necessary to stop the infringement
and recover any damages, profits, and awards which might be obtained.
11.3 PROSECUTION OF INFRINGEMENT
During the term of this Restated Agreement, BioAxone at its own expense, shall
be deemed to have the right, as authorized pursuant to the appropriate statutes:
(i) to bring suit in its own name or, if required by law, jointly with the
University in which case the University grants a full power of attorney to
BioAxone, at BioAxone's expense and on its own behalf for infringement of the
Licensed Patents; (ii) in any such suit, to enjoin infringement, and for
infringing the Licensed Patents, to collect damages, profits, and awards of
whatever nature recoverable for such infringement for its own and sole benefit;
and (iii) to settle any claim or suit for infringement of the Licensed Patents
by granting the infringing Party a sub-license as authorized by this Restated
Agreement.
11.4 INFRINGEMENT OF THIRD PARTY'S RIGHTS
Without prejudice to any other right they may have, should a claim that the
Licensed Products (as it relates to the Licensed Patents) or any material part
thereof, infringe a third party's intellectual property rights be threatened or
made against the University, BioAxone, or any party receiving rights to the
Licensed Patents through BioAxone, each of the University and BioAxone agree
that it shall give the other Party prompt written notice detailing as many facts
as possible concerning such claim and shall cooperate fully with the other in
the defense of such claim. The reasonable expenses incurred by BioAxone, in the
defense of such claim, shall be first deducted from any royalty owing and then
any balance shall be held in trust by BioAxone until such time that the
potential infringement case is terminated or settled and the University shall
only have a right to such royalties held in trust if the third party claiming is
unsuccessful in obtaining a judgment against BioAxone or any-of its
Sub-Licensees. If the third party claiming the infringement is successful in
obtaining a judgment against BioAxone or any of its Sub-Licensees
-15-
or if the Parties agree (BioAxone acting reasonably) to amicably settle the
matter, any amount held in trust and any future royalty shall first serve to pay
the third party's indemnity or damages awarded pursuant to a judgment of a court
of competent jurisdiction or pursuant to any settlement and the balance, if any,
shall be payable to the University pursuant to the provisions of Articles 7 and
8.
12. REPRESENTATIONS, WARRANTIES AND COVENANTS
12.1 JOINT REPRESENTATIONS
Each of BioAxone and the University hereby represents and declares to the other
that:
12.1.1 Authority. It has full power and authority to enter into and perform
its obligations pursuant to this Restated Agreement and to consummate
the transactions contemplated herein.
12.1.2 Binding Obligation. The execution, delivery and performance of this
Restated Agreement has been duly authorized by all necessary corporate
action and constitutes a legal, valid and binding obligation, subject
to applicable bankruptcy, reorganization, insolvency, moratorium and
similar laws affecting creditors' rights generally, and to general
equitable principles, whether such enforcement is sought in a
proceeding at law or in equity.
12.1.3 No Conflict. The execution, delivery and performance of this
Restated Agreement does not contravene any provision of the existing
laws of any country or jurisdiction in which BioAxone or University,
as the case may be, is located; the execution and delivery of this
Restated Agreement and the performance of the terms and conditions
thereof will not conflict with or result in the breach of, default
under or creation of any lien, charge or encumbrance upon its
properties pursuant to the terms, conditions or provisions of any
judgment, decree, order or judicial decision to which it is a party or
by which it or its properties is bound.
12.1.4 No Brokers. Neither Party has taken any action or has entered into
any agreement, understanding or other arrangement that would obligate
the other Party to pay any broker's or finder's fee or any commission
or similar fee to any agent, broker, investment banker or other Person
in connection with any of the transactions contemplated by this
Restated Agreement.
12.2 REPRESENTATIONS OF UNIVERSITY
12.2.1 The University represents to the best of its knowledge after
diligent inquiry that:
12.2.2 No Contravention. There is no provision in its charter documents and
no provision in any existing mortgage, indenture, contract or
agreement to which it is bound that would be contravened by the
execution, delivery or performance of this Restated Agreement. Neither
the execution nor the delivery of this Restated Agreement or its
fulfillment of or compliance with the terms and provisions hereof
shall contravene any provision of the laws of any jurisdiction,
including,
-16-
without limitation, any statute, rule, regulation, judgment, decree,
order, franchise or permit of any governmental body applicable to it.
12.2.3 No Proceedings Pending. There is no action or proceeding pending or,
in so far as it knows, threatened in writing against it before any
court, administrative agency or other tribunal which might have a
material adverse effect on its ability to perform its obligations
hereunder.
12.2.4 Ownership and Validity of the Licensed Patents. (i) it owns the
entire right, title and interest in and to the Licensed Patents and in
corresponding applications or in the right to apply for such
corresponding applications that are part of the Licensed Patents, (ii)
it has obtained written assignments to the Licensed Patents from all
the appropriate Persons and has filed all necessary documents to
evidence such assignments with the relevant patent offices or other
administrative bodies or agencies charged to administer such
assignments, (iii) no property, hypothec, charge, lien, or other
encumbrances with regard to the Licensed Patents remains vested with
others, and (iv) any rights in the Licensed Patents that may have
vested with the Inventors collectively or with any of them
individually at any given time have been assigned to the University in
accordance with the University policy.
12.2.5 No Other License Apart from this Restated Agreement, it has not
granted licenses or other rights to any other Person with regards to
the Licensed Patents.
12.2.6 No Infringement The Licensed Patents do not infringe on the rights
or technology of any other Person, that the University's rights in the
Licensed Patents are not currently being challenged by a third party
and are not threatened to be challenged by any third party.
12.2.7 No Breach of the University Policy (i) it is not in breach of the
University policy, (ii) it undertakes to abide by the terms and
conditions of the University policy and (iii) it undertakes to
indemnify BioAxone in respect of any loss, damage, claim, action,
suit, proceeding, deficiency or expense, including, without
limitation, all reasonable legal, expertise and accounting fees and
all out-of-pocket costs relating to, arising from or in connection
with the University policy.
12.2.8 No warranty of merchantability of Licensed Patents The University
makes no warranties, express, implied or statutory, and assume no
liabilities or responsibilities with respect to (i) the use, sale or
other disposition by BioAxone, its Affiliates, Sub-Licensees or
transferees of Licensed Products or any licensing rights herein, and
(ii) any representations or warranties that BioAxone may extend to any
of its Affiliates or Sub-Licensees, and which is not expressly set
forth in this Restated Agreement. All Licensed Patents are or will be
made available to BioAxone on an "as is" basis. The University does
not warrant that the underlying technology described in or claimed as
inventions in any of the Licensed Patent is error free or that it will
meet BioAxone's requirements. All
-17-
implied warranties of merchantability and fitness for a particular
purpose are expressly disclaimed and excluded.
12.3 REPRESENTATIONS AND UNDERTAKINGS OF BIOAXONE
12.3.1 Commercial Exploitation BioAxone represents and undertakes that it
will take commercially reasonable measures to assure the optimal
development and commercial exploitation of the Licensed Products.
12.3.2 Research Agreement BioAxone represents that it has fulfilled its
research commitment with University as it has on August 20, 2001
entered into a research agreement with five (5) subsequent Addendum
with the University (collectively the "RESEARCH
AGREEMENT") and which Research Agreement has ended on September 24,
2004 at both Parties' satisfaction.
13. GENERAL PROVISIONS
13.1 EFFECTIVE DATE
This Restated Agreement becomes effective retroactively on the Effective Date.
13.2 ASSIGNMENT
Except when the transferee agrees to be bound by all the terms and conditions of
this Restated Agreement, this Restated Agreement may not be assigned or
transferred by a Party to any third party without the prior written consent of
the other Party, which shall not be unreasonably withheld.
13.3 ALTERNATIVE DISPUTE RESOLUTION
13.3.1 Good Faith Effort to Resolve Any disputes which arise between the
Parties relating to this Restated Agreement shall be referred to a
member of the senior staff of the Parties respectively who shall meet
and make a good faith effort to resolve the matter. If after ninety
(90) days the dispute has not been so resolved, the dispute shall
automatically go to arbitration in accordance with Subsection 13.3.2
hereafter.
13.3.2 Arbitration Subject to Subsection 13.3.1 hereabove, any disputes
which shall arise between the Parties relating to this Restated
Agreement shall be referred to an arbitration subject to the
procedures set out in Schedule "13.3.2" to this Restated Agreement,
the award and determination of which shall be final and binding upon
the Parties hereto, the whole in accordance with the provisions of the
Code of Civil Procedure of the Province of Quebec; except in respect
of the exercise of hypothecary rights available in accordance with the
Civil Code of Quebec.
-18-
13.4 FURTHER ASSURANCES
Each Party hereto agrees to co-operate with the other to ensure that each may
have and enjoy to the fullest extent, all rights conveyed under this Restated
Agreement. If at any time after the date hereof any Party requests further
documents, instruments or assurances in order to carry out the provisions
hereof, then the Party from which such documents, instruments or assurances are
requested shall promptly execute and deliver any such documents, instruments and
assurances and do all things reasonably necessary to carry out the provisions
hereof, all at the cost and expense of the Party requesting such assurance.
Without limiting the generality of the foregoing, the Parties hereto undertake
to file, in any and all jurisdictions deemed necessary or useful by BioAxone,
confirmatory licenses, substantially in the form reasonably acceptable to both
Parties with regard to the Licensed Patents and to sign as many copies of such
confirmatory licenses as may be required for each jurisdiction in which such
confirmatory licenses will be filed from time to time.
13.5 ENTIRE AGREEMENT
This Restated Agreement constitutes the entire agreement and understanding
between the University and BioAxone with respect to the Licensed Patents, and
any modification of this Restated Agreement shall be in writing and shall be
signed by a duly authorized representative of both the University and BioAxone.
There are no understandings, representations, or warranties between the
University and BioAxone concerning the Licensed Patents except as expressly set
forth in this Restated Agreement and, as the case may be, in (i) the Agreement
in Principle, (ii) the Research Agreement, (iii) the Product Royalty Agreement
dated June 10, 2002 as amended on June 14, 2004 by an Amendment to the Product
Royalty Agreement and a Restated Product Royalty Agreement executed concurrently
with this Restated Agreement.
Except as otherwise expressly set forth in this Agreement, in the event of a
conflict between the Articles and Sections of this Restated Agreement and any of
(i) the Agreement in Principle or (ii) the Research Agreement, the Articles and
Sections of this Restated Agreement shall prevail.
13.6 NOTICES
Any demand, notice or other communication to be given in connection with this
Restated Agreement shall be given in writing and shall be given by personal
delivery, by registered mail or by electronic means of communication addressed
to the recipient as follows:
IF TO BIOAXONE:
BioAxone Therapeutic Inc.
0000, Xxxxxxxxx-Xxxxxxx, xxxxx 000
Xxxxx-Xxxxxxx, Xxxxxx
X0X 0X0
Attention: The President
Facsimile No: (000) 000-0000
-19-
IF TO THE UNIVERSITY:
Universite de Montreal
Bureau Recherche Developpement Valorisation
0000, Xxxx Xxxxxxx, Xxxxx 000
Xxxxxxxx, Xxxxxx
X0X 0X0
Attention: Mr. Real Xxxxxxx
Vice-recteur adjoint - Recherche
Facsimile No: (000) 000-0000
or to such other address, individual or electronic communication number as may
be designated by notice given by either Party to the others in accordance
herewith. Any demand, notice or other communication given by personal delivery
shall be conclusively deemed to have been given on the day of actual delivery
thereof and, if given by registered mail, on the fifth (5th) Business Day
following the deposit thereof in the mail and, if given by electronic
communication, on the day of transmittal thereof if given during the normal
business hours of the recipient and on the Business Day during which such normal
business hours next occur if not given during such hours on any day. If the
Party giving any demand, notice or other communication knows or ought reasonably
to know of any difficulties with the postal system which might affect the
delivery of mail, any such demand, notice or other communication shall not be
mailed but shall be given by personal delivery or by electronic communication.
13.7 WAIVER OF RIGHTS
In order to be effective, any waiver, by either Party, of any right under this
Restated Agreement, must be in writing signed by an authorized representative of
the Party making the waiver. No such waiver or failure of the University or
BioAxone to enforce a right or strict performance under this Restated Agreement
shall be deemed to be a waiver or forbearance which would in any way prevent the
University or BioAxone from subsequently asserting or exercising any such
rights, making a claim not specifically waived, or requiring strict performance
of this Restated Agreement. No such waiver or failure to enforce shall affect
the validity of this Restated Agreement or be a continuing waiver excusing
compliance with any provision of this Restated Agreement in the future.
13.8 EXTENDED OPERATION
This Restated Agreement binds the Parties, their heirs, personal
representatives, successors and permitted assigns.
13.9 PARTIAL INVALIDITY
If any provision of this Restated Agreement or the application of it to any
Person or circumstances is held to any extent invalid or unenforceable, the
remainder of this Restated Agreement or the application of the provision to
Persons or circumstances other than those as to which it is held invalid or
unenforceable is not affected.
-20-
13.10 EXECUTION IN COUNTERPARTS
This Restated Agreement may be executed in counterparts, each of which, when so
executed and delivered, shall be deemed to be an original, and all of which
counterparts, taken together, shall constitute one and the same instrument.
13.11 LANGUAGE
Due to the nature of BioAxone's business, the need to obtain financing in other
provinces and countries, the fact that all relevant patents, correspondence and
due diligence were done or conducted in English, the Parties hereto hereby
acknowledge that they have required this Restated Agreement to be drawn up in
the English language. Les parties reconnaissent avoir demande que le present
contrat soit redige en anglais.
-21-
IN WITNESS WHEREOF, the University and BioAxone have caused this Restated
Agreement to be executed by their duly authorized representative.
UNIVERSITE DE MONTREAL
Per: /s/ Real Xxxxxxx
-----------------------------------
Real Xxxxxxx
Vice-recteur adjoint - Recherche
[Illegible date]
BIOAXONE THERAPEUTIC INC.
Per: /s/ Xxxxx Xxxx
-----------------------------------
Xxxxx Xxxx
President
16 Oct 06
-22-
SCHEDULE 1.1.11
(re B100, B200 and B400)
The patents applications are:
1. B100
[**]
2. B200
[**]
3. B400
[**]
SCHEDULE 6.1
PATENT COSTS TO BE REIMBURSED
[SEE DOCUMENTS ATTACHED TO THE ORIGINAL AGREEMENT]
SCHEDULE 13.3.2
ARBITRATION
1. Upon the written demand of any of the Parties concerned, the Parties shall
meet and attempt to appoint a single arbitrator. If they are unable to
agree on a single arbitrator then upon the written demand of any of them
and within thirty (30) days of such demand, the Person making the demand
shall apply to any Judge of the Superior Court of the Province of Quebec to
appoint such arbitrator that meets the criteria set forth pursuant to the
provisions of Section 2 of this Arbitration Schedule.
2. The arbitrator selected to act hereunder shall be qualified by education
and training to decide the particular question or questions in dispute.
3. The single arbitrator so chosen shall proceed immediately to hear and
determine the matter or matters in dispute. The decision of the arbitrator
shall be made within forty-five (45) days after his/her appointment,
subject to any reasonable delay due to unforeseen circumstances.
Notwithstanding the foregoing, in the event the single arbitrator fails to
make a decision within ninety (90) days after his/her appointment then any
of the Parties concerned may elect to have a new single arbitrator chosen
in like manner as if none had previously been selected.
4. The decision of the single arbitrator shall be in writing and signed by the
single arbitrator and shall be final and binding upon all of the Parties
hereto as to any matter or matters so submitted to arbitration and the
Parties shall perform the terms and conditions thereof.
5. The compensation and expenses of the single arbitrator (unless otherwise
determined by the arbitrator) shall be paid equally by the Parties that are
party to the arbitration unless otherwise directed.
6. None of the Parties concerned shall be deemed to be in default of any
matter being arbitrated until ten (10) days after the decision of the
arbitrator is delivered to all of them.
EXHIBIT E
DEVELOPMENT PLAN
I. DEVELOPMENT SCHEDULE
TARGET
ACTIVITY/MILESTONE COMPLETION DATE
------------------ ---------------
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
II. DILIGENCE MILESTONES
The following events shall constitute milestones for which the failure to meet
the Outside Completion Date (unless such failure is caused by (i) demonstrated
toxicity or drug safety issues with the Compounds and/or Licensed Products
determined in accordance with industry standards or (ii) a failure to
demonstrate statistically significant efficacy of the Compounds and/or Licensed
Products in a well-designed, well-controlled clinical trial as measured by
appropriate industry standards) shall give rise to termination remedies for BA
as set forth in Section 8.2 of the Agreement.
TARGET OUTSIDE PAYMENT BY BLSI ON
ACTIVITY/MILESTONE COMPLETION DATE COMPLETION DATE TERMINATION BY BA
------------------ --------------- --------------- ------------------
1. [**] [**] [**] $[**]
2. [**] [**] [**] $[**]
3. [**] [**] [**] $[**]
4. [**] [**] [**] $[**]
5. [**] [**] [**] $[**]
6. [**] [**] [**] $[**]
7. [**] [**] [**] $[**]
8. [**] [**] [**] $[**]
9. [**] [**] [**] $[**]
10. [**] [**] [**] $[**]
11. [**] [**] [**] $[**]
* Target Completion Date and Outside Completion Date for this milestone will
be [**] and [**] respectively [**].
EXHIBIT F
MINIMUM ROYALTIES
The tables below set out the Minimum Royalties payable by BLSI to BA pursuant to
Section 4.5 of the Agreement. The Minimum Royalties are calculated based on
annual sales forecasts that assume that the first Marketing Approval of the
first Licensed Product will occur in the United States during the first six (6)
months of the Year 1 followed one (1) year later by approval in the European
Union. BLSI and BA agree that, commencing on January 2, 2009, this forecast will
be reviewed and, if agreed by the parties, amended in a separate writing to
reflect new market data, it being understood that BA shall be under no
obligation to renegotiate the Minimum Royalties based on such review.
TABLE 1. UNITED STATES
($ [**])
YEAR 1 YEAR 2 YEAR 3 YEAR 4
------ ------ ------ ------
Minimum Royalties $[**] $[**] $[**] $[**]
TABLE 2. KEY EUROPEAN COUNTRIES
($ [**])
YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5
------ ------ ------ ------ ------
Minimum Royalties $[**] $[**] $[**] $[**] $[**]
