LICENSE AGREEMENT
BETWEEN
MEDISTEM LABORATORIES,
INC.
AND
RIO VALLEY MEDICAL
CLINIC
DATED JANUARY 2, 2007
TABLE OF CONTENTS
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Page
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1.
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DEFINITIONS
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1
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2.
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REPRESENTATIONS AND WARRANTIES
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3
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2.1
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Representations and Warranties of Medistem
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3
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2.2
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Representations and Warranties of Licensee
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4
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3.
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PROGRAM
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5
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3.1
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Generally
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5
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3.2
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Specific Licensee Responsibilities
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5
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3.3
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Medistem Activities
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6
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3.4
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Implementation of the Program
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7
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3.5
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Regulatory Matters
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7
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3.6
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Liability
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8
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3.7
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Termination
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8
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3.8
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Warrants for the Program in the Territory
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8
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3.9
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Assistance with Additional Programs; Additional
Warrants.
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8
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4.
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GRANT OF RIGHTS; MARKETING
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9
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4.1
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Development License
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9
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4.2
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Commercialization License
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9
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4.3
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Sublicensing
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9
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4.4
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Marketing Obligations, Rights
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9
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4.5
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Trademarks
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9
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5.
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FEES
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9
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5.1
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Fees
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9
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5.2
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Mode of Payment
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9
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6.
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REPORTS
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9
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6.1
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Reports
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9
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6.2
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Records Retention
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10
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6.3
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Audit Request
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10
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6.4
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Cost of Audit
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10
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6.5
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Taxes.
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10
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7.
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OWNERSHIP; PATENTS
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10
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7.1
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Ownership
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10
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7.2
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Patent Maintenance.
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11
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7.3
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Patent Enforcement.
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11
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7.4
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Infringement Action by Third Parties
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12
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8.
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PUBLICATION; CONFIDENTIALITY
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13
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8.1
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Notification
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13
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8.2
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Review
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13
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8.3
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Exclusions
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13
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8.4
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Confidentiality; Exceptions
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13
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8.5
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Exceptions to Obligation
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14
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i
TABLE OF CONTENTS
(continued)
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Page
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8.6
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Limitations on Use
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14
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8.7
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Remedies
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14
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9.
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INDEMNIFICATION
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14
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9.1
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Indemnification by Licensee
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14
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9.2
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Indemnification by Medistem
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15
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9.3
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Notice of Indemnification
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15
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9.4
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Complete Indemnification
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16
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10.
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TERM; TERMINATION
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16
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10.1
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Term
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16
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10.2
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Termination for Cause
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16
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10.3
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Effect of Expiration or Termination.
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16
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10.4
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Accrued Rights; Surviving Obligations
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16
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11.
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FORCE MAJEURE
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17
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11.1
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Events of Force Majeure
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17
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12.
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MISCELLANEOUS.
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17
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12.1
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Relationship of Parties
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17
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12.2
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Assignment
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17
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12.3
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Books and Records
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17
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12.4
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Further Actions
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18
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12.5
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Notice
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18
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12.6
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Use of Name
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18
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12.7
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Public Announcements
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18
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12.8
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Waiver
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19
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12.9
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Compliance with Law
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19
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12.10
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Severability
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19
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12.11
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Amendment
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19
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12.12
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Governing Law.
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19
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12.13
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Arbitration
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19
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12.14
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Entire Agreement
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20
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12.15
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Parties in Interest
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20
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12.16
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Descriptive Headings
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20
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12.17
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Counterparts
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20
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ii
LICENSE AGREEMENT
THIS LICENSE AGREEMENT
(“Agreement”), dated as of January 2, 2007, is entered
into by and between Medistem Laboratories, Inc., a corporation
organized and existing under the laws of Nevada, having offices
located at 2027 E. Cedar St. #102, Tempe, AZ 85281
(“Medistem”), and Rio Valley Medical Clinic, an entity
controlled by Dr. Frank Morales, having offices located at Av.
Bursatil #300 Ste 306, Tijuana BC Mexico (“Licensee”).
All capitalized terms used in this Agreement have the meanings set
forth in Section 1 .
PRELIMINARY STATEMENTS
A.
Medistem owns the rights to the
Intellectual Property in existence as of the Effective
Date.
B.
Licensee has the personnel, facilities
and expertise necessary for the development and commercialization
of the Product in the Territory.
C.
Licensee wishes to perform all of the
functions required to develop and commercialize the Product in the
Territory, and Medistem wishes to license Licensee do so, upon the
terms and subject to the conditions set forth in this Agreement.
In connection therewith, Licensee desires to obtain, and
Medistem desires to grant to Licensee, a non-exclusive license for
the Licensed Technology with respect to the commercialization of
the Product in the Territory for applications in the Field, subject
to Medistem’s right to manufacture and supply post-natal and
adult stem cells for Licensee, all on the terms and subject to the
conditions set forth below.
NOW, THEREFORE, in consideration of the
foregoing Preliminary Statements and the mutual agreements and
covenants set forth herein, the Parties hereby agree as
follows:
1.
DEFINITIONS.
As used in this Agreement, the following
terms shall have the meanings set forth in this
Section 1 unless the context dictates
otherwise:
1.1
“ Additional Programs
” shall have the meaning assigned to such term in Section
3.8 .
1.2
“ Affiliate ,” with
respect to any Party, shall mean any entity controlling, controlled
by, or under common control with, such Party. For these
purposes, “control” shall refer to: (i) the
possession, directly or indirectly, of the power to direct the
management or policies of an entity, whether through the ownership
of voting securities, by contract or otherwise, or (ii) the
ownership, directly or indirectly, of at least 50% of the voting
securities or other ownership interest of an entity.
“Affiliate” shall include entities that are formed or
come into existence after the date of this Agreement.
1.3
“ Confidential Information
” shall have the meaning assigned to such term in
Section 8.4 .
1
1.4
“ Effective Date ”
shall mean the date of this Agreement.
1.5
“ Field ” shall mean
the therapeutic treatment of various medical conditions in
humans.
1.6
“ IND ” shall mean any
filing made with the Regulatory Authority having jurisdiction in
the Territory for initiating clinical trials with respect to the
Product.
1.7
“ Intellectual Property
” shall mean any and all Patents and Know-how.
1.8
“ Invention(s) ” shall
mean any new or useful process, manufacture, compound or
composition of matter relating to the Product (including, without
limitation, the formulation, delivery or use thereof), whether
patentable or unpatentable, or any improvement thereof, that is
conceived or first reduced to practice or demonstrated to have
utility during the term of this Agreement.
1.9
“ Know-how ” shall
mean any and all Inventions, improvements, discoveries, claims,
formulae, processes, trade secrets, technologies and know-how
(including confidential data and Confidential Information) that is
generated, owned or controlled by Medistem at any time before or
during the term of this Agreement relating to, derived from or
useful for the use or sale of the Product, including, without
limitation, synthesis, preparation, recovery, and purification
processes and techniques, control methods and assays, chemical
data, toxicological and pharmacological data and techniques,
clinical data, medical uses, product forms, and product
formulations and specifications.
1.10
“ Licensed Claim ”
shall mean any claim of any Patent that relates to and is necessary
for the use and sale of the Product, which claim has not been held
invalid or unenforceable by decision of a court or other
governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which is not
admitted to be invalid through disclaimer or otherwise not admitted
by Medistem to be invalid.
1.11
“ Licensed Technology
” shall mean the Licensed Claims and Know-how,
collectively.
1.12
“ Licensee ” shall
mean Dr. Frank Morales and all Affiliates of Dr. Frank Morales that
engage in stem-cell related activities in the Territory.
1.13
“ Medistem ” shall
mean Medistem Laboratories, Inc. and/or its Affiliates.
1.14
“ Net Revenues ” shall
mean shall mean cash receipts actually collected by Licensee during
a given calendar month from Licensee’s activities in
connection with the Program, after deducting discounts and refunds
but before deducting any of Licensee’s costs or expenses
incurred in connection with Licensee’s activities in
connection with the Program.
2
1.15
“ Party ” shall
mean Medistem or Licensee and, when used in the plural, shall mean
Medistem and Licensee.
1.16
“ Patents ” shall mean
a provisional patent application and any other patents, patents
pending or patent applications owned or controlled by Medistem
during the term of this Agreement that relate to the Product,
together with any patents that may issue therefor, including any
and all extensions, renewals, continuations, continuations-in-part,
divisions, patents-of-additions, reissues, supplementary protection
certificates or foreign counterparts of any of the
foregoing.
1.17
“ Product ” shall mean
all infusion quality post-natal and adult stem cells suitable for
use in the Field, the manufacture, use or sale of which either is:
(i) based upon, derived from or related to any of the Know-how;
and/or (ii) covered by one or more Licensed Claims and, but for
this Agreement, would constitute an infringement (whether directly,
contributorily or by inducement) thereof, and such other ancillary
services related to the foregoing.
1.18
“ Program ” shall mean
the activities that the Parties intend that Licensee will perform
and engage in under this Agreement.
1.19
“ Regulatory Authority
” shall mean the authority(ies) having jurisdiction in the
Territory with responsibility for granting regulatory approval for
the manufacturing and sale of the Product, and any successor(s)
thereto.
1.20
“ Territory ” shall
mean metropolitan areas in Mexico in which Licensee currently
conducts stem cell activities; namely Tijuana, Mexico.
1.21
“ Third Party ”
shall mean any person who or which is neither a Party nor an
Affiliate of a Party.
1.22
“ Trademark ” shall
have the meaning assigned thereto in Section 4.4
.
1.23
“ Warrant ” shall have
the meaning assigned thereto in Section 3.8.
2.
REPRESENTATIONS AND
WARRANTIES.
2.1
Representations and Warranties of
Medistem. Medistem
represents and warrants to Licensee, as of the Effective Date,
that:
(a)
Medistem is a corporation duly organized,
validly existing and in good standing under the laws of the State
of Nevada;
(b)
Medistem has full corporate power and
authority to enter into this Agreement and to carry out the
provisions hereof and is free to enter into this
Agreement;
3
(c)
by entering into this Agreement, Medistem
will not violate any other agreement to which it is a
party;
(d)
Medistem has taken all corporate action
necessary to authorize the execution and delivery of this Agreement
and the performance of its obligations under this
Agreement;
(e)
no person or entity has or will have, as
a result of the transactions contemplated by this Agreement, any
right, interest or valid claim against or upon Medistem for any
commission, fee or other compensation as a finder or broker because
of any act or omission by Medistem or any of its agents;
(f)
Medistem is the owner of, or has
exclusive rights to, all of the Intellectual Property in existence
on the Effective Date, and has the exclusive right to grant the
licenses granted under this Agreement;
(g)
to the best of Medistem’s
knowledge, without investigation, Medistem has exclusive rights to
all of the Know-how in existence on the Effective Date and the
exclusive right to grant licenses with respect thereto;
(h)
to the best of Medistem’s
knowledge, without investigation, Licensee’s use of the
Product in the Field, in accordance with the terms of this
Agreement, does not infringe upon or conflict with any patent or
other proprietary rights in the Territory of any Third Party;
and
(i)
Medistem has not entered into any
agreement with any Third Party that is in conflict with the rights
granted to Licensee pursuant to this Agreement.
2.2
Representations and Warranties of
Licensee . Licensee
represents and warrants to Medistem, as of the Effective Date,
that:
(a)
Licensee a natural person with full legal
capacity to enter into this binding Agreement and to carry out the
provisions hereof;
(b)
Licensee is free to enter into this
Agreement;
(c)
by entering into this Agreement, Licensee
will not violate: (i) any law, regulation or order of any
Regulatory Authority, government agency or court, or (ii) any other
agreement to which it is a party;
(d)
no person or entity has or will have, as
a result of the transactions contemplated by this Agreement, any
right, interest or valid claim against or upon Licensee for any
commission, fee or other compensation as a finder or broker because
of any act or omission by Licensee or any of its agents;
4
(e)
Licensee has the facilities, personnel
and experience sufficient in quantity and quality to perform its
obligations under this Agreement or will have such resources within
a reasonable period of time following the Effective
Date;
(f)
Licensee has all necessary approvals,
licenses and permits with Regulatory Authorities and other
government agencies as are required to perform its obligations
under this Agreement and will maintain such approvals, licenses and
permits during the Term of this Agreement;
(g)
All of the personnel assigned to perform
such obligations shall be qualified and properly trained and shall
do so in accordance with applicable law; and
(h)
Licensee shall perform such obligations
in a manner commensurate with professional standards generally
applicable in its industry.
3.
ROGRAM.
3.1
Generally . Licensee shall use all commercially
reasonable efforts diligently to develop and commercialize the
Product in the Territory, in such order of priority as Licensee
reasonably shall deem appropriate. In connection therewith,
Licensee shall dedicate such resources to the development and
commercialization of the Product consistent, at a minimum, with the
resources that Licensee dedicated to stem cell related activities
of a similar nature to those involving the Product that were
engaged in by Licensee and Licensee’s Affiliates prior to
entering into this Agreement.
3.2
Specific Licensee
Responsibilities. As
part of the Program, Licensee shall:
(a)
Conduct or cause to be conducted, manage,
and oversee growth and development of the Product for use in
clinical applications, studies, and for subsequent
marketing;
(b)
Market clinical treatment services
relating to the Product and generate a minimum of $20,000 of
monthly revenues from stem-cell related patient treatment
activities involving the Product and under this
Agreement;
(c)
Make, effect and pursue, on behalf of
Medistem, all filings and other actions with and before Regulatory
Authorities as requested by Medistem to develop or enhance
Medistem’s Intellectual Property and/or to pursue and perfect
INDs arising from or relating to the subject matter of this
Agreement;
(d)
Use all commercially reasonable efforts
and proceed diligently to perform such obligations, including,
without limitation, by using personnel with sufficient skills and
experience, together with sufficient equipment and
facilities;
5
(e)
Make a good faith effort to accept
patient applications for stem cell related treatment using the
Product, and to treat all such applicants that conform to
established medical protocols as mutually agreed between both
Parties;
(f)
Conduct the Program in good scientific
manner, and in compliance in all material respects with all
requirements of applicable laws, rules and regulations of any
Regulatory Authority or government agency, and all other
requirements of any applicable current good clinical practice,
current good laboratory practice and current good manufacturing
practice to attempt to achieve the objectives of the Program
efficiently and expeditiously;
(g)
Maintain existing facilities and
equipment in an acceptable and professional manner and be
responsible for expenditures necessary to maintain such facilities
and equipment;
(h)
Provide, hire, train, supervise, ensure
the licensure of and compensate all professional and support staff
as required for Licensee to perform its obligations and conduct the
activities contemplated under this Agreement;
(i)
Within 30 days after the end of each
six-month period during the term of the Program and within 30 days
following the expiration or termination of the Program, furnish, at
Medistem’s request, reasonably detailed, written reports on
all activities conducted by Licensee under the Program during such
six-month period or the term of the Program, as the case may
be;
(j)
Comply with all reporting, accounting,
bookkeeping and record keeping and retention policies and
procedures established by Medistem as reasonably required in order
to manage, conduct, record and account for the operations of
Licensee under this Agreement, and maintain records, in sufficient
detail and in good scientific manner, which shall be complete and
accurate and shall fully and properly reflect all work done and
results achieved in connection with the Program in the form
required under all applicable laws and regulations;
(k)
Maintain all necessary approvals,
licenses and permits with Regulatory Authorities and other
government agencies as are required to perform its obligations
under this Agreement in accordance with Section 3.4
;
(l)
Allow representatives of Medistem, upon
reasonable notice and during normal business hours, to visit
Licensee’s facilities where the Program is being conducted,
and consult informally, during such visits and by telephone, with
Licensee’s personnel performing work on the Program;
and
(m)
It being understood by the Parties that
all Intellectual Property relating to the Product, including any
and all Inventions as may arise from, out of, as a result of or in
any way in connection with the Program, is and shall always be and
remain the sole property of Medistem, Licensee agrees to perform
all of its obligations and agreements contained in Section 7
, “ Ownership; Patents ,” of this
Agreement.
6
3.3
Medistem Activities.
In support of the Program, Medistem
shall:
(a)
promptly after the Effective Date,
provide to Licensee copies of all (or relevant portions of)
Know-how, trade secrets, Intellectual Property, and such other
related information relating to the development and
commercialization of the Product, in Medistem’s possession
and control;
(b)
make available to Licensee reasonable
management oversight with respect to the Program and the
commercialization of the Product;
(c)
supply Licensee with Product for the
activities contemplated under this Agreement in such quantities and
upon such delivery schedules as Licensee may reasonably request,
provided that Medistem shall not be required to deliver any minimum
amount of Product or meet Licensee’s requested delivery
schedule, and provided further that Medistem shall not be liable to
Licensee for any failure or inability to deliver Product in the
quantities or upon the delivery schedules requested by
Licensee;
(d)
manage certain functions with respect to
the conduct of Licensee’s activities under this Agreement,
including: application intake and processing; patient booking;
support for marketing the services of Licensee under the Program;
patient billing; revenue and cash management and treasury functions
with respect to patient billings and revenue-sharing arrangements;
accounting and bookkeeping; travel arrangements, coordination and
booking; training of licensee’s personnel in the use of
equipment and operational procedures; consulting services relating
to the conduct of all aspects of the Program; and any other duties
specifically agreed to by Licensee and Medistem; provided that such
agreement is documented in a writing duly executed by both
Parties;
(e)
have the right, in its sole discretion,
if it determines that leasehold improvements, facility
improvements, or additional laboratory or medical equipment are
desired to further the cause of this License Agreement, to provide
or facilitate financing for such facilities or equipment, or to
provide directly such laboratory or medical equipment, provided
that all personal property and equipment acquired under this
provision shall be the sole property of Medistem; and
(f)
have the right, during normal business
hours and upon reasonable notice, to inspect and copy all such
records and all such records and the data therein and any and all
Inventions contained or embodied therein, are and shall be the sole
property of Medistem. Medistem shall maintain such records
and information contained therein in confidence in accordance with
Section 8 and shall not use such records or information
except to the extent otherwise permitted by this
Agreement.
7
3.4
Implementation of the
Program. Licensee and
Medistem shall cooperate in good faith and use their commercially
reasonable best efforts to commence the Program on or about January
2, 2007; provided that the actual commencement date of the Program
in general or specific aspects of the Program shall be subject to
implementation at such time or times as the Parties may mutually
agree upon in good faith.
3.5
Regulatory Matters
.
(a)
As provided in Sections 2.3(b) and
3.2(k) , Licensee is responsible for obtaining and
maintaining all necessary approvals, licenses and permits with
Regulatory Authorities and other government agencies as are
required to perform its obligations under this Agreement, and shall
maintain such approvals, licenses and permits during the Term of
this Agreement.
(b)
In the event that new approvals, licenses
and permits are needed from any Regulatory Authority or other
government agency to perform Licensee’s obligations under
this Agreement, whether as a result of new legislation or
otherwise, Licensee is responsible for obtaining and maintaining
such licenses or approvals.
(c)
In order to assist Licensee in the
performance of its obligations under this Section 3.4 ,
Medistem shall provide Licensee or its designee(s) with complete
copies (or copies of relevant portions) of, and shall grant
Licensee or its designee(s) the right to cross-reference, all of
Medistem’s registrations or other regulatory filings made or
held in any country for the Product and shall do all such further
acts, as promptly as possible after Licensee’s request
therefor, that may reasonably be necessary or appropriate in
furtherance of Licensee’s obligations under this Section
3.4 .
(d)
Licensee shall provide Medistem with
complete copies of, and shall keep Medistem informed as to the
status of, all regulatory filings made pursuant to this
Section 3.4 .
3.6
Liability . Licensee shall be responsible for, and hereby
assumes, any and all risks of personal injury or property damage
attributable to the negligent or willful acts or omissions, during
the term of the Program, of Licensee or its Affiliates, and their
respective directors, officers, employees and agents.
Medistem shall be responsible for, and hereby assumes, any
and all risks of personal injury or property damage attributable to
the negligent or willful acts or omissions, during the term of the
Program, of Medistem and its directors, officers and
employees.
3.7
Termination. In the event that Medistem believes that
Licensee has not made reasonably sufficient progress in the
development and commercialization of the Product in the Territory
in a manner consistent with its obligations under
Section 3.1 , Medistem may terminate this Agreement in
its entirety pursuant to Section 10.2 .
8
3.8
Warrants for the Program in the
Territory. In
consideration for Licensee’s activities in connection with
the Program, Medistem shall grant to Dr. Frank Morales, a Common
Stock Purchase Warrant to acquire an aggregate of 700,000 shares of
Medistem’s common stock at an exercise price equal to the
closing price of Medistem’s common stock on the OTC Bulletin
Board on the Effective Date. Such Warrant shall vest and
become exercisable for one-third of the shares of common stock on
each of the first, second, and third anniversaries of the Effective
Date. The form of Warrant is attached as Exhibit A to
this Agreement.
3.9
Assistance with Additional Programs;
Additional Warrants. Licensee, in Licensee’s discretion, shall
assist Medistem in connection with opening additional clinics in
other locations for the purpose of developing and commercializing
the Product in such locations (“Additional Programs”).
Licensee and Medistem shall mutually agreed upon the terms
and conditions of Licensee’s assistance to Medistem in
connection with each such Additional Program. Upon the
successful commencement of revenue generating operations at each
Additional Program for which Licensee and/or Dr. Frank Morales has
provided assistance, Medistem shall issue to Dr. Frank Morales, a
Warrant for an additional 150,000 shares of Medistem common stock
at an exercise price equal to the closing price of Medistem’s
common stock on the OTC Bulletin Board on the date of grant.
The form of such Warrant shall be substantially the same as
Exhibit A attached to this Agreement, except that such
Warrant shall be fully vested and exercisable for all 150,000
shares as of the date of grant.
4.
GRANT OF RIGHTS;
MARKETING.
4.1
Development License
. Medistem hereby grants to
Licensee, during the term of this Agreement, a non-exclusive,
non-transferable license, under the Licensed Technology, to perform
the activities described herein.
4.2
Commercialization License
. Medistem hereby grants to
Licensee a non-exclusive, non-transferable license throughout the
Territory, under the Licensed Technology, to develop, use,
manufacture, register, market, and sell Products in the Field.
With respect to any Patents that may issue in Mexico during
the term of this Agreement, a statement referencing the license
granted to Licensee pursuant to this Section 4.2 shall
be registered with the Mexican Patent Office (or similar authority)
at Licensee’s cost, as soon as is practically possible after
the issuance of the respective Patents.
4.3
Sublicensing. Licensee shall not be permitted to sublicense
the rights granted to Licensee pursuant to this Agreement without
the express, specific, prior written approval Medistem, which
approval shall be in Medistem’s sole and absolute
discretion.
4.4
Marketing Obligations,
Rights. Licensee shall
use all commercially reasonable efforts to market the Product in
the Territory.
9
4.5
Trademarks. Licensee shall market the Product throughout
the Territory under a trademark or trademarks (collectively, the
“Trademark”) selected by Medistem. Medistem shall
own all right, title and interest in and to such
Trademark.
5.
FEES.
5.1
Fees. As consideration to Medistem for the license,
the provision of stem cells, the funding of additional equipment
and facilities, the management of key processes, and the other
rights granted to Licensee under this Agreement, Licensee shall pay
to Medistem or its assignee royalty payments equal to 90% of all of
Licensee’s monthly Net Revenues in excess of $20,000.
5.2
Mode of Payment
. Medistem will manage and control
treasury functions with respect to patient billing in connection
with the Program. Medistem will maintain a separate bank
account for purposes of isolating revenues generated under this
arrangement. Revenues will be distributed to Medistem and
Licensee on a monthly basis within 10 days of the receipt of
reports outlined in Section 6.1 below. All payments
shall be made in U.S. Dollars.
6.
REPORTS.
6.1
Reports.
During the term of this Agreement,
Licensee shall furnish to Medistem, within 5 days after the end of
each month, written reports containing detailed information
regarding each and all patient treatments and aggregate monthly
data reflecting revenues earned and unearned. Formats for such
reports shall be in conformity with such templates and data
collection protocols as may, from time-to-time be provided by
Medistem. Such reports and the information therein shall be
supported by the Licensee’s medical and financial
records.
6.2
Records Retention
. Licensee and its Affiliates shall
keep complete and accurate records, including detailed financial
records, pertaining to the activities of Licensee relating to the
Program and the commercial use of the Product and the Licensed
Technology, for a period of three calendar years after the year in
which such activities and financial transactions occurred, and in
sufficient detail to permit Medistem to confirm the accuracy of the
aggregate fee calculations hereunder.
6.3
Audit Request . During the term of this
Agreement and for a period of two (2) years thereafter, at the
request of Medistem, Licensee and its Affiliates shall permit an
independent, certified public accountant appointed by Medistem and
reasonably acceptable to Licensee, at reasonable times and upon
reasonable notice, to examine such records as may be necessary to:
(i) determine the correctness of any report or payment made under
this Agreement; or (ii) obtain information as to the aggregate fees
payable for any calendar quarter in the case of Licensee’s
failure to report or pay pursuant to this Agreement. Said
accountant shall not disclose to Medistem any information other
than information relating to said reports, fees, and payments.
Results of any such examination shall be made available to
both Parties.
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6.4
Cost of Audit.
Medistem shall bear the full cost of the
performance of any audit requested by Medistem except as
hereinafter set forth. If, as a result of any inspection of
the books and records of Licensee or its Affiliates, it is shown
that Licensee’s payments under this Agreement were less than
the amount which should have been paid, then Licensee shall make
all payments required to be made to eliminate any discrepancy
revealed by said inspection within 30 days after Medistem’s
demand therefor. Furthermore, if the payments made were less
than 95% of the amount that should have been paid during the period
in question, Licensee shall also reimburse Medistem for the
reasonable costs of such audit.
6.5
Taxes . In the event that Licensee is required to
withhold and pay any tax to the local, state or federal tax or
revenue authorities having jurisdiction over the Territory
regarding any payment to Medistem due to the laws of such
jurisdiction, such amount shall be deducted from the payment to be
made by Licensee. Licensee shall promptly notify Medistem of
such withholding and, within a reasonable amount of time after
making such deduction, furnish Medistem with copies of any tax
certificate or other documentation evidencing such withholding.
Each Party agrees to cooperate with the other Party in
claiming exemptions from such deductions or withholdings under any
agreement or treaty from time to time in effect.
7.
OWNERSHIP; PATENTS.
7.1
Ownership .
(a)
Medistem shall retain all right, title
and interest in and to all Patents, Know-how (including, without
limitation, Inventions and trade secrets), and other Intellectual
Property, regardless of which Party develops, prepares and
prosecutes the applications associated therewith, or maintains the
patents, copyrights or other Intellectual Property rights related
thereto, subject to the license granted to Licensee pursuant to
Section 4.2 .
(b)
Rights to Inventions made solely by
employees of Medistem shall belong to Medistem.
(c)
Rights to Inventions made solely by
employees of Licensee shall belong to Medistem.
(d)
Rights to Inventions which were made
jointly by employees of Medistem and employees of Licensee shall
belong to Medistem. Such joint Inventions shall be subject to
the Field and territorial restrictions of this Agreement with
respect to manufacture, use and sale of such Inventions.
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7.2
Patent Maintenance.
(a)
Medistem shall have full responsibility
for, and shall control the preparation and prosecution of, all
patent applications and the maintenance of all patents relating to
the Licensed Technology (including the Patents) throughout the
Territory. In connection therewith, Medistem shall consult
with Licensee in order to assure that all future filings with
respect to the Patents are made in a timely manner and identify the
relevant countries in the Territory, to the extent that Medistem
can do so. Medistem shall pay all costs and expenses of
filing, prosecuting and maintaining the Patents and the patents
covering Inventions owned by Medistem in the Territory.
(b)
Medistem shall select qualified
independent patent counsel to file and prosecute all patent
applications pursuant to Section 7.2(a) .
Medistem shall provide copies to Licensee of any filings made
to, and written communications received from, any patent office
relating, in whole or in part, to the Licensed Claims.
(c)
Each Party agrees promptly to provide to
the other Party a complete written disclosure of any Invention made
by such Party. Medistem shall determine whether any Invention
is patentable and whether filing a patent application is
economically justifiable, and if so, shall proceed with the
preparation and prosecution of a patent application covering any
such Invention.
(d)
Each Party agrees to cooperate with the
other Party to execute all lawful papers and instruments, to make
all rightful oaths and declarations and to provide consultation and
assistance as may be necessary in the preparation, prosecution,
maintenance and enforcement of all such patents and patent
applications.
7.3
Patent Enforcement.
(a)
If either Party learns of an
infringement, unauthorized use, misappropriation or ownership claim
or threatened infringement or other such claim (any of the
foregoing, an “infringement”) by a Third Party with
respect to any Licensed Technology within the Territory, such Party
shall promptly notify the other Party and shall provide such other
Party with available evidence of such infringement.
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(b)
Medistem shall have the first right, but
not the duty, to institute patent infringement actions against
Third Parties based on any Licensed Technology in the Territory.
If Medistem (or its designee) does not secure actual
cessation of such infringement or institute an infringement
proceeding against an offending Third Party within 180 days of
learning of such infringement, Licensee shall have the right, but
not the duty, to institute such an action with respect to any
infringement by such Third Party. The costs and expenses of
any such action (including fees of attorneys and other
professionals) shall be borne by the Party instituting the action,
or, if the Parties elect to cooperate in instituting and
maintaining such action, such costs and expenses shall be borne by
the Parti