Exhibit 4.8
[*] =Certain confidential information contained in this exhibit, marked by
brackets with asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
CONFIDENTIAL
LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT
BETWEEN
XXXXXX PDI Inc.
(acting through its XXXXXX Consumer Healthcare division)
AND
IMI INTERNATIONAL MEDICAL INNOVATIONS INC.
TABLE OF CONTENTS
Page
----
ARTICLE I DEFINITIONS............................................... 2
ARTICLE II DEVELOPMENT OF THE PRODUCT................................ 8
ARTICLE III LICENSE GRANTS, EXCLUSIVITY, AND FUTURE RIGHTS............ 10
ARTICLE IV PAYMENTS AND REPORTS...................................... 11
ARTICLE V GOVERNMENT AUTHORIZATIONS................................. 13
ARTICLE VI SUPPLY REQUIREMENTS....................................... 14
ARTICLE VII MANUFACTURE............................................... 19
ARTICLE VIII PURCHASE PRICE............................................ 22
ARTICLE IX PACKAGING AND LABELING.................................... 24
ARTICLE X INSPECTION................................................ 25
ARTICLE XI WARRANTIES AND INDEMNITIES................................ 26
ARTICLE XII INSURANCE................................................. 29
ARTICLE XIII PRODUCT RECALLS........................................... 30
ARTICLE XIV PATENTS AND TRADEMARKS.................................... 30
ARTICLE XV CONFIDENTIALITY........................................... 33
ARTICLE XVI CONTRACTUAL RELATIONSHIP.................................. 36
ARTICLE XVII TERM AND TERMINATION...................................... 36
ARTICLE XVIII MISCELLANEOUS PROVISIONS.................................. 39
Appendix A - Clinical Development Program
Appendix B - Consumer Product Development Program
Appendix C - Licensed Patents
Appendix D - IMI Trade Marks
Appendix E - Professional Product Specifications
Appendix F - Stability Test Program
Appendix G - Royalty Report
Appendix H - Sales Forecast
Appendix I - Quality Control Procedures
Appendix J - J&J Corporate Quality Systems Regulations
Appendix K - Price Schedule for X-Rite Reader
Appendix L - Statement of Non-Conformity
Appendix M - Returned Goods and Authorization Form
i
LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT
THIS AGREEMENT is made effective the 9/TH/ day of May 2002 by and between IMI
International Medical Innovations Inc., a Canadian corporation, having its
principal place of business at Xxxxx 000, 0000 Xxxxx Xxxxxx, Xxxxxxx, Xxxxxxx,
X0X 0X0, Xxxxxx ("IMI") and XxXxxx PDI Inc., a Canadian corporation, having its
principal place of business at 000 Xxxxxxx Xxxxxx, Xxxxxxxx, Xxxxxx, Xxxxxx
(acting through its XxXXXX Consumer Healthcare division on behalf of XxXxxx PDI
Inc.) ("XXXXXX").
A. IMI has developed a cardiac risk predictor that measures skin cholesterol (a
novel and independent predictor for Coronary Artery Disease), and a test for use
by trained medical personnel and/or trained healthcare workers was approved for
sale in Canada January 29, 2001 (and a test for consumer use without the
intervention of medical practitioners is currently under development).
X. XXXXXX has experience and expertise in marketing, sales and supply chain
management for manufacturing and assembling medical products.
X. XXXXXX desires to jointly develop with IMI and market certain cardiac risk
predictors, for both professional and consumer markets.
D. IMI desires to have manufactured and supply to XXXXXX such cardiac risk
predictors, at least for an initial period, and XXXXXX desires to have IMI have
manufactured and supply to XXXXXX such cardiac risk predictors, at least for an
initial period.
1
ARTICLE I
DEFINITIONS
As used in this Agreement, the following terms shall have the following
respective meanings:
1.1 All currency used in this Agreement shall be denominated in Canadian
Dollars, unless specifically identified otherwise.
1.2 "Affiliate(s)" shall mean any company(ies) or other legal entity(ies)
directly or indirectly controlling, controlled by, or under common control with
a respective party. For purposes of this definition, "control" shall mean
possession of the power to direct or cause the direction of the management and
policies of the company or other legal entity, whether pursuant to the ownership
of at least 50% of its voting securities, by contract, or otherwise.
1.3 "Annual Sales" shall mean the Net Sales in a calendar year.
1.4 "Business Day" shall mean any day other than a Saturday, Sunday or any day
that is a national, provincial, municipal or civic holiday in Xxxxxxx, Xxxxxxx,
Xxxxxx.
1.5 "Clinical, Development Program" shall mean the program described in Appendix
A.
1.6 "Confidentiality Agreement" shall mean the confidentiality agreement of
December 7, 2000, between IMI and XXXXXX, which is herein incorporated by
reference.
1.7 "Consumer Product Development Program" shall mean the program described in
Appendix B.
1.8 "Effective Date" shall mean the date first written above.
1.9 "Field" shall mean and include the following to the extent that they relate
exclusively to systems measuring skin cholesterol:
1.9.1 "Consumer Field" shall mean the field of diagnosing, predicting and
monitoring of cardiac risk utilizing systems that are approved by the
applicable governmental
2
regulatory authorities for use by individuals without supervision by a
licensed medical practitioner and that are directly marketed to public
consumers, other than the Nutraceutical Field, as described below;
1.9.2 "Nutraceutical Field" shall mean the field of diagnosing, predicting
and monitoring of cardiac risk utilizing systems that are approved by the
applicable governmental regulatory authorities for use by individuals
without supervision by a licensed medical practitioner and that are
directly marketed to public consumers in association or combination with a
nutraceutical, vitamin, nutritional supplement, health food or similar
product;
1.9.3 "Laboratory Field" shall mean the field of diagnosing, predicting and
monitoring of cardiac risk utilizing systems that are approved by the
applicable governmental regulatory authorities for use under the
supervision of trained medical personnel and/or trained healthcare workers
and that are operated in an outpatient clinic, medical laboratory, patient
collection center associated with a laboratory, hospital laboratory or
similar venue providing laboratory services;
1.9.4 "Professional Field" shall mean the field of diagnosing, predicting
and monitoring of cardiac risk utilizing systems that are approved by the
applicable governmental regulatory authorities for use under the
supervision of a licensed medical practitioner, other than the Laboratory
Field, as described above;
1.9.5 "Other Medical Field" shall mean the field of diagnosing, predicting
and monitoring of cardiac risk utilizing systems that are approved by the
applicable governmental regulatory authorities for use in all fields other
than the Consumer, Nutraceutical, Laboratory and Professional Fields.
3
1.10 "Key Cardiologists" shall mean medical practitioners that are, in XXXXXX'x
sole determination, opinion leaders among cardiologists, endocrinologists,
lipidaemiologists and/or general practitioners with a cardiology practice in
Canada.
1.11 "Licensed Fields" shall mean the Consumer, Nutraceutical, Professional and
Other Medical Fields defined above.
1.12 "Licensed Patents" mean (i) the patents and patent applications (and
patents granted therefrom) owned or controlled by IMI at the date hereof set
forth and as described in Appendix C; and (ii) any and all extensions, renewals,
continuations, continuations-in-part, divisions, patents-of-addition, reissues,
reexaminations, supplementary protection certificates or foreign counterparts of
any of the foregoing; and (iii) any and all patents and patent applications
owned or controlled by IMI with the right to sublicense (now or in the future)
which contain claims, the practice of which would infringe the claims of a
patent or patent application included in i) or ii), to the extent that the
foregoing are used in and solely for the purposes of the Licensed Technology.
1.13 "Licensed Product" means any cardiac risk prediction system which measures
skin cholesterol in the Licensed Fields (or any component thereof) which would
infringe a Valid Claim of any Licensed Patent, but for the license granted in
this Agreement. Licensed Product includes:
1.13.1 "Consumer Product", which is a cardiac risk prediction system (or
component thereof) which is marketed in the Consumer Field or Nutraceutical
Field; and
1.13.2 "Professional Product" which is a cardiac risk prediction system (or
component thereof) which is marketed in the Professional Field or Other
Medical Field.
4
1.14 "Licensed Technology" means a cardiac risk predictor system exclusively
employing a test that measures skin cholesterol by measuring color changes after
application of an indicator component.
1.15 "Licensed Know-How" means the trademarks identified in Appendix D hereto
together with any and all present and future inventions, improvements,
discoveries, claims, formulae, processes, data, trade secrets, software,
technologies, and know-how that are owned or controlled or licensed (to the
extent that such are freely sub-licensable without consent or consideration of
any kind by any third party) by IMI the practice of which would infringe any
Licensed Patents and which are i) incorporated in the manufacture, use or sale
of Licensed Products or ii) claimed or disclosed in any patent or patent
application included in Licensed Patents.
1.16 "Manufacturer's Cost" shall mean the total monies and other consideration
paid by IMI to its suppliers, contractors, and/or subcontractors for the
Licensed Product that is supplied to XXXXXX (including all costs incurred by IMI
to unaffiliated third parties in connection with the importation, sale and
shipment or delivery of Licensed Products to XXXXXX as contemplated herein) less
the following amounts (i) discounts, rebates, or trade allowances actually
allowed or granted to IMI in connection with the Licensed Products (other than
discounts associated with early or prompt payment) and (ii) credits or
allowances actually granted to IMI upon claims (including, without limitation,
claims for destroyed goods) or returns in connection with the Licensed Products,
regardless of the party requesting the return.
1.17 "Net Sales" shall mean the total of (a) all amounts billed, invoiced, or
received (whichever occurs first) for sales or other transfers by (and includes
the fair market value of all non-cash consideration received by) XXXXXX and its
Affiliates and sublicensees from the sale or other transfer of Licensed Product
to third parties and (b) all cash and non-cash consideration
5
(valued at the fair market value thereof) received by XXXXXX and its Affiliates
in respect of issue fees, maintenance fees, option payments, milestone payments,
and similar non-royalty payments made by sublicensees on account of sublicenses
pursuant to this Agreement from the sublicensing of some or all of the Licensed
Patents and the Licensed Know-How or any grant of rights in connection
therewith, less the following amounts (i) discounts, rebates, or trade
allowances actually allowed or granted in connection with the Licensed Products,
(ii) credits or allowances actually granted upon claims (including, without
limitation, claims for destroyed goods) or returns in connection with the
Licensed Products, regardless of the party requesting the return, (iii) 2% of
the total monies received by XXXXXX and its sublicensees from the sale of
Licensed Product to independent third parties for freight and distribution
charges paid for delivery, and (iv) sales taxes or other governmental charges
(including GST) levied on or measured by the invoiced amount whether absorbed by
the billing or the billed party.
1.17.1 In the event that the Licensed Products are sold as part of a
combination product, the Net Sales of the Licensed Products, for the
purposes of determining royalty payments shall be determined by multiplying
the Net Sales (as defined in this definition) of the combination product,
on a per product basis, by the fraction A/(A + B), where A is the average
sales price of the Licensed Product over the prior 12 month period when
sold separately in finished form and B is the average sales price of the
other product(s) over the same 12 month period sold separate in finished
form. In the event that such average sales price cannot be determined for
both the Licensed Products and other product(s) in combination, Net Sales
for purposes of determining royalty payments shall be calculated by
multiplying the Net Sales of the combination products, on a per product
basis, by the fraction C/(C + D), where C is XXXXXX'x Purchase Price (as
defined in Section 8.1
6
hereof) of the Licensed Products and D is the cost of goods of the other
product(s), determined in accordance with the method of accounting normally
employed by XXXXXX in computing cost of goods.
1.17.2 In the event of (i) a sale or transfer of any Licensed Products by
XXXXXX, including a sale or transfer to an Affiliate, which are not
intended for commercial use and which are not to be sold to third parties
or (ii) the use by XXXXXX or any of its Affiliates of any Licensed Products
which have been acquired, such Licensed Products shall for the purposes of
calculating Net Sales be deemed to have been sold to third parties at a
price equal to the lesser of (i) ***** ***** (as defined in Section
8.1 hereof). Notwithstanding the foregoing, the provision of Licensed
Products as samples in a manner and in quantities consistent with customary
industry practice shall not be deemed to amount to a Net Sale of such
Licensed Products.
1.17.3 For the purposes of the determination of Net Sales for a particular
sale, such sale shall be deemed to be invoiced at the earlier of (i) the
date of the actual invoice in respect of such sale and (ii) the date of
shipment of the Licensed Products to a customer.
1.18 "Specifications" shall mean, in respect of a particular Licensed Product,
the specifications for the Licensed Product and/or the imprinting and bulk
packaging thereof including physical, quality analysis and assurance, test
methodologies, bulk packaging, handling, shipping and other standards,
instructions and procedures for the Licensed Product and its Raw Materials. All
Specifications and any changes agreed to by the parties from time to time shall
be in writing. The current Specifications with respect to the Professional
Product (in its currently intended embodiment) are attached hereto as Appendix
E.
1.19 "Stability Test Program" shall mean the program described in Appendix F.
7
1.20 "Territory" shall mean Canada and its territories and possessions.
1.21 "Valid Claim" means a claim in any unexpired, issued patent within the
Licensed Patents which has not been held invalid or unenforceable by a
nonappealed or unappealable decision by a court or other appropriate body of
competent jurisdiction, and which is not admitted to be invalid through
disclaimer, dedication to the public or otherwise.
ARTICLE II
DEVELOPMENT OF THE PRODUCT
2.1 IMI will work with XXXXXX as herein set out in an effort to commercialize
Licensed Product in the Professional Field. At XXXXXX'x expense, IMI agrees to
conform Licensed Product, including without limitation software, to reflect
XXXXXX'x trademarks and commercially reasonable packaging, product format, and
labeling requirements. IMI will conduct research and development as herein set
out to work towards the development of a commercially salable Licensed Product
in the Consumer Field.
2.1.1 IMI will conduct the Clinical Development Program as described in
Appendix A. The data generated by this program is intended to be sufficient
to support and/or investigate product claims, product indications, and/or
market positioning, as appropriate. The data generated is intended to be
used in preparing submissions by IMI to gain governmental regulatory
approvals in the Territory relating to a Licensed Product in the
Professional Field.
2.1.2 IMI will conduct the Consumer Product Development Program as
described in Appendix B. The data generated by this program is intended to
provide support for and/or investigate product claims, product indications,
and/or market positioning of a Licensed Product in the Consumer Field, as
appropriate. The data generated is intended
8
to be used in preparing submissions by IMI to gain governmental regulatory
approvals in the Territory relating to a Licensed Product in the Consumer
Field.
2.2 IMI shall bear all of its costs related to the Clinical Development Program
and the Consumer Product Development Program, including without limitation the
portions of such program which relate to the consumer delivery system(s) for a
Consumer Product, testing technology(ies) and related computer software to meet
specifications mutually agreed upon by IMI and XXXXXX.
2.3 Either IMI or XXXXXX may suggest changes to the scope, activities,
direction or sequence of the research and development, including without
limitation product design goals, specifications, and schedules, which shall be
effected upon mutual agreement of the parties.
2.4 Prior to and (with the exception of Section 2.4.1 hereof) after the launch
of a Licensed Product in any applicable Licensed Field, XXXXXX agrees to perform
the following activities and services:
2.4.1 Conduct market research on any such Licensed Product opportunity as
needed and as determined by XXXXXX, acting reasonably;
2.4.2 Provide consumer expertise and direction in the development of such
Licensed Product (design specifications, costing, etc.);
2.4.3 Provide consumer marketing/development expertise in the development
of such Licensed Product;
2.4.4 Develop marketing strategies and appropriate sales support material
for such Licensed Product; and
2.4.5 Provide IMI with sales forecasts for any such Licensed Product in
each of the Licensed Fields for IMI's contract manufacturers.
2.5 After the launch of a Licensed Product in the Professional Field, XXXXXX
agrees to perform the following activities and services:
2.5.1 XXXXXX medical sales force will drop off selected product literature
to *****;
2.5.2 Provide Professional Products to a total of ***** for testing
purposes;
2.5.3 As XXXXXX attends a number of health-related exhibits annually, some
of which may relate to the Licensed Products, XXXXXX may desire to
invite and to provide space for IMI personnel in the XXXXXX
exhibiting booth, at least during calendar years 2002 and 2003,
unless this Agreement is terminated earlier, to demonstrate the
Licensed Products at professional event exhibits mutually agreed
upon by XXXXXX and IMI. XXXXXX reserves the right to establish
professional event exhibit guidelines and procedures covering IMI's
involvement and activities at these exhibits. The guidelines and
procedures will include, but not be limited to, the allocation of
exhibit space, the priority of messages provided, the amount of
promotional/advertising space, etc. to ensure, in XXXXXX'x sole
opinion, the appropriate message delivery of the products, services
or opportunities being presented. XXXXXX shall reimburse IMI for its
out-of-pocket costs of having its personnel attend and participate
in such exhibits.
9
ARTICLE III
LICENSE GRANTS, EXCLUSIVITY, AND FUTURE RIGHTS
3.1 For the term of this Agreement, IMI hereby grants to XXXXXX the exclusive
right and license in the Licensed Fields under the Licensed Patents and Licensed
Know-How to use, sell and have sold products. processes and/or apparatus
embodying the Licensed Patents and/or Licensed Know-How in the Territory. XXXXXX
may grant sublicenses of such rights, subject to IMI's prior written approval.
IMI's approval will be deemed granted unless it provides written objection
within fifteen (15) Business Days of XXXXXX'x written notification of its desire
to grant a particular sublicense. XXXXXX shall not use or sublicense any rights
granted hereunder or offer any Licensed Products to any person whom XXXXXX has
reason to believe will use such rights or Licensed Products outside of the
Territory.
3.2 IMI hereby grants to XXXXXX a non-assignable option to an exclusive license
in the Laboratory Field in the Territory, exercisable by written notice to IMI
of such exercise prior to the first anniversary of the Effective Date (subject
to payment by XXXXXX to IMI of a one-time fee of one hundred thousand dollars
($100,000.00) within ten (10) days of providing such notice to IMI). Upon due
and timely payment of such one-time fee, the Licensed Fields, as defined in
Section 1.11 above, will be deemed to include the Laboratory Field, and the
Licensed Products, as defined in Section 1.13 above, will be deemed to include a
cardiac risk prediction device or component thereof developed for and intended
for sale in the Laboratory Field, provided that such inclusions shall not
obligate IMI to develop any Licensed Product independent of any existing
Consumer Product or Professional Product. In the event of XXXXXX'x exercise of
such option, it shall perform similar activities and services as those outlined
in Sections 2.4 and 2.5 hereof in connection with the Laboratory Field.
10
3.3 Subject to the provisions of Article XV hereof, and solely for the purposes
of obtaining marketing data for use in Canada, IMI hereby consents to XXXXXX
reviewing and testing the Licensed Product for use in the Professional Field and
the concept relating thereto (including, without limitation, the
pharmaco-economic model associated therewith) in the United States solely as a
basis for discussions with a U.S. third party health management organization.
Notwithstanding the foregoing, no disclosure shall be made without the prior
written approval of IMI and on terms which IMI determines in its sole discretion
appropriately protect its proprietary interests.
3.4 If, at any time during the term of this Agreement, XXXXXX has a desire to
obtain a license, as otherwise described in this Article III but outside of
Territory, XXXXXX shall have the right to enquire about such license from IMI.
If IMI has not, at the time of XXXXXX'x enquiry,
already licensed the desired rights to a third party or unless IMI otherwise
considers that it is not in IMI's best interests to engage in such discussions,
IMI will enter into discussions with XXXXXX concerning such license (provided
that nothing herein contained shall in any way limit IMI's right and ability to
terminate any such discussions at any time for any reason).
ARTICLE IV
PAYMENTS AND REPORTS
4.1 As consideration for the rights granted herein by IMI to XXXXXX, XXXXXX
hereby agrees to make the following payments to IMI:
4.1.1 XXXXXX will pay a royalty to IMI on the Net Sales of Licensed Product
at one of the following rates:
(a) ***** of Net Sales in a calendar year if Annual Sales for such
calendar year are less than or equal to *****.
(b) ***** of Net Sales in a calendar year if Annual Sales for such
calendar year are greater than ***** and less than or equal to
*****.
(c) ***** of Net Sales in a calendar year if Annual Sales for such
calendar year are greater than *****.
11
By way of example, if Annual Sales are $*****, then the royalty shall be
*****. If royalty payments for a given quarterly period, as contemplated
in Section 4.1.1, are based upon a particular level and expectation of
Annual Sales in a given calendar year giving rise to a calculation based
upon one of subsections (a) - (c), as applicable, and it is subsequently
determined that the Annual Sales for such year will require payments to be
made as contemplated in a different subsection (a) - (c), as applicable,
then XXXXXX shall make an additional payment or shall be credited to
adjust for the prior underpayment or overpayment. By way of example, if
Net Sales in the first half of a year are $*****, and if XxXxxx pays
royalties based upon ***** of that amount for such periods, and if the Net
Sales in the third quarter of such calendar year are *****, then the
royalty payment for such third quarter shall be the sum of (i) ***** and
(ii) ***** (in order to compensate for the underpayments in respect of the
first two quarters of such year).
4.1.2 XXXXXX will make the following one-time milestone payments to IMI
based on the combined Net Sales of all Licensed Product:
(a) ***** after the Annual Sales first exceed *****
(b) ***** after the Annual Sales first exceed *****
(c) ***** after the Annual Sales first exceed *****
(d) ***** after the Annual Sales first exceed *****
The one-time milestone payments due under this Section 4.1.2 are
cumulative, such that if in the first year Annual Sales total *****, the
milestone payment to IMI would be *****.
4.1.3 XXXXXX will make the following one-time milestone payments to IMI
based on the Net Sales of Consumer Products:
(a) ***** after the Annual Sales first exceed *****
(b) ***** after the Annual Sales first exceed *****
The milestone payments due under this Section 4.1.3 are cumulative, such
that if in the first year Annual Sales of the Consumer Products total
*****, the milestone payment to IMI would be *****.
4.2 XXXXXX shall keep true and accurate records and books of account containing
all data reasonably required for the computing of and verification of the Net
Sales and payments to be made in accordance with this Article. Such records
shall be retained for at least the period of time that documentation must be
preserved in accordance with the requirements and guidelines of applicable
government authorities (but in no event less than seven years) and shall be
available during normal business hours for inspection by IMI's agents on its
behalf for the sole purpose of verifying the amount of payments to be made
hereunder. In the event that any such inspection shows an under-reporting and
underpayment for any three month period, then XXXXXX shall pay such amount to
IMI. In the event that any such inspection shows an over-
12
reporting and overpayment for any three month period, then XXXXXX shall reduce
any then current payments owed to IMI by such amount. In the event that any such
inspection shows an under-reporting and underpayment in excess of five percent
for any three month period, then IMI shall also be entitled to be reimbursed for
the cost of the inspection. Within fifteen (15) days following each quarterly
period of a calendar year during which royalties are due under this Agreement,
XXXXXX shall render to IMI the written report attached as Appendix G which sets
forth the amount of royalties due and payable based on sales of such Licensed
Products during such calendar quarter, and XXXXXX shall, upon rendering such
report, remit to IMI the amount of royalties shown thereby to be due.
ARTICLE V
GOVERNMENT AUTHORIZATIONS
5.1 IMI shall conduct the Consumer Product Development Program in accordance
with Section 2.1.2 hereof.
5.2 Notwithstanding the previous section, XXXXXX shall have the right to
participate with IMI in communications with the governmental health authorities
in the Territory for all issues relating to a Licensed Product. Therefore, IMI
shall promptly provide copies to XXXXXX of all correspondence received from any
governmental health authorities in the Territory relating to any Licensed
Product and shall consult with XXXXXX prior to responding to any such
correspondence and prior to initiating any other communications with any
governmental health authorities in the Territory relating to any Licensed
Product.
5.3 Under terms of this Agreement XXXXXX will have the responsibility of
communicating with consumers and the health care profession and some of these
communications may relate to complaints related to the Licensed Products. XXXXXX
agrees to provide notice of any complaint
13
relating to the Licensed Products to IMI within 72 hours of the receipt of such
complaint, confirmed in writing within fifteen (15) days of the receipt of such
complaint. IMI agrees to provide written notice of any complaints relating to
the Licensed Products that it may receive to XXXXXX within 72 hours of the
receipt of such complaint, confirmed in writing within fifteen (15) days of the
receipt of such complaint. IMI agrees to undertake all actions necessary to
comply with regulatory and legal requirements relating to the Licensed Products
arising from the complaints to the extent that IMI determines that the
complaints are justified. Should XXXXXX, in XXXXXX'x sole discretion, deem
further actions necessary, IMI agrees to cooperate with XXXXXX and to allow
XXXXXX to make any notification XXXXXX in its sole discretion deems appropriate
to any governmental agency. Should IMI, in IMI's sole discretion, deem further
actions necessary, XXXXXX agrees to cooperate with IMI and to allow IMI to make
any notification IMI in its sole discretion deems appropriate to, or make any
response required of, any governmental agency. Following these actions, XXXXXX
will have the responsibility of communicating with consumers and the health care
profession. Unless otherwise required by law, each of IMI and XXXXXX will
consult with one another with respect to the form and substance of all
communications contemplated in this Section.
ARTICLE VI
SUPPLY REQUIREMENTS
6.1 During the term of this Agreement in the Territory, and subject to the
provisions of this Article VI, IMI shall have manufactured for and supply to
XXXXXX, all of the Licensed Product as may be required of IMI by XXXXXX, and
XXXXXX shall purchase all of its requirements for the Licensed Product from IMI,
all of which shall be manufactured in accordance with their respective
Specifications.
14
6.1.1 In the event that IMI is unable to supply all of the Licensed Product
as may be required by XXXXXX from the manufacturing facilities as referred
to in Section 7.1 because of either: (i) a force majeure as detailed in
Section 19.8, which force majeure continues uninterrupted for a period in
excess of ninety (90) days; and/or (ii) a failure to meet binding estimates
for expected purchases of Licensed Product pursuant to the forecasts
provided pursuant to Section 6.3 hereof for a consecutive three (3) month
period, IMI hereby grants to XXXXXX and its Affiliates under Licensed
Patents and Licensed Know-How, a license, with the right to grant
sublicenses, to make, have made, and use Licensed Product anywhere in the
world solely for sale in the Territory only for that period of time during
which the force majeure and/or production limitations continue to exist and
only to the extent necessary to meet any binding estimate for such expected
purchases pursuant to such forecasts, after which such license shall
immediately terminate (and, for greater certainty, XXXXXX shall be entitled
to sell or otherwise distribute such levels of inventories of such Licensed
Product). For greater certainty, the parties acknowledge that such license
grant shall not be operative in connection with any failure by IMI to meet
revised projections for formerly binding estimates provided pursuant to
succeeding forecasts. Subject to Section 10.3, IMI shall reimburse any
extra costs paid to third parties that XXXXXX shall incur as a result of
IMI's failure to supply XXXXXX'x required quantities of Licensed Product.
6.1.2 In the event that XXXXXX believes that:
(i) one or more components of any Licensed Product may be obtained
at an appropriate quality level for a lower price than supplied
through IMI, or
15
(ii) the supply of any Licensed Product or one or more components of
any Licensed Product may be improved through sources other than
through IMI's suppliers;
and XXXXXX identifies to IMI a potential supplier (the "Alternate
Supplier") anywhere in the world which is satisfactory to IMI and which is
able to manufacture Licensed Product or such components, as the case may
be, in accordance with the Specifications, then provided that the obtaining
of such components would not have an effect on the regulatory approval
relating to the marketing of such Licensed Product, IMI may enter into a
supply agreement with the Alternate Supplier on terms and conditions
satisfactory to IMI and XXXXXX.
6.1.2.1 XXXXXX shall reimburse IMI for all costs paid to third
parties in connection with entering into supply arrangements with the
Alternate Supplier and in connection with verifying that the
Alternate Supplier will be able to manufacture in accordance with the
Specifications and that such arrangements will not effect any
governmental or regulatory approvals obtained or required to be
obtained to market such Licensed Product (or, if they will affect
such approvals, that such approvals may be obtained on reasonable
terms if the Alternate Supplier supplies the Licensed Product), and
shall indenmify and hold IMI harmless from all liabilities and
obligations arising under such supply arrangements relating to any
payments which IMI shall be required to make in connection therewith
relating to obtaining such supply (including, without limitation, any
up-front payments and any minimum quantities which must be
purchased).
16
6.1.2.2 Notwithstanding anything contained in this Agreement, IMI
shall have no liability to XXXXXX as a result of any breach or
non-performance of an Alternate Supplier that provides Licensed
Products or otherwise in respect of any Licensed Products supplied by
the Alternate Supplier unless (i) IMI shall have expressly agreed in
writing with XXXXXX that the provisions of this Section 6.1.2.2 and
the indemnification (and hold harmless) provisions of Section 6.1
.2.1 shall not apply or (ii) IMI has contracted with the Alternate
Supplier on an exclusive basis for the supply of Licensed Products.
6.2 Upon ninety (90) days written notice to XXXXXX, IMI may assign or otherwise
transfer to XXXXXX any or all of its rights and obligations arising under its
agreements relating to the supply and/or manufacture of Licensed Products and/or
components thereof in the Territory. XXXXXX shall have the right to amend or
renegotiate any agreement prior to accepting such assignment or transfer.
6.3 Prior to the beginning of the first full calendar month following the
execution of this Agreement, and thereafter by the ***** Business Day of each
succeeding calendar month, XXXXXX shall provide IMI with an estimate of and
commitment for its expected purchases of each Licensed Product in each of the
following twelve (12) months, which forecast shall be non-binding in respect of
each of the last ***** months of such ***** month period and shall be binding in
respect of each of the first ***** months of such ***** month period. Each
succeeding forecast shall revise any preceding forecasts (but shall not amend
any month in respect of which there was a binding commitment except with the
consent of IMI). To the extent that any succeeding forecast reflects revised
increased projections for purchases for a month for which a binding estimate has
already been given through a prior forecast, IMI shall use commercially
reasonable efforts to meet such increased demand but shall have no liability to
XXXXXX if it is unable for any reason to do so. The form of estimate and
commitment of XXXXXX with respect to the Licensed Product is attached as
Appendix H hereto. Notwithstanding anything contained herein, IMI shall have no
liability to XXXXXX in respect of the failure to deliver Licensed Product in
respect of which a binding commitment has not been
17
made by XXXXXX hereunder. All forecasts and commitments by XXXXXX shall be
subject to the provisions of Section 6.4 hereof.
6.4 XXXXXX shall place purchase orders for the Licensed Product with IMI from
time to time in accordance with the amounts committed under Section 6.3,
specifying the quantities of the Licensed Product desired, and the place(s) to
which and the manner and dates by which, shipment is to be made; said shipment
dates to be no less than thirty (30) days from the purchase order date. IMI
agrees to use commercially reasonable efforts to fulfill purchase orders,
including such as may be in excess of the forecast amounts which are binding
pursuant to Section 6.3, but shall have no obligation to accomplish such
fulfillment beyond such binding forecast amounts. Should the purchase orders, in
any given period, exceed the forecast amounts which are binding pursuant to
Section 6.3, the parties will jointly undertake commercially reasonable
activities to attempt to fulfill such requirements. XXXXXX shall be responsible
for making all commercially reasonable arrangements necessary associated with
delivery of Licensed Products and/or the components thereof after such items are
available for pick-up at the site of manufacture thereof.
6.5 Subject to the foregoing provisions of this Article VI, IMI shall satisfy
all purchase orders by shipment of all ordered Licensed Product, no later than
the shipment dates provided in XXXXXX'x purchase orders to the place(s) and in
the manner directed by XXXXXX.
6.6 As of the time of delivery by IMI, the Licensed Product will conform to the
Specifications.
6.7 IMI and its selected manufacturer shall perform quality control tests and
assays, as appropriate and set out in Appendix I, on all packaging, raw
materials and finished Licensed Product or portions thereof, in accordance with
the Specifications, and IMI's and its selected
18
manufacturer's customary procedures. IMI and its selected manufacturer shall
prepare and maintain, as hereinafter contemplated, batch records and a retained
sample, properly stored, from each lot or batch of Licensed Product or portions
thereof manufactured, sufficient to perform quality control tests specified in
the Specifications at least twice; the obligation in the foregoing sentence
shall apply:
(a) in respect of the Reader, for the duration of the then-projected
useful life of the Reader; and
(b) in respect of all other components of the test kits, samples shall be
maintained until the expiry date of the particular samples and batch
records shall be maintained for ***** thereafter.
A copy of the certificate of analysis shall be provided to XXXXXX with each
batch or lot shipped to XXXXXX.
6.8 All Licensed Product, from the time it is available to be shipped by IMI or
on its behalf in accordance with the purchase orders, shall have a remaining
shelf life of not less than *****, provided, however, that IMI shall undertake
research and development with a view to increasing such shelf life.
6.9 In the event IMI is unable to fill all orders for Licensed Product,
including its own demand thereof, IMI shall first allocate all of its available
capacity to XXXXXX before filling the orders of its other customers or
fulfilling its own demand.
ARTICLE VII
MANUFACTURE
7.1 In the manufacture of the Licensed Product for XXXXXX, IMI shall ensure
compliance, by itself and its suppliers and subcontractors, with all applicable
US FDA and J&J Corporate Quality Systems Regulations as outlined in Appendix J
and all applicable federal, provincial and local government and regulatory
requirements (including, without limitation, safety and
19
environmental requirements) and all applicable Specifications. IMI agrees to
keep exact, true and complete records of the supply of the Licensed Product to
XXXXXX and IMI agrees to require that its suppliers keep exact, true and
complete records of the manufacture and supply of the Licensed Product to
XXXXXX, which shall at all reasonable times, and upon reasonable notice be
available for examination, audit and copying by XXXXXX and its representatives.
IMI shall have the Licensed Product manufactured at its suppliers plants located
in Diagnostic Chemicals Limited, Charlottetown, Xxxxxx Xxxxxx Island, Canada and
X-Rite Incorporated, Grandville, Michigan, USA. or such other manufacturers
selected by IMI and which are satisfactory to XXXXXX, acting reasonably.
7.2 In the event XXXXXX and IMI mutually determine to amend the Specifications
in any respect, IMI shall use its reasonable commercial efforts to implement
such amendments through its suppliers (and, if considered commercially
reasonable and if such suppliers are unwilling or unable to implement such
amendments, then the parties will mutually consider changing suppliers or
further modifying the Specifications in a manner which may be implemented
through the existing suppliers), or such other amendments as may be mutually
agreed to by the parties. If any such amendments are requested by XXXXXX, XXXXXX
shall be responsible for reimbursing IMI for all costs associated therewith.
Except as contemplated in Section 9.1, IMI and XXXXXX shall agree on all
amendments to the Specifications.
7.3 XXXXXX shall have the right, at its own expense, to inspect at all
reasonable times during normal business hours, and on reasonable prior notice to
IMI and the manufacturer, as applicable, the operations and facilities of IMI
and its suppliers in which the Licensed Product is manufactured, packaged,
inspected, tested, labeled, stored or shipped; provided, that IMI or such
supplier may refuse entry to areas where products of other customers are being
manufactured,
20
inspected or packaged, in order to fulfill its obligations of confidentiality to
these customers. IMI agrees to comply with XXXXXX'x reasonable requests and to
ensure that its suppliers comply with XXXXXX'x reasonable requests to modify
plant conditions, policies or practices, to conform said conditions, policies or
practices to all applicable regulatory requirements and all Specifications.
7.4 IMI and XXXXXX agree to permit and fully cooperate with, and to require its
suppliers to permit and fully cooperate with, any inspections by federal or
provincial regulatory representatives of the facilities used to manufacture or
store Licensed Product. IMI shall notify XXXXXX immediately when the inspection
is scheduled, allow representatives of XXXXXX to be present at such inspection
and report the results of any such inspection relating to the manufacture of
Licensed Product to XXXXXX. IMI further agrees to comply with and require its
suppliers to comply with all required modifications as may be necessary to
conform to all applicable regulatory requirements.
7.5 IMI shall, and shall require its supplier to, conduct regular stability
tests of chemical components and finished goods of the Licensed Product pursuant
to the Stability Test Program (Appendix F) and to provide written stability
reports in compliance with such test program to XXXXXX within one month of the
conclusion of each calendar year. IMI agrees to initiate and pursue an ongoing
stability program with the objective of extending the *****. IMI shall
promptly notify XXXXXX of any batch of Licensed Product or component thereof
that fails to meet any minimum standard set out in such Test Program.
21
ARTICLE VIII
PURCHASE PRICE
8.1 XXXXXX shall purchase from IMI and IMI shall sell to XXXXXX all of the
Licensed Product as may be ordered by XXXXXX at a price (the "Purchase Price")
equal to the amount which results when the Multiple is multiplied by the
Manufacturer's Cost. For the purposes hereof, the "Multiple" shall, in a given
calendar year, be
(i) ***** in respect of all components of the Purchase Price other than
that amount (the "Reader Amount") of the Manufacturer's Costs
relating to monies and other consideration paid by IMI to the
suppliers, contractors, and/or subcontractors of the colour
measurement instrument (the "Reader"), if royalties are paid pursuant
to Section 4.1.1(a) in the year in which the Licensed Product is
shipped to XXXXXX;
(ii) ***** in respect of all components of the Purchase Price other than
the Reader Amount, if royalties are paid pursuant to Section
4.1.1(b) in the year in which the Licensed Product is shipped to
XXXXXX;
(iii) ***** in respect of all components of the Purchase Price other than
the Reader Amount, if royalties are paid pursuant to Section 4.1.1(c)
in the year in which the Licensed Product is shipped to XXXXXX; and
(iv) ***** for the Reader Amount, *****
If the Multiple for a given Manufacturer's Cost is based upon a particular
level and expectation of Annual Sales in a given calendar year giving rise
to a calculation based (and, therefore, a particular royalty rate pursuant
to Section 4.1.1), and if it is subsequently determined that the royalty
rate for such year is different, then IMI shall,
22
after it is determined what the royalty rate in respect of such year
is, shall make such payments to XXXXXX to adjust for the prior
payment, without interest. ***** Subject to the terms hereof, XXXXXX
shall be able to consult with IMI in connection with any problems
arising in connection with service, regulatory or cost of goods issues
associated with the manufacture of Licensed Products. However, if IMI
ceases to supply any Licensed Products to XXXXXX, no Administration
Charge or Minimum Administration Charge shall be payable to IMI.
8.2 The Purchase Price will be F.O.B. IMI's place of manufacture or supply
and will be inclusive of all imprinting and bulk packaging costs.
8.3 XXXXXX shall pay all actual freight, insurance and government sales
tax imposed on purchases of finished goods for resale, and import and export
duties and other fees and costs incurred in connection with the importation,
sale and shipment of the Licensed Product to XXXXXX. Risk of loss shall belong
to XXXXXX when such goods are provided to the carrier designated by XXXXXX
responsible for transporting the Licensed Product from IMI's place of
manufacture or supply.
8.4 Payments to IMI for the Purchase Price of the Licensed Product shall
be made by XXXXXX within thirty (30) days after the earlier of (i) the date of
shipment thereof to the destination specified by XXXXXX and (ii) the date of
shipment contemplated in the original purchase order or commitment provided by
XXXXXX as contemplated in Sections 6.3 and 6.4 (if the Licensed Products are
available for shipment but XXXXXX requests that delivery be delayed for any
reason), except as to the Licensed Product orders which do not conform to the
Specifications.
23
8.5 IMI and XXXXXX shall cooperate in identifying and implementing
raw material and manufacturing improvements that result in increased Licensed
Product production efficiencies and capabilities, subject to ensuring that such
improvements are in compliance with applicable regulatory and governmental
approvals and permits. ***** The Purchase Price for the Licensed Product shall
be adjusted accordingly to reflect any such cost savings/improvements and shall
be effective upon the implementation of such improvements. *****
8.6 *****
ARTICLE IX
PACKAGING AND LABELING
9.1 All Licensed Product supplied by IMI to XXXXXX shall be in the finished
goods format as set out in the Specifications, including, but not limited to,
package sizes, shapes and formats. XXXXXX will work with IMI to develop
packaging and labeling that is suitable and in compliance with applicable
government and regulatory regulations and requirements. XXXXXX has the
discretion to establish Specifications for packaging, labeling, and finished
goods format provided that such Specifications would conform to the foregoing
regulations and requirements. XXXXXX shall be responsible for ensuring that such
Specifications are in compliance with the foregoing regulations and
requirements.
9.2 IMI agrees to xxxx, affix, label or otherwise use XXXXXX'x trademarks,
tradenames and tradedresses on the Licensed Products and its bulk packaging in
such manner as XXXXXX may reasonably request and, in this regard, IMI is hereby
granted a non-exclusive license, sublicensable to all of IMI's manufacturers and
suppliers, to use the same for such purpose. IMI shall not use any markings,
logos, legends, labels or notices whatsoever on the Licensed Product
24
or its packaging except as may be authorized in advance in writing by XXXXXX.
XXXXXX shall reimburse IMI for all costs associated with matters contemplated in
this Section.
ARTICLE X
INSPECTION
10.1 Acceptance of the Licensed Product ordered by XXXXXX shall be subject
to inspection and approval by XXXXXX'x quality assurance personnel or such other
technical representatives as XXXXXX may select, with respect to whether each
order of the Licensed Product conforms to the applicable Specifications.
10.2 XXXXXX shall, as promptly as practical, but not more than fifteen (15)
working days after actual receipt of a Licensed Product order, notify IMI of its
disapproval, if any, of samples of the Licensed Product inspected and its
non-acceptance of the Licensed Product order in the event XXXXXX is of the
opinion that a Licensed Product sample fails to conform to the Specifications.
The foregoing time period is not intended to include Licensed Product which
contains a latent defect which has not been caused by XXXXXX.
10.3 IMI shall, within thirty (30) days after it is determined that any
Licensed Product does not conform to the applicable Specifications, replace any
Licensed Product not conforming to the applicable Specifications (unless such
defect is due to any negligent or wrongful act or omission by XXXXXX or its
agents or subcontractors). If XXXXXX shall previously have paid for the Licensed
Product being replaced, then the replacement shall be at IMI's cost and expense,
including shipping costs. XXXXXX'x remedy for the delivery by IMI of Licensed
Product which does not conform to the Specifications and which has not caused
damages to any third party is to require that IMI replace such Licensed Product.
If XXXXXX shall not have previously paid for the Licensed Product being
replaced, then XXXXXX shall be obliged to pay for the replacement
25
Licensed Product on the same terms and conditions as if originally delivered in
accordance with the Specifications. IMI shall be responsible for all costs
related to the return or destruction of the nonconforming Licensed Product.
Notwithstanding the foregoing, any non-conformance relating to the performance
of the Licensed Product in accordance with the Specifications shall be reported
to IMI within the time period set out in Section 10.2.
10.4 If XXXXXX alleges that any Licensed Product does not conform to the
applicable Specifications. it shall give written notice thereof to IMI as herein
contemplated, which notice shall contain such information as required by the
"Non-Conforming Notice" attached as Appendix X. XXXXXX shall not return any such
Licensed Product to IMI or its manufacturer except as permitted hereunder. Upon
receipt by IMI of the Non-Conforming Notice, IMI shall deliver to XXXXXX a
"returned goods authorization form" attached as Appendix M, executed by IMI,
containing instructions and directions as to the disposition of the Licensed
Product which XXXXXX alleges does not conform to the applicable Specifications.
If IMI requires that such products be returned or destroyed by XXXXXX, such
return or destruction shall be at IMI's expense including shipping costs.
10.5 XXXXXX'x right to inspect and right to replacement of the Licensed
Product not conforming to applicable Specifications shall not preclude XXXXXX
from exercising or enforcing any other rights or remedies it may have to redress
any loss or damage resulting from IMI's failure to timely supply the Licensed
Product conforming to the Specifications.
ARTICLE XI
WARRANTIES AND INDEMNITIES
11.1 IMI warrants that it has the unencumbered right to convey the rights
granted by this Agreement.
26
11.2 IMI warrants that all Licensed Product when supplied to XXXXXX shall
conform to and shall be produced in compliance with all relevant US FDA
requirements and with all applicable Canadian federal, provincial, and local
government and regulatory requirements and the Specifications.
11.3 IMI warrants that, to its knowledge as of the Effective Date (without
having made any additional enquiries beyond its actual knowledge), the
manufacture, importation, use and sale of the Professional Product (in its
currently intended embodiment) does not infringe the patents of any third party
in Canada.
11.4 IMI represents and warrants that the intellectual property rights
licensed or made available to XXXXXX hereunder are all intellectual property
rights owned by IMI or to which IMI has a valid license that relate to the
Licensed Technology.
11.5 IMI warrants that it has not granted any license, right or interest in
or to any Licensed Product, or any method of manufacture thereof, to any third
party relating to Licensed Products which are to be marketed in the Territory,
other than licenses for the purposes of manufacturing for IMI.
11.6 IMI agrees to indemnify and hold XXXXXX and its Affiliates harmless
against any action, claims, damages, injuries, losses, costs and expenses
(including reasonable attorney's fees and disbursements) arising from or alleged
or claimed to arise from (i) personal injury, death or property damage sustained
by any person resulting from any intentionally wrongful act or omission or sole
negligence of IMI or its employees or agents in performing services specified in
this Agreement; (ii) personal injury, death or property damage sustained by any
person resulting from use of the Licensed Product manufactured or supplied by
IMI unless such arises solely from a negligent or intentionally wrongful act or
omission by XXXXXX or its Affiliates,
27
employees or agents; or (iii) any material breach by IMI of its obligations or
warranties under this Agreement.
11.7 XXXXXX agrees to indemnify and hold IMI and its Affiliates harmless against
any actions, claims, damages, injuries, losses, costs and expenses (including
reasonable attorney's fees and disbursements) arising from or alleged or claimed
to arise from (i) any material breach by XXXXXX of its obligations or warranties
under this Agreement; or (ii) personal injury, death or property damage
sustained by any person resulting from any intentionally wrongful act or
omission or sole negligence of XXXXXX or its Affiliates, employees or agents.
11.8 A party seeking indemnification hereunder agrees to give prompt written
notice to the indemnifying party after the receipt of any written notice of the
commencement of any action, suit, proceeding or investigation or threat thereof
made in writing for which such party will claim indemnification pursuant to this
Agreement provided that the failure to so notify will relieve the indemnifying
party from liability to the extent it has been prejudiced by such failure.
11.9 IMI recognizes that XXXXXX and its Affiliates have been actively involved
in investments and developments in the fields of cardiac risk assessment and
cardiac health and in the investigation of entries into such fields. XXXXXX and
its Affiliates intend to continue with such activities and make no
representation or warranty that it will be able to successfully market any
Licensed Product under this Agreement or that Licensed Product will be the
exclusive means by which XXXXXX and its Affiliates may participate in these
fields. IMI agrees that the activities and services that XXXXXX undertakes under
Sections 2.4 and 2.5, the royalties provided for in Article III, and the other
covenants of XXXXXX contained in this Section 11.9, herein, are full
consideration for the licenses granted herein. Furthermore, all business
decisions including, without limitation, the sale, price and promotion of
Licensed Product in the Territory and the
28
decision whether to sell a particular Licensed Product shall be within the sole
discretion of XXXXXX. IMI and XXXXXX further agree that the activities and
services that XXXXXX undertakes under Sections 2.4 and 2.5 and the termination
provisions provided for under Section 17.4, herein, are in lieu of any
obligation of any specific level or standard of efforts to be used by XXXXXX in
the marketing of Licensed Products.
11.10 Except for the express warranties or representations contained in this
Agreement, each party hereby disclaims all warranties, conditions or
representations, express, implied or statutory, to the other party hereto, with
respect to any products, services, content or other materials provided by such
party hereunder relating to merchantability or fitness for a particular purpose
other than in respect of such uses and purposes as are permitted under
applicable regulatory licenses. Notwithstanding any other provision hereof,
under no circumstances shall either party be liable to the other for any
consequential, incidental, indirect, punitive or special damages arising from or
in any way out of this Agreement or the services to be provided hereunder,
however caused, whether arising under a theory of contract, tort (including
without limitation negligence) or otherwise including without limitation damages
for lost profits, revenues, business or goodwill, whether or not such party has
been advised of the possibility of such damages.
11.11 The provisions and obligations of this Article XI shall survive expiration
or any termination of this Agreement.
ARTICLE XII
INSURANCE
12.1 IMI shall obtain and maintain at all times during the term of this
Agreement Comprehensive General Liability Insurance, including Products
Liability, with limits of liability of not less than One Million Dollars
($1,000,000). IMI shall
29
provide XXXXXX with a Certificate of Insurance evidencing this coverage within
thirty (30) days following written request by XXXXXX.
ARTICLE XIII
PRODUCT RECALLS
13.1 In the event of a recall of the Licensed Product required by a governmental
agency or authority of competent jurisdiction or if recall of the Licensed
Product is considered by XXXXXX to be advisable, such recall shall be promptly
implemented and administered by XXXXXX in a manner which is appropriate and
reasonable under the circumstances and in conformity with accepted trade
practices. The costs of any such recall shall be borne by the party or parties
whose actions caused the recall to be necessary (provided that if the recall is
initiated by XXXXXX in circumstances where it considers that such recall is
advisable but where the recall is not suggested by governmental agency or
authority of competent jurisdiction or due to non-compliance with applicable
Specifications, the costs of such recall shall be borne by XXXXXX).
13.2 The provisions and obligations of this Article XIII shall survive any
termination of this Agreement.
ARTICLE XIV
PATENTS AND TRADEMARKS
14.1 IMI agrees to prosecute or cause to be prosecuted the applications for
patents included in the Licensed Patents, maintain such Licensed Patents, and
defend, at its option, against any action by any third party for invalidation or
revocation of any Licensed Patent. IMI shall notify XXXXXX in the event IMI (A)
decides to abandon or discontinue the prosecution in the Territory of any patent
application included in the Licensed Patents; (B) decides not to pay the
maintenance fee in the Territory due on any patent application or patent
included in the Licensed
30
Patents; or (C) decides not to defend against any action by any third party for
invalidation or revocation of any patent application or patent included in the
Licensed Patents insofar as such Licensed Patents relate to the Territory. Such
notice to XXXXXX shall be sufficiently in advance of any abandonment,
discontinuance, maintenance fee due date, or response date so as to give XXXXXX
reasonable time to consider and exercise the following option:
14.1.1 XXXXXX shall have the option, exercisable upon written notice to
IMI, to assume full responsibility for the prosecution of the affected
application in the Territory, to pay the maintenance fees due on the patent
application or patent in the Territory, or to defend against such third
party action insofar as such action relates to the Territory. In such
circumstances, IMI agrees to assign to XXXXXX any such subject patent or
patent application.
14.2 If IMI or XXXXXX become aware of any infringement in the Territory by a
third party of any issued patent included in Licensed Patents, that party shall
promptly notify the other party in writing to that effect. IMI shall have the
right, but not the obligation, to initiate a suit relating to such infringement.
If IMI determines to initiate such a suit, IMI shall bear all the expenses of
any suit brought by it and shall retain all damages or other moneys awarded or
received in settlement of such suit. XXXXXX will cooperate with IMI in any such
suit and shall have the right to consult with IMI and be represented by its own
counsel at its own expense.
14.2.1 If, after the expiration of said one hundred and twenty (120) days
from the date of said notice, IMI has not obtained a discontinuance of such
infringement, or brought suit against the third party infringer, then
XXXXXX shall have the right, but not the obligation, to bring suit against
such infringer and join IMI as a party plaintiff, provided that XXXXXX
shall bear all the expenses of such suit (and shall reimburse IMI for all
expenses
31
(excluding legal expenses) incurred by it in connection with such suit, if
any) and shall retain all damages or other moneys awarded or received in
settlement of such suit. Any such suit shall relate solely to the Territory
and shall not extend to any territory outside the Territory. IMI will
cooperate with XXXXXX in any suit for infringement in the Territory of any
infringement of a patent of the Licensed Patents brought by XXXXXX against
a third party, and shall have the right to consult with XXXXXX and to
participate in and be represented by independent counsel in such litigation
at its own expense (except as contemplated in the immediately preceding
sentence or if IMI's involvement in such litigation is necessary as a
result of XXXXXX having initiated the suit). XXXXXX shall incur no
liability to IMI as a consequence of such litigation or any unfavorable
decision resulting therefrom, including any decision holding the patent
invalid or unenforceable.
14.3 In the event IMI or XXXXXX learn that the making, using or selling of
Licensed Product infringes, will infringe or is alleged by a third party to
infringe, in the Territory, a third party patent, the party becoming aware of
same shall promptly notify the other. IMI and XXXXXX shall thereafter attempt to
agree upon a course of action which may include: (a) modifying of the Licensed
Product or its use and manufacture so as to be non-infringing; or (b) obtaining
a license or assignment from said third party. In the event IMI or XXXXXX cannot
agree on modifying the Licensed Product pursuant to the foregoing sentence, (and
whether or not IMI or XXXXXX have received notice from a third party alleging
that the making, importing, using or selling of Licensed Product infringes or
will infringe, in the Territory, a third party patent), IMI shall in the first
instance have the right to negotiate with said third party for such license or
assignment in a territory including the Territory. In the event that such
negotiation results in a consummated agreement, then (i) all costs associated
with any lump sum payment and/or royalties to be paid
32
thereunder shall, when paid, be shared equally by IMI and XXXXXX and (ii) such
licensed patents shall be included in the definition of Licensed Patents only to
the extent that such licensed patents relate to the measurement of skin
cholesterol. In the event that such negotiation results in a consummated
agreement with XXXXXX, then any lump sum payment and/or royalties to be paid
thereunder shall be paid by XXXXXX, in which case XXXXXX shall set off royalties
paid to one or more of those third parties against the royalties due under
Article III, by an amount equal to the amount paid to those third parties up to
a maximum of one-half (1/2) of the royalties due IMI. If any dispute arises
between IMI and XXXXXX relating to this Section 14.3.1, XXXXXX may escrow the
set-off of royalties to be paid during the pendency of any dispute resolution.
14.4 XXXXXX and its Affiliates may advertise, promote, market and sell the
Licensed Product in the Territory under any trademark(s), tradename(s) and
tradedress of their own choosing provided that they have rights at law to use
such trademark(s), tradename(s) and tradedress. IMI shall not acquire any right,
title or interest whatsoever in or to any such trademark(s), tradename(s) or
tradedress by virtue of such use by XXXXXX and its Affiliates. So long as XXXXXX
or its Affiliates shall have any interest in and to any such trademarks,
tradenames or tradedress, whether as proprietor, owner, licensee, or licensor in
any country of the world, IMI shall not adopt, use, apply for registration,
register, own or acquire any such trademarks, tradenames or tradedress, or any
xxxx, name or tradedress confusingly similar thereto, in any state or country of
the world.
14.5 In the event XXXXXX or IMI learn that any XXXXXX trademark, tradename or
tradedress used in connection with the advertising, promotion, marketing or sale
of the Licensed Product in the Territory is being infringed by a third party, it
shall promptly notify the other of such infringement. XXXXXX shall exclusively
be responsible for taking any action to terminate such infringement of their
respective trademarks at their sole discretion.
ARTICLE XV
CONFIDENTIALITY
15.1 Disclosures of confidential information hereunder by either party to the
other shall be made in writing (or confirmed in writing within one month if made
in another form), and shall be clearly marked "Confidential". Such confidential
information shall be safeguarded by the
33
recipient, shall not be disclosed to third parties and shall be made available
only to recipient's employees or independent contractors who agree in writing to
conditions equivalent to those in this Article XV and who have a need to know
the information for the purposes specified under this Agreement, subject to the
provisions of Section 15.3. All confidential information shall remain the
property of and be returned to the disclosing party within thirty (30) days of
receipt of a written request by the disclosing party, or within thirty (30) days
of termination of this Agreement. However, each party's counsel may retain one
copy of these documents for archival purposes to be used to monitor compliance
herewith and in respect of any litigation relating to the provisions of this
Agreement including the provisions of this Article. All confidential information
shall only be used for the purposes contemplated in this Agreement. These mutual
obligations of confidentiality shall not apply to any information that:
(i) is or hereafter becomes generally available to the public other
than by reason of any default with respect to a confidentiality obligation
by the recipient to the disclosing party; or
(ii) was already known to the recipient as evidenced by prior written
documents in its possession; or
(iii) is disclosed to the recipient by a third party who is not in
default of any confidentiality obligation to the disclosing party
hereunder; or
(iv) is developed by or on behalf of the receiving party, without
reliance on confidential information received hereunder; or
(v) has been approved in writing for publication by each of the
parties.
15.2 Notwithstanding the restrictions of Section 15.1 hereinabove, IMI and
XXXXXX may disclose such portions of the confidential information that:
34
(i) are provided to third parties under appropriate terms and
conditions including confidentiality provisions equivalent to those in this
Agreement for consulting, manufacturing development, manufacturing,
external testing and marketing trials with respect to the Licensed
Products; or
(ii) are used with the consent of the disclosing party (which consent
shall not be reasonably withheld) in applications for patents or copyrights
under, and as specifically permitted under, the terms of this Agreement; or
(iii) are required to be disclosed in compliance with applicable laws
or regulations in connection with the manufacture or sale of Licensed
Products; or
(iv) are otherwise required to be disclosed in compliance with
applicable laws or regulations or order by a court or other regulatory body
having competent jurisdiction; or
(v) are product-related information that is reasonably required to
be disclosed in connection with marketing of Licensed Products.
In making such disclosures under this Section 15.2 (other than pursuant to
subsection (i) thereof), the disclosing party shall obligate the recipient to
secrecy, if possible.
15.3 Notwithstanding the restrictions of Section 15.1 hereinabove, XXXXXX and
IMI may disclose confidential information to their employees, consultants,
advisors and subcontractors who are engaged directly or indirectly in the
manufacture, use or sale of the Licensed Product who have first been instructed
to maintain such confidential information in confidence and who have agreed in
writing to conditions equivalent to those in this Article XV. For the avoidance
of doubt, however, XXXXXX and IMI shall be free to disclose the existence of
this Agreement and
35
the nature of the licenses granted hereunder to its Affiliates and prospective
sublicensees with an appropriate obligation of confidentiality and non-use.
15.4 With respect to information disclosed on or after the Effective Date
between XXXXXX and IMI under the provisions of this Agreement, the provisions of
the Agreement shall govern and prevail. In the event of any conflict between
this Agreement and the Confidentiality Agreement, with respect to information
disclosed on or after the Effective Date, the terms of this Agreement shall
govern and prevail.
15.5 The conditions and restrictions of this Article XV shall remain in force
during the term of this Agreement and for ten (10) years thereafter, surviving
the termination of this Agreement.
ARTICLE XVI
CONTRACTUAL RELATIONSHIP
16.1 The relationship of the parties under this Agreement is that of independent
contractors and not as agents of each other or partners or joint venturers, and
neither party shall have the power to bind the other in any way with respect to
any obligation to any third party unless a specific power of attorney is
provided for such purpose. Each party shall be solely and exclusively
responsible for its own employees and operations.
ARTICLE XVII
TERM AND TERMINATION
17.1 This Agreement shall become effective upon the Effective Date. The
Agreement shall remain effective, subject to any renewals, in full force and
effect until it expires on the day following the fifteenth (15th) anniversary of
the Effective Date unless earlier terminated in accordance with any of the
provisions of this Article XVII.
36
17.2 This Agreement may be renewed for an additional five (5) year period,
unless earlier terminated in accordance with any of the provisions of this
Article XVII. The parties will complete the negotiation of terms for such
renewal at least 180 days prior to the expiration of this Agreement.
17.3 XXXXXX may terminate this Agreement at any time prior to XXXXXx'x first
commercial sale of Licensed Product in the Territory upon thirty (30) days
prior written notice to IMI and thereafter, upon ninety (90) days prior
written notice to IMI.
17.4 IMI may terminate:
17.4.1 the provisions of this Agreement relating to the Professional
Field if:
i) by the first anniversary of the Effective Date, XXXXXX has
not had any Net Sales of any Licensed Product in the
Professional Field or Territory, or
ii) in any subsequent calendar year commencing after the first
anniversary of the Effective Date, XXXXXX has not had Net
Sales of any Licensed Product in the Professional Field in
the Territory of at least *****.
iii) at any time XXXXXX or any of its Affiliates is marketing or
otherwise distributing in the Professional Field in the
Territory a cardiac risk predictor that measures skin
cholesterol,
whereupon Licensed Fields, as defined in Section 1.1 above,
will exclude the Professional Field;
17.4.2 the provisions of this Agreement relating to the Consumer Field
if:
i) by the first anniversary of the date upon which IMI
receives regulatory approval for the marketing of the a
Licensed Product in the Consumer Field, XXXXXX has not had
any Net Sales of any Licensed Product in the Consumer
Field in the Territory, or
ii) in any subsequent calendar year commencing after the first
anniversary of the Effective date, XXXXXX has not had Net
Sales of any Licensed Product in the Consumer Field in the
Territory of at least *****, or
iii) at any time XXXXXX or any of its affiliates is marketing or
otherwise distributing in the Consumer Field in the
Territory a cardiac risk predictor that measures skin
cholesterol;
whereupon Licensed Fields, as defined in Section 1.1 above,
will exclude the Consumer Field,
17.4.3 the provisions of this Agreement relating to the Nutraceutical
Field if:
i) by the first anniversary of the date upon which IMI
receives regulatory approval for the marketing of the a
Licensed Product in the Consumer Field, XXXXXX has not had
any Net Sales of any Licensed Product in the Nutraceutical
Field in the Territory, or
ii) in any subsequent calendar year commencing after the first
anniversary of the Effective Date, XXXXXX has not had Net
Sales of any Licensed Product in the Consumer Field in the
Territory of at least *****, or
iii) at any time XXXXXX or any of its Affiliates is marketing or
otherwise distributing in the Nutraceutical Field in the
Territory a cardiac risk predictor that measures skin
cholesterol;
whereupon Licensed Fields, as defined in Section 1.1 above,
will exclude the Nutraceutical Field; or
17.4.4 the provisions of this Agreement relating to the Laboratory Field
if:
i) in any year (and in succeeding years) ending on the
anniversary of the date on which the option contemplated in
Section 3.2 is exercised, XXXXXX has not had Net Sales of
at least ***** related to any Licensed Product in the
Laboratory Field in the Territory, or
ii) at any time XXXXXX or any of its Affiliates is marketing or
otherwise distributing in the Laboratory Field in the
Territory a cardiac risk predictor that measures skin
cholesterol;
whereupon Licensed Fields, as defined in Section 1.1 above,
will exclude the Laboratory Field (notwithstanding any
other provision hereof including, without limitation,
Section 3.2).
37
17.5 IMI may terminate this Agreement, except as limited hereinafter,
immediately upon written notice, in the event:
17.5.1 XXXXXX fails to make any payment due and owing within fifteen (15)
days after notice thereof; or
17.5.2 XXXXXX commits a breach of any material provision of this Agreement
that is not cured within sixty (60) days after notice thereof if such
breach is curable.
17.6 XXXXXX may terminate this Agreement immediately upon written notice in the
event IMI commits a breach of any material provision of this Agreement which is
not cured within sixty (60) days after notice thereof.
17.7 The rights of termination set forth in Sections 17.5 and 17.6 hereinabove,
however, cannot be exercised by IMI or XXXXXX, as the case may be, if at any
time during said sixty (60) day period, XXXXXX or IMI, as the case may be,
advises the other party in writing that it challenges the alleged payment owed
or the alleged breach. In such event, the parties will negotiate in good faith
to resolve the dispute concerning the alleged payment owed or the alleged
breach.
17.8 Either party may terminate this Agreement if the other party is declared
insolvent or bankrupt by a court of competent jurisdiction, or files a voluntary
petition of bankruptcy in any court of competent jurisdiction, or shall make or
execute an assignment of substantially all its assets for the benefit of
creditors. However, the parties agree that IMI has transferred exclusive,
proprietary rights and interest in the Licensed Patents in the Territory to
XXXXXX under this Agreement.
17.9 Termination of this Agreement for any cause shall not release either party
from any obligation theretofore accrued.
38
17.10 The failure on the part of either party to exercise or enforce any right
conferred upon it hereunder shall not be deemed to be a waiver of any such
right, or any other right conferred hereunder, nor operate to bar the exercise
or enforcement thereof at any time thereafter.
17.11 Upon termination of this Agreement for any reason,
17.11.1 IMI shall fill all binding orders of XXXXXX for the Licensed
Product which were placed prior to the date of notice of termination given
by IMI pursuant to this Agreement (or place prior to the effective date of
the termination if notice is given by XXXXXX hereunder), unless otherwise
instructed by XXXXXX; and -.
17.11.2 XXXXXX shall have the right to sell any Licensed Product in its
inventory provided XXXXXX pays to IMI the applicable royalty, if any. This
Section 17.11 shall survive termination or expiration of this Agreement.
ARTICLE XVIII
MISCELLANEOUS PROVISIONS
18.1 The rights and obligations of IMI and XXXXXX under this Agreement are
personal thereto and neither party shall have the right to sublicense, assign,
transfer or delegate, in whole or in part, any of its rights or obligations
hereunder to any third party without the prior written consent of the other
party except that either party may assign this Agreement to any Affiliate
provided that the assignor guarantees all of the covenants and obligations of
such Affiliate arising pursuant to such assignment.
18.2 {intentionally deleted}
18.3 Notwithstanding Section 18.1, XXXXXX shall have the right to sublicense
all or part of its rights and obligations under this Agreement only to its
Affiliates (which shall not have the right to further sublicense such rights and
obligations) upon sixty (60) days prior written notice to IMI,
39
provided that in any event XXXXXX guarantees all of the covenants and
obligations of such Affiliate arising pursuant to such sublicense.
18.4 The illegality, invalidity, or otherwise voidability or unenforceability
of any provision of this Agreement shall not impair, affect or invalidate the
other provisions of this Agreement. In the event that any part, section, clause,
paragraph or subparagraph of this Agreement shall be held to be indefinite,
invalid, illegal or otherwise voidable or unenforceable, the entire agreement
shall not fail on account thereof, and the balance of the Agreement shall
continue in full force and effect. The parties shall replace such illegal or
invalid provisions with a valid and enforceable provision which most closely
approaches the idea, intent, and purpose of this Agreement, and in particular,
the provision to be replaced.
18.5 Any notice required or permitted under this Agreement shall be deemed to
have been sufficiently provided and effectively made (i) as of the delivery date
if hand-delivered in person or by a reputable courier service, (ii) as of the
delivery date if delivered by facsimile transmission (provided that if the
transmission occurs on a day other than a day on which the main branches of
chartered banks are open for business in the City of Toronto or after 5:00 p.m.
on any day, then the facsimile transmission shall be deemed to be delivered on
the next day on which such branches are open for business in the City of
Toronto), or (iii) as of the fifth day following the mailing date if mailed by
registered mail, postage-prepaid, and addressed to the receiving party at the
following respective address:
XXXXXX PDI INC.
XXXXXX CONSUMER HEALTHCARE
000 Xxxxxxxx Xxxx Xxxx
Xxxxxx, Xxxxxxx
NIK lA5
Attn: President
Facsimile: 000-000-0000
40
With a copy to:
XXXXXXX & XXXXXXX
Xxx Xxxxxxx & Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, XX 00000
Attn: Chief Patent Counsel
Facsimile: 000-000-0000
IMI INTERNATIONAL MEDICAL INNOVATIONS INC.
Xxxxx 000
0000 Xxxxx Xxxxxx
Xxxxxxx, Xxxxxxx
X0X 0X0
Xxxxxx
Attn: Chief Financial Officer
Facsimile: (000) 000-0000
or such other address which the receiving party has given notice pursuant to the
terms of this Section 18.5.
18.6 Neither party shall, without the other party's prior written consent, make
any announcement or other disclosure regarding this Agreement or that any
business relationship exists between the parties except as may be required
pursuant to applicable securities legislation (as interpreted and advised in
good faith by counsel to the disclosing party).
18.7 This Agreement represents the entire understanding between XXXXXX and IMI,
and supersedes all other understandings and agreements, express or implied, not
specifically referenced and incorporated herein, concerning the Licensed
Product. Any modification of this Agreement to be effective must be in writing,
specifically refer to this Agreement, and be signed by both parties.
18.8 Any delays in or failures of performance by a party under this Agreement
shall not be considered a breach of this Agreement if and to the extent caused
by occurrences beyond the reasonable control of the party affected, including
but not limited to: acts of terrorism, acts of God; acts, regulations or laws of
any government; strikes or other concerted acts of workers;
41
fires; floods; explosions; riots; wars; rebellions; and sabotage; and any time
for performance hereunder shall be extended by the actual time of delay caused
by such occurrence.
18.9 This Agreement shall be interpreted and applied in accordance with the
laws of the Province of Ontario, Canada. The parties hereby irrevocably attorn
to the non-exclusive jurisdiction of the courts of such province.
18.10 Il est convenu par le present acte que les deux parties demandent que ce
contrat et tout avis, consentement, autorisation, communication et approbation
soient rediges en langue anglaise. It is hereby agreed that both parties
specifically require that this Agreement and any notices, consents,
authorizations, communications and approvals be drawn up in the English
language.
18.11 The parties agree that time shall not be of the essence of this Agreement
or any matter contemplated herein other than the provisions of Article XV II.
IN WITNESS WHEREOF, the parties have duly executed this Agreement as of the day
and year first written above.
XxXXXX PDI INC.
(acting through its XxXXXX Consumer Healthcare
division on behalf of XxXxxx PDI Inc.)
By: /s/ Xxxxx Xxxxxx
--------------------------------
Name: Xxxxx X. Xxxxxx
Title: President
Authorized Signing Officer
IMI INTERNATIONAL MEDICAL INNOVATIONS INC.
By: /s/ Xxxxx Xxxxxx
---------------------------------
42
Name: X. Xxxxxx
Title:President and C.E.O.
Authorized Signing Officer
43
APPENDIX A
Clinical Development Program for Cholesterol 1,2,3
Professional System
Clinical Trials in Progress
1. Non-Invasive Evaluation of Skin Cholesterol Levels with Avasimibe
Therapy (A-Plus)
. 250 patients, 10 sites
. Assess the effect of Avasimibe on Cholesterol 1,2,3 values
over time
2. To Determine Whether Skin Cholesterol Can be Used to Measure
Compliance with Statin Therapy (Statin Compliance)
. 100 patients, 1 site (The Cleveland Clinic Foundation,
Cleveland, Ohio)
. To determine if Cholesterol 1,2,3 can monitor a response to
statin therapy
3. Multi-Ethnic Study of Atherosclerosis (MESA)
. 6500 patients, 6 sites (Currently Cholesterol 1,2,3 is used
at only one site (John's Xxxxxxx) but may be expanded to
others)
. To assess ethnic, age, and gender differences in subclinical
disease prevalence, risk of disease progression and clinical
CVD
4. To Determine whether Skin Cholesterol Measurement in Children with
Hyperlipidemia is Elevated (Pediatric)
. 50 patients, I site (St. Joseph's Hospital, Xxxxxxxx
Ontario)
. To determine if' hyperlipidemic children have higher skin
cholesterol levels than nomolipidemic children
5. Non-Invasive Evaluation of Skin Cholesterol levels with Warfarin
Therapy (Wave)
. 200 patients, I site (The Xxxxxxxx General Hospital,
Hamilton, Ontario
. Patients are placed on Warfarin therapy. Skin Cholesterol is
tested at baseline and after one and 2.5 years to see
whether skin cholesterol can predict cardiac events
--------------------------------------
Trials under IMI's Control
. Statin Compliance - In Progress
(degree)Completed Q3/2002
(degree)Results Q4/2002
. Pediatric - In Progress
(degree)Completed Q3/2002
(degree)Results Q4/2002
. Wave - In Progress
(degree)Completed Q2/2003
(degree)Results Q3/2003
--------------------------------------
--------------------------------------
Trials not under IMI's Control
. A-Plus-In Progress
(degree)Completed Q3/2003
(degree)Results Q4/2003
. MESA - In Progress
(degree)Completed 2010
(degree)Results 2010
--------------------------------------
00
XXXXXXXX X
Skin Cholesterol Consumer Product Development Plan
*****
00
XXXXXXXX X
Skin Cholesterol Consumer Product Development Plan
Products Under Development
*****
46
APPENDIX C
IMI Patent Estate and Status
------------------------------------------------------------------------------------------------------------------------------------
Patent Official Filing Title Inventors Jurisdiction Patent Filing Date Expiry Date
Status Number
------------------------------------------------------------------------------------------------------------------------------------
Granted Method for Visual Indication of Jury X. Xxxxxxxx, United States 5,489,510 Feb 9, 1993 Feb 6, 2013
Cholesterol on Skin Surface Xxxxxx X. Zuevsky,
Agents Used Therefore and Xxxxxxxxx X. Xxxxxxxx,
Methods for Producing Xxxxx X. Xxxxxxxxx
------------------------------------------------------------------------------------------------------------------------------------
Granted Method for Producing Jury X. Xxxxxxxx, United States 5,587,295 July 19, 1994 Dec 24, 2013
Affino-enzymatic Compounds and Xxxxxx X. Zuevsky,
Visualizing Agent and Xxxxxxxxx X. Xxxxxxxx,
Application Thereof Xxxxx X. Xxxxxxxxx
------------------------------------------------------------------------------------------------------------------------------------
Granted Method for Producing Jury X. Xxxxxxxx, Canada 1,335,968 January 19, 1989 June 20, 2012
Affinity-enzymatic Compounds for Xxxxxx X. Zuevsky,
Visual Indication of Cholesterol Xxxxxxxxx X. Xxxxxxxx,
on Skin Surface Xxxxx X. Xxxxxxxxx
------------------------------------------------------------------------------------------------------------------------------------
Granted Method of Producing Jury X. Xxxxxxxx, Europe 0 338 189 January 19, 1988 April 24, 2013
Affinity-enzymatic Compounds for Xxxxxx X. Zuevsky,
the Visual Detection of Xxxxxxxxx X. Xxxxxxxx,
Cholesterol on the Surface of Xxxxx X. Xxxxxxxxx
the Skin of a Patient based on a
Detecting Agent with any
Affinity for Cholesterol and a
Visualizing Agent
------------------------------------------------------------------------------------------------------------------------------------
Granted Multilayer Analytical Element Xxxxxxxxx X. Maleev Australia 702663 December 14, 1995 December 14, 2015
------------------------------------------------------------------------------------------------------------------------------------
Granted Multilayer Analytical Element Xxxxxxxxx X. Maleev Korea 97-704028 December 14, 1995 December 14, 2005
------------------------------------------------------------------------------------------------------------------------------------
47
-----------------------------------------------------------------------------------------------------------------------------
Patent Official Filing Title Inventors Jurisdiction Patent Filing Date Expiry Date
Status Number
-----------------------------------------------------------------------------------------------------------------------------
Granted Method of Determining Skin Xxxxxxxxx X. Xxxxxxxx USA 6,365,363 August 20, 1999 April 2, 2019
Tissue Cholesterol Jury X. Xxxxxxxx
-----------------------------------------------------------------------------------------------------------------------------
Pending Multilayer Analytical Element Xxxxxxxxx X. Maleev PCT CA95/00698 December 14, 1995 N/A
Brazil PI95/0038-5
Canada 2,207,555
China 95197367.3
Europe 95940097.9
Japan XX0-0-00000
Xxxxxx 000000
XXX 08/849,252
-----------------------------------------------------------------------------------------------------------------------------
Pending ***** Xxxxxxxxx X. Xxxxxxxx PCT RU98/00010 January 26, 1998 N/A
Jury X. Xxxxxxxx Brazil PI9807594-2
Europe 98901608.4
Japan 10-536529
Canada 2281769 February 20, 1997
Russia 97102570
-----------------------------------------------------------------------------------------------------------------------------
Pending ***** Xxxxxxx Xxxxxxx PCT CA00/00918 August 4, 2000 N/A
Australia
Brazil PI0013096-6
China
Europe 00954181.4
India
Japan 2001-515964
Russia
USA 09/830708
-----------------------------------------------------------------------------------------------------------------------------
48
APPENDIX D
IMI Trademark Status
---------------------------------------------------------------------------------------------------
Pending Xxxx Date Filed Application # Status
---------------------------------------------------------------------------------------------------
Canada Cholesterol 1,2,3 02/22/2000 1,047,894 Granted
---------------------------------------------------------------------------------------------------
United States Cholesterol 1,2,3 03/21/2000 76/006,213 Pending
---------------------------------------------------------------------------------------------------
European Union Cholesterol 1,2,3 07/10/2000 001747344 Granted
---------------------------------------------------------------------------------------------------
APPENDIX E
Professional Product Specifications
*****
50
*****
APPENDIX J
J&J Corporate Quality Systems Regulations
*****
51
APPENDIX K
Price Schedule for X-Rite Reader
*****
00
XXXXXXXX X
Xxxxxxxxx xx Xxx-Xxxxxxxxxx
*****
53
APPENDIX M
Returned Goods Authorization
To: XxXxxx Consumer Healthcare
--------------------------------------------------------------------------------------------------------------
Product
Quantity Product Code Description Lot # Details Action/Disposition
--------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------
Description of Action Required
Authorized By:
Date: ____________
54
