AMENDMENT TO LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT
Exhibit
4.12
Canadian
License Amendment
AMENDMENT
TO LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT
THIS
AMENDMENT AGREEMENT effective
as of December 9, 2005 is made by and between PREMD
INC. (previously
known as IMI
International Medical Innovations Inc.),
a corporation incorporated under the laws of Canada, and having its principal
place of business at Xxxxx 000, 0000 Xxxxx Xxxxxx, Xxxxxxx, Xxxxxxx, X0X 0X0,
Xxxxxx (hereinafter referred to as “PreMD”)
and XxXXXX PDI Inc., a corporation incorporated under the laws of Canada, with
and having its principal place of business at 000 Xxxxxx Xxxxxx, Xxxxxxxx,
Xxxxxx, Xxxxxx (acting through its XxXXXX Consumer Healthcare division)
(hereinafter referred to as “XxXXXX”).
XxXXXX
and PreMD may also be referred to as“Parties.”
Whereas:
A. The
Parties are parties to a License, Development And Supply Agreement dated as
of
May 9, 2002, as amended by agreement dated December 20, 2002 (the “Agreement”);
B.
The
Parties wish to waive certain rights and obligations they may have pursuant
to
certain provisions contained in the Agreement and to amend the provisions of
the
Agreement, in each case as specifically contemplated herein;
C. The
Parties are parties to a License, Development and Supply Agreement dated as
of
May 28, 2004 (the “International
Agreement”);
and
D. Capitalized
terms used herein which are not otherwise defined shall have their respective
meanings ascribed thereto in the Agreement.
NOW,
THEREFORE, in consideration of the mutual covenants and obligations contained
herein and for other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties agree as
follows:
Sales
Minimums
Professional
Product
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1.
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PreMD
hereby waives any rights which it may have pursuant to section 17.4.1
of
the Agreement as a result of XxXxxx’x not having the amount of Net Sales
of Licensed Products as contemplated thereunder provided
that:
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a.
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The
provisions of section 17.4.1(i) shall be
deleted;
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b.
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The
provisions of section 17.4.1(ii) shall be deemed to be amended by
deleting
the phrase “in any subsequent calendar year commencing after the first
anniversary of the Effective Date” and replacing it with “in any calendar
year commencing on and after 2005” and adding the following phrase at the
end of section 17.4.1(ii): “subject to the provisions of section
17.4.5”;
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Consumer
Product
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2.
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PreMD
hereby waives any rights which it may have pursuant to section 17.4.2
of
the Agreement as a result of XxXxxx’x not having the amount of Net Sales
of Licensed Products as contemplated thereunder provided
that:
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a.
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The
provisions of section 17.4.2(i) shall be deleted and replaced with
the
following:
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“i)
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by
the
end of the calendar year in which a Licensed Product is cleared for
sale
in Canada as a Consumer Product and when PreMD has made such product
available for sale to XxXxxx that meet the Consumer Product Specifications
agreed to by the Parties as defined in paragraph 2 c. hereto and
PreMD has
given XxXxxx notice in writing that all of the aforesaid conditions
have
been satisfied (the “Availability
Date”),
XXXXXX has not had Net Sales of such Consumer Products in an amount
equal
to at least the amount which results when *****; provided however,
that
the minimum Net Sales obligation set forth in this Section 17.4.2
(i)
shall not apply *****”
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b.
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The
provisions of section 17.4.2(ii) shall be deemed to be amended
by:
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i.
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Deleting
“first anniversary of the Effective date” and replacing it with
“Availability Date”); and
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ii.
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adding
the following phrase at the end thereof: “subject to the provisions of
section 17.4.5”;
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c. The
Parties acknowledge that as of the effective date of this Amendment, the Parties
have not established and agreed upon specifications for the Consumer Product
for
sale in the Consumer and Nutritional Fields. The Parties agree to use reasonable
efforts to mutually agree upon such specifications for the Consumer Product
in
writing. After such specifications have been mutually agreed upon by the
parties, such specifications will be attached hereto as Appendix A and made
a
part hereof (hereinafter referred to as the “Consumer Product Specifications”).
Nutraceutical
Field
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3.
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PreMD
hereby waives any rights which it may have pursuant to section 17.4.3
of
the Agreement as a result of XxXxxx’x not having the amount of Net Sales
of Licensed Products as contemplated thereunder provided
that:
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a.
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The
provisions of section 17.4.3(i) shall be deleted and replaced with
the
following:
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“i)
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by
the
end of the calendar year in which a Licensed Product is cleared for
sale
in Canada as a Consumer Product and when PreMD has made such product
available for sale to XxXxxx that meet the Consumer Product Specifications
agreed to by the Parties and PreMD has given XxXxxx notice in writing
that
all of the aforesaid conditions have been satisfied (the “Availability
Date”),
XXXXXX has not had Net Sales of Licensed Products in the Nutraceutical
Field in an amount equal to at least the amount which results *****
provided, however that the minimum Net Sales obligation set forth
in this
Section 17.4.3 (i) shall not apply
*****
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b.
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The
provisions of section 17.4.3(ii) shall be deemed to be amended
by:
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i.
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Deleting
“first anniversary of the Effective Date” and replacing it with
“Availability Date”); and
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ii.
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adding
the following phrase at the end thereof: “subject to the provisions of
section 17.4.5”;
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Laboratory
Field
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4.
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PreMD
hereby waives any rights which it may have pursuant to section 17.4.4
of
the Agreement as a result of XxXxxx’x not having the amount of Net Sales
of Licensed Products as contemplated thereunder provided
that:
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a.
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The
provisions of section 17.4.4(i) shall be deleted and replaced with
the
following:
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“i)
in
any year (and in succeeding years) after the earlier of:
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1.
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the
first commercial sale of the Tape Test (as defined in the International
Agreement) in the Laboratory Field ,
and
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2.
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the
date the Tape Test is cleared for sale in Canada and when product
is
available for sale to XxXxxx that meets the specifications set out
on
Appendix I to the International Agreement in respect of such Tape
Test
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(the
earlier of such times being herein referred to as the “Commencement
Date”)
XxXxxx has not had Net Sales of at least ***** related to any Licensed Product
in the Laboratory Field in the Territory, including at least ***** in Net Sales
in Canada relating to the Laboratory Field (or, in the case of the first partial
calendar year after the Commencement Date, at least the amount which results
when both such foregoing dollar amounts ***** after the Commencement Date);
provided however, that such minimum Net Sales obligation shall not apply
*****.
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5.
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The
Agreement shall be amended by adding the following as a new section
17.4.5
thereto:
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“Notwithstanding
the foregoing provisions of section 17.4. if XXXXXX’x minimum Net Sales in a
Field do not exceed the minimums outlined above, XXXXXX has the right *****
in
respect of each Field unless otherwise extended by the mutual consent of the
parties, to make a payment to PreMD equivalent to ***** to maintain its rights
hereunder in respect ***** shall only be exercisable within the *****. Such
conversion shall become effective at the end of such thirty (30) day period,
unless during such thirty (30) day period *****.
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6.
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The
parties acknowledge and agree that nothing contained herein shall
affect
the entitlement of PreMD to receive the amount by which the Minimum
Administration Charge exceeds the Administration Charge for such
year.
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*****
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The
provisions of section 8.5 of the Agreement (other than the first
sentence
thereof) shall not apply in respect of the Product in circumstances
where
the Product is *****, the specifications of which are identified
in
Appendix “A” hereto. *****
For example, if the initial *****, and development work results in
a
*****.
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8.
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Notwithstanding
the provisions of section 7 of this amending agreement, in the event
that
the specifications for the ***** (a) change from those identified
on
Appendix A ***** solely by PreMD, its affiliates and/or its
subcontractors, then PreMD may deem the provisions of section 8.5
of the
Agreement to be ***** the purposes of such Products. For example,
if
subsequent development efforts are required that *****, then the
going
forward *****
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a)
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*****;
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b)
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*****;
and
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c)
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*****.
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9.
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PreMD
agrees to use commercially reasonable efforts, which for purposes
of
clarity may, at a minimum, include the need to expend funds or
make
payments (other than PreMD’s attorneys fees and any other PreMD’s
out-of-pocket expenses in connection with the negotiations thereof)
of
***** to renegotiate the development agreement with ***** (such
agreement,
as amended from time to time, being herein referred to as the
***** to
further define the rights of PreMD in Collaboration IP (as defined
in the
***** in the event that intellectual property is created during
development work in order to provide that PreMD will be granted
a
worldwide, irrevocable, royalty-free, non-exclusive license,
with the
right to grant a sublicense, to use and sell Design Elements
(as defined
in the *****. It is acknowledged that there is a similar obligation
to
make the ***** and certain other payments to ***** pursuant to
an
amendment to the International Agreement dated the date hereof.
For
greater certainty, ***** contemplated in such amendment to the
International Agreement, without
duplication.
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9.1
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In
the event that the amount of payment required to obtain the rights
set
forth in this Paragraph exceeds the amount of the ***** (other than
attorneys fees and any other out-of-pocket expenses in connection
with the
negotiations thereof) *****.
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9.2
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In
the event that the amount of payment required to obtain the rights
set
forth in this Paragraph exceeds a total of ***** shall be equally
responsible for any additional payment ***** in an amount of *****
(other
than attorneys fees and any other out-of-pocket expenses in connection
with the negotiations thereof) in excess of the sum of
*****.
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9.3
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In
the event that the amount of payment required to obtain the rights
set
forth in this Paragraph exceeds a total of ***** shall discuss their
respective payment responsibilities for the amount, if any, that
may be
due to ***** (but, for greater certainty, no Party shall be required
to
make any payment under Section 9.3 unless such Party specifically
agrees
to do so).
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9.4
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Each
party shall be responsible for the payment of their own, respective,
attorneys fees and out of pocket expenses that it may incur in connection
with the negotiations as set forth in this Section 9.
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10
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To
the extent commercially practicable, PreMD shall offer to include
a
designated representative of XxXxxx (the “XxXxxx
Designate”)
in all meetings with ***** and persons from whom ***** licenses any
patents or rights to patent applications to the extent that such
meetings
relate to Collaboration IP ***** in all cases to the extent that
XxXxxx
shall wish to participate in such meetings. PreMD shall provide the
XxXxxx
Designate with such advance notice of such meetings as PreMD shall
have
received and PreMD shall use commercially reasonable efforts to schedule
such meetings at least 48 hours after notice of such meeting has
been
provided to the XxXxxx Designate. XxXxxx acknowledges that this advance
notice shall not always be possible, and that the obligations of
PreMD
under this section 10 shall
be subject to PreMD’s need and desire to proceed with meetings with such
persons on a commercially reasonable and timely and efficient basis.
If
such a meeting occurs and XxXxxx has not been provided with such
advance
notice, PreMD will as soon as reasonably practicable after such meeting
provide the XxXxxx Designate with a summary of the material matters
discussed and agreed upon at such
meeting.
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11
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Subject
to compliance with the terms and conditions of the *****, the parties
agree that the Collaboration IP shall be considered as Licensed Know-How
for the purposes of the Agreement.
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Royalty
on ***** Sales
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12
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The
parties acknowledge and agree that for the purposes of provisions
of
Article IV of the Agreement the Net Sales of the Licensed Product
are to
include any Net Sales attributed to the sales of
*****.
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Miscellaneous
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13
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In
all other respects, the terms and conditions of the Agreement shall
remain
in full force and effect,
unamended.
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14
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The
provisions of sections 18.7, 18.9 and 18.10 shall apply, mutatis
mutandis,
to this amending agreement.
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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/______________________
Name:
Title:
Authorized
Signing Officer
A
Canadian corporation
By:
/s/______________________
Name:
Title:
Authorized
Signing Officer
