AMENDMENT TO LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT
Exhibit
4.13
AMENDMENT
TO LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT
|
THIS
AMENDMENT AGREEMENTeffective
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 (“PreMD-Canada”),
PREMD
INTERNATIONAL INC.(previously
known as IMI
International Medical Innovations Inc.,
a corporation incorporated under the laws of Switzerland, and having
its
office c/x Xxxxxx Attorneys at Law, Xxxxxxxxxxxxxx 00 Xxxxxxxxxxxxx
0,
XX-0000 Xxxxx, Xxxxxxxxxxx (“PreMD-Switzerland”)
(PreMD-Canada together with PreMD-Switzerland being herein referred
to
collectively as “PreMD”
or “Party”)
and XxXXXX Consumer & Specialty Pharmaceuticals Division of
XxXXXX-PPC, Inc., incorporated under the laws of the State of New
Jersey,
the United States of America, and having its principal place of business
at 0000 Xxxx Xxxx Xxxx, Xxxxxxxxxxxx, XX 00000 (“XxXXXX-US”),
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) (“XxXXXX-Canada”
)(XXXXXX-US together with XXXXXX-Canada being herein referred to
collectively as “XXXXXX”
or “Party”).
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 28th,
2004 (the “International
Agreement”);
B.
The
Parties wish to waive certain rights and obligations that 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;
and
C. 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
|
1.
|
PreMD
hereby waives any rights which it may have as a result of XxXxxx’x not
having cumulative Net Sales of Products pursuant to section 17.3(a)
for
the 2004, 2005 and 2006 Calendar Years (it being understood that
the
obligations of XxXxxx pursuant to section 17.3(a) shall arise only
in
respect of the 2007 and subsequent Calendar Years), subject to the
ability
of XxXxxx to ***** provided for in section 17.3 of the Agreement.
|
|
2.
|
PreMD
hereby waives any rights which it may have as a result of XxXxxx’x not
having cumulative Net Sales of Products pursuant to section 17.3
(b) for
the 2004 and 2005 Calendar Years (it being understood that the obligations
of XxXxxx pursuant to section 17.3(b) shall arise only in respect
of the
2006 and subsequent Calendar Years), subject to the ability of XxXxxx
to
***** provided for in section 17.3 of the Agreement.
|
|
3.
|
For
greater certainty, it is understood and agreed that XxXxxx
*****
in respect of obligations arising
under:
|
|
a.
|
Subsection
17.3(a), commencing in 2007; and
|
|
b.
|
Subsection
17.3(b) commencing in 2006.
|
US
Patent Matters
|
4.
|
In
the event that both US Patent No. 5,489,510 and US Patent No. 5,587,295
(collectively, the “Expired Patents”)
are not reinstated by the United States Patent Office by 1
August in a given Calendar Year, then the reference subsection 17.3(a)
to
***** in respect of such Calendar Year shall be read as
*****.
|
| 5. |
In
the event that one but not both of the Expired Patents is reinstated
by
the United States Patent Office by 1
August in a given Calendar Year, then the reference subsection 17.3(a)
to
***** in respect of such Calendar Year shall be read as
*****.
|
*****
|
6.
|
The
provisions of section 8.7 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.
*****
as contemplated in section 8.1 of the Agreement.
*****
and development work results in a lower *****.
|
|
7.
|
Notwithstanding
the provisions of section 6 of this amending agreement, in the event
that
the specifications for the *****
(a)
change from those identified on Appendix A as a result of additional
development costs *****.
For
example, if subsequent development efforts are required *****, then
the
going forward *****
|
|
a)
|
*****
|
|
b)
|
*****
|
|
c)
|
*****
|
|
8.
|
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 up to ***** 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 *****
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
*****.
|
|
8.1
|
In
the event that the amount of payment required to obtain the rights
set
forth in this Paragraph exceeds the amount of the ***** shall be
responsible for any additional payment ***** (other than attorneys
fees
and any other out-of-pocket expenses in connection with the negotiations
thereof) *****.
|
|
8.2
|
In
the event that the amount of payment required to obtain the rights
set
forth in this Paragraph exceeds a total of ***** responsible for
any
additional payment ***** (other than attorneys fees and any other
out-of-pocket expenses in connection with the negotiations thereof)
*****.
|
|
8.3
|
In
the event that the amount of payment required to obtain the rights
set
forth in this Paragraph exceeds a total of ***** discuss their respective
payment responsibilities for the amount, if any, that may be due
*****
(but, for greater certainty, no Party shall be required to make any
payment under Section 8.3 unless **** to do
so).
|
|
8.4
|
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 8.
|
Royalty
on ***** Sales
|
9.
|
The
parties acknowledge and agree that for the purposes of provisions
of
Article IV of the Agreement the Net Sales of the Product are to include
any Net Sales attributed to the sales of
*****.
|
*****-
PreMD Collaboration IP
|
10.
|
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.
|
|
11.
|
Subject
to compliance with the terms and conditions of the *****, the parties
agree that the Collaboration IP shall be considered as IMI Improvement
Intellectual Property under Section 2.5.4 of the International
Agreement.
|
|
12.
|
The
provisions of 14.1 and 14.2 of the Agreement shall apply in respect
of the
Collaboration IP.
|
Milestone
Payments
|
13.
|
|
x.
|
XxXxxx
shall pay PreMD-Canada a payment of 1) ***** upon completion of the
Principal Design Review Meetings (within the meaning of the *****);
and 2)
***** upon completion of the Critical Design Review Meeting (within
the
meaning of the ***** in consideration of IMI’s costs incurred in
developing the ***** and for XxXXXX’x right to obtain a ***** unit cost
pursuant to Paragraphs 7 and 8 herein.
|
Miscellaneous
|
14.
|
In
all other respects, the terms and conditions of the Agreement shall
remain
in full force and effect,
unamended.
|
|
15.
|
The
provisions of sections 19.4 and 19.7 shall apply, mutatis
mutandis,
to this amending agreement.
|
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
XXXXXX
CONSUMER & SPECIALTY PHARMACEUTICAL DIVISION OF XXXXXX-PPC,
INC.
By:
/s/______________________
Name:
Title:
Authorized
Signing Officer
A
Canadian corporation
By:
/s/______________________
Name:
Title:
Authorized
Signing Officer
PREMD
INTERNATIONAL INC.
A
Swiss corporation
By:
/s/______________________
Name:
Title:
Authorized
Signing Officer
