Exhibit 10.53
[*] = Certain confidential
information contained in this document, marked by brackets, is
filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
GILEAD SCIENCES LIMITED –
PHARMACHEM TECHNOLOGIES (GRAND BAHAMA), LTD.
ADDENDUM TO TENOFOVIR DISOPROXIL
FUMARATE MANUFACTURING SUPPLY AGREEMENT
The Parties hereby acknowledge and
agree to the following:
This Addendum agreement (the “
Addendum ”) is entered into as of December 5,
2008 by and between PharmaChem Technologies (Grand Bahama) Ltd., a
Commonwealth of the Bahamas company (“ PharmaChem
”) having its principal place of business at West Sunrise
Highway, Freeport, Grand Bahama, Commonwealth of the Bahamas, and
Gilead Sciences Limited, an Irish limited company (“
GSL ”) whose registered address is Unit 12, Stillorgan
Industrial Park, Blackrock, Co. Dublin, Ireland. PharmaChem and GSL
may be referred to individually as a “ Party ”
and collectively as the “ Parties ” in this
Addendum.
WHEREAS by a
Manufacturing Supply Agreement dated July 17, 2003 made
between PharmaChem and Gilead World Markets Ltd. (“
GWM ”), as novated by a Novation Agreement dated
June 14, 2004 and further amended on July 15, 2005
, July 31,
2005, May 10, 2007, and August 20,2007, made between
GWM, GSL and PharmaChem (the “ Agreement ”),
PharmaChem agreed to manufacture and supply bulk tenofovir
disoproxil fumarate (the “ Product ”) to GSL on
the terms and conditions therein set out and until
December 31, 2010;
WHEREAS the Parties hereto desire to
extend the term of the Agreement until December 31, 2012 at
the same terms and conditions thereof except as provided
herein;
WHEREAS a previous Addendum provided
for GSL to sell to PharmaChem certain key raw materials required
for manufacturing of TDF (the “ Key Raw Materials
”);
WHEREAS Gilead has secured from
[ * ] .
NOW THEREFORE, in consideration of
the covenants herein and intending to be legally bound hereby, the
“Whereas” clauses being an integral and material part
of this Addendum, the Parties hereby agree as follows:
1. Article 2 of the Agreement is
cancelled and replaced by the following:
“The Term of this Agreement
shall begin as of the effective Date, and shall remain in effect
until December 31, 2012 (the “ Initial Term
”), and thereafter for subsequent automatic two-year renewal
terms (each a “ Renewal Term ”), unless
terminated by either Party effective at the end of the Initial Term
or any Renewal Term by at least twelve (12) months prior
written notice or unless earlier terminated according to
Section 12 “Termination” of this
Agreement.”
[*] = Certain confidential information contained
in this document, marked by brackets, is filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
1
2. The Price of Product delivered in accordance
with the Agreement (Exhibit B) will be as set forth on Schedule 1.
It is intended that all purchases of Product within a calendar
year, [ * ] and at whatever modified pricing agreed
to by Gilead, will be counted towards the commitment under Schedule
1, Combined Quantity, and that pricing for Gilead will be
calculated following the formula and examples in Schedule 1 based
on quantities of Product purchased/forecasted by [ *
] .
3. The current and projected
purchase prices for the Key Raw Materials are set forth on Schedule
2. The current and projected purchase prices for the other Raw
Materials are set forth on Schedule 3. The current and projected
energy costs are set forth on Schedule 4. Deviations of actual
costs, and energy prices from the values in Schedules 2, 3, and 4,
may be used to modify the purchase price for Product pursuant to
Section 10 of the Agreement for years 2009 through 2012,
however, any price increase calculated under Section 10 for
the year 2009 will be reduced by [ * ] .
4. Price reductions for yield
improvements under Process Improvements Sections 8 and 10 will be
calculated using the per step yields as listed in Schedule
5.
5. Gilead may substitute quantities
of a different compound for tenofovir disoproxil fumarate (“
TDF ”) as the “Product” to be manufactured
by PharmaChem under this Agreement, on terms and conditions
[ * ] to be mutually agreed in writing by Gilead and
PharmaChem. If that happens, the quantities of such other compound
manufactured by PharmaChem shall [ * ] .
6. This Addendum may only be amended
by a written instrument signed by each of the parties
hereto.
7. This Addendum shall be deemed
severable; the invalidity or unenforceability of any term or
provision of this Addendum shall not affect the validity or
enforceability of this Addendum or of any other term thereof, which
shall remain in full force and effect.
8. The Agreement amended hereby
shall continue in full force and effect except as expressly amended
hereby.
In WITNESS WHEREOF, the parties
hereto hereby execute this Addendum as of the date first indicated
above.
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PharmaChem
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