Exhibit 10.2
Amendment 10 July 96
July 10, 1996
Re: Development and License Agreement between Pharmacia S.p.A.
("Pharmacia") and PDT, Inc. ("PDTI") dated July 1st, 1995, amended July 25,
1995, September 11, 1995, and March 20, 1996 ("License Agreement")
Pharmacia and PDTI have entered into the License Agreement with respect to the
fields of Oncology, Urology and Dermatology, and now wish to amend the License
Agreement with respect to the field of Ophthalmology.
Pharmacia and PDTI agree to amend the License Agreement according to the
following terms and conditions:
Section 1.06.01 shall be inserted:
"1.06.01 Ophthalmology Effective Date. The term "Ophthalmology
Effective Date" as used herein shall mean ___ of _________ , 1996."
Section 1.08 shall be deleted and replaced by:
"1.08 Fields. The term "Fields" as used herein shall mean the fields
of Oncology, Urology, Dermatology and Ophthalmology, unless otherwise
indicated."
Section 1.24 shall be inserted as follows:
"1.24 Other Indications. The term "Other Indications" as used herein
shall mean the indications in the Fields as set forth in Schedule
1.24. The parties will agree on additional Other Indications through
the Operating Committee, based on criteria including, but not limited
to, *****, ***** and ***** ."
The numbering on the remainder of Article I shall be amended accordingly.
Section 1.35 shall be deleted and replaced by:
"1.35 Schedules. The Schedules which are attached to this Agreement
and which are herein incorporated, are as follows: Schedule
Description
1.17 Major Indications
1.18 Minor Indications
1.24 Other Indications
3.04 Key Countries
The following shall be added at the end of Section 3.01:
"Pharmacia intends to sublicense its rights in the Field of
Ophthalmology to its affiliate, Pharmacia & Upjohn AB. In respect to
such Field, the parties intend for such affiliate to make all royalty
and other payments, exercise all rights and perform all obligations
directly to PDT."
Section 3.04.01 shall be inserted as follows:
"3.04.01 Ophthalmology Milestones. Notwithstanding anything herein to
the contrary, for Ophthalmology Major and Minor Indications Pharmacia
shall pay PDTI only the following sums upon achievement of the stated
milestones:
(i) if, after conducting ***** for any Ophthalmology Major and Minor
Indication, the Ophthalmology Operating Committee decides to proceed with *****
for such indication, Pharmacia shall pay PDTI: ***** for each Major Indication;
and ***** for each Minor Indication; or in the event ***** are not required for
any indication and the Operating Committee decides to proceed with *****,
Pharmacia shall not owe PDTI a ***** milestone payment for each such indication;
and
(ii) for each Major and Minor Indication, at the ***** in one or more of
the Key Countries as specified by Schedule 3.04, Pharmacia shall pay PDTI *****
for each Major Indication so approved, and ***** for each Minor Indication so
approved.
(iii) Pharmacia shall not owe PDTI any milestone payments for Other
Indications in Ophthalmology."
*****Confidential Treatment Requested
Section 3.05.01 shall be inserted as follows:
"3.05.01 Ophthalmology Royalties. Notwithstanding anything herein to
the contrary, for Ophthalmology, Pharmacia or Pharmacia & Upjohn AB
shall, for the term of the license specified by Section 3.02, pay PDT
royalties on Net Sales of Product to third parties at the rate of
***** on total Net Sales of Product of *****, per calendar year and a
royalty of ***** on the part of total Net Sales of Product ***** per
calendar year, *****.
Section 3.12 shall be inserted as follows:
"3.12 Reimbursement. Within fifteen (15) business days following the
Ophthalmology Effective Date, Pharmacia shall pay to PDTI the sum of
Five Hundred Thousand US Dollars ($500,000), as reimbursement for
prior expenses incurred by PDTI in the development of SnET2 for
Ophthalmology."
Section 4.01.01 shall be inserted as follows:
"4.01.01 Ophthalmology Strategic Plan. Notwithstanding anything
herein to the contrary, for Ophthalmology, the Strategic Plan shall
be governed by the following provision: Unless otherwise agreed to by
the parties, within one hundred twenty (120) days following the
Ophthalmology Effective Date, the parties shall mutually develop a
written plan, the format and content as set forth in Section 4.01,
with respect to Ophthalmology. This plan shall be called the
"Ophthalmology Strategic Plan". References to the Strategic Plan in
the remainder of the Agreement shall also apply to the Ophthalmology
Strategic Plan, unless otherwise indicated."
Section 4.02.01 shall be inserted as follows:
"4.02.01 Ophthalmology Steering Committee. Notwithstanding anything
herein to the contrary, for Ophthalmology, there shall be no Steering
Committee. References to the Steering Committee in the remainder of
the Agreement shall apply to the Ophthalmology Operating Committee as
defined in Section 4.03.01, unless otherwise indicated."
Section 4.03.01 shall be inserted as follows:
"4.03.01 Ophthalmology Operating Committee. Notwithstanding anything
herein to the contrary, for Ophthalmology, the Operating Committee
shall be governed by the following provision: Unless otherwise agreed
to by the parties, within thirty (30) days following the
Ophthalmology Effective Date, the parties shall appoint an
"Ophthalmology Operating Committee", having the membership and
purpose as set forth in Section 4.03, with respect to the
Ophthalmology Strategic Plan. References to the Operating Committee
in the remainder of the Agreement shall also apply to the
Ophthalmology Operating Committee, unless otherwise indicated."
Section 4.09.01 shall be inserted as follows:
"4.09.01 SnET2 for Ophthalmology. Notwithstanding anything herein to
the contrary, for Ophthalmology, unless otherwise determined by the
Ophthalmology Operating Committee, PDTI shall be responsible for
conducting all necessary Preclinical Tests and Phase I and Phase II
Clinical Tests for SnET2 to be used in any Ophthalmology indications
within the Fields. The Out-of-Pocket Expenses associated with
Preclinical Tests, Phase I and Phase II Clinical Tests being conducted
by PDT on the Ophthalmology Effective Date, or conducted by PDT
thereafter, shall be refunded by Pharmacia, provided that these
studies have been conducted in agreement with the Ophthalmology
Operating Committee. Pharmacia shall be responsible for conducting and
shall bear all costs associated with Phase III Clinical Tests of SnET2
to be used in all Ophthalmology indications, as well as for all
post-NDA approval studies which may be necessary; provided, however,
that the Ophthalmology Operating Committee has the right to determine,
in its reasonable judgment, whether to proceed to Phase III Clinical
Tests as to any Ophthalmology indication. PDTI shall supply to
Pharmacia SnET2 and Light Devices to enable Pharmacia to carry out
Phase III Clinical Tests required to support an NDA for SnET2. The
actual costs of SnET2 and Light Devices for all Clinical Test phases
shall be shared equally by the parties hereto."
Article XVI "Ophthalmology Negotiation" shall be deleted.
*****Confidential Treatment Requested
Schedule 1.17 shall be deleted and replaced by:
"SCHEDULE 1.17 Major Indications.
*****
Schedule 1.18 shall be deleted and replaced by:
"SCHEDULE 1.18 Minor Indications.
*****
Schedule 1.24 shall be inserted as follows:
"SCHEDULE 1.24 Other Indications.
*****
The parties shall revise the SnET2 Device Supply and Product Supply Agreements,
dated July 1st, 1995, to reflect the field of Ophthalmology as appropriate.
IN WITNESS WHEREOF, the parties hereto have caused this Development
and License Agreement to be executed in duplicate by their respective officers
duly authorized as of the date first above written.
PDT, INC.
By
Name:
Title:
PHARMACIA S.p.A.
By
Name:
Title:
PHARMACIA & UPJOHN AB
By:
Name:
Title:
*****Confidential Treatment Requested