AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT
This Amendment to the Collaboration and License Agreement by and
between Oclassen Pharmaceuticals, Inc. and Symbollon Corporation dated as of May
14, 1996 (the "Agreement") is made as of this 14th day of August, 1997. All
capitalized terms not defined herein shall have the meaning ascribed to them in
the Agreement.
This Amendment, when signed by the parties to the Agreement, shall
constitute a written amendment in accordance with Section 17.6 of the Agreement.
The parties hereby agree that the Agreement shall be amended as follows:
1. The first sentence of Section 2.1 after the heading "Formation" shall be
deleted and replaced with the following language "The Joint Development
Committee will be comprised of five (5) members with three (3) being appointed
and replaced by Oclassen and two (2) being appointed and replaced by Symbollon."
2. Exhibit C shall be amended to provide that the three (3) members of the Joint
Development Committee appointed by Oclassen are as follows: "1. Xxxxx Xxxx; 2.
Xxxxxx Xx; 3. Xxxx Xxxxxx"
3. Section 2.3 shall be deleted in its entirety.
4. Section 2.4 shall be deleted and replaced with the following language:
"If at any time during the term of this Agreement, Oclassen
wishes to revise the marketing strategy for any Product
involving a switch to OTC sales, either exclusively or
concurrently with prescription sales, it may so notify the
JDC. If the JDC fails to reach unanimous agreement on such
switch, the top executive officer of each party will confer as
soon as reasonably practicable and each use commercially
reasonable efforts to effect resolution. Should such
conference not resolve the disagreement, the JDC will then
determine, by majority vote, whether to permit the desired
revision to the marketing strategy. If an OTC marketing
strategy is adopted following the process contemplated by this
paragraph, then upon agreement by the parties of Symbollon's
economic return with respect thereto, which return the parties
will negotiate in good faith, Oclassen will have the exclusive
right to make, have made, use, sell and have sold such Product
in the OTC market, and the license granted under Section 4.1
shall be deemed to be amended to reflect such right. Should
the parties not reach agreement with respect to Symbollon's
economic return in connection with OTC sales, such matter will
be decided by arbitration under Section 17.3"
5. In Subsection (b) of Section 3.2 the language "pay Symbollon for its work
under the Project Plan" shall be deleted and replaced with the following
language: "pay Symbollon for its research and development work under the Project
Plan (but not for any non-research work, including JDC
meetings, travel to or from meetings, discussions regarding the Agreement
itself, presentations and preparations for such presentations)".
6. In Section 4.1 the language "and/or co-promotion pursuant to Section 4.2(b)"
shall be inserted following the words "research and development". The words
"(but not distribution)" shall be deleted.
7. Subsection 4.2(b)(d) shall be deleted and replaced with the following
language:
"(d) that (i) Symbollon shall receive [* INDICATES THAT
MATERIAL HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.] of any
and all amounts received and all other consideration received
(when in a form other than cash or its equivalent, the fair
market value thereof when received) by Oclassen or its
Affiliates directly or indirectly from such co-promoter by
reason of the sale, distribution or use of Product(s), and
(ii) that should Symbollon's economic return with respect to a
co- promotion contemplated by this paragraph not be equivalent
to that which Symbollon would have received in the aggregate
if Symbollon had received a [* INDICATES THAT MATERIAL HAS
BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY
WITH THE COMMISSION PURSUANT TO RULE 24b-2.] royalty on the
sale of such Product directly by Oclassen to an unrelated
third party (not to include the sale by Oclassen to a
co-promoter), then the parties will negotiate in good faith to
reach an agreement with respect to Symbollon's economic return
in connection with such co-promotion. Should the parties not
reach agreement with respect to Symbollon's economic return in
connection with such co-promotion, such matter will be decided
by arbitration under Section 17.3"
8. The Milestones as set forth in subsections (b), (c), (d) and (e) of Section
6.1 of the Agreement shall be deleted and shall be replaced with the following
language:
"(b) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH
OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION
PURSUANT TO RULE 24b-2.] upon execution of this amendment;
plus
(c) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH
OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION
PURSUANT TO RULE 24b-2.] on November 11, 1997; plus
(d) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH
OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION
PURSUANT TO RULE 24b-2.] upon completion of a Phase I/II,
Phase II or Phase II/III clinical trial of a Product (but not
upon completion of a Phase I clinical Trial of a Product)
("completion" means Oclassen having received actual clinical
reports pertaining to the submitted protocols of such trial);
plus
(e) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH
OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION
PURSUANT TO RULE 24b-2.] upon the first filing of an NDA for
any indication for a Product; plus"
9. In Section 6.2 the language "up to an additional [* INDICATES THAT MATERIAL
HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL
SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO
RULE 24b-2.]" shall be deleted and replaced with the following language: "up to
an additional [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.]". Additionally, in line
8 of Section 6.2 the words "two (2) consecutive years" shall be deleted and
replaced with the words "four (4) consecutive years".
10. Article 7 shall be deleted and replaced with the following language:
7.1 Symbollon Sale of Products Outside the Territory. If Symbollon sell
Products and/or any other product(s) which incorporate and/or rely on a
Joint Invention and/or Oclassen's Regulatory Filings or Regulatory
Approvals outside the Territory, either directly or in conjunction with
a third party, Symbollon shall pay Oclassen with respect to each
calendar quarter a royalty equal to [* INDICATES THAT MATERIAL HAS BEEN
OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL
SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION
PURSUANT TO RULE 24b-2.] of (1) the amount received by Symbollon from
the Net Sales of such Product(s) or product(s) and, without
duplication, (2) all amounts received and all other consideration
received (when in a form other than cash or its equivalent, the fair
market value thereof when received) by Symbollon by reason of the sale,
license, distribution or use of such Product(s) or product(s), in each
case during such quarter and subject to the following limitations: (a)
for purposes of calculating the preceding royalty amount no royalties
shall be paid on any monies paid to Symbollon by a third party
expressly intended for the additional direct formulation and/or
technical development, nor on any Manufacturing Costs of Product(s) or
product(s) and (b) in no event shall Symbollon's royalty payments owed
under this Article 7 ever exceed [* INDICATES THAT MATERIAL HAS BEEN
OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL
SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION
PURSUANT TO RULE 24b-2.] in the aggregate.
7.2 Oclassen's Right of First Negotiation Outside the Territory.
Symbollon shall offer to Oclassen the first opportunity to negotiate
with Symbollon for the exclusive right to develop, manufacture, have
manufactured, use, market, have marketed, sell and/or have sold any
Products and/or any other product(s) which incorporate and/or rely on a
Joint Invention and/or Oclassen's Regulatory Filings or Regulatory
Approvals outside the Territory ("Extra-Territorial Projects").
Symbollon will notify Oclassen as to each Extra-Territorial Project
such that Oclassen shall have at least fifteen (15) days during which
time to consider whether Oclassen wishes to pursue such
Extra-Territorial Project. Within fifteen (15) days after receipt of
notice of an Extra-Territorial Project, Oclassen shall, if it desires
to pursue negotiations with respect to such Extra-Territorial Project,
notify Symbollon of such desire. Symbollon shall then refrain from
negotiating such Extra-Territorial Project with any entity other than
Oclassen for a period of sixty (60) days. During such sixty (60) day
period the parties shall engage in exclusive, good faith negotiations
regarding the Extra-Territorial Project. If such negotiations do not
result in a definitive agreement within the sixty (60) day period, the
exclusive negotiation period shall terminate and Symbollon shall be
entitled to pursue negotiations with respect to such Extra-Territorial
Project with third parties.
11. Section 9.1 shall be deleted and replaced with the following language:
"During the term of this Agreement and unless this Agreement is
terminated by Oclassen due to a material breach by Symbollon, for two
(2) years after termination of this Agreement, Oclassen will not
directly or indirectly research and develop for the topical treatment
and
prevention of recurrence of human skin diseases except with Symbollon
pursuant to this Agreement a multi-part system which, upon mixing prior
to use, forms a composition containing from 5 to in excess of 300 ppm
of diatomic iodine (I2) or (ii) the use of excipients used in
combination with such compositions that modify the properties of said
compositions including, by way of example, decolorizers, reducing
agents, sequestrants, potentiators or viscosifiers."
12. In Section 11.2(a) the words "pertains to Iodine" shall be deleted and
replaced with the following language:
"pertains to (i) any multi-part system which, upon mixing prior to use,
forms a composition containing from 5 to in excess of 300 ppm of
diatomic iodine (I2), or (ii) the use of excipients used in combination
with such compositions that modify the properties of said compositions
including, by way of example, decolorizers, reducing agents,
sequestrants, potentiators or viscosifiers".
13. In Section 11.3 the words "or acquired" in the line preceding the final line
of Section 11.3 shall be deleted.
14. In Section 12.3(a) the following language shall be inserted in the third
line following the words "Actively Developing": "or shall have plans to
develop".
15. Section 15.3 shall be renumbered as 15.3.1.
16. A new Section 15.3.2 shall be inserted following Section 15.3.1 and shall
read as follows:
15.3.2 Termination by Symbollon. Within thirty (30) days following the
respective milestone dates set forth below, Symbollon may terminate
this Agreement by giving forty-five (45) days written notice to
Oclassen if Oclassen shall fail to meet the corresponding milestone:
(a) by December 31, 1998 Oclassen shall have made a first filing
of an IND for any indication of a Product;
(b) by December 31, 1999 Oclassen shall have completed full patient
enrollment in a Phase I clinical trial of a Product; and
(c) by December 31, 2000 Oclassen shall have completed a Phase I/II,
Phase II or Phase II/III clinical trial of a Product (but not upon
completion of a Phase I clinical Trial of a Product) ("completion"
means Oclassen having received actual clinical reports pertaining to
the submitted protocols of such trial).
Oclassen shall have forty-five (45) days from receipt of Symbollon's
notice to terminate pursuant to this Section 15.3.2 within which to
cure the failure which has provided Symbollon
a basis to terminate the Agreement in which case such termination by
Symbollon shall be ineffective.
17. In Section 17.1 the addresses for Oclassen and Symbollon shall be changed as
provided below:
Oclassen Pharmaceuticals, Inc.
000 Xxxxxx Xxxxxx
Xxxxxx, XX 00000
Telephone: 000-000-0000
Fax: 000-000-0000
Attention: President
Symbollon Corporation
00 Xxxxxx Xxxxx
Xxxxxxxxxx, XX 00000
Telephone: 000-000-0000
Fax: 000-000-0000
Attention: President
Additionally the following party, rather than "Venture Law Group" shall
receive copies of any Notices to Oclassen:
X'Xxxxxx & Xxxxxx
00 X. Xx Xxxxx Xxxxxx Xxxxx 0000
Xxxxxxx, XX 00000
Telephone: (000) 000-0000
Fax: (000) 000-0000
Attention: Xxxxxx X. Xxxxxxx
Except as herein modified, all other terms and conditions of the
Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, the undersigned have executed this Amendment as of
the date first written above.
OCLASSEN PHARMACEUTICALS, INC SYMBOLLON CORPORATION
By: /s/ Xxxxx Xxxx By: /s/ Xxxx X. Xxxxxxxxx
------------------------------- -------------------------------
Its: _______________________________ Its: Executive Vice President
