AMENDMENT
THIS AMENDMENT ("Amendment") is made and entered into as of July 6, 2005,
by and between Interpharm, Inc., having its principal place of business at 00
Xxxxx Xxxxxx, Xxxxxxxxx, Xxx Xxxx, 00000 ("Interpharm"), and Tris Pharma, Inc.,
having its principal place of business at 0000 Xxxxx 000, Xxxxx X, Xxxxxxxx
Xxxxxxxx, XX 00000 ("Tris").
W I T N E S S E T H :
WHEREAS, on February 24, 2005, Interpharm and Tris entered into an
agreement whereby Tris is to transfer certain research and technology to
Interpharm which it will use to develop and manufacture certain solid oral
dosage pharmaceutical products (the "Solids Agreement"); and
WHEREAS, Interpharm and Tris desire to amend the Solids Agreement to add
certain pharmaceutical products;
NOW, THEREFORE, in consideration of the premises herein contained and
other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties, intending to be legally bound, agree as
follows:
ARTICLE I
AMENDMENT
1. Amendment to Exhibit A. Exhibit A of the Solids Agreement shall be
amended with the addition of the following products:
2. Amendment of Article I. Section 1.32 of the Solids Agreement shall be
deleted and replaced with the following:
1.32 "Products" shall mean the generic finished dosage pharmaceutical form
of the Products listed on Exhibit A annexed hereto, as may be amended from
time to time.
The following shall be added to Article I of the Solids Agreement:
1.50 "Additional Product Payments" shall mean the aggregate of the
_____________ Softgel Payments, the _____________ Payments and the Second
Softgel Payments.
1.51 "Additional Products" shall mean the generic finished dosage
pharmaceutical form of the Products listed as number 8, 9 and 10 on
Exhibit A, as amended by the Amendment.
1.52 "Amendment" shall mean the July 6, 2005 Amendment to this Agreement.
1.53 "___________Softgel Payments" shall mean a payment of $125,000 to
Tris upon execution of the Amendment to this Agreement and another payment
of $125,000 to Tris upon successful completion of a bioequivalency study
with respect to ___________ Softgel.
For the sake of clarity, throughout this Agreement, "successful
completion" shall mean completion of a bioequivalency study wherein i) the
results demonstrate bioequivalence as defined by the FDA and ii) meet the
requirements for filing an ANDA.
1.54 "Initial Products" shall mean the Products listed on Exhibit A of the
Solids Agreement prior to the Amendment.
1.55 "___________Payments" shall mean the following: (i) a payment of
$125,000 to Tris no later than two weeks after execution of the Amendment,
in the event that Interpharm decides to proceed with _____________ in
accordance with the terms of this Agreement; (ii) a second payment of
$125,000 to Tris upon successful completion of a bioequivalency study with
respect to _____________; and (iii) a payment of $125,000 upon receipt of
final FDA approval of a _____________ ANDA. Should Interpharm decide not
to proceed with _____________, (i) it shall not be deemed to be included
as a Product under this Agreement, (ii) Interpharm shall not owe Tris any
money for _____________, and (iii) Tris may develop ___________ with a
third party.
1.56 "Second Softgel" shall mean the Product listed as number 10 on
Exhibit A, as amended by the Amendment.
1.57 "Second Softgel Payments" shall mean a payment of $125,000 to Tris no
later than the date on which Interpharm notifies Tris in writing of the
designation of the Second Softgel (the "Second Softgel Notice").
3. Amendment of Section 1.44.Section 1.44 of the Solids Agreement shall be
deleted and replaced by the following:
1.44 "Total Tris Payments" shall mean the Initial Payment, plus the total
of all of the Quarterly Payments, plus the total of the Additional Product
Payments, as of a particular date.
4. Amendment of Section 2.1.1. The second sentence of Section 2.1.1 of the
Solids Agreement shall be deleted and replaced with the following:
"Tris shall deliver the Development Schedule for each of the Initial
Products by April 1, 2005, for __________ Softgel and ___________, by the
date of execution of the Amendment, and for the Second Softgel, within
thirty (30) days of Tris' receipt of the Second Softgel Notice."
5. Amendment of Section 2.2. (a) The first sentence of Section 2.2 of the
Solids Agreement shall be deleted and replaced by the following:
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"By April 1, 2005, Tris shall deliver to the PMC and Interpharm the
Development Schedule for each of the Initial Products for their review and
Interpharm's approval. Tris shall deliver to the PMC and Interpharm, for
their review and Interpharm's approval, the Development Schedule for
_______ Softgel and ____________ by the date of execution of the
Amendment, and for the Second Softgel, within thirty days of Tris' receipt
of the Second Softgel Notice."
(b) The second sentence of Section 2.2 of the Solids Agreement shall be
amended by deleting the first word, and replacing it with the following:
"With the exception of the Additional Products, in"
6. Amendment of Section 2.7.1. The following shall be added as a second
paragraph to Section 2.7.1:
"In the case of _____________ Softgel, the exclusivity referred to in the
preceding paragraph shall apply only to the manufacture, supply, marketing
and distribution of _____________ Softgel for the generic prescription and
generic over-the-counter markets. Tris' commitment, and Interpharm's
rights, with respect to the branded prescription and branded
over-the-counter markets shall be non-exclusive, meaning that Tris shall
have the right to cooperate with any other person or entity with respect
to the manufacture, supply and/or distribution of _____________ Softgel
for the branded prescription and/or branded over-the-counter markets
without the prior consent of Interpharm and Interpharm shall have no
rights with respect to any sales resulting therefrom. Notwithstanding
anything to the contrary contained herein, if _____________ Softgel is
sold generically within the Territory by a third party with whom Tris has
any direct or indirect agreement with respect to the sale of _____________
Softgel, Interpharm shall still maintain all its rights as set forth in
the preceding paragraph, even if such direct or indirect agreement was
entered into in compliance with this paragraph."
7. Amendment of Section 2.8.1.1. Section 2.8.1.1 of the Solids Agreement
shall be deleted and replaced by the following:
"Making the following payments to Tris. In the event that
Interpharm fails to make any of the following payments, Tris's sole
remedy shall be the commencement of an arbitration in accordance
with Section 8.2:
2.8.1.1.1 the Initial Payment;
2.8.1.1.2 the Quarterly Payments; and
2.8.1.1.3 the Additional Product Payments."
8. Additions to Section 2.8. The following shall be added as Section
2.8.1.12 of the Solids Agreement:
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"2.8.1.12 Notifying Tris, in writing, whether it wishes to proceed with
_____________ within fourteen (14) days of Interpharm's receipt of
_____________ Preliminary Product Details. In furtherance thereof, on the
date of the Amendment, but not later than 48 hours after said date, Tris
shall deliver to Interpharm's in-house intellectual property counsel ("IP
Counsel") as many of the Product Details that Tris may have in its
possession, as of such delivery date, with respect to _____________ (the
"_____________ Preliminary Product Details"). Such disclosure shall be
made by Tris based on Interpharm's assurances and agreement that (i)
Interpharm's IP Counsel may use and evaluate such _____________
Preliminary Product Details to provide an opinion and recommendation to
Interpharm but shall not disclose any of the _____________ Preliminary
Product Details to anyone within or outside Interpharm, except
Interpharm's outside patent counsel, prior to Interpharm's notification of
its decision on whether to proceed with Tris' _____________ and (ii) if
Interpharm decides not to proceed with _____________, Interpharm's IP
Counsel will return the _____________ Preliminary Product Details to Tris
and shall not keep any copies thereof or any notes thereon. In the event
that Interpharm, in its sole and absolute discretion, decides not to
proceed with _____________, it shall not be responsible to make the
_____________ Payments as is set forth in Section 1.55. In addition,
nothing in this Agreement shall prevent Interpharm from developing,
manufacturing, selling, marketing or distributing _____________ on its own
in the future so long as Interpharm does not improperly use any
Confidential Information of Tris. In such event, however, prior to
submitting a _____________ ANDA to the FDA, Interpharm shall disclose
under strict confidentiality its _____________ formula to Tris in
sufficient detail to enable Tris to determine whether that formula is
based in whole or in part on Tris' Confidential Information. If Tris
reasonably believes that Interpharm's formulation is so based, nothing in
this Agreement shall prevent Tris from seeking an injunction to block
Interpharm from submitting the ANDA and/or from commercializing that
_____________ product."
9. Amendment of Section 3.1. The first sentence of Section 3.1 of the
Solids Agreement shall be deleted and replaced with the following:
"The Parties hereby agree, that for the purpose of clarity, Net Profits
shall be calculated separately for each of (i) _______________, (ii) the
Additional Products as a group and (iii) the Non-DS Products (as defined
below) as a group."
10. Amendment of Section 3.1.3.1. Section 3.1.3.1 shall be amended by
deleting the first seven (7) words and replacing them with the following:
"With respect to all Products other than the Additional Products and"
A second paragraph shall be added to Section 3.1.3.1 and read as
follows:
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"With respect to the Additional Products, the Set Aside shall be
distributed to the Parties pro rata based on each Party's share of the
aggregate of all of the Additional Product Payments, Development Costs and
the Tris Reimbursable Set Aside for the Additional Products until the
aggregate of the Set Aside for the Additional Products is equal to the sum
of the Additional Product Payments plus all Development Costs plus the
Tris Reimbursable Set Aside relating to the Additional Products."
11. Amendment of Section 3.1.3.2. Section 3.1.3.2 of the Solids Agreement
shall be amended by adding a second sentence as follows:
"After the Set Aside, each Party shall be entitled to 50% of the remaining
Net Profits, if any, from the sales of Additional Products, with the
exception of _____________ Softgel, for which Interpharm shall be entitled
to 60% of the remaining Net Profits and Tris shall be entitled to 40% of
the remaining Net Profits."
12. Amendment of Section 10.5. Section 10.5 of the Solids Agreement shall
be deleted and replaced by the following:
"This Agreement, as amended by the Amendment, contains the sole and entire
agreement and understanding of the parties hereto and their respective
affiliates and representatives relating to the subject matter hereof and
supersedes all prior agreements, understandings and arrangements, oral or
written, between the parties concerning the subject matter hereof made
prior to the date of this Agreement, as amended by the Amendment."
ARTICLE II
MISCELLANEOUS
1. Amendments. The terms and provisions set forth in this Amendment shall
modify and supercede all inconsistent terms and provisions set forth in the
Solids Agreement. The parties agree that the Solids Agreement, as amended
hereby, shall continue to be legal, valid, binding and enforceable in accordance
with its terms.
2. Survival of Representations and Warranties. All representations and
warranties made in the Solids Agreement shall survive the execution and delivery
of this Amendment.
3. Headings. The section headings contained in this Amendment are for
purposes of convenience only, and shall in no way bear upon the construction or
interpretation of this Amendment.
4. Modification and Waiver. This Amendment may not be modified or amended
except by an instrument or instruments in writing signed by the parties hereto.
No waiver of any of the provisions of this Amendment shall be deemed, or shall
constitute, a waiver of any other provisions, whether or not similar. No waiver
shall be binding unless executed in writing by the party making the waiver.
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5. Counterparts. This Amendment may be executed simultaneously in one or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
6. Severability. The provisions of this Amendment are severable, and the
invalidity of any provision shall not affect the validity of any other
provisions.
7. Binding Effect. This Amendment shall be binding upon, and shall inure
to the benefit of, the parties hereto and their respective successors and
permitted assigns.
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8. Governing Law. This Amendment, its validity, interpretation and
performance shall be governed by and construed in accordance with the internal
laws of the State of New York without giving effect to the conflict of laws
provisions thereof.
IN WITNESS WHEREOF, this Amendment has been executed and is effective as
of the date first above-written.
INTERPHARM, INC.
By: /s/ Xxx Xxxxxxx
-------------------------------------
Xxx Xxxxxxx, President
TRIS PHARMA, INC.
By: /s/ Katan Mehta
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Xxxxx Xxxxx, CEO and President
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