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EXHIBIT 10.21
AMENDMENT TO COLLABORATION AGREEMENT
May 3, 2000
Xxxxxx X. Xxxxxxx
President
Inpharmakon Corporation
000 Xxxxxxxx Xxxxxx
Xxxxx 000
Xxxxxxxxxx, Xxxxxxxx 00000
Dear Xxxxxx,
This letter records the terms on which First Horizon Pharmaceutical Corporation
(formerly Horizon Pharmaceutical Corporation) ("First Horizon") and Inpharmakon
Corporation ("Inpharmakon") have agreed to settle their differences with regard
to certain issues arising out of their Collaboration Agreement made as of
October 31, 1998 ("Collaboration Agreement").
1. First Horizon shall pay to Inpharmakon a total of $200,000 (the "IPO
Payment") within 30 days of the closing of First Horizon's initial
public offering of its shares of Common Stock ("IPO"); provided,
however, that In the event that the IPO has not closed by October 20,
2000, First Horizon shall pay to Inpharmakon one half of the IPO
Payment ($100,000) on October 20, 2000 and provided further, that in
the event that the IPO has not closed by April 20, 2001, First Horizon
shall pay to lnpharmakon the remaining balance of the IPO Payment
($100,000) on April 20, 2001. For the purposes of this paragraph
"closing" of the IPO refers to the date on which First Horizon's
underwriters fund the purchase of IPO shares from First Horizon. The
IPO is a firm commitment underwriting.
2. Secondly the Collaboration Agreement is amended to provide for the
following:
a. First Horizon shall pay to Inpharmakon a total of $200,000, in
place of the $100,000 payment required by Section 4.01(ii) of
the Collaboration Agreement, such payment to be made on the
earlier to occur of (i) within 30 days after the filing of the
NDA for the Product for the Indication by First Horizon, and
(ii) December 31, 2001.
b. First Horizon shall pay to Inpharmakon a total of $500,000 in
place of the payment of $400,000 required by Section 4.01
(iii) of the Collaboration Agreement, within 30 days after
approval of such NDA.
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3. Subsections 8.04(iii) and (iv) of the Collaboration Agreement are
deleted.
4. In order to avoid future misunderstandings and to xxxxxx a closer
spirit of collaboration, First Horizon will designate Xx. Xxxxx Xxxxxx,
or such other individual as First Horizon may designate from time to
time as Project Liaison between Inpharmakon and First Horizon and as
the individual to whom Inpharmakon may direct all questions and
inquiries regarding the development of, and FDA registration activities
concerning, the Product. In addition First Horizon agrees to provide
Inpharmakon with detailed written quarterly reports to be delivered to
Inpharmakon within 30 days after the end of each quarter during the
term of the Collaboration Agreement, such reports to include but not be
limited to a reasonable explanation of the progress of and any changes
in Horizon's regulatory strategies for the Product. In addition to the
foregoing and as part of its undertaking hereunder, First Horizon will
provide Inpharmakon with (a) at the same time as the FDA, the summary
sections of any IND, New Drug Application (whether full, partial or
abbreviated) and amendments thereto, excluding attachments, filed for
the Product with the FDA until such time as the FDA has approved the
NDA, and (b) copies of all other written communications to or from the
FDA concerning the Product, including but not limited to
correspondence, filings, minutes of meetings, briefing documents,
responses to and from the FDA, and supporting documentation whether in
printed or electronic form. First Horizon agrees to make available to
Inpharmakon knowledgeable personnel with the knowledge and authority to
discuss all such activities and to give Inpharmakon access in Horizon's
offices, at no cost to First Horizon, to the attachments to Horizon's
filings for the Product with the FDA on not less than 48 hours notice
to Horizon.
5. Provided that First Horizon makes the payments in accordance with the
provisions of the above Paragraphs 1 and 2, each of Inpharmakon and
First Horizon shall and does hereby remise, release and forever
discharge and, by these presents, does, for itself, its directors,
officers, agents, successors, assigns, employees and representatives
and each of them, release and forever discharge the other party and its
directors, officers, agents, successors, assigns employees and
representatives, and each of them. from and against all manner of
actions, complaints, causes of action, claims, suits, debts, breaches,
sums of money, accounts, reckonings, contracts, torts, controversies,
agreements, promises, damages, judgments, executions, claims and
demands whatsoever in law or in equity arising out of, directly or
indirectly, any matter. transaction, representation, event or thing
from the first day in time to and including the date of this letter,
including, but without limitation, any and all previously unreleased
and/or unfulfilled obligations of either party arising under or
pursuant to the Collaboration Agreement.
6. As a material inducement to Inpharmakon agreeing to the terms and
conditions of this Letter, First Horizon hereby represents and warrants
to Inpharmakon that (a) the only formulation for the Product that it is
now being developed is for the Indication; (b) it will promptly inform
Horizon in the event it abandons such formulation or does or causes
others to do any work on any other formulation for the Product, (c) it
has provided Inpharmakon with true copies of all written communications
through the date of this letter
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to or from the FDA concerning the Product, including but not limited to
correspondence, filings, minutes of meetings, briefing documents,
responses to and from the FDA, and supporting documentation whether in
printed or electronic form; (d) the attached amendment to the Product
Development and Supply Agreement entered into as of March 25, 1999 by
and between Penwest Pharmaceuticals Co. (Penwest") and First Horizon
(the "Penwest Agreement") is a true and correct copy of an amendment to
the Penwest Agreement executed by the parties thereto on May 3, 2000,
which amendment is in full force and effect, and (a) it will not
further amend the assignment provisions of the Penwest Agreement
without Inpharmakon's prior written consent which consent will not be
unreasonably withheld.
7. In the event of a material breach or material default by First Horizon
under the representations and warranties contained in Paragraph 6
above, Inpharmakon may give notice of termination to First Horizon
specifying the breach or default, in which event the Collaboration
Agreement shall terminate immediately if the breach or default is not
capable of cure, or, if the breach or default is capable of cure, after
30 days unless First Horizon cures the breach or default within the 30
period. In the event that the Collaboration Agreement is terminated
pursuant to Inpharmakon's notice hereunder, Inpharmakon shall have the
exclusive right to proceed with a NDA for the Product for the
Indication using the Formulation and the data from the Clinical Trials
as has been acquired or developed by Horizon at the date of
termination, and shall have the right to assume Horizon's rights to the
same and the NDA, 9 applicable, without cost to Inpharmakon or
Inpharmakon Affiliates. In that event Horizon shall release to
Inpharmakon its rights to the Opportunity Package, the Formulation, the
related not publicly available information provided by Inpharmakon or
developed by or for Horizon, and registration data related to the NDA
for the Product for the Indication.
8. In the event that First Horizon grants Penwest a sublicense under the
provisions of Section 11.4 of the Penwest Agreement or otherwise to the
Horizon Test and Regulatory Data (as defined in the Penwest Agreement),
Horizon agrees to pay to Inpharmakon the royalties provided under the
provisions of Section 4.02 of the Collaboration Agreement whether or
not the Collaboration Agreement is still in force provided that the
Collaboration Agreement is not terminated by First Horizon under
Section 8.02 of the Collaboration Agreement in which case the right to
such royalties would terminate with the Collaboration Agreement.
9. Defined terms used in this letter have the same meaning as they have in
the Collaboration Agreement.
10. All other provisions of the Collaboration Agreement will continue in
full force and effect except to the extent changed by the provisions of
this letter.
11. The parties agree to execute a formal amendment to the Collaboration
Agreement within 30 days of the date of this letter incorporating the
above provisions into the Collaboration Agreement. At such time as that
amendment has been executed and exchanged by the parties, the amendment
will replace the agreement contained in this letter.
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12. This letter agreement may be executed in one or more counterparts, each
of which shall be an original, but all of which taken together shall
constitute one and the same agreement,
If the above terms and conditions accurately record our agreement,
please sign and return the acknowledgment at the foot of this letter.
Sincerely,
AGREED AND ACCEPTED
Inpharmakon Corporation
Xxxxxxx X. Xxxxxxxx
Controller
Xxxxxx X. Xxxxxxx
President
cc: Xxxxxxxxxxx X. Xxxxxxx (Xxxxx, Xxxxxx, XxxXxx & Xxxxxxxxxx)
Xxxxxxx X. Xxxx (Business Counsel)
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