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EXHIBIT 10.21
CONFIDENTIAL TREATMENT REQUESTED
Confidential Portions Of This Agreement Which Have Been Redacted Are Marked With
Brackets ("[****]"). The Omitted Material Has Been Filed Separately With
The Securities And Exchange Commission.
Amendment to Collaboration Agreement
May 3, 2000
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
President
Inpharmakon Corporation
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Dear ▇▇▇▇▇▇,
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 Inpharmakon 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 additional compensation:
a. First Horizon shall pay to Inpharmakon a total of $[****], in place of
the $[****] 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 $[****], in place of
the payment of $[****] required by Section 4.01(iii) of the
Collaboration Agreement, within 30 days after the approval of such
NDA.
3. Subsections 8.04(iii) and (iv) of the Collaboration Agreement are deleted.
4. In order to avoid future misunderstandings and to ▇▇▇▇▇▇ a closer spirit of
collaboration, First Horizon will designate ▇▇. ▇▇▇▇▇ ▇▇▇▇▇▇, or such other
individual as First Horizon may designate
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from time to time as Project Liaison between Inpharmakon and First Horizon
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 communications through the date of
this letter to or from the FDA concerning the Product, (c) it has provided
Inpharmakon with true copies of all written communications through the date
of this letter 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 (e) 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 day 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
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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, if
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.
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 acknowledgement at the foot of this letter.
Sincerely,
AGREED & ACCEPTED
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ Inpharmakon Corporation
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Controller
/s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
President
cc. ▇▇▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ (▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇▇▇)
▇▇▇▇▇▇▇ ▇. ▇▇▇▇ (Business Counsel)